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VAERS ID: 785546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Bone loss, Breast pain, Bronchitis, Confusional state, Death, Diarrhoea, Dysphagia, Dyspnoea, Ear pain, Face injury, Fall, Fungal infection, Gastrointestinal inflammation, Haemarthrosis, Mucous stools, Nausea, Non-cardiac chest pain, Oesophageal discomfort, Oesophagitis, Osteonecrosis of jaw, Renal cyst, Upper limb fracture, Urinary hesitation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Osteonecrosis (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM; VITAMIN D3; LISINOPRIL; HCT BETA; PANTOPRAZOLE
Current Illness: Aortic valve incompetence; Arrhythmia absoluta; Atrial fibrillation; Essential hypertension; Hypertension arterial; Mitral valve incompetence; Osteoporosis; Senility; Tricuspid incompetence
Preexisting Conditions: Medical History/Concurrent Conditions: Arm fracture; Fall; Flu vaccination
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESANOFIAVENTIS2013SA0376

Write-up: Initial report received on 10-Apr-2013: This case was extracted from the website of the Health Authority (authority number DE-BFARM-13103437), initially reported by a consumer via the regulatory authority (DE-CADRBFARM-2013004808) to the agency. The case involves an 83-year-old female patient who suffered from osteoporosis. In 2004, she fell and broke both arms (hospitalisation for more than three weeks) after a flu vaccination. Concomitant medication was not provided. At an unspecified date, a therapy with ibuprofen (trade name not provided) for unknown indication was started. Additionally, the patient was treated with the following drugs: clodronic acid once weekly for osteoporosis since 01-Jul-2000, alendronate sodium, influenza virus vaccine polyvalent, tetanus toxoid and alendronic acid. On 01-Jan-2005, the patient experienced diarrhoea, confusion, bronchitis, esophagitis, fungal infection, swallowing disorders, dyspnoea, osteonecrosis of jaw, non-cardiac chest pain, ear pain, renal cyst and mucus in stool. Control examinations for bone density were not performed according to the reporter. Action taken concerning the suspect drugs and corrective treatment were not provided. On 22-Jan-2006, the patient died. The causal relationship between the events and suspected drugs were not provided. Additional information received on 22-JUL-2013 by letter. The hospital physician stated that they could not provide the patient''s hospital file, on legal and ethical grounds. Further information will therefore not be available. Additional information regarding this unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 05-Nov-2018 from a Physician via Health Authority under reference DE-EMA-DD-20181030-zaviour_n-110139. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. On 30 Nov 2004, patient received MUTIGRIP (batch number, expiry date were not reported). In 2004, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via oral route. On 28-Nov-2005 she also received a dose of the same vaccine with an unknown batch number via unknown route. On 30-Nov-2004 she also received a dose of the same vaccine with an unknown batch number via oral route. On an unknown patient received Ibuprofen, FOSAMAX Via Oral Route, FOSAVANCE and ALENDRONATE SODIUM via oral route, however stopped on 22 Jan 2006. On an unknown date, patient received TETANOL PUR. On 01-Jul-2000, the patient started taking BONEFOS 1 DF QW oral (with an unknown batch number) for Osteoporosis. As concomitant medication, patient received Calcium Brause, Vitamin D3, Lisinopril, Hct Beta, and Pantoprazole. Patient''s ongoing medical history included: Hypertension arterial, Osteoporosis, Mitral valve incompetence, Atrial fibrillation, Arrhythmia absoluta, Senility, Tricuspid incompetence, Aortic valve incompetence, Essential hypertension. As previous vaccination, patient received TETANUS VACCINE on 07-Feb-1997. It was also a case of actual medication error due to wrong route of administration (Both vaccines were given via oral route). On 05-DEC-2005, 5 years 5 months 4 days post vaccination, patient developed events Bacterial pneumonia, Injury in face, Common Cerebri, Swelling at right knee, Chest ache, Vomiting once, Wound at forehead and eyebrow, Heamatoma at right knee, Colitis. On 15-DEC-2005, 5 years 5 months 14 days post vaccination, patient developed events Dyspnoea. On 01-JAN-2005, 4 years 6 months post vaccination, patient developed events Respiratory distress, Breast pain, Fall, Oesophageal discomfort, Bone loss in jaw, mucus in stool, Renal cyst, Ear pain, esophagitis, Fungal infection NOS, chest pain (non-cardiac), swallowing disorder, dyspnea, Osteonecrosis of jaw, Bronchitis, Confusional state, Diarrhoea, this events assessed as death. Acute respiratory insufficiency this event assessed as medical significant. On an unknown date, patient developed non-serious Gastroenteritis non-infectious NOS, Joint hematoma, Nausea, Urinary hesitancy. Autopsy was not performed. Causes of death was reported as Confusion, Face injury, Commotio cerebri, Dyspnea, Joint hematoma, Renal cyst, Oesophageal discomfort, Swelling of R knee, Chest pain, Breast pain, Mucous stool, Esophagitis, Bone loss in jaw, Chest pain (non-cardiac), Bacterial pneumonia, unspecified, Fungal infection NOS, Vomiting, Swallowing disorder, Ear pain, Diarrhea, Osteonecrosis of jaw, Respiratory distress, Bronchitis, fall, Wound. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Sender''s Comments: Medical comment: Based on review of available reported data does not allow for a proper causality assessment. Causality cannot be completely assessed due to limited information. MAC for ibuprofen: The review of available reported data does not allow for a proper causality assessment of the role of ibuprofen for reported events due to limited information. Sender''s Comments: Follow-up information received on 05-Nov-2018 changes the previous company assessment as follows: This case concerns a 83 years old female patient who died after presented with Bronchitis, Osteonecrosis of jaw, Non-cardiac chest pain, Oesophagitis, Renal cyst, Mucous stools, Face injury, Concussion, Haemarthrosis, Oesophageal discomfort, Respiratory distress, Pneumonia bacterial, Haemarthrosis, Acute respiratory failure, Urinary hesitation and other symptoms. Post intake of Tetanus Toxoid, Influenza Vaccine, MUTAGRIP along with other non-company suspects. Concomitant therapies included Ibuprofen, Vitamin D3, Lisinopril, Hct Beta, Pantoprazole. Time to onset is too long to be compatible. Autopsy was not performed although cause of death suggestive of death due to Confusion, Face injury, Commotio cerebri, Dyspnea, Joint hematoma, Renal cyst, Oesophageal discomfort, Swelling of R knee, Chest pain, Breast pain, Mucous stool, Esophagitis, Bone loss in jaw, Chest pain (non-cardiac), Bacterial pneumonia, unspecified, Fungal infection NOS, Vomiting, Swallowing disorder, Ear pain, Diarrhea, Osteonecrosis of jaw, Respiratory distress, Bronchitis, fall, Wound. Patient had multiple ongoing medical conditions which give suspicion of progression of the events. For a precise causality assessment, detailed descriptions of the events along with autopsy and lab results are needed. Based on available information the role of individual suspects cannot be assessed. Reported Cause(s) of Death: Bacterial pneumonia, unspecified; Fungal infection NOS; Vomiting; Swallowing disorder; Ear pain; Diarrhea; Osteonecrosis of jaw; Respiratory distress; Bronchitis; Fall; Wound; Breast pain; Face injury; Brain disorder NOS; Joint hematoma; Oesophageal.


VAERS ID: 785553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Malignant atrophic papulosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GT0095075131811GTM004348

Write-up: This spontaneous report was received from a physician via company representative regarding a female child of unknown age. The patient was not pregnant. The patient''s medical history and concomitant medications were not reported. Her concurrent condition included "Degos Disease". On an unknown date, the patient was vaccinated with a dose of GARDASIL (route, frequency, lot# and expiration date unknown) for prophylaxis. On an unknown date, the patient died. Cause of death was not reported. It was unknown if autopsy was performed. Despite there was no relation at all with the vaccination, several parents and doctors had recommended that the patient''s death occurred due to the vaccine administration. It was reported that the patient was not hospitalized. The reporting physician who was not the patient''s pediatrician mentioned that two patients (unspecified) who had to start vaccination scheme this week, desisted due to the rumors. The reporter assessed the event to be related with the GARDASIL. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 785768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Disease progression, Leukaemia
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131811GRC003149

Write-up: This spontaneous report was received from a Pediatrician, via a company representative, and refers to an adolescent female patient of unknown age (age reported as "12-13 years old"). No information was provided regarding the patient''s medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In approximately 2013, (reported as "4-5 years ago"), the patient was vaccinated with her first dose of GARDASIL injection (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. In approximately 2013, (reported as "one month later"), the patient was diagnosed with leukaemia. In approximately 2015, (reported as "two years later"), the patient deceased due to progression of leukaemia. It was unknown if an autopsy was performed or not. The reporter considered the patient''s leukaemia and subsequent death as not related to GARDASIL. Upon internal review, the patient''s leukaemia was determined to be a medically significant event. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL vaccine and the reported event leukemia cannot be established. Information regarding time to onset, patient''s medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications, detailed clinical course are not provided and would be relevant for further assessment. Company Comment- No changes to the GARDASIL product safety information are warranted at this time. Merck and Co., Inc., known as MSD, continues to monitor the safety profile of the product. Reported Cause(s) of Death: progression of leukaemia.


VAERS ID: 785896 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-02
Onset:2018-10-05
   Days after vaccination:3
Submitted: 2018-11-13
   Days after onset:39
Entered: 2018-11-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251703B1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute hepatic failure, Alanine aminotransferase, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood creatine increased, Death, Malaise
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-17
   Days after onset: 12
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: Metformin; Memantine; CALCICHEW; Docusate
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12-OCT-2018, Alanine aminotransferase, 833, elevated; 14-OCT-2018, Alanine aminotransferase, 1473, elevated; 12-OCT-2018, Blood alkaline phosphatase, 139, elevated; 14-OCT-2018, Blood alkaline phosphatase, 174, elevated; 12-OCT-2018, Blood bilirubin, 31, elevated; 14-OCT-2018, Blood bilirubin, 81, elevated; 12-OCT-2018, Blood creatine, 159, elevated; 14-OCT-2018, Blood creatine 252, elevated
CDC Split Type: 201805183

Write-up: This spontaneous case, reported by pharmacist to regulatory authority and initially retrieved on 05-Nov-2018 by Seqirus from regulatory authority (regulatory reference number: GB-MHRA-MIDB-66784cac-dea7-4c53-8752-1376963b4c04), concerns an 81-year-old, elderly female patient. The patient''s concomitant medications included metformin, memantine, CALCICHEW and Docusate for unknown indications. On 02-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, batch number: 251703B1A (reported as 251703BIA), anatomical location and expiry date: not reported]. On 05-Oct-2018, 3 days after vaccination, the patient was unwell and was diagnosed with fulminant hepatic failure. On an unspecified date in Oct-2018, the patient was hospitalized. On 12-Oct-2018, the patient''s alanine aminotransferase was 833, alkaline phosphatase was 139, billrubin was 31 and creatine was 159 (units not reported) which showed elevated. On 14-Oct-2018, the patient''s alanine aminotransferase was 1473, alkaline phosphatase was 174, bilirubin was 81 and creatine was 252 (units not reported) which showed elevated. On 17-Oct-2018, the patient died. The patient''s cause of death was reported as fulminant hepatic failure and it was unknown whether autopsy was performed. The outcome of the events unwell was unknown, at the time of death. The reporter assessed the case as serious (death and hospitalization). Case Comment: An 81-year-old female patient experienced malaise and fulminant hepatic failure, 3 days after receipt of FLUAD (TIV) vaccine. The company assesses the causality for malaise as related due to plausible temporal relationship between vaccination and reported malaise. The company assesses the causality for acute hepatic failure as not related as there is no established evidence to suggest the causal role of suspect vaccine. However, acute hepatic failure might have contributed to the event malaise. At a later date, patient also experienced abnormal increase in liver enzymes such as alanine aminotransferase, alkaline phosphatase, bilirubin and raised serum creatinine which can be explained alternately by acute hepatic failure and hence company assesses the causality as not related.


VAERS ID: 786188 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-07
Onset:2018-11-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiovascular disorder, Death, Goitre, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-07
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUPFIZER INC2018462380

Write-up: The initial case was missing the following minimum criteria: reporter has no firsthand knowledge of the event. Upon receipt of the follow-up information on 08Nov2018, case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and consumer. A 2-month-old female received PREVENAR 13, via an unspecified route of administration in the morning of 07Nov2018 at a single dose for regular vaccination from pneumococcal infection. The patient''s medical history and concomitant medications were not reported. The patient previously received BCG-m plus HBV (1) at the maternity hospital and HBV (2) at a month age both for immunization. There were no post-vaccination reactions reported. The patient was regularly reviewed by a neurologist at one month time - no paralogues revealed. On 07Nov2018, it was reported that after vaccination, the patient was left by the mother with the father. While waiting in the car for about 1,5 hours, the father noticed that the patient was not breathing. The patient was delivered to the nearest clinic. The patient died on 07Nov2018. An autopsy was performed however results were not provided. The causes of death were reported as sharp decentralization of blood circulation, thymomegalia of grade 3, no signs of anaphylaxis revealed and working concussion were sudden death syndrome. Information on the batch number has been requested. Sender''s Comments: Based on available limited information, there is not a reasonable possibility that the reported events SIDS, thymomegalia and circulatory collapse are related to the suspect product. Case reevaluated up additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Reported Cause(s) of Death: sudden death syndrome; sharp decentralization of blood circulation. Thymomegalia of grade 3, no signs of anaphylaxis revealed; thymomegalia of grade 3.


VAERS ID: 786529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Lyssavirus test positive, Polymerase chain reaction, Rabies
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: Exposure to communicable disease (exposed to rabies infection, following at-risk contact with a dog presumed to be rabid).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 1997; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: FRGLAXOSMITHKLINEFR2018GS

Write-up: This case was reported in a literature article and described the occurrence of rabies in a adult subject who received Rabies Vaccine for prophylaxis. Concurrent medical conditions included exposure to communicable disease (The patient was exposed to rabies infection, following at-risk contact with a dog presumed to be rabid). On an unknown date, less than a month after receiving Rabies Vaccine, the subject developed rabies. Serious criteria included death and GSK medically significant. The outcome of rabies was fatal. The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the rabies may have been caused by Rabies Vaccine. Relevant Tests: Lab tests were performed on unspecified dates. The laboratory technique used for intra-vitam diagnosis of human rabies infection in patient was RT-hnPCR on CSF and saliva. The patient was diagnosed and reported with human rabies infection. Diagnostic results (unless otherwise stated, normal values were not provided): In 1997, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the human rabies infection in a patient aged between 50 and 54 years of unspecified gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. The patient was exposed to rabies infection, following at-risk contact with a dog presumed to be rabid. [In this study, 6 of 7 cases laboratory confirmed rabies cases were males, 6 of the 7 cases did not seek medical attention, reflecting a lack of awareness about rabies]. No information on patient''s medical or family history or concomitant medication was provided. On an unspecified date, the patient had received unspecified rabies vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The patient was not administered rabies immunoglobulin (RIG). The age of vaccination was not provided. On an unspecified date in 1997, an unknown period after vaccination, the patient developed symptoms of human rabies infection. The incubation period was 12 days. The duration of clinical symptoms was 14 days. [In this study, cases were defined as individuals whose infection was laboratory-confirmed and who were residents. The laboratory techniques used for intra-vitam diagnosis of human rabies were those recommended by World Health Organization (WHO): heminested and real-time reverse transcription polymerase chain reaction (RT-hnPCR and RT-qPCR, respectively) and virus genotyping by Sanger sequencing in saliva, skin biopsy or cerebrospinal fluid (CSF), and potentially, detection of rabies antibodies by rapid fluorescent focus inhibition test (RFFIT) or enzyme linked immunoassay (ELISA) test in serum or CSF. For post-mortem diagnosis of human rabies, fluorescent antibody test (FAT) was used on brain biopsy as well as rabies tissue culture infectious test (RTCIT) using murine neuroblastoma cells and detection of viral ribonucleaic acid (RNA) by RT-hnPCR or RT-qPCR]. The laboratory technique used for intra-vitam diagnosis of human rabies infection in patient was RT-hnPCR on CSF and saliva. The patient was diagnosed and reported with human rabies infection. On an unspecified date, the patient died. It was unknown if an autopsy was performed. This case has been considered as serious due to death. Treatment was unknown. The author did not comment on the event of human rabies infection and unspecified rabies vaccine. The authors concluded, "Healthcare professionals'' perception of rabies risk is slowly changing. The risk of being infected is extremely low or even negligible in mainland and rabies is now perceived as a threat only if exposure takes place outside this western country. The decline of PEP administration over the past 22 years illustrates the growing understanding of the changing risk by both the public and healthcare professionals. However, adapting medical practice to the actual rabies risk is a long and difficult process, in the field of potentially lethal and rare communicable diseases, especially in the absence of any active curative treatment. Information and education are needed at different levels to allay patients'' and healthcare professionals'' unjustified concerns and emphasize real risks. Firstly, healthcare professionals would greatly benefit from validated guidelines at a national level to support their efforts to adjust rabies risk assessment to new epidemiological data and to focus on the most important risks: exposure in endemic areas, exposure to imported animals and exposure to bats. Targeted communication about the risk of rabies and preventive measures to travelers to a few countries could have a notable effect on the number of PEP courses delivered in this western country and could contribute to saving lives". Lab Comments: Lab tests were performed on unspecified dates. The laboratory technique used for intra-vitam diagnosis of human rabies infection in patient was RT-hnPCR on CSF and saliva. The patient was diagnosed and reported with human rabies infection. Reported Cause(s) of Death: rabies.


VAERS ID: 786532 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2018-08-22
Onset:2018-08-01
Submitted: 0000-00-00
Entered: 2018-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS RT005 / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Autopsy, Death, Vomiting
SMQs:, Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPGLAXOSMITHKLINEJP2018JP

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of asphyxia in a 3-month-old male patient who received ROTARIX liquid formulation (batch number RT005, expiry date unknown) for prophylaxis. Concomitant products included ROTARIX liquid formulation, ACTHIB, PREVENAR 13, HEPTAVAX-II and DIPHTHERIA TOXOID + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (SQUAREKIDS). On 22nd August 2018, the patient received the 2nd dose of ROTARIX liquid formulation (oral). In August 2018, 1 day 8 hrs after receiving ROTARIX liquid formulation, the patient experienced asphyxia (serious criteria death and GSK medically significant), vomit aspiration (serious criteria GSK medically significant) and vomiting. On 23rd August 2018 08:00, the outcome of the asphyxia was fatal. On an unknown date, the outcome of the vomit aspiration and vomiting were unknown. The patient died on 23rd August 2018. An autopsy was performed. The autopsy determined cause of death was asphyxia. The reporter considered the asphyxia, vomit aspiration and vomiting to be unrelated to ROTARIX liquid formulation. Additional Details The subject''s temperature before vaccination was unknown. The subject had no family history. Points requiring caution in the vaccination screening questionnaire were unknown. The subject''s birth weight was 3105g. On 22 August 2018, the subject received ROTARIX. The lot number was RT005. On 23 August 2018, around 8:00 (estimated time), he died during sleep. An autopsy revealed that he vomited the gastric contents and accidentally swallowed the vomit. The reporter considered the events were not related to the vaccination. It was determined that he was suffocated to death. The reporter considered the death was accidental and unrelated to the vaccination.; Autopsy-determined Cause(s) of Death: Asphyxia.


VAERS ID: 786544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-06-20
Onset:2015-06-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-16
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: Other       Purchased by: ?
Symptoms: Allergy test positive, Basophil percentage increased, Blood culture negative, Body temperature increased, C-reactive protein normal, Cardiac arrest, Culture stool negative, Culture urine negative, Death, Fatigue, Hyperhidrosis, Lumbar puncture normal, Lymphocyte percentage decreased, Middle insomnia, Monocyte percentage, Neutrophil percentage decreased, Procalcitonin normal, Resuscitation, Rubella antibody positive, 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), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (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: Medical History/Concurrent Conditions: Breast feeding problem (infant); Familial risk factor (father''s sister: sudden infant death; mother and bigger sister: psychiatric disorders); Gastroesophageal reflux disease; Milk protein allergy (milk from NOVALAC ALLERNOVA was initiated and symptoms improved); Term birth (with no neonatal issue)
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Allergy test; Result Unstructured Data: Test Result: positive to cow''s milk protein; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Basophil count; Test Result: 51 %; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Blood culture; Result Unstructured Data: Test Result: Normal, twice; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 20150623; Test Name: Body temperature; Result Unstructured Data: Test Result: 39, Test Result Unit: Centigrade; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: C-reactive protein; Result Unstructured Data: Test Result: Normal; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Stool culture; Result Unstructured Data: Test Result: Negative; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Lumbar puncture; Result Unstructured Data: Test Result: Normal; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Lymphocyte count; Test Result: 13.7 %; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Monocyte count; Test Result: 2.8 %; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Neutrophil count; Test Result: 26 %; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Procalcitonin; Result Unstructured Data: Test Result: Normal; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Rubella antibody test; Result Unstructured Data: Test Result: positive; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Urine analysis; Result Unstructured Data: Test Result: Negative; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: Viral test; Result Unstructured Data: Test Result: Negative; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.; Test Date: 2015; Test Name: White blood cell count; Result Unstructured Data: Test Result: 43600, Test Result Unit: /mm3; Comments: Bacteriology work-up (2015): included 2 normal blood cultures.
CDC Split Type: FRPFIZER INC2015224703

Write-up: This is a spontaneous report obtained from a contactable Health Care Professional through the National Health Products Safety Agency (ANSM). The regulatory authority report number is FR-AFSSAPS-PC20150328. A 4-month-old male patient received the second dose of PREVENAR 13 (lot number: L39179), 0.5 ml, single dose; and second dose of INFANRIX HEXA (lot number: A21CC425A), at 1 dose formula (DF), single dose; both via intramuscular route, on 20Jun2015, as immunization. The patient was born at full term with no neonatal issue, no breastfeeding. Relevant medical history included digestive tract disorders as gastroesophageal reflux, treated with esomeprazole magnesium (INEXIUM) for several days then discontinued 15 days prior to the event, with adjustment of feeding to a probable intolerance to cow milk protein. Diallertest returned positive result (allergy test to cow''s milk protein). Thus, milk was initiated and symptoms improved. No abdominal pain was reported for 8 days. Family history included the following: the patient''s father who was born in 1972 had a little sister who died from sudden infant death at the age of 6 months. The mother had psychiatric disorders for which she was followed in a psychiatry unit on a weekly basis, unknown whether under medication. The patient''s big sister aged of 4 years old was not sick within the days prior to the patient''s death. She was also followed by a child psychiatrist. Numerous visits in mother and child health services and to the pediatrician were reported. The patient was up-to-date regarding BCG and ROTARIX vaccinations. Concomitant medications were unknown. On 13Mar2015, he received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) and diphtheria vaccine, haemophilus influenza type b vaccine, hepatitis b vaccine, pertussis vaccine, polio vaccine, tetanus vaccine. After the first dose, the patient did not experience any adverse events. During consultation, the pediatrician noted that the newborn had satisfying growth with a very correct weight gain and normal psychomotor development. The newborn started to turn himself from the abdomen to the back. No antipyretic drug was administered following the second 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. Post-mortem laboratory work-up included positive rubella serology. 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 diphtheria vaccine, haemophilus influenza type b vaccine, hepatitis b vaccine, pertussis vaccine, polio vaccine, tetanus vaccine and pneumococcal 13-val conj vac (dipht crm197 protein) (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) were 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 pneumococcal 13-val conj vac (dipht crm197 protein) and diphtheria vaccine, haemophilus influenza type b vaccine, hepatitis b vaccine, pertussis vaccine, polio vaccine, tetanus vaccine and the adverse event, unexplained death, was assessed by the Agency as "doubtful". Investigational result concluded that all investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the batch records, the release results are deemed satisfactory. The batch met all criteria for the market and was QP released. No issues impacting the identity, strength, purity or quality of the products were identified during the technical evaluation. The complaint is unconfirmed as no root cause has been identified by the Global Safety team. The manufacturing site will continue to monitor this drug product lot. No follow-up attempts possible. No further information expected. Follow-up (15Jul2015): New information received from ANSM includes: medical history and familial situation details, clinical course, lab test. No follow-up attempts possible. No further information expected. Follow-up (12Aug2015): New information from Product Quality Complaints includes: Investigation result from the manufacturing site for bulk and interim lot H38801 and final lot L39179. No follow-up attempts possible. No further information expected. Follow-up (12Nov2018): New information downloaded from the Medicines Agency (MA) WEB FR-EMA-DD-20181101-roy_s-122004, includes: new case identifiers and patient''s information updated. SENDER COMMENT: This case is a master made from existing duplicates in database by the MA duplicate management team. The case numbers of the underlying duplicates are in the Other Case Identifiers section. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : 2015224703 Legacy paper report number; Reported Cause(s) of Death: Death unexplained.


VAERS ID: 786869 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-19
Onset:2018-10-19
   Days after vaccination:0
Submitted: 2018-11-16
   Days after onset:28
Entered: 2018-11-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 1030C1A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Wheelchair user; COPD
Preexisting Conditions: Flu jab, product used for unknown indication, previously the patient had flu jab for many years
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201805357

Write-up: This spontaneous case, initially received from a pharmacist on 12-Nov-2018, concerning an 81-year-old, elderly, female patient. The patient received flu jab for many years in past. The patient''s current condition included chronic obstructive pulmonary disease (COPD) (since an unspecified date). It was reported that, the patient brought by someone on a wheelchair for a flu jab. The patient had been trying to administer a flu jab but her surgery (unspecified) could not offer her until 31-Oct-2018 (as reported). On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 1030C1A, dose, route of administration, anatomical location and expiry date: not reported]. The patient was given all advice if she felt unwell and also patient information leaflet (PIL) was given. The patient waited in pharmacy to ensure no adverse effects. It was reported the following morning that, the patient died in her sleep in previous night. The cause of death and autopsy results were unknown. The reporter assessed the case as serious (death). Case Comment: A 81-year-old female patient with current condition of chronic obstructive pulmonary disease (COPD), was reported to have died in sleep the same night of vaccination with FLUAD (TIV). Considering the minimal information regarding medical history, signs/symptoms leading to death, cause of death and autopsy reports, the causal role of suspect vaccine cannot be assessed. Hence, the company assessed the causality as unassessable.


VAERS ID: 786735 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse reaction, Cerebrovascular accident, Death, Multiple sclerosis, Noninfective encephalitis, Seizure, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131811JPN005045

Write-up: This non-valid report has been received from other reporter who post in social media, via a vendor, concerning an unknown number of patients of unspecified age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. In 2013, the patients started therapy with GARDASIL (strength, dose, anatomical location, lot number, route of administration expiration date and indication were not reported). On unspecified dates, the patients experienced adverse reaction including seizures, brain inflammation, lupus, multiple sclerosis, strokes and death (death causes were unknown). At the time of report, the outcome of the patients regarding seizures, brain inflammation, lupus, multiple sclerosis, strokes was unknown and the causal relationship between all afore mentioned adverse events with GARDASIL was considered as related. Upon internal review seizures, brain inflammation, lupus, multiple sclerosis and strokes are considered medically significant events. Reported Cause(s) of Death: Death.


VAERS ID: 786739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-31
Onset:2018-10-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 2011116 / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 090318 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Gastritis, Gastrointestinal infection, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUPFIZER INC2018468530

Write-up: This is a spontaneous report obtained from a non-contactable Health Care Professional through Local regulatory authority; regulatory authority report number 186763. A 2-month-old female patient received, on 31Oct2018, PREVENAR 13, (Lot. 090318) at single dose; and hepatitis B vaccine (Lot. 201-1116); both for immunization. Relevant medical history and concomitant medications were unknown. On 31Oct2018, the patient experienced acute gastritis, gastrointestinal tract infection and vomiting that were considered fatal. Hospitalization was also required. The patient died on 01Nov2018. It was not reported if an autopsy was performed. Reported Cause(s) of Death: death cause unknown; Acute gastritis; Gastrointestinal tract infection; Vomiting.


VAERS ID: 786926 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-12
Onset:2010-03-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-11
   Days after onset: 88
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 17-year-old female subject who received Rabies Vaccine for prophylaxis. On 15th March 2010, 3 days after receiving Rabies Vaccine, the subject developed acute disseminated encephalomyelitis. Serious criteria included death and GSK medically significant. The outcome of acute disseminated encephalomyelitis was fatal on 11th June 2010. The subject died on 11th June 2010. The reported cause of death was acute disseminated encephalomyelitis. The investigator considered the acute disseminated encephalomyelitis to be possibly related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 17-year-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis. The patient was a part of study that analysed the correlation between death cases and vaccination from 2009 to 2017, and provided reference for improving the safety of vaccination. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On 12 March 2010, the patient received 5th dose of rabies vaccine (administration route and site unspecified, batch number not provided). It was reported that all vaccines were inoculated within the validity period, and the purchase, transportation and storage of vaccines were complied with relevant regulations, and the vaccination units and personnel had relevant qualifications, and the vaccination procedures and vaccination process were in accordance with the "Standards for Vaccination Work". On an unspecified date, 3 days after vaccination, the patient developed acute disseminated encephalomyelitis. In this study, the abnormal events following inoculation (AEFI) was classified as abnormal reaction. On an unspecified date, 91 days after vaccination, the patient died. It was unknown if an autopsy was performed. The author commented, "In the 7 death cases, 4 cases were vaccinated with rabies vaccine, which occurred after 3-5 doses of vaccination, including 2 cases of abnormal reactions clinically diagnosed with acute disseminated encephalomyelitis, and it could not be ruled out that the death was related to vaccination with rabies vaccine." The author concluded, "in order to improve the safety of vaccination, the registrars and vaccinators should double check the health conditions of the recipients. Particularly, recipients possibly in an infection period of certain diseases should be treated cautiously so as to reduce the occurrence of coincidence and prevent the abnormal reaction of vaccination. Parents should pay close attention to children''s health after vaccination, and strengthen the care of children to prevent accidents such as asphyxia. Vaccination outpatient should reported the death event following inoculation in time, and try to persuaded the family members to consent the autopsy if the death cause is not clear, so as to reduce the occurrence of medical disputes." This is 1 of the 2 valid cases reported in same literature article. The article corresponding to this case is not available for regulatory submission due to copyright restriction. Reported Cause(s) of Death: Acute disseminated encephalomyelitis.


VAERS ID: 786927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-19
Onset:2010-04-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 4-year-old male subject who received Rabies Vaccine for prophylaxis. On 22nd April 2010, 3 days after receiving Rabies Vaccine, the subject developed acute disseminated encephalomyelitis. Serious criteria included death and GSK medically significant. The outcome of acute disseminated encephalomyelitis was fatal on 24th April 2010. The subject died on 24th April 2010. The reported cause of death was acute disseminated encephalomyelitis. The investigator considered the acute disseminated encephalomyelitis to be possibly related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 4-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis. The patient was a part of study that analysed the correlation between death cases and vaccination from 2009 to 2017 and provided reference for improving the safety of vaccination. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On 19 April 2010, the patient received 3rd dose of rabies vaccine (administration route and site unspecified, batch number not provided). It was reported that all vaccines were inoculated within the validity period, and the purchase, transportation and storage of vaccines were complied with relevant regulations, and the vaccination units and personnel had relevant qualifications, and the vaccination procedures and vaccination process were in accordance with the "Standards for Vaccination Work". On an unspecified date, 3 days after vaccination, the patient developed acute disseminated encephalomyelitis. In this study, the abnormal events following inoculation (AEFI) was classified as abnormal reaction. On an unspecified date, 5 days after vaccination, the patient died. It was unknown if an autopsy was performed. The author commented, "In the 7 death cases, 4 cases were vaccinated with rabies vaccine, which occurred after 3-5 doses of vaccination, including 2 cases of abnormal reactions clinically diagnosed with acute disseminated encephalomyelitis, and it could not be ruled out that the death was related to vaccination with rabies vaccine." The author concluded, "in order to improve the safety of vaccination, the registrars and vaccinators should double check the health conditions of the recipients. Particularly, recipients possibly in an infection period of certain diseases should be treated cautiously so as to reduce the occurrence of coincidence and prevent the abnormal reaction of vaccination. Parents should pay close attention to children''s health after vaccination, and strengthen the care of children to prevent accidents such as asphyxia. Vaccination outpatient should reported the death event following inoculation in time, and try to persuaded the family members to consent the autopsy if the death cause is not clear, so as to reduce the occurrence of medical disputes." This is 1 of the 2 valid cases reported in same literature article. The article corresponding to this case is not available for regulatory submission due to copyright restriction. Reported Cause(s) of Death: Acute disseminated encephalomyelitis.


VAERS ID: 787037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131811GBR006658

Write-up: This spontaneous report was received from a consumer regarding female patients of unknown age. The reporter stated that an article was published regarding a short film on manufacturing of HPV crisis in which the documentary exposed cases of severe adverse reactions experienced by girls who received doses of HPV vaccines GARDASIL and CERVARIX. Patients'' historical condition/drugs, concurrent condition and concomitant drugs were unknown. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, lot# and expiration date were unknown). Other suspect therapy included CERVARIX (strength, dose, frequency, lot# and expiration date were unknown) for unknown indication. The recorded adverse reactions in the film included severe disability, paralysis and even death. It was unknown if autopsy was performed or not. Outcome of disability and paralysis was unknown. All the events were reported to be related to GARDASIL and CERVARIX. Upon internal review, the events disability and paralysis were considered to be medically significant. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 787167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-08
Onset:2018-11-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N3L792V / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH PAA012800 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB973AG / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201820

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of unknown cause of death in a 3-month-old male patient who received Rotarix liquid formulation (batch number AROLB973AG, expiry date unknown) for prophylaxis. Co-suspect products included HEXYON (batch number N3L792V, expiry date unknown) for prophylaxis and PREVENAR (batch number PAA012800, expiry date unknown) for prophylaxis. On 8th November 2018, the patient received Rotarix liquid formulation (oral) 1.5 ml, HEXYON (intramuscular) .5 ml and PREVENAR (intramuscular) .5 ml. On 10th November 2018, 2 days after receiving Rotarix liquid formulation, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 10th November 2018, the outcome of the unknown cause of death was fatal. The patient died on 10th November 2018. 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 liquid formulation. Additional information: The age at vaccination was not reported. However the patient could be 2 or 3 months old at time of vaccination. The batch number of Rotarix was reported as AR0LB973AG. However upon batch number review it was corrected to AROLB973AG. It was unknown if the reporter considered the unknown cause of death to be related to HEXYON and PREVENAR. Initial information was received from consumer via regulatory authority on 19th November 2018: Died. Reporter''s comments: 2 days after vaccination, the patient was found dead. Sender''s comments: None. Notes: The time between drug administration and start of reaction was reported as 3 days in source document. However it was taken as per reported event onset and vaccination dates. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 787458 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Rotavirus test; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown
CDC Split Type: SZGLAXOSMITHKLINEZA2018GS

Write-up: This case was reported by a other health professional and described the occurrence of vaccination failure in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and diarrhea rotavirus (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus was fatal. The reported cause of death was diarrhea rotavirus. It was unknown if the reporter considered the vaccination failure and diarrhea rotavirus to be related to ROTARIX. Additional information received as follows: The reporter was on an assignment working with Expanded Programme on Immunization (EPI) at Ministry of Health (MoH). The EPI were responsible of surveillance and the team was involved in the investigation case of diarrhoea resulting in deaths in a few weeks. This information was not public. The reporter was informed GlaxoSmithKline because ROTARIX was the vaccine used in the country and some specimens contain strains from the vaccine. Investigations were ongoing. No conclusion was received till the reporting time. On an unknown date, the patient''s Rotaviris test was resulted positive. This case was considered as a suspected vaccination failure case as the vaccination schedule of ROTARIX and time to onset of diarrhea rotavirus were unknown. Lab Comments: On an unknown date, the patient''s Rotaviris test was resulted positive.; Reported Cause(s) of Death: Diarrhea rotavirus.


VAERS ID: 787728 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-16
Onset:2018-10-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N035532 / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Respiratory arrest, Sudden death, 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), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-18
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131811DEU007378

Write-up: This spontaneous report was received from a physician via company representative, and refers to an approximately 3 month old male patient, with no known concomitant diseases. The patient''s medical history and concomitant medications were not reported. On 16-OCT-2018, the patient was vaccinated with VAXELIS, lot # N035532 (bulk lot # U5684AA), for prophylaxis (dose, route of administration, anatomical location and expiration date were not reported). Other suspect therapies included PREVENAR (indication, route of administration, anatomical location, lot # and expiration date were not reported) and ROTARIX (indication, route of administration, anatomical location, lot number and expiration date were not reported). On 17-OCT-2018, the patient experienced cardiac arrest and he was reanimated. On 18-OCT-2018, the child experienced sudden death (sudden infant death syndrome). It was not reported neither the cause of death, nor if an autopsy was performed. The outcome of cardiac arrest was reported as fatal. The physician was unsure and could not assess the causal relationship between the events and the suspect vaccines. Upon internal review, cardiac arrest and sudden infant death syndrome were considered to be medically significant events. Follow-up information has been received from the physician on 20-NOV-2018. The patient was a healthy baby, who was born in week 38 +5 of pregnancy with a birth weight of 3540 grams, Apgar score 10. The physician reported that the patient received ROTATEQ, dose 1 orally for prophylaxis (lot number and expiration date were not reported) instead of ROTARIX as previously reported, on 16-OCT-2018. It was reported that on the same day, the patient also received the first dose of VAXELIS and PREVENAR. In the afternoon of 17-OCT-2018, the patient experienced respiratory arrest (also reported as cardiac arrest). The reporter stated that the father lay on the couch with the baby and fell asleep; then, the mother came into the room and noticed that the baby was not breathing. The emergency physician was called and the patient was successfully reanimated and brought to the hospital. On 18-OCT-2018, all the machines were switched off and the patient died. The cause of death was reported as sudden infant death syndrome (SIDS), however, it was unknown by the reporter if an autopsy was performed. The reporting physician was informed via phone by the hospital, and she stated that she felt that the baby did not have any risk factors for SIDS and her causality assessment was that most likely, there was a random coincidence between the vaccination and SIDS. The outcome of cardio-respiratory arrest was fatal. The causality assessment between the suspect vaccines and cardio-respiratory arrest was not provided. Upon internal review, cardio-respiratory arrest was considered to be a medically significant event. Reported Cause(s) of Death: sudden infant death syndrome.


VAERS ID: 788301 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-06
Onset:2018-11-06
   Days after vaccination:0
Submitted: 2018-11-23
   Days after onset:17
Entered: 2018-11-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 1030A1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Heart rate increased, Hyperpyrexia, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown to Ongoing, Bedridden
Preexisting Conditions: Unknown date, Decubitus ulcer, Sacral decubitus injury; Unknown date, Senile dementia, Patient bedridden
Allergies:
Diagnostic Lab Data: On 07-Nov-2018, the blood pressure was performed and the result was not reported. 07-NOV-2018, Heart rate, 130, elevated; 07-NOV-2018, Oxygen saturation, 70%, depressed
CDC Split Type: 201805593

Write-up: This is a spontaneous case, reported by physician to regulatory authority (regulatory reference number: IT-MINISAL02-510139) and initially retrieved (combinedly processed with follow-up received on 19-Nov-2018) on 16-Nov-2018, concerning a 89-year-old, elderly female patient. The patient''s historical condition included senile dementia and sacral decubitus injury (on an unspecified date) and the current condition included bedridden (reported as medical history) (since an unspecified date). On 06-Nov-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, batch number: 1030A1A, anatomical location and expiry date: not reported). On the same day, after vaccination, the patient experienced hyperpyrexia (reported as appearance of fever). On 07-Nov-2018, the patient was taken to emergency room (ER) with equipment. The patient had gasping but not intubated through the will of her family. The patient''s general conditions got worsen. The patient''s oxygen (O2) saturation showed 70 percent (normal range not provided), heart rate showed 130 (normal range not provided) and blood pressure was performed for which result was not reported. On the same day (07-Nov-2018), the patient died. The cause of death was unknown and the autopsy was not performed. The outcome of the event hyperpyrexia was fatal, and for the events (oxygen saturation decreased and heart rate increased) was unknown. The outcome of the events reduced general condition and gasping was not reported. The reporter assessed the case as serious (death). Case Comment: An 89-year-old bedridden female patient with history of senile dementia, sacral decubitus injury experienced hyperpyrexia on the same day after receipt of FLUAD (TIV). Considering the plausible temporal relationship between vaccination to hyperpyrexia and plausible biological mechanism, the company assessed the causality for hyperpyrexia as related to suspect vaccine. On the next day the patient was taken to ER with dyspnea, decreased oxygen saturation, increased heart rate and worsened general condition. The events decreased oxygen saturation, increased heart rate and worsened general condition were considered as not related to suspect vaccine as they can be explained by concurrent dyspnoea and progressive age of the patient. The causality for the event dyspnoea (gasping) cannot be assessed in relation to suspect vaccine, as beside the progressive age of the patient, minimal details regarding diagnostic investigations, physical findings and medical history are provided, which can be alternate explanation for the event. The patient had a fatal outcome, however details regarding cause of death, autopsy are unavailable. Further assessment will be done upon receipt of new information.


VAERS ID: 788362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Death, Intensive care, Meningitis pneumococcal, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 39.8, Test Result Unit: degree C
CDC Split Type: FRGLAXOSMITHKLINEFR2018GS

Write-up: Pneumococcal meningitis; convulsing; This case was reported in a literature article and described the occurrence of pneumococcal meningitis in a infant female subject who received Rotavirus vaccine for prophylaxis. On an unknown date, 1 day after receiving Rotavirus vaccine and DTPa-IPV+Hib vaccine, the subject developed pneumococcal meningitis. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included convulsion with serious criteria of hospitalization and GSK medically significant. The outcome of pneumococcal meningitis was fatal. The outcome(s) of the additional event(s) included convulsion (unknown). The reported cause of death was pneumococcal meningitis. It was unknown if the investigator considered the pneumococcal meningitis and convulsion to be related to Rotavirus vaccine and DTPa-IPV+Hib vaccine. Diagnostic results (unless otherwise stated, normal values were not provided): Lab test was performed on unspecified date. On an unknown date, Body temperature result was 39.8 degree C. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumococcal meningitis in a female aged less than 2 months and 20 days who was vaccinated with Infanrix Quinta and Rotarix (GlaxoSmithKline) for prophylaxis. The patient was a part of the study to evaluate the presence of vaccine criticism on the Website and to analyse strategies and arguments used by opponents of vaccination. The most frequently used keywords associated with the terms "vaccination" and "vaccine" on the internet were identified and searched for individually on the internet. The links presented in the first three pages of results were reviewed to identify the most frequent providers of information. The proportion of critical content was determined by website type and a content analysis was performed. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received Infanrix Quinta and Rotarix vaccine (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, next day after vaccination, the patient had an elevated temperature (39.8 deg.C). The patient had started convulsing in the evening and was brought to the emergency room. The patient was admitted to paediatric intensive care. On an unspecified date, a few days later, the patient died in the parent''s arms in the paediatric intensive care. It was reported by the father that the patient died of pneumococcal meningitis at the age of 2 months and 20 days. It was unknown if an autopsy was performed. The case was reported between 30 September 2013 and 18 October 2013 in Healthcare website. This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors did not comment on the relationship between the event of pneumococcal meningitis and Infanrix Quinta and Rotarix. The authors concluded, "Internet users searching for vaccination information are much likely to come across anti-vaccine content using various arguments and passionate styles that could have an impact on their decision. To prevent manipulation of Internet users, online content on vaccination should be monitored and public institutions should strive to answer the needs of Internet users and help them acquire a critical view of online contents". Lab Comments: Lab test was performed on unspecified date; Reported Cause(s) of Death: Pneumococcal meningitis.


VAERS ID: 788459 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse reaction, Death, Disability, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: DK0095075131811DNK010280

Write-up: This spontaneous case was received via company representative from an online article regarding female patients of unknown age. Information about concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose number, dose, unit, route, lot #, expiration date and anatomical location were not reported) for cervical cancer prophylaxis. Other suspect therapies included CERVARIX. The article regarding new film release mention that there were cases of severe, life-changing adverse reactions experienced by girls and young women following doses of the GARDASIL or CERVARIX. It was also reported that the recorded adverse reactions included severe disability, paralysis and even death. The cause of death was not reported. It was unknown if autopsy was performed. The outcome of adverse event and paralysis was unknown. Upon internal review, the event of paralysis was determined to be medically significant. This is one of the several reports from the same reporter. Sender''s Comments: DK-009507513-1811DNK010325: DNK/18/0574 DK-009507513-1811DNK010331: DNK/18/0576 DK-009507513-1811DNK010352: DNK/18/0575; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 788460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Disability, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES0095075131811ESP009550

Write-up: This spontaneous report was received from a consumer via social media regarding female patients of unknown ages. The reporter posted on social media regarding an online article. Patient''s historical condition/drugs, concurrent conditions and concomitant drugs were unknown. On an unknown date, the patients were vaccinated with HPV vaccine (strength, dose, frequency, lot # and expiration date were unknown) for cervical cancer prophylaxis (product origin unknown). On an unknown date the patients experienced severe secondary effects include disability, paralysis and even death. The outcome of adverse event, product origin unknown and paralysis was unknown. The reporter considered adverse event, death and paralysis was reported to be related to HPV vaccine. This is one of the several reports from the same reporter. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 788513 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatinine increased, Blood lactate dehydrogenase increased, C-reactive protein increased, Cardiac arrest, Computerised tomogram thorax abnormal, Conjunctival hyperaemia, Death, Discoloured vomit, Endotracheal intubation, Fibrin D dimer normal, Pain in extremity, Platelet count decreased, Pneumococcal infection, Postsplenectomy syndrome, Prothrombin time prolonged, Purpura, Pyrexia, Resuscitation, Streptococcus test positive, White blood cell count decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Hyposplenism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: APTT; Test Result: 139 s; Test Name: SpO2; Test Result: 99 %; Test Name: Plt; Test Result: 11000 uL; Test Name: PT; Test Result: 37.8 s; Test Name: WBC; Test Result: 2300 uL
CDC Split Type: JP0095075131811JPN002440J

Write-up: This literature marketed report was received from authors of a published article and refers to a 66-year-old female patient with primary/concomitant disease of hypertension and hyposplenism. On an unspecified date, the patient was vaccinated with vaccinated with PNEUMOVAX NP for vaccination (start date and dose not reported). No concomitant medications were reported. On 11-MAY-unspecified year, the patient visited a near-by hospital due to black vomitus and bilateral upper leg pain. Pyrexia of 39.0 degrees Celsius (C) was noted. Physical findings and blood test showed no abnormality. The patient was prescribed acetaminophen and antiemetic drug, and went home. On 12-MAY-unspecified year, the patient was told by the patient''s family member about purpura on the face at the time of awaking, and was transferred by ambulance to the reporter''s hospital. After transportation to the hospital, the patient''s oxygenation gradually worsened, and was managed with intubation. Body temperature on admission: 37.7 degrees C, blood pressure: 168/115 mmHg, heart rate: 99/min, respiratory rate: 26/min, pulse oximetry (SpO2): 99% (5L mask), palpebral conjunctival hyperaemia/ purpura, purpura from the face to lower abdomen. Laboratory finding; white blood cells (WBC): 2300 MicroL, platelet count (Plt): 11000 MicroL, creatinine (Cr): 2.23 mg/dL, aspartate aminotransferase (AST): 382 U/L, alanine transaminase (ALT): 131 U/L, LD: 1498 U/L, PT: 37.8 seconds, activated partial thrombin time (APTT): 139 seconds, D-Dimer: more than 240.0 ?g/mL, C-reactive protein (CRP): 13.98 mg/dL. Since anaphylaxis due to acetaminophen was initially suspected, treatments including adrenaline subcutaneous injection were performed. Trunk computed tomography (CT) revealed perirenal opacity of fatty tissue. Splenic hypoplasia was suspected. After the CT, cardiac arrest occurred. Cardiopulmonary resuscitation, continuous intravenous infusion with dopamine hydrochloride (dopamine) and noradrenaline were started. Subsequently, cardiac arrest occurred again. There was no response despite resuscitation. The patient was confirmed dead 2.5 hours after the hospital visit. The cause of death was invasive pneumococcal infection. Performance of autopsy was not reported. On an unspecified date, 2/2 sets of streptococcus pneumoniae were detected from blood cultures that were taken at the hospital visit. Time to positivity of blood cultures were 3.5 and 4 hours, respectively. Overwhelming postsplenectomy infection (OPSI) due to streptococcus pneumoniae was diagnosed. On an unspecified date, the capsular serotype of the bacteria was identified as 10A. Reporter''s comment: In patient with hyposplenism, it is known that overwhelming postsplenectomy infection (OPSI) due to capsular type bacteria can occur. Therefore, vaccination is recommended for these patients. In this report, we reported the experience of a case of OPSI due to vaccine type streptococcus pneumoniae despite vaccination with pneumococcal vaccine. The reporting physician considered that "overwhelming postsplenectomy infection due to streptococcus pneumoniae" was related to pneumococcal vaccine. The reporting physician considered that "overwhelming postsplenectomy infection due to streptococcus pneumoniae" was serious due to death. Upon internal review, overwhelming postsplenectomy infection was determined to be serious due to other important medical event. This case is linked to report 1811JPN002166J as both were derived from the same article. Reported Cause(s) of Death: Overwhelming postsplenectomy infection due to streptococcus pneumonia.


VAERS ID: 788622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Disability, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131811GBR010405

Write-up: This spontaneous report was received from a consumer via social media regarding multiple female patients of unknown age. The reporter posted on social media regarding an online article on which included information on documentary film. Patients'' historical condition/drugs, concurrent condition and concomitant drugs were unknown. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, frequency, lot# and expiration date were unknown) for preventing cervical cancer. On unknown dates, the patients experienced severe adverse reactions that includes disability, paralysis and even death. It was unknown, if autopsy was performed. Outcome of the events paralysis and adverse reaction was unknown. Causality assessment was not provided. Upon internal review, the events paralysis and death were determined to be medically significant. The event adverse reaction was considered to be serious due to disability. This is one of the two reports from the same reporter. Reported Cause(s) of Death: Death NOS.


VAERS ID: 788752 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-19
Onset:2018-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA326BB / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Breath sounds abnormal, Cough, Death, Gravitational oedema, Productive cough
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-19
   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: Triatec; Seretide; AMIODAR; DIBASE; NORMIX; ELIQUIS; LASIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac valve disease; Cough weak; Emphysema pulmonary; Hepatitis C; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT201821

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of dependent edema in a 88-year-old male patient who received Flu Seasonal QIV Dresden (FLUARIX TETRA 2018-2019 season) (batch number AFLBA326BB, expiry date unknown) for prophylaxis. Concurrent medical conditions included cardiac valve disease, renal failure, hepatitis C, atrial fibrillation, cough weak and emphysema pulmonary. Concomitant products included TRIATEC, SERETIDE, AMIODAR, DIBASE, NORMIX, ELIQUIS and LASIX. On 19th November 2018, the patient received FLUARIX TETRA 2018-2019 season (intramuscular) .5 ml. On 19th November 2018, less than an hour after receiving FLUARIX TETRA 2018-2019 season, the patient experienced dependent edema (serious criteria death), diminished lung sounds (serious criteria death), phlegm (serious criteria death) and cough (serious criteria death). On 19th November 2018, the outcome of the dependent edema, diminished lung sounds, phlegm and cough were fatal. The patient died on 19th November 2018. The reported cause of death was phlegm, dependent oedema, diminished lung sounds and cough. It was unknown if the reporter considered the dependent edema, diminished lung sounds, phlegm and cough to be related to FLUARIX TETRA 2018-2019 season. Additional details: The formulation for SERETIDE was reported as pressurized suspension. Initial information was reported by a physician via regulatory authority on 28th November 2018: From a few days a light cough with light, no fever eupnoic mucus, no peripheral edema, no pathological noises at the base of the lung, reduced respiratory physiological noises.. good blood pressure and heartbeat. Death one hour after vaccination. Reporter''s comment: I administered FLUARIX because I had finished FLUADS. I visited the patient before administering the vaccine and the patient was in compensation as I specified in a previous box. The vaccine was administered at home, where I remained over half an hour because I visited his wife also. When I left the patient was perfectly fine. Reported Cause(s) of Death: Phlegm; Dependent oedema; Diminished lung sounds; Cough.


VAERS ID: 788753 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood test normal, Death, Dehydration, Diarrhoea, Electroencephalogram abnormal, Gastroenteritis norovirus, Hypovolaemic shock, Infection, Intensive care, Investigation normal, Mydriasis, Norovirus test positive, Polymerase chain reaction positive, Pupillary reflex impaired, Rotavirus infection, Rotavirus test positive, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypovolaemic shock conditions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Trisomy 21
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result: See text, Test Result Unit: unknown; Test Name: Electroencephalogram; Result Unstructured Data: Test Result: See text, Test Result Unit: unknown; Test Name: Stool analysis; Result Unstructured Data: Test Result: See text, Test Result Unit: unknown
CDC Split Type: JPGLAXOSMITHKLINEJP2018JP

Write-up: This case was reported in a literature article and described the occurrence of rotavirus infection in a 1-year-old male subject who received ROTARIX liquid formulation for prophylaxis. Concurrent medical conditions included trisomy 21. On an unknown date, the subject received ROTARIX liquid formulation (oral). On an unknown date, less than a year after receiving ROTARIX liquid formulation, the subject experienced rotavirus infection (serious criteria death), gastroenteritis norovirus (serious criteria death and GSK medically significant), infection mixed (serious criteria death). On an unknown date, less than a year after receiving Rotarix liquid formulation, the subject experienced vomiting (serious criteria hospitalization), diarrhoea (serious criteria hospitalization), consciousness disturbed (serious criteria hospitalization and GSK medically significant), hypovolaemic shock (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization), tachycardia, blood pressure decreased. On an unknown date, less than a year after receiving ROTARIX liquid formulation, the subject experienced pupils dilated and pupillary light reflex lost.On an unknown date, the outcome of the rotavirus infection, gastroenteritis norovirus and infection mixed were fatal and the outcome of the consciousness disturbed, hypovolaemic shock, vomiting, diarrhoea, dehydration, tachycardia, blood pressure decreased, pupils dilated and pupillary light reflex lost were unknown. The reported cause of death was rotavirus infection, gastroenteritis norovirus and infection mixed. It was unknown if the reporter considered the rotavirus infection, gastroenteritis norovirus, infection mixed, consciousness disturbed, hypovolaemic shock, vomiting, diarrhoea, dehydration, tachycardia, blood pressure decreased, pupils dilated and pupillary light reflex lost to be related to ROTARIX liquid formulation. Case A 1-year-old boy with trisomy 21 visited the reporting hospital with chief complaints of vomiting, diarrhoea and disturbed consciousness. At the visit to the hospital, the subject was in a state of hypovolemic shock due to dehydration. Combined modality therapy was performed at the pediatric intensive care unit (PICU) and his tachycardia resolved and the blood pressure increased. However, consciousness level remained disturbed at 1 for eye (E) response, 1 for verbal (V) response and 1 for motor (M) response. On day 2 of hospitalization, flat brain waves were noted on electroencephalography (EEG). On day 3 of hospitalization, the subject had dilation of pupils and loss of pupillary light reflex. On day 4 of hospitalization, the subject started to have decreased blood pressure and on day 5 of hospitalization, the subject died. After death, real-time polymerase chain reaction (RT-PCR) assays were performed using the fecal samples taken on day 3 of hospitalization, which detected norovirus and rotavirus genes, and the subject was found to have mixed infection with both viruses. The results of serum RT-PCR were negative for both viruses. The subject completed series of a monovalent human rotavirus vaccine 9 months before visiting the reporting hospital. Analysis of VP7 gene of rotavirus isolates revealed the same G1 genotype as the vaccine. In addition, gene analysis of the capsid region of norovirus found that it was GII.4 Sydney variant, which had been prevalent in recent years. Screening test was performed to identify the subject''s predisposing factors resulting in increasing severity such as immunodeficiency and metabolic disorder but the results were normal. Discussion There has been no specific treatment for norovirus infection and thus it may become serious and can lead to death. Recently, a norovirus vaccine, which covers 2 virus genotypes causing human infection, has been developed and the clinical study has been under way. Early practical use of the vaccine has been awaited. Since norovirus gastroenteritis could lead to death, early practical use has been awaited. Lab Comments: (On an unknown date) Electroencephalography (EEG):flat brain waves.Fecal samples :real-time polymerase chain reaction (RT-PCR) assays detected norovirus and rotavirus genes.Serum RT-PCR:negative for both viruses. Analysis of VP7 gene of rotavirus isolates : G1 genotype. Gene analysis of the capsid region of norovirus :GII.4 Sydney variant. Screening test of immunodeficiency and metabolic disorder:normal.; Reported Cause(s) of Death: Rotavirus infection; Gastroenteritis norovirus; Infection.


VAERS ID: 788880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Product administered to patient of inappropriate age, Wrong product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA323355

Write-up: Initial information received on 22-Nov-2018 regarding an unsolicited valid serious case received from received from Physician via from partner company on 22-Nov-2018 and transmitted to Sanofi on 22-Nov-2018 and additional information was received on 23-Nov-2018. This case involves a 9 days old male patient who died after receiving Influenza Vaccine instead of Hepatitis B Vaccine. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect Influenza Vaccine produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site instead of suspect Hepatitis B Vaccine not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received the influenza vaccine instead the hepatitis B vaccine (medication error situation). It was an actual medication error due to wrong product administered, inappropriate age at vaccine administration and died 9 days after the application (death). Lab data was not provided. Final diagnosis was (fatal) patient received the influenza vaccine instead the hepatitis B vaccine (medication error situation) and died 9 days after the application. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on 24-Jul-2016. It is unknown if an autopsy was done. The cause of death was reported as Death NOS and Wrong product administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none. Sender''s Comments: This case concerns a neonate patient who received the Influenza Vaccine produced by unknown manufacturer instead the hepatitis B vaccine (medication error situation) and died 9 days after the application. Patient''s past history, medical condition at time of vaccination and clinical course of the events which preceded to death are not reported. Death could have been caused due to any of the alternate etiologies unrelated to vaccination. Autopsy results confirming the cause of death along with any lab tests performed if any should be provided. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: Death NOS; wrong vaccine administered.


VAERS ID: 789365 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-19
Onset:2018-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX776AA / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infanrix hexa; Synflorix; Rotavirus vaccine; Bexsero; Infanrix hexa; Synflorix; Rotavirus vaccine
Current Illness:
Preexisting Conditions: Comments: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT2018GS

Write-up: This case was reported by a physician via call center representative and described the occurrence of cardiopulmonary arrest in a 5-month-old male patient who received BEXSERO (batch number ABX776AA, expiry date July 2020) for prophylaxis. Additional patient notes included none. Concomitant products included INFANRIX HEXA, SYNFLORIX, Rotavirus vaccine, BEXSERO, INFANRIX HEXA, SYNFLORIX and Rotavirus vaccine. On 19th November 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 20th November 2018, 1 days after receiving BEXSERO, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant), cyanosis (serious criteria death) and rigidity (serious criteria death). On an unknown date, the outcome of the cardiopulmonary arrest, cyanosis and rigidity were fatal. The patient died on 20th November 2018. The reported cause of death was cardiopulmonary arrest, cyanosis and rigidity. The reporter considered the cardiopulmonary arrest, cyanosis and rigidity to be unrelated to BEXSERO. Additional details were provided as follows: This case was found to be a duplicate of the regulatory case IT-MINISAL02-512448 and all the future corresponding information would be submitted to IT2018GSK214015 (case of record). The Authority reference number for the duplicate case IT-MINISAL02-512448. The patient was born in good clinical conditions, born at term (birth weight as 3.2kg), medical history was negative. In August 2018, the patient received according to National Immunization plan, first doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. No adverse events were reported following these vaccinations. On 20th September 2018, the patient received the first dose of the BEXSERO. On 15th October, 2018, the patient received second doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. Also, after these vaccinations no adverse event were reported. The patient received BEXSERO (not known the precise administration''s hour). The patient came home with his parents and was fine. During the night between 19th and 20th November 2018, the patient''s mother went to his room and realized that the patient was cyanotic and that he was already dead. At night that the parents found the baby in bed cyanotic without breathing. The doctors from emergency diagnosed cardiorespiratory arrest with presence of rigor. CPR until arrival in hospital. The patient''s mother tried to do a cardiac massage, without success, the patient was then taken to the hospital, but he had already passed away. The reporter would inform GlaxoSmithKline of any further detail as soon as they become aware. On 27th November 2018, during follow up from press review the patient demographic details were updated. The press reports that, according to experts who were investigating on the case, the patient''s death was due, at the moment, to the infant''s sudden death syndrome. The expert reports no correlation between the suspect product and the death. Reported Cause(s) of Death: Cardiorespiratory arrest; Cyanosis; Rigidity.


VAERS ID: 789604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-08
Onset:2018-11-01
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2018-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB869BA / 2 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEGLAXOSMITHKLINESE201821

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of sudden death in a 4-month-old female patient who received ROTARIX liquid formulation (batch number AROLB869BA, expiry date unknown) for prophylaxis. Co-suspect products included ROTARIX liquid formulation (batch number AROLB869BA, expiry date unknown) for prophylaxis. Concomitant products included sertraline. On 8th October 2018, the patient received the 1st dose of ROTARIX liquid formulation (oral). In November 2018, the patient received the 2nd dose of ROTARIX liquid formulation (oral) 1.5 ml. In November 2018, less than a year after receiving ROTARIX liquid formulation and less than a month after receiving ROTARIX liquid formulation, the patient experienced sudden death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death was fatal. The reported cause of death was sudden death. It was unknown if the reporter considered the sudden death to be related to ROTARIX liquid formulation and ROTARIX liquid formulation. Additional details: The age at vaccination was not reported, however the patient could be 3 to 4 months old at the time of vaccination. Initial information was reported by a other health professional via regulatory authority on 28th November 2018: Sudden death. Reported Cause(s) of Death: Sudden death.


VAERS ID: 789843 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-04-27
Onset:2018-05-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Feeling abnormal, Gastrointestinal haemorrhage, Haematemesis, Haematochezia, Haemorrhage, Hypovolaemic shock, Influenza, Neck pain, Pain in extremity, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Dementia (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131812BRA000914

Write-up: Information was received from a promoter of justice who was also a lawyer concerning a case in litigation representing the "special prosecutor''s office for public health defense". A consumer attended the lawyer''s office to report concerning his 9 years old daughter. Medical history, concurrent conditions and concomitant medications were not reported. On 27-APR-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown), lot number reported as 170017, for prophylaxis (dose, strength, route of administration and expiration date were not provided). On unspecified dates approximately in 2018, the patient started to feel bad, with a pain in the back of the neck and developed flu with intense weakness, pain in the legs and wheezing. On an unspecified date approximately in May 2018, the patient developed hemorrhage, vomited blood and had blood in the stool; therefore, she was taken to an hospital and later transferred to a different hospital in which she died on 08-MAY-2018 at 01:00 right after arrival, 11 days after the administration of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine. The cause of death was reported in the death certificate as hypovolemic shock, upper digestive hemorrhage and digestive hemorrhage. All medical records would be provided when available. It was unclear whether the patient was admitted to any hospital facility. At the reporting time, the outcome of the event influenza was unknown. The reporter considered the events hypovolemic shock, upper digestive hemorrhage and digestive hemorrhage to be related to quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine. The causality assessment for the event influenza was not provided. Upon internal review, the events hypovolemic shock, upper digestive hemorrhage and digestive hemorrhage were determined to be medically significant. Reported Cause(s) of Death: Digestive hemorrhage; Hypovolemic shock; Upper gastrointestinal haemorrhage.


VAERS ID: 789990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-10-12
Submitted: 0000-00-00
Entered: 2018-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autopsy, Base excess decreased, Bilirubin conjugated increased, Bladder catheterisation, Blood albumin decreased, Blood bicarbonate decreased, Blood bilirubin increased, Blood calcium normal, Blood chloride normal, Blood creatine increased, Blood fibrinogen increased, Blood glucose normal, Blood lactate dehydrogenase increased, Blood lactic acid increased, Blood pH decreased, Blood potassium increased, Blood sodium decreased, Blood thromboplastin increased, Blood urea increased, C-reactive protein increased, Chest X-ray normal, Cold agglutinins positive, Coma scale abnormal, Consciousness fluctuating, Contusion, Cough, Cryoglobulinaemia, Death, Decreased appetite, Dyspnoea, Endotracheal intubation, Epstein-Barr virus test positive, Fatigue, Gamma-glutamyltransferase normal, General physical health deterioration, Haemoglobin decreased, Haemolytic uraemic syndrome, Hypophagia, Hypotension, Hypothermia, Infection susceptibility increased, Jaundice, Multiple organ dysfunction syndrome, PCO2 decreased, PO2 increased, Platelet count normal, Pleurisy, Pneumonia, Pneumonia bacterial, Polymerase chain reaction positive, Procalcitonin increased, Productive cough, Prothrombin level decreased, Pulmonary sepsis, Purpura fulminans, Pyrexia, Rash erythematous, Rash generalised, Respiratory distress, Septic shock, Somnolence, Splenomegaly, Streptococcus test positive, Thrombotic microangiopathy, Upper respiratory tract infection, Urine output decreased, Vomiting, White blood cell count normal, Yellow skin
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (broad), Renovascular disorders (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-17
   Days after onset: 5
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: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20171017; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: 165, Test Result Unit: IU/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: 991, Test Result Unit: IU/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Bilirubin conjugated; Result Unstructured Data: Test Result: 47, Test Result Unit: umol/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Albumin; Result Unstructured Data: Test Result: 28.7, Test Result Unit: g/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Bilirubin total; Result Unstructured Data: Test Result: 107, Test Result Unit: umol/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Calcium; Test Result: 2.31 mmol; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Creatine; Result Unstructured Data: Test Result: 177, Test Result Unit: umol/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 9.8, Test Result/ Unit: g/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Glucose; Result Unstructured Data: Test Result: 4.1 (at 14:06); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Glucose; Result Unstructured Data: Test Result: 4.7 (at 15:05); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: LDH; Result Unstructured Data: Test Result: 11654; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Potassium; Result Unstructured Data: Test Result: 7.2, Test Result Unit: mmol/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Blood pressure; Result Unstructured Data: Test Result: 76/60 (at 13:56); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Blood pressure; Result Unstructured Data: Test Result: 110/44 (at 14:06); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Blood pressure; Result Unstructured Data: Test Result: 90/50 (at 15:05); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Sodium; Result Unstructured Data: Test Result: 132, Test Result Unit: mmol/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Plasma thromboplastin; Result Unstructured Data: Test Result: $g120, Test Result Unit: seconds; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Urea; Result Unstructured Data: Test Result: 31.3, Test Result Unit: mmol/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171012; Test Name: Body temperature; Result Unstructured Data: Test Result: $g39, Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171013; Test Name: Body temperature; Result Unstructured Data: Test Result: $g39, Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171014; Test Name: Body temperature; Result Unstructured Data: Test Result: $g39, Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171015; Test Name: Body temperature; Result Unstructured Data: Test Result: $g39, Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171016; Test Name: Body temperature; Result Unstructured Data: Test Result: $g39, Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Body temperature; Result Unstructured Data: Test Result: 35.7 (at 14:20), Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Body temperature; Result Unstructured Data: Test Result: 39 (at 13:50), Test Result Unit: Centigrade; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171016; Test Name: Chest X-ray; Result Unstructured Data: NI; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result: Glasgow 6; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 442, Test Result Unit: mg/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: GGT; Result Unstructured Data: Test Result: 18, Test Result Unit: IU/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Haemoglobin; Result Unstructured Data: Test Result: 70, Test Result Unit: g/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Heart rate; Result Unstructured Data: Test Result: 129 (at 14:06); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Heart rate; Result Unstructured Data: Test Result: 130 (at 14:25); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Heart rate; Result Unstructured Data: Test Result: 120 (at 15:05); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: saturation 96% on 70% 02, Test Result Unit: %; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: saturation 97% on 30% 02 )at 15:05), Test Result Unit: %; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: 15, Test Result Unit: g/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Procalcitonin; Result Unstructured Data: Test Result: 22.5; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Prothrombin; Test Result: 31 %; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 35 (at 14:06); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 35 (at 15:05); Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Weight; Test Result: 12 kg; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L; Test Date: 20171017; Test Name: Leukocyte count; Result Unstructured Data: Test Result: 14.9, Test Result Unit: g/l; Comments: PCR test on frozen liver fragment (date unknown): positive for EBV (12100 copies/mL) PCT (17Oct2017): 22.5 ug/L
CDC Split Type: CHPFIZER INC2018484295

Write-up: This is a spontaneous report received from a contactable physician via Pfizer Company Representative. A 3-year-old male patient was vaccinated with 3 doses of PREVENAR 13 at single dose, on unknown dates for immunization. The patient medical history and concomitant medications were not reported. The patient was born with no particular problems, good general health. The patient previously took 4 doses of INFANRIX, 1 dose of NEISVAC, 2 doses of PRIORIX, all on unknown dates for immunization. The patient experienced severe sepsis of pulmonary origin (bacterial pneumonia - pneumoniae serotype 3) on an unspecified date, multi-organ failure on 17Oct2017, present for 5 days: fever $g39C resistant to antipyretics, productive cough on 12Oct2017, upper respiratory tract infection and treatment of symptoms on 12Oct2017, deterioration in general state of health and food intake on 16Oct2017, child tired on 16Oct2017, vomiting on 16Oct2017, did not want to eat but still drinking on 17Oct2017, wants to sleep, stays in bed until lunchtime on 17Oct2017, child very yellow on 17Oct2017, difficulty breathing on 17Oct2017, red spots all over his body on 17Oct2017, decompensated septic shock with multi-organ failure on 17Oct2017, purpura fulminans on 17Oct2017, acute bilateral bronchopneumonia, more marked on the left, partially abscessed with purulent pleurisy on 17Oct2017, a fresh glomerular thrombotic microangiopathy consistent with haemolytic uraemic syndrome (hus) on 17Oct2017, cryoglobulinaemia due to the presence of glomerular igm deposits on 17Oct2017. The patient was hospitalized for the events on 17Oct2017. Therapeutic measures were taken as a result of the events. The patient died on 17Oct2017. Clinical course and autopsy results were described as follows: Present for 5 days: fever $g39C resistant to antipyretics, productive cough. Contagion: father had rhinitis and a cough the previous week. Sees the paediatrician on day 1 of development (13Oct2017): Diagnosis of upper respiratory tract infection and treatment of symptoms. Sees the paediatrician again on day 4: persistent fever, cough, deterioration in general state of health and food intake. Chest X-Ray Child tired, vomiting ++ Parents unable to administer antibiotics: Takes just one dose in the evening. Morning of 17Oct2017: Patient very tired, does not want to eat but still drinking. The mother thinks he is a little yellow, some red spots in his ears and on his feet. Wants to sleep, stays in bed until lunchtime. On waking: child very yellow, tired, had difficulty breathing and red spots all over his body In the resuscitation room. (0 min) 13:45 Patient arrives at the emergency room in his father''s arms (sleepy, IRDS, jaundice, bruising). Taken immediately to the resuscitation room, paediatrician called. (5 min) 13:50 12kg medical history, temperature 39 degrees, unable to take BP and saturation; High concentration 02 mask (anaesthetist called), 2 PVCs; Status A) Respiratory tracts open B) Tachypnoea 40 grunting ++ with superficial breathing, hypoventilation at basal breath C) Tachycardia 138, pulse present, mottling, extremities cold to the top of the limbs, nonpalpable petechiae and purpura all over the body. Time for skin to return to normal colour $g5 seconds in central and peripheral area (at base of limbs), liver 3cm from costal margin, cutaneous and scleral jaundice D) Fluctuating state of consciousness (Glasgow 6) E) No active external bleeding identified T 39C Decompensated septic shock with multi-organ failure (10 min) 13:54 1 PVC and bolus Ringer''s Lactate 20ml/kg rapid; Venous gasometer pH 7.1, pCO2 3 kPa (22.5mmHg), HC03 7.9, BE 20mmol/L, lactates 16mmol/L, Hb 50g/L, Gly 0.1mg/L, K 7.1, Na 129, Cl 100; Attn. 2 boluses of G20% 5ml/kg; Ceftriaxone antibiotic iv 100 mg/kg Isolation of the team with masks. Purpura fulminans; Order O- blood; 13:56 First BP 76/60 and 88% saturation on high concentration 02 mask Completion of case history. Last urine the previous evening, but not much. The mother noticed he had been urinating less for 2 days. Suspicion of possible HUS in the context of complicated pneumonia. In view of the suspicion: No immediate transfusion. Waited for lab results while the patient stabilized 2nd PVC applied, blood tests (group, Coombs, haemoculture, chemistry with haemolysis, haemogram, coagulation) Infusion of GS10% at 80% BE (15 min) 13:58 Intubation induced and maintained with propofol 10mg/ml BP 62/52, bolus NaCl 0.9% 10ml/k BP normalized Request to insert arterial cath (20 min) 14:06 Status: heart rate 129, BP 110/44, respiratory rate 35, saturation 96% on 70% 02, Gly 4.1 A-B intubated, tube 4, symmetrical thoracic elevation, vesicular breath sounds, decreased left pulmonary range C Pulse present, better peripheral perfusion, purpura stable, TR 4 sc, liver 3cm from costal margin, regular heart rate. D Child sedated Attn: Bolus CaCl2 0.2 ml/kg Konakion 10mg 14:07 Femoral arterial catheter fitted D Dopamine 1ml/h = 5ug/kg/min prepared but not started due to stable haemodynamic condition (30 min) 14:10 NG tube aspiration of 200ml of brownish liquid FAST no free liquid, pleural effusion Urinary catheter fitted: little urine present Gasometry check: superimposable. No data found! Requested chest X-Ray 14:20 Hypothermia at 35.7C, warmed the patient up with heated blanket Stable haemodynamic condition Called Air Rescue and Hospital for transfer Glucose meter at 2.1 bolus 60ml of 10% glucose (0.5g/kg glucose) 14:25 First lab results Hb 70g/l, Leukocytes 14.9 G/L Thrombocytes 15 G/L, no distribution K 7.2 mmol/L, Na 132 mmol/L, Calcium 2.31 mmol/L PT 31%, PTT $g 120 sc Lab noted presence of cold agglutinins. All results conditional Administered a dose of Clarithromycin 7.5 mg/kg to cover the mycoplasma Paediatric haematologist called (Dr.) Requested advice on transfusion In view of the current haemodynamic condition (normotensive child, heart rate 130 and needing 02 constant at 40%), no transfusion of O blood if child remains stable, wait for compatible blood as long as possible. (60 min) 14:51 Arterial blood gas: pH 6.93, pCO2 4.7 kPa (35mmHg), p02 19.2 kPa (144 mmHg), Bic 7.2 mmol/L, lactates 14.9 mmol/L, BE - 22.8 mmol/L, Hb 35 g/L, K 6.50 mmol/L, Na 126 mmol/L, Cl 98 mmol/L Child still in stable haemodynamic condition Attn: Call to the lab, compatible blood not yet available Nabic 1 mEq/kg infusion over 60 min 15:05 Air arrived, patient prepared for departure Status: heart rate 120, BP 90/50, Respiratory rate 35, saturation 97% on 30% 02, Gly 4.7 (105 min) 15:30 Departure of patient for hospital with Dr. During the journey: Hypotension requiring 10ml/kg NaCl 0.9% and put on dopamine, increasing to 20 ug/kg/min Difficulty keeping the patient warm Rest of lab results received during transfer: LDH 11654, albumin 28.7 g/L CRP 442 mg/l, PCT 22.5 ug/L Creatine 177 umol/L, urea 31.3 mmol/L ALT 165 U/L, AST 991 U/L, total bilirubin at 107 umol/L and conjugated at 47 umol/L, GGT 18 U/L Fibrinogen 9.8 g/L The patient died shortly after arrival at hospital. Autopsy Results - FINAL REPORT Diagnosis: Death of a 3-year-old male, with: Acute bilateral bronchopneumonia, more marked on the left, partially abscessed with purulent pleurisy; Positive PCR for streptococcus pneumoniae serotype 3 in the pulmonary parenchyma and pericardial and peritoneal effusion fluids; Fresh glomerular thrombotic microangiopathy and glomerular IgM deposits in immunofluorescence (see comments); Splenomegaly and macrophage infiltration of the bone marrow, splenic parenchyma and hepatic sinusoids with signs of haemophagocytosis (see comments); No significant histological abnormality of central nervous system, in particular no inflammation, thrombosis or signs of ischemia. Comments: The child died in a context of severe sepsis of pulmonary origin (bacterial pneumonia - pneumoniae serotype 3). Certain factors can be identified that probably led to increased susceptibility to infection and/or precipitated multi-organ failure. A fresh glomerular thrombotic microangiopathy consistent with haemolytic uraemic syndrome (HUS), the aetiology of which could be: secondary to the pulmonary infection, with bacterial pneumonia serotype 3 in particular; or linked to a genetic disease (atypical HUS, a complement disorder). In fact, a study of the complement activity was carried out on the serum sample, revealing overconsumption of immunological markers of the complement disorder, suggesting a deficit of the alternative pathway. A biochemical analysis and search for a constitutional mutation could be carried out to support this diagnosis, with a view to possible family genetic counselling. In addition, some aspects suggest cryoglobulinaemia due to the presence of glomerular IgM deposits; these deposits may be linked to HUS. PCR test on frozen liver fragment positive for EBV (12100 copies/mL); this raises the possibility of underlying Epstein Barr virus infection. The suspected cryoglobulinaemia could also be part of an infection of this kind. The combination of splenomegaly and accumulation of macrophages in the reticuloendothelial system with the presence of haemophagocytosis may be consistent with macrophage activation syndrome. Information on the batch number has been requested. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities. Additional information received on 29Nov2018 from a contactable physician includes: Diagnosis, Cause of death updated to Severe sepsis of pulmonary origin (bacterial pneumonia - pneumoniae serotype 3) from death was probably due to a pneumococcal Streptococcus serogroup 3, Autopsy Results, past vaccines, new events (Fever, productive cough, Upper respiratory tract infection, General physical health deterioration, Markedly reduced food intake, Tiredness, Vomiting, Appetite lost, Sleepiness, Yellow skin, Difficulty breathing, Rash generalized, Septic shock, Purpura fulminans, Pleurisy, Haemolytic uraemic syndrome, Cryoglobulinaemia), lab tests (Chest X-Ray, Body Temperature, Weight, Coma scale, Blood pressure, heart rate, respiratory rate, oxygen saturation, Blood glucose (gly), hemoglobin, White blood cell count, Platelet count, Blood potassium, Blood sodium, Blood calcium, Prothrombin level (PT), Blood thromboplastin (PTT), Blood lactate dehydrogenase, Blood albumin, C-reactive protein, Procalcitonin, Blood creatine, Blood urea, Alanine aminotransferase, Aspartate aminotransferase, Blood bilirubin, Bilirubin conjugated, Gamma-glutamyltransferase, Blood fibrinogen), clinical course.; Sender''s Comments: A possible contributory role of the suspect product cannot be excluded for the reported event lack of efficacy, Pneumococcal pneumonia and the associated multi organ failure. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Reported Cause(s) of Death: severe sepsis of pulmonary origin (bacterial pneumonia - pneumoniae serotype 3); Multi-organ failure; Autopsy-determined Cause(s) of Death: severe sepsis of pulmonary origin (bacterial pneumonia - pneumoniae serotype 3).


VAERS ID: 790386 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Agitation, Anxiety, Confusional state, Death, Hydrophobia, Paraesthesia, Paralysis, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (exposure to animals with rabies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included immunoglobulin human anti-rabies (Rabies Immunoglobulin) for prophylaxis. Concurrent medical conditions included animal bite (exposure to animals with rabies). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of GSK medically significant, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (unknown), tingling skin (unknown), agitation (unknown), anxiety (unknown), confusion (unknown), hydrophobia (unknown) and aerophobia (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S2 reported in this literature article. The patient was a part of the study that analysed information from human rabies case investigations, conducted between 2006 and 2012, in order to describe exposure history, clinical characteristics and post exposure prophylaxis (PEP) practices of rabies cases. The findings can help to target future interventions, and to improve community awareness and clinical practice involving rabies exposures. The patient was exposed to rabies (category 2) caused by bite. [In this study, out of 3 patients of rabies infection with category 2 exposure, the time from exposure to wound treatment was within 1 day for 2 patients and missing information for 1 patient]. The patient belonged to an area. [In this study, 2 belonged to province and 1 belonged to province]. No information on patient''s family or medical history or concomitant medication was provided. On an unspecified date between 2007 and 2011, the patient received unspecified rabies vaccine intramuscularly as post exposure prophylaxis (administration site unspecified; dosages unknown; batch number not provided). [In this study, out of 31 clinically diagnosed rabies cases, 30 case-patients used 5-doses regimen and received at least 5 doses of rabies vaccine, 1 case-patient used regimen and received 4 doses of rabies vaccine. The PEP vaccination series can be administered as either 2-1-1, in which two doses of vaccine are injected intramuscularly on day 0 (one into each of the two deltoid or thigh sites) followed by a single dose on days 7 and 21, or the five-dose regimen, in which one dose is administered intramuscularly on days 0, 3, 7, 14, and 28, based on the World Health Organization (WHO) Expert Consultation on Rabies]. The patient also received rabies immunoglobulin (RIG) along with integrated wound treatment in the medical facility. [In this study, human rabies immune globulin (HRIG) and equine rabies antiserum (ERA) were approved for use]. [In this study, out of 3 patients with category 2 exposure, the time from exposure to vaccination was within 1 day for 2 patients and missing information for 1 patient, time from exposure to injecting RIG was 1 day for 1 patient and missing information for 2 patients]. The age of vaccination was not provided. On an unspecified date between 2007 and 2011, an unknown period after vaccination, the patient developed clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves (active rabies infection). [In this study, before 2008, the criteria for human rabies case was classified as clinically diagnosed cases if a patient had been licked, bitten or scratched by dog, cat or other mammal, with clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves. In 2008, rabies was classified as furious rabies or paralytic rabies based on clinical symptoms. The clinical symptoms of furious rabies were similar to those defined in the criteria before 2008. However, in paralytic rabies, which lacks hyperactivity or hydrophobia, muscles gradually become paralyzed, starting at the site of the bite or scratch, and progress with systemic flaccid paralysis. A clinically diagnosed case of rabies was defined as the occurrence of typical manifestations in a patient with a history of exposure to animals with rabies]. The patient was categorised as clinically diagnosed rabies infection case. [In this study, the incubation period ranged from 1 month to 5 months after exposure]. On an unspecified date, the patient died as a result of rabies infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset and laboratory confirmation was unknown. This case has been considered as serious due to death/suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of active rabies infection related to unspecified rabies vaccine. The authors stated, "However, even when appropriate and timely treatment was administered regardless of exposure category, including wound flushing and disinfection, completion of a PEP vaccination series, and RIG, 31 cases in our study developed active rabies infections. The results of this study suggest that males, farmers and older age groups are at highest risk for rabies infection, and as such, should be prioritized for rabies awareness, bite reduction and infection prevention education. Even though all 31 cases were clinically diagnosed, definitions of clinical diagnosis are strict with regards to clinical manifestation, and our analysis showed 99% cases developed symptoms of furious rabies. These deaths could also be due to PEP failure due to non-standard practice, insufficient RIG dosing, ineffective vaccine or immunocompromised patients. We suggest assessing antibody levels after PEP vaccination for patients with documented immunodeficiency, and a booster should be administered if antibody levels drop below 0.5 IU /mL". This is 1 of the 7 valid cases reported in same literature article.; Reported Cause(s) of Death: rabies.


VAERS ID: 790387 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Agitation, Anxiety, Confusional state, Death, Hydrophobia, Paraesthesia, Paralysis, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (exposure to animals with rabies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included Rabies Immunoglobulin for prophylaxis. Concurrent medical conditions included animal bite (exposure to animals with rabies). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of GSK medically significant, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (unknown), tingling skin (unknown), agitation (unknown), anxiety (unknown), confusion (unknown), hydrophobia (unknown) and aerophobia (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that analysed information from human rabies case investigations, conducted between 2006 and 2012, in order to describe exposure history, clinical characteristics and post exposure prophylaxis (PEP) practices of rabies cases. The findings can help to target future interventions, and to improve community awareness and clinical practice involving rabies exposures. The patient was exposed to rabies (category 3) caused by bite. The time from exposure to wound treatment was within 1 day for patient. The patient belonged to province. [In this study, out of 28 patients of rabies infection with category 3 exposure, 2 were from urban area and 22 were from rural area, the area information was categorised as missing for 4 patients]. No information on patient''s family or medical history or concomitant medication was provided. On an unspecified date between 2007 and 2012, the patient received unspecified rabies vaccine intramuscularly as post exposure prophylaxis (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 31 clinically diagnosed rabies cases, 30 case-patients used 5-doses Essen regimen and received at least 5 doses of rabies vaccine, 1 case-patient used Zagreb regimen and received 4 doses of rabies vaccine. The PEP vaccination series can be administered as either Zagreb 2-1-1, in which two doses of vaccine are injected intramuscularly on day 0 (one into each of the two deltoid or thigh sites) followed by a single dose on days 7 and 21, or the five-dose Essen regimen, in which one dose is administered intramuscularly on days 0, 3, 7, 14, and 28, based on the World Health Organization (WHO) Expert Consultation on Rabies]. The patient also received rabies immunoglobulin (RIG) along with integrated wound treatment in the medical facility. [In this study, human rabies immune globulin (HRIG) and equine rabies antiserum (ERA) were approved for use]. [In this study, out of 3 patients of rabies infection with category 3 exposure, the time from exposure to vaccination was within 1 day for patient, time from exposure to injecting RIG was within 1 day for 25 patients, was 1 day for 2 patients and 2 days for 1 patient]. The age of vaccination was not provided. On an unspecified date between 2007 and 2012, an unknown period after vaccination, the patient developed clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves (active rabies infection). [In this study, before 2008, the criteria for human rabies case was classified as clinically diagnosed cases if a patient had been licked, bitten or scratched by dog, cat or other mammal, with clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves. In 2008, rabies was classified as furious rabies or paralytic rabies based on clinical symptoms. The clinical symptoms of furious rabies were similar to those defined in the criteria before 2008. However, in paralytic rabies, which lacks hyperactivity or hydrophobia, muscles gradually become paralyzed, starting at the site of the bite or scratch, and progress with systemic flaccid paralysis. A clinically diagnosed case of rabies was defined as the occurrence of typical manifestations in a patient with a history of exposure to animals with rabies]. The patient was categorised as clinically diagnosed rabies infection case. [In this study, the incubation period was 0-13 months after exposure]. On an unspecified date, the patient died as a result of rabies infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset, and laboratory confirmation was unknown. This case has been considered as serious due to death/suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of active rabies infection related to unspecified rabies vaccine. The authors stated, "However, even when appropriate and timely treatment was administered regardless of exposure category, including wound flushing and disinfection, completion of a PEP vaccination series, and RIG, 31 cases in our study developed active rabies infections. The results of this study suggest that males, farmers and older age groups are at highest risk for rabies infection, and as such, should be prioritized for rabies awareness, bite reduction and infection prevention education. Even though all 31 cases were clinically diagnosed, definitions of clinical diagnosis are strict with regards to clinical manifestation, and our analysis showed 99% cases developed symptoms of furious rabies. These deaths could also be due to PEP failure due to non-standard practice, insufficient RIG dosing, ineffective vaccine or immunocompromised patients. We suggest assessing antibody levels after PEP vaccination for patients with documented immunodeficiency, and a booster should be administered if antibody levels drop below 0.5 IU /mL". This is 1 of the 7 valid cases reported in same literature article. Reported Cause(s) of Death: rabies.


VAERS ID: 790388 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Agitation, Anxiety, Confusional state, Death, Hydrophobia, Paraesthesia, Paralysis, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (exposure to animals with rabies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included Rabies Immunoglobulin for prophylaxis. Concurrent medical conditions included animal bite (exposure to animals with rabies). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of GSK medically significant, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (unknown), tingling skin (unknown), agitation (unknown), anxiety (unknown), confusion (unknown), hydrophobia (unknown) and aerophobia (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that analysed information from human rabies case investigations, conducted between 2006 and 2012, in order to describe exposure history, clinical characteristics and post exposure prophylaxis (PEP) practices of rabies cases. The findings can help to target future interventions, and to improve community awareness and clinical practice involving rabies exposures. The patient was exposed to rabies (category 3) caused by bite. The time from exposure to wound treatment was within 1 day for patient. The patient belonged to province. [In this study, out of 28 patients of rabies infection with category 3 exposure, 2 were from urban area and 22 were from rural area, the area information was categorised as missing for 4 patients]. No information on patient''s family or medical history or concomitant medication was provided. On an unspecified date between 2007 and 2012, the patient received unspecified rabies vaccine intramuscularly as post exposure prophylaxis (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 31 clinically diagnosed rabies cases, 30 case-patients used 5-doses Essen regimen and received at least 5 doses of rabies vaccine, 1 case-patient used Zagreb regimen and received 4 doses of rabies vaccine. The PEP vaccination series can be administered as either Zagreb 2-1-1, in which two doses of vaccine are injected intramuscularly on day 0 (one into each of the two deltoid or thigh sites) followed by a single dose on days 7 and 21, or the five-dose Essen regimen, in which one dose is administered intramuscularly on days 0, 3, 7, 14, and 28, based on the World Health Organization (WHO) Expert Consultation on Rabies]. The patient also received rabies immunoglobulin (RIG) along with integrated wound treatment in the medical facility. [In this study, human rabies immune globulin (HRIG) and equine rabies antiserum (ERA) were approved for use]. [In this study, out of 3 patients of rabies infection with category 3 exposure, the time from exposure to vaccination was within 1 day for patient, time from exposure to injecting RIG was within 1 day for 25 patients, was 1 day for 2 patients and 2 days for 1 patient]. The age of vaccination was not provided. On an unspecified date between 2007 and 2012, an unknown period after vaccination, the patient developed clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves (active rabies infection). [In this study, before 2008, the criteria for human rabies case was classified as clinically diagnosed cases if a patient had been licked, bitten or scratched by dog, cat or other mammal, with clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves. In 2008, rabies was classified as furious rabies or paralytic rabies based on clinical symptoms. The clinical symptoms of furious rabies were similar to those defined in the criteria before 2008. However, in paralytic rabies, which lacks hyperactivity or hydrophobia, muscles gradually become paralyzed, starting at the site of the bite or scratch, and progress with systemic flaccid paralysis. A clinically diagnosed case of rabies was defined as the occurrence of typical manifestations in a patient with a history of exposure to animals with rabies]. The patient was categorised as clinically diagnosed rabies infection case. [In this study, the incubation period was 0-13 months after exposure]. On an unspecified date, the patient died as a result of rabies infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset, and laboratory confirmation was unknown. This case has been considered as serious due to death/suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of active rabies infection related to unspecified rabies vaccine. The authors stated, "However, even when appropriate and timely treatment was administered regardless of exposure category, including wound flushing and disinfection, completion of a PEP vaccination series, and RIG, 31 cases in our study developed active rabies infections. The results of this study suggest that males, farmers and older age groups are at highest risk for rabies infection, and as such, should be prioritized for rabies awareness, bite reduction and infection prevention education. Even though all 31 cases were clinically diagnosed, definitions of clinical diagnosis are strict with regards to clinical manifestation, and our analysis showed 99% cases developed symptoms of furious rabies. These deaths could also be due to PEP failure due to non-standard practice, insufficient RIG dosing, ineffective vaccine or immunocompromised patients. We suggest assessing antibody levels after PEP vaccination for patients with documented immunodeficiency, and a booster should be administered if antibody levels drop below 0.5 IU /mL". This is 1 of the 7 valid cases reported in same literature article. Reported Cause(s) of Death: rabies.


VAERS ID: 790413 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Agitation, Anxiety, Confusional state, Death, Hydrophobia, Paraesthesia, Paralysis, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (exposure to animals with rabies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included Rabies Immunoglobulin for prophylaxis. Concurrent medical conditions included animal bite (exposure to animals with rabies). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of GSK medically significant, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (unknown), tingling skin (unknown), agitation (unknown), anxiety (unknown), confusion (unknown), hydrophobia (unknown) and aerophobia (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that analysed information from human rabies case investigations, conducted between 2006 and 2012, in order to describe exposure history, clinical characteristics and post exposure prophylaxis (PEP) practices of rabies cases. The findings can help to target future interventions, and to improve community awareness and clinical practice involving rabies exposures. The patient was exposed to rabies (category 2) caused by bite. [In this study, out of 3 patients of rabies infection with category 2 exposure, the time from exposure to wound treatment was within 1 day for 2 patients and missing information for 1 patient]. The patient belonged to rural area. No information on patient''s family or medical history or concomitant medication was provided. On an unspecified date between 2007 and 2011, the patient received unspecified rabies vaccine intramuscularly as post exposure prophylaxis (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 31 clinically diagnosed rabies cases, 30 case-patients used 5-doses Essen regimen and received at least 5 doses of rabies vaccine, 1 case-patient used Zagreb regimen and received 4 doses of rabies vaccine. The PEP vaccination series can be administered as either Zagreb 2-1-1, in which two doses of vaccine are injected intramuscularly on day 0 (one into each of the two deltoid or thigh sites) followed by a single dose on days 7 and 21, or the five-dose Essen regimen, in which one dose is administered intramuscularly on days 0, 3, 7, 14, and 28, based on the World Health Organization (WHO) Expert Consultation on Rabies]. The patient also received rabies immunoglobulin (RIG) along with integrated wound treatment in the medical facility. [In this study, human rabies immune globulin (HRIG) and equine rabies antiserum (ERA) were approved for use]. [In this study, out of 3 patients of rabies infection with category 2 exposure, the time from exposure to vaccination was within 1 day for 2 patients and missing information for 1 patient, time from exposure to injecting RIG was 1 day for 1 patient and missing information for 2 patients]. The age of vaccination was not provided. On an unspecified date between 2007 and 2011, an unknown period after vaccination, the patient developed clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves (active rabies infection). [In this study, before 2008, the criteria for human rabies case was classified as clinically diagnosed cases if a patient had been licked, bitten or scratched by dog, cat or other mammal, with clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves. In 2008, rabies was classified as furious rabies or paralytic rabies based on clinical symptoms. The clinical symptoms of furious rabies were similar to those defined in the criteria before 2008. However, in paralytic rabies, which lacks hyperactivity or hydrophobia, muscles gradually become paralyzed, starting at the site of the bite or scratch, and progress with systemic flaccid paralysis. A clinically diagnosed case of rabies was defined as the occurrence of typical manifestations in a patient with a history of exposure to animals with rabies]. The patient was categorised as clinically diagnosed rabies infection case. [In this study, the incubation period ranged from 1 month to 5 months after exposure]. On an unspecified date, the patient died as a result of rabies infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset, and laboratory confirmation was unknown. This case has been considered as serious due to death/suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of active rabies infection related to unspecified rabies vaccine. The authors stated, "However, even when appropriate and timely treatment was administered regardless of exposure category, including wound flushing and disinfection, completion of a PEP vaccination series, and RIG, 31 cases in our study developed active rabies infections. The results of this study suggest that males, farmers and older age groups are at highest risk for rabies infection, and as such, should be prioritized for rabies awareness, bite reduction and infection prevention education. Even though all 31 cases were clinically diagnosed, definitions of clinical diagnosis are strict with regards to clinical manifestation, and our analysis showed 99% cases developed symptoms of furious rabies. These deaths could also be due to PEP failure due to non-standard practice, insufficient RIG dosing, ineffective vaccine or immunocompromised patients. We suggest assessing antibody levels after PEP vaccination for patients with documented immunodeficiency, and a booster should be administered if antibody levels drop below 0.5 IU /mL". This is 1 of the 7 valid cases reported in same literature article. Reported Cause(s) of Death: rabies.


VAERS ID: 790414 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Agitation, Anxiety, Confusional state, Death, Hydrophobia, Paraesthesia, Paralysis, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (exposure to animals with rabies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included Rabies Immunoglobulin for prophylaxis. Concurrent medical conditions included animal bite (exposure to animals with rabies). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of GSK medically significant, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (unknown), tingling skin (unknown), agitation (unknown), anxiety (unknown), confusion (unknown), hydrophobia (unknown) and aerophobia (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table reported in this literature article. The patient was a part of the study that analysed information from human rabies case investigations, conducted between 2006 and 2012, in order to describe exposure history, clinical characteristics and post exposure prophylaxis (PEP) practices of rabies cases. The findings can help to target future interventions, and to improve community awareness and clinical practice involving rabies exposures. The patient was exposed to rabies (category 2) caused by bite. [In this study, out of 3 patients of rabies infection with category 2 exposure, the time from exposure to wound treatment was within 1 day for 2 patients and missing information for 1 patient]. The information for the area to which patient belonged was categorised as missing by the case investigator of the study. [In this study, 2 belonged to one area and 1 belonged to other area]. No information on patient''s family or medical history or concomitant medication was provided. On an unspecified date between 2007 and 2011, the patient received unspecified rabies vaccine intramuscularly as post exposure prophylaxis (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 31 clinically diagnosed rabies cases, 30 case-patients used 5-doses Essen regimen and received at least 5 doses of rabies vaccine, 1 case-patient used Zagreb regimen and received 4 doses of rabies vaccine. The PEP vaccination series can be administered as either Zagreb 2-1-1, in which two doses of vaccine are injected intramuscularly on day 0 (one into each of the two deltoid or thigh sites) followed by a single dose on days 7 and 21, or the five-dose Essen regimen, in which one dose is administered intramuscularly on days 0, 3, 7, 14, and 28, based on the World Health Organization (WHO)]. The patient also received rabies immunoglobulin (RIG) along with integrated wound treatment in the medical facility. [In this study, human rabies immune globulin (HRIG) and equine rabies antiserum (ERA) were approved for use]. [In this study, out of 3 patients of rabies infection with category 2 exposure, the time from exposure to vaccination was within 1 day for 2 patients and missing information for 1 patient, time from exposure to injecting RIG was 1 day for 1 patient and missing information for 2 patients]. The age of vaccination was not provided. On an unspecified date between 2007 and 2011, an unknown period after vaccination, the patient developed clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves (active rabies infection). [In this study, before 2008, the criteria for human rabies case was classified as clinically diagnosed cases if a patient had been licked, bitten or scratched by dog, cat or other mammal, with clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves. In 2008, rabies was classified as furious rabies or paralytic rabies based on clinical symptoms. The clinical symptoms of furious rabies were similar to those defined in the criteria before 2008. However, in paralytic rabies, which lacks hyperactivity or hydrophobia, muscles gradually become paralyzed, starting at the site of the bite or scratch, and progress with systemic flaccid paralysis. A clinically diagnosed case of rabies was defined as the occurrence of typical manifestations in a patient with a history of exposure to animals with rabies]. The patient was categorised as clinically diagnosed rabies infection case. [In this study, the incubation period ranged from 1 month to 5 months after exposure]. On an unspecified date, the patient died as a result of rabies infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset, and laboratory confirmation was unknown. This case has been considered as serious due to death/suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of active rabies infection related to unspecified rabies vaccine. The authors stated, "However, even when appropriate and timely treatment was administered regardless of exposure category, including wound flushing and disinfection, completion of a PEP vaccination series, and RIG, 31 cases in our study developed active rabies infections. The results of this study suggest that males, farmers and older age groups are at highest risk for rabies infection, and as such, should be prioritized for rabies awareness, bite reduction and infection prevention education. Even though all 31 cases were clinically diagnosed, definitions of clinical diagnosis are strict with regards to clinical manifestation, and our analysis showed 99% cases developed symptoms of furious rabies. These deaths could also be due to PEP failure due to non-standard practice, insufficient RIG dosing, ineffective vaccine or immunocompromised patients. We suggest assessing antibody levels after PEP vaccination for patients with documented immunodeficiency, and a booster should be administered if antibody levels drop below 0.5 IU /mL". This is 1 of the 7 valid cases reported in same literature article. Reported Cause(s) of Death: rabies.


VAERS ID: 790415 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Aerophobia, Agitation, Anxiety, Confusional state, Death, Hydrophobia, Paraesthesia, Paralysis, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Animal bite (exposure to animals with rabies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Rabies Vaccine for prophylaxis. Co-suspect products included immunoglobulin human anti-rabies (Rabies Immunoglobulin) for prophylaxis. Concurrent medical conditions included animal bite (exposure to animals with rabies). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of GSK medically significant, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (unknown), tingling skin (unknown), agitation (unknown), anxiety (unknown), confusion (unknown), hydrophobia (unknown) and aerophobia (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis, tingling skin, agitation, anxiety, confusion, hydrophobia and aerophobia may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S2 reported in this literature article. The patient was a part of the study that analysed information from human rabies case investigations, conducted between 2006 and 2012, in order to describe exposure history, clinical characteristics and post exposure prophylaxis (PEP) practices of rabies cases. The findings can help to target future interventions, and to improve community awareness and clinical practice involving rabies exposures. The patient was exposed to rabies (category 3) caused by bite. The time from exposure to wound treatment was within 1 day for patient. [In this study, out of 28 patients of rabies infection with category 3 exposure, 2 were from urban area and 22 were from rural area, the area information was categorised as missing for 4 patients]. No information on patient''s family or medical history or concomitant medication was provided. On an unspecified date between 2007 and 2012, the patient received unspecified rabies vaccine intramuscularly as post exposure prophylaxis (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 31 clinically diagnosed rabies cases, 30 case-patients used 5-doses and received at least 5 doses of rabies vaccine, 1 case-patient used and received 4 doses of rabies vaccine. The PEP vaccination series can be administered as either 2-1-1, in which two doses of vaccine are injected intramuscularly on day 0 (one into each of the two deltoid or thigh sites) followed by a single dose on days 7 and 21, or the five-dose regimen, in which one dose is administered intramuscularly on days 0, 3, 7, 14, and 28, based on the World Health Organization (WHO) Expert Consultation on Rabies]. The patient also received rabies immunoglobulin (RIG) along with integrated wound treatment in the medical facility. [In this study, human rabies immune globulin (HRIG) and equine rabies antiserum (ERA) were approved for use in certain country]. [In this study, out of 3 patients of rabies infection with category 3 exposure, the time from exposure to vaccination was within 1 day for patient, time from exposure to injecting RIG was within 1 day for 25 patients, was 1 day for 2 patients and 2 days for 1 patient]. The age of vaccination was not provided. On an unspecified date between 2007 and 2012, an unknown period after vaccination, the patient developed clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves (active rabies infection). [In this study, before 2008, the criteria for human rabies case was classified as clinically diagnosed cases if a patient had been licked, bitten or scratched by dog, cat or other mammal, with clinical symptoms of a prickling or itching sensation at the site of the bite, progressing within days to agitation anxiety, confusion, hydrophobia, aerophobia, and paralysis of muscles or cranial nerves. In 2008, rabies was classified as furious rabies or paralytic rabies based on clinical symptoms. The clinical symptoms of furious rabies were similar to those defined in the criteria before 2008. However, in paralytic rabies, which lacks hyperactivity or hydrophobia, muscles gradually become paralyzed, starting at the site of the bite or scratch, and progress with systemic flaccid paralysis. A clinically diagnosed case of rabies was defined as the occurrence of typical manifestations in a patient with a history of exposure to animals with rabies]. The patient was categorised as clinically diagnosed rabies infection case. [In this study, the incubation period was 0-13 months after exposure]. On an unspecified date, the patient died as a result of rabies infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset, and laboratory confirmation was unknown. This case has been considered as serious due to death/suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of active rabies infection related to unspecified rabies vaccine. The authors stated, "However, even when appropriate and timely treatment was administered regardless of exposure category, including wound flushing and disinfection, completion of a PEP vaccination series, and RIG, 31 cases in our study developed active rabies infections. The results of this study suggest that males, farmers and older age groups are at highest risk for rabies infection, and as such, should be prioritized for rabies awareness, bite reduction and infection prevention education. Even though all 31 cases were clinically diagnosed, definitions of clinical diagnosis are strict with regards to clinical manifestation, and our analysis showed 99% cases developed symptoms of furious rabies. These deaths could also be due to PEP failure due to non-standard practice, insufficient RIG dosing, ineffective vaccine or immunocompromised patients. We suggest assessing antibody levels after PEP vaccination for patients with documented immunodeficiency, and a booster should be administered if antibody levels drop below 0.5 IU /mL". This is 1 of the 7 valid cases reported in same literature article.; Reported Cause(s) of Death: rabies.


VAERS ID: 790602 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-06-05
Onset:2018-06-01
Submitted: 0000-00-00
Entered: 2018-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201821

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 2-month-old male patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included ROTARIX for prophylaxis, BEXSERO for prophylaxis, paracetamol unknown for fever and PREVENAR 13 for prophylaxis. On 5th June 2018, the patient received INFANRIX HEXA(intramuscular), ROTARIX (oral) and BEXSERO (intramuscular). On 6th June 2018, the patient started paracetamol (oral) at an unknown dose and frequency. On 5th June 2018, the patient received PREVENAR 13 (intramuscular). On 8th June 2018, 3 days after receiving INFANRIX HEXA, ROTARIX and BEXSERO and 2 days after starting paracetamol, the patient experienced death unexplained (serious criteria death, GSK medically significant and other: serious per reporter). In June 2018, the patient experienced feeling unwell (serious criteria other: serious per reporter) and high temperature (serious criteria other: serious per reporter). Paracetamol was discontinued on 7th June 2018. On 8th June 2018, the outcome of the death unexplained was fatal. On an unknown date, the outcome of the feeling unwell and high temperature were unknown. The patient died on 8th June 2018. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the death unexplained, feeling unwell and high temperature to be related to INFANRIX HEXA, ROTARIX, BEXSERO and paracetamol. Additional information: It was unknown if the reporter considered the death unexplained, feeling unwell and high temperature to be related to PREVENAR 13. Age at vaccination was not reported, However the patient could be 1 or 2 months old at the time of vaccination. Initial information was received from a physician via regulatory authority on 3rd December 2018: Death unexplained, feeling unwell and high temperature.; Reported Cause(s) of Death: Death unexplained.


VAERS ID: 790800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-08-24
Onset:2018-08-01
Submitted: 0000-00-00
Entered: 2018-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood test, Cardiac monitoring, Coma, Death, Functional gastrointestinal disorder, Intensive care, Intestinal haemorrhage, Neurological symptom, Oedema, Pneumonia, Poisoning, Pyrexia, Renal failure, Seizure, Tachycardia, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result: 80/55, Test Result Unit: mmHg; Test Name: Blood test; Test Date: 20180826; Test Name: Body temperature; Result Unstructured Data: Test Result: temperature increase up to 38,5 degree; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 44
CDC Split Type: UZPFIZER INC2018479795

Write-up: The initial case was missing the following minimum criteria: unidentifiable reporter without firsthand knowledge of the patient. Upon receipt of follow-up information on 30Nov2018, this case now contains all required information to be considered valid. This is a spontaneous report from non-contactable consumers, received from a Regulatory manager of Authorized representative of "Pfizer HCP Corporation" company. A 2-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on 24Aug2018 at single dose for immunization, polio vaccine, oral on 24Aug2018, single for immunization. The patient medical history and concomitant medications were not reported. A criminal case was opened at the end of the summer. A mother of the infant applied with information that after vaccination with pneumococcal vaccine and polio vaccine in a Family clinic an infant''s condition worsen. Then parents with an infant came to a city hospital. They said the infant would stay in emergency department for a day to release oedema. They gave us to buy list, I would not say about other medicines, but there were no syringes, no novokain, no emplastrum. We performed blood tests in a private clinic on the opposite side of a road. As a result in two days an infant got into coma, experienced renal failure, intestinal canal hemorrhage, developed two-sided pneumonia. Later an infant was transferred to intensive care department of the emergency center where an infant died. According to available data on 24Aug2018 a 2 month old infant was examined by a family center physician and was given an oral polio vaccine and vaccine ''Pneumo''. On 26Aug2018 about 11am a boy experienced temperature increase up to 38,5 degree, he was hospitalized with a help of emergency car to a children clinical city hospital. A physician-neuropathologist diagnosed ''''a somatogenic nature convulsive disorder, risk of brain oedema,'''' handled a medical emergency. On 27Aug2018 about 20:00 pm due to a sharp deterioration of an infant''s general condition, namely due to increase of general intoxication symptoms, tachypnea, tachycardia, neurological symptoms and intestinal paresis, the infant was connected to a lung monitor. Per medicolegal investigation during examination in the hospital a neuropathologist assessed this condition as severe. In such cases physicians on duty should examine a patient every tree hours, but the infant was examined every six hours. Respiratory rate index and arterial blood pressure were reporter for the same time as 44 and 80/55 mmHg that disclosed the fact that the results were copied. The was no specific clinical diagnosis made in intensive care department. Due to the absence of tests results interpretation a treatment was not updated. A council of physicians was set vary late (after three days) that caused a boy condition deterioration. It was mentioned in the report that a death of the infant was caused by careless and conscienceless attitude of physicians from the children clinical city hospital, how did not perform their duties. On August 28 the child was admitted to a local hospital with fever and consciousness disrupt. Per a nurse prescription he was administered suppository ''''Cefecon''''. But in spite the treatment, the patient died 30Aug2018 at 24:00. It was not reported if an autopsy was performed. The outcome of the other events was unknown. Per specialists'' conclusion the cause of baby''s death was not a vaccine". Per the Ministry of health, on 24Aug at the clinic in the district, 128 patients were vaccinated, and no one (including this baby) didn''t experience any AE related to the vaccination". Follow-up (30Nov2018): New information was received from a Regulatory manager of Authorized representative of "Pfizer HCP Corporation" company from a consumer included: reporter information, event details. No follow up attempts are possible. No further information is expected. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 791076 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Autism spectrum disorder, Death, Depression, Encephalitis, Hypoaesthesia, Ill-defined disorder, Injury, Paralysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131812USA004467

Write-up: This spontaneous report was received from an unspecified reporter via social media and refers to a 15 year old patient (adolescent, reported as "child") of an unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, unidentified Merck HPV vaccine was administered (name and lot number not provided). On an unknown date, the patient experienced paralysis, encephalitis, depression, anxiety, damage, autism, numbness of arm, illness and died due to unspecified reason. The outcome of autism spectrum disorder, depression, anxiety, injury, hypoaesthesia, ill-defined disorder, paralysis and encephalitis is unknown. The causality between the events and the suspect vaccine was not provided. Upon internal review, the events of autism, encephalitis, paralysis were considered to be medically significant.


VAERS ID: 791193 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Amyotrophic lateral sclerosis, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESGLAXOSMITHKLINEES2018GS

Write-up: This case was reported by a non-health professional via other and described the occurrence of amyotrophic lateral sclerosis in a female patient who received HPV 16-18 (Human papilloma type 16 + 18 vaccine) for prophylaxis. On an unknown date, the patient received Human papilloma type 16 + 18 vaccine at an unknown dose. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine, the patient experienced amyotrophic lateral sclerosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the amyotrophic lateral sclerosis was fatal. The reported cause of death was amyotrophic lateral sclerosis. It was unknown if the reporter considered the amyotrophic lateral sclerosis to be related to Human papilloma type 16 + 18 vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case reported on a newspaper website identified while performing social listening duties. It was posted literally that the association of affected patient with the Papilloma Vaccine, sent a condolence statement due to the death of a patient with amyotrophic lateral sclerosis (ALS). In the statement, the Association explained that this patient had been diagnosed with this disease after the inoculation of the Human Papilloma Vaccine. No follow up would be performed as there were no reporter contact details.


VAERS ID: 791352 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Autopsy, Biopsy skin abnormal, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Computerised tomogram thorax abnormal, Cough, Death, Drug eruption, Dyspnoea, Epidermal necrosis, Hypoxia, Immunoglobulin therapy, Lung assist device therapy, Lung consolidation, Lymphadenopathy, Lymphocytic infiltration, Measles, Mechanical ventilation, Morbillivirus test positive, Mouth ulceration, Mumps antibody test negative, Neutropenia, Oropharyngeal pain, Pharyngitis, Platelet count decreased, Pneumonitis, Polymerase chain reaction, Polymerase chain reaction positive, Puncture site haemorrhage, Pyrexia, Rash maculo-papular, Rubella antibody negative, Shock, Streptococcus test negative, Thrombocytopenia, Transaminases increased, Venous haemorrhage, Viral test negative, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (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), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Skin tumours of unspecified malignancy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: sulfamethoxazole (+) trimethoprim; valacyclovir hydrochloride
Current Illness: Antiviral prophylaxis; Pneumocystis jiroveci prophylaxis; Small lymphocytic lymphoma, consistent with CLL (Working Formulation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CH0095075131812CHE002410

Write-up: This literature marketed report has been received from the authors of the published article and refers to a 26-year-old male patient. The patient was receiving Pneumocystis pneumonia prophylaxis with trimethoprim (+) sulfamethoxazole and herpes simplex virus prophylaxis with valacyclovir hydrochloride. There was no recent travel history, no known animal contact, no recent sexual risk exposure, and no known infectious disease in close contacts. On an unknown date in 1993, the patient was vaccinated with his first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (exact dose, route of administration, lot # and expiration date were not reported). He received the second dose on an unknown date in 1999, and therefore completed the vaccinations according to recommendations. The patient had chronic lymphocytic leukemia (CLL) (small lymphocytic lymphoma, low risk, Binet stade B, Rai II; 11q deletion, no TP53 mutation), diagnosed 7 months before hospital admission, and had been treated with 7 cycles of chemotherapy with fludarabine, cyclophosphamide, and rituximab until 1 month before hospital admission. On an unknown date, the patient was hospitalized with fever and neutropenia. At hospital entry, the patient reported sore throat, unproductive cough, and fever without chills since 1 day before admission. The clinical exam was only remarkable for pharyngitis and the previously known cervical lymphadenopathy. C-reactive protein was moderately elevated (53 mg/L). The patient was thrombocytopenic (73 G/L) and had a leukocytopenia (1.08 G/L; 0.67 G/L neutrophile granulocytes). A chest x-ray showed no infiltrates, and a rapid-antigen detection test for group A streptococci from a throat swab was negative. Empirical treatment with cefepime was started. Blood cultures and multiplex polymerase chain reaction (PCR) for respiratory viruses using a nasopharyngeal swab remained negative. Four days after symptom onset, the patient developed a confluent maculopapular rash of the face and upper trunk. Skin biopsy showed a perivascular lymphohistiocytic infiltrate and necrotic keratinocytes- changes compatible with an exanthematous drug eruption. For this reason, trimethoprim (+) sulfamethoxazole was stopped, and cefepime was switched to meropenem. Besides a progressive craniocaudal evolution of the maculopapular rash the patient developed ulcerative stomatitis compatible with Koplik spots and bilateral conjunctivitis on day 7 after symptom onset. These findings raised the suspicion of a measles virus infection, although the patient had been vaccinated as a child, as previously described. Positive measles real-time PCR from a throat swab confirmed the suspected diagnosis. In the month before, there had been no measles outbreaks in the patient''s region of residence, and he was not aware of any contact with a measles-infected individual. Measles IgG and IgM and rubella virus IgG were negative on day 6 after symptom onset, and mumps virus IgG was borderline positive (93 U/mL; cutoff, 70 U/mL), despite documented prior vaccination with 2 doses. Total IgG was in the lower normal range (8.6 G/L). Treatment with intravenous ribavirin, intravenous immunoglobulins, and vitamin A was started. On day 8 after symptom onset, the patient developed progressive dyspnea and hypoxia in addition to the unproductive cough, while the fever persisted. A chest computed tomography scan showed bilateral, in part nodular pulmonary consolidations with adjacent ground glass infiltrations, compatible with pneumonitis. Computed tomography lung scan showed nodular peribronchial infiltrates. Elevated transaminases up to 2 to 3 times the upper norm were observed as well. On day 15, he fulfilled the definition of acute respiratory distress syndrome (ARDS) and required invasive ventilation, and on the following day veno-venous extracorporeal membrane oxygenation (VV-ECMO). On an unknown date, on day 17 after the onset of symptoms, the patient developed venous bleeding at the puncture site of the VV-ECMO and succumbed to mixed shock and severe pneumonitis. Postmortem examination showed macroscopically severe diffuse micronodular parenchymal consolidations of the lungs. Apart from the aspect of a diffuse alveolar damage, correlating with the clinical picture of ARDS, histology revealed numerous syncytial multinuclear giant cells with intracytoplasmic and intranuclear inclusions lining the alveolar walls, consistent with measles pneumonitis. The authors stated that rituximab can compromise previously acquired humoral immunity. At the time of diagnosis, the patient had no measurable antibodies to measles or rubella, and he had borderline mumps IgG. The authors assumed this was due to his rituximab-containing chemotherapy. Additionally, the patient''s underlying disease might had played a role in his vulnerability, although pretreatment hypogammaglobulinemia in CLL is far less commonly seen than after treatment with rituximab. Fludarabine, in addition to its effect on T-lymphocytes, also leads to prominent B-cell depletion; the combination of fludarabine with rituximab has been independently associated with higher infection rates. The T-lymphocyte cytolytic response was heavily compromised due to chemotherapy with fludarabine and cyclophosphamide. A primary measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine failure could not be ruled out as an explanation for the missing immunity against measles; however, it was a far less probable explanation given the vaccine''s high 2-dose effectiveness and the multiple reasons for humoral immunodeficiency depicted above. Upon internal review, the events measles and measles pneumonitis were determined to be medically significant. Reported Cause(s) of Death: measles; measles pneumonitis.


VAERS ID: 791543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, General physical health deterioration, Intensive care, Pneumococcal infection, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result: positive to Streptococcus pneumoniae; Comments: Blood test (unknown): positive to Streptococcus pneumoniae
CDC Split Type: HKPFIZER INC2018510476

Write-up: This is a spontaneous report from a non-contactable non-HCP consumer via medical affairs colleague. The case was reported on a newspaper. A 30-month-old male patient received completed 4 doses of PREVENAR 13 via an unspecified route of administration at single dose on an unspecified for immunization. The patient medical history was and concomitant medications were not reported. The patient experienced invasive pneumococcal disease on an unspecified date. The patient died from invasive pneumococcal disease 10Dec2018 morning. Course of events: The patient had symptoms like fever, vomiting, choking and convulsions on 26Nov2018. Blood test showed positive result to Streptococcus pneumoniae. Patient was diagnosed with pneumococcal disease and was sent to hospital on the same day, and then to ICU later for treatment. Patient''s condition was deteriorating and died on 10Dec2018 morning. It was not reported if an autopsy was performed. The patient did not go travelling recently. Patient''s parents and grandmother did not have any symptoms. No similar case was found in patient''s kindergarten. A pediatrician commented that patients received PREVENAR 13 before 1 year-old had 70% more protection compared to general pneumococcal vaccines; however, no vaccine would be 100% effective. No further information is available and expected, information about batch number cannot be obtained. Reported Cause(s) of Death: invasive pneumococcal disease.


VAERS ID: 791662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a female subject who received Human papilloma type 16 + 18 vaccine + AS04D for prophylaxis. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine + AS04D, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided. This case was reported in a literature article and described the death not otherwise specified (NOS) in a female patient who was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that investigated the deployment of HPV vaccine discourses and interrogated their impact on girls and adults by deepening the understanding of how they take up, make sense, negotiate or resist HPV vaccine and/or HPV vaccine discourses between May 2014 and July 2016. The patient had parents. No information on patient''s medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified HPV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author did not comment on the relationship between the event of death NOS and unspecified HPV vaccine. The author concluded that, "catering to market needs and, in the case of the HPV vaccine, moving to a costly form of chemoprevention constitute a dubious priority in public health. We question whether public health is advanced when dominant HPVV discourses and practices transform healthy bodies into "at-risk" bodies, and when cancer prevention is instrumentalized in the pharmaceuticalization of public health. We hope that our contribution legitimates areas and types of research that are crucial for "real" dialogue in public health, that is, dialogue that involves multiple stakeholders and that is not dominated by vaccine manufacturers and their key opinion leaders." The article corresponding to this case is not available for regulatory submission due to copyright restriction. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 792141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Death, Dyspnoea, Intensive care, Seizure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DK0095075131812ESP005718

Write-up: This spontaneous report as received from a consumer via social media and refers to unspecified female patients of unknown age. The patient''s concurrent condition included asthma. On an unknown date, the patients were vaccinated with human papillomavirus vaccine: either, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dosing details, lot# unknown) for prophylaxis. On unknown date, the patient experienced severe exacerbation of asthma, severe dyspnoea and seizures. On an unknown date, the patient was admitted to intensive care unit (ICU) for an unspecified reason. On an unknown date (two weeks later), the patient had died. Cause of death was not reported. It was unknown, if an autopsy was performed. The outcome of exacerbation of asthma, dyspnoea, unspecified adverse event and seizure was unknown. Causality assessment was not reported. Upon internal review, seizure was determined to be medically significant. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 792429 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-16
Onset:2018-11-18
   Days after vaccination:2
Submitted: 2018-12-13
   Days after onset:25
Entered: 2018-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251225C1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Electromyogram, 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: 2018-11-30
   Days after onset: 12
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: On 23-Nov-2018, electromyogram was performed, and the results were not reported.
CDC Split Type: 201805902

Write-up: This is a spontaneous case, reported by a physician to Regulatory Authority (regulatory reference number: IT-MINISAL02-513213) and initially retrieved on 27-Nov-2018, concerning an 87-year-old, elderly male patient of body weight 72 kg and height 171 cm. On 16-Nov-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml (frequency reported as 1DF), route of administration: intramuscular, batch number: 251225C1A, expiry date: 30-Jun-2019 and anatomical location: not reported]. On 18-Nov-2018, 2 days after vaccination, the patient was diagnosed with Guillain Barre syndrome (GBS). On 23-Nov-2018, electromyogram was performed but the results were not reported. On an unspecified date, lab tests (unspecified) were performed, and the results were not reported. On 30-Nov-2018, the patient died and the cause of death was unknown. It was unknown whether autopsy was performed. The patient had not recovered from the event GBS, at the time of death. The reporter assessed this case as serious (life threatening) and the causality as related to suspect vaccine. Follow-up reported by a physician and retrieved from Regulatory Authority (regulatory reference number: IT-MINISAL02-513213) on 10-Dec-2018: The date of vaccination (16-Nov-2018), batch number (251225C1A) and expiry date (30-Jun-2018) were added. It was reported that patient underwent unspecified lab tests. The patient died on 30-Nov-2018. Added new event ''death''. The narrative was amended accordingly. Case Comment: A 87-year-old male patient was diagnosed with Guillain Barre syndrome (GBS), 2 days after receipt of FLUAD (TIV). The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. It was reported that patient died, 14 days post vaccination. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event GBS as possibly related to suspect vaccine. Due to lack of information regarding, cause of death, diagnoses/symptoms leading to death, medical history of the patient at the time of vaccination, the causality of event death is unassessable. Progressive age of the patient with the event GBS (outcome not recovered) is considered as a risk factor for the event death. The company assessed the event (Guillain Barre syndrome) as serious (medically significant).


VAERS ID: 792408 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + 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
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Blood urine present, Contusion, Crying, Cyanosis, Decreased appetite, Dyspnoea, Irritability, Pallor, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage 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 (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COGLAXOSMITHKLINECO2018GS

Write-up: This case was reported by a consumer via local affiliate and described the occurrence of respiratory failure in a 2-month-old female patient who received Rotavirus vaccine for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis, Polio vaccine for prophylaxis and DTPw-HBV/Hib for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral), Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib. On an unknown date, 1 day after receiving Rotavirus vaccine, Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib, the patient experienced respiratory failure (serious criteria death and GSK medically significant), abnormal breathing (serious criteria life threatening), crying, blood in urine, pallor, bruising of leg, cyanosis, appetite lost and difficulty breathing. On an unknown date, the outcome of the respiratory failure was fatal and the outcome of the abnormal breathing, crying, blood in urine, pallor, bruising of leg, cyanosis, appetite lost and difficulty breathing were unknown. The reported cause of death was respiratory failure. An autopsy was performed. It was unknown if the reporter considered the respiratory failure, abnormal breathing, blood in urine, pallor, bruising of leg, cyanosis, appetite lost and difficulty breathing to be related to Rotavirus vaccine, Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib. The reporter considered the crying to be related to Rotavirus vaccine, Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib. Additional details were received as follows: This case was identified during media monitoring and was reported by a radio program. The patient?s mother was described the occurrence of fatal case, for the patient who received Polio vaccine, Pentavalent vaccine, Pneumococcal vaccine and Rotavirus vaccine, according to local schedule of 2 months. The reporter informed that 3 hours after application the patient started with irritable crying, loss of appetite. On the next day, the patient started with pallor and at night when the patient''s mother was to change the diaper and she saw blood in urine and decided to visit emergency service. In emergency service the patient started with fast abnormal breathing and after that the patient presented cyanosis and difficult breathe. Due this situation, the physician decided to supply 0.5 L of oxygen and was referred to another hospital with pediatrician. The patient''s mother arrived to vital emergency service and there the physician increased oxygen to 2 L and after to 3L, however the patient was not able to breath. Because of that, physician decided to sedate, intubate and place mechanical ventilation, but 4 hours after that the patient presented respiratory failure and baby died. The physician requested a necropsy, of which was not available at the moment of this report. During the interview was not mention a trade name of GSK, however taking into account the local health care system, Pneumococcal vaccine and rotavirus vaccine could be GSK products. Follow-up was not possible due to the reporter did not have access to contact information, however If the reporter would receive additional information they would reply. Reported Cause(s) of Death: respiratory failure.


VAERS ID: 792656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131812AUT009316

Write-up: This spontaneous report as received from an unspecified reporter, who found this case, refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot#, expiry unknown) for prophylaxis. It was reported by the Medicines Agency (MA) that on an unknown date, shortly after the vaccination, patient died due to unknown causes. It was unknown if an autopsy was performed or not. Causality assessment was not provided. This is one of the two reports received from the same reporter.; Sender''s Comments: DE-009507513-1812DEU008885:; Reported Cause(s) of Death: died.


VAERS ID: 792657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131812DEU008885

Write-up: This spontaneous report as received from an unspecified reporter, who found this case in a publish, refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot#, expiry unknown) for prophylaxis. It was reported by the Agency that on an unknown date, shortly after the vaccination, patient died due to unknown causes. It was unknown if an autopsy was performed or not. Causality assessment was not provided. This is one of the two reports received from the same reporter. Reported Cause(s) of Death: died.


VAERS ID: 793302 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Alopecia, Amnesia, Anxiety, Behaviour disorder, Coagulation test, Death, Decreased appetite, Depression, Encephalitis autoimmune, Fatigue, Gait disturbance, Gastrointestinal obstruction, Headache, Hot flush, Liver disorder, Loss of consciousness, Malaise, Mood altered, Multiple organ dysfunction syndrome, Myalgia, Nausea, Paraesthesia, Prothrombin time, Renal failure, Septic shock, Syncope, Weight decreased
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), Acute pancreatitis (broad), Peripheral neuropathy (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REPEVAX; TEMESTA
Current Illness: Anxiety; Obsessive-compulsive disorder (Stop Date: Continuing); Prophylactic vaccination; Trichotillomania
Preexisting Conditions: Medical History/Concurrent Conditions: Nervousness; Tonsillectomy; Comments: Medical history: Consultation on 28-Sep-05 : nervousness. Obsessive-compulsive disorder; major depressive disorder; tonsillectomy and adenoidectomy on 15-Jun-2010; psychiatric therapy since 2008; frequent nervous breakdown that began after the birth of her first child in 1986. No convulsion in her childhood but trichotillomania which would have started in 2005, anxiety, stress and somatization symptoms which would have started following a move. No known neonatal distress. According to the parents she had not experienced any psychomotor retardation. According to the parents, she was healthy and had no relevant medical history. She was active, joyful, enthusiastic and had many projects.
Allergies:
Diagnostic Lab Data: Test Date: 20100815; Test Name: Coagulation factor VII level; Test Result: 48 %; Test Date: 20100815; Test Name: Coagulation factor X level; Test Result: 48 %; Test Name: Prothrombin ratio; Result Unstructured Data: Lab result: 15Aug and 14Oct : below N 48 and 65 percent; Test Name: Prothrombin ratio; Result Unstructured Data: Lab result: 15Aug and 14Oct : below N 48 and 35 percent; Test Date: 20101014; Test Name: Prothrombin ratio; Test Result: 35 %
CDC Split Type: FR0095075131206USA03351

Write-up: Due to narrative field size limitation, info submitted in previous version was revised in this FU. Case received from the Health Authorities on 15-Jun-2012 under the reference number TO20101212 and medically confirmed. Fup received from HAs on 28-Jun-2012, 04-Jul-2012. Fup received via a media press article (not medically confirmed information) on 19-Dec-2013, 3-Apr-2014 and 08-Apr-2014 on 25-Aug-2014. Fup information received via a legal source on 16-Dec-2014. A 17-year-old female patient had received the 3 doses of GARDASIL (batch numbers not reported) on 24-Oct-2008, 19-Dec-2008 and 24-Apr-2009 via IM route. The patient died on 20-Oct-2010. The patient had no history of convulsion. She had a medical history of obsessive-compulsive disorder, trichotillomania, major depressive disorder, and tonsillectomy in Jun-2010. It was reported that she was having a long-term treatment with Citalopram (SEROPRAM) since probably Feb-2009. The parents reported that before the vaccination, the patient was healthy and had no relevant medical history. She had been active, joyful, enthusiastic, with many projects. According to the parents, she experienced headache and abdominal pain on unspecified onset of time after receiving her first dose of GARDASIL on 24-Oct-2008. The patient''s parents reported that at the time it was not alarming for an adolescent, but symptoms became increasingly significant after second dose on 19-Dec-2008. She developed anxiety, hot flushes, paraesthesia in lower limbs, muscle pain, walking difficulties. On 18-Apr-2009, she presented with marked syncope preceded by lipothymic sensations and nausea. Emergency medical assistance was called injected her with magnesium.There was no recurrence of malaise. After the third dose of Gardasil on 24-Apr-2009, she still presented with intermittent symptoms, along with intense fatigue, fainting, mood changes and loss of appetite. EEG performed on 06-May-2009 was unremarkable, no specific elements of epileptic nature was found. The media press article stated that during the winter season before patient''s death, she had complained of being tired, with dark thoughts and formication in legs. She had no more energy and had increasing difficulties to climb stairs. Within the following months, she was suffering from intensified muscular pain and experienced malaise, hair loss and memory loss. In summertime, the patient had stayed prostrate and was unable to stand on her legs when she was admitted to hospital. She had additionally a "raging fever". The article also mentioned that the hospital neurologist was considering the relationship between the events and the vaccine as a hypothesis, but that there were no further elements allowing to confirm such a statement. The patient''s medical file had also established the vaccine imputability as possible, although it was considered doubtful by the Health Authorities. The patient''s health status abruptly worsened at the end of July 2010: loss of weight, loss of references, behavior disorders and memory lapses. The patient was hospitalized at the beginning of Aug-2010 in three successive hospitals. She was placed into induced coma from which she could not wake up due to irreversible convulsions. According to the HAs reports : she was hospitalized since 06-Aug-2010 due to major depressive disorder and catatonia. During hospitalization, on unspecified date between 06-Aug-2010 and 12-Aug-2010, she was given Lorazepam (Temesta) per os, 2 injections of Cyamemazine (Tercian) 50 Mg via intravenous route and one injection of Risperdone (Risperdal) via intravenous route. On 13-Aug-2010 she was hospitalized with clinical features of hyperthermia at 38,7 degree Celsius associated with mutism and generalized hypertonia with neurovegetative dysautonomia. Biological work-up on 13-Aug-2010 showed inflammatory syndrome with CRP at 100 mg/l and rhabdomyolysis with CPK at 2400 IU/l. EEG and brain MRI were normal. The following non drug-induced aetiologies were ruled out: EEG did not provide any evidence of epileptic activity. Brain CT scan showed no cerebral thrombophlebitis but right maxillary sinusitis was present. Lumbar puncture showed CSF white cell count at 20/mm3, CSF glucose at 1,78 g/l and CSF protein at 0,27 g/l. Infectious work-up were negative for Cytomegalovirus, HIV, varicella, Lyme disease, Leptospirosis and syphilis. Autoimmune workup was negative. Further to lumbar puncture results, a treatment with Aciclovir and Clonazepam was started and the patient was transferred to a neurology unit where she was given Dantrolene on 14-Aug-2010. Zovirax was maintained. On 15-Aug-2010 at 4.00 am the patient experienced acute respiratory distress on right lung atelectasis. She was intubated, ventilated, sedated and treatments with Ceftriaxone and Levofloxacine were initiated. These treatments failed. Dantrolene was also stopped then started again on 16-Aug-2010. On 26-Aug-2010 the patient was still intubated and sedated as attempts of extubation failed. She still presented with neurovegetative dysautonomia. On 29-Aug-2010 tracheal aspiration showed P.aeruginosa therefore the patient was put on Imipenem/Cilastatine and Amikacine. On 02-Sep-2010 she experienced epilepticus status which regressed on Thiopental, as well as Phenobarbital and Levetiracetam. Hemodynamic status was stable. According to the physicians the only differential diagnosis was malignant catanonia, which was very rare. On 09-Sep-2010, the patient experienced clonism after each lifting of sedation despite treatment with Temesta, Gardenal and Keppra.Autoimmune limbic encephalitis was treated with Immunoglobulin Human Normal. On 21-Sep-2010, she experienced a convulsion treated by Fosphenytoine and Penthotal. It was followed by ketogenic diet causing hepatic cytolysis, acute renal insufficiency, cardiac insufficiency and hypertriglyceridemia. On 04-Oct-2010, corticotherapy was initiated. On 08-Oct-2010, ketogenic diet was poorly tolerated, causing hepatocellular insufficiency, acute renal insufficiency, hyperkalemia and gastrointestinal obstruction. On 17-Oct-2010, the patient experienced a septic shock (pyo). On 19-Oct-2010, she was found to have multi-organ failure. The patient died on 20-Oct-2010. The patient''s parents sent a letter to the Health Authorities questioning the causal relationship between vaccination with GARDASIL and their daughter''s death by meningoencephalitis. Autopsy report from 22-Oct-2010: absence of spongiform encephalopathy. Quite diffuse astrocytic gliosis of the focal signal of the meningitis were noted. Elements suggesting meningoencephalitis. Time to onset of the event made it difficult to attribute a causal relationship to GARDASIL. On 29-Oct-2010, the conclusion of hospital report (intensive care) was provided : Malignant epilepticus status. Early failure of ketogenic diet. Significant immune suppression induced by barbiturates and corticotherapy. Septic shock with pulmonary and digestive starting point. Acute respiratory distress. Multi-organ failure. Brain autopsy was suggested and accepted by the parents.On 08-Jun-2012, a discussion with the neurologist in charge of the patient was reported: Autoimmune encephalitis was the central problem, the other manifestations being complications. The neurologist affirmed that the symptomatologylinked to the autoimmune encephalitis started before 06-Aug-2010, at the end of July 2010 and beginning of August. It seemed at least possible that the symptoms which sneakily appeared over the previous months (which, according to the parents started beginning of 2009) could be related to autoimmune encephalitis. Upon medical review, the company judged relevant to code the adverse events respiratory distress, septic shock, renal insufficiency, cardiac insufficiency, hepatic cytolysis, right lung atelectasis, pseudomonas aeruginosa infection, status epilepticus, gastrointestinal obstruction, malaise, nausea and lipothymic sensations which were mentioned by the CA in the narrative but not coded. The patient''s medical history revealed no convulsion in her childhood but reported trichotillomania with onset 2005, anxiety, stress and somatization disorders triggered after moving home. Since 27-Feb-2009, psychiatric monitoring was initiated for frustrates depression, aggressivity and OCD (obsessive compulsive disorder) with trichollomania. Treatment with citalopram was prescribed. On 18-Apr-2009, the patient experienced loss of consciousness without clonic-like abnormal movements or vomiting. She gradually woke-up with tremors. The EEG on 06-May-2009 showed a discreetly unstable drawing but no specific elements of epilepsy. On 15-Jun-2010, amydalectomy and adenoidectomy were performed. On 16-Jul-2010, she received a dose of REPEVAX (batch number E0572). On 06-Aug-2010, she was hospitalized in psychiatric unit due to psychotic decompensation. Treatment with cyamemazine (Tercian) and risperidone (Risperdal) was introduced. On 12-Aug-2010, her condition worsened, she could not walk any longer, she was totally mute and she refused all food. On 13-Aug-2010, acyclovir (Zovirax) was introduced against herpetic meningoencephalitis. Cerebral CT-scan found no cerebral thrombophlebitis. Skull CAT ruled out thrombophlebitis but found right maxillary sinusitis. She experienced 2 episodes of tachycardia with clonies in upper limbs relieved by clonazepam (Rivotril). CSF showed 20 leucocytes /mm3, glycorachia at 1.78 g/l, proteinorachia at 0.27 g/l. Treatment with Zovirax was started. On 14-Aug-2010, she was hospitalized in neurology for neuroleptic malignant syndrome. She was still febrile. Neurological symptoms were unchanged and Dantrolen was started. On 15-Aug-2010, she experienced hypoxemia and acute respiratory distress and atelectasis of right lung. She was transferred in reanimation were she was conscious with open eyes but not responsive, with decreased of rigidity and absence of focalization signs, polpneic, decreased of right vesicular murmur and tachycardia. Treatment with recephin and tavanic with no improvement. She was intubated. Dantroelne was stopped. Full autoimmune work-up was performed with blood culture, tracheal aspirates, HIV and CMV serologies (negative), investigations of syphilis, Borrelia, leptospirosis and VZV. Autoimmune work-up was performed with investigations of ANCA, anti-DNA antibodies and antiphospholipid antibodies as well as normal C3-C4 assay complement and CH50. Tracheal aspiration was positive for Streptococcus viridans and Staphylococcus coagulase negative. Hemostatsis showed decreased value for Factor VII and X. On 16-Aug-2010, a new lumbar puncture found 18 nucleated elements with CSF protein level slightly decreased and CSF glucose normal. CSF analysis of 16-Aug-2010 were negative for mycological examination, toxoplasmosis and cryptococcal serologies, no DNA toxoplasma gondii and no CMV, EBV, HSV1, HSV2, VZV and enterovirus. On 16-Aug-2010, repeat EEG showed no signs of epilepsy or encephalitis but irregularity of the track was found and monitored. On 18-Aug-2010, sedation was stopped and patient was extubated. But persistent catatonia and neck stiffness with no Babinski sign but opposition movements on mobilization. On 19-Aug-2010, she was intubated again for inhalation pneumopathy with "white" left lung. Fibroscopy was normal. Brain MRI on 19-Aug-2010 was normal. On 20-Aug-2010, she presented with extra-pyramidal deterioration syndrome. That day, she was given piperacilline, tazobactam (Tazocilline) until 22-Aug-2010 for viridens 105 streptoccocus pneumonia and for coagulase staphylococcus negative at 105 found in the tracheal aspirates. CSF was negative. Blood culture was negative. She had no fever. On 26-Aug-2010, no fever and she was off antibiotics. On 26-Aug-2010, she experienced tonic-clonic seizures and persistent neurovegetative dysautonomia. Despite sedation, she ended up in a generalized convulsive epilepticus state resistent to benzodiazepines. She was put on fosphenytoine (Prodilantin) with enhanced sedation, then on levetiracetam (Keppra) clinically for sedation seizures. On 02-Sept-2010, she was found in epilepticus state regressing under high doses of thiopental-sodium (Pentothal). After Pentothal was discontinued, no more signs of status epilepticus but presence of spike and waves discharges. On 02-Sept-2010, tracheal aspirates from 29-Aug-2010 showed Pseudomonas aeruginosa and lack of Acinotobacter leading to stopping antibiotherapy on 31-Aug-2010 with imipenem cilastatine (Tienam) and amikacine (Amiklin) both at day 3 substituted by ceftazidine (Fortum) on 01-Sept-2010. Lyme disease in CSF, direct examination and HIV serology were negative. The patient was apyretic. Repeat EEG on 02-Sep-2010 found no convulsive activity. On 07-Sep-2010, she was tracheotomized to allow respiratory weaning. On 09-Sep-2010, despite treatment with levetiracetam (Keppra), phenobarbital (Gardenal) and lorazepam (Temesta) for catatonia, the patient experienced clinical clonic episodes after each lifting of sedation confirmed by EEG. Hypothesis of autoimmune limbic encephalitis was discussed. Treatment with Tegeline 2 g/kg for 5 days was started on 09-Sep-2010 with clinical reassessment. On 09-Sep-2010, she was apyretic after 7 days treatment with Fortum for pseudomonas aeruginosa in tracheal aspirates. Partial fits observed on EEG on 13-Sep-2010. On 16-Sep-2010, Pseudomonas aeruginosa found in tracheal aspirates on 06-Sep-2010 and enterococcus faecium was marked in urine test of 10-Sep-2010. Since 16-Sep-2010, these bacteria were treated with meropenem trihydrate (Meronem) and linezolide (Zyvoxid), central venous line was removed and urinary catheter changed. Daily EEGs showed a discontinuation of status epilepticus, persistent track of diffuse brain-damage, presence of some epileptic seizures depending on the day and lack of reactivity. Prodilantin treatment was reintroduced on 21-Sep-2010 due to new seizures. MRI scan on 21-Sep-2010 was normal. On 21-Sep-2010, she was transferred to intensive care. On arrival in ICU, she was intubated, sedated, hemodynamics was stable, she was put on assisted ventilation in low Fi02, without obvious abnormality at physical examination and she was apyretic. She did not convulse clinically. Progression in intensive care: from a neurological standpoint, she was in status epilepticus resistent to Keppra, Hypnovel, Prodilantin and Gardenal. Reintroduction of Pentothal was decided and seizures stopped after bolus treatment, then intravenous infusion through syringe driver. On 27-Sep-2010, she was placed in barbiturate coma 1g/h to avoid seizures or paroxysm on EEG. With lower doses of barbiturates, periodic bursts were found on EEG due to persistence of encephalitic-like brain-damage. Unfortunately, on 29-Sep-2010 her status worsened with cystolitic hepatitis, hepatocellular insufficiency, lactic acidosis and hyperkalemic and acute renal failure (complicated by cardiac conduction disorders). On 30-Sep-2010, investigations of CSF, HIV, CMV, EVB, HSV1, HSV2, VZV, Herpes virus 6, enterovirus, polyomavirus and bacteriology were negative. The immunological exploration in CSF and serum showed negative antiGAD65. Laboratory tests showed hypertriglyceridemia. On 04-Oct-2010, high dose corticotherapy was initiated with Solumedrol bolus 1g/30 min for 3 days. A new course of human normal immunoglobulins (Tegeline) was considered but not possible due to continued hemofiltration for acute renal insufficiency. A ketogenic diet was initiated on 06-Oct-2010. Bolus of solumedrol was initiated again on 9-Oct-2010 (500 mg/30 min) repeated 3 days. On 17-Oct-2010, while the patient was under 350mg/h of Pentothal, EEG showed again a low veiled recording, overloaded by diffuse spikes either isolated or in short bursts. Treatment with Zonegran was advised. There was no obvious favorable neurological outcome. From hemodynamic, renal and infectious respiratory standpoint, the patient promptly presented with septic shock with acute respiratory distress syndrome and presence of Pseudomonas aeruginosa resistant to imipenem in tracheal aspirates. An extended spectrum beta lactamase (ESBL) was found in tracheal aspirates and vaginal secretions. A thoracic, abdominal and pelvic injected CAT-scan did not find evidence of deep focus. Ketogenic diet initiated was complicated by hepatic and renal intolerance with hepatocellular insufficiency, acute anuric and hyperkalemic renal insufficiency (with cardiac repercussions) requiring continuous hemofiltration (PRISMAFLEX) on 08-Oct-2010. After diet was discontinued hepatic cytolysis and prothrombin time regressed but the patient did not recover effective renal function, she was still anuric. She experienced gastrointestinal obstruction. On 17-Oct-2010, the patient''s condition deteriorated with a right pneumonia. She was febrile under Prisma. Tracheal aspirates were positive to multiresistant Pseudomonas aeruginosa. Blood culture was positive to enterococcus faecium. She had severe diarrhoea. Antibiotherapy was adjusted. The outcome was not favorable with new acute respiratory distress syndrome followed by septic shock. On 19-Oct-2010, the patient was found to have multi-organ failure. On 20-Oct-2010, arterial PH was 6.87under Prisma, intensive reanimation was initiated (protective ventilation, catecholamines, Prisma, anti-infection treatment). Patient died in the evening. In conclusion: malignant epileptic seizure, autoimmune limbis encephalitis evoked, initial psychiatric symptoms, induced barbituric coma, early failure of ketogenic diet (hepatic intolerance), strong immunosuppression induced by barbiturates and corticotherapy, sceptic shock with initial pulmonary and digestive trigger, acute respiratory distress syndrome, multi-organ failure. Immu?nological and bacterial lab sample did not provide diagnosis orientation. Autopsy report showed no lesions suggestive of negative anti-PrP immunohistochemistry (Spibio, 12F10, 1/200th) and negative Western Blot. She was diagnosed with malignant neuroleptic syndrome associated with sepsis and meningitis. The patient had presented with a malaise following severe alcohol intoxication. This info was not reported by the general practitioner who provided medical assistance to the patient that day. Follow up information has been received from Sanofi Pasteur MSD on 20-FEB-2015.FU on 17-Feb-2015 from lawyer: Cerebral biopsy on 22-OCT-2010: Analysis of 26 samples on left cerebral hemisphere. Western Blot test for prion protein on right cerebral hemisphere negative on 10-FEB-2011. Creutzfeldt-Jakob disease ruled out, absence of spongiform encephalopathy, data in favor of meningoencephalitis diagnosis. Immunohistochemistry confirms diagnosis of meningitis associated with diffuse microgliosis, presence of B and T cells on leptomeningeal area. No toxicological titration on brain sample during the autopsy. FU received from Sanofi Pasteur MSD on 11-SEP-2015. FU on 8-Sep-15 from lawyer: Consultation on 28-Sep-05: nervousness. F/U information has been received from the patient''s parents via reposted online article. It was reported that the patient was mown down by the GARDASIL and that the vaccine killed their daughter. It has been determined that case #FR-009507513-1812FRA003087 is a duplicate of case #FR-009507513-1206USA03351. Therefore, case # FR-009507513-1812FRA003087 is being deleted from our files and the cases are consolidated into case #FR-009507513-1206USA03351.; Reported Cause(s) of Death: Meningoencephalitis; Neuroleptic malignant syndrome; Sepsis; Autopsy-determined Cause(s) of Death: Meningoencephalitis; Neuroleptic malignant syndrome; Sepsis


VAERS ID: 793321 (history)  
Form: Version 2.0  
Age: 0.92  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-17
Onset:2016-10-01
Submitted: 0000-00-00
Entered: 2018-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 150201 / UNK - / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Apathy, Crying, Encephalitis viral, Fatigue, Hepatic failure, Irritability, Lethargy, Meningitis, Opisthotonus, Pallor, Panencephalitis, Pneumonia, Pyrexia, Somnolence, Thrombocytopenia, Tremor
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131812BRA010453

Write-up: Information has been downloaded from regulatory authority (BR-GLAXOSMITHKLINE-BR2017GSK076666). This spontaneous report was received from a health professional concerning a 11-month-old male patient. The patient''s medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On 17-OCT-2016, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) solution for injection, intramuscularly with reported lot number 155VPN009A (strength, dose, frequency and expiry date were not reported), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) subcutaneously with reported lot number 015N5002 (strength, dose, frequency and expiry date were not reported) and MENJUGATE solution for injection, intramuscularly with reported lot number 150201 (strength, dose, frequency and expiry date were not reported), all three vaccines for prophylaxis. On an unspecified date in October 2016, the patient experienced meningitis, persistent crying, hepatic insufficiency, metabolic disorder, alteration in transaminase, thrombocytopenia, lethargy, pallor, apathy and bronchopneumonia. Also, on an unspecified date in October 2018, a body temperature test was performed to the patient, showing a result of more than or equal to 39 (units not provided). On 18-OCT-2016, the patient experienced prostration condition and fever. On 04-NOV-2016, the patient experienced opisthotonus, somnolence and irritability. On an unspecified date in November 2016, the patient experienced viral encephalitis, trembling in extremities, viral panencephalitis post vaccine and faraway look. Also, on an unspecified date in November 2016, a computerized tomogram head test was performed to the patient (no information was available). On an unknown date, the patient died. It was unknown if an autopsy was carried out. The reported causes of death were hepatic insufficiency and metabolic disorder, with a reported date of end of both events on 08-NOV-2016 (conflicting information). The outcome of opisthotonus, trembling in extremities, alteration in transaminases, viral panencephalitis post vaccine, faraway look, somnolence, thrombocytopenia, irritability, lethargy, pallor, apathy, bronchopneumonia, viral encephalitis, fever, meningitis and prostration condition was reported as unknown (conflicting information as the reporter determined all the aforementioned events to be serious due to death and medically significant). The outcome of crying was reported as recovered (date not provided) (conflicting information as the reporter determined the event to be serious due to death and medically significant). The causality assessment between pneumococcal vaccine (manufacturer unknown) and all the aforementioned events, was reported as unknown. The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and all the aforementioned events, was not provided. The causality assessment between MENJUGATE and all the aforementioned events, was reported as unknown. Lot number 155VPN009A is an invalid lot number for pneumococcal vaccine. Lot number 015N5002 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Reported Cause(s) of Death: Hepatic insufficiency; Metabolic disorder.


VAERS ID: 793763 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131812DEU011846

Write-up: This spontaneous report was received from a physician via social media refers to a 14-year-old male patient. The patient''s medical history, concurrent conditions, and concomitant medications were unknown. On an unknown date the patient was vaccinated with GARDASIL (Lot#, expiry, frequency and route of administration unknown) for prophylaxis. On an unknown date the patient experienced myocarditis, which resulted in the patient''s death on an unknown date. The reporter considered myocarditis to be related to GARDASIL and stated that further causal relationship was established by looking to the proximate temporal relationship between vaccination and death. The reporter also informed that the deceased patient being healthy and without any health problems provide strong circumstantial evidence that the death was caused by GARDASIL. It was reported that this case was recently filed under the vaccine injury compensation program. It was also reported that the expert witness in this case was so disturbed by his findings that he felt compelled to publicly issue the following warning that the teenagers vaccinated with should away from competitive sports such as football for at least two months, and should have an electrocardiogram to rule out silent myocardial Infarction if there is any Incidence of syncope, chest discomfort, tachycardia or hypotension within two months after GARDASIL vaccination. Sender''s Comments: DE-009507513-1812DEU011309.


VAERS ID: 793766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE0095075131812XAA010596

Write-up: This spontaneous report was received from a physician who reported on a lay press article published in an online daily newspaper, via a company representative, via other unspecified reporter, and refers to an unknown number of female patients (also reported as "girls") of unknown age. Information about the patients'' medical history, concurrent conditions, concomitant medications and drug reactions or GARDASIL, for prophylaxis (strengths, doses, frequency, route, lot numbers and expiration date were not provided). Since unknown dates, it was reported that GARDASIL might already have caused several hundred deaths and caused serious injuries for more than 50,000 girls in the countries were GARDASIL, had been used. He also referred to hidden statistics, since he claimed that most of the adverse reactions were never reported to the authorities by physicians. According to the article, until 14-OCT-2018, 54,123 reports of noxious adverse reactions were reported, whereof 331 were events of death after vaccination with GARDASIL. No information was provided regarding the causes of the patient''s deaths and if autopsies were performed or not. At the time of reporting, the outcome of injury and adverse event was unknown. Causality assessment was not provided. 28-DEC-2018 - This is an amended report. The COI has been changed.


VAERS ID: 794129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2018527724

Write-up: This is a literature report received from an Other Health Professional via the Regulatory Authority online database search. The regulatory authority report number is E2B_00570987. Literature citation was not provided. This information was initially reported to regulatory authority on 03Dec2015 an unknown Market Authorization Holder (AER# CA2015GSK171385). A patient of unspecified age and gender received PREVNAR 13 at single dose, diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid, ROTAVIRUS VACCINE, all on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the batch number has been requested. Follow-up attempts not possible. No further information expected. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 794791 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R012427 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HK0095075131812HKG012739

Write-up: This spontaneous report was received from a physician via company representative regarding a currently 85 years-old male patient. The patient''s relevant medical history, concurrent conditions and concomitant medications were not reported. On 17-NOV-2018, the patient went to hospital for anti-itch shot and on the same day he was vaccinated with PNEUMOVAX 23 (strength, dose, frequency were not reported, lot # R012427 and expiration date: 07-DEC-2019 for prophylaxis) and influenza virus vaccine inactivated (unspecified). On an unknown date in 2018, the patient died (medically significant), and the patient''s daughter informed the doctor about his death on 24-DEC-2018. The cause of death was not reported. It was unknown if autopsy was performed. The patient''s daughter also stated that it was the doctors fault to inject the three shots on the same day for her father. After the evaluation, the physician thought the patient''s death did not relate to PNEUMOVAX 23 because the patient did not come back for assessment after 3 days, and he did not know what was happened in that month period. This is one of the three reports received from the same reporter. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between PNEUMOVAX 23 and the reported event of death cannot be established. Causality assessment is impacted by concurrent vaccination and limited information regarding concurrent conditions, medical history, concomitant medications and cause of death. Company Comment- No changes to the PNEUMOVAX 23 product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: HK-009507513-1812HKG012745: HK-009507513-1812HKG012741:; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 795053 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2018; Test Name: Cardiotocography
CDC Split Type: PTGLAXOSMITHKLINEPT2019GS

Write-up: This case was reported by a other health professional and described the occurrence of death nos in an unspecified neonate patients who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced death nos (serious criteria death and GSK medically significant) and fetal exposure during pregnancy. On an unknown date, the outcome of the death nos was fatal and the outcome of the fetal exposure during pregnancy was unknown. The reported cause of death was unknown cause of death. The reporter considered the death nos to be unrelated to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was working in the hospital from May 2018 to the end of the year, where around 10 to 15 deaths of neonates occurred. On the medical report of these deaths was referred, as cause of death, where the administration of BOOSTRIX (vaccine administered to their mother- exposure during the pregnancy). Last week before the date of reporting, a neonate was transferred from hospital to do culling procedure and his or her mother was still hospitalized. The reason alleged for the complications of the patient was, again, the administration of BOOSTRIX. Analyzing the Cardiotocography was clear that was not due to the vaccine. The reporter did not has enough information to open individual cases. If any follow up was scheduled because reporter did not has permission to contact the reporter that wanted to remain anonymous. The reporter agreed that if he had relevant information to share with us, he would proactively contact GSK. Reported Cause(s) of Death: Death NOS.


VAERS ID: 795436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-24
Onset:2018-10-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD114A / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 172601 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W91639 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB846BF / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-26
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201900

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of death unexplained in a 8-week-old male patient who received INFANRIX HEXA (batch number A21CD114A, expiry date unknown) for prophylaxis. Co-suspect products included BEXSERO (batch number 172601, expiry date unknown) for prophylaxis, ROTARIX liquid formulation (batch number AROLB846BF, expiry date unknown) for prophylaxis and PREVENAR 13 (batch number W91639, expiry date unknown) for prophylaxis. On 24th October 2018, the patient received INFANRIX HEXA (intramuscular), BEXSERO (intramuscular) 1 dosage form(s), ROTARIX liquid formulation (oral) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 26th October 2018, 2 days after receiving INFANRIX HEXA, BEXSERO and ROTARIX liquid formulation, the patient experienced death unexplained (serious criteria death and GSK medically significant). On 26th October 2018, the outcome of the death unexplained was fatal. The patient died on 26th October 2018. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death unexplained to be related to INFANRIX HEXA, BEXSERO and ROTARIX liquid formulation. Additional information: The age at vaccination was not reported. However, the patient could be 8 weeks or less than 8 weeks at the time of vaccination. Initial information was received a other health professional via regulatory authority on 8th January 2019: Child died 2 days after vaccination. I do not think the vaccination was the cause of the death. I have been advised to complete a yellow card and submit to the RA in line with best practice. Reported Cause(s) of Death: Death unexplained.


VAERS ID: 795522 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2018-06-21
Onset:2018-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Hypotonic-hyporesponsive episode, Irritability, Skin warm, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: CALPOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201900

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hypotonic-hyporesponsive episode in a 2-month-old male patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included BEXSERO for prophylaxis, ROTARIX for prophylaxis and PREVENAR 13 for prophylaxis. Concomitant products included CALPOL. On 21st June 2018, the patient received the 1st dose of INFANRIX HEXA (intramuscular), the 1st dose of BEXSERO (intramuscular), the 1st dose of ROTARIX (unknown) and the 1st dose of PREVENAR 13 (intramuscular). On 21st June 2018, less than a day after receiving INFANRIX HEXA, BEXSERO and ROTARIX, the patient experienced hypotonic-hyporesponsive episode (serious criteria death) and sudden death unexplained (serious criteria death and GSK medically significant). On an unknown date, the patient experienced irritable (serious criteria death) and skin warm (serious criteria death). On an unknown date, the outcome of the hypotonic-hyporesponsive episode and sudden death unexplained were fatal and the outcome of the irritable and skin warm were unknown. The reported cause of death was sudden death unexplained and hypotonic-hyporesponsive episode. An autopsy was performed. It was unknown if the reporter considered the hypotonic-hyporesponsive episode, irritable, skin warm and sudden death unexplained to be related to INFANRIX HEXA, BEXSERO and ROTARIX. Additional information: The outcome of Hypotonic-hyporesponsive episode was reported as Not Recovered/Not Resolved. Initial information was received from a physician via regulatory authority on 8th January 2019: Hypotonic-hyporesponsive episode, irritable, skin warm and sudden death unexplained. Note: The date of death was reported as 23rd June 2018. However, the date for sudden death event was reported as 21st June 2018. Reported Cause(s) of Death: Sudden death; Hypotonic-hyporesponsive episode.


VAERS ID: 795792 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSA2019SA008724

Write-up: Initial information received on 08-Jan-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional via press release. This case involves 3 patients (age was not reported) of unknown demographics had died because of the flu, according to the Health Department web page Country three of the deceased patients were vaccinated with INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patients had died because of flu. This event was leading to death. According to the information indicated in the press release (based on the information included in the Health Department web page of the Country, four people of unknown demographics had died because of the flu since the vaccination campaign had started in the Country. According to the Health Department web page of the Country three of the deceased patients were vaccinated. (Other relevant tests included no lab data.) Final diagnosis was (fatal) three people of unknown demographics had died because of the flu. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as flu. List of documents held by sender: none. Sender''s Comments: Three people of unknown age and gender passed away due to influenza infection were reported by Health Department. Date of vaccination, past medical history, concomitant medication, date of death are not reported. Additional details from vaccination history, past medical history, concomitant medication, as well as clinical and laboratory investigation. Surrounding reported events are needed to fully assess causality for this case. Based on available information the role of vaccine cannot be assessed. Reported Cause(s) of Death: Flu like symptoms.


VAERS ID: 795996 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-12-02
Onset:2008-12-21
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2019-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA482A / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH P661966 / 1 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-21
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2019018508

Write-up: This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number DE-PEI-PEI2018005328. A 5-month-old male patient received PREVENAR 13, (lot number: P661966) at single dose (first dose), INFANRIX HEXA, (lot number: A21CA482A) at an unspecified dose, both via an unspecified route of administration on 02Dec2008 for prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. The patient previously took diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid for immunization on 23Sep2008. The infant patient suddenly died 19 days after vaccination on 21Dec2008 and the cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796001 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-10
Onset:2018-10-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2019-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Respiratory arrest
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), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-15
   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: CALPOL; NUROFEN
Current Illness: Routine childhood immunisation; Teething
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131901GBR002034

Write-up: Information has been downloaded from Regulatory Authority (GB-MHRA-ADR 24367043). This spontaneous report was received from a consumer concerning a 3.5 years old male patient with teething. The patient''s medical history was not provided. On 10-OCT-2018, the patient was vaccinated with a booster dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), administered by parenteral route, for immunisation (lot # and expiration date was not reported). Concomitant therapies included CALPOL and NUROFEN. On 15-OCT-2018, the patient experienced cardiac arrest and respiratory arrest, and died due to cardiac arrest. It was unknown if an autopsy was performed. The outcome of respiratory arrest was reported as not recovered (conflicting information - also reported as a fatal event). The relatedness between the events and the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 796180 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-10
Onset:2019-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Sudden death
SMQs:, Torsade de pointes/QT prolongation (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), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSAKK2019SA009896AA

Write-up: Initial information received on 11-Jan-2019 regarding an unsolicited valid serious case received from Other non-health care professional via social media. This case involves a 67 years old male patient who suffered total (multi) organ failure soon after having the jab, while he received vaccine YELLOW FEVER VACCINE. The patient''s past medical history, concomitant medication and family history were not provided. On 10-Jan-2019, the patient received injection of suspect YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On 10-Jan-2019, the patient suffered serious, total (multi) organ failure soon after having the jab same day following the administration of YELLOW FEVER VACCINE. This event led to death of the patient. The doctor (patient) was a professor and died suddenly yesterday after a routine inoculation for yellow fever. Lab data was not provided. Final diagnosis was (fatal) patient suffered total (multi) organ failure soon after having the jab. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on 10-Jan-2019 for patient suffered total (multi) organ failure soon after having the jab. It is unknown if an autopsy was done. The cause of death was reported as Multiple organ dysfunction syndrome. List of documents held by sender- none. Sender''s Comments: This is a case received from a social media involves a 67-y.o. male who suffered (multi) organ failure unspecified time (reported as "soon") after receiving vaccine YELLOW FEVER VACCINE produced by unknown manufacturer. There is no information regarding patient''s medical condition at time of vaccination and the details of the illness (time to onset, symptoms and their evolution, investigation results) are not provided. The autopsy report is also not provided. Based upon the reported information, the role of the vaccine cannot be assessed. Reported Cause(s) of Death: Multi-organ failure.


VAERS ID: 796352 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2019009082

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 12-month-old female patient receive 3 doses of PREVENAR 13, via unspecified routes of administration, on unspecified dates, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient experienced pneumococcal meningitis- unknown serotype on an unspecified date. The patient died on an unspecified date in a hospital due to pneumococcal meningitis unknown serotype, which lasted for one day. It was unknown if an autopsy was performed. Initially meningococcal infection/was suspected, but it was not confirmed. Lot numbers has been requested. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: pneumococcal meningitis-unknown serotype; pneumococcal meningitis-unknown serotype.


VAERS ID: 796354 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Death, Endotracheal intubation, Lumbar puncture, Meningitis pneumococcal, Productive cough, Pyrexia, Seizure, Sepsis
SMQs:, Angioedema (broad), 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), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019015427

Write-up: This is a spontaneous report from a contactable consumer (the patient''s mother) via the medical information team. A 11-months-old female patient received the first dose of PREVENAR 13 at single dose and HEXYON, at 1DF the first doses of both on 20Mar2018 when she was 2 months old and the second doses on 17May2018 at 4 months old all for immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled to receive the booster dose at 10.5 months old but she could not because of fever. She died at 11 months old, due to pneumococcal meningitis as final diagnosis. The patient''s mother asked whether the booster dose might have helped her daughter to overcome that disease. Details as follows: the patient developed bronchitis on Thursday. She consulted at hospital then returned at home. She again consulted on Saturday: fever, bronchitis. She was treated with antibiotics. On Sunday/Monday, she was found to have "severe blood infection", the patient went to an Emergency unit, she was intubated, she had convulsions, a product was injected to calm her, she underwent a lumbar puncture but her brain did no longer respond. It went very quickly, the patient spit only phlegm. The mother told about "silent disease". The patient was finally diagnosed with pneumococcal meningitis and died. It was not reported if an autopsy was performed. Information on the batch number has been requested. Reported Cause(s) of Death: pneumococcal meningitis.


VAERS ID: 796520 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza, Influenza A virus test positive, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hemodialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza A virus test positive; Result Unstructured Data: Test Result: Influenza A(H1N1) subtype, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: BEGLAXOSMITHKLINEBE2019GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received quadrivalent seasonal influenza vaccine for prophylaxis. Concurrent medical conditions included hemodialysis. On an unknown date, unknown after receiving quadrivalent seasonal influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included H1N1 influenza with serious criteria of death. It was unknown if an autopsy was performed. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included H1N1 influenza (fatal). The reported cause of death was H1N1 influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and H1N1 influenza may have been caused by quadrivalent seasonal influenza vaccine. Relevant Tests: Lab tests were performed between December 2017 and April 2018, the patient was found positive for type A influenza virus (H1N1 subtype) through PCR Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza A virus test positive result was Influenza A (H1N1) subtype unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified quadrivalent seasonal influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of retrospective analysis that assessed the group of hemodialysis (HD) patients from December 2017 to April 2018 who were infected by the influenza virus type A or B and their vaccination status. The study also determined whether C-reactive protein (CRP) analysis and influenza virus detection by polymerase chain reaction (PCR) assay help to distinguish bacterial or viral infection and improve patient care. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified quadrivalent seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date between December 2017 and April 2018, an unknown period after vaccination, the patient developed symptoms suggestive of flu and/or unexplained CRP. The patient was found positive for type A influenza virus (H1N1 subtype) through PCR. [In this study, in the ?PCR positive'' group (n = 29), 20 patients were empirically treated with antibiotics. When the PCR returned positive, immediately stopped the antibiotics in a large majority of patients (n = 13/20), except for bacterial superinfection (n = 7/20)]. Subsequently, on an unspecified date, the patient died. The cause of death was Influenza A (H1N1) infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The author did not comment on the relationship between the event of influenza A (H1N1) infection and unspecified quadrivalent seasonal influenza vaccine. The author concluded, "In our study, influenza virus vaccination rate in our HD centre was higher than those published in the literature but it does not reach the goal of the WHO. Half of infected HD patients were vaccinated which confirms the data and the relative lack of effectiveness of the vaccine in this population. For this 2017-2018 epidemic, vaccinated HD patients were more infected by influenza virus type B than type A in our centre. This might suggest that influenza virus type B was more virulent or not well covered by the quadrivalent vaccine. Interestingly, high CRP level was frequently seen and not helpful to discriminate bacterial or viral infection. However, we suggest that PCR analysis on nasopharyngeal swabs is a promising tool to reduce the rate of futile antibiotic treatment". Lab Comments: Lab tests were performed between December 2017 and April 2018, the patient was found positive for type A influenza virus (H1N1 subtype) through PCR. Reported Cause(s) of Death: Influenza A (H1N1) infection.


VAERS ID: 796527 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 78.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 Influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 15 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the Southeast region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796528 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 92.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 46 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 81.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 50 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796530 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 82.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 43 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Cerebrovascular disease and never smoked. The patient''s age at the time of enrollment was 73.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 23 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Diabetes; Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, diabetes and smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Cancer and Diabetes. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 66.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 3 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796533 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The had comorbidity of Cerebrovascular disease and never smoked. The patient''s age at the time of enrollment was 69.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 41 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pulmonary tuberculosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included pulmonary tuberculosis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of pulmonary tuberculosis and never smoked. The patient''s age at the time of enrollment was 77.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 5 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder; Smoker (Still smokes or ever smoked but stop less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder and smoker (Still smokes or ever smoked but stop less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cerebrovascular disease and the patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 74.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder; Chronic kidney disease; Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes, smoker (Ever smoked but stopped equal to or more than 1 month), hypertension, cerebrovascular disorder and Chronic kidney disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes, hypertension, cerebrovascular disease and chronic kidney disease and the patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 82.1-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 33 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes. Additional information was provided. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes and never smoked. The patient''s age at the time of enrollment was 72.8-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 43 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary tuberculosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and pulmonary tuberculosis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of pulmonary tuberculosis and diabetes and never smoked. The patient''s age at the time of enrollment was 67.8-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 26 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796562 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 68.9 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 72.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 26 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 82.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 31 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 76.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 10 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 75.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 7 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796567 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Ever smoked but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 70.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 4 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 73.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 4 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 75.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 38 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 68.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 46 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Ever smoked but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 67.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 28 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 79.5 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 32 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and and never smoked. The patient''s age at the time of enrollment was 74.5 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 2 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and and never smoked. The patient''s age at the time of enrollment was 89.9 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 34 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 83.6-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 49 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults in Thailand, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796576 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Smoker (The patient had a smoking status but stopped smoking less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and smoker (Still smokes or ever smoked but stop less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of hypertension. The patient still smokes or ever smoked but stop less than 1 month. The patient''s age at the time of enrollment was 76.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 40 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796577 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and chronic kidney disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Diabetes and Chronic kidney disease and never smoked. The patient''s age at the time of enrollment was 67.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 38 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796578 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder and smoker (Ever smoked but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Cerebrovascular disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 81.8 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 6 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine. Concurrent medical conditions included hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Hypertension and never smoked. The patient''s age at the time of enrollment was 80.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 33 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Diabetes and never smoked. The patient''s age at the time of enrollment was 71.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 28 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Diabetes and never smoked. The patient''s age at the time of enrollment was 69.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 27 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disease; Heart disorder (Abnormal heart rythms); Thalassemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included thalassemia, coronary artery disease and abnormal heart rythms. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Thalassemia, Coronary artery disease and Abnormal heart rythms. The patient never smoked. The patient''s age at the time of enrollment was 67.8 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 25 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic bronchitis and smoker (Ever smoked but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of chronic bronchitis and the patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 69.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 37 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796584 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Cancer; Chronic bronchitis; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, hypertension, chronic bronchitis, asthma and smoker (Ever smoked but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer, hypertension, chronic bronchitis and asthma and the patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 78.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 20 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. 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 trivalent inactivated influenza vaccine. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of hypertension and never smoked. The patient''s age at the time of enrollment was 78.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 33 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


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