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VAERS ID: 576417 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-11
Onset:2014-12-29
   Days after vaccination:18
Submitted: 2015-03-20
   Days after onset:80
Entered: 2015-03-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0235 / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pH decreased, Body temperature increased, CSF cell count normal, Computerised tomogram normal, Death, Encephalopathy, Hepatic function abnormal, International normalised ratio increased, Multi-organ disorder, Seizure, Shock, Shock haemorrhagic, Vomiting, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-01
   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:
Current Illness:
Preexisting Conditions: Febrile convulsion (elder brother)
Allergies:
Diagnostic Lab Data: Confirmatory Tests: cervical CT was normal and spinal fluid cell was 1/uL. Body temperature, 29DEC2014, 38-40 DEGREE C; WBC, 14500; PROTHROMBIN TIME, 1.42; PH, 6.07
CDC Split Type: 2015SA031780

Write-up: Initial unsolicited report received from the health authority, Agency (Ref: #V14101315) via a pediatrician on 12 March 2015. A 35 months old female patient, whose medical history and concomitant medications were not reported, had received a 0.5 ml dose of IMOVAX POLIO (batch number: J0235) (expiry date, dose number, site of adminsitration were not reported) via Subcutaneous route on 11 December 2014 and also he received INFLUENZA VACCINE (batch number: 379C) (expiry date, dose, dose number, route and site of administration were not reported) on 11 December 2014. It was reported that the patient had received VARICELLA VACCINE (LIVE) (batch number: V2125) (expiry date, dose, dose number, route and site of administration were not reported) on 11 December 2014. It was reported that on 29-Dec-2014, at 23:00, patient developed acute encephalopathy. She had vomiting since around 05:00, and was taken to a hospital. Her temperature was 38-40 degree C. She was prescribed antibiotics and returned home. Patient was active, but an ambulance was called at around 23:00 and convulsion occurred in the ambulance car. When patient arrived at the reporting hospital, she was in convulsive state and anticonvulsants were administered. Corrective treatment for convulsion were reported as diazepam, midazolam, and thiopental sodium. Patient was diagnosed with acute encephalopathy and received steroid pulse therapy and antibiotics as corrective treatment. Subsequently, multi-organ abnormalities including shock state and abnormal hepatic function occurred. She had vomiting. The diagnosis of haemorrhagic shock and encephalopathy syndrome was made. Laboratory investigation was reported as cervical CT was normal and spinal fluid cell was 1/uL and blood test showed WBC on 14500/uL, PT-INR of 1.42, and pH of 6.07. Encephalopathy acute (Encephalopathy acute). Reporting pediatrician''s seriousness assessment: Serious (death). Reporting pediatrician''s causality assessment: Unknown. Reporting physician''s comment: The event was possibly triggered by some kind of infection, but the pathogen was not identified and infection was unproved. In addition, the causal relationship to the vaccines was unknown. It was reported that patient was died on 1 January 2015. Documents held by sender: none. Cause (s) of Death: encephalopathy acute, haemorrhagic shock, multi-organ disorder.


VAERS ID: 576458 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-15
Onset:2014-11-21
   Days after vaccination:6
Submitted: 2015-03-26
   Days after onset:124
Entered: 2015-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CB176A / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH PAA012887 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA971AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Restlessness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-22
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015037234

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of unknown cause of death in a 2-month-old female patient who received INFANRIX-polio-HIB (batch number A20CB176A, expiry date unknown). Co-suspect products included ROTARIX liquid formulation (batch number AROLA971AA, expiry date unknown) and PREVENAR 13 (batch number PAAO12887, expiry date unknown). On 15th November 2014, the patient received INFANRIX-polio-HIB (parenteral), ROTARIX liquid formulation (oral) and PREVENAR 13 (parenteral) at an unknown dose and frequency. On an unknown date, 6 days after receiving INFANRIX-polio-HIB, ROTARIX liquid formulation and PREVENAR 13, the patient experienced restlessness. On an unknown date, 9 days after receiving INFANRIX-polio-HIB, ROTARIX liquid formulation and PREVENAR 13, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 22nd November 2014, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the restlessness was not recovered/not resolved. The patient died on 22nd November 2014. The reported cause of death was death unexplained. It was unknown if the reporter considered the unknown cause of death and restlessness to be related to INFANRIX-polio-HIB and ROTARIX liquid formulation. Additional details: The suspect vaccine was reported as INFANRIX Hib, however, as the batch number reported (A20CB176A) corresponds to INFANRIX-polio-HIB, the suspect vaccine was corrected accordingly. Regulatory authority verbatim: 20-MAR-2015 I believe my daughter died as an adverse reaction to the vaccines she was given. She was a perfectly healthy baby until she had these. She became restless 6 days later then died 9 days after her vaccines.


VAERS ID: 576483 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2015-02-25
Onset:2015-03-03
   Days after vaccination:6
Submitted: 2015-03-24
   Days after onset:20
Entered: 2015-03-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-03
   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: VENTOLINE
Current Illness:
Preexisting Conditions: JAN-2015, Bronchiolitis; 16-FEB-2015 to 17-FEB-2015, Hospitalization; PREVENAR-13, immunisation, 1st dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015098403

Write-up: This is a spontaneous report from a contactable physician via Medical Information team. A 4-month and a half-old female patient received the second dose of PREVENAR 13 (Lot number unknown) 0.5 ml, single and a dose of INFANRIX HEXA (Lot number unknown), on separate injection sites, both on 25Feb2015. Injections were done by the reporting physician''s substitute. The patient was born at 40 weeks post last menstrual period and did not have neonatal problems. Then, her medical history included bronchiolitis in mid Jan2015 which continued for a long time and for which she was hospitalized on 16 and 17Feb2015. At the time of vaccination she was still on concomitant treatment with VENTOLINE which was instituted after hospitalization. On 03Mar2015, the patient was found dead during her sleep by her nanny. It was unknown if an autopsy was performed.


VAERS ID: 576492 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-26
Onset:2015-03-02
   Days after vaccination:4
Submitted: 2015-03-24
   Days after onset:21
Entered: 2015-03-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J86920 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015095536

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2015015612. A 72-year-old male patient was vaccinated with first dose of PREVENAR 13; lot J86920 on 26Feb2015, at 0.5 ml single, in left arm. PREVENAR 13 was not given previously. No previously vaccination complication was reported. Medical history and concomitant medications were not reported. On 02Mar2015 the patient developed Guillain Barre syndrome which required hospitalization from 03Mar2015 to 07Mar2015 and condition was life threatening. Diagnosis was confirmed by hospitalization. The patient died on unknown date in Mar2015 and cause of death was unknown. At that time Guillain Barre syndrome had not resolved. It was not reported whether the autopsy was performed or not. This case is being treated according to the Protection against Infection Act. No follow-up attempts needed. No further information expected.


VAERS ID: 576620 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-10
Onset:2014-11-10
   Days after vaccination:0
Submitted: 2015-03-31
   Days after onset:140
Entered: 2015-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Public       Purchased by: Other
Symptoms: Death, Dyspnoea, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-26
   Days after onset: 16
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: ADALAT CR; LASIX; Clarith; ITOROL; MUCOSTA, ALINAMIN F; DEPAS; OPALMON; pirfenidone; LANDSEN
Current Illness: Unknown
Preexisting Conditions: Idiopathic pulmonary fibrosis
Allergies:
Diagnostic Lab Data: 11/10/2014, Body temperature, 38.5 degrees C; 11/11/2014 Body temperature, 36.7 degrees C
CDC Split Type: WAES1503JPN014186

Write-up: This spontaneous report as received from a physician refers to a 82 year old female patient with history of idiopathic pulmonary fibrosis. On 28-FEB-2008, the patient was vaccinated with a dose of PNEUMOVAX NP (dose, route, lot # and expiration date were not provided. Then, in the morning of 10-NOV-2014, the patient was vaccinated again with a dose of PNEUMOVAX NP, 0.5 ml dose, subcutaneous, (lot # and expiration date were not provided). Concomitant therapies included ADALAT CR, LASIX, Clarith, ITOROL, MUCOSTA, ALINAMIN F, DEPAS, OPALMON, PIRESPA and LANDSEN. On the same date, in the afternoon, the patient developed pyrexia (38.5 degrees C). On 11-NOV-2014, the symptom of pyrexia disappeared (36.7 degree C) (the patient recovered from pyrexia). On 26-NOV-2014, the patient was sent to the emergency center by ambulance (with oxygen mask) because of dyspnoea. On the same date, the patient died due to respiratory failure after hospitalization. No information of autopsy had been provided. The outcome of respiratory failure was reported as fatal. The outcome of pyrexia was reported as recovered. The reporter considered respiratory failure to be not related to PNEUMOVAX NP. The reporter considered pyrexia to be related to PNEUMOVAX NP. The reporter''s comment: direct relationship to PNEUMOVAX NP was denied. The reporting physician considered that the dyspnoea (respiratory failure) was serious due to death and hospitalization. The reporting physician considered that the pyrexia was non-serious. Upon internal review the event of respiratory failure was considered to be medically significant. Additional information is not expected because the reporter did not wish to be contacted.


VAERS ID: 576695 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-01
Entered: 2015-04-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal bacteraemia, Sepsis, Streptococcus test positive
SMQs:, 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: Unknown
Allergies:
Diagnostic Lab Data: Serology test, Pneumococcal infection with serotype 6A
CDC Split Type: 2015083969

Write-up: This case was considered ICH-invalid due to unspecified product. Follow-up (26Mar2015): The initial case was missing the following minimum criteria: specified suspect product. Upon receipt of follow-up information on 26Mar2015, 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. An 8-year-old patient for an unspecified dates. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was fully vaccinated with PREVENAR 7 and died due to sepsis/died of pneumococcal bacteraemia on an unspecified date. Serology work up on unspecified date identified pneumococcal infection with serotype 6A. It was not reported if an autopsy was performed. The reporter stated "PREVENAR 13" was not suspected.


VAERS ID: 577602 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-28
Onset:2012-05-11
   Days after vaccination:13
Submitted: 2013-02-26
   Days after onset:291
Entered: 2015-04-05
   Days after submission:767
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER F40A / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1477 / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 11J01A / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-11
   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: No medical history (including allergy); No concomitant therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201205492

Write-up: Case received from the Health Authorities on 23 May 2012 under the reference number A20120814 (HA''s number HIB-374). A 05-month-old male patient, with no medical history (including allergy) and no concomitant therapy, had received his 3rd subcutaneous dose of ACTHIB (batch number G1477) in the left upper arm, his 3rd subcutaneous dose of PREVENAR (other manufacturer, batch number 11J01A) in the right upper arm and his 2nd subcutaneous dose of DTP (other manufacturer, batch number F40A) in the right upper arm on 28 April 2012 around 09:00am. The patient''s body temperature before vaccination was 36.2 degrees C. The patient''s weight was 2 366g at birth. On 11 May 2012, around 06:00am, the patient was found lying on his face and in respiratory arrest. He was taken to hospital by ambulance and confirmed dead. An autopsy was performed at other hospital. (The report above was based on the hearing from the patient''s mother.) Physician''s comment: A causal relationship between the vaccines and the patient''s death is not assessable. Follow-up information received from the Health Authorities through the local affiliates on 29 October 2012. Based on the autopsy findings, the cause of death was sudden infant death syndrome. Relevant Test/Laboratory Data: not reported.


VAERS ID: 576800 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-06
Onset:2014-11-10
   Days after vaccination:4
Submitted: 2015-04-02
   Days after onset:142
Entered: 2015-04-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time ratio, Alanine aminotransferase increased, Aspartate aminotransferase increased, Autopsy, Blood gases abnormal, Coagulation factor V level decreased, Coagulation factor X level normal, Fatigue, Haemoglobin decreased, Hypertonia, Hypophagia, Hypotonia, Irritability, Metabolic acidosis, Opisthotonus, Oxygen saturation decreased, Platelet count normal, Prothrombin level, Respiratory acidosis, Respiratory arrest, Resuscitation, Sudden death, Sudden infant death syndrome, Thrombin time, Toxicologic test normal, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INEXIUM; OCT-2014 / OCT-2014
Current Illness:
Preexisting Conditions: Unknown date, GERD; Unknown date, Ectopic kidney, of asymmetric size in respect to the right one
Allergies:
Diagnostic Lab Data: NOV-2014, Activated partial thromboplastin time ratio, 50/34; NOV-2014, Alanine aminotransferase, 159 IU/l; NOV-2014, Aspartate aminotransferase, 231 IU/l; NOV-2014, Coagulation factor V level, 36%; NOV-2014, Coagulation factor X level, 60%; NOV-2014, Haemoglobin, 8.4 g/dl; 09-NOV-2014, Oxygen saturation, 80%; NOV-2014, Platelet count, 187 x 10 9/l; NOV-2014, Prothrombin level, 44%; NOV-2014, Thrombin time, 44%; NOV-2014, Toxicologic test, negative; NOV-2014, White blood cell count, 8.6 x 10 9/l
CDC Split Type: 2015109904

Write-up: This is a spontaneous report received from the Agency, regulatory authority report number FR-AFSSAPS-GR20150119. A 02-month-old male patient received the first dose of the following suspect vaccines intramuscular route on 06Nov2014 (unknown batch numbers): PREVENAR 13 and INFANRIX HEXA. Relevant medical history included ectopic left kidney in pelvis of asymmetric size in respect to the right one and gastroesophageal reflux treated with INEXIUM until late-Oct2014. On 06Nov2014, the baby was seen by his attending physician and was healthy. The patient was the subject of unexplained death on 10Nov2014. From 06Nov2014, the baby started to become more grouchy and tired. As of 09Nov2014 decreased food intake was noted. On 09Nov2014 in the evening, after the bottle-feeding, he developed a transient episode of hypertonia with opisthotonus, followed by global hypotonia then respiratory arrest, at around 9:30 PM. Cardiopulmonary resuscitation was initiated by the father and done for 20 minutes, then continued by the emergency medical unit. At 10:05 PM, spontaneous cardiac rhythm was resumed after institution of ventilation by mask and 2 doses of epinephrine (unspecified trade name). During transfer to the hospital, he has presented several episodes of desaturation up to 80% under fraction of inspired oxygen at 100%. During hospital stay, hemodynamic parameters progressively worsened despite continuous epinephrine administration and iterative bolus. The baby died on 10Nov2014 at 4:27 AM. Differential diagnosis. Regarding laboratory tests: blood count was mildly impaired with leukocytes 8.6 x 10^9/l, hemoglobin 84 g/l and platelets 187 x 10^9/l. Coagulation profile showed impaired prothrombin ratio decreased to 44%, activated partial thromboplastin time ratio at 50/34, Factor II 44%, Factor V 36% and Factor X 60%. Aspartate aminotransferase and alanine aminotransferase marked respectively 231 and 159 IU/L. Blood gases analysis revealed respiratory and metabolic acidosis. Toxicology screening returned negative. There was no evidence of infection, no fever. On 12Nov2014, autopsy was performed and did not find any explanation to death. Conclusion: sudden and unexplained death of a 2 month-old infant, with absence of cerebral activity and multi organ failure, especially hemodynamic. Based on the Official Method of Causality Assessment, the causal relationships between the vaccines and the adverse event were assessed by the Agency as "doubtful". No FU attempts possible. No further information expected.


VAERS ID: 576831 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-07
Entered: 2015-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral atrophy congenital, Congenital anomaly, Foetal exposure during pregnancy, Ischaemia, Mechanical ventilation, Spinal muscular atrophy
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Azathioprine
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015043359

Write-up: This retrospective pregnancy case was reported by a physician via regulatory authority and described the occurrence of cerebral atrophy congenital in a patient exposed to Influenza vaccine in utero. The mother received the product for routine immunization. Co-suspect product exposures included azathioprine unknown. The parent''s medical history included investigation (all genetic investigations normal), pregnancy loss (three times previously), ulcerative colitis and influenza vaccine. On an unknown date, the 30-year-old mother received Influenza vaccine (intramuscular) and azathioprine 50 mg once daily. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The action taken with azathioprine was unknown. The patient was diagnosed with cerebral atrophy congenital (serious criteria death, GSK medically significant, congenital anomaly and other), ischaemia (serious criteria death, congenital anomaly and other) and spinal muscular atrophy congenital (serious criteria death, congenital anomaly and other). On an unknown date, the outcome of the cerebral atrophy congenital was fatal and the outcome of the ischaemia and spinal muscular atrophy congenital were not recovered/not resolved. The reported cause of death was cerebral atrophy congenital. An autopsy was not performed. It was unknown if the reporter considered the cerebral atrophy congenital, ischaemia and spinal muscular atrophy congenital to be related to Influenza vaccine and azathioprine. Regulatory authority verbatim: Mum pregnant and baby delivered at term, which then died at 23 days. Atrophy of cervical spinal cord and medulla oblongata noted. Baby was ventilator dependent and care was withdrawn. Unknown cause of ischaemia/atrophy of cord - developed antenatally. Medically significant details: Mum was unwell for 2 weeks post-influenza injection. Mother had had three previous pregnancy losses, but all genetic investigations were normal.


VAERS ID: 576836 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-28
Onset:2015-03-28
   Days after vaccination:0
Submitted: 2015-04-03
   Days after onset:6
Entered: 2015-04-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K00121 / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Crying, Death, Pallor, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-29
   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: Con Meds -Unknown; IMOVAX Polio (IPV (Vero)) (Prev.) Dose # 1, Mfg: Sanofi Pasteur, Lot # Unk, Route: Unknown, Site: Unknown 14 FEb2015
Current Illness:
Preexisting Conditions: She was an early born baby (35w+5d), and had her skull fractured on the right side. After the surgery, the fracture was recovered.
Allergies:
Diagnostic Lab Data: Lab tests unknown; Cause (s) of Death: death NOS
CDC Split Type: 2015SA039887

Write-up: Initial unsolicited report received from a physician via company representative on 29 March 2015. A 06-month-old female patient had received a 0.5ml second dose of IMOVAX Polio (IPV (Vero) (batch number K0012-1) intramuscularly in left arm on 28 March 2015. Medical history included that the patient had a mild cough from an unspecified date and she was an early born baby (35w+5d), and had her skull fractured on the right side. After the surgery, the fracture was recovered. Concomitant medication was not reported. Past drug history included that first dose of IMOVAX Polio (IPV (Vero)) was administered on 14 February 2015 and nothing unusual observed after the vaccination. On 28 March 2015 she experienced drowsiness after the drug administration. On 29 March 2015 at 3:00 am patient was crying abnormally, at 4:30 am her face turned pale and she was taken to nearby hospital for rescue. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome was reported as death on 29 March 2015 at 6:30 am and the outcome for the other events (drowsiness, crying abnormally and face turned pale) was reported as unknown. Documents held by sender: none.


VAERS ID: 576900 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-14
Onset:0000-00-00
Submitted: 2015-04-10
Entered: 2015-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood bilirubin increased, Bronchoalveolar lavage abnormal, Confusional state, Contraindication to vaccination, Death, Dysstasia, Endotracheal intubation, Fall, General physical health deterioration, Histiocytosis haematophagic, Immunoglobulin therapy, Incorrect route of drug administration, Injection site rash, Intensive care, Jaundice, Lethargy, Malaise, Mechanical ventilation, Medication error, Multiple organ dysfunction syndrome, Neutropenia, Platelet transfusion, Polymerase chain reaction positive, Pyrexia, Rash vesicular, Respiratory failure, Skin haemorrhage, Thrombocytopenia, Transfusion, Urine analysis normal, Varicella virus test positive, Viral test positive
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), 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), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: aspirin; Lisinopril; timoptol-LA
Current Illness: Unknown
Preexisting Conditions: Neutropenia; Fatigue; Pyrexia; Hypertension; Pneumocystis jirovecii pneumonia; Lymphoma, The patient had a medical history of lymphoma. The patient was treated with cyclophosphamide, fludarabine and rituximab chemotherapy until Apr-2014 for chronic lymphocytic leukemia. The patient had also been treated with pentamidine for pneumocystis pneumonia. The patient also had a history of a widespread erythematous skin rash either to allopurinol or SEPTRIN, and hypertension; pentamidine isethionate, Rash erythematous
Allergies:
Diagnostic Lab Data: Blood bilirubin, very high, increased; Bronchoalveolar lavage, initially positive for varicella zoster virus; Bronchoalveolar lavage, became negative for varicella zoster virus; Laboratory test, vesicle fluid confirmed clinical imp. of v. zoster; Polymerase chain reaction, VZV in skin lesions and bronchoalveolar lavage; Urine analysis, negative; Viral test, positive for shingles vaccine
CDC Split Type: WAES1504GBR004638

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer no E2015-00473) on 8-APR-2015. Initial case received on 21-Jan-2015 from health authority. GB-MHRA ADR 22824299. The case is medically confirmed as it was reported by a physician. A 79 year old male patient, with medical history of lymphoma, received an injection of ZOSTAVAX (batch number K00514) intramuscularly in the right deltoid, dose in series not reported, on 14-Oct-2014. On an unreported date, 2 weeks after the vaccine, the patient experienced flu like symptoms and lethargy and was unwell. On 19-Nov-2014, the patient was admitted to hospital with rash, consistent clinically with varicella zoster virus infection, was febrile and slightly confused but had no respiratory symptoms. Rash initially developed around the injection site on right deltoid but then developed widespread vesicles. On admission, the patient was treated with high dose of intravenous aciclovir. Subsequent vesicle fluid analysis confirmed the clinical impression of varicella zoster virus. He continued to develop new skin lesions over the next few days but remained clinically stable. On 24-Nov-2014, the patient rapidly deteriorated with respiratory failure requiring transfer to intensive care and invasive ventilation. With the increased doses of intravenous aciclovir and intravenous immunoglobulin the patient received, his skin became clear and subsequent bronchoalveolar lavage which had initially been positive for varicella zoster virus became negative. Despite this, the patient continued to deteriorate. He was extubated and briefly improved. For a short duration he was able to communicate with his family before deteriorating again. On an unreported date, the patient developed acute liver failure with a very high bilirubin which was already unexplained. On 14-Dec-2014 the patient died from multi-organ failure. The patient was treated with cyclophosphamide, fludarabine and rituximab chemotherapy until Apr-2014 for chronic lymphocytic leukemia that was why the patient was known in haematology department. The reporter had confirmation from colleagues in virology that the strain of varicella zoster virus identified was that of the shingles vaccine and therefore. The case was reported to Procurator fiscal. At the time of reporting, the patient had recovered from varicella-like rash and varicella zoster and he had not recovered from acute liver failure, confusion, fever, flu like symptoms, lethargy, respiratory failure and unwell. On 14-Dec-2014, the outcome of multi-organ failure was fatal. The case was considered as serious due to the patient''s death and hospitalisation. Upon internal review on 03-Feb-2015 the company considered this to be a case of medication error as the vaccine was given by the wrong route (intramuscular instead of subcutaneous). Follow up information received from the RA on 17/Feb/2015. The reporter stated: The hospital letter mentions that the death was reported to the Procurator Fiscal and as far as I am aware of postmortem was not undertaken. Follow up received from the RA on 18-Mar-2015 under ref GB-MHRA-ADR 22902190. The patient had also previously been treated with pentamidine for pneumocystis pneumonia. The patient also had a history of a widespread erythematous skin rash either to allopurinol or SEPTRIN, and hypertension. The patient was taking concomitant aspirin, lisinopril 10mg and Timoptol 0.25% for unknown indications. The patient had completed a course of chemotherapy for chronic lymphocytic leukaemia. About two weeks after vaccination the patient started to feel non-specifically unwell. The respiratory failure required intubation and ventilation. Varicella zoster virus was detected by polymerase chain reaction for skin lesions and bronchoalveolar lavage. The patient then developed fulminant liver failure and died of multi-organ failure. He developed disseminated herpes zoster infection with subsequent pneumonitis. The reporter stated that this vaccine is contraindicated in any patients with a diagnosis of lymphoma which CLL is and the patient was only just six months from completion of chemotherapy. Therefore he should not have been given the vaccine. Upon internal medical review the event of contraindication to vaccination was coded. Follow up received from a consumer (the patient''s son) on 02-Apr-2015: The patient had completed a course of chemotherapy and between that time and vaccination five months afterwards he was admitted to hospital for ten days with a fever of unknown origin. He was relatively active and walked 2-3 miles round the local park on a daily basis. He wanted to take up golf again post chemotherapy but was too tired to consider it in the last year. Prior to vaccination his haemotological indicators were the best they had been for a couple of years and he was considered at most to be borderline neutropenic but his platelet count and haemoglobin were within normal limits and there was no evidence of an excess of lymphocytes. The patient presented to his GP one month post vaccination after a fall in the park with malaise and pyrexia. Despite negative urinalysis he was sent home with antibiotics for a UTI and the promise of a referral to a "falls" clinic. He presented again at the GP five days later as he was feeling worse with the same symptoms and a pustular rash. The patient''s wife told the GP that she thought it was chickenpox but the GP disagreed and even brought in a colleague to verify that it wasn''t chickenpox and sent him home with antibiotics and took a blood sample. Five further days later he could hardly raise himself and despite being averse to causing anyone any trouble his wife called his Consultant Haemotologist at the local hospital. The latter was the first person to look at the blood result from the sample taken by his GP five days earlier and it showed that he was both neutropenic and thrombocytopenic. She organised an ambulance to take him in to the hospital that morning. Incidentally the rash was more purpuric than a conventional chickenpox or shingles rash most probably because his platelets were now in his boots and he was bleeding into the pustules. He progressed from dermatitis to chickenpox pneumonitis. When ITU sedation was reduced 12 days after ventilation he did not awaken at which point it was realised that he had chickenpox encephalitis. A decision was taken to withhold treatment (acyclovir and bucket loads of platelets) at this point. Then he did awaken one day later. Treatment was recommenced but bleeding into various sites plus the repeated platelet and blood transfusions heralded the development of a post infectious haemophagocytic syndrome and deep jaundice. He never recovered from this and probably ''stroked out'' in the final hours.


VAERS ID: 576907 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-03-20
Onset:2015-04-06
   Days after vaccination:17
Submitted: 2015-04-10
   Days after onset:4
Entered: 2015-04-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Imaging procedure abnormal, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prostate cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Image: (From 2013 to 2015). There was no pathological image. Image: (06-APR-2015). Shadow was confirmed by the pathological image
CDC Split Type: WAES1504JPN005097

Write-up: This spontaneous report as received from a physician refers to an 80 year old male patient with prostate cancer who on an unknown date was vaccinated with a first dose of PNEUMOVAX NP (dose, lot #, and expiration date were not reported) by parenteral route. From 2013 to 2015, there was no pathological image. On 20-MAR-2015, the patient received second dose of PNEUMOVAX NP, subcutaneously, 0.5 ml. On 06-APR-2015, the patient was suspected of having interstitial pneumonia (interstitial lung disease) and was transferred to the reporter''s hospital. Shadow was confirmed by the pathological image, so the patient was hospitalized. At the time of the report, the patient was under unspecified treatment. The outcome of interstitial lung disease was unknown. Reporter''s comment: Drug Lymphocyte Stimulation Test (DLST) has been requested. The reporting physician considered that interstitial lung disease was serious due to hospitalization. The reporting physician did not assess the relationship of interstitial lung disease to PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 576940 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-15
Entered: 2015-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Atrophy, Cerebral atrophy, Death, Foetal exposure during pregnancy, Ischaemia, Malaise, Mechanical ventilation, Spinal cord ischaemia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Azathioprine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015050284

Write-up: This medically confirmed regulatory report (initial receipt 01-Apr-2015) concerns a foetus patient. The 30 year-old mother had a medical history of ulcerative colitis and had three previous pregnancy losses, but all genetic investigations were normal. She was unwell for two weeks post influenza injection (see case 2015050283). On an unspecified date, the foetus was exposed to Influenza virus vaccine, manufacturer and batch number not provided via the transplacental route of administration for vaccination in the mother. The foetus was also exposed to azathioprine 50mg once a day via the transplacental route of administration for ulcerative colitis in the mother. On an unspecified date, the patient was delivered at term. The patient had an atrophy of cervical spinal cord and medulla oblongata, and was ventilator-dependent and care was withdrawn. The patient died at 23 days. The cause of ischaemia/atrophy of cord was unknown - they developed antenatally. The outcome was reported as fatal. Cause(s) of death: Unknown case of death.


VAERS ID: 577216 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-15
Onset:2014-05-15
   Days after vaccination:0
Submitted: 2015-04-17
   Days after onset:337
Entered: 2015-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR J1521 / UNK RL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C340111 / 1 RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER K5091 / 1 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H91663 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA581BA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Autopsy, Decreased appetite, Flatulence, Hypopnoea, Listless, Mental impairment, Musculoskeletal stiffness, Peripheral coldness, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-16
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: 01/31/2014 to 01/31/2014, Premature baby, weight 1.4 kg, length 43 cm, head circumference 31 cm. Nursed at ICU 8 weeks and discharged on 02Mar2014; Poliovirus vaccine live oral, The patient was received her due at birth immunization before discharge from hospital, Prophylaxis, No adverse event; Bacillus Calmette-Guerin Vaccine, The patient was received her due at birth immunization before discharge from hospital, Prophylaxis, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2015GSK050999

Write-up: This case was reported by a physician via licensee and described the occurrence of sudden death unexplained in a 4-month-old female patient who received ROTARIX liquid formulation (batch number AROLA581BA, expiry date unknown). Co-suspect products included Poliovirus vaccine live oral (OPV) (batch number K5091, expiry date unknown, PENTAXIM (batch number J1521, expiry date unknown), Hepatitis B vaccine (batch number 3C340111, expiry date unknown) and pneumococcal vaccine (batch number H91663, expiry date unknown). The patient''s past medical history included premature birth (at an unspecified age, with a weight of 1.4 kg, a length of 43 cm, a head circumference of 31 cm. Nursed at neonatal ICU for 8 weeks and was discharged on 02Mar2014). Previously administered products included oral polio with an associated reaction of no adverse event (The patient was received her due at birth immunization before discharge from hospital) and BCG with an associated reaction of no adverse event (The patient was received her due at birth immunization before discharge from hospital). On 15th May 2014 09:00, the patient received the 1st dose of ROTARIX liquid formulation (oral), the 1st dose of OPV (oral), PENTAXIM (intramuscular), the 1st dose of Hepatitis B vaccine (intramuscular) and pneumococcal vaccine (intramuscular). On 15th May 2014, several hours after receiving ROTARIX liquid formulation, the patient experienced shallow breathing (serious criteria death), listless (serious criteria death), mental dullness (serious criteria death and GSK medically significant), appetite absent (serious criteria death) and swollen abdomen (serious criteria death). On 16th May 2014, the patient experienced sudden death unexplained (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death unexplained, shallow breathing, listless, mental dullness, appetite absent and swollen abdomen were fatal. The patient died on 16th May 2014. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the sudden death unexplained, shallow breathing, listless, mental dullness, appetite absent and swollen abdomen to be related to ROTARIX liquid formulation. Additional information was provided as follow: The mother of the patient had no past or current medical history. She attended adequate antenatal care before giving birth to the child and there were no abnormalities associated with pregnancy. She was not HIV positive. The baby did not have any know allergies. She had an older brother aged 11 years who is well and fit. He had all his scheduled childhood immunization without any untoward developments. Because of her premature condition the patient had to be nursed for over 8 weeks at the neonatal ICU of the hospital until she was discharged on satisfactory clinical grounds on 02 March 2014. Her weight on discharge was 3.7 kg. The patient received her due "at birth" immunization before discharge at the same hospital and there were no untoward sequelae after these two vaccinations. According to the mom, the baby was fine until she was given her six weeks immunizations at the hospital. The baby''s first clinic visit for vaccinations was at 4 months. The condition was satisfactory. Before administering the vaccinations the baby was examined. The nurse reported that there was no fever, no recording of any temperature rise. Other vitals were normal. The child was recorded to be well and healthy immediately before and after vaccination. She was taken home by mother on satisfactory clinical grounds after some few minutes or an on the spot observation. About an hour or so after receiving the vaccinations and later on, the child started becoming dull and listless and refused her food. They did not notice any swellings around the areas of injections. There was no fever, there were no fitting episodes and there was no vomiting or diarrhea. Within the night of the 15th May 2014, the child who normally snored and groaned during her sleep, started to develop shallow breathing with associated swollen gassy abdomen. The child got worse by the next morning of 16thMay2014. The baby was rushed to the clinic. The baby was already dead upon arrival at the hospital. There was no breathing, no chest movement, eyes already closed with mouth wide opened/gaping, legs stiff and extremities and body cold. It looked as though the baby had been dead for 6 hours. The mom reported that the baby was alive at 5:30 AM when she woke up. It is at the moment not clear what could have caused the sudden death of this child. A post mortem report is being awaited. It was unknown if the reporter considered the shallow breathing, listless, mental dullness, appetite absent and swollen abdomen to be related to OPV, PENTAXIM, Hepatitis B vaccine and Pneumococcal vaccine.


VAERS ID: 577224 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-03-17
Onset:2015-03-25
   Days after vaccination:8
Submitted: 2015-04-13
   Days after onset:19
Entered: 2015-04-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-25
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015120697

Write-up: This is a spontaneous report obtained from a contactable pharmacist. A 2-month-old patient of an unspecified ethnicity and gender received, on 17Mar2015, PREVENAR 13 via an unspecified route of administration, single dose. Relevant medical history and concomitant medications were unknown. A patient died on 25Mar2015 and the cause of death was unknown. No information was provided if autopsy was performed. No assessment of causality was provided at the time of the report.


VAERS ID: 577459 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-17
Entered: 2015-04-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test positive, Areflexia, Asthenia, Biopsy skin abnormal, CSF glucose normal, CSF virus identified, CSF white blood cell count increased, CSF white blood cell differential, Central nervous system lesion, Coma scale, Dysphonia, Encephalitis brain stem, Flail chest, Guillain-Barre syndrome, Headache, Hypopnoea, Lyssavirus test positive, Mechanical ventilation, Muscular weakness, Paralysis, Polymerase chain reaction positive, Pyrexia, Quadriplegia, Rabies, Regurgitation, Respiratory failure, Respiratory paralysis, Tachycardia, Vaccination failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (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) (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Cat scratch, 2 months back, patient had cat scratch on face
Allergies:
Diagnostic Lab Data: Glasgow coma scale, 15/15; Cerebrospinal fluid cell count, 412 cells; Cerebrospinal fluid glucose, 62 mg/dl
CDC Split Type: 2015SA047022

Write-up: Initial unsolicited report received from literature on 09 April 2015. Abstract: Only few reports of failure of intradermal postexposure prophylaxis for rabies following cat scratch exist in the published literature. We are reporting such a case in a 15 year old girl. The child had category III cat scratch on her face. She presented with progressive paralysis, finally developing quadriplegia and respiratory paralysis. Typical hydrophobia and aerophobia were absent. She received intra dermal anti rabies cell culture vaccine. She did not receive anti rabies immunoglobulin. The girl succumbed on the 10th day of weakness. Diagnosis of rabies was confirmed by isolation of rabies vaccine RNA in cerebrospinal fluid and skin biopsy sample by reverse transcription polymerase chain reaction. A 15-year-female patient, whose medical history and concomitant medications were not reported had received a dose of Rabies Vaccine (manufacturer: unknown, batch number, route of administration, site of administration were not reported) on an unspecified date. The patient had a history of unprovoked cat scratch over the face 2 months back. The patient was immunized with a complete course of intradermal cell culture anti rabies vaccine first dose started on day 2 of cat scratch. Updated schedule (2 2 2 2 2) was used for intradermal vaccination. Cat scratch was not cleaned. Cat was bitten by a rabid dog according to the mother. Rabies immunoglobulin (RIG) was not given. On an unspecified date, post vaccination, the patient was brought to the with the complaints of fever of 5 days, headache and vomiting of 4 days, weakness of bilateral lower limbs, followed by upper limbs, change in voice and nasal regurgitation of feeds since 2 days. Patient had tachycardia, shallow respiration with paradoxical movement of the chest wall. Glasgow coma scale was 15/15. Gag reflex was absent with pooling of secretions and absence of movements of soft palate and uvula. Power in bilateral upper and lower limbs was 1/5. Other systemic examination was normal. Child was mechanically ventilated at admission in view of respiratory failure. Initially, a diagnosis of brainstem encephalitis was made. A diagnosis of brain stem mass lesion was also considered. Provisional diagnosis of paralytic rabies was made on the basis of paralysis with history of cat scratch. Although rare with the modern cell culture vaccines, the possibility of vaccine induced GBS was also considered. Laboratory investigations revealed normal complete blood counts, serum electrolytes, liver and kidney function tests. Cerebrospinal fluid (CSF) analysis showed 412 cells with 10% neutrophils and 90% lymphocytes with sugar of 62 mg/dl. Computed tomography brain was normal. Rabies virus RNA was detected in CSF and skin biopsy samples by reverse transcription polymerase chain reaction. Neutralizing antibodies to rabies virus were detected in both serum and CSF by the rapid fluorescent focus inhibition test. Conservative management was started, but rapid progression with respiratory paralysis occurred over the next 2 days. There was no improvement and the patient succumbed on the 10th day of onset of the disease. Documents held by sender: none/yes. Confirmatory Tests: Gag reflex was absent with pooling of secretions and absence of movements of soft palate and uvula. Power in bilateral upper and lower limbs was 1/5. Other systemic examination was normal. Cerebrospinal fluid (CSF) analysis showed 412 cells with 10% neutrophils and 90% lymphocytes with sugar of 62 mg/dl. Computed tomography brain was normal. Neutralizing antibodies to rabies virus were detected in both serum and CSF by the rapid fluorescent focus inhibition test. Cause(s) of Death: rabies, respiratory failure, respiratory paralysis, encephalitis brain stem, brain lesion, Guillain-Barre syndrome.


VAERS ID: 577574 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-14
Onset:0000-00-00
Submitted: 2015-04-22
Entered: 2015-04-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumonia, Streptococcal bacteraemia, Streptococcus test positive
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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:
Current Illness:
Preexisting Conditions: Unknown; PREVNAR 13, single dose, immunization, 07-OCT-2011; PREVNAR 13, single dose, immunization, 28-DEC-2011; PREVENAR 13, single dose, immunization, 05-MAR-2012
Allergies:
Diagnostic Lab Data: 07-JAN-2014, Blood culture, streptococcus pneumonia serotype 19F
CDC Split Type: 2015138737

Write-up: Surveillance for invasive and respiratory pneumococcal disease in metropolitan region in 2013 (with determination of serotypes and vaccination status). This is a report from a non-interventional study, for Investigator-Initiated Research (IIR), subject ID not provided. A 30 months old patient of an unspecified gender and ethnicity received PREVNAR 13 on 07Oct2011, 28Dec2011, 05Mar2012 and 14Nov2012. Relevant medical history and concomitant medications were not reported. The primary infection site was blood, laboratory data included a blood culture on 07Jan2014 which showed streptococcus pneumonia serotype 19F. There were no pre-disposing factors. It was unknown if there was use of antipyretic. The patient died of pneumonia. It was unknown if an autopsy was performed. The reporter''s assessment of the causal relationship of the event 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.


VAERS ID: 577674 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-23
Entered: 2015-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Gastroenteritis rotavirus, General physical health deterioration, Parvovirus infection, Respiratory failure, Rhinovirus infection, Rotavirus test positive, Stem cell transplant, Vaccination failure
SMQs:, Anaphylactic reaction (broad), 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), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (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: No other medications
Current Illness: Combined immunodeficiency
Preexisting Conditions: Death of relative, died at 20 months of age suffering from postvaccinal BCGitis and severe cytomegalovirus infection
Allergies:
Diagnostic Lab Data: On an unknown date: the Rotavirus vaccine strain was identified in stool samples by sequencing 8 different gene segments (VP1, VP2, VP4, VP6, VP7, NSP2, NSP4 and NSP5). No ther pathogen could be identified im multiple stoool stamples.
CDC Split Type: DE2015GSK054490

Write-up: This case was reported in a literature article and described the occurrence of death unexplained in a 21-month-old male patient who received ROTARIX. Co-suspect products included ROTARIX. The patient''s past medical history included death of brother (died at 20 months of age suffering from postvaccinal BCGitis and severe cytomegalovirus infection). Concurrent medical conditions included combined immunodeficiency. On an unknown date, the patient received the 1st dose of ROTARIX (oral) and the 2nd dose of ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX and ROTARIX, the patient experienced death unexplained (serious criteria death and GSK medically significant), vaccine virus shedding, vaccination failure (serious criteria GSK medically significant), rotavirus gastroenteritis (serious criteria GSK medically significant), general physical health deterioration, rhinovirus infection, parvovirus infection, respiratory failure (serious criteria GSK medically significant) and labeled drug-disease interaction medication error. The patient was treated with Allogenic Stem Cell Transplant. On an unknown date, the outcome of the death unexplained was fatal and the outcome of the vaccine virus shedding, vaccination failure, rotavirus gastroenteritis, general physical health deterioration, rhinovirus infection, parvovirus infection, respiratory failure and labeled drug-disease interaction medication error were unknown. The reported cause of death was death. The reporter considered the death unexplained and general physical health deterioration to be probably related to ROTARIX and ROTARIX. The reporter considered the vaccine virus shedding, vaccination failure and rotavirus gastroenteritis to be related to ROTARIX and ROTARIX. It was unknown if the reporter considered the rhinovirus infection, parvovirus infection and respiratory failure to be related to ROTARIX and ROTARIX. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccine-acquired rotavirus infection in a 21-month-old male patient who had received ROTARIX (GlaxoSmithKline). The authors reported that the patient was originally from a certain country and that he had been transferred to another country''s hospital for treatment of his severe combined immunodeficiency syndrome with stem cell transplantation. The severe combined immunodeficiency syndrome was caused by an x-linked hemizygous mutation in Exon 2 of the IL2RG gene. His older brother had died at 20 months of age due to post-vaccination BCGitis and severe cytomegalovirus infection. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received 2 doses of ROTARIX at 3 and 4 months of age (dosages unknown; administration routes unspecified; batch numbers not provided). On an unspecified date, an unknown period after the vaccinations, he developed chronic gastroenteritis that resulted in severe stunting and wasting. Once at the hospital, he was found to have a rotavirus-vaccine-strain infection. This case was considered as a vaccine virus shedding case and a possible vaccination failure. SCID is a contraindication for vaccination with ROTARIX. Therefore, this vaccination was considered as a labeled drug-disease interaction medication error. The patient was also found to have high number copy of human bocavirus and rhinovirus in respiratory tract samples. He underwent the stem cell transplant, but his condition deteriorated despite intensive support care. He died on day 1 after the procedure. This was a serious case as the outcome was fatal. Cause of death was not provided. It was not reported if a post-mortem was performed. Eight different viral gene segments found in stool samples were sequenced and they were all found to be vaccine-associated sequences with few new mutations: gene NSP2/vaccine strain JX943605 100% nt and aa sequence identity (length of coding sequence: 606 nt; coding mismatched: 0 nt; non-synonymous mutations: 0 aa); gene NSP4/vaccine strain JX943607: 99.6% nt/ 98.9% aa sequence identity (length of coding sequence: 528 nt; coding mismatched: 2 nt; non-synonymous mutations: 2 aa); gene NSP5/vaccine strain JX943608: 99.5% nt/ 100% aa sequence identity (length of coding sequence: 567 nt; coding mismatched: 3 nt; non-synonymous mutations: 0 aa); gene VP1/vaccine strain JX943609: 100% nt/ 100% aa sequence identity (length of coding sequence: 558 nt; coding mismatched: 0 nt; non-synonymous mutations: 0 aa); gene VP2/vaccine strain JX943610: 99.5% nt/ 98.6% aa sequence identity (length of coding sequence: 660 nt; coding mismatched: 3 nt; non-synonymous mutations: 3 aa); gene VP4/vaccine strain JX849113: 99.2-99/3% nt/ 97.6-97.9% aa sequence identity (length of coding sequence: 873 nt; coding mismatched: 6-7 nt; non-synonymous mutations: 6-7 aa); gene VP6/vaccine strain (JX943613: 99.0% nt/ 98.0% aa sequence identity (length of coding sequence: 597 nt; coding mismatched; 6 nt; non-synonymous mutations: 4 aa) and gene VP7/vaccine strain JN849114: 99.5-99.6% nt/ 98.4-98.8% aa sequence identity (length of coding sequence: 963 nt; coding mismatched: 4-5 nt; non-synonymous mutations: 4-5 aa). Respiratory tract samples showed high copy numbers of human bocavirus and rhinovirus. No other pathogen could be identified. Treatment was unknown. The authors believed that the chronic gastroenteritis had been caused by the persisting infection with the vaccine strain and that this infection had probably contributed significantly to the fatal outcome. The authors concluded that "the severe combined immunodeficiency syndrome patient presented already with advanced disease and severely reduced general condition. We believe that viral shedding of rotavirus for such a prolonged period of time has not been previously reported and might be explained by the lack of timely adequate medical management. We cannot completely exclude that other gastrointestinal infections and other comorbidities might have been involved, but we propose that vaccine-acquired rotavirus-infection had probably contributed significantly to the fatal outcome. The clinic manifestation and diagnosis of severe combined immunodeficiency syndrome patients might be delayed well into the life period after the recommended vaccination schedule. Therefore, we emphasize the negative effect that rotavirus vaccination might have in these endangered patients and we strongly support effects of mandatory newborn screening for severe combined immunodeficiency syndrome".


VAERS ID: 577901 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-22
Onset:2015-04-23
   Days after vaccination:1
Submitted: 2015-04-29
   Days after onset:6
Entered: 2015-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A020B / 1 UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y081A / 1 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1492 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14C05A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Child abuse, Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-23
   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: Unknown
Allergies:
Diagnostic Lab Data: 22-APR-2015, Body temperature, 36.9 Centigrade
CDC Split Type: 2015146777

Write-up: This is a spontaneous report received from Agency, under the regulatory authority report number of V15100087. A 5-month-old male patient of an unspecified ethnicity started received the first dose of PREVENAR 13 (lot number: 14C05A) 0.5ml single dose, the first dose of ACT-HIB (lot number: K1492), the first dose of QUATTROVAC (lot number: A020B) and the first dose of BIMMUGEN (lot number: Y081A), all subcutaneously at 14:45 on 22Apr2015 as a single dose. The patient''s body temperature before vaccination was 36.9 degrees C. The patient''s medical history and the patient''s concomitant medications were not reported. The patient''s birth weight was 3976 g. The patient did not have a familial history. The patient had a one-year-old elder brother. Clinical course was reported as follows: In the evening of 23Apr2015, it was confirmed that the patient was not responsive at home. Ambulance was called and the patient was transported to another hospital by doctor helicopter. It was confirmed that the patient died of an unknown cause in the evening of the same date. Information was not provided whether or not autopsy was performed. The reporting physician classified the event as serious due to death and assessed the event as unassessable. Other factor related to the event was child abuse. The reporting physician commented as follows: The patient had been receiving care by municipal employee at the department of child care support, since it was difficult for his parents to care for him.


VAERS ID: 577939 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-29
Entered: 2015-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Unknown date, Meningococcal C vaccine, Immunization; Unknown date, MMR, Immunization; Unknown date, Pneumococcal conjugate vaccine, Immunization
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015141987

Write-up: This is a spontaneous report from a contactable physician. A 14 month old female patient of an unspecified ethnicity received a single dose of PREVENAR 13 on an unspecified date. Medical history and concomitant medications were not provided. The patient previously received all of her 12 ''months'' scheduled vaccinations: meningococcal C vaccine, measles mumps and rubella vaccine (MMR), pneumococcal conjugate vaccine, all on unspecified dates. The patient was found dead in bed an unspecified date in 2013, 6 and a half days after receiving pneumococcal 13-val-conj vac (dipht crm197 protein) vaccination. Cause of death was not provided. It was not reported if an autopsy was performed.


VAERS ID: 577942 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-30
Entered: 2015-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood culture positive, Death, Streptococcus test positive
SMQs:, 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: Malnutrition; Pneumonia; Bacteraemia; Hospitalisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Between April 2011 and July 2012, blood culture showed growth of Streptococcus pneumoniae.
CDC Split Type: BD2015GSK058475

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received DTP (A or W not known) vaccine. Co-suspect products included BCG vaccine and Measles Vaccine. Concurrent medical conditions included malnutrition, pneumonia, bacteremia and hospitalization. On an unknown date, an unknown time after receiving DTP (A or W not known) vaccine, Poliomyelitis vaccine oral Trivalent, Hepatitis B vaccine and Hib vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The subject was treated with antibiotics NOS. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP (A or W not known) vaccine, Poliomyelitis vaccine oral Trivalent, Hepatitis B vaccine and Hib vaccine. Relevant Tests: Between April 2011 and July 2012, blood culture showed growth of Streptococcus pneumoniae. Additional information was provided: This case was reported in a literature article and it described the occurrence of a death of a child of unspecified gender, up to 59 months old, who had received unspecified DTP vaccine, unspecified oral polio vaccine, unspecified Haemophilus influenzae vaccine, unspecified hepatitis vaccine, unspecified measles vaccine and unspecified BCG vaccine (manufacturers unknown). The patient''s concomitant conditions included severe acute malnutrition, pneumonia and bacteraemia for which they had been admitted to the high/intensive care unit. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date between April 2011 and July 2012, on admission to hospital, the patient received an unspecified DTP vaccine, an unspecified oral polio vaccine, an unspecified Haemophilus influenzae vaccine, an unspecified hepatitis vaccine, an unspecified measles vaccine and an unspecified BCG vaccine. Dosages were unknown; administration routes and sites were unspecified apart from the route for the polio vaccine, and the batch numbers were not provided. On an unspecified date, an unknown period after receiving vaccinations, the patient died while still in hospital. This was a serious case as the outcome was fatal. Cause of death was not specified, it was unknown if a post-mortem was performed. Pneumonia was confirmed via radiology. Streptococcus pneumoniae was isolated from a blood culture taken on admission. Antimicrobial susceptibility test results of the isolates confirmed that the antibiotic treatment provided was appropriate. Treatment consisted of unspecified antibiotics. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "we have found that severe acute malnutrition children with pneumonia often present with Gram-negative bacteraemia. Infection in these children appears to be strongly associated with a history of lack of BCG vaccination. This finding underscores the importance of the continuation of BCG vaccination in children to attain the non-tubercular substantial benefit of the vaccination". This case is 1 of the 3 valid cases reported in the same literature article.


VAERS ID: 577943 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-30
Entered: 2015-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acinetobacter test positive, Death
SMQs:, Infective pneumonia (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: Hospitalisation; Malnutrition; Pneumonia; Bacteraemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Between April 2011 and July 2012, blood culture showed growth of Acinetobacter bacteria
CDC Split Type: BD2015GSK058490

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received DTP (A or W not known) vaccine. Co-suspect products included BCG vaccine and measles vaccine. Concurrent medical conditions included malnutrition, pneumonia, bacteremia and hospitalization. On an unknown date, an unknown time after DTP (A or W not known) vaccine, Poliomyelitis vaccine oral trivalent, Hepatitis B vaccine and Haemophilus influenza type b vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The subject was treated with antibiotics nos. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP (A or W not known) vaccine, Poliomyelitis vaccine oral trivalent, Hepatitis B vaccine and Haemophilus influenza type be vaccine. Relevant Tests: Between April 2011 and July 2012, blood culture showed growth of Acinetobacter bacteria. Additional information was provide: This case was reported in a literature article and it described the occurrence of a death of a child of unspecified gender, up to 59 months old, who had received unspecified diphtheria-pertussis-tetanus vaccine, unspecified oral polio vaccine, unspecified Haemophilus influenza vaccine, unspecified hepatitis vaccine, unspecified measles vaccine and unspecified bacillus Calmette-Guerin vaccine (manufacturer unknown). The patient''s concomitant conditions included sever acute malnutrition, pneumonia and bacteraemia for which they had been admitted to the high/intensive care unit. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date between April 2011 and July 2012, on admission to hospital, the patient received an unspecified diphtheria-pertussis-tetanus vaccine, an unspecified oral polio vaccine, an unspecified Haemophilus influenza vaccine, an unspecified hepatitis vaccine, an unspecified measles vaccine and an unspecified bacillus calmette-Guerin vaccine. Dosages were unknown; administration routes and sites were unspecified apart from the route for the polio vaccine, and the batch numbers were not provided. On an unspecified date, an unknown period after receiving the vaccinations, the patient died while still in hospital. This was a serious case as the outcome was fatal. Cause of death was not specified, it was unknown if a post-mortem was performed. Pneumonia was confirmed via radiology. Acinetobacter bacteria were isolated from a blood culture taken on admission. Antimicrobial susceptibility test results of these isolates confirmed that the antibiotic treatment provided was appropriate. Treatment consisted of unspecified antibiotics. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that they have found that sever acute malnutrition children with pneumonia often present with gram-negative bacteraemia. Infection in these children appears to be strongly associated with a history of lack of BCG vaccination. This finding underscores the importance of the continuation of bacillus calmette-guerin vaccination in children to attain the non-tubercular substantial benefit of the vaccination. This case is 1 of the 3 valid cases reported in the same literature article.


VAERS ID: 577946 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-30
Entered: 2015-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Antimicrobial susceptibility test resistant, Blood culture positive, Death, Pneumonia, Pseudomonal bacteraemia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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: Hospitalisation; Malnutrition; Pneumonia; Bacteraemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Between April 2011 and July 2012, blood culture showed growth of Pseudomonades bacteria
CDC Split Type: BD2015GSK058489

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received DTP (A or W not known) vaccine. Co-suspect products included BCG vaccine and Measles vaccine. Concurrent medical conditions included malnutrition, pneumonia, bacteremia and hospitalization. On an unknown date, an unknown time after receiving DTP (A or W not known) vaccine, OPV, Hepatitis B vaccine and Hib vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The subject was treated with antibiotics nos. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP (A or W not known) vaccine, OPV, Hepatitis B vaccine and Hib vaccine. Relevant Tests: Between April 2011 and July 2012, blood culture showed growth of Pseudomonades bacteria. Additional information was provided: This case was reported in a literature article and it described the occurrence of a death of a child of unspecified gender, up to 59 months old, who had received unspecified DTP vaccine, unspecified OPV, unspecified Hib vaccine, unspecified hepatitis vaccine, unspecified measles vaccine and unspecified BCG vaccine (manufacturers unknown). The patient''s concomitant conditions included severe acute malnutrition, pneumonia and bacteraemia for which they had been admitted to the high/intensive care unit. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date between April 2011 and July 2012, on admission to hospital, the patient received an unspecified DTP vaccine, an unspecified OPV, an unspecified Hib vaccine, an unspecified hepatitis vaccine, an unspecified measles vaccine and an unspecified BCG vaccine. Dosages were unknown; administration routes and sites were unspecified apart from the route for the polio vaccine, and the batch numbers were not provided. On an unspecified date, an unknown period after receiving the vaccinations, the patient died while still in hospital. This was a serious case as the outcome was fatal. Cause of death was not specified, it was unknown if a post-mortem was performed. Pneumonia was confirmed via radiology. Pseudomonades were isolated from a blood culture taken on admission. Antimicrobial susceptibility test results received after the death confirmed resistance to the antibiotic treatment provided. Treatment consisted of unspecified antibiotics. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "we have found that severe acute malnutrition children with pneumonia often present with Gram-negative bacteraemia. Infection in these children appears to be strongly associated with a history of lack of BCG vaccination. This finding underscores the importance of the continuation of BCG vaccination in children to attain the non-tubercular substantial benefit of the vaccination." This case is 1 of the 3 valid cases reported in the same literature article.


VAERS ID: 578235 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-27
Onset:2014-05-27
   Days after vaccination:0
Submitted: 2015-05-05
   Days after onset:343
Entered: 2015-05-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER H1638 / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C32010 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H18108 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA799AC / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Death, Diarrhoea, Dyspnoea, Fontanelle depressed, Heart rate normal, Lethargy, Lid sulcus deepened, Mydriasis, Oxygen therapy, Pyrexia, Respiratory rate increased, Resuscitation, Sepsis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cesarean delivery, without mention of indication, delivered via C-section; Tonsillitis bacterial; Feeding disorder neonatal, breastfed with feeding problems
Allergies:
Diagnostic Lab Data: 12-FEB-2014, Apgar score, 10/10; 27-MAY-2014, Body temperature increased, 37.8 Centigrade; 29-MAY-2014, Body temperature increased, 38 Centigrade; 29-MAY-2014, Heart rate, 140 bpm; 27-MAY-2014, Respiratory rate, 37 bpm; 29-MAY-2014, Respiratory rate, 80 bpm
CDC Split Type: 2015149339

Write-up: A 14-week-old female patient received a PREVENAR 13, via an unspecified route of administration, BIOVAC-B via an unspecified route of administration, DTAP-IPV/HIB via an unspecified route of administration, ROTARIX via an unspecified route of administration, all on 27May2014. Medical history included delivered via C-section, Apgar score: 10/10, no problems during pregnancy, breastfed with feeding problems, bacterial tonsillitis. No family history, no history of convulsions. Routine examination and developmental assessment conducted on 31Mar2014 (Follow-up at 10 weeks) 31Mar2014 (Follow-up at 14 weeks) and 27May2014 (Follow-up at 6 months): no abnormalities detected. The patient''s concomitant medications were not reported. The vaccination history included: BCG, OPV0 at birth; DaPT-Hib-IPV1, OPV1, HepB1, PCV1, RV1 at 6 weeks, DaPT-Hib-IPV2, HepB2 at 10 weeks, DaPT-Hib-IPV3, HepB3, PCV2, RV2 at 14 weeks; next immunization date: 12Jul2014. This child had no previous reaction after immunization. On 27May2014 the neonate experienced cough and fever, both with outcome of unknown. On 29 May 2014 the baby was brought back to the clinic by the caregiver with a history of difficulty in breathing. On 29May2014 the neonate experienced septicemia with fatal outcome, and sunken eyes, eyes dilated, sunken fontanelle, and was lethargic, all with outcome of unknown. The patient underwent lab tests and procedures which included body temperature increased: 37.8 centigrade on 27May2014, 38 centigrade on 29May2014, heart rate: 140 bpm (beats per minute) on 29May2014, respiratory rate: 37 bpm (breaths per minute) on 27May2014, respiratory rate: 80 bpm on 29May2014. Therapeutic measures were taken as a result of difficulty breathing. The patient died on an unspecified date. An autopsy was not performed. Cause of death was reported as septicemia. Course of events: A 14-week-old female patient was brought in by the aunt and caregiver with a history of difficulty in breathing. The caregiver stated that the child had difficulty breathing. The baby was wrapped in a towel and a baby blanket. On opening the blanket, the baby had difficulty breathing, sunken eyes which were dilated, a sunken fontanelle and was very lethargic. The baby was rushed to the emergency room where she was put on oxygen. When the child was undressed, no swelling was noted on the body. The doctor attempted to put a drip with no success. In the emergency room the baby was given a dose of Ceftriaxone 250mg. At 09:05 they contacted the ambulance as the baby was deteriorating. Resuscitation was done by the doctor with the assistance of a nursing sister. The baby''s mother came in while the baby was being resuscitated. She gave a history of the child having diarrhea and vomiting since 25May2014. The baby was brought to the clinic on 27May2014 where she was immunized and treated with bacterial tonsillitis. The mother reported the baby getting worse after that visit.


VAERS ID: 578250 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-22
Onset:2015-04-23
   Days after vaccination:1
Submitted: 2015-05-01
   Days after onset:8
Entered: 2015-05-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A020B / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y081A / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1492 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14C05A / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-23
   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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Confirmatory Tests: Family history: None in particular (the patient had a sibling [1 year old]); Remarkable history: None
CDC Split Type: 2015SA055476

Write-up: Initial unsolicited report received from health authority (under the reference number-V15100087) via physician on 27 April 2015. A 05-month-old male patient, whose concomitant medications were not reported, had received a 0.5 ml first subcutaneous dose of ACTHIB (batch number- K1492), first dose of PREVENAR 13 (batch number- 14C05A), first dose of DPT-IPV (batch number- A020B), first dose of BIMMUGEN (batch number- Y081A) (site of administration was not reported for all vaccines) on 22 April 2015 at around 14:45:00. Patient''s family history was reported as none in particular and remarkable history was also reported as none. On 23 April 2015, 1 day after vaccination in the evening, the patient found unresponsive at home and hospital confirmed dead. Laboratory investigations and corrective treatments were not reported. Body temperature of patient before the vaccination was reported as 36.9 degree Celsius. Outcome of event was reported as fatal on 23 April 2015 and cause of death was unspecified. Reporting physician''s seriousness assessment was Serious (death). Reporting physician''s causality assessment was Unknown. Reporting physician''s comment- Another possible causative factor for the event was abuse. Documents held by sender: none.


VAERS ID: 578292 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-22
Onset:0000-00-00
Submitted: 2015-05-06
Entered: 2015-05-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H06883 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Meningitis, Pneumococcal infection, Pneumococcal sepsis, Streptococcus test positive, Sudden death, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-26
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: 29-JAN-2014, First dose. batch/lot G34370 expiry date Jun2015, Asplenia; 29-JAN-2014, First dose, batch/lot G34370 expiry date Jun2015, PREVENAR 13; Drug Indication: immunization; Unknown, Intestinal obstruction; due to a congenital band; Unknown, Laparotomy; congenital band which was resected by laparotomy and a primary anastomosis
Allergies:
Diagnostic Lab Data: 26-NOV-2014, Blood culture, Pneumococcal infection, serotype 6C
CDC Split Type: 2015150724

Write-up: This is a spontaneous report from a contactable healthcare professional via the Health Protection Agency. An 11-month-old female patient received PREVENAR 13, first dose (batch/lot G34370, expiry date Jun2015) on 29Jan2014 at the age of 8-weeks and second dose on 22Apr2-14 (batch/lot H06883, expiry date: Jul2015) at the age of 4 months, both at single dose. Concomitant medications were not reported. The patient was not born prematurely. The patient was in a clinical risk group for asplenia. The patient had no homozygous sickle cell disease or other haemoglobinopathy, no history of previous invasive bacterial disease, no immunosuppressive condition or drug, no malignancy, no congenital abnormality, no conditions associated with CSF leakage, no chronic respiratory disease, no chronic diseases (including cardiac, renal or liver), no diabetes mellitus, no cochlear implants, no coeliac disease or any other disorders. The patient had no complications with empyema, haemolytic uraemic syndrome or cerebral abscess. It was reported that the patient also had intestinal obstruction due to a congenital band which was resected by laparotomy and a primary anastomosis. On an unknown date, the patient experienced a pneumococcal infection, serotype 6C. Even if serotype was provided as 6C, the reporter considered the event as a vaccination failure. The specimen was taken from the blood culture at post mortem on 26Nov2014. The patient also experienced meningitis on an unknown date. On 26Nov2014 the patient experienced sudden unexpected death. A sample taken at post mortem showed acute septicaemia due to streptococcus pneumonia which developed rapidly and the patient died in her sleep. An autopsy was performed. It was not reported if autopsy results were available or not. The patients final risk group was reported to be asplenia (shown at post mortem). The outcome of the events prior to death were unknown at the time of the report. No follow-up attempts possible. No further information expected.


VAERS ID: 578323 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-08
Entered: 2015-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Cleft lip and palate
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK061422

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 15-day-old subject who received Hepatitis B vaccine. Concurrent medical conditions included cleft lip and palate. On an unknown date, less than a month after receiving Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was unknown. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information provided: This case was reported in a literature article and it described the occurrence of death in a 15-day-old infant of unspecified gender who had received an unspecified hepatitis B vaccine (manufacturer unknown). The patient had been born with cleft lip and palate. No information was provided on the type of delivery for the feeding method. Their mother was between 18 and 40 years old, positive for hepatitis B surface and E antigens, and had a high hepatitis B viral load. She had received telbivudine (Novartis; 600 mgs; unspecified administration route) from 28 weeks of pregnancy as part of a clinical study (February 2008 to February 2014). Exclusion criteria for this study included co-infections with hepatitis A, E, or human immunodeficiency virus; as well as any concomitant liver disease or evidence of foetal dysplasia. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received 1 dose of an unspecified recombinant hepatitis B vaccine after birth (10 ug; administration site unspecified; batch number not provided). On an unspecified date, within 15 days of vaccine administration, the infant developed unspecified complications and died at 15 days of age. Cause of death was unspecified, it was unknown if a post-mortem was performed. This was a serious case as the outcome was fatal. Treatment was unknown. The authors did not comment on any causal relationship between the vaccine and the event; but they mentioned that causal relationship between the case and the telbivudine had not been elucidated fully yet. The authors concluded that the long-term follow-up results of this study suggest that telbivudine is effective and safe in preventing mother to child transmission, and it is an appropriate choice for hepatitis B infected pregnant women with a high viral load. However, the long-term influence of using telbivudine, when compared with tenofovir, particularly in viral resistance during re-treatment with nucleoside analogues, remains to be explored. This case is 1 of the 16 valid cases reported in the same literature article.


VAERS ID: 578327 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-08
Entered: 2015-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Hypoxia, Pulmonary haemorrhage
SMQs:, Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (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: No other medications
Current Illness: Low birth weight baby; Premature baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: CN2015GSK061423

Write-up: This case was reported in a literature article and described the occurrence of pulmonary hemorrhage in a infant subject who received Hepatitis B vaccine. Concurrent medical conditions included birth weight low and premature birth. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the subject developed pulmonary hemorrhage. Serious criteria included death and GSK medically significant. Additional event(s) included hypoxia with serious criteria of death and GSK medically significant. The outcome of pulmonary hemorrhage was fatal. The outcome(s) of the additional event(s) included hypoxia (fatal). The reported cause of death was pulmonary hemorrhage and hypoxia. It was unknown if the investigator considered the pulmonary hemorrhage and hypoxia to be related to Hepatitis B vaccine. Additional information provided: This case was reported in a literature article and it described the occurrence of pulmonary haemorrhage in an infant of unspecified gender who had received an unspecified hepatitis B vaccine (manufacturer unknown). The patient had been born premature and with low birth weight. No information was provided on the type of delivery or the feeding method. Their mother was between 18 and 40 years old, positive for hepatitis B surface and E antigens, and had a high hepatitis B viral load. She had received telbivudine (Novartis; 600 mgs; unspecified administration route) from 28 weeks of pregnancy as part of a clinical study (February 2008 to February 2014). Exclusion criteria for this study included co-infections with hepatitis A, E, or human immunodeficiency virus; as well as any concomitant liver disease or evidence of foetal dysplasia. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received at least 1 dose of an unspecified recombinant hepatitis B vaccine after birth (10 ug; administration site unspecified; batch number not provided). On an unspecified date, an unknown period after the vaccination, the infant died of pulmonary haemorrhage. The authors identified hypoxia as the primary cause of death. They did not specify if a post-mortem was performed. This was a serious case as the outcome was fatal. Treatment was unknown. The authors did not comment on any causal relationship between the vaccine and the event; but they mentioned that causal relationship between the case and the telbivudine had not been elucidated fully yet. The authors concluded that the long-term follow-up results of this study suggest that telbivudine is effective and safe in preventing mother to child transmission, and it is an appropriate choice for hepatitis B infected pregnant woman with a high viral load. However, the long-term influence of using telbivudine, when compared with tenofovir, particularly in viral resistance during re-treatment with nucleoside analogues, remains to be explored. This case is 1 of the 16 valid cases reported in the same literature article.


VAERS ID: 578340 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:2010-08-03
Onset:2013-04-11
   Days after vaccination:982
Submitted: 2015-05-07
   Days after onset:756
Entered: 2015-05-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E32633 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Cough, Pneumococcal infection, Pneumonia, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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:
Current Illness:
Preexisting Conditions: 01-SEP-2009, PREVENAR, immunisation, dose 1; 10-NOV-2009, PREVENAR, immunisation, dose 2; Therapy regimen changed; Carbohydrate metabolism disorder, known glycosylation defect/metabolic problem
Allergies:
Diagnostic Lab Data: 15-APR-2013, Blood culture, Pneumococcal infection, serotype 6C; Chest X-ray, changes consistent with bilateral basal pneumonia
CDC Split Type: 2015150708

Write-up: This is a spontaneous report from a contactable healthcare professional via the Agency. A 3-year-old (46.02 months) female patient of unspecified ethnicity received booster dose of PREVENAR 13 (Batch# E32633), via an unspecified route of administration, on 03Aug2010 when she was 13.6 months old, at single dose. Relevant medical history included known glycosylation defect / metabolic problem. Concomitant medications were not reported. Previously the patient received PREVENAR, first dose (Batch# D88789) on 01Sep2009 when she was 2.5 months old and second dose (Batch# D88789) on 10Nov2009 when she was 4.8 months old. On 15Apr2013 the patient experienced pneumococcal infection, serotype 6C which was found in blood culture. It was also reported that the patient experienced unexplained death on an unknown date in Apr2013, during a holiday. The cause of death was unknown and it was not reported if an autopsy was performed. The patient had a cough on 11Apr2013. A chest X-ray performed on an unknown date showed changes consistent with bilateral basal pneumonia. It was also reported that the patient had a known glycosylation defect, metabolic problem. The outcome of the events was unknown at the time of the report. No follow-up attempts possible. No further information expected.


VAERS ID: 577666 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-12
Onset:2015-03-31
   Days after vaccination:19
Submitted: 2015-04-24
   Days after onset:24
Entered: 2015-05-11
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood electrolytes normal, Body temperature decreased, Breath holding, C-reactive protein increased, Cardiomegaly, Death, Diagnostic procedure, Heart sounds abnormal, Hepatic function abnormal, Hepatomegaly, Infection, Lymphadenopathy mediastinal, Resuscitation
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Immunisation
Preexisting Conditions: Hypertrophic cardiomyopathy; Cardiomegaly; 02/2015, Bronchial hyperreactivity
Allergies:
Diagnostic Lab Data: Blood electrolytes (31-MAR-2015): Normal. 03/31/2015, Body temperature, no temperature; 03/31/2015, C-reactive protein, 4.6; 03/31/2015, Hepatic function abnormal, disorder in liver function; 03/31/2015, Investigation, enlarged liver; 03/31/2015, Investigation, enlarged hypertrophic heart; 03/31/2015, Investigation, gallop rhythm; 03/31/2015, Investigation, mediastinal lymphadenopathy
CDC Split Type: WAES1504NLD020599

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Case Report N. NL-1577272925-E2015-03678) on 21-APR-2015. Fatal case received from the Health Authorities on 16-Apr-2015 under the reference number NL-LRB-195796. Initial source was a physician from a community health service. Medically confirmed. Case reported as serious by the Agency (category reported by the Agency: results in death). A 14-month-old female patient (weight 9 kg, height 75 cm) had received the first dose of MMRVAXPRO, lot number unknown, subcutaneous route, site of vaccination left upper arm and the first dose of NEISVAC-C, Baxter, lot number unknown, intramuscular route, site of vaccination left thigh on 12-Mar-2015. Concomitant medication was salbutamol since a few weeks. The patient developed an infection (not further specified) on 31-Mar-2015 with a latency of 19 days after vaccination. The clinical course was not clear. About 12 or 14 days after vaccination there was a period of about 5 days of fever, followed by a period of 2 days without fever. At the day the patient died, on 31-Mar-2015, there was an emergency call for medical assistance because of sudden breath holding spells. There was a resuscitation by the general practitioner and after that the patient was transferred to the hospital. The medical history indicated that the patient had bronchial hyperreactivity since Feb-2015 for which she was in follow-up by a pediatrician. The patient had no known past drug therapy. Physical findings and investigations on 31-Mar-2015: gallop rhythm. Autopsy: Enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy. Blood and lab results: cultures were deployed, results were not yet known except for CRP 4.6, electrolytes normal, disorder in liver function. No temperature. Preliminary conclusion: fatal infection in a patient with a preexistent serious heart disease. Cause of death unknown for the moment, but possible hypertrophic obstructive cardiomyopathy. Treatment and clinical course: despite resuscitation the patient died 10 minutes after she arrived in the hospital. Causality assessment reported by the Agency: causality for the event infection (not other specified) and both vaccinations was considered not assessable because of the inconsistent information of the latency of the period of fever and the not clear clinical course. It was most likely that the patient had preexistent cardiac problems (enlargement of the heart and hypertrophic cardiomyopathy) and died by an infection. Patient outcome: fatal. Date of death 31-Mar-2015. More information to follow. The following was coded by the Agency: infection. Upon internal review the company judged relevant to code the following adverse events fever and breath holding spells which were mentioned in the narrative but not coded. Noteworthy: the Agency reported that it was unknown if an autopsy was performed, but the narrative reported results of the autopsy: enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy.


VAERS ID: 578356 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-08-21
Onset:2014-01-03
   Days after vaccination:500
Submitted: 2015-05-08
   Days after onset:489
Entered: 2015-05-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F81972 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal infection, Streptococcus test positive
SMQs:, 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:
Current Illness:
Preexisting Conditions: 06-OCT-2011, PREVENAR 13, Immunisation; 08-DEC-2011, PREVENAR 13, Immunisation
Allergies:
Diagnostic Lab Data: 03-JAN-2014, Blood culture, Pneumococcal infection, serotype 6C
CDC Split Type: 2015150716

Write-up: This is a spontaneous report from a contactable healthcare professional via the Health Protection Agency. A 29 month-old male patient of unspecified ethnicity received the first dose of PREVENAR 13, (Lot. unknown) on 06Oct2011 when he was 2 months old. The patient''s second dose was received on 08Dec2011 (Lot. unknown) when he was 4 months old and the patient''s booster dose was received on 21Aug2012 (Lot. F81972) when he was 12 months old. Relevant medical history and concomitant medications were unknown. On 03Jan2014, the patient experienced a pneumococcal infection, serotype 6C. The specimen was taken from the blood culture on 03Jan2014. The patient was reported to be 29 months old at the time of infection. On an unknown date, the patient died. The cause of death was unknown and it was not reported whether an autopsy was performed. Clinical outcome of pneumococcal infection was unknown at the patient''s death. No follow-up attempts possible. No further information expected.


VAERS ID: 578445 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2015-05-04
Onset:2015-05-05
   Days after vaccination:1
Submitted: 2015-05-12
   Days after onset:7
Entered: 2015-05-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-05
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015157279

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 6 week-old female patient received a single dose of PREVENAR 13 via an unspecified route of administration on 04May2015. The patient medical history was not reported. The child was vaccinated with 2 other unspecified vaccines on 04May2015. The patient died due to an unknown cause the next day on 05May2015. It was not reported if an autopsy was performed.


VAERS ID: 578461 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2015-05-08
Onset:2015-05-08
   Days after vaccination:0
Submitted: 2015-05-14
   Days after onset:6
Entered: 2015-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Pyrexia, Respiratory symptom, Seizure, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505MEX004911

Write-up: This spontaneous report was received from a physician, via social media and refers to a 28 day old male patient who was part of the vaccination plan under the Vaccination Program. 52 children less than one year old received 3 vaccines, were part of the vaccination plan. After receiving the three vaccines, BCG live vaccine (Manufacturer unknown), hepatitis B vaccine (manufacturer unknown) and ROTATEQ, at least 25 children developed sleepiness and unfortunately, 2 children died. This case concerns a 28 days year old patient who was one of the two children who died. Concurrent conditions, medical history and concomitant medications were not reported. On 08-MAY-2015, the patient was vaccinated with ROTATEQ, of strength 2 ml, lot number unspecified, frequency: single, orally. Other suspect therapies included BCG live vaccine (Manufacturer unknown) (lot number, dosage and route unspecified; frequency: single) and hepatitis B vaccine (manufacturer unknown) (lot number, dose and route unspecified; frequency: single). On 08-MAY-2015, 10 hours after vaccination the patient developed fever, sleepiness, convulsions (unconfirmed) and respiratory symptoms. Liver involvement was not clear. After falling asleep for 12 hours the patient did not arouse and died on an unknown date. The cause of death was not reported. Relatives and communities were reluctant to provide additional information. The major suspicion of the events was related with hepatitis B vaccine, while causality of the events to rotavirus vaccine, live, oral, pentavalent was unknown. Upon internal review convulsion was considered to be medically significant. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 578592 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2015-05-08
Onset:2015-05-08
   Days after vaccination:0
Submitted: 2015-05-14
   Days after onset:6
Entered: 2015-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Pyrexia, Respiratory symptom, Seizure, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505MEX004880

Write-up: This spontaneous report was received from a physician, via social media and refers to a 30 day old female patient who was part of the vaccination plan. 52 children less than one year old received 3 vaccines, were part of the vaccination plan. Medical history of the patient was not reported. On 08-MAY-2015 the patient was vaccinated with ROTATEQ, of strength 2 ml, lot number unspecified, frequency: single, orally. Other suspect therapies included BCG vaccine (manufacturer unknown) (lot number, strength, dosage and route unspecified; frequency: single) and hepatitis B vaccine (manufacturer unknown) (lot number, strength, dosage and route unspecified; frequency: single). On 08-MAY-2015, the patient developed fever, sleepiness, convulsions (unconfirmed) and respiratory symptoms. Liver involvement was not clear. The patient died on an unknown date. Cause of death was not reported. The major suspicion of the events was related with hepatitis B vaccine, while causality of the events to rotavirus vaccine, live, oral, pentavalent was unknown. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 578616 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2015-03-31
Onset:2015-05-03
   Days after vaccination:33
Submitted: 2015-05-14
   Days after onset:11
Entered: 2015-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal lymphadenopathy, Abdominal mass, Appendicectomy, Cardiac arrest, Crying, Death, Decreased appetite, Dehydration, Diarrhoea, Haematochezia, Intussusception, Necrosis, Pyrexia, Ultrasound abdomen abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), 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), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Digital examination of rectum (MAY-2015): blood noted and abdomen had a mass in the area below the umbilicus; 05/04/2015, Body temperature, tactile fever not provided; 05/06/2015, Ultrasound abdomen, intussusception
CDC Split Type: WAES1505MLI005433

Write-up: This report has been received from an investigator concerning a 4 month old male subject enrolled in a study. The subject''s concurrent condition and medical history were not reported. On 03-FEB-2015, the subject was vaccinated with first dose of ROTATEQ. On 31-MAR-2015, the subject was vaccinated with the second dose of ROTATEQ. On 03-MAY-2015 the subject experienced intussusception. The subject was well until 03-MAY-2015, when he developed diarrhea and loss of appetite. He had 2 loose stools and blood was noted in the second episode. He was taken to the local health center. He was rehydrated with Ringer''s lactate. He was prescribed cefixime, paracetamol and artemether (+) lumefantrine. Upon returning home, on 04-MAY-2015, he developed tactile fever and vomiting (non-bilious, more than 3 times) and returned to the health center. Then the infant was referred to the Hospital but they went home and instead consulted with a traditional healer and the infant began treatment with traditional medications. On 06-MAY-2015, since there was no improvement and after spending the night with abdominal distention and crying, they went to hospital. Upon arrival, he was in fair condition and dehydrated, on digital examination of the rectum there was blood noted and the abdomen had a mass in area below the umbilicus. An ultrasound was ordered (and performed at an outside facility close to the hospital) which demonstrated intussusception. He was hospitalized and started intravenous (IV) fluid, IV paracetamol and ceftriaxone sodium. He was taken to the operating room (OR) 07-MAY-2015 (due to delayed availability of funds for surgery). In the OR, a cecal-colic intussusception was noted. This was manually reduced and a necrotic appendix was noted. There was also mesenteric lymphadenitis. After appendectomy, the surgery was finished. Reversal of anesthesia was difficult and the infant had 2 cardiac arrests and died on 07-MAY-2015. Action taken with study therapy was reported as not applicable. The investigator considered the intussusception to be related to study therapy and not related to study procedure. Additional information is not expected. No follow-up required/available.


VAERS ID: 578280 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Ill-defined disorder
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505USA005092

Write-up: This spontaneous, unconfirmed report as received from a nurse via company representative refers to a unspecified number of children of unknown age and gender. On an unknown date the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (dose and frequency were not reported, route of administration defaulted to oral). Other suspect therapies included hepatitis b vaccine (recombinant) (manufacturer unknown) and BCG live (manufacturer unknown) (dose, frequency and route of administration were not reported). Use of ROTATEQ, BCG, and RECOMBIVAX could not be ruled out. It could not be determined if the unspecified products were Merck products. The nurse stated that an unspecified media report announced that an unspecified number of children experienced illness and died on unspecified dates following the vaccination with unspecified hepatitis B, tuberculosis, and rotavirus products. The outcome of illness was unknown. The relatedness between the events and vaccination was not reported. Additional information has been requested.


VAERS ID: 578640 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2011-02-18
Onset:2011-02-19
   Days after vaccination:1
Submitted: 2015-05-15
   Days after onset:1545
Entered: 2015-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Arrhythmia neonatal, Autopsy, Death, Pallor, Peripheral coldness, Pupil fixed, Respiratory arrest
SMQs:, Anaphylactic reaction (narrow), Congenital and neonatal arrhythmias (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK063737

Write-up: This case was reported in a literature article and described the occurrence of allergic shock in a 6-week-old female subject who received Hepatitis B vaccine. On 19th February 2011 04:30, 1 days after receiving Hepatitis B vaccine, the subject developed allergic shock. Serious criteria included death and GSK medically significant. Additional event(s) included pale skin on 19th February 2011 04:30, pupils fixed on 19th February 2011 04:30 with serious criteria of GSK medically significant, heart beat abnormal neonatal on 19th February 2011 04:30 with serious criteria of GSK medically significant, breathing arrested on 19th February 2011 04:30 with serious criteria of GSK medically significant and coldness of skin on 19th February 2011 04:30. The outcome of allergic shock was fatal on 19th February 2011 05:30. The outcome(s) of the additional event(s) included pale skin (unknown), pupils fixed (unknown), heart beat abnormal neonatal (unknown), breathing arrested (unknown) and coldness of skin (unknown). The subject died on 19th February 2011. The reported cause of death was allergic shock. An autopsy was performed. The autopsy determined cause of death was allergic shock. It was unknown if the investigator considered the allergic shock, pale skin, pupils fixed, heart beat abnormal neonatal, breathing arrested and coldness of skin to be related to Hepatitis B vaccine. Additional information received: The female patient received second dose HepB on 15:00 of 18 Feb 2011. She experienced pale complexion, static pupil, no heartbeat, no breathing and cold skin on 4:30 of 19 Feb 2011, she died out of hospital without a clear reason on 5:30 of 19 Feb 2011. Autopsy Results: allergic shock.


VAERS ID: 578651 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-17
Entered: 2015-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Adverse reaction, Death, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505MEX004001

Write-up: Information has been received from a newspaper referring to two infants of unknown age and gender. On an unknown date in MAY-2015, the patients got vaccinations for tuberculosis, rotavirus and hepatitis B (dose not provided, lot # not provided) (products were suspect as with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), hepatitis B vaccine (recombinant) (manufacturer unknown) and BCG live vaccine (manufacturer unknown)). Families of the babies reported that they had become sick within hours. The cause of the adverse reactions was not known. There were other babies who also got reactions (related case ID: 1505MEX004603 and 1505MEX004604) and all the babies were taken to a local hospital. The 2 babies died on an unknown date in MAY-2015 (death reason not provided). The reactions started since 08-MAY-2015 (onset date for each baby unspecified). The local public health system had suspended infant vaccinations nationwide on 09-MAY-2015 as a precaution and begun an investigation. Additional information is not expected because no contact information was provided.


VAERS ID: 578643 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-25
Onset:2013-12-26
   Days after vaccination:1
Submitted: 2015-05-18
   Days after onset:507
Entered: 2015-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Autopsy, Death neonatal, Foaming at mouth, Rhinorrhoea
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-26
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK064238

Write-up: This case was reported in a literature article and described the occurrence of allergic shock in a 5-week-old male subject who received Hepatitis B vaccine. On 26th December 2013 02:00, 1 days after receiving Hepatitis B vaccine, the subject developed allergic shock. Serious criteria included death and GSK medically significant. Additional event(s) included bullous eruption on 26th December 2013 02:00 with serious criteria of GSK medically significant and nasal discharge on 26th December 2013 02:00. The outcome of allergic shock was fatal on 26th December 2013 06:00. The outcome(s) of the additional event(s) included bullous eruption (unknown) and nasal discharge (unknown). The subject died on 26th December 2013. The reported cause of death was allergic shock. An autopsy was performed. The autopsy determined cause of death was allergic shock. It was unknown if the investigator considered the allergic shock, bullous eruption and nasal discharge to be related to Hepatitis B vaccine. Additional information received: The male patient received second dose Hepatitis B vaccine at 11:40 on 25th December 2013. She experienced bubbles and secretion around mouth and nasal cavity at 2:00 on 26th December 2013. She died out of hospital without a clear reason at 6:00 on 26th December 2013. Autopsy Results: allergic shock. This case is 1 of 3 valid cases identified in the literature article (see case CN2015GSK063737).


VAERS ID: 578657 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-18
Entered: 2015-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505MEX005484

Write-up: This spontaneous unconfirmed report as received from a healthcare worker via company representatives, refers to 2 children of unknown age and gender. The healthcare worker was informed by the people in physician''s office that they heard from the news, (the exact source of this news report: TV versus newspaper versus internet, etc was not specified) that on an unknown date, after vaccination with unspecified tuberculosis vaccine (manufacturer unknown) (lot#, strength, dose, frequency and route were not reported), unspecified rotavirus vaccine (lot#, strength, dose, frequency and route were not reported), and hepatitis B vaccine (lot#, strength, dose, frequency and route were not reported) - the children died. The dates and causes of death were not specified. The relatedness between vaccination with rotavirus vaccine (manufacturer unknown), hepatitis B vaccine (manufacturer unknown) and tuberculosis vaccine (manufacturer unknown) and death was not reported. Additional information has been requested.


VAERS ID: 578682 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-06
Onset:2013-11-06
   Days after vaccination:0
Submitted: 2015-05-18
   Days after onset:557
Entered: 2015-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory failure, Anaphylactic shock, Autopsy, Cyanosis, Death, Ecchymosis, Epistaxis
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (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 (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-06
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: Hepatitis B vaccine, 1st dose, Prophylaxis, No adverse event; Hepatitis B vaccine, 2nd dose, Prophylaxis, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK064237

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory failure in a 6-month-old female subject who received Flu seasonal TIV Dresden. On 6th November 2013 11:20, 50 min after receiving Flu seasonal TIV Dresden and Hepatitis B vaccine, the subject developed acute respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included allergic shock on 6th November 2013 11:20 with serious criteria of death and GSK medically significant, cyanosis on 6th November 2013 11:20, ecchymosis on 6th November 2013 11:20 and nasal bleeding on 6th November 2013 11:20. The outcome of acute respiratory failure was fatal on 6th November 2013 12:30. The outcome(s) of the additional event(s) included allergic shock (fatal on 6th November 2013 12:30), cyanosis (unknown), ecchymosis (unknown) and nasal bleeding (unknown). The subject died on 6th November 2013. The reported cause of death was acute respiratory failure and allergic shock. An autopsy was performed. The autopsy determined cause of death was acute respiratory failure and allergic shock. It was unknown if the investigator considered the acute respiratory failure, allergic shock, cyanosis, ecchymosis and nasal bleeding to be related to Flu seasonal TIV Dresden and Hepatitis B vaccine. Additional information received: The female patient received first dose of Influenza Vaccine and third dose Hepatitis B vaccine on 06th November 2013 at 10:30. She experienced cyanosis, multiple site ecchymosis on skin and a little red liquid in nasal cavity at 11:20 on 06th November 2013. She died at 12:30 on 06th November 2013 out of hospital without a clear reason (the patient had received twice Hepatitis B vaccine from the same factory and had no adverse reaction). Autopsy Results: Allergic shock caused acute respiratory failure. This case was 1 of 3 valid cases in this literature article (see case CN2015GSK063737).


VAERS ID: 578747 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-09-22
Onset:2014-10-01
   Days after vaccination:9
Submitted: 2015-05-19
   Days after onset:230
Entered: 2015-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015508 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Death, Encephalitis, Headache, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505BRA007659

Write-up: This spontaneous report was received via Business Partner: Institute (manufacturer control # was not provided so far) by a consumer (patient''s mother) and concerns a 14 years old non-pregnant female patient. Information about patient''s medical history was not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose: 0.5 ml, intramuscularly, lot# and anatomical location were unspecified). Then, on 22-SEP-2014, she was vaccinated with the second dose of GARDASIL (dose: 0.5 ml, intramuscularly, anatomical location reported as left deltoids) (lot # J015508, expiration date: 05-JUN-2016). On an unknown date in September 2014, the patient experienced vomiting, headache, agitation and generalized convulsion. These adverse events led patient to the emergency room on 24-SEP-2014. She was hospitalized since approximately the same day. On 01-OCT-2014, the patient was diagnosed with encephalitis. The patient died on an unknown date. It was unknown if autopsy was done. The outcome of encephalitis was reported as fatal. The outcome of agitation, vomiting, headache and generalized convulsion was unknown. The relatedness between the events and GARDASIL was not reported. Adverse event of generalized convulsion was considered to be medically significant event. Upon internal review, encephalitis was considered to be medically significant event. Additional information is not expected, as reporter could not provide patient''s physician contact details.


VAERS ID: 578893 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2015-04-20
Onset:2015-04-21
   Days after vaccination:1
Submitted: 2015-05-18
   Days after onset:27
Entered: 2015-05-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram normal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-21
   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: PREVENAR 13, Immunization, No adverse event, first administration; INFANRIX HEXA, Immunization, No adverse event, first administration
Allergies:
Diagnostic Lab Data: Computerised tomogram, without sign of abuse or trauma
CDC Split Type: 2015163100

Write-up: This is a spontaneous report received from the Agency, regulatory authority report FR-AFSSAPS-NC20150403. A 4-month-old female patient received the second doses of the following suspect vaccines, PREVENAR 13 0.5ml single dose and INFANRIX HEXA, both by intramuscular route, on 20Apr2015. Past drug history included a first administration of both vaccines on unknown date, which was uneventful. The patient did not receive concomitant treatment or premedication. She was subject to sudden death on 21Apr2015. The physician reported "sudden infant death within 12 hours following vaccination. No background could provide any obvious etiological hypothesis. Following vaccination on 20Apr2015, no remarkable sign was noted; no fever was detected; the infant get asleep normally. Body computed tomography was unrevealing, without sign of abuse or trauma. No sign could suggest any toxicity or infection. No autopsy was performed, because of religious belief. Based on the Causality Assessment, the causal relationships between the vaccines and the adverse event sudden death were assessed by the Agency as "doubtful". No FU attempts possible. No further information expected.


VAERS ID: 578936 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-26
Onset:0000-00-00
Submitted: 2015-05-20
Entered: 2015-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 1584 ? / 1 UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 03AA ? / 1 UN / UN

Administered by: Other       Purchased by: Other
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2015GSK065792

Write-up: This case was reported by a regulatory authority and described the occurrence of unknown cause of death in a infant male patient who received ROTARIX (batch number 03AA ?, expiry date unknown). Co-suspect products included IPV (batch number 1584 ?, expiry date unknown) and SYNFLORIX. On 26th December 2013, the patient received the 1st dose of ROTARIX, IPV and SYNFLORIX. On an unknown date, an unknown time after receiving ROTARIX, IPV and SYNFLORIX, 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 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 ROTARIX, IPV and SYNFLORIX. Additional details were provided as follows: The patient was taken to an emergency room. No further detail was provided.


VAERS ID: 579202 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-22
Entered: 2015-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pharyngeal oedema, Pulmonary haemorrhage
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505CHN007389

Write-up: Information has been obtained from a published Abstract. Introduction: To investigate the features and general pattern of suspected deaths caused by drug uses for providing references of clinically rational and safe use of drugs. Methods: A total of 23 deaths collected for ADR monitoring in 2012 were analyzed retrospectively. Results: A total of 71 drugs were involved in the 23 deaths, among which the main type was anti-infective drugs (25. 35%). The main route of administration was by intravenous drip (71. 83%). More than half of the deaths appeared symptoms of adverse reactions within 2 hours after using the drugs. Death resulted from allergic-like reactions and anaphylactic shock was the most common (47.80%), followed by circulatory system damage and respiratory injury. This case refers to a 3 year old male patient who was inoculate with the PNEUMOVAX 23 who subsequently developed pneumorrhagia (fatal) and died. The cause of death was reported as pharyngeal oedema (fatal) after drug use. The author considered that there was a temporal relationship between pneumorrhagia and vaccination. Additional information has been requested.


VAERS ID: 579688 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-04-23
Onset:0000-00-00
Submitted: 2015-05-21
Entered: 2015-05-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4386AA / 4 UN / UN
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER UI086AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA067461

Write-up: This unsolicited case report is part of a batch of reports associated with several products that was received by our affiliate which received the report from the Agency on 14 May 2015. A male patient (age reported was not reported), whose medical history and concomitant therapies were not reported, had received a 1st booster of Influenza USP Trival A-B subvirion vaccine, lot number U4386AA, route and site of administration was not reported on 23 Apr 2014. The patient also received campaign dose of TD, lot number UI086AA route and site of administration was not reported on 23 Apr 2014. On an unspecified date, post-vaccination, the patient was dead. The reported diagnosis was not reported. The patient''s pregnancy information was reported as not informed and lactent information was not reported. The patient underwent medical care. The patient received emergency care on unspecified date. The outcome was reported as recovered as death. Lab tests unknown. Cause(s) of Death: Death.


VAERS ID: 580237 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-25
Entered: 2015-05-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 33978 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Death, Encephalitis, Meningitis pneumococcal, Pneumonia pneumococcal, Pneumovirus test positive, Sepsis, Sputum culture positive
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune 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:
Preexisting Conditions: Asthma bronchial, well controlled under inhalation
Allergies:
Diagnostic Lab Data: Blood culture, pneumococcus serotype 7F; CSF culture, pneumococcus serotype 7F; Sputum culture, pneumococcus serotype 7F
CDC Split Type: 2015173122

Write-up: This is a spontaneous report from a contactable physician. A 7-year-old female patient received 4 doses of PREVENAR at 0.5 ml single: the first one (lot number 25471) on unspecified date at the age of 3 months, the second one (lot number 25643) on unspecified date at the age of 6 months, the third one (lot number 25642) on unspecified date at the age of 7 months, and the last one (lot number 33978) at the age of 20 months. Medical history included asthma bronchial (was well controlled under inhalation), but no immune defect and the patient was not a premature baby. Concomitant medication were not provided. At the age of 95 months, the patient experienced pneumococcal meningitis, pneumococcal pneumonia, sepsis and encephalitis on an unspecified date in 2015 with a fatal outcome. Pneumococcus serotype 7F was detected by blood, liquor and tracheal secretion cultures. Causality was not provided. No follow-up attempts possible. No further information expected.


VAERS ID: 580288 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-12-01
Onset:2014-12-07
   Days after vaccination:6
Submitted: 2015-05-28
   Days after onset:171
Entered: 2015-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-07
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505JPN014005

Write-up: Information has been received from an other non-health professional reporter concerning an 85 years old male patient who was subcutaneously vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection in about 2012 for the first time (Lot. number, dose and indication not reported). There was no concomitant medication reported. In about 2012, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) for the first time at the hospital. On an unspecified date, the lungs became pure white. On 01-DEC-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for the second time at B the clinic (revaccination within five years). On 07-DEC-2014, the patient died. The cause of death as well as autopsy information were not provided. At the time of this report, the outcome of "lungs became pure white" was unknown. Reporter''s comment: felt doubts about vaccinating the patient although his lungs were pure white. The reporter did not assess the seriousness of "lungs became pure white". The reporter did not assess the relationship of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) to death and "lungs became pure white". Additional information is not expected, as the reporter did not wish to be contacted.


VAERS ID: 580434 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-27
Onset:0000-00-00
Submitted: 2015-05-22
Entered: 2015-05-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI090AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Intensive care, Radiculopathy
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: 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: Con Meds -Unknown; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA067460

Write-up: This unsolicited case report is part of a batch of reports associated with several products that was received by our affiliate which received the report from the Health on 14 May 2015. A female patient born (age not reported), whose medical history and concomitant therapies were not reported, had received a campaign dose of Influenza Vaccine, lot number UI090AB (route and site of administration were not reported) on 27-May-2014. On an unspecified date, the patient experienced local event: Polyradiculitis (GBS). The diagnoses were not reported. The patient underwent medical care in the Intensive Care Unit. The outcome was reported as death.


VAERS ID: 580303 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2015-05-21
Onset:2015-05-22
   Days after vaccination:1
Submitted: 2015-05-29
   Days after onset:7
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC322A / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J74593 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K007086 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-22
   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: No other medications
Current Illness: Prophylaxis; Bronchiolitis; Chondrodystrophy, diagnosed antenatally
Preexisting Conditions: 05/19/2015 - 05/21/2015, Hospitalisation; 05/2015, Fluid replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505AUS014202

Write-up: Information has been received from BIOCSL on 27-MAY-2015. This spontaneous report as received from a nurse via Agency, refers to a 7 week old male patient with achondroplasia and bronchiolitis. The patient''s medical history included hospitalisation for nasogastric tube (NGT) rehydration. On 21-MAY-2015, the patient was vaccinated with the first dose of ROTATEQ lot # K007086 (dose and expiration date were not reported). Other suspect therapies included PREVENAR 13 dose 1, lot # J74593, (dose, route, and expiration date were not reported) and INFANRIX HEXA dose 1, lot # A21CC322A (dose, route and expiration date were not reported). The nurse reported that the patient was discharged home after two days of hospitalization and was vaccinated on day of discharge (on 21-MAY-2015). The patient died the following day on 22-MAY-2015. Cause of death was unknown. It was unknown if autopsy was done. The reporter considered death to be possible related to ROTATEQ. Additional information is expected.


VAERS ID: 580311 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-29
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia, Sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PH2015GSK073381

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a unk subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included systemic lupus erythematosus. On an unknown date, not applicable after receiving Flu seasonal TIV Dresden and 1 year after receiving Flu seasonal TIV Dresden and 10PN-PD-Dit vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included severe - grade 3 sepsis with serious criteria of death and GSK medically significant and pneumonia with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included sepsis (fatal) and pneumonia (unknown). The reported cause of death was sepsis. It was unknown if the investigator considered the sepsis and pneumonia to be related to Flu seasonal TIV Dresden and 10PN-PD-Dit vaccine. It was unknown if the investigator considered the vaccination failure to be related to 10PN-PD-Dit vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a possible vaccination failure in a patient of unspecified gender and age, who had been vaccinated with an unspecified pneumococcal vaccine and an unspecified influenza vaccine (manufacturers unknown). The patient''s concurrent medical conditions included systematic lupus erythematosus. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received one dose of an unspecified pneumococcal vaccine and one dose of an unspecified influenza vaccine (dosages unspecified; administration sites and routes unknown; batch numbers not provided). On an unspecified date, within 1 year of the vaccination, the patient developed pneumonia followed by severe sepsis and death. The authors identified the sepsis as the cause of death but they did clarify if a post-mortem had been performed. Please note that this case has been considered a possible vaccination failure as time to onset was not specified, no laboratory confirmation was provided and it was unknown if the schedule was completed. This was a serious case as the outcome was fatal. Treatment was unknown. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "while various guidelines recommend vaccination among patients with systemic lupus, we have observed that better outcome is seen among patients with low disease activity and those with little or no intake of immunosuppressive agents. These factors should be well accounted for to ensure the best vaccination outcomes among lupus patients." This case is 1 of the 5 valid cases reported in the same literature article (see case PH2015GSK073372).


VAERS ID: 580328 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2015-05-14
Onset:2015-05-18
   Days after vaccination:4
Submitted: 2015-05-29
   Days after onset:11
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA950BA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Choking, Cough, Death, Dyspnoea, Hypoxic-ischaemic encephalopathy, Intensive care, Mood altered, Multiple organ dysfunction syndrome, Resuscitation, Selective eating disorder, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), 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), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: 2015-05-19
   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: No other medications
Current Illness: Trisomy 12; Trisomy 21; Ventricular septal defect; Atrial septal defect; Anaemia; Packed red blood cell transfusion
Preexisting Conditions: Duodenal stenosis; Duodenal operation; Myeloproliferative disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN073263

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of feeding disorder of infancy or early childhood in a 5-month-old female subject who received ROTARIX (batch number AROLA950BA, expiry date unknown). The subject''s past medical history included duodenal stenosis, duodenal operation and myeloproliferative disorder. Concurrent medical conditions included trisomy 12, trisomy 21, ventricular septal defect, atrial septal defect, anaemia and packed red blood cell transfusion. On 14th May 2015 11:04, the subject received ROTARIX (oral). On 18th May 2015, 4 days after receiving ROTARIX, the subject experienced feeding disorder of infancy or early childhood (serious criteria death), vomiting (serious criteria death) and bad mood. On 19th May 2015, the subject experienced hypoxic encephalopathy (serious criteria death and GSK medically significant), multi-organ failure (serious criteria death and GSK medically significant), dyspnoea, cough and cardio-respiratory arrest (serious criteria GSK medically significant). On an unknown date, the outcome of the feeding disorder of infancy or early childhood, vomiting, hypoxic encephalopathy and multi-organ failure were fatal and the outcome of the bad mood, dyspnoea, cough and cardio-respiratory arrest were unknown. The subject died on 19th May 2015. The reported cause of death was hypoxic encephalopathy and multi-organ failure. It was unknown if the reporter considered the feeding disorder of infancy or early childhood, vomiting, hypoxic encephalopathy, multi-organ failure, bad mood, dyspnoea, cough and cardio-respiratory arrest to be related to ROTARIX. Birth weight: 3,262g. The subject was hospitalized in the neonatal period for transient abnormal myelopoiesis until the 139th day of age. From the 24th to 59th day of age, the subject had received steroids. At the 23rd day of age, the subject received red cell concentrate (RCC) for anaemia. Since the following day after the ROTARIX, a decrease in breast-fed milk intake had been observed. On the 4th day after the vaccination, the subject went into a bad mood and barely took breast-fed mild. On the 5th day after the vaccination, the subject developed shortness of breath and choking, and immediately went into cardio-respiratory arrest. On arrival at the hospital, the subject had been in cardio-respiratory arrest for about 30 minutes and resuscitation was initiated. Upon the initiation of resuscitation, a large amount of milk was suctioned out of the mouth. The last milk intake was more than 3 hours before the subject arrived at the hospital, and was only 10mL. Despite the whole-body management performed in the intensive care unit (ICU), the subject died of hypoxic encephalopathy and multi organ failure on the 5th day after the ROTARIX. The causality to the ROTARIX was unclear but cannot be ruled out.


VAERS ID: 580337 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-10
Onset:2014-03-10
   Days after vaccination:0
Submitted: 2015-05-29
   Days after onset:445
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 136VPN001A / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA693AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2015GSK073542

Write-up: This case was reported by a healthcare professional (National Immunization Program) and described the occurrence of exanthema in a 2-month-old male patient who received ROTARIX liquid formulation (batch number QROLA693AA, expiry date unknown). Co-suspect products included pneumococcal vaccine (batch number 136VPN001a, expiry date unknown). On 10th March 2014, the patient received the 1st dose of ROTARIX liquid formulation (oral) and the 1st doses of pneumococcal vaccine (intramuscular). On 10th March 2014, 1 hr after receiving ROTARIX liquid formulation, the patient experienced exanthema (serious criteria death). On an unknown date, the outcome of the exanthema was fatal. The reported cause of death was exanthema. It was unknown if the reporter considered the exanthema to be related to ROTARIX liquid formulation. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 580350 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-01
Onset:0000-00-00
Submitted: 2015-05-29
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: 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: 2015-04-23
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: Dialysis; Hospitalisation; Cerebral haemorrhage
Preexisting Conditions: Influenza HA vaccine
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505JPN014843

Write-up: Initial information has been received from a non health professional, reported as consumer, concerning a 65 year old male inpatient with cerebral haemorrhage. On an unknown date, in mid-November 2014, the patient was vaccinated with PNEUMOVAX NP injection subcutaneously (lot number, dosage not reported). Other concomitant medications included influenza HA vaccine started in 2014. On 23-APR-2015, originally the patient had disease (cerebral hemorrhage and under hemodialysis) and was hospitalized. During the hospitalization, the patient died of pneumonia. Autopsy information was not reported. The reporter considered that the pneumonia was serious due to death. The reporter did not assess the relationship of pneumonia to pneumococcal vaccine. Additional information has been requested.


VAERS ID: 580523 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-04-01
Submitted: 2015-06-01
   Days after onset:426
Entered: 2015-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA143AA / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA6976A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Epistaxis, Rhinorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (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: No other medications
Current Illness: Nasopharyngitis, previous reported by parents
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2015GSK073555

Write-up: This case was reported by a healthcare professional (Immunization Program) and described the occurrence of death in a 2-month-old female patient who received ROTARIX (batch number QROLA6976A, expiry date unknown). Co-suspect products included SYNFLORIX (batch number ASPNA143AA, expiry date unknown). DTPW-HBV-HIB and Poliomyelitis vaccine inactivated. Concurrent medical conditions included common cold (previous reported by parents). On 25th April 2014, the patient received the 1st dose of ROTARIX (oral), the 1st dose of SYNFLORIX (intramuscular), DTPW-HBV-HIB and Poliomyelitis vaccine inactivated. In April 2014, 1 day after receiving ROTARIX, SYNFLORIX and Poliomyelitis vaccine inactivated, the patient experienced death (serious criteria death, GSK medically significant and other: per reporter), nasal discharge and nasal mucus blood tinged. On an unknown date, the outcome of the death was fatal and the outcome of the nasal discharge and nasal mucus blood tinged were unknown. The patient died in April 2014. The reported cause of death was unknown cause of death. The reporter considered the death to be probably related to ROTARIX, SYNFLORIX and Poliomyelitis vaccine inactivated. It was unknown if the reporter considered the nasal discharge and nasal mucus blood tinged to be related to ROTARIX, SYNFLORIX and Poliomyelitis vaccine inactivated. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected. Additional details provided as follows: Death was temporally associated to vaccination. Previous common cold reported by parents. At the same day of vaccination, the mother fed the child at dawn and in next morning found the baby with nasal secretion followed by bloody secretion. The parents took the child to the hospital but she was already dead.


VAERS ID: 580670 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-16
Onset:0000-00-00
Submitted: 2015-05-27
Entered: 2015-06-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 1453092 / 2 RL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 1453092 / 2 RL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER ASPN233DA / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA682AA / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory failure, Body temperature increased, Death, Lethargy, Moaning, Pneumonia, Pyrexia, Tachypnoea, Use of accessory respiratory muscles
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Respiratory tract infection, unknown
Allergies:
Diagnostic Lab Data: Body temperature, UNK date, greater than or equal to 39 degree C
CDC Split Type: 2015SA067455

Write-up: This unsolicited case report is part of a batch of reports associated with several products that was received by our affiliate which received the report from the Ministry of Health on 14 May 2015. A female patient (age reported as 4 months), had received a 2nd dose of IPV (VERO) (lot number J1203), by intramuscular route, in the left thigh vastus lateralis on 06-Jan-2014. The patient also received 2nd dose of PNC10 vaccine (lot number: ASPN233DA) by intramuscular route, in the left thigh vastus lateralis, 2nd dose of DTP/HB/Hib vaccine (lot number: 1453092), by intramuscular route, in the right thigh vastus lateralis and 2nd dose of Rotavirus Human Oral vaccine (lot number: QROLA682AA), by oral route, all on 16-Jan-2014. The patient had respiratory tract infection a week before the vaccination and after three days she did not have fever. Concomitant therapies were not reported. Twenty four hours post-vaccination, the patient experienced systemic events of tachypnea and intercostal retractions, other event of fever which was greater than or equal to 39 degree C (axillary). The reported diagnosis was death. Twenty four hours after the vaccination she developed fever, tachydyspnea, intercostal retractions, lethargy and moaning and had medical attendance when she received DIPIRONE, hydrocortisone, oxygen via catheter, nebulization with Fenoterol bromidate and ATROVENT. Due to aggravation of the conditions, a transfer to a medical unit of higher complexity was solicited. The patient deceased on 18-Jan-2014 in the way to the higher complexity unit. The cause of death in the death certificate was acute respiratory failure, inespecific pneumonia. The patient underwent medical care. The patient was under observation from 17-Jan-2014. The discharge date was not provided. The outcome was reported as death.


VAERS ID: 580894 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-24
Onset:0000-00-00
Submitted: 2015-06-01
Entered: 2015-06-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 137Q3027 / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA906A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Blood count abnormal, Cardio-respiratory arrest, Cardiomegaly, Circulatory collapse, Death, Grunting, Hepatomegaly, Imaging procedure abnormal, Mechanical ventilation, Pyrexia, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic cytopenias affecting more than one type of blood cell (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), 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 (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/25/2014, Blood count, infectious pattern; 11/25/2014, Body temperature, unknown; 11/25/2014, Imaging procedure, enlargement of liver and cardiac area
CDC Split Type: BR2015GSK074256

Write-up: This case was reported by a healthcare professional (Immunization Program) and described the occurrence of cardiopulmonary arrest in a 4-month-old female patient who received ROTARIX (batch number AROLA906A, expiry date unknown). Co-suspect products included Pneumococcal Vaccine (batch number 137Q3027, expiry date unknown), Poliomyelitis vaccine inactivated and DTPa-HBV-HIB. On 24th November 2014, the patient received the 2nd dose of ROTARIX (oral), the 2nd dose of Pneumococcal Vaccine (intramuscular), Poliomyelitis vaccine inactivated and DTPa-HBV-HIB. On 25th November 2014, 1 days after receiving ROTARIX, Poliomyelitis vaccine inactivated and DTPa-HBV-HIB, the patient experienced fever (serious criteria hospitalization and other: Per reporter), abdominal distention (serious criteria hospitalization) and grunting (serious criteria hospitalization). On an unknown date, the patient experienced cardiopulmonary arrest (serious criteria death, hospitalization, GSK medically significant and other: Per reporter), respiratory failure (serious criteria death, hospitalization and GSK medically significant) and circulatory failure (serious criteria death, hospitalization and GSK medically significant). The patient was treated with non-drug therapy (Ventilation) and cardiovascular system drugs (Vasopressors). On an unknown date, the outcome of the cardiopulmonary arrest, respiratory failure and circulatory failure were fatal and the outcome of the fever, abdominal distention and grunting were unknown. The reported cause of death was cardiopulmonary arrest, respiratory failure and circulatory failure. It was unknown if the reporter considered the cardiopulmonary arrest, fever, abdominal distension, grunting, respiratory failure and circulatory failure to be related to ROTARIX, Poliomyelitis vaccine inactivated and DTPa-HBV-HIB. Additional details were provided as follows: The subject received Pneumococcal 10 valent vaccine, inactivated poliomyelitis, DTP-Hib hepatitis B vaccine and oral rotavirus vaccine on 24 November 2014. The child was admitted to hospital on 25 November 2014, one day after vaccination, presenting abdominal distension, fever and grunting. According to image exams presented enlargement of liver and cardiac area. The complete blood count had a infectious pattern. Evolved with respiratory and circulatory failure. There was need of mechanical ventilation and vasopressive drugs. Evolved with 3 cardiac arrests and no response. It was unknown if the reporter considered the cardiopulmonary arrest, fever, abdominal distension, grunting, respiratory failure and circulatory failure to be related to Pneumococcal Vaccine. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 580925 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-16
Onset:2014-01-17
   Days after vaccination:1
Submitted: 2015-06-02
   Days after onset:500
Entered: 2015-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA233DA / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA682AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory failure, Death, Dyspnoea, Grunting, Lethargy, Oxygen therapy, Pneumonia, Pyrexia, Use of accessory respiratory muscles
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-18
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: 01/2014, Respiratory tract infection; 01/2014, Pyrexia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2015GSK074528

Write-up: This case was reported by a healthcare professional (Immunization Program) and described the occurrence of acute respiratory failure in a 5-month-old female patient who received SYNFLORIX (batch number ASPN233DA, expiry date unknown). Co-suspect products included ROTARIX (batch number QROLA682AA, expiry date unknown) and DTPA-HBV-HIB. The patient''s past medical history included respiratory tract infection and fever. On 16th January 2014, the patient received SYNFLORIX, ROTARIX and DTPA-HBV-HIB. On 17th January 2014, 1 days after receiving SYNFLORIX and ROTARIX and an unknown time after receiving DTPA-HBV-HIB, the patient experienced acute respiratory failure (serious criteria death, GSK medically significant and other: per reporter), pneumonia (serious criteria death and GSK medically significant), fever (serious criteria other: per reporter), dyspnea (serious criteria other: per reporter), intercostal retraction (serious criteria other: per reporter), lethargy (serious criteria other: per reporter) and grunting (serious criteria other: per reporter). The patient was treated with hydrocortisone, oxygen and BEROTEC AEROSOL. On 18th January 2014, the outcome of the acute respiratory failure and pneumonia were fatal. On an unknown date, the outcome of the fever, dyspnea, intercostal retraction, lethargy and grunting were unknown. The patient died on 18th January 2014. The reported cause of death was acute respiratory failure and pneumonia. It was unknown if the reporter considered the acute respiratory failure, pneumonia, fever, dyspnea, intercostal retraction, lethargy and grunting to be related to SYNFLORIX and ROTARIX. Additional details were reported as follows: The patient had a history of respiratory tract infection the week before vaccination. After three days without fever, she received vaccination. Twenty-four hours after vaccination, the patient presented fever, tachydyspnea, intercostal retraction, lethargy and grunting. She received medical care: dipyrone, hydrocortisone, oxygen under catheter, nebulization with BEROTEC and ATROVENT. There was worsening of symptoms and was requested transfer to a high complex hospital unit. The patient died on 18 January 2014 during transport. Death certificate indicated severe acute respiratory failure and pneumonia not specified as having as cause of death. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 581008 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-05-19
Onset:0000-00-00
Submitted: 2015-06-02
Entered: 2015-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 12PVPO240 / 3 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA847AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Death, Febrile convulsion, Pneumonia, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 05/19/2014, Body temperature, higher than 39 degree C
CDC Split Type: BR2015GSK075190

Write-up: This case was reported by a healthcare professional (Immunization Program) and described the occurrence of pneumonia in a 6-month-old patient who received ROTARIX (batch number QROLA847AA, expiry date unknown). Co-suspect products included pneumococcal vaccine (batch number 12PVPO240, expiry date unknown), DTPA-HBV-HIB and Flu Seasonal TIV Dresden (Influenza vaccine unspecified). On 19th May 2014, the patient received the 2nd dose of ROTARIX (oral), Pneumococcal vaccine (intramuscular), DTPA-HBV-HIB and Influenza vaccine unspecified. On 19th May 2014, less than a day after receiving ROTARIX and Influenza vaccine unspecified and an unknown time after receiving DTPA-HBV-HIB, the patient experienced febrile seizure (serious criteria GSK medically significant and other: per reporter), vomiting (serious criteria other: per reporter) and fever (serious criteria other: per reporter). On an unknown date, the patient experienced pneumonia (serious criteria death, hospitalization, GSK medically significant and other: per reporter) and septicemia (serious criteria death, hospitalization, GSK medically significant and other: per reporter). On an unknown date, the outcome of the pneumonia and septicemia were fatal and the outcome of the febrile seizure, vomiting and fever were unknown. The reported cause of death was pneumonia and septicemia. The reporter considered the pneumonia, septicemia, febrile seizure, vomiting and fever to be unrelated to ROTARIX and Influenza vaccine unspecified. Additional details were reported as follows: There was a discrepancy regarding the onset date of febrile seizure, vomiting and fever (higher than 39 Deg C). 9 May 2014 was reported although the narrative stated the events occurred at an unspecified time after vaccination. The patient admitted at hospital care on June 17th of 2014. There was no information about the date of the death. According to death declaration, the death was caused by septicemia and pneumonia not specified. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 581044 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-12
Onset:2014-05-13
   Days after vaccination:1
Submitted: 2015-06-02
   Days after onset:385
Entered: 2015-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 136VPN003A / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA803AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Bronchitis, Cyanosis, Death, Hyporesponsive to stimuli, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2015GSK075229

Write-up: This case was reported by a healthcare professional (Immunization Program) and described the occurrence of death in a 4-month-old female patient who received ROTARIX (batch number QROLA803AA, expiry date unknown). Co-suspect products included Pneumococcal vaccine (batch number 136VPN003A, expiry date unknown and DTPA-HBV-HIB. On 12th May 2014, the patient received the 2nd dose of ROTARIX (oral), the 2nd dose of Pneumococcal vaccine (intramuscular) and DTPA-HBV-HIB. On 13th May 2014, 1 days after receiving ROTARIX, the patient experienced bronchitis (serious criteria other, per reporter), cyanosis (serious criteria other, per reporter), apnea (serious criteria GSK medically significant and other: per reporter), pallor (serious criteria other: per reporter) and hyporesponsive to stimuli (serious criteria other: per reporter). On an unknown date, the patient experienced death (serious criteria death, GSK medically significant and other: per reporter). On an unknown date, the outcome of the death was fatal and the outcome of the bronchitis, cyanosis, apnea, pallor and hyporesponsive to stimuli were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, bronchitis, cyanosis, apnea, pallor and hyporesponsive to stimuli to be related to ROTARIX. Additional details were reported as follows: On 13 May 14, the child presented cyanosis, apnea, pallor and decreased responsive to a stimulus. The diagnosis was bronchitis. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 581257 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-04
Entered: 2015-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DEU001956

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DE-1577272925-E2015-06023) on 02-JUN-2015. Case of fatal outcome was received from a physician via a company representative on 30-May-2015. Case was medically confirmed. Poorly documented hearsay case from an exchange platform for paediatricians. An infant patient of unspecified gender and age received a dose of rotavirus live vaccine (manufacturer and lot-no. not reported) on an unspecified date. About four weeks later the patient developed intussusception and died.


VAERS ID: 581520 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-29
Entered: 2015-06-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Con Meds-Unknown; Prev Meds-Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: 2015SA070225

Write-up: Initial unsolicited report received from a healthcare professional (pediatrician) on 22 May 2015. A 07-month-old patient (gender not reported), whose medical history and concomitant therapy were not reported, had received a dose of FLUQUADRI (batch number, cycle dose in series, route and site of vaccination were not reported) on an unspecified date. Relationship as per reporter might not be related to the vaccine. It was reported that patient was passed away on an unspecified date. Corrective treatment and lab investigations were not reported. At the time of this report, the outcome was reported as fatal/death. Documents held by sender: none.


VAERS ID: 581595 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-25
Onset:2014-04-26
   Days after vaccination:1
Submitted: 2015-05-29
   Days after onset:398
Entered: 2015-06-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J14851 / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Epistaxis, Rhinorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds -Unknown; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Cause(s) of Death: unknown cause of death
CDC Split Type: 2015SA072948

Write-up: This unsolicited case report is part of a batch of reports associated with several products that was received by our affiliate which received the report from the Health on 15 May 2015. A female patient born (age reported as 02 months), whose medical history and concomitant therapies were not reproted, had received a 1st dose of IPV (VERO) vaccine, lot number J14851, by intramuscular route, in the right thigh vastus lateralis on 25 April 2014. It was reported that vaccines administered were more than one. On an unspecified date post-vaccination, the patient expereince systemic events: nose secretion and nose bleeding. The reported diagnosis was death. The patient was lactant. It was reported that death with temporal relationship to the vaccination. The patient was vaccinated 25 April 2014 and had previously reported common cold, with medical consult without using prescribed medication due to economic condition. Post vaccination the patient was fed artificial milk and had fell asleep. At dawn the patient was fed again and fell asleep alongside her parents. By morning, yellow nasal secretion was observed, followed by blood. The patient was taken to a hospital where death was determined (no vital signs, mydriasis and pink nasal secretion). The family refused to perform necropsy and during investigation, the family''s economic situation was found to be precarious. The patient''s mother had 8 pregnancies (5 births, 3 abortions). First pre-natal consult was at 7 months and was identified as a risk pregnancy, due to fluctuations in arterial pressure. Laboratory examinations were not performed. The new born was with single medical evaluation after-birth with runny nose; however the medication was prescibed but not used. Death diagnosis was R98 (death without assistance). The patient underwent medical care. The patient received emergency care on 26 April 2014 and discharge date was not reported. The outcome was reported as death.


VAERS ID: 581908 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-23
Onset:2015-05-02
   Days after vaccination:9
Submitted: 2015-06-09
   Days after onset:38
Entered: 2015-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Death, Pneumonia, Squamous cell carcinoma of lung
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-09
   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: ATROVENT; Azithromycin; Escitalopram; Heparin sodium; Hydrocortisone; TAMIFLU; TAZOCIN; Vancomycin hydrochloride
Current Illness:
Preexisting Conditions: Severe COPD; Lung cancer; Type 2 diabetes; Cholesterol
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015051497

Write-up: This medically confirmed health authority report (initial receipt 26-May-2015) concerns a 73 year old male patient who suffered from severe COPD (Chronic Obstructive Pulmonary Disease) and lung cancer and had a medical history of type II diabetes and cholesterol. On the 23-Apr-2015, the patient received the influenza vaccine (batch number ''4460'') from his GP (General Practitioner). On the 02-May-2015, the patient was tested positive for influenza A. Medications whilst in hospital included antibiotics, antivirals and heparin. They were piperacillin/tazobactam, azithromycin, ipratropium, vancomycin, heparin, hydrocortisone, oseltamivir, esomeprazole. On the 09-May-2015, the patient died. The cause of death was pneumonia, severe COPD, squamous cell carcinoma of the lung. Outcome was fatal. Reporter comments: The regulator reported the case as possible in relation to the influenza vaccine. There was no autopsy/Coroners court report. The regulator reported the Preferred Term of concomitant disease progression.


VAERS ID: 582013 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-10
Entered: 2015-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Non-Hodgkin's lymphoma
SMQs:, Malignant lymphomas (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK079785

Write-up: This case was reported by a non-health professional via other and described the occurrence of lymphoblastic lymphoma in a 12-year-old female patient who received CERVARIX. On an unknown date, the patient received the 2nd dose of CERVARIX. On an unknown date, several weeks after receiving CERVARIX, the patient experienced lymphoblastic lymphoma (serious criteria death and GSK medically significant). In January 2011, the outcome of the lymphoblastic lymphoma was fatal. The patient died in January 2011. The reported cause of death was lymphoblastic lymphoma. It was unknown if the reporter considered the lymphoblastic lymphoma to be related to CERVARIX. Additional details were provided as follows: This case was reported in a newspaper article. According to patient''s parents, the patient became unwell within weeks of receiving the second dose of CERVARIX. A year later, in January 2011, the patient died of lymphoblastic lymphoma (a rare form of leukaemia). Parents believed that she died as a result of the HPV vaccine. According to medicines agency, there was no indication that the vaccine was the cause. This is 1 of 4 cases reported from the same newspaper article.


VAERS ID: 582025 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-02-01
Onset:2015-05-01
   Days after vaccination:454
Submitted: 2015-06-11
   Days after onset:41
Entered: 2015-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
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: No other medications
Current Illness: Cardiac disorder; Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506COL004105

Write-up: This spontaneous report was received a social media, TV news refers to a 16 year old female patient. The patient''s current condition included lupus and unspecified heart disease and medial history was not reported. On an unknown date in February 2014, the patient was vaccinated with second dose of GARDASIL (vial and prefilled syringe) intramuscularly (strength and frequency were not reported). Concomitant medications were not reported. On an unknown date after vaccination patient experienced fainting and worsening of pre-existing conditions (Lupus (death, life threatening and medically significant) and unspecified heart disease (death and life threatening). The outcome of worsening of pre-existing conditions (Lupus and unspecified heart disease) was reported as fatal. The outcome of fainting was unknown. The patient died on an unknown date in May 2015. The cause of death was unknown. The relatedness of the events with the quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine was not reported. Upon internal review, worsening of pre-existing conditions (Lupus) was determined to be serious as another important medical event. Additional information is not expected as the contact details were not reported.


VAERS ID: 582029 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-05-16
Onset:2015-06-01
   Days after vaccination:16
Submitted: 2015-06-11
   Days after onset:10
Entered: 2015-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster, Road traffic accident
SMQs:, Accidents and injuries (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-01
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505KOR010708

Write-up: Information has been received from a nurse referring to a patient of unknown age and gender with unspecified medical history and concurrent conditions. On 16-MAY-2015, the patient was vaccinated with ZOSTAVAX injection (dose, route and lot number were not reported). Concomitant therapy was not reported. On 19-MAY-2015, the patient experienced herpes zoster. On an unknown date in May 2015, the patient experienced an injection site infection for which a physician inquired if herpes zoster could be an infection caused by the injection. The outcome of herpes zoster and injection site infection was unknown. Follow-up information has been received from a nurse on 08-JUN-2015. The patient was an 86 years old female. The patient was treated with anti-virus medicine, steroids, pain medicine, and gabapentin for the adverse events. On 01-JUN-2015, the patient died from a car accident. It was unknown if autopsy was done. Additional information is not expected. Patient information, event information and narrative were updated.


VAERS ID: 582096 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-12
Entered: 2015-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Non-Hodgkin's lymphoma
SMQs:, Malignant lymphomas (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK079782

Write-up: This case was reported by a non-health professional via other and described the occurrence of lymphoblastic lymphoma in a 13-year-old female patient who received CERVARIX. Concomitant products included CERVARIX. On an unknown date, the patient received the 2nd dose of CERVARIX. On an unknown date, several week after receiving CERVARIX, the patient experienced lymphoblastic lymphoma (serious criteria and GSK medically significant). In January 2011, the outcome of the lymphoblastic lymphoma was fatal. The patient died in 2011. The reported cause of death was lymphoblastic lymphoma. It was unknown if the reporter considered the lymphoblastic lymphoma to be related to CERVARIX. Additional details were provided as follows: This case was reported in a newspaper article. According to patient''s parents, the patient became unwell within weeks of receiving the second dose of CERVARIX. A year later, in January 2011, the patient died of a rare form of leukaemia known as lymphoblastic lymphoma. The parents believed that she died as a result of the HPV vaccine since she rarely fell ill before the vaccination. According to medicines agency, there was no indication that the vaccine was the cause. This is 1 of 4 cases reported from the same newspaper article.


VAERS ID: 582135 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-12
Entered: 2015-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Neoplasm
SMQs:, Non-haematological tumours of unspecified malignancy (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK079784

Write-up: This case was reported by a non-health professional via other and described the occurrence of neoplasm in a 12-year-old female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced neoplasm (serious criteria death). On an unknown date, the outcome of the neoplasm was fatal. The reported cause of death was neoplasm. It was unknown if the reporter considered the neoplasm to be related to CERVARIX. Additional information were provided as follows: This case was reported in the newspaper article. According to medical agency, it said there was no indication that the vaccine was the cause. This is 1 of 4 cases reported from the same newspaper article.


VAERS ID: 582146 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-12
Entered: 2015-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sepsis
SMQs:, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK079786

Write-up: This case was reported by a non-health professional via other and described the occurrence of septicemia in a 12-year-old female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced septicemia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the septicemia was fatal. The reported cause of death was septicemia. It was unknown if the reporter considered the septicemia to be related to CERVARIX. Additional details were provided as follows: This case was reported in a newspaper article. According to medicines agency, there was no indication that the vaccine was the cause. This is 1 of 4 cases reported from the same newspaper article.


VAERS ID: 583086 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-15
Entered: 2015-06-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, 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: NOV-2014, Pneumococcal meningitis
Allergies:
Diagnostic Lab Data: 2015, CSF test, Pneumococcal meningitis without focus, serotype 6A
CDC Split Type: 2015194920

Write-up: This is a spontaneous report obtained from a contactable physician. A 4 year-old male patient of an unspecified ethnicity received, on an unspecified date, the first dose of PREVENAR 13, lot number unknown at 0.5 ml, single dose. Relevant medical history included pneumococcal meningitis in Nov2014. The patient was not a premature baby and had no immune defect. Concomitant medications were unknown. On an unspecified date, in 2015, the patient experienced pneumococcal meningitis without focus which was detected by cerebrospinal fluid diagnostics. The serotype was 6A. The patient died on an unspecified date. No information was provided whether an autopsy was performed. Causality was not provided at time of this report. No follow-up attempts possible. No further information expected.


VAERS ID: 583101 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-06-09
Onset:2015-06-10
   Days after vaccination:1
Submitted: 2015-06-17
   Days after onset:7
Entered: 2015-06-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14C07A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Cardiac arrest, Respiratory arrest, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-10
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015197191

Write-up: This is a spontaneous report from a contactable physician via the Agency. A 2-month old male patient of an unspecified ethnicity, with birth weight of 3100 g, received first dose of PREVENAR 13, subcutaneous on 09Jun2015 at 0.5 ml, single and first dose of ACTHIB, subcutaneous on 09Jun2015 at 1 DF single. Medical history and concomitant medications were not reported. The patient had no family history. On 10Jun2015 at 15:00, the patient fell asleep. Around 17:00 on 10Jun2015, the patient developed respiratory arrest. Therefore, an emergency call was made. Resuscitation was initiated due to cardiac arrest. Despite of resuscitation at the reporting hospital, the patient had no response and died on 10Jun2015. It was not reported if an autopsy was performed. The reporting physician commented as follows: There were other causative factors including sudden infant death syndrome (SIDS) or asphyxia. The event was more attributable to SIDS or asphyxia than PREVENAR 13 or ACTHIB vaccine considering the condition with no underlying disease. The causality of the event to these drugs was unassessable.


VAERS ID: 583727 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-23
Entered: 2015-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cognitive disorder, Completed suicide, Death, Memory impairment, Menstruation irregular, Myalgia, Suicide attempt
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Suicide/self-injury (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN086599

Write-up: This case was reported by a consumer via licensee and described the occurrence of memory disturbance (excl dementia) in a female subject who received CERVARIX. On an unknown date, the subject received CERVARIX (intramuscular). On an unknown date, unknown after receiving CERVARIX, the subject experienced memory disturbance (excl dementia), cognitive disorder, memory impairment, abdominal pain, irregular menstrual cycle, myalgia, suicide (serious criteria death and GSK medically significant) and unsuccessful suicide (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the memory disturbance (excl dementia), cognitive disorder, memory impairment, abdominal pain, irregular menstrual cycle, myalgia and unsuccessful suicide were unknown and the outcome of the suicide was fatal. It was not reported if the reporter considered the memory disturbance (excl dementia), cognitive disorder, memory impairment, abdominal pain, irregular menstrual cycle, myalgia, suicide and unsuccessful suicide to be related to CERVARIX. The information refers to another subject who was mentioned in a query made by the guardian. Details including the number of subjects remained unknown.


VAERS ID: 583825 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-25
Entered: 2015-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza virus test positive, Respiratory distress, Stem cell transplant, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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: No other medications
Current Illness: Ill-defined disorder, required hematopoietic stem cell transplantation after the vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Patient was found to have anti-haemagglutinin inhibition antibody level against the H1 influenza stain of 1:80 30 days after the vaccination. The infecting strain was identified as seasonal influenza H1N1.
CDC Split Type: BR2015GSK089561

Write-up: This case was reported in a literature article and described the occurrence of respiratory distress in a unk subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included ill-defined disorder (required hematopoietic stem cell transplantation after the vaccination). On an unknown date, 180 days after receiving Flu seasonal TIV Dresden, the subject developed respiratory distress. Serious criteria included death and GSK medically significant. Additional event(s) included vaccination failure with serious criteria of GSK medically significant and H1N1 influenza. The outcome of respiratory distress was fatal. The outcome(s) of the additional event(s) included vaccination failure (unknown) and H1N1 influenza (unknown). The reported cause of death was respiratory distress. It was unknown if the investigator considered the respiratory distress to be related to Flu seasonal TIV Dresden. The investigator considered that there was a reasonable possibility that the vaccination failure and H1N1 influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Patient was found to have anti-haemagglutinin inhibition antibody level against the H1 influenza strain of 1:80 30 days after the vaccination. The infecting strain was identified as seasonal influenza H1N1. Additional information received: This case was reported in a literature article and it described the occurrence of a possible vaccination failure in a patient of unspecified gender and age who had received an unspecified trivalent influenza vaccine (manufacturers unknown). The patient''s concurrent condition included an unspecified medical problem for which they required hematopoietic stem cell transplantation after the vaccination. The patient received the vaccine as part of a clinical study with the following exclusion criteria: hematopoietic stem cell transplantation planned for within a week of the recruitment date; egg, chicken protein, neomycin or thimerosal allergy history; past history of severe reaction following influenza vaccine or prior influenza vaccine received less than 6 months before the transplant date. No further information on the patient''s concurrent medical conditions, history or concomitant medication was provided. On an unspecified date between October 2007 and 2009, the patient received a dose of an unspecified Southern-hemisphere trivalent influenza vaccine (dosage for adults unknown, 0.25 mL for children from 6 months to under 3 years of age or 0.5 mL for children between 3 and 8 years of age; administration routes and sites unspecified; batch numbers not provided). On an unspecified date between October 2007 and January 2010, an unknown period after the transplant and within 180 days of the vaccination, the patient was diagnosed with influenza H1N1 (no pandemic according to authors). The patient developed respiratory distress syndrome and died 5 days after the influenza diagnosis. This case was classified as a possible vaccine failure as no other information regarding the time to onset was provided. This was a serious case as the outcome was fatal. Cause of death was respiratory distress syndrome. It was not specified if a post-mortem was performed. Patient was found to have anti-haemagglutinin inhibition antibody level against the H1 influenza strain of 1:80 30 days after the vaccination. The infecting strain was identified as seasonal influenza H1N1. Treatment was unknown. The authors considered that the vaccine had not been effective. The authors concluded that "despite the poor immunogenicity of the vaccine reflected by the low seroresponse and seroprotective rates during follow-up, the pretransplant vaccine efficacy was more than 65%. Previously, we observed a vaccine efficacy of 80% after influenza vaccination at day 180. Unfortunately, the statistical analysis of other relevant risk factors, such as type of immunosuppressive therapy, the occurrence of acute or chronic graft-versus-host disease and the presence of lymphopenia, was not possible because of the small number of patients with influenza. Severe influenza in otherwise healthy individuals is influenced by the viral pathogenicity and the host immune response, which is inherently different in hematopoietic stem cell transplantation recipients because of the immature Band T-cell reconstitution. A future vaccination strategy might be to vaccinate the recipient pretransplant and boost this response early within 3 months after transplantation in the recipient. Efforts should also therefore be made to limit the risk of influenza exposure in hematopoietic stem cell transplantation recipients". This case is 1 of the 2 valid vases reported in the same literature article (see case BR2015GSK089714).


VAERS ID: 584772 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-01
Onset:2015-06-01
   Days after vaccination:396
Submitted: 2015-07-03
   Days after onset:32
Entered: 2015-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Completed suicide, Exposure to toxic agent, Hepatic failure, Metabolic acidosis, Physical disability, Poisoning, Poisoning deliberate, Pulmonary haemorrhage, Renal failure, Respiratory failure, Suicidal ideation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Lactic acidosis (broad), Suicide/self-injury (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-06-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507COL001112

Write-up: This spontaneous report refers to a 13 year old female patient. The case was reported in a local newspaper. In May 2014, the patient was vaccinated with a second dose of GARDASIL intramuscular (dose, lot # and expiration date were not provided). In May 2015, the patient experienced fainting, suicidal ideation referred as feelings of not wanting to live and asthenia reported as weakness and physical deficiencies. The patient ingested a herbicide for weeds called "PARAQUAT" (venom poisoning) and required hospitalization in critical care unit since 17-JUN-2015 to treat intoxication. Relatives informed that patient ingested herbicide because she was desperate due to the continuous fainting episodes, physical deficiencies, weakness and feeling of not wanting to live. On 23-JUN-2015, the patient developed renal failure, pulmonary haemorrhage, metabolic acidosis, respiratory failure and hepatic failure. Newspaper reported that physician in charge of the patient informed (23-Jun-2015) that patient was in critical care unit, receiving attention by nephrologists, gastroenterologists, toxicologists and mental health team. Her medical evolution was the expected in cases of intoxication with "PARAQUAT" with Renal, hepatic and pulmonary failure, pulmonary bleeding and severe metabolic acidosis. At that time prognosis was uncertain. Then in the same month, it was reported that despite of the medical efforts, the patient died on Sunday 28-JUN-2015 (completed suicide reported as poisoning suicide). The outcome of completed suicide, metabolic acidosis, pulmonary haemorrhage, respiratory failure, hepatic failure and renal failure was reported as fatal. The outcome of the suicidal ideation, asthenia and syncope was unknown. The cause of death was reported as poisoning, hepatic failure, pulmonary haemorrhage, completed suicide, respiratory failure, renal failure and metabolic acidosis. Upon internal review, the events of suicidal ideation, completed suicide, renal failure, respiratory failure and hepatic failure were considered to be medically significant. Upon internal review, the events of poisoning, completed suicide, renal failure, pulmonary haemorrhage, metabolic acidosis, respiratory failure and hepatic failure were considered to be life threatening. Additional information is not expected as the source document is a local newspaper.


VAERS ID: 584792 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-06-01
Submitted: 2015-07-03
   Days after onset:32
Entered: 2015-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
JEVX: JAPANESE ENCEPHALITIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Haematemesis, Inappropriate schedule of drug administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Medication errors (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: WAES1507JPN001757

Write-up: This spontaneous report was received from a physician and refers male patient in his 30''s. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient (who was planning to take a voyage to another country), was vaccinated with the first dose of HEPTAVAX-II route parenteral (lot number, expiration date, dose and strength were not reported). Simultaneously the patient was vaccinated with typhoid vaccine (unspecified). On an unspecified date (over about 2 weeks since the first vaccination) the patient was vaccinated with a second dose of HEPTAVAX-II route subcutaneous (lot number, expiration date, dose and strength were not reported), the patient was also vaccinated simultaneously with AIMMUGEN. Other concomitant medications were Japanese encephalitis virus vaccine and other medications (not specified). On an unspecified date (reported as 2 or 3 days later after the second vaccination), the patient took a voyage to another country. On an unspecified date in June 2015, the patient experienced haematemesis and then died directly in that country. The cause of death was unknown, but it was said that it may be shock hemorrhagic (also reported as haematemesis). The information about the autopsy was not reported. The reporter considered haematemesis and inappropriate schedule of drug administration to be not related to HEPTAVAX-II. Additional information is not expected because the reporter did not wish to be contacted.


VAERS ID: 584973 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-01
Onset:2015-01-01
   Days after vaccination:31
Submitted: 2015-07-07
   Days after onset:186
Entered: 2015-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Pemphigoid, Septic shock
SMQs:, Severe cutaneous adverse reactions (broad), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
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: No other medications
Current Illness: Depression
Preexisting Conditions: Appendicectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK096117

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of bullous pemphigoid in a 55-year-old female patient who received ENGERIX B ADULT. The patient''s past medical history included appendectomy. Concurrent medical conditions included depression. In December 2014, the patient received ENGERIX B ADULT (subcutaneous). In January 2015, 30 days after receiving ENGERIX B ADULT, the patient experienced bullous pemphigoid (serious criteria death, hospitalization, GSK medically significant and life threatening) and septic shock (serious criteria death and GSK medically significant). The patient was treated with CORTANCYL and methotrexate. On an unknown date, the outcome of the bullous pemphigoid and septic shock were fatal. The reported cause of death was septic shock and bullous pemphigoid. It was unknown if the reporter considered the bullous pemphigoid and septic shock to be related to ENGERIX B ADULT. Additional details were provided as follows: In January 2015, approximately 1 month after receiving ENGERIX B ADULT, the patient experienced bullous pemphigoid. CORTANCYL was given 80mg daily and methotrexate as 15mg weekly. On an unknown date, the patient died from septic shock and also according to the reporter, bullous pemphigoid might have caused the death. No further information was available.


VAERS ID: 584978 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-05
Onset:2015-05-21
   Days after vaccination:197
Submitted: 2015-07-07
   Days after onset:47
Entered: 2015-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 149202 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Atrial fibrillation, Cognitive disorder, Condition aggravated, Confabulation, Confusional state, Death, Diarrhoea, Dizziness, Dysphagia, Electroencephalogram abnormal, Electromyogram abnormal, Encephalitis post immunisation, Erythema, Gastrointestinal haemorrhage, Hiccups, Lumbar puncture abnormal, Lymphadenopathy, Lymphocytosis, Memory impairment, Meningioma, Nausea, Peripheral sensory neuropathy, Pleural disorder, Pneumonia, Polyneuropathy, Rectal haemorrhage, Retroperitoneal lymphadenopathy, Scan abnormal, Scan brain, Somnolence, Ureteral disorder, Urosepsis, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-21
   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: bisoprolol; metformin; ramipril; furosemide; LANOXIN
Current Illness: Paraesthesia; Asthenia; Hypertension; Bedridden; Claustrophobia; Diuretic therapy; Cardiac failure; Type 2 diabetes mellitus; Cardiac valve disease; Drug hypersensitivity; Dysphagia
Preexisting Conditions: Prostatectomy; Neoplasm; Carpal tunnel syndrome
Allergies:
Diagnostic Lab Data: Electroencephalogram, abnormal, significant, slow theta activity delta on the fronto temporal regions bilaterally that sometimes is organized in bilateral and synchronous bouffees. Intercurrent urosepsis have been reported; 04/02/2015, Electromyogram, abnormal, significant axonal sensory polyneuropathy of the lower limbs; Lumbar puncture, abnormal, significant detection of protein and CSF lymphocytosis; 03/26/2015, Scan brain, abnormal, significant, finding of meningioma; 04/04/2015, Scan brain, abnormal, significant finding of meningioma; 04/16/2015, Scan brain, abnormal, significant finding of meningioma
CDC Split Type: PHHY2015IT076594

Write-up: Case number PHHY2015IT076594, is an initial spontaneous report from a health care professional via Agency (reference number: 314800) received on 23 Jun 2015, with a follow up received from health care professional via Agency on 25 Jun 2015 with a follow up received from the quality assurance department (QA, reference number: 1002411) on 02 Jul 2015. This report refers to an 84-year-old male patient. The patient''s current conditions included diabetes mellitus maturity onset, systemic arterial hypertension, dysphagia to liquids, paresthesia in the upper limbs and strength deficit, decompensation cardiac and cardiac valve disease (mitral valvulopathy). The patient was allergic to penicillin and was on diuretic therapy. Past medical history included epithelioma and bilateral carpal tunnel syndrome. In the past the patient underwent prostatectomy. Concomitant medications included bisoprolol, metformin, ramipril, furosemide and LANOXIN. The patient was vaccinated with AGRIPPAL S1 (batch number: 149202) intramuscularly in to the left deltoid at a dose of 0.5 ml on 05 Nov 2014. On 12 Nov 2014, the patient experienced memory deficit, dizziness, postural instability, vertiginous syndrome, nausea, vomiting, diarrhea, worsening of existing paresthesia in the upper limbs and strength deficit. Further the patient had skin redness infiltrated of about seven cm in the deltoid region. The patient was hospitalized and the diagnosis was encephalitis after vaccination. The patient was hospitalized in department of neurosciences from 26 Mar 2015 to 12 May 2015. During hospitalization, the patient underwent radiological investigations. Among them computerized tomogram (CT) scan of the head, nuclear magnetic resonance imaging of the head were withdrawn due to claustrophobia. On 05 May 2015, the patient underwent lumbar tap, CT scan of the abdomen and of the chest, thoracentesis and lymph nodal inguinal biopsy on the right side anesthesiological class of the patient ASA3 without evidence of neuro-axial infections. However there was an evidence of suspected localization of lymphoproliferative disease at the pleural level, presence of lymphadenopathies at several levels, liver formation art the left liver lobe of 48 into 46 mm of not clear significance, presence of retroperitoneal lymphonodal tissue and/or fibrotic tissue that involve the ureter on the left side and the retroperitoneal region upstream of the bifurcation of the iliac in para-aortic on the left side. The patient underwent brain scan on 26 MAR 2015, 04 Apr 2015 and 16 Apr 2015 and it showed findings of meningioma. On 02 Apr 2015, electromyography revealed axonal sensory polyneuropathy of the lower limbs. In lumbar puncture there was a detection of protein and CSF lymphocytosis. On 14 Apr 2015, the patient underwent echo Doppler carotid arteries but the results were not reported. Electroencephalogram (EEG) showed slow theta activity delta on the fronto temporal regions bilaterally that sometimes was organized in bilateral and synchronous bouffees and inter-current urosepsis were reported. Later the patient was transferred on 12 May 2015 with the diagnosis of sub-acute cognitive deterioration, postural instability, suspected encephalitis and suspected lymphoproliferative disease associated with hemorrhage of the lower digestive ways under mild improvement. At the time of the transferring the patient was soporous, with a cognitive deterioration and was dysphagic as far as the liquids were concerned. Paroxystic atrial fibrillation was not treated prophylactically due to rectal bleeding of not determined nature and abdominal lesions under investigations in suspected lymphoproliferative disease. Further, patient presented with episodes of soporous state alternated with moments of greater alertness, mental confusion, confabulation, hiccups, and arrhythmias due to probable atrial fibrillation. Histological examination performed on the lymph node inguinal had no evidence of any localization of the lymphoproliferative disease in that area. The patient was initially mobilized to the armchair and was soon forced on to the bed. The outcome of the events was not reported. The patient at last presented with bilateral bronchopneumonia. On 21 May 2015, the patient died due to bilateral bronchopneumonia complicating hypokinetic adynamic syndrome secondary to possible encephalitis. It was reported that autopsy was not performed. The reporter considered causality to be suspected to the administration of AGRIPPAL S1 (vaccination may have contributed to the events). Follow up received from a health care professional via Agency on 25 Jun 2015: updated current condition (decompensation cardiac), concomitant medications (bisoprolol, metformin, ramipril, furosemide and LANOXIN), lab data (lumbar puncture, scan brain and electromyogram), new events (cognitive deterioration, rectal bleeding, sopor, mental confusion, confabulation, hiccups, atrial fibrillation, meningioma, lymphoproliferative disorder, generalised lymphadenopathy, retroperitoneal lymphadenopathy, sensory polyneuropathy axonal, urosepsis and bronchopneumonia) and other clinically relevant information in the narrative. Non significant follow-up received from Quality Assurance Department (QA, reference number: 1002411) on 02 Jul 2015: Updated QA reference number.


VAERS ID: 584986 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-19
Onset:2013-08-19
   Days after vaccination:0
Submitted: 2015-07-07
   Days after onset:687
Entered: 2015-07-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Culture negative, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Polymerase chain reaction, Resuscitation, Syncope, Toxicologic test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-19
   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: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC Split Type: 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


VAERS ID: 585133 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:2015-05-11
Onset:2015-05-11
   Days after vaccination:0
Submitted: 2015-07-09
   Days after onset:59
Entered: 2015-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K010490 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Bronchitis, Death, Infection, Middle ear inflammation, Respiratory tract infection
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Hearing impairment (narrow), Respiratory failure (broad), Infective pneumonia (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: No other medications
Current Illness: Immunisation, no information regarding the patient''s medical history was provided
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507DEU003312

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) with (MFR# DE-1577272925-E2015-07701) on 07-JUL-2015. Case of fatal outcome was received from the Health Authority on 02-Jul-2015 (reference no. PEI2015038770). Case is medically confirmed. A 13-month-old female patient received a first dose of VARIVAX, lot-no. K010490 Intra muscular on 11-May-2015. On the same day she developed signs and symptoms of infection and bronchitis with signs of asphyxia persisting for 8 days. The patient was not hospitalized and condition was not described as life-threatening. The patient died on an unspecified date. Autopsy revealed: suspected respiratory infection and middle ear inflammation as cause of death. According to the autopsy report no evidence that the varicella vaccination may have played a role. Middle ear inflammation was not reported as AE by reporter but mentioned in autopsy report. Upon medical review, the company had added this term as AE.


VAERS ID: 585262 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-09
Onset:2015-07-01
   Days after vaccination:114
Submitted: 2015-07-10
   Days after onset:9
Entered: 2015-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Appendicectomy, Appendicitis, Death, Diarrhoea, Discoloured vomit, Haematemesis, Haematochezia, Intensive care, Intestinal perforation, Intussusception, Pyrexia, Seizure, Septic shock, Smear site unspecified abnormal, Surgery, Transfusion, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Toxic-septic shock conditions (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), 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: 2015-07-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature (30Jun2015): fever (assessment: increased); Smear test (30Jun2015): positive (assessment: positive). 07/03/2015, Ultrasound abdomen, intussusception in the right iliac fossa
CDC Split Type: WAES1507MLI003532

Write-up: This spontaneous report as received from a physician refers to a 6 month old female patient, enrolled in a Post Marketing Active Surveillance. The patient''s medical history and concurrent conditions were not reported. On 09-FEB-2015, the patient was vaccinated orally with a dose of ROTATEQ (dose, lot# and expiry date were not reported). On 09-MAR-2015, the patient was vaccinated orally with another dose of ROTATEQ (dose, lot# and expiry date were not reported). Concomitant medications were not reported. On 30-JUN-2015 in the morning, the patient experienced diarrhea, fever and post-prandial emesis, which was the onset of the later diagnosed intussusception. On 30-JUN-2015, due to the symptoms, the patient was brought to a hospital. On the same date, thick smear test was performed with a positive result and the patient received treatment of metoclopramide, artemether (plus) lumefantrine, paracetamol and domperidone. On 30-JUN-2015 at night, the stools became bloody and the patient was transferred to the health center, where she was consulted and placed on therapy with ceftriaxone, paracetamol, electrolytes (unspecified) (plus) Ringer lactate and vogalene. On 03-JUL-2015, the patient was consulted in the another health center due to greenish vomiting and persistence of symptoms. On the same day, an abdominal ultrasonography was requested for an abdominal mass and bloody stool, which demonstrated intussusception in the right iliac fossa. The patient was referred to the pediatric surgery department and on 03-JUL-2015 in the evening, the patient underwent a surgery, which found an ileocecal intussusception without necrosis with an inflamed appendix. A manual reduction of intussusception, appendectomy and suturing of 3 pre-perforated areas on either side of the ileocecal valve were performed. On 04-JUL-2015, the patient experienced haematemesis and convulsions, and due to these events the patient was transferred to the intensive care unit, where the treatment with oxygen, antibiotics, infusion and transfusion was given. The patient''s condition deteriorated and on 06-JUL-2015, the patient died due to septic shock. The outcome of septic shock and intussusception was reported as fatal whereas the outcome of rest of the events was unknown. The reporting physician considered intussusception as not related to ROTATEQ. The relatedness between the event of fever, appendicitis, intestinal perforation, hematemesis, convulsions and septic shock and ROTATEQ was not reported. Upon internal review the events of intussusception, convulsions, appendicitis, intestinal perforation and septic shock were considered to be medically significant. Additional information has been requested.


VAERS ID: 585341 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-09
Onset:2014-04-24
   Days after vaccination:15
Submitted: 2015-07-01
   Days after onset:433
Entered: 2015-07-10
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adrenal haemorrhage, Autoimmune endocrine disorder, Brain oedema, Bronchitis bacterial, Cerebral disorder, Death, Ependymitis, Haemorrhagic pneumonia, Immunodeficiency, Pneumonia bacterial, Pneumonia viral
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-24
   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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA091875

Write-up: Initial unsolicited report received by Agency from their partner on 20 February 2015 from the Agency and transmitted to Sanofi Pasteur on 23 June 2015. Mfr number: UA-LGEVX1721. A 19-day-old female patient, whose medical history and concomitant medications were not reported, had received a 0.5 ml dose of EUVAX B (batch number, expiry date, route and site of administration were not reported) and also received 0.1 ml dose of BCG vaccine (batch number, expiry date, route and site of administration were not reported) both vaccine administered on 09 April 2014. The child was born from the first pregnancy without abnormalities at the 39-40 weeks of gestation, cephalic presentation, weight 3860 g, height 55 cm, head circumference 35 cm, the evaluation of Apgar score 7-8 points; conjugation hyperbilirubinemia and was administered phototherapy in April 2014. On 24 Apr 2014, i.e. 15 day after vaccination patient died approximately at 06.00 am the parents found out dead baby in bed. Patient''s parent called an ambulance and ambulance stated the biological death of the child. On an unspecified date, patient had forensic diagnosis of bilateral common viral and bacterial hemorrhagic pneumonia, catarrhal-desquamative bronchitis, cell-lymphoid ependimatit, brain swelling, hemorrhage in adrenal glands and morphological evidence of immune-endocrine insufficiency. Laboratory investigations and corrective treatments were not reported. Outcome of event was fatal. There was a temporal relationship between the onset of events and administration of vaccine, but there are also existing concomitant pathology that likely was the cause of the death neonatal. Causality with the vaccine was reported as unlikely. Documents held by sender: none. Lab tests unknown. Cause(s) of Death: pneumonia viral, pneumonia bacterial, purulent bronchitis, ependymitis, brain swelling, adrenal hemorrhage, immunodeficiency.


VAERS ID: 585367 (history)  
Form: Version 1.0  
Age: 0.04  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-03
Onset:2014-03-15
   Days after vaccination:12
Submitted: 2015-07-01
   Days after onset:473
Entered: 2015-07-10
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA13016 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Ill-defined disorder, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-15
   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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Forensic medical conclusion: the cause of death became sudden death of a breastfed child against the background of the lymphoidotoxemia, which is confirmed by detection in the investigation of acute hemodynamic disorders in internal organs and general venous plethora, which were detected in the examination of small-droplet, dark-red extravasations on the surface of lung and heart, dystelectasis in lung and site of damage of acute emphysema, accidental transformation and hyperplasia of the thymus of 2-3 degrees, without any congenital malformation and disorders. Forensic diagnosis: sudden death. Cause(s) of Death: death neonatal
CDC Split Type: 2015SA091719

Write-up: Initial unsolicited report received by Agency from their partner. (number: 15-0000109) (MFR control number UA-LGEVX1717) on 20 February 2015 from the Regulatory Authority and transmitted to Sanofi Pasteur on 23 June 2015. A 16 days old male patient, whose medical history and concomitant medications were not reported had received a 0.5 ml dose of EUVAX B (batch number UFA 13016, expiry date and site of administration was unknown), via intramuscular route and the patient also received a 0.1 ml dose of BCG vaccine (batch number, expiry date and site of administration were not reported) via intramuscular route both on 3 March 2014. The patient from the 2nd pregnancy (mother was not registered in the antenatal clinic and was not examined), the 2nd emergency delivery (mother applied to maternity hospital with complaints of abdominal pain and bursting of the waters), the patient is the second of twins; birth weight 2120 g, height 45 cm, an assessment with APGAR score 8-9 points; latched on breasts in the delivery room; the child was not ill during his life, epidemiological environment - favorable. On 15 March 2014 (12 days after vaccination), at 5:40, the mother found out patient without signs of life and was dead. Laboratory investigations involved forensic medical conclusion: the cause of death became sudden death of a breastfed child against the background of the lymphoidotoxemia, which is confirmed by detection in the investigation of acute hemodynamic disorders in internal organs and general venous plethora, which were detected in the examination of small-droplet, dark-red extravasations on the surface of lung and heart, dystelectasis in lung and site of damage of acute emphysema, accidental transformation and hyperplasia of the thymus of 2-3 degrees, without any congenital malformation and disorders. Forensic diagnosis: sudden death. Corrective treatments was not reported. The reporter assessed the causal relationship with Medicinal Product as - Unlikely. Sender''s comment: [Partner] There is a temporal relationship between the onset of events and administration of vaccine, but there is also existing concomitant pathology or concomitant medicine that likely were the cause of the death neonatal. Documents held by sender: none.


VAERS ID: 585369 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2013-02-05
Onset:2013-02-22
   Days after vaccination:17
Submitted: 2015-07-01
   Days after onset:858
Entered: 2015-07-10
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER J41631 / UNK UN / UN
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J41631 / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA12001 / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H018176 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Biopsy kidney abnormal, Bradycardia, Cardiopulmonary failure, Congestive cardiomyopathy, Crying, Decreased appetite, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation, Enteral nutrition, Gastrointestinal disorder, Hypertension, Hypotension, Ill-defined disorder, Immunology test, Infection, Liver function test abnormal, Mechanical ventilation, Metabolic acidosis, Metabolic function test, Multiple organ dysfunction syndrome, Oliguria, Parenteral nutrition, Poor sucking reflex, Pulmonary hypertension, Pyrexia, Selective eating disorder, Swelling, Tachycardia, Viral test negative, 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) (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), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (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: Con Meds -Unknown; EUVAX B , Route: unknown, Site: unknown, 23DEC2012, Mfg: LG Life Sciences, Lot unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: bacteriological tests were performed and additional the following test: virological (with negative result), immunological and biochemical. ECHO was monitored every day and EF was between 26-22%; echocardiogram, UNK; Liver function tests, Elevated; Kidney biopsy, Moderately elevated; Echocardiogram, 21 %
CDC Split Type: 2015SA091685

Write-up: Initial unsolicited report received from health care professional on June 2015. A 13-month-old female patient, whose medical history and concomitant medications were not reported, had received a one dose of EUVAX B (batch number UFA12001, expiry date, route and site of administration were not reported), a dose of BCG vaccine (batch number J4163-1, expiry date, route and site of administration were not reported), and also received PENTAXIM (batch number J4163-1, (expiry date, route and site of administration were not reported), had received orally ROTATEQ (batch number H018176, expiry date, route and site of administration were not reported on 05 February 2013. Patient had received a dose of EUVAX and BCG vaccine on 23 December 2012. It was reported that, after post vaccination patient had experienced crying and had decreased appetite which according to patient''s parent was associated with rotavirus vaccination. In a few days the child became tedious with aversion for sucking and experienced vomiting. These adverse reactions were reported to the physician who recommended hydration. On February 18, 2013 parents also reported mentioned above adverse reactions to the district nurse who saw nothing alarming. As the child was still vomiting, parents decided to go with her to the hospital. On February 18, 2013 during hospitalization the coronary cauterization was urgently made but Bland-White-Garland syndrome was ruled out. Acute viral infection and bacterial inflammation were also excluded during hospitalization between 20 February 2013 to 27 February 2013. On 62 day of the patient''s life, i.e. on 22 February 2013 the cardio-respiratory failure was developed, the child was intubated and the treatment was intensified. At admission to the hospital ECHO examination was done: parameter of systolic function EF was 20 percent and after next 5 days: 41 percent what proved that heart function was not permanently damaged. It was also reported that, dilated cardiomyopathy was diagnosed and the patient was transported to the another hospital. Cardiac surgery Department between 27 February 2013 to 01 March 2013 and in intensive care unit between 01 March 2013 to 06 March 013. Non-compaction cardiomyopathy as well as hypophosphatemia, hypokalaemia, hypomagnesaemia were excluded. Bacteriological tests were performed and additional the following test were virological (with negative result), immunological and biochemical. During treatment in ICU the child required mechanical ventilation as well as involvement of cardio- and vasoactive drugs because of worsening of circulation failure and respiratory failure. The infant has been qualified to heart transplantation and artificial heart therapy. On March 6, 2013, As parents did not agree for that and the infant was admitted again to the hospital. At admission the patient''s condition was stable, mechanical ventilation was continued with medium parameters and the treatment in infusion: Adrenaline, Levosimendan, COROTROPE, Dopamine, Sodium nitroprusside. Medicines were gradually withdrawn due to stabilization of circulation without one drug COROTROPE. On the 4th day the patient was extubated. Echocardiogram was monitored every day and EF was between 26-22 percent. Because of swelling and circulation failure diuretics were Administered CATOPRIL was administered for short time because of hypertension. Since 5th day the patient was fed enteral. Besides of short periods of absent of infection, the patient required antibiotic therapy, modified in line with results of bacterial culture. In 3rd week of therapy a discharge was planned. During that time the condition of the patient was stable with tachycardia, EF approx. 22 percent, and she received treatment with milrinone, and was fed enteral. Due to worsening of patient condition a discharge was postponed. At the beginning the patient experienced gastrointestinal disorders. Next day: cardio-respiratory failure progression with hypotension, oliguria without worsening of EF(22 percent). The child was intubated, respiratory therapy was used with medium parameters of mechanical ventilation, and patient received analog-sedative therapy as well as catecholamines, Levisimendan, diuretics, COROTROPE, and changed antybiotycotherapy due to elevated acute-phase reactants. Biochemical tests: LDH liver function tests very elevated, kidney tests was moderately elevated. Because of digestive disorders, parenteral nutrition was included. The condition of the child improved and was stable, cardiac medicines were reduced. After several days, during preparation for extubation, the condition of the patient got worse with fever, incremental circulation failure, oliguria, metabolic acidosis. The extubation was not done, the cardiovascular treatment was modified and increased included catecholamines, Furosemide in infusion I.V., antybiotycotherapy was also modified. ECHO test EF still approx. 21 percent, but pulmonary hypertension symptoms were noticed so sildenafil was included. After that the condition of the patient has improved for short time. After a few days significant worsening of heart wall motion, ECHO test: EF 10 percent, persistent pulmonary hypertension. Multiple organ dysfunction developed. Hypotension was increasing with arrhythmias (Fibrillatio et flagellation ventriculorum). It was reported that, patient death was confirmed on 24 April 2013 at 21:00 hours. At the time of report, outcome was fatal. Documents held by sender: none. Cause of death: circulatory failure, dilated cardiomyopathy, poor suckling reflex, cardio-respiratory failure, swelling, hypertension, ejection fraction decreased, metabolic acidosis, arrhythmia, bradycardia, oliguria, tachycardia, decreased appetite, hypotension, gastrointestinal disorder, vomiting, fever.


VAERS ID: 585370 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-06-17
Onset:2015-06-26
   Days after vaccination:9
Submitted: 2015-07-10
   Days after onset:14
Entered: 2015-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC279C / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 MO / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB126BA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Acidosis, Alanine aminotransferase normal, Bilirubin conjugated, Blood bicarbonate, Blood bilirubin, Blood chloride normal, Blood creatinine, Blood gases abnormal, Blood glucose decreased, Blood glucose increased, Blood potassium normal, Blood pressure fluctuation, Blood sodium normal, Body temperature fluctuation, Bradycardia, C-reactive protein, Cardiac arrest, Chest X-ray abnormal, Death, Dyspnoea, Electrocardiogram abnormal, Endotracheal intubation, Haematocrit normal, Haemoglobin normal, Halo vision, Heart rate increased, Hyperglycaemia, Lymphocyte percentage increased, Mechanical ventilation, Neutrophil percentage decreased, Oxygen saturation decreased, Pallor, Peripheral coldness, Platelet count normal, Pyrexia, Red blood cell count normal, Respiratory distress, Resuscitation, pH body fluid decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (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), Glaucoma (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-27
   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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Congenital aortic stenosis; Left ventricular failure; Pulmonary sequestration; Left ventricular hypertrophy
Preexisting Conditions: Premature baby, pre-term birth 33.4 weeks
Allergies:
Diagnostic Lab Data: Chest x-ray showed nuanced hypodiafania bilateral parenchymal major in the apical right. Thickening right scissurale. 06/27/2015, Alanine aminotransferase, 20 u/L; 06/27/2015, Bilirubin conjugated, 0.7 mg%; 06/27/2015, Blood bicarbonate, -14.2 - -20 --13.9--7.4; 06/27/2015, Blood bilirubin, 1.1 mg%; 06/27/2015, Blood calcium, 5.6 - 5.2 mEq/L; 06/27/2015, Blood chloride, 104 - 105 mEq/L; 06/27/2015, Blood creatinine, 0.3 mg%; 06/27/2015, Blood glucose, 222 - 280 - 134 - 58 mg/dL; 06/27/2015, Blood potassium, 4.6 - 4.8 mEq/L; 06/26/2015, Blood pressure, 91/40 mmHg; 06/27/2015, Blood pressure, 87/55/66 mmHg; 06/27/2015, Blood sodium, 139 - 135 mEq/L; 06/26/2015, Body temperature, 35.6 degree C; 06/27/2015, Body temperature, 38.8 degree C; 06/26/2015, C-reactive protein, 2.1 mg/L; 06/27/2015, Electrocardiogram, sinusal rhythm; 06/27/2015, Haematocrit, 31.7%; 06/27/2015, Haemoglobin, 10 g/dL; 06/2015, Heart rate, 200 beats/min; 06/26/2015, Heart rate, 160 beats/min; 06/27/2015, Heart rate, 190 beats/min; 06/27/2015, Lymphocyte count, 59.8%; 06/27/2015, Neutrophil count, 30.1%; 06/26/2015, Oxygen saturation, 95%; 06/27/2015, Oxygen saturation, 96%; 06/27/2015, PCO2, 33.4 - 54.3 - 59.4 - 44; 06/26/2015, PO2, 133 mmHg; 06/27/2015, PO2, 131 - 45.2 - 48.9 - 41.8 mmHg; 06/27/2015, Platelet count, 431 x10e3/mcL; 06/27/2015, Red blood cell count, 3.96 x10e6/microL; 06/27/2015, pH body fluid, 7.19 - 6.96 - 7.07 - 7.26
CDC Split Type: IT2015GSK096914

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death in a 11-week-old male patient who received INFANRIX HEXA (batch number A21CC279C, expiry date 31st January 2017). Co-suspect products included ROTARIX (batch number AROLB126BA, expiry date 28th February 2017) and PREVENAR 13. The patient''s past medical history included infant premature (pre-term birth 33.4 weeks). Concurrent medical conditions included congenital aortic stenosis, left ventricular overload, pulmonary sequestration and left ventricular hypertrophy. On 17th June 2015, the patient received the 1st dose of INFANRIX HEXA (intramuscular) .5 ml, the 1st dose of ROTARIX (oral) 1 units and the 1st dose of PREVENAR 13 (intramuscular) 1 unit. On 26th June 2015, 9 days after receiving INFANRIX HEXA and ROTARIX, the patient experienced dyspnea, heart rate increased, pallor, cold extremities and halo vision. On 27th June 2015, the patient experienced death (serious criteria death and GSK medically significant) and cardiac arrest (serious criteria death and GSK medically significant). On 27th June 2015, the outcome of the cardiac arrest was fatal and the outcome of the dyspnea, heart rate increased, pallor, cold extremities and halo vision were not recovered/not resolved. On an unknown date, the outcome of the death was fatal. The patient died on 27th June 2015. The reported cause of death was unknown cause of death. The reporter considered the death, cardiac arrest, dyspnea, heart rate increased, pallor, cold extremities and halo vision to be possibly related to INFANRIX HEXA, ROTARIX and PREVENAR 13. Additional information was provided: The Report mentioned that the AEs were not due to the vaccines. Nevertheless, the vaccines were still considered as suspect. The cardiac arrest was at 6:45 on 27 June 2015 after 7 hours of admission. Action Taken were: endotracheal intubation, mechanical ventilation and maneuver of reanimation cardiopulmonary. Follow-up information received on 7 July 2015 from clinical report: The child was born at 33.4 weeks of pregnancy; spontaneous delivery, good condition at birth. Cardio-respiratory monitoring and glycemic control showed hypoglycemia. The umbilical vein was catheterized and 10% glucose solution was given. The glycemic value improved. He underwent phototherapy due to jaundice. Regular growth. Chest XR showed presence of pulmonary sequestration, already diagnosed in utero. Echocardiogram done on 8 April 2015 showed dysplasia and mild stenosis of bicuspid aortic valve. Eco ultrasound on 21 April 2015 showed mild bicuspid aortic valve stenosis (max28mmHG) and mild dilatation of post-stenosis ascending tract. The child was discharged in good clinical condition on 29 April 2015, then regularly visited by the pediatrician. The child was admitted on 26 June 2015 at 11:30 pm. The parents reported that the respiratory distress started around 7 pm. General serious condition, wailing, pallor, hypotonic and hypertrophic muscular mass. Dyspnoea, wheezing and rales. Heart beat 160 bpm, systolic murmur 2/6 Levine. Generalized hypotonia, sensory torpidity, SAT 02 95% blood pressure 91/40, BT 35.6 degree. The child was admitted to neonatal intensive care. The child was placed in incubator in Nasal continuous positive airway pressure (NCPAP) with FiO2 0.25, Sat O2 96-98%, H.R. 190 bpm. Alkalizing therapy (NaHCO3), antibiotic therapy (Ampicillin plus sulbactam and netilmicin) and Sedative therapy (continuous infusion of Fentanyl). At 2am: The child had further worsening of acidosis (ph 6.96, pCO2 54.3, pO2 45.2 mmHG, HCO3 12.1 mmol/l; E.B. -20 mmol/l). Alkalizing therapy was enhanced (continuous infusion NaHCO3 2.5 mEq/h plus additional bolus 10 mEq). Mechanical ventilation, SatO2 96, H.R. 190 bpm. Axillary temperature 38.8 degree. BP 87/55/66 mmHg. The child showed hyperglycemia (280 mg/dl) and a bolus of insulin (0.6 U.I.) was administered. Cardiological Assessment and EKG: The child was in Respiratory Distress, fever (38.5 degree) and bronchospasm in conditions of respiratory acidosis. EKG: sinus rhythm and HR of 200 bpm, signs of left ventricular overload. At 5:08 am: The acidosis improved (Arterial blood gas values). At 6:00 am: sudden crisis of bradycardia (50 bpm) and desaturation. The Actions Taken: cardiopulmonary resuscitation and administration of adrenaline (5 bolus). At 6:45 am: After 45 minutes of cardiopulmonary resuscitation attempts exitus was ascertained. Post mortem electrocardiogram was performed (20 minutes, no electrical activity) and autopsy arranged.


VAERS ID: 585585 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-13
Entered: 2015-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Polymerase chain reaction positive, Respiratory failure, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
SMQs:, Anaphylactic reaction (broad), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (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: No other medications
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date: Nasopharyngeal swab showed a positive polymerase chain reaction for RSV
CDC Split Type: AU2015GSK098860

Write-up: This case was reported in a literature article and described the occurrence of respiratory failure in a adult subject who received 10PN-PD-Dit vaccine. Concurrent medical conditions included lung transplant. On an unknown date, an unknown time after receiving 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included respiratory syncytial virus infection. The subject was treated with ribavirin and prednisolone. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included respiratory syncytial virus infection (unknown). The reported cause of death was respiratory failure. It was unknown if the investigator considered the respiratory syncytial virus infection to be related to 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unknown date: Nasopharyngeal swab showed a positive polymerase chain reaction for RSV. Additional information was provided: This case was reported in a literature article and it described the occurrence of respiratory failure in an adult between 18 and 73 years of age and of unspecified gender who had received an unspecified pneumococcal vaccine and unspecified influenza vaccines (manufacturers unknown). The patient had received the pneumococcal vaccination as preparation for a lung transplant (underlying pathology unspecified). Concurrent immunosuppressive treatment included cyclosporine (monitored using C2 levels or tacrolimus), with prednisolone (0.1-0.15 mg/kg/day) and azathioprine (1-2 mg/kg/day), mycophenolate mofetil or everolimus. Other concurrent medication included routing Pneumocystis jirovecii prophylaxis (either sulfamethoxazole and trimethoprim, or dapsone or inhaled pentamidine if allergic to sulfamides); chlamydia prophylaxis (roxithromycin or azithromycin as tolerated) and cytomegalovirus prophylaxis if considered to be at risk (intravenous ganciclovir or oral valganciclovir). No further details on their medical or family history, concurrent medication or concomitant conditions were provided. On an unspecified date before the transplant, the patient received an unspecified pneumococcal vaccine. On unspecified dates after the transplant, the patient received an annual unspecified influenza vaccine. Dosages were unknown; administration routes and sites were unspecified and batch numbers were not provided. On an unspecified date between December 2011 and May 2014, an unknown period after the pneumococcal vaccination and the transplant, the patient developed symptoms of a lower respiratory tract infection that was identified as a respiratory syncytial virus infection. 235 days after the infection the patient died of respiratory failure. This was a serious case as it was fatal. Cause of death was respiratory failure. It was unknown if a post-mortem was performed. A nasopharyngeal swab taken at the time of the lower respiratory tract infection symptoms and analysed within 24 hours of collection showed a positive polymerase chain reaction for respiratory syncytial virus. Treatment for the respiratory syncytial infection consisted of experimental administration of an intravenous loading dose of ribavirin 33 mg/kg in 3 doses on day 1; followed by a maintenance dose of oral ribavirin at 20 mg/kg divided into 2 doses per day for a minimum of 6 days. The patient was also commenced on an increased dose of oral prednisolone 1 mg/kg (maximum 60 mg/day), that was reduced by 5 mg every second day until the usual baseline dose was reached. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "In conclusion, we present to our knowledge the largest cohort of lung transplant recipients treated with oral ribavirin for respiratory syncytial virus. Oral ribavirin appears to be effective and well-tolerate alternative to intravenous or inhaled ribavirin and provides considerable cost savings and reduction in length of hospital stay. Further studies are required to confirm the optimal dosing strategy and to determine the long-term benefits of ribavirin in preventing the development of chronic lung allograft dysfunction". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 585592 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-05-27
Submitted: 2015-07-09
   Days after onset:43
Entered: 2015-07-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-27
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015224550

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 2-month-old patient of an unspecified ethnicity and gender received PREVENAR 13 on an unspecified date in 2015 at single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced seizure and fever on an unspecified date in 2015, 2-11 hours after pneumococcal 13-val conj vac (dipht crm197 protein) was given. The patient died on 27May2015. Cause of death was not provided. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 585595 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-13
Entered: 2015-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Death, Polymerase chain reaction positive, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
SMQs:, Anaphylactic reaction (narrow), 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), Hypersensitivity (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: No other medications
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date. Nasopharyngeal swab showed positive polymerase chain reaction for RSV.
CDC Split Type: AU2015GSK098863

Write-up: This case was reported in a literature article and described the occurrence of death in a adult subject who received 10PN-PD-Dit vaccine. Concurrent medical conditions included lung transplant. On an unknown date, an unknown time after receiving 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden, the subject developed death. Serious criteria included death and GSK medically significant. Additional event(s) included collapse circulatory with serious criteria of death and GSK medically significant and respiratory syncytial virus infection. The subject was treated with ribavirin and prednisolone. The outcome of death was fatal. The outcome(s) of the additional event(s) included collapse circulatory (fatal) and respiratory syncytial virus infection (unknown). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the death, collapse circulatory and respiratory syncytial virus infection to be related to 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unknown date. Nasopharyngeal swab showed positive polymerase chain reaction for RSV. Additional information was provided: This case was reported in a literature article and it described the occurrence of respiratory syncytial virus infection in an adult between 18 and 73 years of age and of unspecified gender who had received an unspecified pneumococcal vaccine and unspecified influenza vaccines (manufacturers unknown). The patient had received the pneumococcal vaccination as preparation for a lung transplant (underlying pathology unspecified). Concurrent immunosuppressive treatment included cyclosporine (monitored using C2 levels or tacrolimus), with prednisolone (0.1-0.15 mg/kg/day) and azathioprine (1-2 mg/kg/day), mycophenolate mofetil or everolimus. Other concurrent medication included routine Pneumocystis jiroveci prophylaxis (either sulfamethoxazole and trimethoprim, or dapsone or inhaled pentamidine if allergic to sulfamides); chlamydia prophylaxis (roxithromycin or azithromycin as tolerated) and cytomegalovirus prophylaxis if considered to be at risk (intravenous ganciclovir or oral valganciclovir). No further details of their medical or family history, concurrent medication or concomitant conditions were provided. On an unspecified date before the transplant, the patient received an unspecified pneumococcal vaccine. On unspecified dates after the transplant, the patient received an annual unspecified influenza vaccine. Dosages were unknown; administration routes and sites were unspecified and batch numbers were not provided. On an unspecified date between December 2011 and May 2014, an unknown period after the pneumococcal vaccination and the transplant, the patient developed symptoms of a lower respiratory tract infection that was identified as a respiratory syncytial virus infection. The patient collapsed at home 35 days after the infection and died. This was a serious case as it was fatal. Cause of death was unknown. It was not specified if a post-mortem was performed. A nasopharyngeal swab taken at the time of the lower respiratory tract infection symptoms and analysed within 24 hours of collection showed a positive polymerase chain reaction for respiratory syncytial virus. Treatment for the respiratory syncytial infection consisted of experimental administration of an intravenous loading dosage of ribavirin 33mg/kg in 3 doses on day 1; followed by a maintenance dose of oral ribavirin at 20mg/kg divided into 2 doses per day for a minimum of 6 days. The patient was also commenced on an increased dose of oral prednisolone 1 mg/kg (maximum 60 mg/day), that was reduced by 5 mg every second day until the usual baseline dose was reached. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "In conclusion, we present to our knowledge the largest cohort of lung transplant recipients treated with oral ribavirin for respiratory syncytial virus. Oral ribavirin appears to be an effective and well-tolerated alternative to intravenous or inhaled ribavirin and provides considerable cost savings and reduction in length of hospital stay. Further studies are required to confirm the optimal dosing strategy and to determine the long-term benefits of ribavirin in preventing the development of chronic lung allograft dysfunction". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 585596 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-13
Entered: 2015-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Polymerase chain reaction positive, Respiratory failure, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
SMQs:, Anaphylactic reaction (broad), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (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: No other medications
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date. Nasopharyngeal swab showed a positive polymerase chain reaction for RSV
CDC Split Type: AU2015GSK098861

Write-up: This case was reported in a literature article and described the occurrence of respiratory failure in a adult subject who received 10PN-PD-Dit vaccine. Concurrent medical conditions included lung transplant. On an unknown date, an unknown time after receiving 10PN-PD-Dit vaccine and Flu TIV Dresden, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included respiratory syncytial virus infection. The subject was treated with ribavirin and prednisolone. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included respiratory synctial virus infection (unknown). The reported cause of death was respiratory failure. It was unknown if the investigator considered the respiratory failure and respiratory syncytial virus infection to be related to 10PN-PD-Dit vaccine and Flu TIV Dresden. Relevant Tests: Lab tests performed on unknown date. Nasopharyngeal swab showed a positive polymerase chain reaction for RSV. Additional information was provided: This case was reported in a literature article and it described the occurrence of respiratory failure in an adult between 18 and 73 years of age and of unspecified gender who had received an unspecified pneumococcal vaccine and unspecified influenza vaccines (manufacturers unknown). The patient had received the pneumococcal vaccination as preparation for a lung transplant (underlying pathology unspecified). Concurrent immunosuppressive treatment included cyclosporine (monitored using C2 levels or tacrolimus), with prednisolone (0.1-0.15 mg/kg/day) azathioprine (1-2 mg/kg/day), mycophenolate mofetil or everolimus. Other concurrent medication included routine Pneumocystis jiroveci prophylaxis (either sulfamethoxazole and trimethoprim, or dapsone or inhaled pentamidine if allergic to sulfamides); chlamydia prophylaxis (roxithromycin or azithromycin as tolerated) and cytomegalovirus prophylaxis if considered to be at risk (intravenous ganciclovir or oral valganciclovir). No further details on their medical or family history, concurrent medication or concomitant conditions were provided. On an unspecified date before the transplant, the patient received an unspecified pneumococcal vaccine. On unspecified dates after the transplant, the patient received an annual unspecified influenza vaccine. Dosages were unknown; administration routes and sites were unspecified and batch numbers were not provided. On an unspecified date between December 2011 and May 2014, an unknown period after the pneumococcal vaccination and the transplant, the patient developed symptoms of a lower respiratory tract infection that was identified as a respiratory syncytial virus infection. 298 days after the infection the patient died of respiratory failure. This was a serious case as it was fatal. Cause of death was respiratory failure. It was unknown if a post-mortem was performed. A nasopharyngeal swab taken at the time of the lower respiratory tract infection symptoms and analysed within 24 hours of collection showed a positive polymerase chain reaction for respiratory syncytial virus. Treatment for the respiratory syncytial infection consisted of experimental administration of an intravenous loading dose of ribavirin 33 mg/kg in 3 doses on day 1; followed by a maintenance dose of oral ribavirin at 20 mg/kg divided into 2 doses per day for a minimum of 6 days. The patient was also commenced on an increased dose of oral prednisolone 1 mg/kg (maximum 60 mg/day), that was reduced by 5 mg every second day until the usual baseline does was reached. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "In conclusion, we present to our knowledge the largest cohort of lung transplant recipients treated with oral ribavirin for respiratory syncytial virus. Oral ribavirin appears to be an effective and well-tolerated alternative to intravenous or inhaled ribavirin and provides considerable cost savings and reduction in length of hospital stay. Further studies are required to confirm the optimal dosing strategy and to determine the long-term benefits of ribavirin in preventing the development of chronic lung allograft dysfunction". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 586001 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-02
Onset:2015-07-03
   Days after vaccination:1
Submitted: 2015-07-14
   Days after onset:11
Entered: 2015-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR K8487 / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 30054010 / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER K5378 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L03775 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-03
   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: 1st dose BCG, Immunization, No adverse effect, 14-Jul-2015 08:31; OPV, Immunization, No adverse event
Allergies:
Diagnostic Lab Data: 21-MAY-2015, Head circumference, 35; 21-MAY-2015, Length at birth, 49
CDC Split Type: 2015230101

Write-up: This is a spontaneous report from a contactable consumer. A 6-week old male patient received on 02Jul2015 at around 11:00 first dose of PREVENAR 13 (batch/lot L03775 Exp date: Jul2017) at single dose, second dose of OPV (batch K5378 Exp date: Jul2015), first dose of PENTAXIM (batch K8487 Exp date: Oct2016) and first dose of Hepatitis B (batch 305401/0 Exp date: Nov2016), all via an unspecified route of administration. The patient''s concomitant medications were none. Previously on unknown date, patient received BCG and polio vaccine without adverse event. Patient had 3 siblings. The patient was born via vaginal delivery at home, then infant and mother were taken to hospital. Birth weight was 2.96 kg, birth length 49 cm and head circumference 35 cm; gestational age was 38/40 weeks (full term baby) and there were no neonatal problems. Mother was gravida 3, para 3 and she had low hemoglobin after delivery; HIV test during pregnancy was negative. At 3 day post-delivery visit on 25May2015, exclusive breastfeeding, umbilical care and infant to be kept warm were suggested. On 02Jul2015 at 11:00, infant was taken to the clinic for healthy visit and immunization: patient was growing well (his weight was 4.2 kg) and breastfed. No signs of illness were detected and baby received the immunizations as scheduled. According to mother normal routine was followed and patient breastfed after immunizations at 14:00, at 16:00, 20:00, at 24:00 and at 02:00 (when baby was drowsy). Infant slept between feeds. No temperature detected by mother and no medication were given to the infant after immunizations. On 03Jul2015 between 04:00 and 05:00 mother felt that the infant was cold and saw bubbles around the infant''s mouth. The patient passed away on 03Jul2015 at 04:00 and was buried on the 04Jul2015. No symptoms reported by the mother that indicated any problems before death. No treatment given. Outcome and medical diagnosis were undetermined. Autopsy was not done as patient was buried before the death was reported to the clinic. Family notified the clinic of death on the 06Jul2015.


VAERS ID: 586017 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2015-06-20
Onset:2015-06-23
   Days after vaccination:3
Submitted: 2015-07-10
   Days after onset:17
Entered: 2015-07-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC425A / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L39179 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Basophil percentage increased, Blood culture negative, Body temperature increased, C-reactive protein normal, Cardiac arrest, Culture stool negative, Death, Fatigue, Hyperhidrosis, Lumbar puncture normal, Lymphocyte percentage decreased, Monocyte percentage, Neutrophil percentage decreased, Procalcitonin normal, Skin warm, Urine analysis normal, Viral test negative, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant 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), Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-23
   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: Unknown date, Term birth; Unknown date, Breast feeding problem (infant); Unknown date, Gastroesophageal reflux disease; Unknown date, INEXIUM, Gastroesophageal reflux disease; Unknown date, Milk protein allergy; Unknown date, Familial risk factor, int eh mother and in one 4-year-old sister; 13-MAR-2015 to 13-MAR-2015, PREVENAR 13, Immunisation, No adverse event, 1st dose; 13-MAR-2015 to 13-MAR-2015, INFANRIX HEXA, Immunisation, No adverse event, 1st dose
Allergies:
Diagnostic Lab Data: 2015, Basophil count, 51%; 2015, Blood culture, Normal; 23-JUN-2015, Body temperature, 39 Centigrade; 2015, C-reactive protein, Normal; 2015, Culture stool, Negative; 2015, Lumbar puncture, Normal; 2015, Lymphocyte count, 13.7%; 2015, Monocyte count, 2.8%; 2015, Neutrophil count, 26%; 2015, Procalcitonin, Normal; 2015, Urine analysis, Negative; 2015, Viral test, Negative; 2015, White blood cell count, 43600/mm3; Bacteriology work-up (2015): included 2 normal blood cultures.
CDC Split Type: 2015224703

Write-up: This is a spontaneous report obtained from a contactable Health Care Professional through the Agency; regulatory authority report number: FR-AFSSAPS-PC20150328. A 4 month old male patient (height 65 cm, weight 7.69 kg) received the suspect products by intramuscular route, on 20Jun2015: second dose of PREVENAR 13, (Lot. L39179) 0.5 ml, single dose and second dose of INFANRIX HEXA, (Lot. A21CC425A) 1 dose formula (DF), single dose. Relevant medical history included that the patient was born at full term with no neonatal issue, no breastfeeding, digestive tract disorders as gastroesophageal reflux, treated with INEXIUM for several days then discontinued 15 days prior to the event, with adjustment of feeding to a probable intolerance to cow milk protein, no abdominal pain reported for 8 days. Familial situation was the following: psychiatric disorders in the mother, followed in a psychiatry unit on a weekly basis, unknown whether under medication. The infant was the second child of the family: a 4-year-old sister also followed by a child psychiatrist. Numerous visits in mother and child health services and to the pediatrician were reported. Concomitant medications were unknown. Patient''s clinical course was the following: on 13Mar2015, he received the first dose of PREVENAR 13 and INFANRIX HEXA. After the first dose, the patient did not experience any adverse events. On 20Jun2015, the patient received the second dose of the same vaccines. On 23Jun2015, the patient died (unexplained death). No antipyretic drug was administered following vaccination. No fever was reported for 48 hours following vaccination, according to the mother, with no pain on the injection site or grumpiness. On 22Jun2015, the infant presented with fatigue. He was placed in bed at 7 PM and awoke several times during the night (loss of his dummy), he was not hot (body temperature not measured). On 23Jun2015, the infant awoke at 7:15 AM as usual, took his bottle satisfyingly and did not seem to have fever. He played normally and remained awake until 9:30 AM. He was then placed in bed for sleeping, as usual. On 23Jun2015 at 11:30 AM, the infant was found dead in his bed. The mother called the emergency service. Resuscitation failed. No milk rejection was found in the bed, but the infant was hot (sweating). On arrival of the emergency medical service, body temperature was 39 Centigrade while the infant had had cardiac arrest for at least 20 minutes. The mother reported having found the baby lying with his face buried in the bolster, the head half covered with a blanket. He was holding his comforter on his mouth with the blanket over it. Post-mortem laboratory work-up revealed abnormalities of the full blood count: increased white blood cells at 43600/mm3 including 51% of basophils, 2.8% monocytes, 26% neutrophils and 13.7% lymphocytes (results checked by the laboratory). C-reactive protein and procalcitonin levels were normal. Lumbar puncture was normal. Bacteriology work-up included 2 normal blood cultures, negative direct microscopy and culture of urine, negative stool culture. Virology work-up returned negative. No autopsy was performed because of refusal from the mother, possibly due to religious beliefs. Conclusion: unexplained death in a 4-month-old infant, 72 hours following vaccination with INFANRIX HEXA and PREVENAR 13 (second injections). The involvement of the sleeping position leading to suffocation cannot be excluded in this case. However, the high body temperature in the infant (39 centigrade) at the time of rescue arrival (at least 20 minutes after cardiopulmonary arrest), as well as the laboratory disturbances (increased white blood cells with increased basophils) are unusual in cases of unexplained infant death, motivating the reporting of the case. Based on the Official Method of Causality Assessment, the causal relationships between PREVENAR 13 and INFANRIX HEXA and the adverse event, unexplained death, was assessed by the Agency as "doubtful". No Follow-up attempts possible. No further information expected.


VAERS ID: 586022 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-10
Entered: 2015-07-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis bacterial
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015226770

Write-up: This is a spontaneous report from a contactable physician. The physician reported seven cases for different patients. This is the first of seven reports. A patient of unspecified age ethnicity and gender received a single dose of PREVENAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bacterial meningitis, which required hospitalization. The patient died on an unspecified date. It was not reported if an autopsy was performed.


VAERS ID: 586026 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-10
Entered: 2015-07-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015226818

Write-up: This is a spontaneous report from a contactable physician. The physician reported seven cases for different patients. This is one of the seven cases. A patient of unspecified age, ethnicity and gender started to receive PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient developed seizure which lead to hospitalization. The patient died on an unspecified date due to seizure. It was not reported if an autopsy was performed.


VAERS ID: 586360 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-07-08
Onset:2015-07-09
   Days after vaccination:1
Submitted: 2015-07-17
   Days after onset:8
Entered: 2015-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase, C-reactive protein increased, Death, Fall, Injection site swelling, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-09
   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: No other medications
Current Illness: Sinusitis; Bronchitis chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CRP C-reactive protein (09-JUL-2015): Positive; CPK Blood creatine phosphokinase (09-JUL-2015): Positive; 07/09/2015, Body temperature, 37.8 degrees C
CDC Split Type: WAES1507JPN008322

Write-up: Initial information has been received from a physician concerning a 85 year old female patient with bronchitis chronic and sinusitis, who on 08-JUL-2015 was vaccinated subcutaneously with PNEUMOVAX NP injection, 0.5 ml once a day. There was no other concomitant medication reported. From 06-JUL-2015, the patient developed the symptom of bronchitis chronic. On 08-JUL-2015, the patient was vaccinated with PNEUMOVAX NP as she felt well. On 09-JUL-2015, at about 3 o''clock, the patient fell to the ground a few feet away the bed. At about 5 and a half o''clock, emergency response team and police came to investigate and identified the patient as dead. According to the data at the time, rectal temperature was 37.8 celsius degrees, C-reactive protein was positive and creatine phosphokinase was positive, myocardia infarction was suspected. PNEUMOVAX NP injection site swelling was found. The cause of death was the suspicion of myocardial infarction. Autopsy information was not provided. At the time of this report, the outcome of injection site swelling was unknown. The reporter''s comment: "Myocardial infarction was suspected according to the data, and I considered that it was not related to PNEUMOVAX NP". The reporting physician considered that the suspicion of myocardia infarction was serious due to death. The reporting physician did not assessed the seriousness of injection site swelling. The reporting physician felt that the suspicion of myocardial infarction was not related to PNEUMOVAX NP. The reporting physician did not assessed the relationship of injection site swelling PNEUMOVAX NP. Upon internal review myocardial infarction was considered as a medically significant event. No further information is available. Additional information has been requested.


VAERS ID: 586388 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-02-09
Submitted: 2015-07-17
   Days after onset:157
Entered: 2015-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER 0323AE / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bradycardia, Congenital anomaly, Foetal death, Foetal distress syndrome, Foetal exposure during pregnancy, Trisomy 21
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-09
   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: Folic acid; labetalol
Current Illness: Prophylaxis; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507GBR005415

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (E2015-08037) on 10-JUL-2015. Serious case received from the Regulatory Authority on 9/Jul/2015. This case is linked to 1409GBR002566 (E2014-07777) (mother case). This case is medically confirmed. A neonate patient of unreported sex had been exposed in utero to M-M-RVAXPRO, (batch number H018326, Lot number 0323AE (rHA), via transplacental route, administered in the mother before pregnancy on 03/Jun/2014. The patient''s mother experienced a foetal death at 35 weeks of gestation on 9/Feb/2015 described as a full term stillbirth. The patient had trisomy 21 and severe congenital anomalies. The patient experienced fetal distress, bradycardia. At this time of the reporting, the outcome was fatal. The case was considered serious for congenital anomaly reason. The patient''s mother was a 36-year-old female patient, with concomitant treatment including folic acid and labetalol started on 20/May/2014 for high blood pressure, received an injection of M-M-RVAXPRO, (batch number not reported), dose 2, site and route not reported, on 03/Jun/2014. The patient''s mother was susceptible to measles mumps rubella before vaccination. The LMP was 04/Jun/2014. The patient was vaccinated before pregnancy. The patient''s mother had a medical history of dose 1 of M-M-R vaccine (manufacturer unknown, batch number not reported) site and route not reported, on unreported date. The patient''s mother had an acute myeloid leukemia as a child and heart dysfunction. The patient''s mother had one previous full term pregnancy. The patient''s mother had complications during pregnancy described as emergency C-section, pre-eclampsia on 09/Feb/2015. The patient''s mother also experienced anhydramnios on unreported date.


VAERS ID: 586354 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-02
Onset:2015-07-02
   Days after vaccination:0
Submitted: 2015-07-16
   Days after onset:14
Entered: 2015-07-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L48815 / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-07-04
   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: 2013, DTAP, no adverse event; 16-OCT-2014, VAXIGRIP, no adverse event, lot no. L7249
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015232089

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2015041487. A 87-year-old male patient was vaccinated with the first dose of PREVENAR 13, batch number: L48815 at 0.5 ml single, subcutaneous in left upper arm on 02Jul2015. Medical history and concomitant medications were not provided. The patient received DTAP in 2013 and VAXIGRIP; lot no. L7249 on 16Oct2014 and both had been tolerated. On 03Jul2015 the patient developed pneumonia, was hospitalized and condition was considered life threatening. Diagnosis was done at the emergency room. The patient died on 04Jul2015 due to pneumonia. It was not reported whether the autopsy was performed or not. This case was being treated according to the Protection against Infection Act. No follow-up attempts needed. No further information expected.


VAERS ID: 586489 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-20
Entered: 2015-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507ESP008491

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number ES-1577272925-E2015-08215) on 17-JUL-2015. Case received from health care professional, published in a digital media on 13-JUL-2015. Case medically confirmed. An adolescent female patient with none medical history reported, had received an unspecified number of doses of a human papillomavirus vaccine (manufacturer not reported, batch number not reported), route not reported, date of administration not reported, and later (date not reported) she died. According to the newspaper it has not been clarified yet if the event could be a complication of the vaccine or not. No further information was reported.


VAERS ID: 586900 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-06-12
Onset:2015-06-12
   Days after vaccination:0
Submitted: 2015-07-20
   Days after onset:38
Entered: 2015-07-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CB224A / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J74192 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-12
   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: Small for gestational age (Small for dates baby)
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015234235

Write-up: This is a spontaneous report from a physician received via the contactable Regulatory Authority. Regulatory Authority Number GB-MHRA-ADR 23058573. A 2-month-old (10-week-old) female patient of an unspecified ethnicity received first dose of PREVENAR 13 (lot/batch J74192, expiry date Apr2017) at 0,5 ml single in right thigh and first dose of INFANRIX IPV HIB (lot/batch A20CB224A, expiry Apr2017) at 1 DF, in left thigh, both on 12Jun2015. Medical history included small for gestational age. Concomitant medications were not reported. The patient died on 12Jun2015. The reporter did not think it was connected to vaccines, however the baby died approximately 12 hours post vaccinations. The patient was asymptomatic. Provisional post mortem result was unascertained. Autopsy results were not available. Risk factors were present for sudden infant death syndrome (SIDS). The baby was small for gestational age, plus over wrapped. First vaccines were given late due to missed appointments, as reported. The cause of death was reported as death unexplained. No follow-up attempts possible. No further information expected.


VAERS ID: 586908 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-14
Onset:2012-07-16
   Days after vaccination:2
Submitted: 2015-07-22
   Days after onset:1101
Entered: 2015-07-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cerebrovascular accident, Death, Somnolence
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), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-16
   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: Con Meds = None; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Diabetes Mellitus; Hypertension; dyslipoproteinemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA106411

Write-up: Initial unsolicited report received from literature on 16 July 2015. A 76-year-old female patient had received a dose of Influenza vaccine (batch number, route of administration, site of administration were unknown) on 14 July 2012. Patient''s diabetes mellitus (DM), hypertension (HTN) and dyslipoproteinemia (DLP). The patient did not receive concomitant medication. On 16 July 2012; two day after vaccination, the patient developed symptoms of drowsiness, weakness and patient was diagnosed with stroke disease. On 16 July 2012, two day after vaccination, the patient developed symptoms of drowsiness, weakness and patient was diagnosed with stoke disease. On 16 July 2012, patient was found dead. Laboratory investigations were not reported and corrective treatments were unknown. Special tests or treatment required and their result was reported as not applicable. The causality was reported as non-related (unrelated). Documents held by sender: none. Lab tests unknown. Cause(s) of Death: stroke.


VAERS ID: 586909 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-27
Onset:2012-07-27
   Days after vaccination:0
Submitted: 2015-07-22
   Days after onset:1090
Entered: 2015-07-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-27
   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: Con Meds =None; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: COPD-Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA106413

Write-up: Initial unsolicited literature report received from a healthcare professional on 16 July 2015. A 47-year-old female patient had received a dose of Influenza vaccine (batch number, route and site of administration were unknown) on 27 July 2012. Patient''s medical history included COPD (chronic obstructive pulmonary disease) and HTN (hypertension). The patient did not receive any concomitant medication. On 27 July 2012, same day unspecified time after vaccination, the patient was found dead, lonely at home, Laboratory investigations were not reported and corrective treatments were unknown. It was unknown if autopsy performed. Patient died of an unknown cause. The causality was reported as not related (unrelated) to vaccine. Documents held by sender: none. Lab tests unknown. Cause(s) of Death: Unknown cause of death.


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