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VAERS ID: 846792 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-17
Onset:2019-10-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER P100124184 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CASSIA SENNA; BISOPROLOL; FORTISIP; NIQUITIN [NICOTINE POLACRILEX]; MACROGOL; LANSOPRAZOLE; LACTULOSE; BUPRENORPHINE; GLYCERYL TRINITRATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Chest infection; Fluid intake reduced; Frailty (severe); Markedly reduced food intake; Respiratory disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201905978

Write-up: Death unexplained; This is a spontaneous case reported by other health professional to regulatory authority (Authority Number: GB-MHRA-EYC 00210749) and initially retrieved on 08-Nov-2019, concerning a 98-year-old female patient. The patient medical history includes respiratory disorder, frailty, chest infection, fluid intake reduced, markedly reduced food intake and cardiac disorder. The patient concomitant medications included Fortisip (carbohydrates nos, fats nos, minerals nos, protein, vitamins nos), lactulose, Niquitin (nicotine resinate), nutritional supplement nos, Cassia (senna), lansoprazole, macrogol, buprenorphine, glyceryl trinitrate and bisoprolol. On unspecified date in Jul-2019, may not be directly related to her frail and elderly, the patient end of life (EOL) meds were initiated (as reported). On 17-Oct-2019, the patient was administered Flucelvax Tetra [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, batch number: P100124184, anatomical location and expiration date: not reported] for flu vaccination. On 20-Oct-2019, the patient died. It was unknown whether autopsy was performed. The case was assessed as serious. The reporter did not provide causality assessment to Flucelvax Tetra. Company comment: The event is considered as related to Flucelvax Tetra.; Sender''s Comments: The event is considered as related to Flucelvax Tetra.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 846820 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adenovirus test, Apoptosis, Autopsy, Bed sharing, Brain oedema, Bronchitis, C-reactive protein normal, Cardio-respiratory arrest, Cough, Coxsackie virus test, Death, Haemophagocytic lymphohistiocytosis, Imaging procedure abnormal, Immunisation reaction, Influenza A virus test negative, Influenza B virus test, Influenza like illness, Influenza virus test negative, Interstitial lung disease, Laboratory test, Lymphadenopathy, Nasopharyngitis, Procalcitonin, Pulmonary congestion, Pulmonary oedema, Rhinorrhoea, Rotavirus test negative, Sneezing, Splenic infection, Splenitis, Splenomegaly, Streptococcus test negative, Sudden infant death syndrome, Tracheitis, Tryptase, Viral test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ad; Test Result: Negative ; Test Name: Autopsy findings; Result Unstructured Data: Main autopsy findings were as follows: Development was consistent with the patient''s age. No notable injury, critical disease or malformation was observed. Numerous ecchymoses were noted on the thymus gland and lung surface. Blood clotting in the heart was present. On the cut surface of lung, white turbidity around bronchi was seen. Summary of autopsy findings was as follows: Cold-like symptoms before death and marked splenomegaly and swollen lymph nodes on the autopsy suggested some infection; however, only mild tracheitis/bronchitis was found histologically. Neutrophil infiltration in spleen (acute splenitis/infected spleen) and haemophagocytosis imaing by macrophage in spleen, liver and lymph nodes were observed. Numerous instances of lymphocyte shedding/apoptosis imaging and abundant nuclear debris were found in the lymphoid tissue of the whole body, such as the lymph nodes, white pulp of the spleen, gut-associated lymphoid tissue, and BALT.; Test Name: Main histological findings; Result Unstructured Data: Main histological findings were as follows: Acute tracheitis/bronchitis, pulmonary congestion and oedema, leukomalacia in the cerebral cortex, acute splenitis (splenic infection), haemophagocytosis imaging, and lymphocyte shedding and apoptosis imaging in the lymph nodes and bronchus-associated lymphoid tissue (BALT).; Test Name: Severe pulmonary congestion; Result Unstructured Data: 91g/106g; Test Name: Spleen enlarged; Test Result: 27 g; Test Name: GAS; Test Result: Negative ; Test Name: Serum viral antibody level: Coxsackievirus group B type 3; Result Unstructured Data: 4-fold; Test Name: Serum viral antibody level: Coxsackievirus group B type 4; Result Unstructured Data: 8-fold; Test Name: CRP; Test Result: 0.45 {DF}; Test Name: hMP; Test Result: Negative ; Test Name: FluA; Test Result: Negative ; Test Name: FluB; Test Result: Negative ; Test Name: Serum IL-6; Test Result: 52.8 {DF}; Test Name: PCT; Result Unstructured Data: less than 0.02 ng/mL; Test Name: RS; Test Result: Negative ; Test Name: Rota; Test Result: Negative ; Test Name: Tryptase; Test Result: 5.8 {DF}
CDC Split Type: JPSA2018SA068932

Write-up: Sudden death/found dead while sleeping; Suspected abnormal immunisation reaction; Mild cold-like symptoms; severe interstitial pneumonia; Acute tracheitis/bronchitis; Acute tracheitis/bronchitis; Pulmonary congestion and oedema; Pulmonary congestion and oedema; Brain oedema; Acute splenitis; Haemophagocytosis imaging; Apoptosis imaging; Splenic infection; splenomegaly; severe interstitial pneumonia with neck and peritoneal lymph node swelling; Nasal discharge; Cough; Sneezing; Initial information received on 07-Mar-2018 regarding an unsolicited valid serious case issued from the literature articles: This case was issued in publication in which another related case was reported: 2018SA068930 (Cluster). This case involves a 3 months old male patient who experienced sudden death/found dead while sleeping, suspected abnormal immunisation reaction, mild cold-like symptoms, severe interstitial pneumonia, acute tracheitis/bronchitis, pulmonary congestion and oedema, brain oedema, acute splenitis, haemophagocytosis imaging, apoptosis imaging and splenic infection, while he received vaccine HIB (PRP/T) VACCINE [ActHIB] and while treated with DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE;TETANUS VACCINE, PNEUMOCOCCAL VACCINE CONJ, HEPATITIS B VACCINE and ROTAVIRUS VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (3 days before death), the patient simultaneously received ActHIB (2nd dose, unknown dosage), PNEUMOCOCCAL VACCINE (2nd dose, unknown dosage), HEPATITIS B VACCINE (2nd dose, unknown dosage), ROTAVIRUS VACCINE (2nd dose, unknown dosage) and SQUAREKIDS (1st dose, unknown dosage) as prophylactic vaccination. After the vaccination, the patient was noted to have mild cold-like symptoms such as sneezing, cough and nasal discharge. As having no pyrexia, the patient was followed at home. On an unknown date, 3 days after the vaccination, the patient was found dead (sudden death) while sleeping: the patient was sleeping with his parents on the same bed and was found lying on the left side and not breathing. The ambulance was called. Upon arrival of the ambulance and in the hospital, the patient was already in cardiopulmonary arrest. Subsequently, the patient had no return of spontaneous circulation and confirmed to die. The patient was found to have acute deterioration while sleeping, and the death situation was similar to those of general SIDS cases. On an unknown date, autopsy findings included severe interstitial pneumonia with neck and peritoneal lymph node swelling and splenomegaly. Acute tracheitis/bronchitis, pulmonary congestion and oedema, brain oedema, acute splenitis (splenic infection) and haemophagocytosis imaging were noted. Abnormal immunisation reaction was suspected. Apoptosis imaging was noted. Main autopsy findings were as follows: Development was consistent with the patient''s age. No notable injury, critical disease or malformation was observed. Numerous ecchymoses were noted on the thymus gland and lung surface. Blood clotting in the heart was present. On the cut surface of lung, white turbidity around bronchi was seen. Severe pulmonary congestion (91 g/106 g) and enlarged spleen (27 g) were observed. Main histological findings were as follows: Acute tracheitis/bronchitis, pulmonary congestion and oedema, leukomalacia in the cerebral cortex, acute splenitis (splenic infection), haemophagocytosis imaging, and lymphocyte shedding and apoptosis imaging in the lymph nodes and bronchus-associated lymphoid tissue (BALT). Summary of autopsy findings was as follows: Cold-like symptoms before death and marked splenomegaly and swollen lymph nodes on the autopsy suggested some infection; however, only mild tracheitis/bronchitis was found histologically. Neutrophil infiltration in spleen (acute splenitis/infected spleen) and haemophagocytosis imaing by macrophage in spleen, liver and lymph nodes were observed. Numerous instances of lymphocyte shedding/apoptosis imaging and abundant nuclear debris were found in the lymphoid tissue of the whole body, such as the lymph nodes, white pulp of the spleen, gut-associated lymphoid tissue, and BALT. The patient developed a serious sudden death/found dead while sleeping (sudden death). This event was assessed as medically significant and was leading to death. The patient developed a serious suspected abnormal immunisation reaction (immunisation reaction). This event was leading to death. The patient developed a serious mild cold-like symptoms (nasopharyngitis). This event was leading to death. The patient developed a serious severe interstitial pneumonia (interstitial lung disease). This event was assessed as medically significant and was leading to death. The patient developed a serious acute tracheitis/bronchitis (bronchitis). This event was leading to death. The patient developed a serious acute tracheitis/bronchitis (tracheitis). This event was leading to death. The patient developed a serious pulmonary congestion and oedema (pulmonary congestion). This event was assessed as medically significant and was leading to death. The patient developed a serious pulmonary congestion and oedema (pulmonary oedema). This event was assessed as medically significant and was leading to death. The patient developed a serious brain oedema. This event was assessed as medically significant and was leading to death. The patient developed a serious acute splenitis (splenitis). This event was leading to death. The patient developed a serious haemophagocytosis imaging (haemophagocytic lymphohistiocytosis). This event was assessed as medically significant and was leading to death. The patient developed a serious apoptosis imaging (apoptosis). This event was leading to death. The patient developed a serious splenic infection. This event was assessed as medically significant and was leading to death. The patient developed a serious splenomegaly. This event was leading to death. The patient developed a serious severe interstitial pneumonia with neck and peritoneal lymph node swelling (lymphadenopathy). This event was assessed as medically significant and was leading to death. The patient developed a serious nasal discharge (rhinorrhoea). This event was leading to death. The patient developed a serious cough. This event was leading to death. The patient developed a serious sneezing. This event was leading to death. Relevant laboratory test results included: Adenovirus test - On an unknown date: Negative Autopsy - On an unknown date: [Main autopsy findings were as follows: Development was consistent with the patient''s age. No notable injury, critical disease or malformation was observed. Numerous ecchymoses were noted on the thymus gland and lung surface. Blood clotting in the heart was present. On the cut surface of lung, white turbidity around bronchi was seen. Summary of autopsy findings was as follows: Cold-like symptoms before death and marked splenomegaly and swollen lymph nodes on the autopsy suggested some infection; however, only mild tracheitis/bronchitis was found histologically. Neutrophil infiltration in spleen (acute splenitis/infected spleen) and haemophagocytosis imaing by macrophage in spleen, liver and lymph nodes were observed. Numerous instances of lymphocyte shedding/apoptosis imaging and abundant nuclear debris were found in the lymphoid tissue of the whole body, such as the lymph nodes, white pulp of the spleen, gut-associated lymphoid tissue, and BALT.]; on an unknown date: [Main histological findings were as follows: Acute tracheitis/bronchitis, pulmonary congestion and oedema, leukomalacia in the cerebral cortex, acute splenitis (splenic infection), haemophagocytosis imaging, and lymphocyte shedding and apoptosis imaging in the lymph nodes and bronchus-associated lymphoid tissue (BALT).]; on an unknown date: [91g/106g]; on an unknown date: 27 g Beta haemolytic streptococcal infection - On an unknown date: Negative C-reactive protein - On an unknown date: 0.45 mg/dL Coxsackie virus test - On an unknown date: [4-fold]; on an unknown date: [8-fold] Human metapneumovirus test - On an unknown date: Negative Influenza A virus test - On an unknown date: Negative Influenza B virus test - On an unknown date: Negative Interleukin level - On an unknown date: 52.8 pg/mL Procalcitonin - On an unknown date: [less than 0.02 ng/mL] Respiratory syncytial virus test - On an unknown date: Negative Rotavirus test - On an unknown date: Negative Tryptase - On an unknown date: 5.8 ug/L Final diagnosis was (fatal) splenic infection, (fatal) apoptosis imaging, (fatal) haemophagocytosis imaging, (fatal) acute splenitis, (fatal) brain oedema, (fatal) pulmonary congestion and oedema, (fatal) acute tracheitis/bronchitis, (fatal) severe interstitial pneumonia, (fatal) mild cold-like symptoms, (fatal) suspected abnormal immunisation reaction and (fatal) sudden death/found dead while sleeping. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for sudden death/found dead while sleeping, as Fatal on an unknown date for mild cold-like symptoms, as Fatal on an unknown date for severe interstitial pneumonia, as Fatal on an unknown date for severe interstitial pneumonia with neck and peritoneal lymph node swelling, as Fatal on an unknown date for splenomegaly, as Fatal on an unknown date for cough, as Fatal on an unknown date for nasal discharge, as Fatal on an unknown date for acute tracheitis/bronchitis, as Fatal on an unknown date for acute tracheitis/bronchitis, as Fatal on an unknown date for pulmonary congestion and oedema, as Fatal on an unknown date for pulmonary congestion and oedema, as Fatal on an unknown date for brain oedema, as Fatal on an unknown date for acute splenitis, as Fatal on an unknown date for haemophagocytosis imaging, as Fatal on an unknown date for suspected abnormal immunisation reaction, as Fatal on an unknown date for sneezing, as Fatal on an unknown date for apoptosis imaging and as Fatal on an unknown date for splenic infection. An autopsy was done. The cause of death was reported as Sudden death, Nasopharyngitis, Interstitial lung disease, Tracheitis, Bronchitis, Pulmonary congestion, Pulmonary oedema, Splenitis, Brain oedema, Haemophagocytic lymphohistiocytosis, Immunisation reaction, Apoptosis and Splenic infection. Reporter comment: Regarding all events: The patient was suspected to have some infection as having cold-like symptoms before death and marked splenomegaly and lymph node swelling at autopsy. It was assumed that the infection triggered an abnormal immunological reaction, which induced hypercytokinemia. In an infant with some predisposition for immune abnormality, cellular immunity can be induced by vaccination and trigger abnormal immunisation reaction, which might led to an abrupt change in the course followed by sudden death. The action mechanism of 2 kinds of inactive vaccines affecting the infant death is unknown, and the simultaneous onset with vaccination cannot be denied. Thus, the causality between SID and vaccines are concluded as unknown, but needs to be suspected. The disorders developing after the multiple vaccinations on the second immunization can be anaphylaxis. Common features such as splenitis and hemophagocytosis were also evident. The uncontrollable immune overreaction mainly caused by the activated lymphocytes and histiocyte/macrophages might have led to hemophagocytic lymphohistiocytosis, which is clinically similar to macrophage activation syndrome. The finding of apoptosis in the lymphoid tissue of the whole body was considered to demonstrate abnormal immunological reaction. Follow-up information received from the forensic medicine specialist on 20-Mar-2018. It was reported that the continuation of the investigation was impossible as the patient was unable to be identified. Additional information was received on 31-Oct-2019 from the physician: Updated information in the fields of general, patient, products, events and analysis.; Sender''s Comments: Followup received on 20-MAR-2018 does not change the previous assessment. This case concerns a literature article in which a 3 month old infant died in sleep 3 days after vaccination (Act-HIB and pneumococcal, hepatitis B, DPT-IPV and rotavirus vaccines) . The infant had mild Flu like symptoms. Autopsy results indicated severe interstitial pneumonia with lymph node swelling and splenomegaly which indicate towards an underlying infection. However, the age and clinical details correspond closely with the general Sudden Infant Death Syndrome (SIDS) cases. Further information regarding patient medical history, details regarding whether it was a premature birth or not, recent infectious history especially upper respiratory, allergic history, past vaccination history and its tolerance are needed to further assess the case. Moreover, multiple vaccinations preceded the event. Based upon the reported information, the role of the vaccines cannot be assessed individually. JP-SA-2018SA068930:CLUSTER; Reported Cause(s) of Death: Sudden death/found dead while sleeping; Mild cold-like symptoms; Severe interstitial pneumonia; Acute tracheitis/bronchitis; Acute tracheitis/bronchitis; Pulmonary congestion and oedema; Pulmonary congestion and oedema; Acute splenitis; Brain oedema;


VAERS ID: 846868 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2019SA311790

Write-up: a patient died after receiving the product MENINGOCOCCAL VACCINE; Initial information received on 07-Nov-2019 regarding an unsolicited valid serious death case received from a consumer/non-hcp. This case involves a patient who was died after receiving the product meningococcal vaccine MENINGOCOCCAL VACCINE (death NOS). The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died after receiving the product meningococcal vaccine (death) (Unknown latency) following the administration of MENINGOCOCCAL VACCINE. This event was assessed as medically significant and was leading to death. The reporter couldn''t inform which vaccine was used. Lab data was not reported. Final diagnosis was Death NOS. It was not reported if the patient received a corrective treatment. The patient outcome was reported as fatal. It is unknown if an autopsy was done. The cause of death was reported as Death. Information on batch number is requested.; Sender''s Comments: This case concerns a patient who died after the vaccination with MENINGOCOCCAL VACCINE (unknown manufacturer). The time to onset is unknown. The patient''s past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS


VAERS ID: 847211 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-16
Onset:2019-10-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine; ASS; Vigantoletten; NORSPAN; PIPAMPERON; TAVOR (NOS); BISOPROLOL
Current Illness: Arthrosis multiple; Coronary heart disease; Dementia; Hypertonus; Osteoporosis; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019EM

Write-up: patient died; This case was reported by a physician via other manufacturer and described the occurrence of unknown cause of death in a 88-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) for prophylaxis. Concurrent medical conditions included hypertonus, coronary heart disease, osteoporosis, dementia, arthrosis multiple and pain. Concomitant products included thyroxine sodium (Thyroxine), acetylsalicylic acid (ASS), ergocalciferol (Vigantoletten), buprenorphine (Norspan), pipamperone hydrochloride (Pipamperon), ambiguous medication nos (Tavor (Nos)) and bisoprolol. On 16th October 2019, the patient received Influsplit Tetra 2019/2020. On 19th October 2019, 3 days after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The patient was treated with dipyrone (Novaminsulfon). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 19th October 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influsplit Tetra 2019/2020. Additional details were provided as follows: The age at vaccination was not reported but it could be 87 years or 88 years. The patient also received Alendronsr as concomitant medication. The reporter stated, there was an increased occurrence of death cases in an old people''s home with timely relatedness with a Tetravalent Influenza Vaccination With Influsplit tetra. The patient was vaccinated with the tetravalent vaccine Infulsplit, batch number was provided via telephone on the 25th October 2019 (but was not mentioned in the source document). As per reporter, there was no causality suspected and this cases had no causal relatedness between the vaccination and the death of the patient. Neither Symptoms like allergic reactions nor symptoms like febrile infections occurred. The reporter asked about information regarding similar reports from other medical practices. The reporter provided more information about the incident. In the timeframe of 4th October 2019 to 25th October 2019, total 5 patients were died in an old people''s home of 74 vaccinated patients. The vaccinations took place from 15th October 2019 to 17th October 2019. The reporter further added, as per their experience, outstandingly more patients of a retirement home died in the 4. Quartal as in the other Quartals. In the 4. Quartal of 2018, 8 out of 92 patients were died in the retirement home where the reporter was taking care. The amount of 5 patients who died out of totally 82 patients from the retirement home during 2 weeks after the vaccination was although exceptional. The death was not predictable at 4 out of the deceased patients. This is 1 of 5 cases reported by the same reporter.; Reported Cause(s) of Death: Death NOS


VAERS ID: 847333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-01-01
Submitted: 0000-00-00
Entered: 2019-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Drug ineffective, Malaise, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FISA2019SA313247

Write-up: the patient received influenza vaccine, but it did not have effect on her, the vaccination did not work; Patient died due to Pneumonia; sick; Initial information received on 08-Nov-2019 regarding an unsolicited valid serious social media case received from a consumer/non healthcare professional (patient''s related) through a Company social media site. This case is linked to case 2019SA313244 via same reporter. This case involves a female patient of (age not reported) who was sick and died due to pneumonia (Pneumonia) while she received vaccine INFLUENZA VACCINE [INFLUENZA VACCINE]. No information regarding medical history past vaccinations, treatments or concomitant drug was reported. In 2017, the patient received a dose of suspect INFLUENZA VACCINE [INFLUENZA VACCINE] produced by unknown manufacturer, lot number and expiry date not reported via unknown route. in 2017, the patient was sick (malaise) (unknown latency) following administration of the vaccine. On Jan-2018, the patient died due to pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. It was a case of drug ineffective. Reportedly, the patient received [influenza] vaccination in 2017, but it did not have effect on her. She was sick and did not recover. She slept away [died] due to pneumonia in the beginning of Jan-2018. It was reported that the vaccination did not work. Other relevant tests included Details of lab data not reported. Final diagnosis was (fatal) Sickness and (fatal) patient died due to pneumonia. It was not reported if the patient received a corrective treatment. The outcome was reported as not recovered for sick and Fatal for patient died due to pneumonia (patient died in Jan-2018). It is unknown if an autopsy was done. The cause of death was reported as Pneumonia. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a female patient (unreported age) who died due to pneumonia with symptom of malaise after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, patient''s medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.; Reported Cause(s) of Death: died due to pneumonia


VAERS ID: 847443 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-17
Onset:2019-10-01
Submitted: 0000-00-00
Entered: 2019-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER R030373 / UNK RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial ischaemia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; BRALTUS
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131911GBR004325

Write-up: Ischaemic heart disease; This spontaneous report was received from a practice manager referring to a 64-year-old male patient. The patient''s medical history included chronic obstructive pulmonary disease (COPD) (considered a concurrent condition). Her concomitant therapies included albuterol and braltus. On 17-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) intramuscular in the right deltoid for prophylaxis (strength and dose were not reported, lot number R030373 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 31-AUG-2020 ). On 18-OCT-2019, was reported the patient had a sudden death. The family said he was fit and well prior to vaccination and the nurse established that he was well enough to have the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOCOCCAL POLYSACCHRIDE VACCINE) vaccination on the day. The patient was given the polyvalent (23-valent) (manufacturer unknown) as he had COPD and was also offered the flu vaccine but decided to have it another day as he was going away. The coroner''s report suggested ischaemic heart disease as cause of death. It was not reported if autopsy was performed. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) administration and the aforementioned event was not reported.; Reported Cause(s) of Death: Ischaemic heart disease


VAERS ID: 847756 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-05
Onset:2019-01-01
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aspiration, Death, Pneumonia, Pneumonia aspiration, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131911JPN000838J

Write-up: Acute pneumonia; Pneumonia aspiration; Information has been received from a physician concerning a 74-year-old male patient, who on 05-OCT-2018 was firstly subcutaneously vaccinated pneumococcal vaccine, polyvalent (23-valent) injection (PNEUMOVAX NP) 0.5 ml for prophylaxis (Lot number not reported). No concomitant medication was reported. On an unknown date (after vaccination of pneumococcal vaccine, polyvalent (23-valent)), cough continued. On 04-JAN-2019, the patient was hospitalized for acute pneumonia. In January 2019(after that), the patient developed aspiration after massive vomiting. As a result, it caused pneumonia aspiration. On 08-JAN-2019, the patient died due to acute pneumonia and pneumonia aspiration. Whether autopsy was performed or not was unknown. Reporter''s comment: the family said that the patient died of pneumonia which was caused by pneumococcal vaccine, polyvalent (23-valent), but it was denied. The reporting physician felt that acute pneumonia and pneumonia aspiration were not related to pneumococcal vaccine, polyvalent (23-valent). Upon internal review, acute pneumonia and pneumonia aspiration were determined to be medically significant. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported events of pneumonia and pneumonia aspiration are considered unlikely related to Pneumovax vaccine. The evidence is not sufficient to suggest a relationship between Pneumovax vaccine and the reported serious adverse events. Massive vomiting constitutes a more plausible alternative explanation for the event of pneumonia aspiration. In regards pneumonia event causality assessment is impacted by the confounding facto of patient elder age. The causality assessment is further impacted by event onset more than 11 weeks since last recorded dose of Pneumovax vaccine. Company Comment- No changes to Pneumovax vaccine safety information are warranted at this time. Merck and Co., Inc., known as MSD, continues to monitor the safety profile of Pneumovax vaccine.; Reported Cause(s) of Death: Pneumonia aspiration; Acute pneumonia


VAERS ID: 847758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-23
Onset:2013-02-22
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J4163-1 / UNK - / OT
HEP: HEP B (FOREIGN) / MERCK & CO. INC. UFA 12001 / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H018176 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Aversion, Biopsy kidney abnormal, Bradycardia, Cardiopulmonary failure, Circulatory collapse, Congestive cardiomyopathy, Decreased appetite, Echocardiogram, Ejection fraction, Ejection fraction decreased, Gastrointestinal disorder, Hypertension, Hypotension, Liver function test increased, Metabolic acidosis, Oliguria, Poor sucking reflex, Pyrexia, Swelling, Tachycardia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Neonatal disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-24
   Days after onset: 60
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BCG VACCINE USP PUNCTURE DEVICE
Current Illness: Prophylactic vaccination; Tuberculosis bladder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiogram; Test Result: 21 %
CDC Split Type: PL0095075131911POL003408

Write-up: swelling; hypertension; EF was between 26-22 percent; metabolic acidosis; arrhythmias; bradycardia; oliguria; tachycardia; decreased appetite; hypotension; gastrointestinal disorders/digestive disorders; vomiting; fever; circulation failure; dilated cardiomyopathy; aversion for sucking; cardio-respiratory failure/respiratory failure; Information has been downloaded from Regulatory Authority (PL-SA-2015SA091685). This spontaneous report was received from a other health professional referring to a 13 month old female patient. The patient''s medical history, concurrent conditions, and concomitant medications were not reported. Tha patient was vaccinated previously with hepatitis b virus vaccine rhbsag (yeast)(EUVAX B) and bcg live(BCG LIVE) on 23-DEC-2012. On 05-FEB-2013, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, frequency, and were unknown) with lot # H018176, expiration date was not reported, but upon internal validation established as 30-JUN-2014, and hepatitis b virus vaccine rhbsag (yeast)(EUVAX B) with lot # UFA 12001 (strength, route, dose, frequency, anatomical location, and expiration date were unknown) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PENTAXIM) with lot # J4163-1 (strength, route, dose, frequency, anatomical location, and expiration date were unknown) and finally with bcg live(BCG LIVE) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) for Prophylactic vaccination. On 22-FEB-2013, the patient experienced cardiopulmonary failure, and on an unknown date the patient experienced a circulatory failure, dilated cardiomyopathy(congestive cardiomyopathy), had an aversion for sucking (Poor sucking reflex), cardio-respiratory failure/respiratory failure (cardio-respiratory failure), swelling, hypertension, Ejection fraction (EF) was between 26-22 percent (ejection fraction decreased), metabolic acidosis, arrhythmias, bradycardia, oliguria, tachycardia, decreased appetite, hypotension, some gastrointestinal disorders/digestive disorders, vomiting, fever and was hospitalized on an unknown date in 2013. It was also reported that some laboratory tests were performed to the patient that included, an Echocardiogram (results were not reported), Liver function tests that was elevated, a Kidney biopsy which result was described as moderately elevated, and and Echocardiogram 21 % on unspecifed dates. The patient died on 24-APR-2013. The cause of death was reported as arrhythmia, decreased appetite, poor sucking reflex, congestive cardiomyopathy, ejection fraction decreased, cardiopulmonary failure, vomiting, tachycardia, swelling, oliguria, metabolic acidosis, hypotension, hypertension, gastrointestinal disorder, pyrexia, circulatory collapse and bradycardia. It was unknown if an autopsy was perforemd. The reporter did not mention the causality assessment between the events and rotavirus vaccine, live, oral, pentavalent(ROTATEQ), hepatitis b virus vaccine rhbsag (yeast)(EUVAX B), hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PENTAXIM) and bcg live(BCG LIVE) vaccination. combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information of availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; evaluationvalue - Patient / Device: N/A / 2993; Reported Cause(s) of Death: Arrhythmia; Bradycardia; Circulatory failure; Fever; Gastrointestinal disorder; Hypertension; Hypotension; Metabolic acidosis; Oliguria; Swelling; Tachycardia; Vomiting; Cardio-respiratory failure; Ejection fraction decreased; Dilated cardiomyopathy;


VAERS ID: 847876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Multiple organ dysfunction syndrome, Streptococcus test positive, Urine analysis abnormal
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PNEUMOVAX; METHOTREXATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Urine analysis; Result Unstructured Data: Test Result: Pneumococcal urinary antigens of unknown serotype
CDC Split Type: FRPFIZER INC2019491005

Write-up: multiorgan failure with pulmonary focus; multiorgan failure with pulmonary focus; urine analysis: pneumococcal urinary antigens of unknown serotype found; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization but prescribed because the patient was under immunosuppressant drugs and followed by an injection of pneumococcal vaccine polysacch 23v (PNEUMOVAX) according to recommendations. The patient medical history was not reported. Concomitant medication included methotrexate (unspecified trade name) in association with corticosteroids and pneumococcal vaccine polysacch 23v. The patient experienced multiorgan failure with pulmonary focus on an unspecified date leading to her death on an unspecified date. The patient underwent lab tests and procedures which included urine analysis: pneumococcal urinary antigens of unknown serotype found. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender''s Comments: The current information is very limited and does not allow a full medically meaningful assessment, especially lack of the following: complete medical history, event onset date, the confirmative workup including serological details and final diagnose. Considering urine analysis indicative of positive pneumococcal urinary antigens of unknown serotype, it might not be fully excluded that lack of effect with PREVENAR 13 and PNEUMOVAX might contribute to multiorgan failure with pulmonary focus which eventually progressed leading to fatal outcome. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: multiorgan failure with pulmonary focus; multiorgan failure with pulmonary focus


VAERS ID: 847920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, H1N1 influenza, Headache, Influenza A virus test, Influenza like illness, Influenza virus test, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: influenza virus A (H1NI), Test Result Unit: unknown
CDC Split Type: MXGLAXOSMITHKLINEMX2019GS

Write-up: Vaccination failure; influenza A (H1NI) infection; Influenza-like symptoms; Fever; Cough; Headache; This case was reported in a literature article and described the occurrence of vaccination failure in a 1-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 57 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), h1n1 influenza (serious criteria death), influenza-like symptoms, fever, cough and headache. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were fatal and the outcome of the influenza-like symptoms, fever, cough and headache were unknown. The reported cause of death was h1n1 influenza and vaccination failure. The reporter considered the vaccination failure, h1n1 influenza, influenza-like symptoms, fever, cough and headache to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 01-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 1 from table 3 reported in this literature article. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, In, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called (System) and was the part of the National System. The main objective of system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 57 days after vaccination, the patient do not had an sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. The patient meets the operational definition of TSI [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the agency, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H1NI) PMD issued by one of the laboratories endorsed by National network of the agency. The patient was diagnosed with the influenza A (H1NI) PMD) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died after 18 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since agency captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: H1N1 influenza; Vaccination failure


VAERS ID: 847921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Headache, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: influenza virus A (H3) positive, Test Result Unit: unknown
CDC Split Type: MXGLAXOSMITHKLINEMX2019GS

Write-up: Vaccination failure; Influenza virus A (H3) infection; Acute respiratory infection; Influenza-like symptoms; Fever; Cough; Headache; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 2-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 93 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza a virus infection (serious criteria death), influenza-like symptoms, fever, cough, headache, acute respiratory tract infection (serious criteria GSK medically significant) and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were fatal and the outcome of the influenza-like symptoms, fever, cough, headache, acute respiratory tract infection and difficulty breathing were unknown. The reported cause of death was influenza a virus infection and vaccination failure. The reporter considered the vaccination failure, influenza a virus infection, influenza-like symptoms, fever, cough, headache, acute respiratory tract infection and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in 2-years-old male patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality.[In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was the part of the National Epidemiological Surveillance System. The main objective of the surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [[The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to 20 of 2018, 93 days after vaccination, the patient had sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea and the patient experienced severe acute respiratory infection (IRAG) along with difficulty breathing (with history of fever greater than or equal to 38 degree Celsius and cough), accompanied by one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient met the operational definition of TSI/ETI and IRAG. [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the National Network of Public Health Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H3) issued by one of the laboratories endorsed by National network of the Public Health Laboratories. The patient was diagnosed with the influenza A (H3) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was unknown. The patient died after 3 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Epidemiological Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza A virus infection; Vaccination failure


VAERS ID: 847922 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: MXGLAXOSMITHKLINEMX2019GS

Write-up: Vaccination failure; Influenza; Fever; Cough; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, more than 2 weeks after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza (serious criteria death), fever and cough. The subject was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the fever and cough were unknown. The reported cause of death was influenza and vaccination failure. The reporter considered the vaccination failure, influenza, fever and cough to be related to Flu vaccine. Additional details were provided as follows: This case was reported in a literature article and described the vaccination failure in an patient of unspecified age and gender who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was the part of the National Epidemiological Surveillance System. The main objective of the surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza. [In this study, the patient. 5 comorbidities of Mellitus diabetes (21), Arterial hypertension (21), Morbid obesity (15), Chronic renal failure (12), Smoking, Immunosuppression (21), COPD (7), Heart disease (7), Asthma (2), Other comorbidity (7), And HIV AIDS (2)]. No information on patient''s medical or family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to 20 of 2018, at least 21 days (average time of immune response induced by vaccination) after vaccination, the patient had an onset of fever greater than or equal to 38 degree celcius and cough. The patient met the one of the operational definition of TSI/ETI or IRAG. [In this study, Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree C, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree C and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who has met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the National Network of Public Health Laboratories, and who in his death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death is subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths. From the epidemiological week 40 of 2010 to 20 of 2018 there were 3089 deaths from influenza, only 65 deaths were reported with a vaccination history with the seasonal vaccine and at least 21 days (average time of immune response induced by vaccination) from vaccination to onset of influenza symptoms. Operational definition (ETI/IRAG) 21% (n = 14) of the 65 deaths did not meet the operational definition of ETI or IRAG despite having a positive final result for influenza. The five deaths in children under five years of age met the operational definition 100%. Of the 32 deaths in the six to 64 year old group, seven (22%) did not meet the operational definition of ETI or IRAG and of the 28 deaths over 65, seven (25%) either. We consider that conditions inherent to the patients determined that 14 deaths did not strictly comply with the operational definition, however, when the clinician suspected, samples were taken, which were positive. In 83% (n = 54) of deaths there was at least one comorbidity, in 29% (n = 19) one, in 26% (n = 17) two, in 18% (n = 12) three, in 8% (n = 5) four and in 1.5% (n = 1) five. [In this study, only 55% of deaths (n = 36) received antiviral treatment, 35 oseltamivir and one zanamivir. Of these, only five had the record of treatment start date; 6% of deaths (n = 4) had registered having started treatment in the first 72 hours after the onset of symptoms; in one case antiviral onset was recorded on day 13 from the onset of symptoms and death was recorded on day 17]. [In this study, In January 2014, the highest number of deaths was recorded, (n = 11). The average number of days from vaccination to the onset of symptoms was 78; 88% (n = 57) of the deaths had a death date record. The average number of days from the onset of symptoms to the date of death was 10.3 (median of 9 and range of 0-37). The majority of deaths (n = 36) were due to subtype A (H1N1); 15 for A (H3), eight for influenza B and two were not subtyped]. The patient had diagnosed with positive result for influenza infection (unknown type) issued by one of the laboratories endorsed by National network of the Public Health Laboratories. On unspecified date, 13 days after the onset of the symptoms, the patient had received antiviral medication. On unspecified date, 17 days after, the onset of the symptoms, the patient died. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. Treatment was unknown. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms, suggests that immunization against seasonal influenza was a profitable strategy, especially when considering group immunity, and that a reduction in disease burden and, therefore, health care costs and sociodemographic costs have been proven. It has been described that the probability that the vaccine was cost-effective to prevent death was 100% and to avoid complications of 96.7%. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. The operational definition of ETI or IRAG was used for epidemiological surveillance purposes and has proven to be sensitive. In practice, the doctor should begin antiviral treatment in the first 48 hours in patients with" cough and fever when it was known that influenza viruses are circulating in the community that was, a case does not meet the operational definition. It was not a reason to delay antiviral treatment. As described in the literature and reported by the Surveillance System, most influenza deaths have at least one comorbidity that aggravates the natural history of the disease. In this study, 83% of the cases presented at least one comorbidity, such as overweight, obesity, diabetes or congestive heart failure, which could trigger a low response of the host''s immune system. Since the 2009 pandemic, obesity was recognized as a risk factor for influenza complications, this was important since in 30% of children, 40% of adolescents and 70% of adults are overweight or obese, Therefore, we face new challenges in disease prevention, since obese adults with a history of vaccination have up to twice the risk of developing influenza due to poor T-cell function. The occurrence of only 10 deaths in patients with immunosuppression in a universe of 3089 deaths also follows an achievement in the country regarding the management of patients living with human immunodeficiency virus infection and adequate compliance with vaccination recommendations in individuals. With immunosuppression. People living with diabetes are more susceptible to getting influenza infection; it had also been documented that cardiovascular diseases associated with influenza can lead to significant hemodynamic compromise that requires cardiac support. It was important for public health to specify the other comorbidities that occurred in these deaths and that the system does not allow clarification to define new risk groups and vaccination strategies. There was strong and consistent evidence that vaccination during pregnancy protects women and their newborns against influenza infection. Not having found deaths in the country of pregnant women with a history of vaccination for the season indicates excellent adherence to the goal of vaccination in any trimester of pregnancy. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza; Vaccination failure


VAERS ID: 847923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, H1N1 influenza, Headache, Influenza A virus test positive, Influenza like illness, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (HINI) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; Influenza A (H1NI) infection; Influenza-like symptoms; Fever; Cough; Headache; This case was reported in a literature article and described the occurrence of vaccination failure in a 38-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 50 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), h1n1 influenza (serious criteria death), influenza-like symptoms, fever, cough and headache. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were fatal and the outcome of the influenza-like symptoms, fever, cough and headache were unknown. The reported cause of death was h1n1 influenza and vaccination failure. The reporter considered the vaccination failure, h1n1 influenza, influenza-like symptoms, fever, cough and headache to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 38-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called surveillance system and was the part of the National Epidemiological Surveillance System. The main objective of surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 50 days after vaccination, the patient do not had an sudden onset of influenza like symptoms (TSI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. The patient meets the operational definition of TSI [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Public Health Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H1NI) PMD issued by one of the laboratories endorsed by Public Health Laboratories. The patient was diagnosed with the influenza A (H1NI) PMD) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died unknown period after symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Epidemiological Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: H1N1 influenza; Vaccination failure


VAERS ID: 847924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, H1N1 influenza, Influenza A virus test positive, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (HINI) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; influenza A (H1NI) PMD infection; Severe acute respiratory infection; Fever; Cough; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 46-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 66 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), h1n1 influenza (serious criteria death), acute respiratory tract infection (serious criteria GSK medically significant), fever, cough and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were fatal and the outcome of the acute respiratory tract infection, fever, cough and difficulty breathing were unknown. The reported cause of death was h1n1 influenza and vaccination failure. The reporter considered the vaccination failure, h1n1 influenza, acute respiratory tract infection, fever, cough and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 46-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 4 from table 3 reported in this literature article. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, In country, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called Surveillance System and was the part of the Surveillance System. The main objective of Surveillance System was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) in country and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 66 days after vaccination, the patient do not had an sudden onset of IRAG such as person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient meets the operational definition of IRAG [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H1NI) PMD issued by one of the laboratories endorsed by Health Laboratories. The patient was diagnosed with the influenza A (H1NI) PMD) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died 2.3 days after symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since Surveillance System captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Program was crucial to protect the country population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: H1N1 influenza; Vaccination failure


VAERS ID: 847925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Headache, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (H3) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; Influenza A (H3) infection; Acute respiratory infection; Influenza-like symptoms; Fever; Cough; Headache; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 51 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza a virus infection (serious criteria death), acute respiratory tract infection (serious criteria GSK medically significant), influenza-like symptoms, fever, cough, headache and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were fatal and the outcome of the acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing were unknown. The reported cause of death was influenza a virus infection and vaccination failure. The reporter considered the vaccination failure, influenza a virus infection, acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in 82-years-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system and was the part of the National Epidemiological Surveillance System. The main objective of surveillance system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 51 days after vaccination, the patient had sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea and the patient also experienced severe acute respiratory infection (IRAG) along with difficulty breathing (with history of fever greater than or equal to 38 degree Celsius and cough), accompanied by one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient met the operational definition of TSI/ETI and IRAG. [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Public Health Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H3) issued by one of the laboratories endorsed by National network of the Public Health Laboratories. The patient was diagnosed with the influenza A (H3) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died after 10 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since surveillance system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Universal Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Epidemiological Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program. This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza A virus infection; Vaccination failure


VAERS ID: 847926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Headache, Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Influenza A (H3) positive, Test Result Unit: unknown
CDC Split Type: MXID BIOMEDICAL CORPORATI

Write-up: Vaccination failure; Influenza A (H3) infection; Acute respiratory infection; Influenza-like symptoms; Fever; Cough; Headache; Difficulty breathing; This case was reported in a literature article and described the occurrence of vaccination failure in a 86-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, 44 days after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza a virus infection (serious criteria death), acute respiratory tract infection (serious criteria GSK medically significant), influenza-like symptoms, fever, cough, headache and difficulty breathing. The subject was treated with oseltamivir. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were fatal and the outcome of the acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing were unknown. The reported cause of death was influenza a virus infection and vaccination failure. The reporter considered the vaccination failure, influenza a virus infection, acute respiratory tract infection, influenza-like symptoms, fever, cough, headache and difficulty breathing to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an 86-year-old female patient who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 6 from table 3 reported in this literature article. The patient was a part of descriptive cross-sectional study that aimed to characterize deaths from influenza with a history of vaccination ratified by the System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality. [In this study, In, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called (System) and was the part of the National System. The main objective of system was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza]. The patient had no comorbidities. The patient''s occupation was reported as home. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza seasonal vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to week 20 of 2018, 44 days after vaccination, the patient had sudden onset of influenza like symptoms (TSI/ETI) such as fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea and the patient also experienced severe acute respiratory infection (IRAG) along with difficulty breathing (with history of fever greater than or equal to 38 degree Celsius and cough), accompanied by one or more of the following symptoms: attack to the general state, chest pain or polypnea. The patient met the operational definition of TSI/ETI and IRAG. [In this study, epidemiological influenza surveillance includes the definitions: Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree celcius, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree celcius and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who had met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Laboratories, and who in patient''s death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the System of Deaths]. The patient had diagnosed with positive result for influenza virus A (H3) issued by one of the laboratories endorsed by Laboratories. The patient was diagnosed with the influenza A (H3) infection. The patient had received antiviral therapy with oseltamivir, but the starting date of treatment was ignored. The patient died after 4 days of symptoms onset. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. The authors commented "Since system captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program.?? This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza A virus infection; Vaccination failure


VAERS ID: 847927 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: MXIDBIOMEDICALCORPORATION

Write-up: Vaccination failure; Influenza; Fever; Cough; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, more than 2 weeks after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza (serious criteria death), fever and cough. On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the fever and cough were unknown. The reported cause of death was influenza and vaccination failure. The reporter considered the vaccination failure, influenza, fever and cough to be related to Flu vaccine. Additional details provided as follows: This case was reported in a literature article and described the vaccination failure in an patient unspecified age and gender who was vaccinated with unspecified influenza seasonal vaccine (manufacturer unknown) for prophylaxis. This case corresponds to comorbidities section reported in this literature article. The patient was a part of descriptive cross-sectional study that that aimed to characterize deaths from influenza with a history of vaccination ratified by the Epidemiological and Statistical System of Deaths for the 2010-2011 to 2017-2018 seasons. Also aimed to check the effectiveness of vaccination that prevents the occurrence of serious cases and reduces mortality.[In this study, epidemiological surveillance of influenza was conventional and sentinel, according to the standards recommended by the World Health Organization. The special surveillance system was called Epidemiological Surveillance System and was the part of the Epidemiological Surveillance System. The main objective of System was to monitor the type of etiologic agent that circulates and produces severe acute respiratory infection (ARI) and identify new cases of respiratory disease associated with the presence of new agents or the increase in seasonal influenza. [In this study, the patient had an ]. The patient had an 5 comorbidities of Mellitus diabetes (21), Arterial hypertension (21), Morbid obesity (15), Chronic renal failure (12),Smoking, Immunosuppression (21), COPD (7), Heart disease (7), Asthma (2), Other comorbidity (7), And HIV AIDS (2)]. The patient had 5 comorbidities which were unspecified. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 2010 and 2018, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [The age of vaccination was not provided. On an unspecified date between week 40 of 2010 to 20 of 2018, at least 21 days (average time of immune response induced by vaccination) after vaccination, the patient had an onset of fever greater than or equal to 38 degree celcius and cough. The patient met the one of the operational definition of TSI/ETI or IRAG. [In this study, Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree C, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree C and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death: a deceased patient who has met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Network Laboratories, and who in his death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death is subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths. From the epidemiological week 40 of 2010 to 20 of 2018 there were 3089 deaths from influenza, only 65 deaths were reported with a vaccination history with the seasonal vaccine and at least 21 days (average time of immune response induced by vaccination) from vaccination to onset of influenza symptoms. Operational definition (ETI/IRAG) 21% (n = 14) of the 65 deaths did not meet the operational definition of ETI or IRAG despite having a positive final result for influenza. The five deaths in children under five years of age met the operational definition 100%. Of the 32 deaths in the six to 64 year old group, seven (22%) did not meet the operational definition of ETI or IRAG and of the 28 deaths over 65, seven (25%) either. We consider that conditions inherent to the patients determined that 14 deaths did not strictly comply with the operational definition, however, when the clinician suspected, samples were taken, which were positive. In 83% (n = 54) of deaths there was at least one comorbidity, in 29% (n = 19) one, in 26% (n = 17) two, in 18% (n = 12) three, in 8% (n = 5) four and in 1.5% (n = 1) five.]. On an unspecified date, the patient died. The patient had diagnosed with positive result for influenza infection (unknown type) issued by one of the laboratories endorsed by network Laboratories. The patient was diagnosed with the influenza infection. On an unspecified date, the patient died. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. [In this study, In January 2014, the highest number of deaths was recorded, (n = 11). The average number of days from vaccination to the onset of symptoms was 78; 88% (n = 57) of the deaths had a death date record. The average number of days from the onset of symptoms to the date of death was 10.3 (median of 9 and range of 0-37). The majority of deaths (n = 36) were due to subtype A (H1N1); 15 for A (H3), eight for influenza B and two were not subtyped]. The patient died on an unknown date. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza (type and subtype unknown). It was unknown whether autopsy was performed or not. This case has been considered as vaccination failure. This case has been considered as serious due to vaccination failure and death. Treatment was unknown. [In this study, Only 55% of deaths (n = 36) received antiviral treatment, 35 oseltamivir and one zanamivir. Of these, only five had the record of treatment start date; 6% of deaths (n = 4) had registered having started treatment in the first 72 hours after the onset of symptoms; in one case antiviral onset was recorded on day 13 from the onset of symptoms and death was recorded on day 17]. The authors commented "Since System captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms, suggests that immunization against seasonal influenza was a profitable strategy, especially when considering group immunity, and that a reduction in disease burden and, therefore, health care costs and sociodemographic costs have been proven. It has been described that the probability that the vaccine was cost-effective to prevent death was 100% and to avoid complications of 96.7%. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. The operational definition of ETI or IRAG was used for epidemiological surveillance purposes and has proven to be sensitive. In practice, the doctor should begin antiviral treatment in the first 48 hours in patients with" cough and fever when it was known that influenza viruses are circulating in the community that was, a case does not meet the operational definition. It was not a reason to delay antiviral treatment. As described in the literature and reported by the Epidemiological Surveillance System, most influenza deaths have at least one comorbidity that aggravates the natural history of the disease. In this study, 83% of the cases presented at least one comorbidity, such as overweight, obesity, diabetes or congestive heart failure, which could trigger a low response of the host''s immune system. Since the 2009 pandemic, obesity was recognized as a risk factor for influenza complications, this was important since 30% of children, 40% of adolescents and 70% of adults are overweight or obese, Therefore, we face new challenges in disease prevention, since obese adults with a history of vaccination have up to twice the risk of developing influenza due to poor T-cell function. The occurrence of only 10 deaths in patients with immunosuppression in a universe of 3089 deaths also follows an achievement in the country regarding the management of patients living with human immunodeficiency virus infection and adequate compliance with vaccination recommendations in individuals. With immunosuppression. People living with diabetes are more susceptible to getting influenza infection; it had also been documented that cardiovascular diseases associated with influenza can lead to significant hemodynamic compromise that requires cardiac support. It was important for public health to specify the other comorbidities that occurred in these deaths and that the system does not allow clarification to define new risk groups and vaccination strategies. There was strong and consistent evidence that vaccination during pregnancy protects women and their newborns against influenza infection. Not having found deaths in the country of pregnant women with a history of vaccination for the season indicates excellent adherence to the goal of vaccination in any trimester of pregnancy. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza; Vaccination failure


VAERS ID: 847928 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: greater than or equal to 38, Test Result Unit: degree C; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: MXIDBIOMEDICALCORPORATION

Write-up: Vaccination failure; Influenza; Fever; Cough; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, more than 2 weeks after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza (serious criteria death), fever and cough. On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the fever and cough were unknown. The reported cause of death was influenza and vaccination failure. The reporter considered the vaccination failure, influenza, fever and cough to be related to Flu vaccine. Additional details provided as follows: On an unspecified date between week 40 of 2010 to 20 of 2018, at least 21 days (average time of immune response induced by vaccination) after vaccination, the patient had fever greater than or equal to 38 degree celcius and cough. The patient was diagnosed with influenza (type unknown). The patient met the one of the operational definition of TSI/ETI or IRAG.[In this study, Influenza-like illness (TSI): a person of any age who has or reports having had a fever greater than or equal to 38 degree C, cough and headache accompanied by one or more of the following signs or symptoms: rhinorrhea, coryza, arthralgia, myalgia, prostration, odynophagia, chest pain, abdominal pain, nasal congestion or diarrhea. IRAG: person of any age who has difficulty breathing, with a history of fever greater than or equal to 38 degree C and cough, or one or more of the following symptoms: attack to the general state, chest pain or polypnea. Influenza death : a deceased patient who has met the operational definition of ETI / IRAG and who has a positive result for influenza issued by one of the laboratories endorsed by the Network Laboratories, and who in his death certificate contain as a basic cause the diagnosis of influenza or pneumonia. An influenza death was subject to epidemiological surveillance, so it must necessarily be ratified or rectified by the methodology of the Epidemiological and Statistical System of Deaths. From the epidemiological week 40 of 2010 to 20 of 2018 there were 3089 deaths from influenza, only 65 deaths were reported with a vaccination history with the seasonal vaccine and at least 21 days (average time of immune response induced by vaccination) from vaccination to onset of influenza symptoms. Operational definition (ETI/IRAG) 21% (n = 14) of the 65 deaths did not meet the operational definition of ETI or IRAG despite having a positive final result for influenza. The five deaths in children under five years of age met the operational definition 100%. Of the 32 deaths in the six to 64 year old group, seven (22%) did not meet the operational definition of ETI or IRAG and of the 28 deaths over 65, seven (25%) either. We consider that conditions inherent to the patients determined that 14 deaths did not strictly comply with the operational definition, however, when the clinician suspected, samples were taken, which were positive. In 83% (n = 54) of deaths there was at least one comorbidity, in 29% (n = 19) one, in 26% (n = 17) two, in 18% (n = 12) three, in 8% (n = 5) four and in 1.5% (n = 1) five]. On an unspecified date, the patient died. The patient had diagnosed with positive result for influenza infection (unknown type) issued by one of the laboratories endorsed by network Laboratories. The patient was diagnosed with the influenza infection. In January 2014, the highest number of deaths was recorded, (n = 11). The average number of days from vaccination to the onset of symptoms was 78; 88% (n = 57) of the deaths had a death date record. The average number of days from the onset of symptoms to the date of death was 10.3 (median of 9 and range of 0-37). The majority of deaths (n = 36) were due to subtype A (H1N1); 15 for A (H3), eight for influenza B and two were not subtyped]. On an unspecified date, the patient was died. It was reported that the patient''s death certificate contain as a basic cause the diagnosis of influenza. It was unknown whether autopsy was performed or not. This case has been considered as suspected vaccination failure. This case has been considered as serious due to vaccination failure and death. Treatment was unknown. [In this study, only 55% of deaths (n = 36) received antiviral treatment, 35 oseltamivir and one zanamivir. Of these, only five had the record of treatment start date; 6% of deaths (n = 4) had registered having started treatment in the first 72 hours after the onset of symptoms; in one case antiviral onset was recorded on day 13 from the onset of symptoms and death was recorded on day 17]. The authors commented "Since System captures 100% of cases of severe acute respiratory infection, the 3089 deaths reported were considered the universe of deaths from influenza, even when one third of the infections were asymptomatic and the cases have to meet criteria subject to surveillance, as the operational definition. That only 65 deaths (2.1% of the total) had a history of vaccination with the vaccine suggested for the season and at least 21 days from vaccination to the onset of symptoms, suggests that immunization against seasonal influenza was a profitable strategy, especially when considering group immunity, and that a reduction in disease burden and, therefore, health care costs and sociodemographic costs have been proven. It has been described that the probability that the vaccine was cost-effective to prevent death was 100% and to avoid complications of 96.7%. The frequency of deaths from influenza with a history of vaccination coincided with the occurrence of cases in the seasons; the 2013-2014 season was the one with the highest number of deaths recorded. The above suggests that influenza deaths could be caused by complications and situations that aggravated the cases; individualizing the investigation of each death would be the subject of another study. The operational definition of ETI or IRAG was used for epidemiological surveillance purposes and has proven to be sensitive. In practice, the doctor should begin antiviral treatment in the first 48 hours in patients with" cough and fever when it was known that influenza viruses are circulating in the community that was, a case does not meet the operational definition. It was not a reason to delay antiviral treatment. As described in the literature and reported by the Surveillance System, most influenza deaths have at least one comorbidity that aggravates the natural history of the disease. In this study, 83% of the cases presented at least one comorbidity, such as overweight, obesity, diabetes or congestive heart failure, which could trigger a low response of the host''s immune system. Since the 2009 pandemic, obesity was recognized as a risk factor for influenza complications, this was important since 30% of children, 40% of adolescents and 70% of adults are overweight or obese, Therefore, we face new challenges in disease prevention, since obese adults with a history of vaccination have up to twice the risk of developing influenza due to poor T-cell function. The occurrence of only 10 deaths in patients with immunosuppression in a universe of 3089 deaths also follows an achievement in the country regarding the management of patients living with human immunodeficiency virus infection and adequate compliance with vaccination recommendations in individuals. With immunosuppression. People living with diabetes are more susceptible to getting influenza infection; it had also been documented that cardiovascular diseases associated with influenza can lead to significant hemodynamic compromise that requires cardiac support. It was important for public health to specify the other comorbidities that occurred in these deaths and that the system does not allow clarification to define new risk groups and vaccination strategies. There was strong and consistent evidence that vaccination during pregnancy protects women and their newborns against influenza infection. Not having found deaths in the country of pregnant women with a history of vaccination for the season indicates excellent adherence to the goal of vaccination in any trimester of pregnancy. Of the six deaths from influenza with a history of vaccination without comorbidities and who received antiviral treatment, four corresponded to individuals at extremes of life, which was consistent with the knowledge that the immune system may be immature in children or in decline in older adults. The authors concluded "According to the results, deaths from influenza in patients with a history of vaccination represent a very low percentage of total deaths, only 2.1%. The existence of comorbidities and membership in the age groups at the extremes of life contribute to influenza mortality. Since its implementation, influenza vaccination has been a specific prevention strategy that has reduced the burden of disease in the general healthy population and mortality in specific populations. This component of the Vaccination Program was crucial to protect the population from one of the most important communicable diseases of our era. The reduction in influenza mortality was the result of the scope of health promotion, the strength of the Surveillance System, the guarantee in the supply of treatment and, above all, the consistency of the vaccination program." This is 1 of the 9 valid cases reported in the same literature article. The article corresponding to this case was not available for submission due to copyright restriction. Lab Comments: Lab test done on an unknown date between week 40 of 2010 to week 20 of 2018.; Reported Cause(s) of Death: Influenza; Vaccination failure


VAERS ID: 848433 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2019SA319392

Write-up: influenza; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a physician and non-healthcare professional. This case involves a patient of unknown demographics who experienced influenza (influenza), while he/she received vaccine INFLUENZA VACCINE. The patient''s past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. In 2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious influenza (influenza) Unknown latency following the administration of INFLUENZA VACCINE. This event was leading to death. Date of death was not reported. No lab test was reported. Final diagnosis was (fatal) influenza. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Influenza. The information on the batch number was requested.; Sender''s Comments: This poorly documented case concerns a patient of unknown demographics who died on an unknown latency due to Influenza after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Patient''s past history, medical condition at time of vaccination and clinical course of the events are not reported. No cause of death has been reported. Autopsy results confirming the cause of death along with any lab tests performed if any should be provided. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: influenza


VAERS ID: 848541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131911USA005370

Write-up: her niece received a HPV immunization in an an unspecidied time and patient dies; product origin unknown; This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient''s concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported. The nurse stated, that there was a patient in the office who was asked if interested in receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) immunization. The patient''s mother refused because on an unknown date, her niece was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis and on an unknown date, she died. It was unknown if an autopsy was done. The relatedness between the patient''s death and suspect vaccines was not provided.


VAERS ID: 848661 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Glioblastoma, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131911AUS007603

Write-up: Glioblastoma; pyrexia; Information has been received from a regulatory authority freedom of Information Act, on 07-NOV-2019 (Agency reference# AU-TGA-0000468362) referring to a 11 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, frequency, route, lot # and expiration date were not reported) and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX) for prophylaxis. On an unknown date, the patient experienced glioblastoma and pyrexia. The outcome of the events was reported as death. It was unknown if an autopsy was performed. The causality assessment between the events and suspect vaccines was not reported. Upon internal review, glioblastoma was determined to be medically significant.; Reported Cause(s) of Death: Glioblastoma; pyrexia


VAERS ID: 848841 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, Pneumonia pneumococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2019497712

Write-up: pneumococcal pneumonia; pneumococcal pneumonia; This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative. The reporter reported similar events for two patients. This is the first of two reports. A child patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient''s medical history and concomitant medications were not reported. The patient fell ill with pneumococci despite being vaccinated with pneumococcal 13-val conj vac (dipht crm197 protein). The physician reported as reason a replacement of serotypes. The patient was hospitalized and died in the hospital of the pneumococcal disease, from the effects of pneumonia. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number will be requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information especially confirmative serotype results and vaccination schedule are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2019497761 same reporter, product and event, different patient.; Reported Cause(s) of Death: pneumococcal pneumonia; Pneumococcal pneumonia


VAERS ID: 849005 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2019SA323689

Write-up: patients died; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a pharmacist. This case involves 3 patients who died, after they received vaccine INFLUENZA VACCINE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patients died (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Lab data was not reported. The patient outcome was reported as Fatal. It was unknown if an autopsy was done. The cause of death was not reported. Information on batch number is requested.; Sender''s Comments: This case concerns 3 patients who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). More details regarding time of death, health status at the time of vaccination, patient''s past medical history, detailed autopsy report, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, no conclusion can be drawn.; Reported Cause(s) of Death: death NOS


VAERS ID: 849079 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3D90 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Crying, Death, Diarrhoea, Melaena, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROTAVIRUS VACCINE LIVE ORAL 1V; PNEUMOCOCCAL VACCINE 10V
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2019SA321758

Write-up: Death; melena; apnea; diarrhea; vomiting; persistent crying; fever; Initial information received on 18-Nov-2019 regarding an unsolicited valid serious case received from Health Care Professional through Business Partner and transmitted to Sanofi on 19-Nov-2019. This case is linked to case 2019SA321757 (same reporter). This case involves a 3 months old male patient who experienced fever (pyrexia), persistent crying (crying), diarrhea (diarrhoea), vomiting (vomiting), melena (melaena) and apnea (apnoea), and was died on an unknown date after vaccination with IPV (VERO). The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTAVIRUS VACCINE LIVE ORAL 1V) for Immunisation; and PNEUMOCOCCAL VACCINE 10V (PNEUMOCOCCAL VACCINE 10V) for Immunisation. On 05-Nov-2019, the patient received a dose of suspect IPV (VERO) lot P3D90 via intramuscular route in unknown administration site. On an unknown date, the patient developed a serious melena (melaena) and apnea (apnoea) (Unknown latency) following the administration of IPV (VERO). These events were assessed as medically significant. On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), vomiting (vomiting), persistent crying (crying) and fever (pyrexia) (Unknown latency) following the administration of IPV (VERO). On an unknown date, the patient was died following the administration of IPV (VERO) (death). This event was assessed as medically significant and was leading to death. Lab data was not reported. Final diagnosis was fever, persistent crying, vomiting, diarrhea, apnea and melena. It was not reported if the patient received a corrective treatment. The patient outcome was reported as fatal for death, as unknown for others. It is unknown if an autopsy was done. The cause of death was not reported.; Sender''s Comments: "This case concerns a 3-month-old male patient who experienced apnea, melena, vomiting, diarrhea, persistent crying, fever and was died after vaccination (unspecified time to onset) with IPV (VERO) concomitantly (simultaneous) with pneumococcal conjugate and rotavirus vaccines. No conclusion on the cause of death can be made at this point, as no autopsy results are available. Further data such as the medical history, medical condition including pre-existing conditions, investigations (i..e endoscopy or others) and autopsy report are missing to fully assess the case.".; Reported Cause(s) of Death: Death


VAERS ID: 849150 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-10
Onset:2019-10-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3E241V / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dehydration, Dyspnoea, Moaning, Pyrexia, Somnolence, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PNEUMOCOCCAL VACCINE 10V
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2019SA321753

Write-up: dehydration; tachycardia; dyspnea; progressed to death; moaning; fever; somnolence; Initial information received on 18-Nov-2019 regarding an unsolicited valid serious case received from Other Health Professional through Business Partner on 18-Nov-2019 and transmitted to Sanofi 19-Nov-2019. This case involves a 2 months old male patient who experienced fever (fever), somnolence (somnolence), moaning (moaning), dehydration (dehydration), tachycardia (tachycardia), dyspnea (dyspnea) and progressed to death (death), while he received vaccines IPV (VERO). Information about previous therapy and pre-medication was not provided. Concomitant medications included Pneumococcal Vaccine 10V for immunization lot number 182VPN007C received on 10-Oct-2019. On 10-Oct-2019, the patient received a dose of suspect IPV (VERO) produced by unknown manufacturer lot P3E241V via intramuscular route in unknown administration site. On 10-Oct-2019, the patient developed a serious fever (pyrexia), somnolence and moaning on same day following the administration of IPV (VERO). The patient was hospitalized for this event. On an unknown date, the patient developed a serious dehydration, tachycardia and dyspnea (dyspnoea) following the administration of IPV (VERO). The patient was hospitalized for this event. On an unknown date, Patient died (Death). (Other relevant tests included no lab data.) Final diagnosis was Death , dyspnea, tachycardia, dehydration, moaning, somnolence and fever. Outcome was reported as fatal for Death NOS and unknown for other events It was not reported if the patient received a corrective treatment. The cause of death was unknown It is unknown if an autopsy was done.; Sender''s Comments: This case involves a 2-month-old male patient presenting fever (unspecified degree), somnolence and moaning the same day post-vaccination with IPV (VERO) followed by dehydration, tachycardia and dyspnea and the patient died three days after despite medical attention at hospital. No conclusion on the cause of death can be made at this point, as no autopsy results are available. No medical history was provided for pre-existing medical conditions. Further data such as the medical history, medical condition, investigations and autopsy report are missing to fully assess the case.


VAERS ID: 849204 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchiolitis, Death, Leukocytosis, Pneumonia, Pulmonary hypertension
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Pulmonary hypertension (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT2019GS

Write-up: Death NOS; pulmonary hypertension; Bronchiolitis; Bilateral pneumonia; Leukocytosis; This case was reported in a literature article and described the occurrence of unknown cause of death in a neonate patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, less than 3 months after receiving DTPa vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), pulmonary hypertension (serious criteria GSK medically significant), bronchiolitis (serious criteria GSK medically significant), bilateral pneumonia (serious criteria GSK medically significant) and leukocytosis. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pulmonary hypertension, bronchiolitis, bilateral pneumonia and leukocytosis were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to DTPa vaccine. The reporter considered the pulmonary hypertension, bronchiolitis, bilateral pneumonia and leukocytosis to be related to DTPa vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of severe pulmonary hypertension in a neonate patient aged less than 3-months of unspecified gender, who was vaccinated with unspecified diphtheria, tetanus and pertussis (dTpa) vaccine (manufacturer unknown) for prophylaxis. The aim of the study was to increase immunization rates during pregnancy in relation to pertussis through diphtheria, tetanus and pertussis (dTpa) vaccination during gestation. [With respect to vaccination in fertile women, the policy 2017-2019 comprises an active proposal for measles-mumps-rubella and varicella in the preconceptional period, for rubella and varicella (or both) during the post-partum, and for influenza, diphtheria-tetanus-pertussis during pregnancy. Clinical features are related to the age at which the patient is infected, to the immune system status, and to the timing of antibiotic therapy. Severity is inversely proportional to the age of the patient: in very young children, pertussis can initially have clinical manifestations other than cough, such as apnea and cyanosis, and it can determine severe respiratory, neurological and nutritional complications. Pulmonary complications are the most frequent (around 10 percent of cases) and can be fatal. Neither mother had received pertussis vaccination during pregnancy, nor over the 2 years preceding pregnancy]. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received only 1st dose of unspecified diphtheria, tetanus and pertussis (dTpa) vaccine (administration route and site unspecified, batch number not provided). [Pertussis vaccination is performed via dTpa (diphtheria-tetanus-pertussis) vaccine. The vaccine used for maternal immunization, is not monovalent, it is a combined vaccine that includes Diphteria toxoid-tetanus toxoid and acellular pertussis (dTpa)]. The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient was admitted with diagnosis of bronchiolitis, leukocytosis and bilateral pneumonia. The patient had severe pulmonary hypertension. [As of August 2018, there have been 2 cases of pertussis related death within the first two months of life: there was no record of immunization during pregnancy. These 2 cases add to 6 more cases of neonatal deaths previously recorded: all neonates were less than 3 months old, 2 were born pre-term. In all cases, admission diagnosis was of bronchiolitis, leukocytosis and bilateral pneumonia. 5 of 6 neonates had severe pulmonary hypertension; 4 were not vaccinated; 1 had received only the first dose and in 1 of the 2 pre-term neonates vaccination was deferred]. On an unspecified date, the patient died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death. Treatment was unknown. The author did not comment on the relationship between the event of severe pulmonary hypertension, bronchiolitis, leukocytosis, and bilateral pneumonia and unspecified diphtheria, tetanus and pertussis (dTpa) vaccine. The authors stated, "Pregnant women and neonates are more vulnerable to some infections, that turned out to be associated with increased morbidity and mortality. All fertile women, and in general women in the preconceptional period, should be protected for varicella, measles and rubella through vaccination. The major objective of pertussis vaccination is to reduce the risk of severe childhood diseases. Vaccination at birth is not a valid option because the neonatal immune system is incapable of antibody production for the first 2 months. Preventive strategies to reduce the risk of pertussis in the first year of life are: a) Maternal immunization via vaccine administration either during pregnancy or during breastfeeding, b) "Cocoon" strategy, as a complementary familial strategy. The procedure is usually performed during the third trimester of gestation, and it stimulates maternal antibody production that are passed to the fetus through the placenta. If the procedure is not performed during pregnancy, the vaccine can be administered during the breastfeeding period in order to obtain an antibody transfer through the maternal milk. In this case the major immunoglobulin component to be passed to the baby via colostrum and milk is represented by IgA, but also some IgG and IgM: these will guarantee protection during the first six months of life. Maternal antibodies persist in the newborn for about 36-55 days. There are not data on the correlation between dTpa vaccine during pregnancy and the increased risk for autism disease. There are many factors that influence maternal acceptance of pertussis vaccination, such as level of education, working conditions and knowledge of the safety of immunization during pregnancy." The author concluded, "Gestational vaccination plan must be considered an efficient and necessary strategy to protect the mother, the fetus and the neonate. In particular, during pregnancy the following vaccinations should be recommended: Pertussis (dTpa) vaccine, Seasonal influenza vaccine. Given the increased number of pertussis cases, maternal administration of dTpa vaccine has to be considered the best protective strategy for neonates against B. pertussis infection during the first few months of life. It can also protect from possible related complications, sometimes severe and/or lethal, that can damage the non-vaccinated newborn that cannot undergo immunization yet. There is no evidence related to maternal immunization regarding maternal risks, increase of obstetrical complications and/or perinatal complications." This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Reported Cause(s) of Death: Death NOS


VAERS ID: 849585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antimicrobial susceptibility test sensitive, Asthenia, Blood glucose normal, Brain oedema, Brudzinski's sign, CSF culture, CSF glucose, CSF neutrophil count increased, Cerebral artery thrombosis, Computerised tomogram head abnormal, Death, Feeling abnormal, Kernig's sign, Lymphocyte percentage decreased, Meningitis, Meningitis pneumococcal, Multiple organ dysfunction syndrome, Musculoskeletal stiffness, Neutrophil percentage increased, Procalcitonin increased, Pyrexia, Rhinorrhoea, Streptococcus test positive, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Congenital hearing disorder (bilateral sensorineural , undergone cochlear implantation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Antimicrobial susceptibility test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Blood culture; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Glucose; Test Result: 102 mg/dl; Test Name: Blood pressure; Result Unstructured Data: Test Result: 120/88, Test Result Unit: mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result: axillary temperature of 38.3, Test Result Unit: degree C; Test Name: Computerized tomogram; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: CSF cell count; Result Unstructured Data: Test Result: uncountablenumber of neutrophils identified in CSF, Test Result Unit: unknown; Test Name: CSF culture; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Cerebrospinal fluid glucose; Test Result: 1 mg/dl; Test Name: Cerebrospinal fluid protein; Test Result: 706 mg/dl; Test Name: Heart rate; Result Unstructured Data: Test Result: 134, Test Result Unit: /min; Test Name: Lymphocyte count; Test Result: 10 %; Test Name: Neutrophils; Test Result: 90 %; Test Name: Procalcitonin; Result Unstructured Data: Test Result: 1.22, Test Result Unit: ng/mL; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 50 breaths, Test Result Unit: /min; Test Name: Leukocyte count; Result Unstructured Data: Test Result: 21.900, Test Result Unit: mm3
CDC Split Type: TRGLAXOSMITHKLINETR2019GS

Write-up: multiple organ failure; Streptococcus pneumoniae; fever; vomiting; weakness; thrombus in the right middle cerebral artery; acute mental fog at postoperative day 3 and showed brain edema; neck stiffness; Kernig; Brudzinski signs; rhinorrhea; acute mental fog /brain fog; This case was reported in a literature article and described the occurrence of multi-organ failure in a 4-year-old female patient who received Haemophilus influenzae type b vaccine for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PCV 13) for prophylaxis. The patient''s past medical history included congenital hearing disorder (bilateral sensorineural , undergone cochlear implantation). On an unknown date, the patient received Haemophilus influenzae type b vaccine at an unknown dose and PCV 13 at an unknown dose. On an unknown date, unknown after receiving Haemophilus influenzae type b vaccine, the patient experienced multi-organ failure (serious criteria death, hospitalization and GSK medically significant), streptococcus pneumoniae meningitis (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), vomiting (serious criteria hospitalization), weakness (serious criteria hospitalization), cerebral artery thrombosis (serious criteria GSK medically significant), brain edema (serious criteria GSK medically significant), stiff neck, kernig''s sign, brudzinski''s sign, rhinorrhea and foggy feeling in head. The patient was treated with vancomycin and ceftriaxone. On an unknown date, the outcome of the multi-organ failure was fatal and the outcome of the streptococcus pneumoniae meningitis, fever, vomiting, weakness, cerebral artery thrombosis, brain edema, stiff neck, kernig''s sign, brudzinski''s sign, rhinorrhea and foggy feeling in head were unknown. The reported cause of death was multi-organ failure. It was unknown if the reporter considered the multi-organ failure, streptococcus pneumoniae meningitis, fever, vomiting, weakness, cerebral artery thrombosis, brain edema, stiff neck, kernig''s sign, brudzinski''s sign, rhinorrhea and foggy feeling in head to be related to Haemophilus influenzae type b vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Streptococcus pneumoniae serotype 24B meningitis in a 4-year-old female patient who was vaccinated with unspecified haemophilus influenzae type b vaccine and unspecified pneumococcal conjugate vaccine (PCV-13) (manufacturer unknown for both) for prophylaxis. The patient had undergone cochlear implantation due to bilateral congenital sensorineural hearing loss. No information on patient''s family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received haemophilus influenzae type b vaccine (administration route and site unspecified; dosages unknown; batch number not provided) and unspecified PCV-13 in line with the national immunization calendar. On an unspecified date, an unknown period after vaccination and approximately 5 months after cochlear implantation, the patient presented to the clinic with fever, vomiting, and weakness. A physical examination showed an axillary temperature of 38.3 degree C, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg (normal range not provided for all). The patient also had a neck stiffness and her Kernig and Brudzinski signs were positive. Her laboratory findings showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/mL (normal range not provided for all). An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. There was also 1 mg/dL of glucose (blood glucose, 102 mg/dL) and 706 mg/dL of protein in her cerebrospinal fluid. Empirically, vancomycin (60 mg/kg/day) and ceftriaxone (100 mg/kg/day) were started. Following 5 days of antibiotic treatment, penicillin-susceptible S. pneumoniae was yielded in her CSF culture and identified as serotype 24B. S. pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Since rhinorrhea was observed on day 16 of hospitalization, she underwent an operation to repair the fistula tract. A computerized tomography cranial scan was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery. On an unspecified date, the patient died on day 42 of hospitalization due to multiple organ failure. It was unknown, if an autopsy was performed. The case was considered as serious due to hospitalisation/death. The author did not comment on the relationship between the event of Streptococcus pneumoniae Serotype 24B meningitis and unspecified hemophilus influenzae type b vaccine. The author stated, "To our knowledge, this is the first case of meningitis reported in our country associated with S.pneumoniae serotype 24B in a patient with a cochlear implant. While there has been a decrease in the prevalence of invasive pneumococcal disease with routine administration of the pneumococcal conjugate vaccine, a relative increase has been observed in its non-vaccine serotypes. This is relevant not only to patients with more risk factors, such as a cochlear implant, but also those who are at lower risk for pneumococcal infection." The article corresponding to this case is not available for regulatory submission due to copyright restriction. Lab Comments: On an unspecified date, Lab test were performed. The patient''s Kernig and Brudzinski signs were positive. Following 5 days of antibiotic treatment, penicillin-susceptible S. pneumoniae was yielded in her CSF culture and identified as serotype 24B. S. pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. computerized tomography cranial scan was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Reported Cause(s) of Death: multiple organ failure


VAERS ID: 849685 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SESA2019SA326003

Write-up: pneumonia; a terrible cold; Initial information received on 21-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional. This case involves a male patient who experienced pneumonia (pneumonia) and terrible cold (nasopharyngitis), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No previous disease. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a horrible cold (nasopharyngitis) and pneumonia (pneumonia), unknown latency following the vaccination of INFLUENZA VACCINE. Both the events were leading to death. Pneumonia (pneumonia) was also assessed as medically significant. Other relevant tests were not reported. Final diagnosis was (fatal) pneumonia and (fatal) cold. It was not reported if the patient received a corrective treatment. The outcome of the events was fatal. It was not reported if an autopsy was done. The cause of death was reported as Nasopharyngitis and Pneumonia. There will be no information available on the batch number for this case.; Sender''s Comments: This case involves a male patient who experienced (fatal) pneumonia and (fatal) cold after few days vaccination and passed away. Time to onset is compatible with the role of vaccine. More details regarding patient''s medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed."; Reported Cause(s) of Death: pneumonia; a terrible cold


VAERS ID: 849774 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-15
Onset:2019-11-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R025490 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 201807031 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Cardio-respiratory arrest, Crying, Death, Dyspnoea, Gastrointestinal haemorrhage, Intensive care, Multiple organ dysfunction syndrome, Muscle twitching, Pneumonitis, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Premature birth; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131911CHN007689

Write-up: death; severe pulmonitis/ difficulty breathing; twitching; low grade fever/ /temperature 37.4 degrees Celsius; the infant developed crying; hemorrhage of digestive tract; Cardiorespiratory arrest; multi-organ failure; Information was received from an Agency (disease control and prevention)(Agency # was not provided) on 18-NOV-2019. In the morning of 15-NOV-2019, a 2 months old infant received a dose of poliovirus vaccine inactivated (unspecified) (IPV), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine. At night (specific time unknown), the infant developed low grade fever with temperature 37 Celsius degree and twitching. The parents sent the infant to county hospital, the treatment was not good. The next day the infant was sent to the city hospital. The specific treatment was unknown. In the evening at 21 :00 the infant died. Follow up information was received from CDC on 19-NOV-2019. On 15-NOV-2019, the 2 months old infant received a dose of poliovirus vaccine inactivated (unspecified)(IPV) (manufacturer: Beijing Beishengyan. batch number 201810129), the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# R025490, expiration date upon internal validation established as: 08-JUN-2020, and Meningococcal Groups A (+) C and Haemophilus b Conjugate Vaccine (manufacturer: Beijing Zhifei Lvzhu, batch number 201807031 ) at the same time on different parts. In the afternoon of that day, the infant developed crying, in the evening of 15-NOV-2019, the infant''s temperature was about 37 degrees Celsius and there was no twitching. The parents sent the infant to county hospital, the treatment was not good, the next day the infant was transferred to the city hospital. In the evening at around 21 :00 the infant died. Whether the autopsy would be done was st ill in the process of communication. The outcome of crying and pyrexia was unknown. The causality assessment between the events and suspected vaccines was not provided. Follow up information was received from CDC on 20-NOV-2019. The female infant was first-born, test-tube baby and two months premature. On 15-NOV-2019 at about 17:00 the infant developed crying. On 16-NOV-2019 at 00:20, the infant experienced fever with temperature 37.4 degrees Celsius. In the morning the infant was sent to the county hospital pediatric clinic. The patient with fever, difficulty breathing and twitching was transmitted to the city hospital intensive care unit at about 11:00 due to severe pulmonitis. In the evening at around 21:00 the infant died in the hospital. The discharged diagnoses were cardiorespiratory arrest, multi-organ failure, severe pulmonitis and hemorrhage of digestive tract. Autopsy was started on 19-NOV-2019. The outcome of severe pulmonitis, cardiorespiratory arrest, multi-organ failure, hemorrhage of digestive tract and twitching was reported as unknown. The causality assessment between the events and suspected vaccines was not provided. Upon internal review the events of: cardiorespiratory arrest, multi-organ failure and hemorrhage of digestive tract were determined to be medically significant. This spontaneous report as received from a regulatory authority refers to a 9 week old female patient with premature baby and prophylaxis. On 15-NOV-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R025490 dose 1 for prophylaxis. Other suspect therapies included poliovirus vaccine inactivated (unspecified)(POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED)), meningococcal ac polysaccharide vaccine(MENINGOCOCCAL A+C) and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2019 the patient experienced gastrointestinal haemorrhage (hospitalization and medically significant). On 15-NOV-2019 the patient experienced pyrexia (hospitalization) and crying (hospitalization). On 16-NOV-2019, 1 day 21 hrs after onset of therapy the patient experienced death (death and medically significant), multiple organ dysfunction syndrome (hospitalization and medically significant), cardio-respiratory arrest (hospitalization and medically significant), pneumonitis (hospitalization) and muscle twitching (hospitalization). The outcome of death was reported as fatal. The outcome of crying, pyrexia, gastrointestinal haemorrhage, multiple organ dysfunction syndrome, cardio-respiratory arrest, pneumonitis and muscle twitching is unknown. The patient died on 16-NOV-2019. {Additional information has been requested. / Additional information is not expected.}


VAERS ID: 849776 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-21
Onset:2019-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 201810130 / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R029528 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Term baby
Allergies:
Diagnostic Lab Data: Test Date: 20190906; Test Name: birth weight; Result Unstructured Data: Lab result: more than 3 kilogram
CDC Split Type: CN0095075131911CHN010001

Write-up: died at home; Information has been received from centers for disease control (CDC) concerning an 11 weeks female patient. Her birth weight was more than 3 kg and she was born at term. The patient''s parents were currently 17 years old. Information about concurrent condition, concomitant medication and drug allergies/reactions of the patient was unknown. In the meantime on 21-NOV-2019, the patient received rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (orally, lot# R029528, expiration date not reported, but upon internal validation established as 28-JUN-2020; strength and dose were unknown), meningococcal groups A and C and haemophilus b conjugate vaccine (triple vaccine) (lot# 201807033; strength, dose, route and expiration date were unknown) and polio vaccine (unspecified) (lot# 201810130; strength, dose, route and expiration date were unknown) for prophylaxis. The batch of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and meningococcal groups A and C and haemophilus b conjugate Vaccine (triple vaccine) were qualified in transport and storage. At 5:00 on the morning of 22-NOV-2019, the patient died at home. It was unknown what caused the death. The patient''s parents approved of autopsy and it would be done recently. On the same day, they contacted an autopsy center and delivered the corpse. It was unknown if autopsy was done. The causality assessment was not provided.


VAERS ID: 849873 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood culture positive, Blood glucose normal, Brain oedema, Brudzinski's sign, CSF culture positive, CSF glucose decreased, CSF neutrophil count increased, CSF protein increased, Cerebral artery thrombosis, Computerised tomogram head abnormal, Death, Feeling abnormal, Fistula repair, Kernig's sign, Lymphocyte percentage decreased, Meningitis pneumococcal, Multiple organ dysfunction syndrome, Musculoskeletal stiffness, Neutrophil percentage increased, Procalcitonin increased, Pyrexia, Rhinorrhoea, Streptococcus test positive, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cochlea implant (five months prior due to bilateral congenital sensorineural hearing loss); Sensorineural hearing loss; Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: S.pneumoniae with the same antibiotic sensitivity; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Glucose; Result Unstructured Data: Test Result: 102, Test Result Unit: mg/dl; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: 120/88, Test Result Unit: mmHg; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.3, Test Result Unit: Centigrade; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result: brain edema and a thrombus in the right middle cer; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: CSF culture; Result Unstructured Data: Test Result: penicillinsusceptible S.pneumoniae was yielded; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: CSF glucose; Result Unstructured Data: Test Result: 1, Test Result Unit: mg/dl; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: CSF neutrophil count; Result Unstructured Data: Test Result: An uncountable number of neutrophils was identifie; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: CSF protein; Result Unstructured Data: Test Result: 706, Test Result Unit: mg/dl; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Heart rate; Result Unstructured Data: Test Result: 134; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Lab test; Result Unstructured Data: Test Result: showed a leukocyte count of 21.900/mm3 (neutrophil; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Lymphocyte percentage; Test Result: 10 %; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Neutrophil percentage; Test Result: 90 %; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Physical examination; Result Unstructured Data: Test Result: showed an axillary temperature of 38.3degreeC, hea; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Procalcitonin; Result Unstructured Data: Test Result: 1.22, Test Result Unit: ng/ml; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 50; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Serology test; Result Unstructured Data: Test Result: serotype 24B; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.; Test Name: Leukocyte count; Result Unstructured Data: Test Result: 21.900, Test Result Unit: /mm3; Comments: Physical examination (Unknown date): showed an axillary temperature of 38.3degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. Heart rate (Unknown date): 134/min. Respiration rate (Unknown date): 50 breaths/minute. Kernig signs (Unknown date): positive. Brudzinski signs (Unknown date): positive. Laboratory findings (Unknown date): showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. Procalcitonin level (Unknown date): 1.22 ng/ml. neutrophils/CSF (Unknown date): An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. Blood culture (Unknown date): S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Computerized tomography cranial scan (Unknown date): was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery.
CDC Split Type: TRPFIZER INC2019496753

Write-up: Meningitis Due to Streptococcus pneumoniae Serotype 24B; This is a literature report. The full publication has been requested. Streptococcus pneumoniae is a major cause of bacterial meningitis in children. It can progress and carries a serious risk of mortality and morbidity despite effective treatment. Cochlear implantation is a fairly successful procedure for restoring hearing in cases of sensorineural hearing loss. Moreover, patients with cochlear implants are at increased risk of contracting pneumococcal meningitis compared to the general population. The development of meningitis is associated with pathogens in the middle ear that contaminate the cerebrospinal fluid (CSF), as a result of congenital anomalies in the cochlea, and the cochlear implant. A 4- year-old girl presented to clinic with fever, vomiting, and weakness. A physical examination showed an axillary temperature of 38.3 degreeC, heart rate of 134/min, respiration rate of 50 breaths/minute, and arterial blood pressure of 120/88 mmHg. The patient also had a neck stiffness and her Kernig and Brudzinski signs were positive. It was discovered that the patient had undergone cochlear implantation approximately five months prior due to bilateral congenital sensorineural hearing loss. She had also received the Haemophilus influenzae type b and PCV-13 vaccines in line with the national immunization calendar. Her laboratory findings showed a leukocyte count of 21.900/mm3 (neutrophils 90% and lymphocytes 10%) and her procalcitonin level was 1.22 ng/ml. An uncountable number of neutrophils was identified in her cerebrospinal fluid, which led to the initial diagnosis of meningitis. There was also 1 mg/dl of glucose (blood glucose, 102 mg/dl) and 706 mg/dl of protein in her cerebrospinal fluid. Empirically, vancomycin (60 mg/kg/day) and ceftriaxone (100 mg/kg/day) were started. Following 5 days of antibiotic treatment, penicillin-susceptible S.pneumoniae was yielded in her CSF culture and identified as serotype 24B. S.pneumoniae with the same antibiotic sensitivity was also identified in her blood culture. Since rhinorrhea was observed on day 16 of hospitalization, she underwent an operation to repair the fistula tract. A computerized tomography cranial scan was performed after the development of acute mental fog at postoperative day 3 and showed brain edema and a thrombus in the right middle cerebral artery. The patient died on day 42 of hospitalization due to multiple organ failure. The author reported that this is the first case of meningitis reported in the country associated with S.pneumoniae serotype 24B in a patient with a cochlear implant. While there has been a decrease in the prevalence of invasive pneumococcal disease with routine administration of the pneumococcal conjugate vaccine, a relative increase has been observed in its nonvaccine serotypes. This is relevant not only to patients with more risk factors, such as a cochlear implant, but also those who are at lower risk for pneumococcal infection. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.; Sender''s Comments: No lack of effect with PREVENAR 13 towards the occurrence of "Meningitis Due to Streptococcus pneumoniae Serotype 24B" (non- PREVENAR 13 containing serotype) which more likely represents a coincidental bacterial infection unrelated to PREVENAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Meningitis Due to Streptococcus pneumoniae Serotype 24B; died on day 42 of hospitalization due to multiple organ failure


VAERS ID: 849895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2019-11-01
Submitted: 0000-00-00
Entered: 2019-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA411AE / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201921

Write-up: The patient was found dead in the apartment the day after the vaccination; This case was reported by a physician via regulatory authority and described the occurrence of found dead in a 45-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA411AE, expiry date unknown) for prophylaxis. On 4th November 2019, the patient received Influsplit Tetra 2019/2020 (intramuscular). In November 2019, 1 day after receiving Influsplit Tetra 2019/2020, the patient experienced found dead (serious criteria death and GSK medically significant). On an unknown date, the outcome of the found dead was fatal. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the found dead to be related to Influsplit Tetra 2019/2020. Additional information: The age at vaccination was not reported however patient could be 44 or 45 years old at the time of vaccination. The agency assessment was reported as D. Unclassifiable. The anatomical location of vaccine was reported as left upper arm. Initial information was received from a Physician via regulatory authority on 22nd November 2019: The patient was found dead in the apartment the day after the vaccination. Sender''s comments: Since October multiple vaccinations. On 04.11 more vaccinations with the same batch number.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 850127 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2019SA327759

Write-up: patient had adverse reaction and died; Initial information received on 25-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp via social media. This case is linked to case 2019SA327755 (same reporter). This case involves patient of an unknown demographics who died (death) due to unknown reason, while patient received INFLUENZA VACCINE. Medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died (death), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The reporter stated that this was the consequences of getting flu shot. Other relevant tests were not reported. Final diagnosis was death NOS. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was done. The cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This case concerns a patient of an unknown demographics who had unknown adverse reaction and died after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient''s past medical history, condition at the time of vaccination, concomitant medications, lab data excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 850148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hypoglycaemia, Shock, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ET0095075131911ETH010029

Write-up: Death/Passed away; Hypoglycaemic; This spontaneous report was received from a non-healthcare professional referring to a female patient of unknown age. Information about patient''s concurrent condition, medical history, drug allergy/reaction and concomitant medications were not reported. On an unknown date in 2019, the patient was vaccinated with first dose of unidentified HPV vaccine(manufacturer unknown) (strength, dose, lot/batch number, expiration date, route and anatomical location were not reported) for prophylaxis. On an unknown date in 2019, the patient experienced hypoglycaemia. It was reported that after receiving the vaccine, the patient fainted, went into shook and the girl was transported to the nearby clinic, but because of lack of proper management the girl passed away. The outcome of hypoglycaemia was unknown. The cause of death was not reported. It was unknown if an autopsy was performed. The reporter considered death to be not related to HPV vaccine(manufacturer unknown). Causality assessment was not provided for the event hypoglycaemia. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between Gardasil 4/Gardasil 9 vaccines and the reported event of "Death" cannot be established. Missing clinically important information includes subject?s age, medical history, date of vaccination and start date of the event, detailed clinical course (including details regarding hypoglycaemia, in addition to sequence of the events that leaded to the death of the patient, etc), concomitant medications/vaccines, diagnostic workup results, treatment and autopsy report (if available) is essential for a proper and meaningful assessment. Company Comment- No changes to Gardasil 4/Gardasil 9 vaccines product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of certain countries, continues to monitor the safety profile of Gardasil 4/Gardasil 9 vaccines product.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 850365 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131911BRA011738

Write-up: a 9-year old girl that died after 11 days of the vaccination; manufacturer origin unknown; This spontaneous report was received from a physician via companies referring to a 9 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, route, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient died after 11 days of the vaccination. It was unknown if the autopsy was done. The causality assessment was not provided. The case is cross referenced to the case 1911BRA011806 due to receive from the same reporter.; Sender''s Comments: US-009507513-1911BRA011806:


VAERS ID: 850433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131911JPN002670J

Write-up: Death; Information has been received from a patients'' family concerning a female patient (age unknown), who was subcutaneously vaccinated with pneumococcal vaccine, polyvalent (23-valent) injection (PNEUMOVAX NP) for prophylaxis(lot number, vaccination date and dose not reported). No concomitant medications were reported. On an unknown date, the patient who had a vaccination history of pneumococcal vaccine, polyvalent (23-valent) was died. The cause of death was unknown. It is unknown whether an autopsy was performed. Reporter''s comment: Not provided. The reporter did not assess the relationship of death to pneumococcal vaccine, polyvalent (23-valent).; Reported Cause(s) of Death: Death


VAERS ID: 850434 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-07
Onset:2019-05-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Feeding disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-01
   Days after onset: 117
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Dyslipidaemia; Late effects of cerebral infarction
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131911JPN003059J

Write-up: Unable to eat; Information has been received from a physician concerning an 89-year-old male patient with chronic obstructive pulmonary disease (COPD) of respiratory diseases caused by asbestos, dyslipidaemia and late effects caused by cerebral infarction and a history of cerebral infarction. On 07-MAY-2019, the patient was subcutaneously vaccinated with pneumococcal vaccine, polyvalent (23-valent) injection (PNEUMOVAX NP) 0.5 ml for prophylaxis against pneumonia (lot number not reported). No concomitant medications were reported. On 07-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) for prophylaxis against pneumonia, then the patient was unable to eat. On 13-AUG-2019, the patient was hospitalized at A medical center. In approximately September 2019 (about one month later), the patient died due to ''''unable to eat ''''. The autopsy performed or not was unknown. Reporter''s comment: I think there was a causal relationship because unable to eat was onset after vaccinating with pneumococcal vaccine, polyvalent (23-valent). The reporting physician felt that unable to eat was related to pneumococcal vaccine, polyvalent (23-valent).; Reported Cause(s) of Death: Unable to eat


VAERS ID: 850477 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-11-05
Onset:2019-11-01
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3D90 / UNK RL / OT
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNB189A / 1 LL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB137AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Cardio-respiratory arrest, Crying, Death, Diarrhoea, Faeces discoloured, Melaena, Musculoskeletal stiffness, Nasal discharge discolouration, Pupillary light reflex tests abnormal, Pyrexia, Rhinorrhoea, Secretion discharge, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (narrow), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Premature birth (born premature (eight months) was in intensive treatment unit and was not breastfeeding)
Allergies:
Diagnostic Lab Data: Test Date: 20190724; Test Name: Thyroid stimulating hormone; Result Unstructured Data: Test Result: 8.0, Test Result Unit: unknown; Test Date: 20190806; Test Name: Thyroid stimulating hormone; Result Unstructured Data: Test Result: 5.4, Test Result Unit: unknown; Test Date: 20190724; Test Name: Immunoreactive trypsinogen increased; Result Unstructured Data: Test Result: 86.4, Test Result Unit: unknown; Test Date: 20190806; Test Name: Immunoreactive trypsinogen increased; Result Unstructured Data: Test Result: 47.5, Test Result Unit: unknown; Test Date: 20190724; Test Name: 17-hydroxysteroid activity increased; Result Unstructured Data: Test Result: 9.8, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2019GS

Write-up: cardiorespiratory arrest; stiffened; yellow nasal secretion; non-reactive pupils; Fever; Diarrhea; Vomiting; persistent Crying; Dark feces; Melena; Apnea; This case was reported by a other health professional via licensee and described the occurrence of cardiopulmonary arrest in a 3-month-old male patient who received 10PN-PD-Dit (Synflorix) (batch number ASPNB189A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLB137AA, expiry date unknown) for prophylaxis and POLIOMYELITIS VACCINE (IPV VACCINE) (batch number P3D90, expiry date unknown) for prophylaxis. The patient''s past medical history included premature birth (born premature (eight months) was in intensive treatment unit and was not breastfeeding). Previously administered products included BCG vaccine (received on 13th September 2019, on 14th September 2019 went to hospital for consultation). On 5th November 2019, the patient received the 1st dose of Synflorix (intramuscular), Rotarix liquid formulation (oral) and IPV VACCINE (intramuscular). On 5th November 2019, less than a day after receiving Synflorix and Rotarix liquid formulation and an unknown time after receiving IPV VACCINE, the patient experienced fever, diarrhea and vomiting. On 6th November 2019, the patient experienced melena (serious criteria GSK medically significant), crying and stool discolored. On 7th November 2019, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant) and apnea (serious criteria GSK medically significant). On an unknown date, the outcome of the cardiopulmonary arrest was fatal and the outcome of the melena, apnea, fever, diarrhea, vomiting, crying and stool discolored were unknown. It was unknown if the reporter considered the cardiopulmonary arrest, melena, apnea, fever, diarrhea, vomiting, crying and stool discolored to be related to Synflorix and Rotarix liquid formulation. Additional details were reported as follows: The patient received Polio inactivated in the vastus lateralis of the right thigh and 10 Pneumococcal vaccine (with reported batch number 182VPN007C) in the vastus lateralis of the left thigh. The patient presented high fever, diarrhea and vomiting and melena. The patient?s mother did not carry him to hospital because she associated the fever to vaccine. Gradually, the patient presented cry, and dark feces. He also presented apnea. On 07th November 2019, the patient had cardiorespiratory arrest without cardiac auscultation, nonreactive pupils and presence of oronasal secretion. Later, The patient''s mother did not seek medical attention and the patient arrived dead in the hospital. Follow-up information required and would be sent as soon as possible. This case is 1 of 3 cases , reported by the same reporter. Follow up information received from licensee on 26th November 2019: The patient was born after 8 months of pregnancy and was hospitalized at the neonatal ICU during a non-specified period. On 14th October 2019, the patient went to a medical appointment (no additional information about that). On 5th November 2019, the following vaccines were administered, pneumococcal 10-valent (batch 182VPN007C), IPV (batch P3D90) and rotavirus (batch AROLC137AA) vaccines. The mother refers that on the same day the patient started to present fever, but she did not go with the child to the health service since she related the symptom to the vaccine. On an unknown time, less than a week after vaccination, the patient started to present persistent crying, diarrhea, vomiting, melena and apnea. On 7th November 2019, 2 days after vaccination, at the morning, the patient''s mother observed the patient was very down and when she manipulated him, he was stiffened. The baby went to the hospital presenting cardiorespiratory arrest, without cardiac auscultation, non-reactive pupils (serious criteria GSK medically significant), with yellow nasal secretion and stiffness. It was concluded the patient was dead. Autopsies was requested (result not available so far). On an unknown date, the outcome of the fixed pupils, stiffness and nasal discharge discoloration were unknown. The first sample of the newborn patient collected on 24th July 2019, which showed results includes neonatal TSH (Thyroid stimulating hormone)8.0 (reference value: 4.5), biotinidase 135.2 (reference value more than 30), phenylketonuria 1.6 (reference value less than 4.0), immunoreactive trypsin 86.4 (reference value until 70), neonatal 17-alpha-OH-progesterone 9.8. New sample was requested to hypothyroidism and cystic fibrosis and it was collected on 6th August 2019. The following results were observed, neonatal TSH 5.4 (reference value 4.5) and immunoreactive trypsin 47.5 (reference value until 70). Necropsy results was not available on 26th November 2019. It was unknown if the reporter considered the fixed pupils, stiffness and nasal discharge discoloration to be related to Synflorix and Rotarix liquid formulation. The vaccines were applied in both patients by the same healthcare professional. The reporter consented to follow up. Lab Comments: On 24th July 2019,the patient did test for biotinidase result shows 135.2 (with reference value more than 30); phenylketonuria showed 1.6 (reference value more than 4.0). The new sample was requested to hypothyroidism and cystic fibrosis and it was collected on 6th August 2019.; Reported Cause(s) of Death: Cardiopulmonary arrest


VAERS ID: 850493 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-06
Onset:2019-11-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 259146C11 / UNK - / OT
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. S008678 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Dementia; Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201906361

Write-up: Temporal correlation between influenza and pneumococcal vaccination and death; This is a spontaneous case, initially reported by physician and initially retrieved from Regulatory Authority (Authority Number: IT-MINISAL02-589091) on 28-Nov-2019, concerning a 94-year-old, female patient. The patient''s current conditions included COPD (chronic obstructive pulmonary disease) with frequent exacerbations, heart disease in feeble compensation and dementia decompensated. The patient''s concomitant medication was not reported. On 06-Nov-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration: intramuscular, batch number: 259146C11, dose, anatomical location and expiry date: not reported] for H1N1 influenza immunisation. On the same date, the patient was administered co-suspect vaccine Pneumovax [pneumococcal vaccine polysacch 23v; batch number: S008678, dose, route of administration, anatomical location and expiry date: not reported] for an unknown indication. On 08-Nov-2019, two days after vaccination, the patient died. It was unknown whether autopsy was performed. The outcome of the event was fatal. The reporter considered the event of death as temporarily related to vaccination, but did not suppose a causal correlation given the precariousness of the pre-existing clinical picture in (high age) elderly patient. The event was assessed as serious due to the criterion of death and medically significant. Company causality: The event was considered as related to Fluad (TIV).; Reporter''s Comments: Reporter''s comment: I report for the temporal correlation, but I do not suppose a causal correlation given the precariousness of the pre-existing clinical picture in (high age) elderly patient.; Sender''s Comments: The event was considered as related to Fluad (TIV).; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 850728 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-13
Onset:2019-11-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0864C1A / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiomyopathy, Death, Expired product administered
SMQs:, Cardiomyopathy (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia aggravated; Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201906461

Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, batch number: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 851206 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-23
Onset:2019-11-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2019-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Glucose; CITALOPRAM; FERROFUMARAAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLGLAXOSMITHKLINENL2019GS

Write-up: Foetal death at 32 week; This case was reported by a other health professional via regulatory authority and described the occurrence of stillbirth in a foetus patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Concomitant products included folic acid, dextrose (Glucose), citalopram and ferrous fumarate (Ferrofumaraat). On 23rd October 2019, the patient received Boostrix (unknown) .5 ml. On 3rd November 2019, 11 days after receiving Boostrix, the patient experienced stillbirth (serious criteria death, GSK medically significant and other: Serious as per reported). The action taken with Boostrix was unknown. On an unknown date, the outcome of the stillbirth was fatal. The reported cause of death was stillbirth. It was unknown if the reporter considered the stillbirth to be related to Boostrix. See case NL2019208753 for details regarding the baby case. Additional details: The age at vaccination was not reported. However, patient Foetus at the time of vaccination. The Concomitant drug Ferrofumaraat was code with other drug company and the formulation was given as tablet. Initial information was received from an Other Health Professional via regulatory authority on 22nd November 2019: Foetal death at 32 week.; Reported Cause(s) of Death: Stillbirth


VAERS ID: 851418 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-29
Onset:2019-11-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S003308 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Crying, Cyanosis, Death, Faecal volume increased, Foaming at mouth, Moaning, Pallor, Peripheral coldness, Pneumonia aspiration, Respiratory rate decreased
SMQs:, Anaphylactic reaction (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: Medical History/Concurrent Conditions: Normal newborn (Weight: 3240 grams. Full-term normal delivery.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131912CHN000376

Write-up: coldness of limbs/cold legs/cough/breathing slowed/forehead cyanosis; Foaming at mouth; Moaning/groaning; crying; This spontaneous report was received from a health professional from the Center for Disease Control and Prevention (CDC) via sales representative referring to a 1-month old female patient. She was born with good condition (weight 3240 grams when born) (full-term normal delivery). The patient did not have family genetic history, psychiatric history, or allergic history. Patient''s concurrent conditions or concomitant therapies were not reported. The Patient''s historical drugs included Hepatitis B vaccine, and Bacillus Calmette Guerin vaccine. On 29-NOV-2019, the patient was taken to the outpatient for vaccination by her parents (the time of arriving at outpatient was unknown) physician of vaccination informed the matters regarding vaccine, the patient had good condition before vaccination. On the same date, at 11:21, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters, orally, lot number S003308 has been verified to be valid; expiration date was reported as 25-NOV-2020, following immunization procedures (strength and frequency were not reported). After vaccination, the patient was kept in observation for 30 minutes, no abnormality was observed. Therefore, the patient was taken back home. On the same date, at 15:20, the patient arrived home, about 16:00, 18:30, 21:00 and on 30-NOV-2019, about 00:00, the mother breast feed the patient four times, the patient was normal every time when took mother''s milk, the mother could not tell clearly the volume of milk for each breastfeeding. It was reported that the patient did not choke on milk. After the fourth breastfeeding, the patient fell asleep as usual. No abnormality was observed. At 4:00 a.m., the patient was found to have foaming at mouth, groaning, cough, crying and forehead cyanosis (aspiration pneumonia). Consequently, she was taken to the hospital by driving, on the way to hospital (at around 7:30 a.m.) the patient was found to have four limbs cold, breath slowing and foaming at mouth. At 8:30 a.m., the patient arrived at hospital and the physician confirmed that the baby had died. After examination, the patient''s body had normal body shape, with blue lips, forehead cyanosis, and pale face. Large amount stools were found at anus. No petechia was found on the whole body. The cause of death was aspiration pneumonia. No autopsy was performed. At the time of this report, the outcome of the events foaming at mouth, groaning, and crying was unknown. However, the outcome of aspiration pneumonia was fatal. The causality assessment between rotavirus vaccine, live, oral, pentavalent (ROTATEQ),administration and the aforementioned events was not provided by the reporter.; Reported Cause(s) of Death: Aspiration pneumonia


VAERS ID: 851585 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA340093

Write-up: death NOS; Initial information received on 05-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp via a web newspaper. This case involves a 31 years old male patient who died because of unspecified reason (Death), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site. On an unknown date, the patient died because of unspecified reason (not otherwise specified) (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. It was reported that the patient entered to emergency room and indicated that on Sunday morning (01-Dec-2019) he was vaccinated in his job and it could be an adverse event which altered his health, and in the end it caused him the death. Other relevant tests were not reported. Final diagnosis was (fatal) death NOS. It was not reported if the patient received a corrective treatment. The patient died on an unknown date and cause of death was not reported. It was unknown whether the autopsy was performed or not. There will be no information available on the batch number for this case.; Sender''s Comments: This is a poorly documented case received from a social media (web newspaper) involves a 31 years old male patient who died due to an unspecified reason after receiving INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. In addition, there is no information regarding patient''s past medical history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS


VAERS ID: 852037 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthmatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FISA2019SA339854

Write-up: My asthmatic friend was murdered with this shot (influenza vaccine) last winter; Initial information received through Company site (social media) on 04-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. The outsourced vendor responsible for social media monitoring noticed the case on 04-Dec-2019 and it was forwarded to PV unit the same day/04-Dec-2019. This case involves an adult patient (below 60 years old) who died (cause was not specified), while he/she received vaccine INFLUENZA VACCINE. The patient''s concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. Reporter stated that the patient was perfectly healthy. At the time of the event, the patient had ongoing Asthma. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died (death) (cause was not specified) Unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The reporter stated that my asthmatic friend was murdered with this shot [ influenza vaccine] last winter. Date of death was not reported. No lab test was reported. Final diagnosis was (fatal) death (cause was not specified. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date. It is unknown if an autopsy was done. The cause of death was not reported (conservatively considered as Death NOS). There will be no information available on the batch number.; Sender''s Comments: This poorly documented case received from Company site (social media) which concerns an adult patient (below 60 years old) who died due to unspecified cause after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Patient''s past history, medical condition at time of vaccination and clinical course of the events are not reported. Death could have been caused due to any of the alternate etiologies unrelated to vaccination. Autopsy results confirming the cause of death along with any lab tests performed if any are not available. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: My asthmatic friend was murdered with this shot (influenza vaccine) last winter


VAERS ID: 852042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza A virus test positive, Influenza like illness
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA341911

Write-up: Influenza A H1N1 PMD; influenza-like illness; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case was linked to cases 2019SA341932, 2019SA341944, 2019SA341964, 2019SA341972 and 2019SA341977 (same article). Article Summary: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 01 years old female patient who developed Influenza A H1N1 PMD (Influenza A virus test positive) while she received vaccine INFLUENZA VACCINE. The patient medical history, concomitant therapy and family history were not provided. Patient had a history of vaccination (brand name not specified). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious Influenza A H1N1 PMD (Influenza A virus test positive), influenza-like illness (Influenza like illness/ILI) 57 days following the administration of INFLUENZA VACCINE. These events were leading to death. The onset of symptoms to death was 18 days. Date of death was not reported. Deceased patient who has met the operational definition of ILI/SARI with a positive result for influenza was issued by one of the laboratories. Final diagnosis was (fatal) Influenza A virus test positive. It was reported that the patient received an unspecified antiviral corrective treatment. It was unknown if an autopsy was done. The cause of death was conservatively considered as Influenza A virus test positive and Influenza like illness. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 01 year old female patient who died post developing Influenza A H1N1 (Influenza A virus subtype H1N1 test positive) with symptom Influenza like illness, 57 days after the vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The onset of symptoms to death was 18 days. The time to onset was compatible with a potential vaccination failure. Positive result for influenza was issued by laboratory examination. The patient''s medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the available information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: influenza-like illness; Influenza A H1N1 PMD


VAERS ID: 852043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H3N2 influenza, Influenza, Influenza like illness, Respiratory tract infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXSA2019SA341932

Write-up: Influenza A H3; influenza-like illness; severe acute respiratory infection; Influenza A H3; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case was linked to cases 2019SA341911, 2019SA341944, 2019SA341964, 2019SA341972 and 2019SA341977 (same article). Article Summary: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 02 years old male patient who developed A H3 (H3N2 influenza) while she received vaccine INFLUENZA VACCINE. The patient medical history, concomitant therapy and family history were not provided. Patient had a history of vaccination (brand name not specified). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious A H3 (H3N2 influenza) (Influenza A virus infection), influenza-like illness (Influenza like illness/ILI), severe acute respiratory infection/SARI (Respiratory tract infection) 93 days following the administration of INFLUENZA VACCINE. These events were leading to death.The onset of symptoms to death was 3 days. Date of death was not reported. Deceased patient who has met the operational definition of ILI/SARI with a positive result for influenza was issued by one of the laboratories. Final diagnosis was (fatal) influenza. It was reported that the patient received an unspecified antiviral corrective treatment. It was unknown if an autopsy was done. The cause of death was conservatively considered as H3N2 influenza, Influenza A virus infection, Influenza like illness/ILI, severe acute respiratory infection/SARI. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 02 years old male patient who died post developing H3N2 influenza, Influenza like illness, severe acute respiratory infection 93 days after the vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The onset of symptoms to death was 3 days. The time to onset was compatible with a potential vaccination failure. Positive result for influenza was issued by laboratory examination. The patient''s medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the available information, the role of the vaccine cannot be ruled out.; Reported Cause(s) of Death: A H3; influenza-like illness; severe acute respiratory infection; Influenza A H3


VAERS ID: 852044 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza, Influenza A virus test positive, Influenza like illness
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: A h1n1; Result Unstructured Data: positive
CDC Split Type: MXSA2019SA341944

Write-up: A H1N1 PMD; Influenza like illness; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case is linked to cases 2019SA341911, 2019SA341932, 2019SA341964, 2019SA341972 and 2019SA341977 (same article). Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 38 years old female patient who developed A H1N1 PMD (influenza) and influenza like illness (influenza like illness), while she received vaccine INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious A H1N1 PMD (influenza) and influenza like illness 50 days following the administration of INFLUENZA VACCINE. These events were leading to death. Relevant laboratory test results included: H1N1 influenza - On an unknown date: positive. Final diagnosis was (fatal) influenza. It was not reported if the patient received a corrective treatment. The patient died because of influenza. It is unknown if an autopsy was done. The cause of death was reported as influenza like illness and influenza. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 38 years old female patient who died due to the influenza (A H1N1 PMD virus infection) 50 days after the vaccination with INFLUENZA VACCINE. The time to onset was compatible with a potential vaccination failure. The patient''s past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Influenza like illness; Influenza A virus infection


VAERS ID: 852045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza A virus test positive, Respiratory tract infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: A H1N1; Result Unstructured Data: Positive
CDC Split Type: MXSA2019SA341964

Write-up: influenza A H1N1; severe acute respiratory infection; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. This case is linked to case 2019SA341944, 2019SA341977, 2019SA341932 (same reporter). The following is verbatim from the article: Introduction: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential.1,2 Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations.New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious The efficacy and effectiveness of the influenza vaccine depends on multiple factors such as age, immunocompetence, the degree of similarity between the viruses contained in the vaccine and the circulating viruses, among others.After vaccination, the levels of viral hemagglutinin proteins and neuraminidase slowly decrease; the reduction can exceed 50% after 600 days.3,5 In adults over 60 years of age, seroprotection after vaccination against influenza type A has been reported; this has been greater than four months in components H3N2 and H1N1.6 A study concluded that people with a history of vaccination greater than 200 days have a higher risk of contracting the disease than those who have done so a few days prior.7 The range of effectiveness in 2011-2012 for influenza A (H3N2) was estimated at 53% in people vaccinated less than three months prior and 12% in those vaccinated three or more months prior. This case involves a 46 year old female patient who was diagnosed with influenza A H1N1 (H1N1 influenza) along with symptoms of severe acute respiratory infection (respiratory tract infection), while she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious influenza A H1N1 (H1N1 influenza) and severe acute respiratory infection (respiratory tract infection) 66 days following the administration of INFLUENZA VACCINE. This event were assessed as medically significant and were leading to death (23 days after onset of symptoms to death). Other relevant tests included Influenza A virus test positive. Final diagnosis was (fatal) H1N1 influenza. It was not reported if the patient received a corrective treatment. On an unknown date, the event outcome was reported as fatal for influenza. It is unknown if an autopsy was done. The cause of death was reported as H1N1 influenza. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 46 years old female patient who died due to the influenza (AH1N1 virus infection) 66 days after the vaccination with INFLUENZA VACCINE. The time to onset is compatible. The patient''s past medical history, concomitant medications, concomitant diseases, and lab data ruling out other etiologies or confirming the diagnosis as well as cause of death would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: influenza H1N1; Respiratory tract infection


VAERS ID: 852046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Influenza A virus test positive, Influenza like illness, Respiratory tract infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza A virus infection; Result Unstructured Data: Positive
CDC Split Type: MXSA2019SA341972

Write-up: A H3; severe acute respiratory infection; Influenza like illness; potential vaccination failure; Initial unsolicited valid serious case report received from the literature on 03-Dec-2019. This case is linked to cases 2019SA341944, 2019SA341932, 2019SA341964 and 2019SA341977 (same literature). The following is verbatim from the article: Introduction: Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential.1,2 Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations.New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious The efficacy and effectiveness of the influenza vaccine depends on multiple factors such as age, immunocompetence, the degree of similarity between the viruses contained in the vaccine and the circulating viruses, among others (Table 1).After vaccination, the levels of viral hemagglutinin proteins and neuraminidase slowly decrease; the reduction can exceed 50% after 600 days.3,5 In adults over 60 years of age, seroprotection after vaccination against influenza type A has been reported; this has been greater than four months in components H3N2 and H1N1.6 A study concluded that people with a history of vaccination greater than 200 days have a higher risk of contracting the disease than those who have done so a few days prior.7 In the country, the range of effectiveness in 2011-2012 for influenza A (H3N2) was estimated at 53% in people vaccinated less than three months prior and 12% in those vaccinated three or more months prior. This case involves an 82 years old female patient who experienced A H3 (Influenza), while she received vaccine INFLUENZA VACCINE. Medical history, past medical treatment, past vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and other dosing details were not reported). On an unknown date, the patient developed A H3 (Influenza) with severe acute respiratory infection (respiratory tract infection) and influenza like illness (influenza like illness), 51 days following the administration of INFLUENZA VACCINE. The event influenza was assessed as medically significant and these events were leading to death. It was reported that, the patient died 10 days after the onset of events. It was also a case of potential vaccination failure Relevant laboratory test results included: On an unknown date, influenza was positive. Final diagnosis was (fatal) influenza. It was not reported if the patient received any corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Influenza.; Sender''s Comments: This case concerns a 82 years old female patient who died due to influenza (AH3 virus infection) 51 days after the vaccination with INFLUENZA VACCINE. The time to onset is compatible with a potential vaccination failure. However, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: A H3; Influenza like illness; severe acute respiratory infection; potential vaccination failure


VAERS ID: 852047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, H3N2 influenza, Influenza A virus test positive, Influenza like illness, Respiratory tract infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: A H3; Result Unstructured Data: Positive
CDC Split Type: MXSA2019SA341977

Write-up: AH3; severe acute respiratory infection; influenza-like illness; potential vaccination failure; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case via other healthcare professional issued from a literature article. Influenza, seasonal or pandemic, is a disease caused by an RNA virus that belongs to the Orthomyxoviridae family. There are three types of influenza viruses: A, B, and C, which include different subtypes. The virus is transmitted through the air or by fomites and has high pandemic potential. Influenza A viruses are divided into subtypes based on the characterization of two surface antigens: hemagglutinin and neuraminidase. Influenza A (H1N1 and H3N2) and B circulate simultaneously in the world. The new variants of the influenza virus appear as a result of specific mutations and recombination events that occur during viral replication, generating frequent antigenic variations. New or very different subtypes of influenza A virus resulting from antigenic variations have the potential to produce a pandemic, from the time they are capable of causing disease in humans, maintaining effective sustained transmission and if there is little or no previous immunity in the population. Influenza epidemics can adversely affect the population and are a greater risk to the young and elderly and in people with comorbidities. Throughout history, influenza has caused major epidemics that have resulted in high mortality rates. Epidemiological surveillance of influenza and vaccination are indispensable for the prevention of outbreaks and epidemics which can be life threatening to the population. Effective vaccination prevents the onset of serious cases and decreases mortality. This case involves a 86 years old female patient who was diagnosed with AH3 (influenza) along with symptoms of severe acute respiratory infection (respiratory tract infection), influenza-like illness (influenza like illness) and potential vaccination failure (vaccination failure) while she received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious AH3 (influenza), severe acute respiratory infection (respiratory tract infection), influenza-like illness (influenza like illness) 44 days following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and were leading to death (4 days after onset of symptoms to death). It was also a case of potential vaccination failure. Relevant laboratory test results included: On an unknown date the Influenza A virus test: Positive. Final diagnosis was influenza (fatal) Patient also recieved antiviral. On an unknown date, the event outcome was reported as fatal for influenza. It was unknown if an autopsy was done. The cause of death was conservatively captured as AH3 (influenza) along with symptoms of severe acute respiratory infection (respiratory tract infection), influenza-like illness (influenza like illness) and potential vaccination failure (vaccination failure) as exact cause of death was not reported. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 86 years old female patient who died due to the influenza (AH3 virus infection) 44 days after the vaccination with INFLUENZA VACCINE. The time to onset is compatible. The patient''s past medical history, concomitant medications, cause of death, concomitant diseases and lab data confirming the diagnosis and relevant tests ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: A H3; Influenza like illness; severe acute respiratory infection; potential vaccination failure


VAERS ID: 852144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-12-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Pneumococcal infection, Septic shock
SMQs:, Lack of efficacy/effect (narrow), Toxic-septic shock conditions (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic; COPD; Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019532104

Write-up: severe septic shock following pneumococcal infection; severe septic shock following pneumococcal infection; Drug ineffective; This is a spontaneous report received from a contactable physician via a sales representative. A 7-decade-old (reported as his 60s) male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13), via an unspecified route of administration on Dec2018 at single dose for immunization, and two months later had received pneumococcal vaccine polysacch 23v (PNEUMOVAX), via an unspecified route of administration on Feb2019 at unspecified dose for an unspecified indication. Medical history included patient was alcoholic, tobacco user and had COPD. The patient''s concomitant medications were not reported. It was reported that the patient experienced severe septic shock with pneumococcal infection and the patient died on an unspecified date. It was unknown if autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results and the events onset date are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Septic shock; Pneumococcal infection; Drug ineffective


VAERS ID: 852393 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis bacterial, Death, Drug ineffective, Meningitis pneumococcal, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Arthritis (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019534683

Write-up: Drug Ineffective; Pneumococcal meningitis; Septic arthritis; Septicemia; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history included immunodeficiency. Concomitant medications were unknown. On an unspecified date, the patient was hospitalized due to septic arthritis with septicemia secondary to pneumococcal meningitis. He died on unspecified date despite the vaccination. It was unknown if autopsy was performed. The information on the lot number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Drug Ineffective; Pneumococcal meningitis; Septic arthritis; Septicemia


VAERS ID: 852518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131912BRA005516

Write-up: cases of the city Goianira (where a girl died after taking the 3 doses) of the [HPV] vaccine; Information has been received from a post published by a consumer on an online blog/ website via media referring to a female patient of unknown age. Information about patient''s concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patient was vaccinated with 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacture unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient died. The cause of death and if an autopsy was performed were not reported. Causality was not reported. This is two of several reports received from the same reporter.; Sender''s Comments: BR-009507513-1912BRA005596:


VAERS ID: 852529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL2019EM

Write-up: death; This case was reported by a consumer via interactive digital media and described the occurrence of death in an upspecified number of patient''s who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, several months after receiving Influenza vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Influenza vaccine. Additonal details were provided as follows: The age at vaccination was not provided. Older patients were vaccinated against flu vaccine and each one of them died several months after the vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 852626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test
CDC Split Type: DKPFIZER INC2019536399

Write-up: Afterwards, the mother died from pneumonia; Afterwards, the mother died from pneumonia; This is a spontaneous report from a contactable nurse (daughter of the patient) via Medical Information. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) (batch number was not reported), via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient''s medical history and concomitant medications were not reported. It was reported that afterwards, the mother (patient) died from pneumonia on an unspecified date. The patient underwent lab test included blood tests on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: The mother died from pneumonia; The mother died from pneumonia


VAERS ID: 852646 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-06
Onset:2019-12-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / 2 - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Death, Dyspnoea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191207; Test Name: Body temperature; Result Unstructured Data: Test Result: high fever
CDC Split Type: ITPFIZER INC2019536423

Write-up: high fever and difficulty breathing; high fever and difficulty breathing; death; This is a spontaneous report from a contactable physician through a Pfizer sales representative, and a contactable consumer. The reporter reported similar event for two patients, this is the first of two reports. A 4-month-old male patient received the second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) at single dose, and second dose of diphtheria vaccine, hepatitis b vaccine, hib vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (trade name unknown) at unknown dose, both via an unspecified route of administration on 06Dec2019 for immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of both vaccines on an unspecified date in Nov2019 for immunization and experienced no adverse effect. A four months old patient died at the hospital on 07Dec2019. He arrived on 07Dec2019 with his twin sister, both of whom had high fever and difficulty breathing. The patient died shortly after arriving in the hospital, the sister was alive but was still under observation. On 07Dec2019, the father of the patients alerted the rescuers, worried because his children were breathing badly and had a high fever. Immediately, the health workers had arrived aboard an ambulance. Given their worrying conditions, the two patients had been rushed to the hospital emergency room. When, unfortunately, the patients came to the emergency room, there was nothing for the male patient to do, his little heart had stopped beating. The physicians had only been able to verify the death. The twin sister instead was entrusted to the care of medical personnel and hospitalized in hospital. On 09Dec2019, an autopsy had been performed on the patient''s body. The police seized all the clinical documentation relating to the patient to carry out investigations. The policemen were investigating the patient''s death. The vaccine recall to which the little brother was subjected on 06Dec2019 was also investigated. As reported, under investigation also the vaccination recall, to which both underwent on 06Dec2019, after exactly one month from the first dose. The Prosecutor''s Office opened an investigation. The police had acquired all the clinical documentation and were carrying out various investigations, pending the results of the autopsy scheduled on 09Dec2019. The investigations also took into consideration various external factors that may have caused the tragedy. In the viewfinder of the investigators also the vaccination recall performed on 06Dec2019, exactly one month after the first, which however had not brought any complication. No follow-up attempts are possible. information about batch number cannot be obtained.; Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results is received. High fever and difficulty breathing are more likely associated with the infant underlying or coincidental medical conditions; however, a contributory role of the suspected vaccines cannot be fully excluded in light of time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IT-PFIZER INC-2019536758 same drug, different patient, similar event; Reported Cause(s) of Death: death


VAERS ID: 852773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-21
Onset:2019-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD450A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX7ABAA ? / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AN3638 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC259AE / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYTRON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201922

Write-up: Death; This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 8-week-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD450A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC259AE, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number abx7abaa ?, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AN3638, expiry date unknown) for prophylaxis. Concomitant products included sodium feredetate (Sytron) and vitamins nos (Dalivit). On 21st November 2019, the patient received Infanrix hexa (unknown), Rotarix liquid formulation (unknown), Bexsero (intramuscular) and PREVENAR 13 (unknown). On 22nd November 2019, 1 days after receiving Infanrix hexa, Rotarix liquid formulation and Bexsero, the patient experienced death unexplained (serious criteria death and GSK medically significant). On 22nd November 2019, the outcome of the death unexplained was fatal. The patient died on 22nd November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death unexplained to be related to Infanrix hexa, Rotarix liquid formulation and Bexsero. Additional details: The age at vaccination was not reported. The reported batch number abx7abaa for bexsero did not match with GSK lot number. Initial information was received from a physician via regulatory authority on 11 December 2019: Death unexplained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 852774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-15
Onset:2019-10-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABXA40AB / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Computerised tomogram head abnormal, Death, Haematoma, Pallor, Somnolence, Subdural haematoma, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-31
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Upper respiratory tract infection (on 11th October 2019)
Allergies:
Diagnostic Lab Data: Test Date: 20191029; Test Name: Body temperature; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20191030; Test Name: Brain computerized tomography; Result Unstructured Data: Test Result: expanded subdural and cerebral haematoma, Test Result Unit: unknown
CDC Split Type: HUGLAXOSMITHKLINEHU201922

Write-up: expanded subdural haematoma; expanded cerebral haematoma; vomited three times; pallor; 4 fingertip-size haematomas on the chest; somnolence; This case was reported by a physician via regulatory authority and described the occurrence of subdural haematoma in a 3-month-old female patient who received Men B NVS (Bexsero) (batch number ABXA40AB, expiry date unknown) for meningococcal immunization. Co-suspect products included PENTAXIM (batch number ROB 851, expiry date unknown) for prophylaxis and MENINGOCOCCAL GROUP C CONJUGATE VACCINE (NEISVAC-C) (batch number ARO6561, expiry date unknown) for prophylaxis. The patient''s past medical history included upper respiratory tract infection (on 11th October 2019). On 15th October 2019, the patient received Bexsero (intramuscular) .5 ml. On 1st October 2019, the patient received PENTAXIM (intramuscular) .5 ml and NEISVAC-C (intramuscular) .5 ml. On 29th October 2019, 14 days after receiving Bexsero and 28 Day after receiving PENTAXIM and NEISVAC-C, the patient experienced vomiting (serious criteria death), pallor (serious criteria death), haematoma (serious criteria death) and somnolence (serious criteria death). On 30th October 2019, the patient experienced subdural haematoma (serious criteria death and GSK medically significant) and cerebral haematoma (serious criteria death and GSK medically significant). On 31st October 2019, the outcome of the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence were fatal. The patient died on 31st October 2019. The reported cause of death was vomiting, pallor, subdural haematoma, cerebral hematoma, hematoma and somnolence. It was unknown if the reporter considered the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence to be related to Bexsero. Additional details: The age at vaccination was not reported, however the patient was 2 or 3-month-old at the time of vaccination. It was unknown if the reporter considered the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence to be related to Neisvac-C and Pentaxim. On 30th October 2019, CT brain scan showed expanded subdural and cerebral haematoma. On 29th October 2019, Body temperature was normal. Initial information was reported by a physician via regulatory authority on 11th December 2019: Vomited three times, subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence. Sender''s comments : According to the SmPCs, vomitus and somnolence are expected adverse events of BEXSERO, PENTAXIM and NEISVAC-C. Pallor is expected for BEXSERO. Cutaneous haematoma is rare adverse event of NEISVAC-C, listed in the product information. Subdural and cerebral haematomas are considered unexpected events. The events occured around the same time, which is suggestive of a common etiology, vomitus, somnolence and pallor is presumably related symptoms of haematomas. Chest subduraland cerebral haematomas are suggestive of an excessive bleeding by the patient. Time to onset was 14 days for BEXSERO and 28 days for PENTAXIM and NEISVAC-C. Due to lack of close temporality and fatal symptoms that are not typical for adverse reactions after vaccination, causal relationship between BEXSERO, PENTAXIM, NEISVAC-C and the reported adverse events (vomitus, pallor, somnolence, chest-, subdural- and cerebral haematomas) is assessed unlikely. The case is considered serious due to fatal outcome. Further information is expected from the national competent authority for vaccines.; Reported Cause(s) of Death: Vomiting; Pallor; Subdural haematoma; Cerebral haematoma; Haematoma; Somnolence


VAERS ID: 852775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-15
Onset:2019-11-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA422AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Hypoaesthesia, Neurological examination
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEO-LOTAN PLUS; ZUGLIMET; IPAMIX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191128; Test Name: Neurological examination; Result Unstructured Data: Test Result: unknown, Test Result Unit: unknown
CDC Split Type: ITGLAXOSMITHKLINEIT201922

Write-up: from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; This case was reported by a physician via regulatory authority and described the occurrence of paralysis ascending in a 81-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number AFLBA422AA, expiry date unknown) for prophylaxis. Concomitant products included hydrochlorothiazide + losartan potassium (Neo-Lotan Plus), metformin hydrochloride (Zuglimet) and indapamide (Ipamix). On 15th November 2019, the patient received Fluarix Tetra 2019-2020 season (subcutaneous) 1 dosage form(s). On 24th November 2019, 9 days after receiving Fluarix Tetra 2019-2020 season, the patient experienced paralysis ascending (serious criteria death and GSK medically significant), hyposthenia (serious criteria death), asthenia (serious criteria death) and hypesthesia (serious criteria death). On an unknown date, the outcome of the paralysis ascending, hyposthenia, asthenia and hypesthesia were fatal. The patient died on 1st December 2019. The reported cause of death was hyposthenia, asthenia, paralysis ascending and hypoesthesia. It was unknown if the reporter considered the paralysis ascending, hyposthenia, asthenia and hypesthesia to be related to Fluarix Tetra 2019-2020 season. Additional details; The age at vaccination was not reported however patient could be 80 or 81 years old at the time of vaccination. On 28th November 2019, Neurological examination was done. Initial information was reported by a physician via regulatory authority on 11th December 2019; From 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. Suspect sindrome guillain-barre ''(progressive paralysis) Reporter''s comment: Felt the physician on 03/12/2019 for clarifications about the report. The patient has carried out the vaccine on 11/15/2019 for the first time (he had never made it back). The symptoms are verified after 9 days from the vaccination on 11/24/2019: Astenia, ipostenia, hypoesthesia lower limbs with initial progressive development of upper arts. Suspect sindrome guillain-barre ''(progressive paralysis). The patient has been recovered to the hospital. Sender''s comment: Rest pending for delivery by the doctor of the report form with addition of the requested information.; Reported Cause(s) of Death: Hyposthenia; Asthenia; Paralysis ascending; Hypesthesia


VAERS ID: 852852 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSEQIRUS201907281

Write-up: Influenza; This is a spontaneous case reported by physician and other non-health professional to Regulatory Authority (Reference number: AU-TGA-0000482240) and initially retrieved on 13-Dec-2019, concerning a patient of unknown age and gender. The patient''s medical history was not reported. The patient concomitant medication was not reported. On an unspecified date in 2017, the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, dose, route of administration, number, anatomical location, trade name, manufacturer and expiry date: not reported] for unknown indication. On an unspecified date, after unknown amount of time after administration of vaccine, the patient developed a serious influenza. The event was leading to death. The patient died. Final diagnoses was influenza and the cause of death was influenza. It was unknown if an autopsy was done. On an unspecified date, the outcome of event was fatal. The event was assessed as a serious due to the criterion of death and medical significance. The reporter did not provided causality. Company comment: The patient developed influenza, on an unknown date after administration of an unspecified Influenza vaccine. Chronology needs more clarification. Reportedly, the patient died and the cause of death was influenza. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.; Reporter''s Comments: The patient developed a serious influenza.; Sender''s Comments: The patient developed influenza, on an unknown date after administration of an unspecified Influenza vaccine. Chronology needs more clarification. Reportedly, the patient died and the cause of death was influenza. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.; Reported Cause(s) of Death: Influenza


VAERS ID: 852891 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131912BRA006917

Write-up: Death of a child after taking HPV vaccine; This spontaneous report was received from a physician via company representative regarding a child of unknown age and gender. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacture unknown) (strength, dose, frequency, route and lot number with expiration date were not reported) for prophylaxis. The physician stated that a report from agency (immunization national program) came via Health Secretariat, which reported that a child had died after taking hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacture unknown). The cause of death was unknown. It was unknown if an autopsy was performed. Causality assessment was not provided. This is one of the 2 reports obtained from same reporter.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 852899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-19
Onset:2019-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR201922

Write-up: DEATH OF INFANT; Cardio-respiratory arrest; This case was reported by a physician via regulatory authority and described the occurrence of crib death in a 4-month-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PREVENAR 13) for prophylaxis. On 19th November 2019, the patient received Infanrix (intramuscular) 1 dosage form(s) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 20th November 2019, 1 days after receiving Infanrix, the patient experienced cardio-respiratory arrest (serious criteria death and GSK medically significant). On 21st November 2019, the patient experienced crib death (serious criteria death and GSK medically significant). Infanrix was discontinued. PREVENAR 13 was discontinued. On an unknown date, the outcome of the crib death and cardio-respiratory arrest were fatal. The reported cause of death was crib death and cardio-respiratory arrest. It was unknown if the reporter considered the crib death and cardio-respiratory arrest to be related to Infanrix. Additional details: The age at vaccination was not reported, however the patient was 3 or 4 month-old at the time of vaccination. It was unknown if the reporter considered the crib death and cardio-respiratory arrest to be related to Prevenar 13. The reported vaccine was Infanrix, however the reported active antigen were belonged to Infanrix hexa only. Initial information was reported by a physician via regulatory authority on 11th December 2019: DEATH OF INFANT, Cardio-respiratory arrest. crib death and cardio-respiratory arrest.; Reported Cause(s) of Death: Crib death; Cardio-respiratory arrest


VAERS ID: 852993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-07-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER R030631 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131912GBR006709

Write-up: Patient died after receiving MMRvaxPro; This spontaneous report was received from a coroner''s officer referring to a 70 year old male patient. Information on the patient''s medical history, concurrent conditions and concomitant medications was not reported. On 24-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-RVAXPRO) subcutaneous injection, (dose details, route and anatomical location not reported) lot # R030631 and expiration date reported as September 2020, but upon internal validation established as 30-SEP-2020 for prophylaxis. On an unknown date in 2019, the patient died after administering the vaccine. The cause of death was not reported. It was not reported if an autopsy was performed. It was reported that the reporter would like to speak to someone in the legal department to look into this report. Causality assessment was not provided by the reporter. However, the patient was administered the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-RVAXPRO) vaccine prior to his death and the patient''s family believed this might have been linked to his death and they were trying to ascertain why he was given the vaccine.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 853286 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-01-25
Onset:2019-12-10
   Days after vaccination:684
Submitted: 0000-00-00
Entered: 2019-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB813AB / 1 - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB813AB / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, Death, Fatigue, Gastroenteritis rotavirus, Pyrexia, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191210; Test Name: Body temperature; Result Unstructured Data: Test Result: 39, Test Result Unit: degree C
CDC Split Type: VNGLAXOSMITHKLINEVN2019AP

Write-up: Brain death; 39 deg Fever; suspected vaccination Failure; Rotavirus infection/ Diarrhea; Vomiting; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 2-year-old patient who received Rota (Rotarix liquid formulation) (batch number AROLB813AB, expiry date 31st May 2019) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLB813AB, expiry date 31st May 2019) for prophylaxis. On 25th January 2018, the patient received the 1st dose of Rotarix liquid formulation. On 12th March 2018, the patient received the 2nd dose of Rotarix liquid formulation. On 10th December 2019, 684 days after receiving Rotarix liquid formulation and 638 days after receiving Rotarix liquid formulation, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria death and GSK medically significant), vomiting (serious criteria death) and fatigue (serious criteria death). On 10th December 2019 21:00, the patient experienced fever (serious criteria death). On 11th December 2019, the patient experienced brain death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus, vomiting, fatigue, fever and brain death were fatal. The patient died on 12th December 2019. The reported cause of death was fever, vomiting, diarrhea rotavirus, fatigue and brain death. It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus, vomiting, fatigue, fever and brain death to be related to Rotarix liquid formulation and Rotarix liquid formulation. Additional details were provided as follows: On the morning of 10th December 2019, the family noticed that the patient was having constant diarrhea with yellow stool, and vomiting 8 to 9 times, with fatigue. On the same day at 2 pm the patient was sent to the general hospital. The hospital diagnosed it as acute diarrhea secondary to Rotavirus infection, prescribed medications and discharged the patient. This case was considered as suspected vaccination failure case since the details regarding confirmatory lab test for rotavirus were unknown at the time of reporting. The family requested for the patient to remain in the hospital to be monitored, but the patient was discharged. At 6 pm, the patient still had diarrhea, vomiting and fatigue. At 9 pm, the patient had 39 degree C fever until accident and emergency visit. On 11th December 2019 at 4 am, the patient was announced as brain dead. On 12th December 2019 at 10 pm, the patient passed away.; Reported Cause(s) of Death: Fever; Vomiting; Rotavirus infection/ Diarrhea; Fatigue; Brain death


VAERS ID: 853383 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2019-06-20
Onset:2019-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNB062FI / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER R009911 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Sudden infant death syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VASELINE CETOMACROGOL CREAM FNA
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131912NLD007191

Write-up: Death 3 days after vaccination. Died in the morning, found lifeless in parent''s bed. Working diagnosis: SIDS (sudden infant death syndrome); Vomiting 1 day after vaccination without further symptoms of being sick.; Information has been downloaded from regulatory authority (NL-LRB-00367068). This spontaneous report was received from a other health professional referring to a 16 week old male patient. The patient''s concurrent conditions, and medical history were not provided. Concomitant medications included cetomacrogol 1000, cetostearyl alcohol, mineral oil, petrolatum, white, propylene glycol(VASELINE CETOMACROGOL CREAM FNA). Historical drugs included diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) and pneumococcal 10v conj vaccine (protein d/dip toxoid/tet toxoid) (SYNFLORIX) vaccines and the patient did not present any adverse event. On 20-JUN-2019, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) with a valid lot # R009911, and expiration date confirm as 30-JUN-2021 upon lot validation; 1 dosage form administered into the left leg intramuscularly, as vaccination as part of the immunisation program for babies and children. On the same date, the patient was vaccinated with pneumococcal 10v conj vaccine (protein d/dip toxoid/tet toxoid) (SYNFLORIX) suspension for injection in disposable syringe 0.5ML + accesories / 2nd injection Pneumococci, administered into the right leg intramuscularly, as part of the immunisation program for babies and children. On 21-JUN-2019, the patient experienced vomiting for one day after vaccination without further symptoms of being sick. On 23-JUN-2019 in the morning, and 3 days after vaccination, the patient was found lifeless in parent''s bed. The working diagnosis or cause of death was sudden infant death syndrome (SIDS). It was unknown if an autopsy was performed. The outcome of vomiting was unknown by the time of reporting. The causal relationship between the events and the suspected vaccines was not provided.; Reported Cause(s) of Death: work diagnosis: SIDS (sudden infant death syndrome)


VAERS ID: 853909 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-18
Onset:2019-11-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2019-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019545671

Write-up: cardiac decompensation; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The hospital physician reported fatal events for two patients. This the first of two reports. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number unknown), via an unspecified route of administration on 18Oct2019 at a single dose for immunization. Medical history included splenectomy on an unknown date. The patient''s concomitant medications were not reported. The patient experienced cardiac decompensation on 01Nov2019. The patient died on an unspecified date in 2019. It was not reported if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Based on the information currently available, there was not a reasonable possibility that the event cardiac decompensation is related to the suspected vaccine PREVENAR 13; the event more likely represents the progression of the underlying medical condition. More information such as medical histories including the reason leading to splenectomy and concomitant medication are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : FR-PFIZER INC-2019545701 same reporter, same product ,different event with fatal outcome; Reported Cause(s) of Death: cardiac decompensation


VAERS ID: 853910 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypothermia, Pneumonia aspiration, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Accidents and injuries (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019545701

Write-up: inhalation pneumonia; This is a spontaneous report from a contactable hospital physician via a sales representative, who reported fatal events for two patients. This is the second of two reports. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) on an unknown date, at single dose for immunization . Medical history included splenectomy on an unknown date. Concomitant medications were not reported. On an unknown date the patient experienced respiratory distress with hypothermia. The patient died on an unspecified date and after his death it was concluded to be due to inhalation pneumonia. It was not reported if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Based on the information currently available, the fatal inhalation pneumonia more likely represents an intercurrent medical condition unrelated to PREVENAR 13 use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : FR-PFIZER INC-2019545671 same reporter, same product ,different event with fatal outcome; Reported Cause(s) of Death: inhalation pneumonia


VAERS ID: 853913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-22
Onset:2019-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AN7600 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Presyncope, Renal impairment, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN; ARANESP; PANTOPRAZOLE; LANTUS; FUROSEMIDE; ALLOPURINOL; DOXAZOSIN; HUMALOG; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; IHD; Renal insufficiency; Unspecified cerebrovascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2019542504

Write-up: PERSISTENT COUGH WITH LIPOTYMICAL CRISIS WITH NEXT ADMISSION IN ER 25Nov2019.; PERSISTENT COUGH WITH LIPOTYMICAL CRISIS WITH NEXT ADMISSION IN ER 25Nov2019.; MEAP This is a non-interventional study report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-590619. A 77-years-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot # AN7600) , via an unspecified route of administration from 22Nov2019 to 22Nov2019 at 1 DF, total for pneumococcal immunisation . Medical history included cerebrovascular disorder from an unknown date and unknown if ongoing , myocardial ischaemia from an unknown date and unknown if ongoing , renal failure from an unknown date and unknown if ongoing , diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included simvastatin (SIMVASTATIN) from 27Nov2017 to 27Nov2019, darbepoetin alfa (ARANESP), pantoprazole (PANTOPRAZOLE) from 02Jan2015 to 27Nov2019, insulin glargine (LANTUS) from 02Jan2015 to 27Nov2019, furosemide (FUROSEMIDE) from 01Jan2015 to 27Nov2019 , allopurinol (ALLOPURINOL) from 01Nov2015 to 27Nov2019 , doxazosin (DOXAZOSIN) from 01Jan2017 to 27Nov2019, insulin lispro (HUMALOG) from 01Nov2015 to 27Nov2019, clopidogrel (CLOPIDOGREL) from 01Jan2019 to 27Nov2019. The patient experienced syncope on 23Nov2019 and persistent cough on 23Nov2019 described as persistent cough with lipotymical crisis with next admission in ER 25nov2019). The patient died on 28Nov2019 because of the events. It was not reported if an autopsy was performed. Sender''s Comments: 29Nov2019: update of the death card on 28Nov2019 occurred in the hospital where the hospitalization took place. Updated the predisposing conditions. The attending physician reports that the patient was vaccinated following a consultation with a nephrologist and cardiologist. The vaccination had been well tolerated. Access to the ER was due to an episode of lipotimia and a deterioration in renal function was found in ER. A report is attached. The reporter''s assessment of the causal relationship of the [enter the event term] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the close temporal relationship, the association between the event syncope and cough with lipotymical crisis with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on close temporal relationship. The medical history of cerebrovascular disorder may also be contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Syncope; Cough


VAERS ID: 854242 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-12-19
Onset:2019-12-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVC015AM / UNK - / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR R3B821V / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAGLAXOSMITHKLINEZA2019EM

Write-up: Death; This case was reported by a nurse via licensee and described the occurrence of unknown cause of death in a 12-year-old male patient who received HAV (Havrix Junior) (batch number AHAVC015AM, expiry date January 2022) for prophylaxis. Co-suspect products included DIPHTHERIA TOXOID, PERTUSSIS TOXOID, TETANUS TOXOID (ADACEL) (batch number R3B821V, expiry date November 2020) for prophylaxis. On 19th December 2019, the patient received Havrix Junior and ADACEL. On 19th December 2019, less than a day after receiving Havrix Junior, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 19th December 2019. The reported cause of death was death nos. It was unknown if the reporter considered the unknown cause of death to be related to Havrix Junior. Additional details were provided as follows: The patient received a dose of Adacel Quadra and Havrix Junior and passed away on the same day of vaccination.; Reported Cause(s) of Death: Death


VAERS ID: 854300 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-16
Onset:2019-10-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Lethargy, Respiratory arrest, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131912CHN010482

Write-up: The patient had been lethargic and couldn''t be woke up after returning home.; The patient had been lethargic and couldn''t be woke up after returning home.; The physician confirmed that the patient had stopped breathing, and the patient was declared death after emergency rescue which was invalid.; This spontaneous report was received from centers for disease control (CDC) through Media monitoring department from an online article regarding an infant of unknown age and gender. The patient was full-term and natural labored and had been in good health. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On 16-OCT-2019 at about 15:00, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (batch/lot# R029531, expiry date and strength were not reported) one dosage form(reported as 1 dose) via oral route for prophylaxis. On the same day, the patient also vaccinated with 1 dose of polio vaccine (unspecified) (lot#, expiry date, strength, route of administration and indication were not reported). On the same day, the patient had been lethargic (lethargy) and could not woke up after returning home(somnolence). On the same day at 19:40, the patient was sent to the hospital. The physician confirmed that the patient had stopped breathing and the patient was declared death after emergency rescue which was invalid. The centers for disease control (CDC) investigation concluded that the adverse event was caused by uncertainties of infant vaccination. The cause of death was not reported. The autopsy was not performed. The outcome of lethargy and somnolence was not reported. The causality assessment was not provided by the reporter.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 854302 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-06-17
Onset:2019-09-01
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2019-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Creutzfeldt-Jakob disease, Death
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-01
   Days after onset: 61
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201923

Write-up: Creutzfeldt-Jakob disease; This case was reported by a physician via regulatory authority and described the occurrence of creutzfeldt-jakob disease in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 17th June 2019, the patient received Shingrix (unknown). On 20th September 2019, the patient received Shingrix (unknown). In September 2019, less than 4 months after receiving Shingrix and less than 2 weeks after receiving Shingrix, the patient experienced creutzfeldt-jakob disease (serious criteria death and GSK medically significant). On an unknown date, the outcome of the creutzfeldt-jakob disease was fatal. The patient died in November 2019. The reported cause of death was creutzfeldt-jakob disease. An autopsy was not performed. It was unknown if the reporter considered the creutzfeldt-jakob disease to be related to Shingrix and Shingrix. Additional details: The age at vaccination was not reported, however the patient could be 70 to 71 years old at the time of vaccination. Initial information was reported by a physician via regulatory authority on 23rd December 2019: Creuzfeldt-jakob disease.; Reported Cause(s) of Death: Creutzfeldt-Jakob disease


VAERS ID: 854660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER R3C184V / UNK RL / OT
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNB197AH / UNK LL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC259AH / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEGLAXOSMITHKLINESE201923

Write-up: Death NOS; This case was reported by a other health professional via regulatory authority and described the occurrence of death nos in a 13-week-old male patient who received 10PN-PD-Dit (Synflorix) (batch number ASPNB197AH, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC259AH, expiry date unknown) for prophylaxis and HEXYON (batch number R3C184V, expiry date unknown) for prophylaxis. In November 2019, the patient received Synflorix (intramuscular) .5 ml, the 2nd dose of Rotarix liquid formulation (oral) 1.5 ml and HEXYON (intramuscular) .5 ml. In November 2019, less than a month after receiving Synflorix and Rotarix liquid formulation, the patient experienced death nos (serious criteria death and GSK medically significant). In November 2019, the outcome of the death nos was fatal. The patient died in November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos to be related to Synflorix and Rotarix liquid formulation. Additional details: Age at vaccination was not reported however patient could be 8 or 9 week old at time of vaccination. Patient received Synflorix on left thigh and HEXYON on right thigh. It was unknown if the reporter considered the death nos to be related to HEXYON. Initial information was reported by a other health professional via regulatory authority on 18th December 2019. Death nos.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 854693 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Influenza A virus test positive, Intensive care, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: type A influenza infection, Test Result Unit: unknown
CDC Split Type: CLGLAXOSMITHKLINECL2019GS

Write-up: Suspected vaccination failure; Influenza A virus infection; Death NOS; This case was reported in a literature article and described the occurrence of death nos in a elderly patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), vaccination failure (serious criteria hospitalization and GSK medically significant) and influenza a virus infection (serious criteria hospitalization). On an unknown date, the outcome of the death nos was fatal and the outcome of the vaccination failure and influenza a virus infection were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos, vaccination failure and influenza a virus infection to be related to Flu vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of death NOS in a patient aged between 4 months and 93 years of unspecified gender, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The primary objective of this project was to characterize the clinical, epidemiological and microbiological aspects of patients with health care associated infections (IAAS) by influenza hospitalized in critical patient units (UPC: ICU and Intermediate Care-CI) and Special Care (EC). Secondary objectives assessed compliance with precautions in addition to standard precautions (PAPE) and adherence to influenza vaccination. It was included the patient was hospitalized in CCU and special care with hospital acquired influenza during 2014-2017. [Healthcare-associated infections due to influenza was defined as: symptom onset and/or positive influenza polymerase chain reaction (PCR) after more than 48 hours of hospital admission, without previous respiratory symptoms or previous negative influenza test study. (19/22) of patients had some co-morbidity being the most common high blood pressure (HTA) (13/22). (4/22) of patients were immunocompromised, including patients receiving TOS, TPH, corticosteroid user and newly diagnosed HIV patients]. The patient had at least two co-morbidities. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 2014 and 2017, an unknown period after the vaccination, the patient had symptoms of influenza. The patient had positive influenza by confirmed with polymerase chain reaction (PCR) after more than 48 hours of hospital admission. The patient had type A influenza infection. [In the institution RT-PCR is used as a technique of choice in hospitalized patients due to their high sensitivity and specificity, 95% for both viruses. IAAS cases were identified from positive RT-PCR records for influenza viruses processed in the laboratory. The infection was acquired between days 3 and 126 of hospitalization. Four patients died. All of the deceased had type A infection and were older patients, over 80 years of age, with the exception of a pediatric patient who was a recipient of hyperparathyroidism (HPT). All had at least two co-morbidities, half were immunocompromised, 75% were hospitalized in ICU and 50% with VM]. This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date, the patient was died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death, hospitalization, suspected vaccination failure. Treatment was unknown. The author did not comment on the relationship between the event of influenza A infection, death NOS and unspecified influenza vaccine. The author stated, "Before the diagnosis of a patient hospitalized with influenza, the medical conduct is to evaluate the use of antiviral and the appearance of possible complications. With regard to the IAAS handling, it is fundamental to emphasize the adhesion to the recommendations of control of infections, wash of hands and use of PAPE. The vaccination is one of the preventive resources, available and without cost used in programmatic form to protect, between others, the persons older than 65 years and to those with factors of risk of complicated or serious evolution. The effectiveness of the vaccination in these years is not available; nevertheless, do numbers found in the Centers for Disease Control and Prevention (CDC) range between 20 and 48 % from the year 2014 to 2017." The author concluded, "HAI due to influenza occurred in chronic, older and unvaccinated patients. Education about HAIs and continuous high vaccination coverage must be reinforced. IAAS for influenza happened in chronic patients, of major age, which entered for the most part for cause not respiratory and not vaccinated. It is essential in the IAAS prevention for respiratory viruses, the education to the health personnel and the relatives, who can be the source of contagion of these patients, especially in the period peak of the seasonal influenza. As another prop of the prevention, it is necessary to insist on maintaining a high vaccination cover in these patients." This article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 2 valid cases reported in the same literature article. Lab Comments: On an unspecified date, between 2014 and 2017, lab test was done.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 854704 (history)  
Form: Version 2.0  
Age: 103.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-15
Onset:2019-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS A031840034 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia, Asthenia, Cerebrovascular accident, Death, Decreased appetite, Presyncope
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-26
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIATEC [RAMIPRIL]; CARDIOASPIRIN; LANSOPRAZOLE; ZYLORIC; LASIX [FUROSEMIDE SODIUM]
Current Illness: Cardiomyopathy; Decompensation cardiac
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201907433

Write-up: Suspected cerebral stroke; Inappetence; Aphasia; Asthenia; Presyncope; This is a spontaneous cas, reported by physician to Agency (reference number: IT-MINISAL02-594481) and initially retrieved on 23-Dec-2019 with additional information (being processed together) retrieved on 24-Dec-2019, concerning a 103-year-old, female patient. The patient''s current condition included cardiac decompensation and cardiomyopathy. The patient''s concomitant medications included Triatec (ramipril), Cardioaspirin (acetylsalicylic acid), Zyloric (allopurinol), Lasix (furosemide sodium) and lansoprazole, all for an unknown indication. On 15-Nov-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: A031840034; dose reported as one dosage form; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 19-Nov-2019, four days after vaccination, it was suspected that the patient experienced cerebral stroke. The patient also experienced aphasia, inappetence, asthenia and presyncope. On an unknown date in Nov-2019, the patient had slight recovery of her state. On 24-Nov-2019, the patient experienced new worsening. On 26-Nov-2019, the patient died. It was unknown if autopsy was done. The events of inappetence, aphasia, asthenia, presyncope and stroke were considered serious due to fatal outcome. The reporter did not provide causality assessment. Company comment: All events are considered as related to Fluad (TIV).; Sender''s Comments: All events are considered as related to Fluad (TIV).; Reported Cause(s) of Death: Suspected cerebral stroke; Inappetence; Aphasia; Asthenia; Presyncope


VAERS ID: 854745 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Graft versus host disease, Multiple organ dysfunction syndrome, Mycobacterium avium complex infection, Nervous system disorder, Osteomyelitis, Pneumococcal infection, Pneumococcal sepsis, Viral infection
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIPHTHERIA AND TETANUS TOXOIDS; DIPHTHERIA AND TETANUS TOXOIDS; DIPHTHERIA AND TETANUS TOXOIDS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2019556903

Write-up: Graft versus host disease in gastrointestinal tract; Multiple organ dysfunction syndrome; Mycobacterium avium complex infection; Nervous system disorder; Osteomyelitis; Pneumococcal infection; Pneumococcal sepsis; Vaccination failure; Viral infection; This is a literature report received from an unspecified published source via the Health Regulatory Authority on-line database search. The regulatory authority report number is E2B_02733216. Literature citation was not provided. This information was initially reported to Health Regulatory Authority on 13Aug2019 from an unknown Market Authorization Holder (# CA2019GSK145032). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via unknown route of administration, on an unspecified date at single dose for immunisation , pneumococcal vaccine polysacch (PNEUMOCOCCAL POLYSACCHARIDE VACCINE) , via unknown route of administration, on an unspecified date at single dose for immunisation . The patient medical history was not reported. Concomitant medication included diphtheria vaccine toxoid, tetanus vaccine toxoid (DIPHTHERIA AND TETANUS TOXOIDS) three single doses on an unknown date. On an unknown date the patient experienced graft versus host disease in gastrointestinal tract, multiple organ dysfunction syndrome, mycobacterium avium complex infection, nervous system disorder, osteomyelitis, pneumococcal infection, pneumococcal sepsis, drug ineffective, viral infection. All the reported events led to patient death on an unknown date. It was not reported if an autopsy was performed. Pfizer is a marketing authorization holder of ''Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)'' in the country of incidence. This may be a duplicate report if another marketing authorization holder of ''Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)'' has submitted the same report to the regulatory authorities. Follow-up attempts not possible. No further information expected.; Reported Cause(s) of Death: Graft versus host disease in gastrointestinal tract; Multiple organ dysfunction syndrome; Mycobacterium avium complex infection; Nervous system disorder; Osteomyelitis; Pneumococcal infection; Pneumococcal sepsis; Drug ineffective; Viral infection


VAERS ID: 854746 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumococcal infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2019556945

Write-up: Pneumococcal infection; Pneumococcal infection; This is a spontaneous report from a contactable other unspecified healthcare professional (HCP). This is a report received from the Health Regulatory Authority via an on-line database search. Regulatory authority report number E2B_02601677. This information was initially reported to Health Regulatory Authority on 28May2019 from an unknown Market Authorization Holder (# CA2019GSK093224). A 10-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL CONJ VAC, 13-VAL), on an unspecified date at a single dose for prophylaxis, pneumococcal vaccine conj 10v (SYNFLORIX) on an unspecified date at unspecified dose for prophylaxis. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumococcal infection on an unspecified date, the seriousness of which was reported as death and other medically important conditions. The patient died on an unspecified date. It was not reported if an autopsy was performed. Pfizer is a marketing authorization holder of Pneumococcal Conj Vac, 13-Val in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal Conj Vac, 13-Val has submitted the same report to the regulatory authorities. No Follow-up attempts possible. information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumococcal infection; Pneumococcal infection


VAERS ID: 854915 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-09-01
Onset:2019-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Constipation, Death, Decreased appetite, Dermatomyositis, Dyspnoea exertional, Febrile infection, General physical health deterioration, Pain in extremity
SMQs:, Acute pancreatitis (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-12
   Days after onset: 72
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201923

Write-up: Death; Exertional dyspnea; Appetite lost; Pain in arm; General physical health deterioration; Obstipation; Dermatomyositis; Febrile infection; Stomach pain; This case was reported by a physician via regulatory authority and described the occurrence of stomach pain in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient''s past medical history included febrile infection. Additional patient notes included Z.n. Hamstring. In September 2019, the patient received Shingrix (unknown). In September 2019, less than a month after receiving Shingrix, the patient experienced stomach pain (serious criteria death and hospitalization), exertional dyspnea (serious criteria death and hospitalization), appetite lost (serious criteria death and hospitalization), pain in arm (serious criteria death and hospitalization), general physical health deterioration (serious criteria death and hospitalization), obstipation (serious criteria death and hospitalization), dermatomyositis (serious criteria death, hospitalization and GSK medically significant) and febrile infection (serious criteria death and hospitalization). On 12th November 2019, the patient experienced death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the stomach pain, death, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration, obstipation, dermatomyositis and febrile infection were fatal. The patient died on 12th November 2019. The reported cause of death was dermatomyositis, febrile infection, stomach pain, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration and obstipation. It was unknown if the reporter considered the stomach pain, death, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration, obstipation, dermatomyositis and febrile infection to be related to Shingrix. Additional details: The age at vaccination was not reported, however the patient could be 83 or 84 years old at a time of vaccination. Agency considered that the stomach pain, death, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration and obstipation to be related to Shingrix. Initial information as received from a physician via regulatory authority on 26th December 2019: Stomach pain, death pain, exertional dyspnea, appetite lost, Pain in arm, general physical health deterioration, obstipation; Reported Cause(s) of Death: Dermatomyositis; Febrile infection; Stomach pain; exertional dyspnea; appetite lost; Pain in arm; general physical health deterioration; obstipation


VAERS ID: 855259 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumococcal infection, Streptococcal infection, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Bacterial test; Result Unstructured Data: Test Result: Streptococcus pneumoniae isolated
CDC Split Type: PTPFIZER INC2019545732

Write-up: Pneumococcal disease/streptococcus pneumoniae; Pneumococcal disease/streptococcus pneumoniae; The initial case was missing the following minimum criteria: no suspect product. Upon receipt of follow-up information on 19Dec2019, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 3-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration at single doses for immunization, for the first, second and third dose at 2, 4 and 12-month-old respectively. The patient''s medical history and concomitant medications were not reported. The patient previously took hepatitis b vaccine for immunization at 0, 2 and 4 month-old, HIB vaccine for immunization at 2, 4, 6 and 18 month-old, diphtheria, tetanus and pertussis adsorbed vaccine for immunization at 2, 4, 6 and 18 month-old, poliomyelitis vaccine for immunization at 2, 4, 6 and 18 month-old, meningococcal vaccine (NEISSERIA MENINGIDITIS C VACCINE) for immunization at 12 month-old and measles vaccine live/mumps vaccine live/rubella vaccine live (VASPR 1) for immunization at 12 monthold. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reported cause of death was pneumococcal disease/streptococcus pneumoniae. The patient underwent lab tests and procedures which included bacterial test: streptococcus pneumoniae isolated. Information on batch number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumococcal disease/streptococcus pneumoniae


VAERS ID: 855286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-13
Onset:2019-11-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. R036096 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctivitis, Cough, Death, Neisseria test positive, Polymerase chain reaction positive, Productive cough, Purpura, Pyrexia, Rhinitis, Rhinorrhoea, Skin discolouration, Somnolence, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-27
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Varicella immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HU0095075131912HUN012397

Write-up: purple hematomas all over the body, mouth became black; somnolence; high fever; vomited several times; eyes were phlegmy; nasal discharge; cough; Information has been downloaded from regulatory authority (HU-OGYI-175819). This spontaneous report as received from an other health professional concerning a 14 month old male patient. No concurrent condition, medical history, or concomitant therapy was reported. On 13-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) powder and solvent for suspension for injection, 0.5 mL (strength and frequency unknown; lot# R036096 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-NOV-2020), intramuscularly for varicella immunisation. On 21-NOV-2019, the patient experienced nasal discharge and cough, and his eyes were phlegmy. On 26-NOV-2019, the patient vomited several times, and experienced high fever (40 degree Celsius) and somnolence. On the same day, the patient experienced purple hematomas all over the body, mouth became black. After 4 hours, the patient died on 27-NOV-2019. The cause of death was not reported. Autopsy was performed. On 29-NOV-2019, multi-pathogen polymerase chain reaction (PCR) test showed presence of Neisseria meningitidis. The outcome of all events was reported as fatal. The causality assessment was not provided by the reporter. Sender Comments (agency): According to the SmPC rhinitis, cough, conjunctivitis, fever, vomiting, somnolence and haematomas are all known adverse events of varicella virus vaccine live (oka/merck)(VARIVAX). Time to onset was 8 days for rhinitis, cough, and conjunctivitis, and 13 days for fever, vomiting, somnolence and haematomas, which do not allow for strong causality. The events fever, vomiting, somnolence and haematomas are rather related to the Neisseria meningitidis infection. The case was investigated by the national competent authority for vaccines. The investigator assessed the relationship between the adverse events and vaccination as ''impossible''. In the assessor''s opinion, the immune system weakening caused by the vaccination could have resulted in infections including Neisseria meningitidis, but due to lack of close temporality and the existence of other possible reasons, assessed the causality as ''unlikely''. No further information is expected. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported events Purpura, somnolence, rhinitis, cough, pyrexia, vomiting and conjunctivitis are considered unlikely related to Varivax vaccine therapy. The evidence is not sufficient to suggest a relationship between the investigational therapy and the reported serious adverse events. Causality assessment is impacted by the confounding factor of findings of presence of Neisseria meningitidis which is associated with the events. Company Comment- No changes to Varivax vaccine product safety information are warranted at this time. Merck and Co., Inc, known as MSD outside of the certain countries, continues to monitor the safety profile of the product.; Autopsy-determined Cause(s) of Death: presence of Neisseria meningitidis


VAERS ID: 855600 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dog bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020AP

Write-up: Treatment failure/suspected vaccination failure; Rabies virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and rabies virus infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure and rabies virus infection were fatal. The reported cause of death was rabies virus infection and vaccination failure. The reporter considered the vaccination failure and rabies virus infection to be related to Rabies Vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient of unspecified age and gender, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) as a part of post -exposure prophylaxis. The patient was the part of retrospective study that object was to analyze the causes of failed management of exposure to rabies in province for scientific evidence to design prevention and control measures for rabies. The analysis was performed in 68 cases of failed rabies post exposure prophylaxis from 2007 to 2018. The patient was hurt by dog. The patient was exposed by being bitten by dog. [In this study, all of the patients in the 68 cases were hurt by dogs. Among them, dogs raised by themselves or neighbors accounted for 31 cases and stray animals took 37 cases. None of the attacking animals had received any rabies vaccine. Nine of 68 patients were exposed to rabies one year or more than one year ago (among them, ten years for one case, six years for one case, four years for one case, three years for two cases, two years for two cases and one year for two cases, recall bias may exist). The latent period median of the remaining cases (59 cases) was 18 days (the range of latent period being 4 to 247 days). Patients exposure levels were all level II and level III exposure, among which 5 of the cases were Level II exposure and 63 were level III exposure. Patients exposure sites included 36 cases of head, face and neck, 13 cases of hand, 9 cases of lower limb below knee, 6 cases of lower limb above knee and 4 cases in other parts. The patient''s exposure dates mainly concentrated within May to October. 59 of 68 patients underwent wound cleansing after exposure, among which the cleansing time of 7 cases were 15 minutes and above. The cleansing time of other patients were less than 15 minutes or the cleansing duration was known. 15 patients had confirmed that soap or soapy water were used. 56 cases of the patients underwent sterilization. Two patients had confirmed that hydrogen peroxide and iodine complex were used while the situation of others were unknown. Most of the patients took an occupation as farmers (58.82%), followed by students (19.12%) and children living at home (17.65%). There were also other patients being retiree, migrant worker and the unemployed, one of them in each case. Among the 68 cases, apart from five of the patients living in the town, the rest of the 63 patients lived in rural areas]. No information on patient''s family history, concomitant medication was provided. On an unspecified date between 2007 and 2018, the patient received unspecified rabies vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [In this study, among the cases of failed management of exposure to rabies, 34 cases of the patients who reached exposure level III received rabies immunoglobulin injection. 7 cases of the patients purchased the vaccine from other places or brought the vaccine back home and received the injection home. 60 cases of the patients were vaccinated with 5-dose regimen. Among them, only 15 cases patients completed the full course of the vaccination. 8 cases of the patients received 2-1-1 regimen, yet only 1 case of the patients completed the full vaccination]. The age of vaccination was not provided. On an unspecified date in 2012, the patient developed rabies virus infection. On an unspecified date, the patient was died due to rabies infection. It was unknown whether autopsy was performed. [In this study, the cases of failed management of exposure to rabies were rabies death cases in which even the patients went through wound cleansing, rabies vaccination and rabies passive immunization injection after exposure].This cases has been considered as suspected vaccination schedule being time to onset, vaccination schedule and laboratory confirmation were unknown. This cases considered as serious due to death and suspected vaccination failure. The author did not comment relationship between the event rabies virus infection and unspecified rabies vaccine. The author concluded "The main reasons that caused cases of failed management of exposure to rabies in this Province might include: firstly, the exposed wounds were not treated in a timely and standard manner in standardized outpatient clinic so that the vaccines were substandard or fake vaccines. Therefore, the body could not produce sufficient neutralizing antibody to neutralize the viruses, which leaded to onset. Secondly, the usage rate of passive immunization preparation was not high. For the patients who did not use passive immunization preparation, after the vaccine injection, the viruses had reached the brain before sufficient neutralizing antibody was produced. The third reason is that the patients failed to completed the full course of the vaccination, which leaded to insufficient protective antibody being produced. Fourthly, with economic development, there is an increasing number of dogs raised in rural and urban areas. Dogs on leash, free-range dogs and stray dogs exist at the same time. Human have more chances to get contact with dogs, which makes it easier for human to be exposed to rabies virus. Dogs administration and immunization still remained to be managed in a standard and effective way, which is one of the reasons that caused rabies onset between humans Therefore, the following methods could effectively reduce the failure rate of failed management of exposure to rabies: enhance the technical training of medical staff working in rabies exposure prevention outpatient clinic, improve the standard rabies postexposure prophylaxis procedure, increase the publicity of rabies and further increase the knowledge, attitude and practice of the masses to rabies prevention, regulate the circulation channels of rabies vaccines, and establish and standardize the dogs raising management approach" This is 1 of the 4 valid cases reported in this literature article. This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Reported Cause(s) of Death: Rabies virus infection; vaccination failure


VAERS ID: 855601 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dog bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020GS

Write-up: Treatment failure/suspected vaccination failure; Rabies virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and rabies virus infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure and rabies virus infection were fatal. The reported cause of death was rabies virus infection and vaccination failure. The reporter considered the vaccination failure and rabies virus infection to be related to Rabies Vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient of unspecified age and gender, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) as a part of post -exposure prophylaxis. This case corresponds to table 1 from this literature article. The patient was the part of retrospective study that object was to analyze the causes of failed management of exposure to rabies in province for scientific evidence to design prevention and control measures for rabies. The analysis was performed in 68 cases of failed rabies post exposure prophylaxis from 2007 to 2018. The patient was hurt by dog. The patient was exposed by being bitten by dog. [In this study, all of the patients in the 68 cases were hurt by dogs. Among them, dogs raised by themselves or neighbors accounted for 31 cases and stray animals took 37 cases. None of the attacking animals had received any rabies vaccine. Nine of 68 patients were exposed to rabies one year or more than one year ago (among them, ten years for one case, six years for one case, four years for one case, three years for two cases, two years for two cases and one year for two cases, recall bias may exist). The latent period median of the remaining cases (59 cases) was 18 days (the range of latent period being 4 to 247 days). Patients exposure levels were all level II and level III exposure, among which 5 of the cases were Level II exposure and 63 were level III exposure. Patients exposure sites included 36 cases of head, face and neck, 13 cases of hand, 9 cases of lower limb below knee, 6 cases of lower limb above knee and 4 cases in other parts. The patient''s exposure dates mainly concentrated within May to October. 59 of 68 patients underwent wound cleansing after exposure, among which the cleansing time of 7 cases were 15 minutes and above. The cleansing time of other patients were less than 15 minutes or the cleansing duration was known. 15 patients had confirmed that soap or soapy water were used. 56 cases of the patients underwent sterilization. Two patients had confirmed that hydrogen peroxide and iodine complex were used while the situation of others were unknown. Most of the patients took an occupation as farmers (58.82%), followed by students (19.12%) and children living at home (17.65%). There were also other patients being retiree, migrant worker and the unemployed, one of them in each case. Among the 68 cases, apart from five of the patients living in the town, the rest of the 63 patients lived in rural areas]. No information on patient''s family history, concomitant medication was provided. On an unspecified date between 2007 and 2018, the patient received unspecified rabies vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [In this study, among the cases of failed management of exposure to rabies, 34 cases of the patients who reached exposure level III received rabies immunoglobulin injection. 7 cases of the patients purchased the vaccine from other places or brought the vaccine back home and received the injection home. 60 cases of the patients were vaccinated with 5-dose regimen. Among them, only 15 cases patients completed the full course of the vaccination. 8 cases of the patients received 2-1-1 regimen, yet only 1 case of the patients completed the full vaccination]. The age of vaccination was not provided. On an unspecified date in 2014, the patient developed rabies virus infection. On an unspecified date, the patient was died due to rabies infection. It was unknown whether autopsy was performed. [In this study, the cases of failed management of exposure to rabies were rabies death cases in which even the patients went through wound cleansing, rabies vaccination and rabies passive immunization injection after exposure].This cases has been considered as suspected vaccination schedule being time to onset, vaccination schedule and laboratory confirmation were unknown. This cases considered as serious due to death and suspected vaccination failure. The author did not comment relationship between the event rabies virus infection and unspecified rabies vaccine. The author concluded "The main reasons that caused cases of failed management of exposure to rabies might include: firstly, the exposed wounds were not treated in a timely and standard manner in standardized outpatient clinic so that the vaccines were substandard or fake vaccines. Therefore, the body could not produce sufficient neutralizing antibody to neutralize the viruses, which leaded to onset. Secondly, the usage rate of passive immunization preparation was not high. For the patients who did not use passive immunization preparation, after the vaccine injection, the viruses had reached the brain before sufficient neutralizing antibody was produced. The third reason is that the patients failed to completed the full course of the vaccination, which leaded to insufficient protective antibody being produced. Fourthly, with economic development, there is an increasing number of dogs raised in rural and urban areas. Dogs on leash, free-range dogs and stray dogs exist at the same time. Human have more chances to get contact with dogs, which makes it easier for human to be exposed to rabies virus. Dogs administration and immunization still remained to be managed in a standard and effective way, which is one of the reasons that caused rabies onset between humans Therefore, the following methods could effectively reduce the failure rate of failed management of exposure to rabies: enhance the technical training of medical staff working in rabies exposure prevention outpatient clinic, improve the standard rabies postexposure prophylaxis procedure, increase the publicity of rabies and further increase the knowledge, attitude and practice of the masses to rabies prevention, regulate the circulation channels of rabies vaccines, and establish and standardize the dogs raising management approach" This is 1 of the 4 valid cases reported in this literature article. This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Reported Cause(s) of Death: Rabies virus infection; vaccination failure


VAERS ID: 855602 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dog bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020GS

Write-up: Treatment failure/suspected vaccination failure; Rabies virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and rabies virus infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure and rabies virus infection were fatal. The reported cause of death was rabies virus infection and vaccination failure. The reporter considered the vaccination failure and rabies virus infection to be related to Rabies Vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient of unspecified age and gender, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) as a part of post -exposure prophylaxis. The patient was the part of retrospective study that object was to analyze the causes of failed management of exposure to rabies in province for scientific evidence to design prevention and control measures for rabies. The analysis was performed in 68 cases of failed rabies post exposure prophylaxis from 2007 to 2018. The patient was hurt by dog. The patient was exposed by being bitten by dog. [In this study, all of the patients in the 68 cases were hurt by dogs. Among them, dogs raised by themselves or neighbors accounted for 31 cases and stray animals took 37 cases. None of the attacking animals had received any rabies vaccine. Nine of 68 patients were exposed to rabies one year or more than one year ago (among them, ten years for one case, six years for one case, four years for one case, three years for two cases, two years for two cases and one year for two cases, recall bias may exist). The latent period median of the remaining cases (59 cases) was 18 days (the range of latent period being 4 to 247 days). Patients exposure levels were all level II and level III exposure, among which 5 of the cases were Level II exposure and 63 were level III exposure. Patients exposure sites included 36 cases of head, face and neck, 13 cases of hand, 9 cases of lower limb below knee, 6 cases of lower limb above knee and 4 cases in other parts. The patient''s exposure dates mainly concentrated within May to October. 59 of 68 patients underwent wound cleansing after exposure, among which the cleansing time of 7 cases were 15 minutes and above. The cleansing time of other patients were less than 15 minutes or the cleansing duration was known. 15 patients had confirmed that soap or soapy water were used. 56 cases of the patients underwent sterilization. Two patients had confirmed that hydrogen peroxide and iodine complex were used while the situation of others were unknown. Most of the patients took an occupation as farmers (58.82%), followed by students (19.12%) and children living at home (17.65%). There were also other patients being retiree, migrant worker and the unemployed, one of them in each case. Among the 68 cases, apart from five of the patients living in the town, the rest of the 63 patients lived in rural areas]. No information on patient''s family history, concomitant medication was provided. On an unspecified date between 2007 and 2018, the patient received unspecified rabies vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [In this study, among the cases of failed management of exposure to rabies, 34 cases of the patients who reached exposure level III received rabies immunoglobulin injection. 7 cases of the patients purchased the vaccine from other places or brought the vaccine back home and received the injection home. 60 cases of the patients were vaccinated with 5-dose regimen. Among them, only 15 cases patients completed the full course of the vaccination. 8 cases of the patients received 2-1-1 regimen, yet only 1 case of the patients completed the full vaccination]. The age of vaccination was not provided. On an unspecified date in 2016, the patient developed rabies virus infection. On an unspecified date, the patient was died due to rabies infection. It was unknown whether autopsy was performed. [In this study, the cases of failed management of exposure to rabies were rabies death cases in which even the patients went through wound cleansing, rabies vaccination and rabies passive immunization injection after exposure].This cases has been considered as suspected vaccination failure being time to onset, vaccination schedule and laboratory confirmation were unknown. This cases considered as serious due to death and suspected vaccination failure. The author did not comment relationship between the event rabies virus infection and unspecified rabies vaccine. The author concluded "The main reasons that caused cases of failed management of exposure to rabies in this Province might include: firstly, the exposed wounds were not treated in a timely and standard manner in standardized outpatient clinic so that the vaccines were substandard or fake vaccines. Therefore, the body could not produce sufficient neutralizing antibody to neutralize the viruses, which leaded to onset. Secondly, the usage rate of passive immunization preparation was not high. For the patients who did not use passive immunization preparation, after the vaccine injection, the viruses had reached the brain before sufficient neutralizing antibody was produced. The third reason is that the patients failed to completed the full course of the vaccination, which leaded to insufficient protective antibody being produced. Fourthly, with economic development, there is an increasing number of dogs raised in rural and urban areas. Dogs on leash, free-range dogs and stray dogs exist at the same time. Human have more chances to get contact with dogs, which makes it easier for human to be exposed to rabies virus. Dogs administration and immunization still remained to be managed in a standard and effective way, which is one of the reasons that caused rabies onset between humans Therefore, the following methods could effectively reduce the failure rate of failed management of exposure to rabies: enhance the technical training of medical staff working in rabies exposure prevention outpatient clinic, improve the standard rabies postexposure prophylaxis procedure, increase the publicity of rabies and further increase the knowledge, attitude and practice of the masses to rabies prevention, regulate the circulation channels of rabies vaccines, and establish and standardize the dogs raising management approach" This is 1 of the 4 valid cases reported in this literature article. This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Reported Cause(s) of Death: Rabies virus infection; vaccination failure


VAERS ID: 855603 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dog bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020GS

Write-up: Treatment failure/suspected vaccination failure; Rabies virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis, Rabies NVS (Rabies Vaccine) for prophylaxis, Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received the 1st dose of Rabies Vaccine, the 2nd dose of Rabies Vaccine, the 3rd dose of Rabies Vaccine, the 4th dose of Rabies Vaccine and the 5th dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and rabies virus infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure and rabies virus infection were fatal. The reported cause of death was rabies virus infection and vaccination failure. The reporter considered the vaccination failure and rabies virus infection to be related to Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient of unspecified age and gender, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) as a part of post -exposure prophylaxis. This case corresponds to result section from this literature article. The patient was the part of retrospective study that object was to analyze the causes of failed management of exposure to rabies in province for scientific evidence to design prevention and control measures for rabies. The analysis was performed in 68 cases of failed rabies postexposure prophylaxis from 2007 to 2018. The patient was hurt by dog. The patient was exposed by being bitten by dog. [In this study, all of the patients in the 68 cases were hurt by dogs. Among them, dogs raised by themselves or neighbors accounted for 31 cases and stray animals took 37 cases. None of the attacking animals had received any rabies vaccine. Nine of 68 patients were exposed to rabies one year or more than one year ago (among them, ten years for one case, six years for one case, four years for one case, three years for two cases, two years for two cases and one year for two cases, recall bias may exist). The latent period median of the remaining cases (59 cases) was 18 days (the range of latent period being 4 to 247 days). Patients exposure levels were all level II and level III exposure, among which 5 of the cases were Level II exposure and 63 were level III exposure. Patients exposure sites included 36 cases of head, face and neck, 13 cases of hand, 9 cases of lower limb below knee, 6 cases of lower limb above knee and 4 cases in other parts. The patient''s exposure dates mainly concentrated within May to October. 59 of 68 patients underwent wound cleansing after exposure, among which the cleansing time of 7 cases were 15 minutes and above. The cleansing time of other patients were less than 15 minutes or the cleansing duration was known. 15 patients had confirmed that soap or soapy water were used. 56 cases of the patients underwent sterilization. Two patients had confirmed that hydrogen peroxide and iodine complex were used while the situation of others were unknown. Most of the patients took an occupation as farmers (58.82%), followed by students (19.12%) and children living at home (17.65%). There were also other patients being retiree, migrant worker and the unemployed, one of them in each case. Among the 68 cases, apart from five of the patients living in the town, the rest of the 63 patients lived in rural areas]. No information on patient''s family history, concomitant medication was provided. On an unspecified date between 2007 and 2018, the patient received 5 dosage regimen of unspecified rabies vaccine (administration route and site unspecified, dosage unknown; batch number not provided). It was reported that the patient was fully vaccinated. [In this study, among the cases of failed management of exposure to rabies, 34 cases of the patients who reached exposure level III received rabies immunoglobulin injection. 7 cases of the patients purchased the vaccine from other places or brought the vaccine back home and received the injection home. 60 cases of the patients were vaccinated with 5-dose regimen. Among them, only 15 cases patients completed the full course of the vaccination. 8 cases of the patients received 2-1-1 regimen, yet only 1 case of the patients completed the full vaccination].The age of vaccination was not provided. On an unspecified date between 2007 and 2018, the patient developed rabies virus infection. On an unspecified date, the patient was died due to rabies infection. It was unknown whether autopsy was performed. [In this study, the cases of failed management of exposure to rabies were rabies death cases in which even the patients went through wound cleansing, rabies vaccination and rabies passive immunization injection after exposure].This cases has been considered as suspected vaccination failure being time to onset and laboratory confirmation were unknown. This cases considered as serious due to death and suspected vaccination failure. The author did not comment relationship between the event rabies virus infection and unspecified rabies vaccine. The author concluded "The main reasons that caused cases of failed management of exposure to rabies in Province might include: firstly, the exposed wounds were not treated in a timely and standard manner in standardized outpatient clinic so that the vaccines were substandard or fake vaccines. Therefore, the body could not produce sufficient neutralizing antibody to neutralize the viruses, which leaded to onset. Secondly, the usage rate of passive immunization preparation was not high. For the patients who did not use passive immunization preparation, after the vaccine injection, the viruses had reached the brain before sufficient neutralizing antibody was produced. The third reason is that the patients failed to completed the full course of the vaccination, which leaded to insufficient protective antibody being produced. Fourthly, with economic development, there is an increasing number of dogs raised in rural and urban areas. Dogs on leash, free-range dogs and stray dogs exist at the same time. Human have more chances to get contact with dogs, which makes it easier for human to be exposed to rabies virus. Dogs administration and immunization still remained to be managed in a standard and effective way, which is one of the reasons that caused rabies onset between humans Therefore, the following methods could effectively reduce the failure rate of failed management of exposure to rabies: enhance the technical training of medical staff working in rabies exposure prevention outpatient clinic, improve the standard rabies postexposure prophylaxis procedure, increase the publicity of rabies and further increase the knowledge, attitude and practice of the masses to rabies prevention, regulate the circulation channels of rabies vaccines, and establish and standardize the dogs raising management approach" This is 1 of the 4 valid cases reported in this literature article. This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Reported Cause(s) of Death: Rabies virus infection; vaccination failure


VAERS ID: 855872 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-16
Onset:2019-12-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S002171 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Brain oedema, Cardiac arrest, Cerebral congestion, Cold sweat, Crying, Cyanosis, Death, Electrocardiogram abnormal, Mydriasis, Peripheral coldness, Pulmonary congestion, Pulmonary haemorrhage, Pulmonary oedema, Respiratory arrest, Resuscitation, Unresponsive to stimuli, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075132001CHN001471

Write-up: death; Information has been received from Center for Disease Control and Prevention and refers to an 8-week-old (also reported as 90-day-old) male patient. The patient did not have any physical discomfort. No information regarding the patient''s pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 16-DEC-2019 at 10:35, the patient was taken to the vaccination clinic of health center by his families. The parents were asked the infant''s physical conditions and if he had any vaccination contraindications before vaccination, and they were informed with the vaccine types, possible adverse reactions and precautions. Parents denied infant''s physical discomfort, then signed the informed consent form. After confirming the product and infant personal information, at 10:52 on that day, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, one dose, orally, lot number S002171, expiration date not reported, but upon internal validation established as 28-OCT-2020 (exact dose was not reported) and with the second dose of hepatitis b virus vaccine rhbsag (yeast) lot number 201903023 (dose, route of administration and expiration date were not reported), both for prophylaxis. The infant was observed for 30 minutes. At approximately 11:00, the infant was cried after vaccination, no other abnormality was seen. On 17-DEC-2019 at 03:00, he was given milk (normal amount) orally, and he fell asleep after about 20 minutes. At 08:00, the patient was found by his mother with facial cyanosis and being unresponsive, then she called the infant''s father and at around 9:00, the parents took the infant to see a doctor. On 17-DEC-2019, at 09:03, the mother carried the infant to the health center. When arrived at the health center, the infant appeared facial cyanosis, clammy and cold limbs. Physical examination indicated that ): the infant had no awareness, dilated pupils on both sides, facial cyanosis, clammy and cold hands and feet, no breathing and heartbeat. Rescue was performed immediately by emergency medical staff and they found the infant''s breathing and heartbeat disappeared. Oxygen inhalation and sternum compression were given immediately, physician cleared the respiratory tract and about 5mL light red mucus was suction out, established a venous channel. After 3 minutes, the breathing, heartbeat of the infant still not restored, electrocardiogram (ECG) was straight. It was considered that the infant''s breathing and heartbeat stopped for more than half an hour, the family members were notified the infant''s condition, and the rescue was stopped. On 20-DEC-2019, Forensic Medical Identification Center issued the judicial opinion, made the justification for the cause of death, based on the basic theories and basic knowledge of various medical and forensic textbooks. According to the autopsy examination of the forensic system, no obvious signs of mechanical damage were found on the infant''s surface except for the Iatrogenic injection pinhole, so mechanical violence to death could be excluded. Facial congestion, cyanosis of the lips, severe cyanosis in the fingernail bed of both hands, extensive spotted bleeding on the lungs and pleural surface was observed. Histological examination showed congestion and edema in the brain and lungs, and congestion in other organs. The infant''s heart blood IgE test result was in normal range, no obvious edema was found in the throat, and no eosinophil infiltration was found in larynx, lung or other organs, no pathological signs of drug allergic reaction was identified. In conclusion, combined with the case and forensic laboratory analysis, the infant met the general forensic pathological changes of acute death. It was reported that based on the limited information, there was only a temporal correlation between this case and vaccination, and it was unlikely to be an adverse events following immunization. After the investigation and diagnosis by expert team, the final conclusion was unlikely to be an adverse events following immunization, and the damage level was Class I.; Autopsy-determined Cause(s) of Death: cyanosis of the lips / severe cyanosis in the fingernail bed of both hands; congestion and edema in the brain and lungs; extensive spotted bleeding on the lungs and pleural surface; congestion and edema in the brain; congestion in other organs; conge


VAERS ID: 855948 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-11-26
Onset:2019-11-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER P3M483V / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Cardiac arrest, Cerebral haemorrhage, Child maltreatment syndrome, Coagulopathy, Death, Diet refusal, Dyspnoea, Infection, Injury, Resuscitation, Sepsis, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Premature baby (born in 36th week of pregnancy)
Allergies:
Diagnostic Lab Data: Test Date: 20191128; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: Centigrade
CDC Split Type: DEPFIZER INC2020008735

Write-up: massive cerebral hemorrhage; cardiac arrest with subsequent resuscitation; child did not drink and was sleepy (somnolent); Body temperature was 38.5 ?C; gasping; unknown cause of death; This is a spontaneous report downloaded from the regulatory authority-WEB other manufacturer number DE-SA-2019SA339890. A 9-week-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration on 26Nov2019 at single dose for prophylactic vaccination, diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXYON, Lot#P3M483V) via an unspecified route of administration on 26Nov2019 at an unspecified dose for prophylactic vaccination. Medical history included premature baby born in 36th week of pregnancy. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death (death, medically significant) on 30Nov2019, massive cerebral hemorrhage (hospitalization, medically significant) on an unspecified date, gasping (hospitalization) on 28Nov2019, cardiac arrest with subsequent resuscitation (hospitalization, medically significant) on an unspecified date, child did not drink and was sleepy (somnolent) (hospitalization) on 28Nov2019, body temperature was 38.5 ?C (hospitalization) on 28Nov2019. The patient died on 30Nov2019. It was not reported if an autopsy was performed. The outcome of unknown cause of death was fatal, the outcome of other events was unknown. Narrative as reported: Follow-up information received on 06-Dec-2019, changes the previous medical assessment. This case concerns the death of a 8-week-old patient occurred 4 days after administration of Hexyon and a pneumococcal vaccine. The child was a preterm birth, born in 36th week of pregnancy. The diagnosis reported was massive cerebral hemorrhage. In this case other differential diagnosis have been considered by the physician such as a severe infection (sepsis), coagulation disorder or trauma (including shaken baby syndrome). Moreover relevant medical history of the mother has been reported such as bulimia and post-traumatic stress disorder. Regarding parents, the physician mentioned also that "there are several entries on disturbed interaction with the child in the patient chart" and that the parents were very young and not "self-maintained". According to the data reported by the physician, the relationship with administration of the vaccine seems unlikely. Causality for HEXYON: Cerebral hemorrhage, Death NOS, Gasping, Cardiac arrest, Somnolence, Fever: Reasonable possibility by regulatory authority and Health Care professional, Unassessable by Pharmaceutical Company, Related by Health Care professional No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: The event death is assessed as related to pneumococcal 13-valent conjugate vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. There is a reasonable possibility that the events dyspnea, somnolence, and pyrexia were related to pneumococcal 13-valent conjugate vaccine based on known drug safety profile. The association between the rest of the events with pneumococcal 13-valent conjugate vaccine can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 856556 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-07-01
Submitted: 0000-00-00
Entered: 2020-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dysarthria, Fatigue, Gait disturbance, Motor neurone disease
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-29
   Days after onset: 151
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075132001GBR001489

Write-up: Tiredness; Slurred speech; Unsteady gait; Motor neurone disease; Information was downloaded from Regulatory Authority (GB-MHRA-ADR 24460547). This spontaneous report was received from a physician regarding a 70 years old male patient. Information on patient''s pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX), lot# RO21Z07 with expiry date of December 2019 for an unknown indication (dose and route of administration were not reported). On an unknown date in July 2019, the patient experienced motor neurone disease. On an unknown date, the patient experienced tiredness (fatigue), slurred speech (dysarthria) and unsteady gait (gait disturbance). On 29-NOV-2019, the patient died due to motor neurone disease. It was unknown if an autopsy was performed. Outcome of the events fatigue, dysarthria and gait disturbance was reported as not recovered, However the seriousness of the events were reported as fatal. Causality of the reported events were not reported.; Reported Cause(s) of Death: Motor neurone disease


VAERS ID: 856878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-28
Onset:2019-11-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Autopsy, Cerebral haemorrhage, Computerised tomogram head abnormal, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYMAFLUOR D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Premature baby (Eutrophic pre-term baby 34+6); Prophylaxis (rachitis prophylaxis)
Allergies:
Diagnostic Lab Data: Test Date: 20191130; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result: present NA
CDC Split Type: DEPFIZER INC2020018132

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB [DE-DCGMA-19183520]. A 8-week-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via intramuscular on 28Nov2019 at single dose for immunization, diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXYON) via intramuscular on 28Nov2019 at 1 DF, single for immunization. Medical history included rachitis prophylaxis, premature baby (Eutrophic pre-term baby 34+6). Concomitant medication included colecalciferol, sodium fluoride (ZYMAFLUOR D) from 09Oct2019 for prophylaxis. The patient experienced cerebral haemorrhage on 30Nov2019. The patient underwent lab tests and procedures which included computerised tomogram head: present NA on 30Nov2019. Therapeutic measures were taken as a result of cerebral haemorrhage. The patient died of cerebral haemorrhage on 03Dec2019. An autopsy was performed and results were not provided. Prevenar 13, Hexyon /cerebral bleeding: Other Assessment: regulatory authority,possible Measures: intensive therapy, hemicraniectomy, ICP-tube, change of therapeutic target due to severe cranial necrosis Information provided in patient''s notes: At the time of the vaccination patient was 56 days old (corrected age: 21days). Persistent drinking weakness with a borderline hytrophic weight gain at the 3rd percentile. No follow-up attempts needed, follow-up automatically provided by regulatory authority.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 856961 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLGLAXOSMITHKLINENL2020GS

Write-up: still birth; Fetal exposure during pregnancy; This case was reported by a physician via regulatory authority and described the occurrence of stillbirth in a foetus exposed to DTPa (Reduced antigen) (Boostrix) in utero. On an unknown date, the mother received Boostrix .5 ml. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The foetus was exposed to at an unknown time during the pregnancy. The foetus was diagnosed with stillbirth (serious criteria death and GSK medically significant) and fetal exposure during pregnancy. On an unknown date, the outcome of the stillbirth was fatal and the outcome of the fetal exposure during pregnancy was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the stillbirth to be related to Boostrix. Additional details: This case is link with NL2020004329, having same reporter. Initial information of retrospective pregnancy case was received from physician via regulatory authority on 9th January 2020. still birth and Fetal exposure during pregnancy. Senders comment: 23/12/2019: Brand name of reported "pertussis vaccine" is not specified. Boostrix? was chosen by the assessor of the Pharmacovigilance Centre as the most plausible vaccine. Additional information is requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 857656 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2020EM

Write-up: Suspected Vaccination failure; influenza - vaccination failure; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 80-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra unspecified season) for prophylaxis. On an unknown date, the patient received Influsplit Tetra unspecified season at an unknown dose. On an unknown date, unknown after receiving Influsplit Tetra unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influsplit Tetra unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient died in the nursing home due to proven influenza. This is 1 of the 4 cases reported by the same reporter. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation at the time of reporting were unknown.; Reported Cause(s) of Death: Influenza


VAERS ID: 858290 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-05-09
Submitted: 0000-00-00
Entered: 2020-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Adenovirus infection, Adenovirus test positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Basophil percentage, Bilirubin conjugated decreased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood bilirubin unconjugated normal, Blood glucose normal, Blood thyroid stimulating hormone increased, Cough, Cytomegalovirus test negative, Death, Encephalopathy, Eosinophil percentage decreased, Epstein-Barr virus antibody negative, Fatigue, Gait disturbance, Gamma-glutamyltransferase, Guillain-Barre syndrome, HIV test negative, Haemoglobin urine present, Hepatitis, Hepatitis A antibody negative, Herpes simplex test positive, Herpes virus infection, Intensive care, Lymphocyte percentage decreased, Monocyte percentage, Mononucleosis heterophile test negative, Neutrophil percentage increased, Paresis, Platelet count normal, Prothrombin time prolonged, Red blood cells urine positive, Secretion discharge, Thyroxine decreased, Transfusion, Urinary sediment present, Urine ketone body present, White blood cell count increased, White blood cells urine negative
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-10
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: influenza virus vaccine (unspecified); PURAN T4; beclomethasone dipropionate
Current Illness: Asthma; Hypothyroidism; Mental retardation; Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation
Allergies:
Diagnostic Lab Data: Test Date: 20190529; Test Name: bast; Test Result: 1 %; Test Date: 20190529; Test Name: eosinophiles; Test Result: 0.5 %; Test Date: 20190529; Test Name: lymphocytes; Test Result: 15.1 %; Test Date: 20190529; Test Name: neutrophiles; Test Result: 75.7 %
CDC Split Type: BR0095075132001BRA008943

Write-up: the patient experienced cough and discharge. It was diagnosed that the patient had positive adenovirus and herpes/; the patient experienced cough and discharge. It was diagnosed that the patient had positive adenovirus and herpes/; hemoglobin transfusion; death; hepatitis; encephalopathy; This spontaneous report was received from a nurse by Institute which was made aware of it through the health authority Immunization National Program and refers to a 10-year-old, male patient. Concurrent conditions included hypothyroidism, asthma and mental retardation. The patient''s medical history included constipation. Concomitant therapies included levothyroxine sodium (PURAN T4), beclomethasone dipropionate (manufacturer unknown) and influenza virus vaccine (manufacturer unknown) (date of vaccination was 03-MAY-2019). On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) dose 1 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 03-MAY-2019 the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) ( lot # was reported as 180044 (upon internal validation established as non-valid), expiration date 06-APR-2020). On 09-MAY-2019, the patient experienced paresis in an uninformed location. On unspecified date, the patient had gait disturbance that was not investigated. On 27-MAY-2019 and 28-MAY-2019, the patient''s mother took the patient to an outpatient care. On an unspecified date in May 2019, the patient was hospitalized due to abdominal pain, prostration and difficulty walking. Tests performed on the same date provided the laboratory data: glutamic oxalacetic transaminase 1450; glutamic-pyruvic transaminase 1033; total bilirubin 0.38; direct bilirubin 0.02; indirect bilirubin 0.36; gama glutamil transpeptidase (reported as gamaglutamiltranspeptidase) 17; white blood cells (reported as total leukocytes) 16980; basophile percentage (reports as bast) 1%; neutrophils percentage (reported as neuthrophiles) 75.7%; eosinophils percentage (reported as eosinophils) 0.5%; lymphocytes percentage (reported as lymphocytes) 15.1%; monocytes percentage (reported as monocytes) 7.2%; platelet count (reported as platelets) 373 000; unspecified test (reported as PCR) 10.10; fasting blood glucose: 90; unspecified test: "equ proteins trace ketonic bodies" ++, "hemoglobin" +++, "some epithelial cells per field, leukocytes less than 1 "p/c", red cells less than 1 "p/c", granulate cylinders 5 "p/c"; unspecified mononucleosis test (reported as mono test) negative; level of Epstein-Barr antibodies IgM(reported as Epstein Barr lgM) 14 (nonreactive (reported as nr) and level of Epstein-Barr antibodies IgG (reported as Epstein Barr lgG) 12.9(nonreactive (reported as nr); unspecified test of anti hepatitis A (HAV) (reported as anti HVA) negative; unspecified test of cytomegalovirus negative. On 03-JUN-2019, the patient experienced cough and discharge. It was diagnosed that the patient had positive adenovirus and herpes since an unknown date in approximately 2019. Tests performed on the same date provided the laboratory data: thyroxine (T4) 1.18; TSH 3.82; unspecified test: "equ" hemoglobine +++, protein+. On 04-JUN-2019, unspecified tests showed bilirubin without changes; alkaline phosphatase (reported as FA) 343;unspecified (reported as KT) 75.8%; prothrombin time (reported as INR) 1.22; partially activated thromboplastin time (reported as KTTP) 27.6; unspecified test (reported as CTRL) 31.1; unspecified anti HIV test (reported as ANTI HIV) nonreactive (reported as NR). On 05-JUN-2019, unspecified tests showed anti herpes type 1 lgM reagent to 2.47; anti herpes type 1 lgG reagent over 30; anti herpes type 2 lgM reagent to 2.47; anti herpes Type 2 lgG reagent over 30. On 06-JUN-2019, the patient started treatment with acyclovir. On 10-JUN-2019, the patient was transferred to intensive care unite (reported as ICU) and started hemoglobin transfusion. The suspicion was Guillain-Barre syndrome associated with vaccination as there was motor function worsening. On 10-JUN-2019, the patient died. In the death certificate, the responsible physician described the disease but did not provide a closed diagnosis for the cause of death. There was no information if autopsy was performed. On 12-JUN-2019, the case was evaluated by a neurologist providing consultancy, who diagnosed acute infection by herpes and adenovirus, hepatitis and encephalopathy as the events and ruled out the possibility of Guillain-Barre syndrome. The outcome of the events was not provided. The causality between adenovirus infection, herpes virus infection, transfusion, encephalopathy, hepatitis and suspect therapy was not provided by the reporter. The final assessment of the case by the Agency, classified the diagnosis "Herpes virus infection" as not related to the suspect vaccine ("C2. Conditions caused by other factors and not by vaccines"). Upon internal review the events hepatitis and encephalopathy were considered as medically significant.


VAERS ID: 858439 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-03
Onset:2019-05-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2020-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Adenovirus test positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase, Blood bilirubin normal, Blood glucose normal, Blood thyroid stimulating hormone increased, Cough, Cytomegalovirus test negative, Dialysis efficacy test, Encephalitis cytomegalovirus, Encephalopathy, Eosinophil percentage, Epstein-Barr virus antibody positive, Fatigue, Gait disturbance, Gamma-glutamyltransferase increased, HIV antibody negative, HIV test negative, Haemoglobin urine present, Hepatitis, Herpes simplex test positive, Herpes virus infection, Increased bronchial secretion, International normalised ratio normal, Monocyte count, Mononucleosis heterophile test negative, Neutrophil percentage increased, Paresis, Platelet count normal, Polymerase chain reaction, Protein urine present, Thyroxine free normal, Urinary sediment present, Urine ketone body present, White blood cell count increased, White blood cells urine negative
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-10
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HPV VACCINE; BECLOMETHASONE [BECLOMETASONE]; PURAN T4; ACICLOVIR; IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190529; Test Name: ALT; Test Result: 1033 {DF}; Result Unstructured Data: 1033; Test Date: 20190529; Test Name: AST; Test Result: 1450 {DF}; Result Unstructured Data: 1450; Test Date: 20190605; Test Name: Alkaline phosphatase; Test Result: 343 {DF}; Result Unstructured Data: 343; Test Date: 20190529; Test Name: BILIRRUBINAS; Test Result: 0.38 {DF}; Result Unstructured Data: 0.38; Comments: Direct: 0,02 Indirect: 0,36; Test Date: 20190604; Test Name: BILIRRUBINAS; Result Unstructured Data: No changes Type; Test Date: 20190529; Test Name: Blood glucose; Test Result: 90 {DF}; Result Unstructured Data: 90; Test Date: 20190603; Test Name: TSH dosage; Test Result: 3.82 {DF}; Result Unstructured Data: 3.82; Test Date: 20190604; Test Name: Type Kt; Test Result: 75.8 {DF}; Result Unstructured Data: 75.8; Test Date: 20190529; Test Name: SEROLOGY FOR CITALOMEGALOVIRUS; Test Result: Negative ; Test Date: 20190529; Test Name: Eosinophils; Test Result: 0.5 %; Test Date: 20190529; Test Name: IgM Epstein Barr; Test Result: 14 {DF}; Result Unstructured Data: 14; Test Date: 20190529; Test Name: IgM Epstein Barr; Test Result: 12.9 {DF}; Result Unstructured Data: 12.9; Test Date: 20190529; Test Name: GAMMA/GT; Test Result: 17 {DF}; Result Unstructured Data: 17; Test Date: 20190605; Test Name: ANTI-HERPES IGG TYPE 2; Result Unstructured Data: Reagent greater than 2.47; Test Date: 20190605; Test Name: ANTI-HERPES IGG TYPE 2; Result Unstructured Data: Reagent greater than 30; Test Date: 20190605; Test Name: ANTI-HERPES IGM TYPE 1; Test Result: 2.47 {DF}; Result Unstructured Data: 2.47; Test Date: 20190605; Test Name: ANTI-HERPES IGM TYPE 1; Result Unstructured Data: Reagent greater than 30; Test Date: 20190529; Test Name: ANTI HVA; Test Result: Negative ; Test Date: 20190603; Test Name: HIV SEROLOGY; Result Unstructured Data: NORMAL; Test Date: 20190604; Test Name: Tipo INR; Test Result: 1.22 {DF}; Result Unstructured Data: 1.22; Test Date: 20190529; Test Name: Lymphocytes; Test Result: 15.1 %; Test Date: 20190529; Test Name: Monocytes; Test Result: 7.2 %; Test Date: 20190529; Test Name: Neutrophils; Test Result: 75.7 %; Test Date: 20190529; Test Name: Platelets; Test Result: 373 {DF}; Result Unstructured Data: 373; Test Date: 20190529; Test Name: PCR; Test Result: 10.10 {DF}; Result Unstructured Data: 10.10; Test Date: 20190603; Test Name: Free T4; Test Result: 1.18 {DF}; Result Unstructured Data: 1.18; Test Date: 20190529; Test Name: URINE TEST; Result Unstructured Data: KETONICAL BODIES ++, HEMOGLOBIN +++, SOME EPITHELIAL CELLS BY FIELD, LEUKOCYTES LESS THAN 1 P/C, RED BLOOD CELLS LESS THAN 1P/C, GRANULOSOS CYLINDERS 5 P/C;; Test Date: 20190603; Test Name: URINE TEST; Result Unstructured Data: HEMOGLOBIN +++, PROTEIN +.; Test Date: 20190529; Test Name: Leukocytes; Test Result: 16980 {DF}; Result Unstructured Data: 16980
CDC Split Type: BRSA2020SA020509

Write-up: Hepatitis; Encephalopathy; Secretion; Cough; Positive adenovirus; Herpes positive / Herpes virus infection; Abdominal pain; Prostration; Change of gait and difficulty walking; Paresis; Initial information regarding an unsolicited valid serious case received from a nurse via physician and other health Care Professional via agency (under the reference number: IBFV-2020-1751) on 23-Jan-2020 and transmitted to sanofi on 23-Jan-2020. This case involves a 12 years old male patient who experienced abdominal pain (abdominal pain), paresis (paresis), prostration (fatigue), change of gait and difficulty walking (gait disturbance), secretion (increased bronchial secretion), cough (cough), positive adenovirus (adenovirus test positive), herpes positive / herpes virus infection (herpes virus infection), hepatitis (hepatitis) and encephalopathy (encephalopathy), while he received INFLUENZA VACCINE (TRIVALENT). Medical history, medical treatment, vaccination and family history were not provided. On 03-May-2019, Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; On 18-MAR-2007, BECLOMETHASONE [BECLOMETASONE] (BECLOMETHASONE [BECLOMETASONE]) for Asthma and LEVOTHYROXINE SODIUM (PURAN T4) for Hypothyroidism; On 06-Jun-2019, ACICLOVIR (ACICLOVIR) for Herpes virus infection; and On 10-Jun-2019, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]). On 03-May-2019, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number not reported) via an intramuscular route in the right deltoid. On 09-May-2019, the patient developed a serious paresis (paresis) 6 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 27-May-2019, the patient developed a serious change of gait and difficulty walking (gait disturbance) 24 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 29-May-2019, the patient developed a serious abdominal pain (abdominal pain) and prostration (fatigue) 26 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 03-Jun-2019, the patient developed a serious secretion (increased bronchial secretion), cough (cough), positive adenovirus (adenovirus test positive) and herpes positive / herpes virus infection (herpes virus infection) 1 month following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On an unknown date, the patient developed a serious hepatitis (hepatitis) and encephalopathy (encephalopathy) (unknown latency) following the administration of INFLUENZA VACCINE (TRIVALENT). These events were assessed as medically significant and was leading to death. Relevant laboratory test results included: Alanine aminotransferase - On 29-May-2019: 1033 [1033] Aspartate aminotransferase - On 29-May-2019: 1450 [1450] Blood alkaline phosphatase - On 05-Jun-2019: 343 [343] Blood bilirubin - On 29-May-2019: 0.38 [0.38]; on 04-Jun-2019: No changes Type [No changes Type] Blood glucose - On 29-May-2019: 90 [90] Blood thyroid stimulating hormone - On 03-Jun-2019: 3.82 [3.82] Dialysis efficacy test - On 04-Jun-2019: 75.8 [75.8] Encephalitis cytomegalovirus - On 29-May-2019: Negative Eosinophil count - On 29-May-2019: 0.5 % Epstein-Barr virus antibody - On 29-May-2019: 14 [14] then 12.9 [12.9] Gamma-glutamyltransferase - On 29-May-2019: 17 [17] HIV antibody - On 29-May-2019: Negative HIV test - On 03-Jun-2019: NORMAL [NORMAL] Herpes simplex - On 05-Jun-2019: Reagent greater than 2.47 [Reagent greater than 2.47] then Reagent greater than 30 [Reagent greater than 30] then 2.47 [2.47] then Reagent greater than 30 [Reagent greater than 30] International normalised ratio - On 04-Jun-2019: 1.22 [1.22] Lymphocyte count - On 29-May-2019: 15.1 % Monocyte count - On 29-May-2019: 7.2 % Neutrophil count - On 29-May-2019: 75.7 % Platelet count - On 29-May-2019: 373 [373] Polymerase chain reaction - On 29-May-2019: 10.10 [10.10] Thyroxine free - On 03-Jun-2019: 1.18 [1.18] Urine analysis - On 29-May-2019: KETONICAL BODIES ++, HEMOGLOBIN +++, SOME [KETONICAL BODIES ++, HEMOGLOBIN +++, SOME EPITHELIAL CELLS BY FIELD, LEUKOCYTES LESS THAN 1 P/C, RED BLOOD CELLS LESS THAN 1P/C, GRANULOSOS CYLINDERS 5 P/C;]; on 03-Jun-2019: HEMOGLOBIN +++, PROTEIN +. [HEMOGLOBIN +++, PROTEIN +.] White blood cell count - On 29-May-2019: 16980 [16980] (Other relevant tests included Bast: 1%. monoteste: negative. Type KTTP: 27.6. Ctrl: 31.1) Final diagnosis were (fatal) paresis, (fatal) change of gait and difficulty walking, (fatal) prostration, (fatal) abdominal pain, (fatal) herpes positive / herpes virus infection, (fatal) positive adenovirus, (fatal) cough, (fatal) secretion, (fatal) encephalopathy and (fatal) hepatitis. It was not reported if the patient received any corrective treatment. On 10-JUN-2019, the patient outcome was reported as Fatal from the all events. It is unknown if an autopsy was done. The cause of death was reported as Abdominal pain, Paresis, Fatigue, Gait disturbance, Cough, Increased bronchial secretion, Adenovirus test positive, Herpes virus infection, Hepatitis and Encephalopathy.; Sender''s Comments: This case concerns an 12 year old male patient who presented with abdominal pain, paresis, fatigue, gait disturbance, increased bronchial secretion, cough, adenovirus test positive, herpes virus infection, hepatitis and encephalopathy, after vaccination with INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer). The time to onset is compatible with the role of vaccine. Laboratory data were reported. The event is most likely the infectious origin. However, patient''s past medical history, medical condition at time of vaccination ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Abdominal pain; Paresis; Prostration; Walking difficulty; Cough; Tracheo-bronchial secretion excess; Adenovirus serology test positive; Herpes viral infection NOS; Hepatitis; Encephalopathy


VAERS ID: 858521 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-13
Onset:2020-01-01
Submitted: 0000-00-00
Entered: 2020-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S003313 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Death, Diarrhoea, Haematocrit normal, Lymphocyte percentage increased, Malaise, Mean cell volume decreased, Monocyte percentage, Neutrophil count decreased, Neutrophil percentage decreased, Platelet count normal, Red cell distribution width increased, Retching
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200118; Test Name: lymphocytes; Test Result: 74.7 %; Test Date: 20200118; Test Name: monocytes; Test Result: 8.3 %; Test Date: 20200118; Test Name: neutrophils; Test Result: 15.3 %
CDC Split Type: CN0095075132001CHN008340

Write-up: malaise; diarrhoea; retching; stomach growl; death; This spontaneous report was received from regulatory authority referring to a 5 months old male patient. The patient''s historical vaccines included BCG, Hep B (also reported as hansenula polymorpha), DTaP-IPV/Hib, 13-valent pneumonia vaccine. The patient''s concurrent conditions and concomitant medications were not reported. On 13-JAN-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with lot number S003313, expiry date 27-NOV-2020 (dose, strength were not reported) orally (defaulted) for prophylaxis. On 15-JAN-2020 (reported as 2-3 days), the patient experienced diarrhea, retching and stomach growl (abdominal discomfort). On 18-JAN-2020 , the patient developed malaise and was taken to Clinic of the Hospital by parents for treatments. The doctor advised him to take a stool test, but the parents did not follow the doctor''s advice and did not take the test. On the same day the following lab tests were performed with results as follows neutrophils 15.3%, lymphocytes 74.7%, monocytes 8.3%, neutrophils 0.7X10*9/L, Hematocrit (HCT) 0.35, Mean corpuscular volume (MCV) 75 fL, Red cell distribution width (RDW-SD) 36 fL, platelets 326X10*9/L. On 22-JAN-2020, morning, the infant was taken to the hospital again and died while in the period of medical treatment. It was unknown if the autopsy was performed. Outcome of the events malaise, abdominal discomfort, retching and diarrhoea is unknown. The causality assessment between the event and the suspect therapy was not provided.; Reported Cause(s) of Death: unknown


VAERS ID: 858738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-12-20
Onset:2019-12-01
Submitted: 0000-00-00
Entered: 2020-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Bexsero
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR202001

Write-up: Pneumococcal meningitis; Fever; Death; This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 6-month-old female patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Men B NVS (Bexsero). On 20th December 2019, the patient received the 2nd dose of Bexsero. In December 2019, less than a week after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced pneumococcal meningitis (serious criteria hospitalization and GSK medically significant) and fever (serious criteria hospitalization). On 24th December 2019, the patient experienced unknown cause of death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pneumococcal meningitis and fever were unknown. It was unknown if the reporter considered the unknown cause of death, pneumococcal meningitis and fever to be related to Bexsero. Additional deatils were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Bexsero 2 months before 2nd dose. Four days after vaccination with 2nd dose of Bexseo, the patient had death. After vaccination. patient experienced fever and hospitalised and documented with pneumococcal meningitis. The reporter stated that, It was unknown whether or not the pneumococcal meningitis was the reason for the death. The reporter stated that the final report on the death was under process and should be issued in 2 weeks now on. The physician did not agree to follow with safety as the final medical document was not prepared yet. It was expected to be available in two weeks on and then the physician may reconsider her decision for a follow up with safety Glaxosmithkline. The reporter did not consent to follow up.


VAERS ID: 858985 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-12
Onset:2019-11-01
Submitted: 0000-00-00
Entered: 2020-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC259AH / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEGLAXOSMITHKLINESE202001

Write-up: Deceased; This case was reported by a other health professional via regulatory authority and described the occurrence of death nos in a 8-week-old male patient who received Rota (Rotarix liquid formulation) (batch number AROLC259AH, expiry date unknown) for prophylaxis. On 12th November 2019, the patient received the 1st dose of Rotarix liquid formulation (oral). In November 2019, less than 3 weeks after receiving Rotarix liquid formulation, the patient experienced death nos (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The patient died in November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos to be related to Rotarix liquid formulation. Additional details: The age at vaccination was not reported, however the patient could be 7 or 8 week at the time of vaccination. Initial information was reported by a other health professional via regulatory authority on 31th January 2020: Death nos.; Reported Cause(s) of Death: Death NOS


VAERS ID: 860719 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-19
Onset:2019-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. S019237 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Death, Dyspnoea, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vaccination
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Ex-alcoholic; Insulin-requiring type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075132002FRA000744

Write-up: Muscular pain; Dyspnea; Rigours; Information has been downloaded from Regulatory Authority (FR-AFSSAPS-PO20200071). This spontaneous report was received from a physician referring to a 72-year-old male patient. The patient''s medical history was not reported. The patient''s concurrent conditions included chronic obstructive pulmonary disease and insulin-requiring type 2 diabetes mellitus. The patient is ex-alcoholic. The patient''s concomitant medications were not reported. On 19-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) in pre-filled syringe (strength was not reported); 1 dosage form (1 total) (lot # S019237, expiration date not reported but upon internal validation established as 28-FEB-2021) via intramuscular route for vaccination. On the same day, patient experienced muscular pain, dyspnea and rigours. On an unknown date, the patient died and the cause of death was not provided. It was unknown if an autopsy was performed. Action taken with the suspect vaccine was reported as withdrawn. On 27-NOV-2019, the patient reportedly recovered from events muscular pain and rigours. The relatedness between events and the suspect vaccine was not provided. The Agency considered events to be serious due to death.


VAERS ID: 861165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatism
Preexisting Conditions: Medical History/Concurrent Conditions: Heart transplant (20 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESA2020SA032045

Write-up: received a flu vaccination (vaccine unknown) and died from it; Initial information was received on 04-Feb-2020 regarding an unsolicited valid serious case from a pharmacist. This case involves female patient of an unknown age who died (death), while she received INFLUENZA VACCINE. Medical historyincluded heart transplant 20 years ago. Medical treatment, vaccination and family history were not provided. At the time of the event, the patient had ongoing rheumatic disorder. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Laboratory data was not provided. Final diagnosis was (fatal) death. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. It was reported that patient received a flu vaccination (vaccine unknown) and died from it. Information on the lot number was requested.; Sender''s Comments: This case concerns a female patient of an unknown age who died after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Medical history included heart transplant 20 years ago. At the time of the event, the patient had ongoing rheumatic disorder. Additional information regarding patient''s condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.


VAERS ID: 861430 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-01-09
Onset:2020-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X63656 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Product storage error, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth premature; Dehydration; Enteritis; Hospitalization; Urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZERINC2020057899

Write-up: temperatures above 8 ? C and below 2 ? C were recorded on the following days and hours; vaccinated with the above mentioned vaccine on 09Jan2020 (...) and died on 11Jan2020; was feverish since 10Jan2020; patient was vaccinated with the vaccine after temperatures excursion above 8 ? C and below 2 ? C; This is a spontaneous report from a contactable physician received by post. A 3-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number: X63656, expiry date Oct2020), via an unspecified route of administration on 09Jan2020 at a single dose for immunization. Medical history included premature, hospitalization, intestinal enteritis, urinary tract infection, and dehydration. The patient''s concomitant medications were not reported. The patient was vaccinated with the vaccine after temperatures excursion above 8 ? C and below 2 ? C on 09Jan2020. A child born on vaccinated with the above mentioned vaccine on 09Jan2020 in the practice of a family doctor was feverish on 10Jan2020 and died on 11Jan2020. The child was premature (34 weeks pregnant) and was hospitalized twice in the ward due to intestinal enteritis, urinary tract infection and dehydration. The vaccine was purchased on 12Dec2019. The outcome of event feverish was unknown. It was unknown if autopsy was performed. In connection with the post-inspection recommendations, the impact of storage conditions for the medicinal product named Prevenar 13 - powder and solvent for suspension for injection lot number: X63656 expiry date Oct2020 on safety of use above-mentioned product. Report of post vaccination adverse reaction after vaccination with the above-mentioned medicinal product was made by the hospital emergency department on 21Jan2020. According to the information, it appeared that the vaccine of this series and expiration date were vaccinated around 20- no reports of adverse reactions were reported. Vaccines factory packed are stored in the refrigerator in the treatment room. There was a 24-hour temperature monitoring in the fridge, with the function of notification by phone in the form of message about temperature fluctuations above 8 ?C or a drop below 2 ?C. In the refrigerator compartment on two shelves (upper and lower) are located temperature sensors of the recorder and additionally two thermometers are placed. Outside the fridge a display was located that indicates the current temperature in the refrigerator compartment. Based on reprints from the electronic temperature control and monitoring system, temperatures above 8 ?C and below 2 ?C were recorded on the following days and hours: Date of reading: 31Dec2019, Hour/ temperature ?C 14.30 - 8.8; 15.00 - 8.5; 15.30 - 8.5; 16.00 - 9.2; 16.30 - 8.3; 17.00 - 8.8. Date of reading: 06Jan2020, Hour/ temperature ?C 0.30 - 1.8; 4.00 - 1.8; 5.30 - 1.6; 7.00 - 1.6; 9.00 - 1.8; 10.30 - 1.5; 12.00 - 1.8; 14.00 - 1.4; 15.30 - 1.5; 17.30 -1.5; 19.00 - 1.7. Date of reading: 10Jan2020, Hour/ temperature ?C: 12.00 - 8.3; 12.30 - 8.9; 13.00 - 9.0; 13.30 - 8.8; 14.00 - 8.3; 14.30 - 8.5; 15.00 - 7.9; 15.30 - 8.7. On other days the temperature did not exceed 2-8 ? C. Due to above we ask to issue an opinion in matters of the impact of the above-mentioned temperature overruns at the vaccine storage site on the safety of its use.; Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until enough information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such as death details especially death cause and autopsy results is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: vaccinated with the above mentioned vaccine on 09Jan2020 (...) and died on 11Jan2020


VAERS ID: 861792 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2020-02-10
Onset:2020-02-01
Submitted: 0000-00-00
Entered: 2020-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Cyanosis, Death, Endotracheal intubation, Eye oedema, Lip oedema, Mechanical ventilation, Pulse absent, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200210; Test Name: Pulse rate; Result Unstructured Data: Test Result: no pulse, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2020GS

Write-up: labial edema; Eye edema; Pulse absent; abdominal distension; cyanosis; Unresponsive to stimulus; Unknown cause of death; This case was reported by a other health professional via licensee and described the occurrence of unknown cause of death in a 2-month-old male patient who received Rotavirus vaccine for prophylaxis. On 10th February 2020 10:30, the patient received Rotavirus vaccine (oral). On 10th February 2020 10:35, 5 min after receiving Rotavirus vaccine, the patient experienced lip edema (serious criteria hospitalization), eye edema (serious criteria hospitalization), pulse absent (serious criteria hospitalization), abdominal distension (serious criteria hospitalization), cyanosis (serious criteria hospitalization) and unresponsive to stimuli (serious criteria hospitalization and GSK medically significant). In February 2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The patient was treated with oxygen (Ventilatory Support (Oxygen)). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the lip edema, eye edema, pulse absent, abdominal distension, cyanosis and unresponsive to stimuli were unknown. The patient died on 11th February 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, lip edema, eye edema, pulse absent, abdominal distension, cyanosis and unresponsive to stimuli to be related to Rotavirus vaccine. Additional case details were reported as follows: The patient presented with labial and eye edema, no pulse, abdominal distension and cyanosis and was unresponsive to stimulus. The patient did not have cough and neither vomited or cried. Life support measures were performed by the local health team with CPR (cardio pulmonary resuscitation), ventilatory support and airway disobstruction. The patient was admitted to hospital, orotracheal intubation was performed. On 11th February at 6:45 pm, 1 day 8 hours and 15 minutes after vaccination, the patient died.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 861971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2020-01-01
Submitted: 0000-00-00
Entered: 2020-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEXSERO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2020066489

Write-up: Death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 6-month-old female patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVENAR 13) and meningococcal group c tetanus toxoid conjugate vaccine (NEISVAC-C), both via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. Concomitant medication included meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) for immunization. The patient died on Jan2020. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: The event death is assessed as related to pneumococcal 13-valent conjugate vaccine and meningococcal group c tetanus toxoid conjugate vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death cause unknown


VAERS ID: 862462 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W34300 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2020071301

Write-up: child died; This is a spontaneous report from a contactable pharmacist. A child patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, batch/lot# W34300, Expiry date: 31Mar2020), via an unspecified route of administration on an unspecified date at single dose for vaccination. The patient medical history and concomitant medications were not reported. The child died on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed. The child''s mother went to the pharmacist as she wanted to know the expiry date of the Batch W34300 as this was administered to her child according to the vaccination pass of her child. Product Quality Group confirmed the Expiry date of Batch W34300 as 31Mar2020. The mother was not quite sure that the vaccination pass was filled out correctly by the physician. The pharmacy also wanted and was provided the following Information: there is a Batch for pneumococcal 13-val conj vac existing with an expiry date of Jul2020: the exact Dates are: Batch X19637, expiry date 31Jul2020. Batch W34300 was distributed to the pharmacy between 27Jun2018 and 29Aug2018, Batch X19637 was distributed to the pharmacy between 05Sep2018 and 03Oct2018.; Sender''s Comments: This report is lacking information critical for an independent medical assessment especially lack of pre-existing medical history, concomitant medications and the time to the onset of the event. Currently, based on the limited information provided, the company considers unlikely a causal relationship between the vaccination with PREVENAR 13 and the infant death. This case will be reassessed when additional information, particularly the autopsy results and death cause, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: child died


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