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VAERS ID: 847509 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Unknown  
Vaccinated:2007-08-23
Onset:2007-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B53981A / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiopulmonary failure, Death, Developmental delay, Failure to thrive, Lactic acidosis, Metabolic acidosis, Poor feeding infant
SMQs:, Cardiac failure (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Congenital anomaly; Immunization
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131911USA003240

Write-up: metabolic acidosis; failure to thrive; developmental delay; feeding difficulties; lactic acidosis; acute cardiopulmonary failure; Information has been downloaded from regulatory authority(HQWYE953231AUG07) This spontaneous report was received from an other healthcare professional, regarding a 2-month-old male patient. The patient''s concurrent condition included congenital anomaly. The patient''s historical conditions, past drugs and concomitant medications were not reported. On 23-AUG-2007, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX); the lot/batch number, expiration date and route were unknown for both the products, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (batch/lot number B53981A; expiry date not reported) via intramuscular route and received all three vaccines received at a dose of one dosage form for immunization. On 25-AUG-2007, 3 days after onset of therapy the patient experienced metabolic acidosis, failure to thrive, developmental delay, feeding difficulties (poor feeding infant), lactic acidosis and acute cardiopulmonary failure (cardiopulmonary failure) and was hospitalized due to the events and on same day, the patient died. The cause of death was reported as lactic acidosis, cardiopulmonary failure and metabolic acidosis. The outcome of the events failure to thrive, poor feeding infant and developmental delay was reported as unknown. Autopsy was not performed. The relatedness between the events and the suspect therapy was not reported.; Reported Cause(s) of Death: Lactic acidosis; Metabolic acidosis; Cardiopulmonary failure


VAERS ID: 847970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USAstraZeneca2019SF60995

Write-up: DIED FROM FLUMIST; A spontaneous report has been received from a consumer concerning a 3 year old male patient. No medical history was reported. No concomitant products were reported. On an unknown date, the patient started receiving a treatment with Flumist (influenza vaccine (live, attenuated)), via nasal route. It was reported that nephew died from the Flumist (Preferred term: death). He was 3. They gave him the mist when he had slight cold like symptoms (cough and runny nose) He died within 36 hours of receiving the mist. It was not known whether an autopsy was performed. The cause of death was unknown. It was unknown if any action was taken with Flumist (influenza vaccine (live, attenuated)). The event was considered serious (death) by the reporter. The reporter considered the following event(s) related to treatment with Flumist (influenza vaccine (live, attenuated)): died from Flumist.; Sender''s Comments: The report concerns a 3 years old male patient, who died while on treatment with Q/LAIV (Flumist), the cause of death was not further specified. Due to limited information, relevant medical history, drug details, concurrent diseases, concomitant medication, circumstances leading to death, date and autopsy report it is not possible to make a conclusive assessment of the causal relationship of the event and suspect drug. ; Reported Cause(s) of Death: DIED FROM FLUMIST


VAERS ID: 848765 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2019-11-07
Onset:2019-11-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2LL97 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: metformin, enalapril, amlodipine, lipitor, vitamin d, hydroxyzine, januvia
Current Illness: DM, HTN, obesity, chronic urticaria, urinary frequency
Preexisting Conditions: as above
Allergies: mold, pollen,
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt was reported to be found dead the morning after vaccination. There is no clear association between vaccination and death, considering patient age and comorbidities. Medical examiner office informed clinic the next day


VAERS ID: 849007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2019-01-11
Onset:2019-11-13
   Days after vaccination:306
Submitted: 0000-00-00
Entered: 2019-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 3 - / OT
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 - / OT
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Autopsy, Blood glucose increased, Body temperature decreased, Bradycardia, Cardiac arrest, Crying, Death, Endotracheal intubation complication, Eye movement disorder, Hypotonia, Intraosseous access placement, Musculoskeletal stiffness, Pulse absent, Respiratory arrest, Resuscitation, Screaming, Seizure, Ultrasound Doppler abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2019-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis; Shoulder dystocia
Preexisting Conditions: Medical History/Concurrent Conditions: Seizures; Shoulder dystocia
Allergies:
Diagnostic Lab Data: Test Date: 20191113; Test Name: glucose; Test Result: 246 mg/dl
CDC Split Type: US0095075131911USA005567

Write-up: Seizure; Information was received from an investigator concerning a 6-month-old male subject enrolled in a study. The subject''s concurrent conditions and concomitant therapies were not reported. The subject''s medical history included shoulder dystocia. ^^The subject had family history of seizures (2 maternal cousins had seizures when they were toddlers). the infant was born at 38 4/7 weeks gestational age, length 52 cm, weight 3470 grams, head circumference 35 cm. No neonatal problems except shoulder dystocia^^ On 11-JUL-2019, the subject was randomized into the study protocol. On that date, at 15:06, the subject was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose: 2 mL) orally (PO), and on the same day, at 15:07, he was vaccinated with the first dose of V114 or pneumococcal 13 valent conjugate vaccine (CRM197) (PREVNAR 13) 0.5 mL intramuscularly (IM), 4 doses in visits 1, 2, 3 and 5. He as was also vaccinated at 15:08, with the first dose of diphtheria toxoid (+) Haemophilus b conjugate vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine, inactivated (unspecified) (+) tetanus toxoid (DTAP-IPV HIB) (PENTACEL) vaccine (dose: 0.5 mL) IM, and at 15:09, with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose: 0.5 mL) IM. On an unspecified date, the subject was also vaccinated with Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (HIBERIX) (dose details not reported). V114 or pneumococcal 13 valent conjugate vaccine (CRM197) (PREVNAR 13) was administered as prophylaxis for pneumococcal disease; while, all other vaccines were administered as prophylaxis (unspecified). On 10-SEP-2019 at 10:31, 10:32 and 10:33, the subject received second doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and the second dose of V114 or pneumococcal 13 valent conjugate vaccine (CRM197) (PREVNAR 13) (doses and route of administration as previously described) and diphtheria toxoid (+) Haemophilus b conjugate vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine, inactivated (unspecified) (+) tetanus toxoid (DTAP-IPV HIB) (PENTACEL). On 12-NOV-2019 at 14:42, 14:44, 14:45 and 14:46, the subject received third doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and the second dose of V114 or pneumococcal 13 valent conjugate vaccine (CRM197) (PREVNAR 13) (doses and route of administration as previously described), diphtheria toxoid (+) Haemophilus b conjugate vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine, inactivated (unspecified) (+) tetanus toxoid (DTAP-IPV HIB) (PENTACEL) and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). Since an unspecified date (reported since the subject was 4-month-old), the subject''s mother reported that he had episodes of seizures that lasted several seconds; ^^the child did not present with seizures prior to randomization at 2 months age. There were no similar events experienced after the administration of the first and second doses of study vaccines, and there were no signs and/or symptoms prior to the administration of the third dose of study vaccines. No evidence of failure to thrive^^. On 12-NOV-2019, the subject was seen for his 6-month well child check. ^^During the clinic visit, his mother reported that a few weeks ago, the child started having episodes where he would be crying and then he would tighten his arms and his legs. This would only last for a few seconds and then he was fine. She reported that last week, the maternal grandmother noted that he did this, and eyes rolled to the back of his head and he seemed like he was not breathing. She blew in his face and then he started crying again. He was immediately fine after this and not lethargic or drowsy. At the WCC, the child was assessed as 6-month-old male with normal growth and development. The episodes of tightening his arms and legs were considered to be more like temper tantrums but it was discussed with the parent that if that was seizure, he would be needed to be evaluated further.^^ Moreover, the physician asked the mother to record a video of the seizures and they would be referred to a specialist for workup and possible treatment. On 13-NOV-2019 at 13:15, the subject was in the grandmother''s arms when he started crying and screaming for several seconds, his eyes rolled back, and he became limp and stopped breathing. The subject experienced seizure (severe). ^^There were no relevant signs / symptoms, apart from crying already noted, prior or concurrent to previous episodes of possible seizures^^. His grandmother took him to freestanding emergency room (ER) (outside the site facility). At the outside facility, the subject was found to be in asystole and apneic; became bradycardic down to 50''s then coded. ^^On that day, his glucose was 246 mg/dl.^^ Cardio pulmonary resurrection (CPR) started with return of spontaneous circulation. He was transferred by ambulance to the site ER but lost the pulse again in route; 6 doses of epinephrine were administered prior to arrival. During transfer pulse less electrical activity noted and asystole on emergency medical services (EMS) monitors, CPR was performed while bagged, EMS attempted to intubate without success in route. An oral airway was placed and bilateral intraosseous lines in lower extremities. They arrived at the site ER with the subject in cardiac arrest and apneic. On arrival to the site, the subject was intubated, epinephrine, atropine, bicarbonate and naloxone (NARCAN) were administered ^^for cardiac arrest^^. An ultrasound for pulse check showed no cardiac activity. ^^It was reported that the subject was hospitalized^^. Core temperature was 94.6 Fahrenheit rectally, CRP continued with no success an at 14:19 (after 1 hour) the subject died due to ^^seizure^^ as per hospital records. ^^An autopsy was performed. No imaging testing to evaluate the seizures was carried out; no medications were given for previous episodes of possible seizures. The subject died in the ER before he could be admitted to the hospital; therefore, admission date, discharge date and discharge diagnosis were not applicable. There was no confirmed diagnosis of seizures prior to the day of death and no further information available regarding onset dates of ''episodes'' reported by the mother^^. The action taken with the study therapies was reported as ^^dose not changed^^. The investigator considered the seizure (severe) to be related to V114 or pneumococcal 13valent conjugate vaccine (CRM197) (PREVNAR 13), Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), to diphtheria toxoid (+) Haemophilus b conjugate vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (DTAP-IPV HIB) (PENTACEL) vaccine and Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (HIBERIX), but not related to the study procedure. ^^The investigator assessed the event related to administration of all vaccines due to temporal relationship and no other definitive cause of death^^. The investigator considered the seizure (severe) to be a life-threatening event. Updated information received on 15-NOV-2019 from the investigator has been captured in between double caret (^^). The record for this subject was unblinded on 18-NOV-2019. Company Causality Assessment: Although there is a family history of seizures and co-suspect use RECOMBIVAX HB (known to be associated with non-fatal seizure), based on the clinically relevant information currently available for this individual case, there is a possibility that the reported serious adverse event of Seizure with a fatal outcome is related to the use of the investigational vaccines (blinded investigational vaccine [V114 or PREVNAR 13] and open-label study vaccine [PENTACEL and HIBERIX). The plausible temporal relationship, the known safety profiles of the blinded comparator (known to be associated with non-fatal seizure and apnea) and open label study vaccines (PENTACEL [known to be associated with non-fatal apnea] and HIBERIX [known to be associated with non-fatal convulsions]) support the possible relationship. Additional information regarding laboratory data due to increased glucose prior to CPR, autopsy report and the history of shoulder dystocia with unknown complications are needed for further assessment. Important missing information includes any record of fever accompanying the event. Febrile seizures have previously been reported in children who have received pneumococcal conjugate vaccines (PREVNAR 13). An Analysis of Similar Events regarding this follow up report of the adverse reaction of Seizure with the serious criteria of hospitalization, life threatening and death was performed. This case refers to a 6-month-old male subject who experienced Seizure after the third dose of the investigational vaccines (blinded investigational vaccine [V114 or pneumococcal 13 valent conjugate vaccine (CRM197) PREVNAR 13] and open label study vaccines [PENTACEL and HIBERIX]). This is the first reported case of Seizure in association with the investigational vaccines (blinded investigational vaccine [V114 or pneumococcal 13 valent conjugate vaccine (CRM197) PREVNAR 13] and open label study vaccines [PENTACEL and HIBERIX]) submitted to the FDA. The Suspected Adverse Reactions of Seizure does not alter the existing benefit-risk profile of the product. Merck and Co., Inc., known as MSD outside of certain countries, will continue to monitor this event and other serious adverse events reported in association with V-114 and will communicate any relevant changes to the protocol, Investigator''s Brochure and/or Core Safety Information.; Reported Cause(s) of Death: Seizure


VAERS ID: 850272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2019-10-01
Onset:2019-10-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dyspnoea, Pneumonia, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-01
   Days after onset: 31
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: Hospitalization (hospital this past month); Sedation (was in a sedative state)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: Pneumonia / Died this past week because his body couldn''t fight it off; Lungs were congested; Couldn''t breathe; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis. Concurrent medical conditions included hospitalization (hospital this past month) and sedation (was in a sedative state). In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, 1 day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pneumonia (serious criteria death, hospitalization and GSK medically significant), lung congestion (serious criteria hospitalization and GSK medically significant) and difficulty breathing (serious criteria hospitalization). The patient was treated with oxygen. In November 2019, the outcome of the pneumonia was fatal. On an unknown date, the outcome of the lung congestion and difficulty breathing were unknown. The patient died in November 2019. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia, lung congestion and difficulty breathing to be related to Influenza vaccine Quadrivalent 2019-2020 season. Additional details were provided as follows: The age at vaccination was not reported. The patient was in the hospital, and while he was in a sedative state, the patient was vaccinated with a flu shot without his permission, and never even told his wife and kids. The day after vaccination, the patient couldn''t breathe, and his lungs were congested. The patient was put on oxygen, because he got pneumonia. The patient died because his body couldn''t fight it off.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 850273 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Coma, Death, Feeling abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: USGLAXOSMITHKLINEUS2019AM

Write-up: Went into a coma, and died 5 days later; Feeling really bad; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced coma (serious criteria death and GSK medically significant) and feeling bad. On an unknown date, the outcome of the coma was fatal and the outcome of the feeling bad was unknown. It was unknown if the reporter considered the coma and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This happened 2 years ago with the patient. Company started giving out free flu vaccines to the workers and their families. The patient was healthy. Right after getting the vaccine, she started feeling really bad, and the next evening when her husband came home, that night he had to call the squad. She went into a coma, and died 5 days later. This case has been linked to US2019AMR211990, reported by the same reporter.; Reported Cause(s) of Death: Coma


VAERS ID: 850821 (history)  
Form: Version 2.0  
Age: 0.67  
Sex: Male  
Location: Louisiana  
Vaccinated:2019-11-27
Onset:2019-11-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS D93B4 / 2 RL / IM

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

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2019-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol sulfate, clonidine,enoxaprin,ativan,morphine,nitrofurantoin, poly vi sol, hydrocortisone 1%
Current Illness:
Preexisting Conditions: chromosomal abnormality - duplication of 7q, terminal deletion of 19q, interstitial deletion of 1q21.1, microarray der(18)t(7;18) (q32;23) resulting in ventilator dependence, midface hypoplasia, club feet, undescended testes and micro penis,hypertrophic cardiomyopathy, bilateral inguinal hernias. MRI of brain showed thinning of the pituitary gland and prominence of the suprasellar and prepontine space extending through the foramen magnum.
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: INFANT DIED PROBABLY NOT RELATED TO IMMUNIZATION


VAERS ID: 850861 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Texas  
Vaccinated:2019-10-01
Onset:2019-10-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Death, Gait inability, Hepatic failure, Peripheral swelling, Sepsis
SMQs:, Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Yes. Enzymes. Various medications for cancer. NHL (MCL)
Current Illness: Cancer.
Preexisting Conditions: Cancer.
Allergies: Reaction to heparin.
Diagnostic Lab Data: Died, Hospital
CDC Split Type:

Write-up: Liver failure. Septic. Legs Swollen, couldn''t walk. Was given Shingles and possibly flu vaccine.


VAERS ID: 851227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131912USA001647

Write-up: death was unconvincingly blamed on Gardasil; This spontaneous report was received from a physician via social media and refers to a 19 year old female patient. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, dose number, route, vaccination site, lot# and expiration date were not reported), for prophylaxis. On an unknown date, the patient died (death). The cause of death was not reported and it was unknown if an autopsy was performed. The reporter considered the patient''s death to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) as he stated that the patient''s death was unconvincingly blamed on the vaccine.


VAERS ID: 851409 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: New Jersey  
Vaccinated:2019-10-23
Onset:2019-10-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Bladder catheterisation, Brain death, Brain injury, Chest X-ray normal, Computerised tomogram normal, Crying, Death, Electroencephalogram abnormal, Eye movement disorder, Eye swelling, Gastrointestinal tube insertion, Grunting, Influenza, Loss of consciousness, Lumbar puncture normal, Magnetic resonance imaging brain abnormal, Mechanical ventilation, Medical induction of coma, Pyrexia, Renal failure, Respiratory arrest, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin D drops
Current Illness: 1. mild fever - fever about 100 centigrade ( on 09-10-2019) - gave Tylenol for 2 times in a day and the baby was fine. 2. Constipation problem for 3 days (on 09-22-2019) - Consulted Pediatrician and baby was fine in next day.
Preexisting Conditions: Nothing
Allergies: Nothing
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dear Officer, My five months old son passed away on 10-28-2019 after vaccination done on 10-23-2019. Here is the sequences of incidents: Wednesday 10-23-2019 : We went to Clinic for vaccinations and regular check-ups. Dr. is primary pediatrician for my son. After the checkup, she told us that baby is good in growth. Vaccination done on 10-23-2019 at 11.30 AM EST. Attached vaccination card in this email. Please check. On the same day around 3 pm, kid was sleeping and suddenly we heard some grunting sounds. We checked baby and observed that baby eyes were rolling and unconscious and unable to breathe. We tried to wake him up but he didn''t wake up. Immediately, we understand the seriousness and called 911. Ambulance came in less than five minutes and they pump the air for breathing problem and they took the baby to hospital. They helped him breathing, given IV fluids, removed urine using catheter, and some first-aid process. Also taken chest x-ray and CT SCAN. They said that X-ray and CT-scan were good. Baby opened eyes, crying a lot and my wife feed him ( breast feeding). On the same day around 7 PM, Pediatrician sent the baby to hospital for observation. Baby reached Hospital around 8 PM. Sr.physician Told me that it may be Hypoxia/seizures due to low level Oxygen in blood and baby is in life & death situation. At this time, the baby is almost normal, opening eyes and recognizing us and crying for pain ( May be pain in hand - intravenous drip) They Started Brain ECG and started giving treatment for seizures. Baby was not sleeping and crying the complete night. (They started giving medicine for stopping seizures, antibiotics, sodium carbonate, liquids and IV fluids.) Thursday 10-24-2019: My son was crying throughout night. He got a fever 102c and in mid night around 2.30 AM and 5.30 AM, he just moved his legs, hands, and head. Doctors said that this may be seizures as they are rhythmic movement. They took him to MRI scan and spinal tap( extract liquid from spinal) test. They said that MRI and spinal tap test looks good. Evening, Baby got the flu and fever went up to 104. Baby eyes were swollen and can''t open. Baby was crying through out night. They continue the seizure medicines and also given Tamiflu, tylenol, antibiotics etc. Friday 10-25-2019: They said the baby had a series of seizures on Thursday night and not stopping. They are using Keppra along with some other medicine for seizures. Also Tamiflu, antibiotics, sodium bicarbonate , and tylenol gave him. He went to deep sleep due to high Seizures medicine dose. Doctors put the baby on ventilator. Also, inserted pipe to stomach through the nose for feeding. No movement.. no crying... Saturday 10-26-2019: Doctors told us that seizures controlled a little bit but the brain is generating abnormal waves. Now they reduced seizures dose. But again seizures come back. Continued same medicine till evening. Doctors told us that baby is in very critical condition. Sunday 10-27-2019: They did MRI again and say that brain damaged and can''t irreversible. Now, they have given (pentabola- something, not sure), to put him on comma and trying to save my baby. Doctors stitched(for intravenous drip) on his groin and wrist. They used catheter to remove urine from bladder. And now they say it''s a five percent chance of living and if he lives, he will have different health issues in the future. At 9.30 Pm, nurses and doctors treating my son continuously till 12.30 AM ( Monday) Monday 10-28-2019: 12.30 AM :Doctor told us that brain dead and kidneys also failed, heart also will stop in a couple of hours. They stopped treatment. We were in deep sad and crying. Baby''s heart beat is reducing slowly. Around 11.40 AM, heart beating also stopped. My son had very painful, dreadful, unbearable treatment but he is not alive. We are crying from the incident (10-23-2019). we had very terrible days and sleepless crying nights. Before Incident: Baby was born. He was a full term 40-week baby and no health issues. First Vaccination on 07-05-2019. (Baby cried a lot about 20 to 30 mints. After that, the baby was normal. We thought that the baby was crying due to pain in thighs. No fever, no other issues.) Baby was in this country till 07-11-2019. Baby went to parents home country with parents on 07-11-2019 and returned this country on 10-20-2019. When baby was in parents home country, no health issues except 1. mild fever - fever about 100c ( on 09-10-2019) - gave Tylenol for 2 times in a day and the baby was fine. 2. Constipation problem for 3 days (on 09-22-2019) - Consulted Pediatrician and baby was fine the next day. I have requested medical reports and waiting for them from hospital. Once, I recieved them, I will submit.


VAERS ID: 851436 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Ohio  
Vaccinated:2019-11-12
Onset:2019-11-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS PR5B2 / 1 LA / SC

Administered by: Pharmacy       Purchased by: ?
Symptoms: Brain injury, Cardiac arrest, Cardioversion, Chills, Death, Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia, Resuscitation, Syncope, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2019-11-18
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ramipril 5mg daily, Metoprolol 50mg daily, Tikosyn 125mcg , 3 every 12hrs, One multivitamin daily, Flaxseed oil 1000mg daily, Iron 28 mg daily, B12 1000mcg daily.
Current Illness: none
Preexisting Conditions: Atrial fibrillation, hypertension
Allergies: Iodine, shellfish, Sulfa medications, horse serum
Diagnostic Lab Data: Squad called. Cpr by family members initiated. Transported to closest hospital. This happened on 11/15/19 . My dad was in vfib, shocked 3 to 4 times. anoxic brain injury resulted. we withdrew care on 11/16/19 . He passed away on 11/18/19
CDC Split Type:

Write-up: The day after receiving the vaccine he complained of chills and fatigue that lasted 2 days and local site injection redness pain and swelling. The third day he felt better, but the evening of the 15th he complained of left hand tingling and collapsed in a vfib arrest.


VAERS ID: 851887 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Death; guillain barre syndrome; respiratory failure; This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for an unknown indication. On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and respiratory failure (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the guillain barre syndrome and respiratory failure were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, guillain barre syndrome and respiratory failure to be related to Shingrix. Additional details were provided as follow: The initial information received via legal attorney indicating a client whose relative experienced Guillain Barre syndrome and resulting respiratory failure and death an unspecified amount of time after receiving Shingrix.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 851942 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2019-10-09
Onset:2019-10-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS J9F97 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chest X-ray abnormal, Condition aggravated, Cough, Decreased appetite, Dyspnoea, Increased tendency to bruise, International normalised ratio increased, Lacrimation increased, Memory impairment, Prothrombin time prolonged, Pruritus, Rhinorrhoea
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Lacrimal disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-25
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Megestrol Acetate 40mg oral tablet, Coumadin 2mg oral tablet, Amiodarone HCL 200mg oral tablet, Toprol XL 25mg oral tablet, Potassiu, CL ER 20 MEQ tablet, Amitiza 8mcg oral capsule, Norco 10-325mg oral tablet, Doxazosin Mesylate 8mg tab, Am
Current Illness: Pulmonary edema, Left lower lobe pneumonia, Loss of appetite
Preexisting Conditions: Nonsustained paroxysmal ventricular tachycardia, Dysphagia, BMI 20, Nutritional marasmus, Opiod use, CAD, Unspecified disorders arteries and arterioles, Presence of cardiac pacemaker, Sick sinus syndrome, Elevated troponin, Incarcerated ventral hernia, Tinea unguium, Syncope due to orthostatic hypotension, Weakness, Pruritic rash, Ventral hernia w/o obstruction, Partial intestinal obstruction, Pneumonia, Hematemesis, Ileus, Noninfective gastroenteritis and colitis, Pain in thoracic spine, Other specified abnormal findings of blood chemistry, Vomiting, unspecified, Viral intestinal infection, Corns and callosities, Nail dystrophy, Osteophyte, left foot, Pain in left ankle and joints of left foot, Other symptoms and signs involving the musculoskeletal system, Pain in left foot, Ingrowing nail, Chronic sinusitis, unspecified, Other dorsalgia, Essential (primary) hypertension, Paroxysmal atrial fibrillation, Long term (current) use of anticoagulants, Hyperlipidemia, unspecified, Hypothyroidism, unspecified, Abdominal aortic aneurysm, w/o rupture, Nonrheumatic aortic (valve) insufficiency, Benign prostatic hyperplasia w/o lower urinary tract symptoms, Umbilical hernia w/o obstruction or gangrene
Allergies: NKA
Diagnostic Lab Data: 10/09/19 Chest Xray-Atelectasis noted L$gR 10/11/19 PT/INR-abnormal (high)
CDC Split Type:

Write-up: 10/09/2019-Patient presented to PCPs office with chief complaint of watery eyes, runny nose, cough, and SOB. Generalized weakness worsening and appetite continues to decline. Memory continues to decline, Itching in hands. Spontaneous bruising. Treatment-Add Megace for appetite, Hold Coumadin and recheck Friday, Increase Ensure to 3 times daily as tolerated, Eat greens today


VAERS ID: 852688 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Ohio  
Vaccinated:2019-11-11
Onset:2019-11-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Autopsy, Completed suicide
SMQs:, Suicide/self-injury (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-08
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Multiple fevers throughout history of immunizations
Other Medications: Adderall Vit D Fluoxetine
Current Illness: pyelonephritis Fever Renal Lithiasis
Preexisting Conditions: Autism ADHD
Allergies: Sulfa Milk Garlic
Diagnostic Lab Data: Please refer to Coroner?s report
CDC Split Type:

Write-up: Patient has Autism. Shortly after shot he began acting different & this was noticed by school, family & friends. Almost a month afterwards, despite seeming much happier & outgoing, he committed suicide.


VAERS ID: 853341 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Nevada  
Vaccinated:2019-10-16
Onset:2019-10-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Rash, Skin disorder
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-15
   Days after onset: 60
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: rash began day of vaccination in the evening
Preexisting Conditions: disk disease, central cord syndrome, 4 vessel coronary bypass in 2015 with stents placed.
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had rash begin the same day which led to larger rash that was not treated. Patient was seen at Medical Center more than once and then was transferred for higher level of care due to skin condition from Medical Center.


VAERS ID: 853488 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Unknown  
Vaccinated:2019-11-19
Onset:2019-12-10
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2019-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CD0208 / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-10
   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: SYNTHROID TAB 100MCG; PREDNISONE TAB 20MG; PAROXETINE TAB 20MG; AMIODARONE TAB 200MG; MYCOPHENOLAT TAB 500MG; FUROSEMIDE TAB 20MG;
Current Illness: ENCOUNTER FOR IMMUNIZATION
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT HAS PASSED AWAY


VAERS ID: 853847 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Unknown  
Vaccinated:2019-12-15
Onset:2019-12-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ308AB / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-15
   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:
Current Illness: history of stroke
Preexisting Conditions:
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died within hours of receiving fluzone hd.


VAERS ID: 853893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue, Gastrointestinal haemorrhage, Packed red blood cell transfusion, Pneumonia bacterial, Renal failure, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Married
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131912USA008340

Write-up: gastrointestinal bleed; bacterial pneumonia; failure of his lungs and kidneys; failure of his lungs and kidneys; died; nursing center; fatigue; adverse event; This spontaneous report was received from a consumer (a patient''s wife) and refers to a male patient of unknown age. No information regarding the patient''s medical history, concomitant medications and concurrent conditions was provided. On an unspecified date in 2000, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, frequency, route of administration, lot# and expiration dates were not provided) for prophylaxis. On an unknown date in 2017, he received second dose (lot # and expiry date were not provided). On an unspecified date in 2017, the patient experienced adverse event. On an unspecified date, the patient experienced gastrointestinal bleeding and was hospitalized, he received two units of packed red blood cells. During this stay, in 2019, the patient received his third dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot # and expiry date were not provided) and unspecified "flu shot". On an unspecified date in 2019, after about three weeks after being discharged from the hospital, the patient started experiencing fatigue. The patient sought medical attention and was admitted to the hospital for a second time, where he was diagnosed with bacterial pneumonia. The patient was given unspecified antibiotics and experienced failure of his lungs and kidneys (approximately in 2019, exact date was not provided). On an unspecified date in 2019, the patient died, after being transferred to nursing center. Cause of death was not reported. It was unknown if an autopsy was performed. The outcome of pneumonia bacterial, fatigue, gastrointestinal haemorrhage, renal failure and respiratory failure was reported as not recovered/not resolved. The outcome of adverse event was unknown. The causality assessment between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not provided. Upon internal review, the events of renal failure, respiratory failure, pneumonia bacterial and gastrointestinal haemorrhage were determined to be medically significant.


VAERS ID: 853943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: 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: USPFIZER INC2019546329

Write-up: Prevnar vaccine killed my healthy husband; This is a spontaneous report from a Pfizer sponsored program Know Pneumonia Unbranded Facebook Page. A non-contactable consumer reported that a male patient (husband) of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient''s medical history and concomitant medications were not reported. The consumer reported that "prevnar vaccine killed my healthy husband" on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Prevnar vaccine killed my healthy husband


VAERS ID: 854032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2019-10-16
Onset:2019-11-30
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2019-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER P100112488 / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; PROMETHAZINE; LOVENOX; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201907407

Write-up: Foetal exposure during pregnancy; Stillbirth; Low birth weight; Premature birth; This is an observational study case, initially received from other health professional on 16-Dec-2019 with an additional information received on 18-Dec-2019 (being processed together), concerning a male, neonatal subject. The subject''s mother was 33-year-old pregnant female of body weight: 246 Ibs, height: 67 in and body mass index (BMI) 38.5 enrolled in a prospective observational safety study. The subject''s mother current medical condition included history of venous thromboembolism, gestational hypertension (GHTN), anxiety, nausea, vomiting, history of deep vein thrombosis (DVT) and obesity. The subject''s mother concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Lexapro (escitalopram oxalate) for anxiety, promethazine for nausea and vomiting and Lovenox (enoxaparin sodium) for history of venous thromboembolism. The subject''s mother had no previous pregnancies. The subject''s mother had no maternal or paternal history with major congenital malformations (MCMs). The subject''s mother had no history of offspring with MCM. The subject''s mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject''s mother last menstrual period (LMP) date was 24-Jun-2019. Estimated delivery date (EDD) was reported as 30-Mar-2020 and corrected estimated delivery date (CEDD) was not reported. The type of pregnancy was singleton. On 18-Sep-2019, the subject''s mother underwent first sequential and nuchal translucency. No MCMs were noted. On 16-Oct-2019, at approximately 16 weeks of gestation, the subject''s mother was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as ?Foetal exposure during pregnancy'') for an influenza immunisation. On the same day, the subject''s mother underwent second sequential and no MCMs were noted. On 30-Oct-2019, the subject''s mother underwent early glucose tolerance test and per reporter, it failed. On 04-Nov-2019, the subject''s mother underwent three-hour glucose tolerance test and no MCMs were noted. At approximately 22 weeks of gestation, mother vaginally delivered a stillbirth male neonate, (explicitly coded as ''Premature birth''). The pregnancy outcome was stillbirth. The characteristics of the neonate included weight: 417 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. No MCMs were identified at the time of birth. On the same day, the subject''s mother was diagnosed with HELLP syndrome (characterised with hemolysis, elevated liver enzymes, and a low platelet count). It was reported that the factors that may had impact on fetal loss included mother''s HELLP syndrome and history of DVT. It was unknown whether the autopsy was performed. The event of stillbirth is considered as serious due to fatal outcome, while the events of low birth weight baby and premature birth are considered as serious due to criterion of medical significance. The reporter did not provide causality assessment to Afluria QIV. This case is linked to case 201907406 (corresponding mother case). Company comment: The patient experienced preterm birth and low birth weight, one months and 14 days after maternal receipt of Afluria QIV. The pregnancy outcome was stillbirth. The subject''s mother was administered vaccine at approximately 16 weeks of gestation. Chronology is plausible. Mother''s medical history of venous thromboembolism, gestational hypertension and concomitant drugs used during pregnancy may have contributed to development of the events. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. The event foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender''s Comments: The patient experienced preterm birth and low birth weight, one months and 14 days after maternal receipt of Afluria QIV. The pregnancy outcome was stillbirth. The subject''s mother was administered vaccine at approximately 16 weeks of gestation. Chronology is plausible. Mother''s medical history of venous thromboembolism, gestational hypertension and concomitant drugs used during pregnancy may have contributed to development of the events. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. The event foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 854824 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Unknown  
Vaccinated:2019-10-16
Onset:2019-12-11
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUR4: INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) / PROTEIN SCIENCES CORPORATION - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Gait inability, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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:

Write-up: 12/6/19 - Presented to Emergency Rm with acute lower extremity weakness 12/7/19 Presented to ER cannot walk. Sent to Hospital 12/30/19 Expired


VAERS ID: 855610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Respiratory failure, Stevens-Johnson syndrome, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (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: AMOXICILLIN [AMOXICILLIN SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Post herpetic neuralgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA001256

Write-up: respiratory failure; stevens johnson syndrome; toxic epidermal necrolysis; Initial information received on 31-DEC-2019 regarding an unsolicited valid serious literature case. This case is linked to cases 2020SA001262, 2020SA001225, 2020SA001235 and 2020SA001250 (Same reporter). The following is verbatim from the article: Background: Since the last review of vaccine safety surveillance data for erythema multiforme (EM), Stevens Johnson syndrome (SJS), SJS/TEN, and toxic epidermal necrolysis (TEN) (EM/SJS/TEN), over 37 new vaccines have been introduced. We sought to describe reported EM/SJS/TEN after vaccines during 1999-2017. Methods: We identified reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) during 1999-2017. We stratified analysis by condition (EM, SJS, or TEN), and analyzed reports by serious or non-serious status, sex, age group, time from vaccination to symptom onset, exposure to known causes of EM/SJS/TEN, and vaccines administered. We used Empirical Bayesian data mining to detect vaccine-AE pairs reported more frequently than expected. Results: Of 466,027 reports to VAERS during 1999-017, we identified 984 reports of EM, 89 reports of SJS, 6 reports of SJS/TEN, and 7 reports of TEN. Few reports of EM (9%), and most reports of SJS (52%), SJS/TEN (100%), and TEN (100%) were serious. Overall, 55% of reports described males, 48% described children aged 4 years; 58% of EM/SJS/TEN occurred 7 days after vaccination. Few reports (5%) described exposure to known causes of EM/SJS/TEN. Overall, childhood vaccines (e.g., combined measles, mumps, and rubella vaccine) were most commonly reported. We identified 6 deaths; 4 were exposed to medications associated with EM/SJS/TEN. EM after smallpox vaccine was reported disproportionately among people aged 19 - 49 years. Conclusions: EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine. This case involves a 43 years old female patient who experienced Stevens-Johnson syndrome (Stevens-Johnson syndrome), respiratory failure (respiratory failure) and toxic epidermal necrolysis (toxic epidermal necrolysis) while she received vaccine INFLUENZA VACCINE. Medical history included Post herpetic neuralgia. Medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE TRIVALENT produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed serious Stevens-Johnson syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (toxic epidermal necrolysis) 3 days following the administration of INFLUENZA VACCINE. The patient was died due to respiratory failure (respiratory failure) on an unspecified date. All events was assessed as medically significant. It is unknown if an autopsy was done. Details of laboratory data not reported. Final diagnosis was toxic epidermal necrolysis, Stevens Johnson syndrome and respiratory failure It was not reported if the patient received a corrective treatment. The outcome of the events toxic epidermal necrolysis, Stevens Johnson syndrome was unknown at the time of reporting. There will be no information available on the batch number for this case.; Sender''s Comments: This case involves a 43 years old female patient who experienced toxic epidermal necrolysis, respiratory failure, Stevens Johnson syndrome and reported (fatal) death after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is compatible with the role of vaccine. Medical history included Post herpetic neuralgia. Additional information regarding condition at the time of vaccination, lab data excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: respiratory failure


VAERS ID: 855611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Skin exfoliation, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), 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: ALLOPURINOL
Current Illness: Gout; Multiple myeloma; Rheumatic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA001262

Write-up: Death NOS; toxic epidermal necrolysis; desquamation of 80?90% of BSA; Initial information received on 31-DEC-2019 regarding an unsolicited valid serious literature case. This case is linked to cases 2020SA001225, 2020SA001235, 2020SA001250, 2020SA001256 (Same reporter). The following is verbatim from the article: Since the last review of vaccine safety surveillance data for erythema multiforme (EM), Stevens Johnson syndrome (SJS), SJS/TEN, and toxic epidermal necrolysis (TEN) (EM/SJS/TEN), over 37 new vaccines have been introduced. We sought to describe reported EM/SJS/TEN after vaccines during 1999-2017. Methods: We identified reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) during 1999-2017. We stratified analysis by condition (EM, SJS, or TEN), and analyzed reports by serious or non-serious status, sex, age group, time from vaccination to symptom onset, exposure to known causes of EM/SJS/TEN, and vaccines administered. We used Empirical Bayesian data mining to detect vaccine-AE pairs reported more frequently than expected. Results: Of 466,027 reports to VAERS during 1999-017, we identified 984 reports of EM, 89 reports of SJS, 6 reports of SJS/TEN, and 7 reports of TEN. Few reports of EM (9%), and most reports of SJS (52%), SJS/TEN (100%), and TEN (100%) were serious. Overall, 55% of reports described males, 48% described children aged 4 years; 58% of EM/SJS/TEN occurred 7 days after vaccination. Few reports (5%) described exposure to known causes of EM/SJS/TEN. Overall, childhood vaccines (e.g., combined measles, mumps, and rubella vaccine) were most commonly reported. We identified 6 deaths; 4 were exposed to medications associated with EM/SJS/TEN. EM after smallpox vaccine was reported disproportionately among people aged 19 - 49 years. Conclusions: EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine. This case involves a 71 years old male patient who experienced toxic epidermal necrolysis (toxic epidermal necrolysis) and later died (death NOS), while he received vaccine INFLUENZA VACCINE TRIVALENT. Medical treatment, vaccination and family history were not provided. At the time of the event, the patient had ongoing Plasma cell myeloma, Rheumatic heart disease and Gout. Concomitant medications included Allopurinol for Gout. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE TRIVALENT (produced by unknown manufacturer) (lot number and other dosing details were not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a serious toxic epidermal necrolysis (toxic epidermal necrolysis) and desquamation of 80-90% of body surface area (skin exfoliation), one day following the administration of INFLUENZA VACCINE (TRIVALENT). These events were assessed as medically significant. On an unknown date, the patient died (death), following the administration of INFLUENZA VACCINE (TRIVALENT). This event was assessed as medically significant and was leading to death. Details of laboratory data not reported. Final diagnosis was severe skin exfoliation and severe toxic epidermal necrolysis and death NOS. It was unknown if an autopsy was done. The cause of death was not reported. The outcome of the events was Unknown for toxic epidermal necrolysis and desquamation of 80-90% of body surface area and later patient died due to unknown reason. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 71 years old male patient who presented with toxic epidermal necrolysis and skin exfoliation one day after vaccination with INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer and died due to unknown reasons. The time to onset is compatible with the role of vaccine. Additional information regarding condition at the time of vaccination, lab data excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 856068 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075130912USA01166

Write-up: died; Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) (dates were not reported). Subsequently the patients died, the cause of death was unknown. This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients. Additional information has been requested. This is an amended report: HCP confirmed has been changed to no for regulatory consumer. Company Causality Assessment: Episode Profile: Medically Confirmed: N


VAERS ID: 856698 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Virginia  
Vaccinated:2020-01-13
Onset:2020-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS K7TF9 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. S000355 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AA7118 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 4PP5L / 1 MO / PO

Administered by: Military       Purchased by: ?
Symptoms: Chest X-ray, 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: VITAMIN D DROPS 10 MCG/ML-400 UNITS PER ML HYDROCORTISONE CREAM 1% APPLY TO AFFECTED AREAS 2 TO 3 TIMES DAILY TO AFFECTED AREAS EMOLLIENT BASE CREAM TOPICAL APPLY AFFECTED AREAS TWICE A DAY ON BODY AND FACE FOR DRY SKIN ESOMEPRAZOLE MAG 2.
Current Illness: NEWBORN RASH V/S ATOPIC ECZEMA V/S MILARIA RUBRA "NOISY BREATHING" REFERRAL PLACED TO ENT
Preexisting Conditions: NONE
Allergies: NO KNOWN DRUG ALLERIES
Diagnostic Lab Data: AN X-RAY WAS DONE THE DAY OF WELL BABY EXAM FOR "NOISY BREATHING". A REFERRAL WAS PLACED FOR PATIENT BY THE PROVIDER TO AN ENT FOR EVALUATION. THIS IS THE DAY THE VACCINES WERE ADMINISTERED.
CDC Split Type:

Write-up: PARENT REPORTED INFANT DEATH. PATIENT WAS FOUND IN CRIB, FACE DOWN DECEASED ON 01/13/2020 IN THE AFTERNOON.


VAERS ID: 856929 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Arizona  
Vaccinated:2018-10-17
Onset:2018-10-20
   Days after vaccination:3
Submitted: 2020-01-16
   Days after onset:453
Entered: 2020-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 250783 / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X13847 / UNK - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Laboratory test, Paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-22
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hospital adm 11.09.18 - extensive labs,etc through date of death
CDC Split Type:

Write-up: Initial weakness, paralysis of extremities, Guilian Barre Syndrome with medical complications, hospital admission commencing 11.09.18 until death, 12.22.18.


VAERS ID: 857105 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2020-01-08
Onset:2020-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 24KZ7 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-10
   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:

Write-up: PATIENT PASSED AWAY 2 DAYS AFTER RECEIVING VACCINATION


VAERS ID: 857115 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Female  
Location: Montana  
Vaccinated:2020-01-14
Onset:2020-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ058AB / 4 RL / SYR
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT6647JA / 1 RL / SYR
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. R013540 / 3 LL / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AL8457 / 1 LL / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen (Tylenol) 160 mgi/5mL Solution
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient arrived to hospital by EMS, CPR in progress. On arrival, patient had no spontaneous cardiac activity or respirations.


VAERS ID: 857195 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2019-08-15
Onset:2019-09-25
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2020-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chemotherapy, Hodgkin's disease, Pneumonia, Vaccination complication
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-01
   Days after onset: 67
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies: None Known
Diagnostic Lab Data:
CDC Split Type:

Write-up: measles vaccine associated pneumonia in pt. with Hodgkins lymphoma treated with chemotherapy.


VAERS ID: 857276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132001USA005823

Write-up: girl dies hours after getting HPV vaccine; This spontaneous report as received from a journalist refers to a female patient of unknown age. No information regarding the patient''s concurrent conditions, medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot number, expiration date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, hours after getting HPV vaccine, the patient died. It was unknown if an autopsy was performed. The relatedness between the patient''s death and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.


VAERS ID: 857290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2019-05-15
Onset:2019-05-01
Submitted: 0000-00-00
Entered: 2020-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4257F / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Death, Deep vein thrombosis, Erythema, Eyelid margin crusting, Ophthalmic herpes zoster, Pneumonia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Ocular infections (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-15
   Days after onset: 228
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ERYTHROMYCIN OINTMENT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202000

Write-up: DVT; Pneumonia; Pharmacist states the patient''s death; forehead redness; forehead; crusting of the eyes; Ocular shingles; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis. Co-suspect products included erythromycin (Erythromycin Ointment) for prophylaxis. On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Erythromycin Ointment at an unknown dose and frequency. In May 2019, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On 22nd May 2019, the patient experienced erythema, blister and eye crusting. On 15th December 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and pneumonia (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and artificial tears nos (Artificial Tears). Erythromycin Ointment was discontinued. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting were unknown. The patient died on 15th December 2019. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting to be related to Shingrix. Additional details were provided as follows: The patient was received Shingrix developed ocular shingles within one week. The medical team were unsure if it was herpes, but the chart notes not clearly bacterial or viral. Patient was prescribed erythromycin ointment for prophylaxis, then on 22nd May 2019 started getting forehead redness and blisters, crusting of the eyes, and she stopped erythromycin.The treatment was changed to artificial tears and started Valcyclovir 1g, 1 BID for 10 days. Patient had consult with ophthalmology and was treated with artificial tears. The consult noted "no evidence of herpetic uvelitis, keratitis, or retinitis in right eye and a treatment with antiviral medication was continue. On 15th December 2019, the patient died exact cause of death unknown. The patient had multiple issues including DVT and pneumonia, and patient elected for comfort care instead of treatment. Pharmacist states the patient''s death does not appear to be related to Shingrix.; Reported Cause(s) of Death: Death


VAERS ID: 857561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2017-10-02
Onset:2018-03-06
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2020-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure congestive, Cardiomyopathy, Death, Dyspnoea, Failure to thrive, Fall, Pleural effusion, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132001USA005269

Write-up: shortness of breath; congestion/congestive heart failure; frequent falls; failure to thrive; pneumonia; severe cardiomyopathy; pleural effusions secondary to congestive heart failure; died; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. On or about 02-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered shortness of breath, congestion, frequent falls and failure to thrive requiring hospitalization. The patient was diagnosed with congestive heart failure, pleural effusions secondary to congestive heart failure, pneumonia and severe cardiomyopathy. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 06-MAR-2018. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company''s conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. All of the events were considered to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the events of cardiomyopathy, pneumonia, failure to thrive and congestive heart failure were considered to be medically significant. The events of congestive heart failure, pleural effusions secondary to congestive heart failure, pneumonia, severe cardiomyopathy, shortness of breath, congestion, frequent falls and failure to thrive were considered to be disabling.


VAERS ID: 857584 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2020-01-01
Onset:2020-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS QS 2019-20 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, General physical health deterioration, Laboratory test, Life support, Organ failure, Pneumonia, Sepsis
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Acetaminophen Albuterol Benzonatate Ipratropium-Albuterol Ketorolac Sodium Chloride Anti Depressant
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10 Days on life support with constant tests, no improvement, quick decline. Currently obtaining full records.
CDC Split Type:

Write-up: Given while ill with fever and flu. Quick deterioration. Lung and blood infection. Sepsis within 24 hours. Life support with organ failure. Death in one week time.


VAERS ID: 857606 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Michigan  
Vaccinated:2019-12-10
Onset:2019-12-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Death, Life support, Loss of consciousness, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-14
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine 10 mg aspirin 81 mg carvedilol 25 mg cyanocobalamin 2500 mcg fenofibrate 160 mg finasteride 1 mg furosemide 20 mg gabapentin 300 mg glimepiride 4 mg hydralazine 25 mg x3 hydrochlorothiazide 25 mg insulin glargine 300 u/ml janumet
Current Illness:
Preexisting Conditions: Hypertension Neuropathy Carpal Tunnel Diabetes 2 Anesthesia of skin Trigger FInger
Allergies: Sulfa (sulfonamide antibiotics) anaphylaxis Penicillins Anaphylaxis
Diagnostic Lab Data: Her doctors in the hospital were not in communication with her doctors outside of the hospital. She had a stress test done a week prior and quite a few labs within pryor. Most of her labs were normal. Her kidneys were beginning to weaken and she had just gotten a recommendation to see a nephrologist. The doctors in the hospital said that she didn''t have a heart attack. There was no heart damage. Her EF was 65. Earlier that day, when she got the vaccines, her vitals were BP 150/64, Temp 97.6 Pulse 89, Oxygen 96%. Her reason for the visit: healthcare maintenance and alopecia. Her death certificate says acute coronary arrest (days), respiratory failure (days). Again , her hospital doctors weren''t in communication with her regular doctors. The office visit clearly showed no signs of respiratory distress. She was with a friend in a car at the time and her friend said that she was fine right up until she died.
CDC Split Type:

Write-up: On 12/10 around 3pm she had a 2 vaccines. Fluzone High Dose 180 mcg/0.5mL and Varicella-zoster 50 mcg/o.5mL. At 9:20pm, after going out to a movie, she suffered sudden cardiac arrest. 911 was immediately called. She never regained consciousness and was taken off of life support on 12/14. I asked multiple doctors why they thought her heart stopped and none of them knew why. I explained to them that I (her daughter) have a genetic condition called MCAS which has been linked to Kounis Syndrome which can cause coronary vasospasms. I was told it was too rare to consider. A couple of weeks later I found her vaccination papers. I called her doctor''s office to let them know. The woman on the phone pulled up her name. As she was reading, she said that they hadn''t been informed and thanks for letting them know and suddenly her entire tone changed and she said I''d have to talk to someone else and hung up. I believe she was trying to transfer me but I can''t help but wonder if she was having a small reaction earlier that day in the office and they let her go.


VAERS ID: 857879 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: New York  
Vaccinated:2020-01-23
Onset:2020-01-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. UNKNOWN / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-26
   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: uncertain
Current Illness: rheumatoid arthritis
Preexisting Conditions: rheumatoid arthritis. alcohol abuse.
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: seizure within 24 hours of vaccination


VAERS ID: 858436 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Florida  
Vaccinated:2020-01-09
Onset:2020-01-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ126AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T81219 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1660112 / 2 MO / PO

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

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

Write-up: Patient expired on 1/12/2020 of unknown cause. Patient was found unresponsive next to his father in father''s bed. Patient was pronounced dead in ER.


VAERS ID: 858617 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2009-08-12
Onset:2009-08-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2020-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Blood albumin decreased, Blood culture positive, Bronchoalveolar lavage abnormal, Bronchospasm, CD4 lymphocytes normal, CD8 lymphocytes decreased, Candida infection, Chest X-ray abnormal, Complement factor normal, Culture urine positive, Death, Dysphagia, Dyspnoea, Endotracheal intubation, Grunting, Hypotonia, Irritability, Lung infiltration, Lung opacity, Mechanical ventilation, Multiple organ dysfunction syndrome, Muscular weakness, Neutrophil count increased, Pneumonia viral, Pneumothorax, Polymerase chain reaction positive, Pseudomonas infection, Pseudomonas test positive, Pulmonary oedema, Pyrexia, Rash maculo-papular, Rash vesicular, Respiratory disorder, Respiratory distress, Scab, Sepsis, Skin lesion, Stridor, T-lymphocyte count decreased, Tachypnoea, Upper respiratory tract infection, Use of accessory respiratory muscles, Varicella virus test positive, Varicella zoster virus infection, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Interstitial lung disease (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-02
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: FERRIN; POLY-VI-SOL; nystatin; BACTROBAN; lansoprazole
Current Illness: Anaemia; Bronchiolitis; Chromosome abnormality; Developmental delay; Failure to thrive; Feeding disorder; Gastrooesophageal reflux disease; Hypotonia; Muscular dystrophy; Pneumonia aspiration; Prophylaxis; Protein allergy; Respiratory syncytial virus infection
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrostomy tube insertion; Hospitalisation; Mechanical ventilation; Otitis media; Varicella
Allergies:
Diagnostic Lab Data: Test Date: 20090924; Test Name: bronchial lavage specimen collected; Test Result: Positive ; Test Date: 20091009; Test Name: bronchial lavage specimen collected; Test Result: Positive
CDC Split Type: US0095075131210USA006581

Write-up: Another episode of respiratory distress/ Severe respiratory complications that worsened with each new crop of varicella lesions; severe respiratory complication/distress; the patient may have underlying immunosuppression for which varicella vaccination contraindicated; episode of acute respiratory failure/multi-organ failure; episode of acute respiratory failure/multi-organ failure; Rash on hands disseminated into a generalized maculopapular vesicular rash/recurrent crops of maculopapular vesicular skin lesions/ Varicella-like rash/Severe respiratory complications that worsened with each new crop of varicella lesions; bilateral pneumothoraces; sepsis; bilateral interstitial infiltrates consistent with viral pnenmonia, with worsening interstitial edema and opacification; This spontaneous report as received from an other health professional describing in a draft of the manuscript referring a case of fatal varicella due to vaccine-strain VZV following vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX). A 15-month old child who developed a varicella-like rash 20 days after varicella virus vaccine live (Oka/Merck) (VARIVAX) that lasted for 2 months despite continued acyclovir treatment. The rash was confirmed to be due to varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient developed severe respiratory complications that worsened with each new crop of varicella lesions; vaccine-strain VZV was detected in the bronchial lavage specimen. Sepsis and multi-organ failure led to death. The patient did not have any diagnosed immuno-compromising conditions for which varicella vaccination would have been contraindicated, but did have a number of underlying conditions that were severe enough to have required several hospitalizations in the past and might have been indicative of underlying immuno-compromising. The possibility of acyclovir resistance and a change in antiviral therapy to foscarnet should be considered if lesions do not improve after 10 days of treatment. Varicella virus vaccine live (Oka/Merck) (VARIVAX) was introduced in 1995. It contains live attenuated varicella-zoster virus (VZV). The routine childhood varicella vaccination program in the country has led to substantial declines in varicella related morbidity and mortality. Serious adverse events reported to the Vaccine Adverse Event Reporting System were rare; those confirmed to be due to the vaccine-strain VZV include pneumonia, hepatitis, herpes zoster with meningitis, and severe rash. The patient received her first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) on 12-AUG-2009, along with vaccinations against measles, mumps, rubella, haemophilus influenza b, and pneumococcal disease at age 1-year. She was born healthy, weighing 6.9 pounds; mother had no pregnancy complications. She did not have any recognized immuno-compromising conditions. Her newborn blood spot was negative for severe combined immunodeficiency. The patient had a milk protein allergy, anemia and chromosomal abnormality. She had a history of global developmental delay, failure to thrive (weight 14 pounds at age 15 months), type 2 muscular dystrophy, profound hypotonia, gastroesophageal reflux disease, otitis media and varicella. She had a gastrostomy tube placed at age 9-months due to poor feeding. She had episodes of bronchiolitis, pneumonia due to respiratory syncytial virus infection (RSV), and aspiration pneumonia (recurrent) that resulted in 5 hospitalizations before her first birthday, two of which required mechanical ventilation. Her only routine medication at the time of vaccination was lansoprazole. Quantitative serum immuno-globulin levels measured at 10 months were normal, except for elevated IgE levels at 424 (normal range: 0.8-7.3 IV/ml^17). On week after vaccination (19-AUG-2009), the patient was hospitalized for severe respiratory distress and was treated with albuterol, budesonide, and amoxicillin clavulanate. On the hospital day 10 (16 days post-vaccination) (29-AUG-2009), she was started on methylprednisolone iv, 3.5 mg q 12 for 3 days (equivalent to 8.8 mg/day of prednisone) followed by prednisolone via g-tube 3.5 mg ql2 for 2 days (equivalent to 7.0 mg/day of prednisone). Her respiratory distress resolved and she was discharged on hospital day 14 (01-SEP-2009). On the day of hospital discharge (01-SEP-2009), her mother noticed a rash on one of her hands that disseminated into a generalized maculopapular vesicular rash by the next day (02-SEP-2009), at which point, she was seen by her primary care physician and started on oral acyclovir. A skin lesion specimen collected on the next day (20 days post-vaccination) (02-SEP-2009) was positive for vaccine-strain VZV by polymerase chain reaction. Four days after rash onset (05-SEP-2009), the patient developed another episode of respiratory distress and was hospitalized. On admission, she had diffuse vesicular and crusted lesions and was febrile to 104 F. Chest x-ray showed increased opacity in the left lung. She was switched to IV acyclovir and was started on broad-spectrum antibiotics. Starting on hospital day 4 (09-SEP-2009), she received IV methylprednisolone (12 mg 1 dose for 1 day then 6 mg qd for 2 days), followed by 2 doses of prednisolone for one day. On hospital day 11 (16-SEP-2009), the patient had an episode of acute respiratory failure and was intubated. She required high-frequency oscillatory ventilation until her death 7 weeks later (02-NOV-2009). IV acyclovir was discontinued on hospital day 12 (17-SEP-2009), restarted on hospital day 21 (26-SEP-2012), and she was remained on it until her death. On hospital day 24 (29-SEP-2009), she was started on low-dose prolonged steroid therapy protocol for acute respiratory distress syndrome (IV methyl prednisolone for 32 days, starting with 13 mg for 1 dose and tapered to 0.4 mg bid). Despite ongoing acyclovir treatment, she continued to develop recurrent crops of maculopapular vesicular skin lesions every 7-8 days throughout her hospitalization. Her respiratory status deteriorated with each new crop of lesions and the chest x-ray showed bilateral interstitial infiltrates consistent with viral pneumonia that became increasingly confluent, with worsening interstitial edema and opacification. The patient subsequently developed bilateral pneumothoraces. On the day of her death, she had 50-100 skin lesions. A bronchial lavage specimen collected on hospital day 19 (24-SEP-2009) was positive for VZV DNA and later confirmed to be vaccine-strain VZV; an additional bronchial lavage specimen collected on hospital day 34 (09-OCT-2009) was also VZV-positive but not genotyped. Blood, respiratory, and tracheal aspirate specimens collected between days 12-19 (17-SEP-2009 to 24-SEP-2009) of hospitalization were positive for Pseudomonas aeruginosa by culture and several urine specimens collected between days 20-44 (25-SEP-2009 to 19-OCT-2009) of hospitalization were positive for Candida albicans by culture. Blood collected on day 11 (16-SEP-2009) of hospitalization showed normal humoral immunity and complement levels. A T-cell deficiency was considered as the patient''s T-cell counts on hospital days 11 (16-SEP-2009) and 17 (25-SEP-2009) were lower than normal: absolute T-cell counts were 223 and 864 respectively (normal range: 1600-6700); CD-8 counts were 46 and 180 (normal range: 400-2100); and CD-4 counts were 169 and 656 (normal range: 1000-4600). It is unknown why the patient described in this report had a prolonged rash that was unresponsive to acyclovir therapy. The patient may have had depressed T-cell function. This case-patient''s symptoms may have been exacerbated by treatment with steroids 2 weeks after vaccination. Although the steroid dosage used to treat this case would not be classified as high-dose, it still may have been immuno-suppressive. The benefits of varicella vaccination outweigh the very low risk of serious adverse events occurring. Providers should carefully monitor for any signs of adverse reactions after vaccination among all persons, especially among persons with medical histories that may be indicative of an immuno-suppressive condition. If these persons develop a rash after vaccination, they should be immediately treated with acyclovir. Death certificate received Date of death 02-NOV-2009, cause of death: multisystem organ failure, acute respiratory distress syndrome, varicella pneumonitis,varicella lesions and sepsis. Discharge summary received for date 27-AUG-2009: DX: respiratory difficulty, bronchospasms, hypotonia. Chief c/o respiratory distress, URI*1day, fever, tachypnea, retractions. Caretaker reports patient having difficulty breathing, fever, irritable. Assessment, (+)fever, grunting, retractions, hypotonia, O2 sat 91% on 3LNC. Speech and swallow eval: oropharyngeal dysphagia. Patient improved over 3 days, stable at discharge. ER/hospital 05-SEP-2009 to 29-OCT-2009. DX: muscular weakness disorder, viral pneumonitis, varicella. Respiratory distress, fever. Parent stated varicella vaccine on 12-AUG-2009. Varicella skin rash formed 31-AUG-2009. EMS presented patient to ER. Assessment: stridor, rash, fever, mild distress. Patient admitted and following day respiratory distress increased, grunting, increas in fever 103F, patient found to be irritable, O2 sats 92% with O2 therapy. TYLENOL was given, within 30 min temperature of 104.5F. One hour later patient heart rate 220-240 bpm. Patient later was stabilized but prognosis was guarded. Follow up information received which stated that the patients lymphoid subsets were all within normal range(CD8 and CD4 T cell percentages were 14% and 51% respectively). Her white blood cell counts were within normal range, neutrophil levels were high at times. her new born blood spot testing performed post mortem was negative for severe combined immunodeficiency/severe T-cell lymphopenia and the result would not exclude severe primary immune deficiencies with detectable T cells but impaired T cell function. In addition, nutritional status can impact T-cell function. One indication of such a problem was low albumin (2.2-2.9 g/dL on multiple samples; normal 3.4-3.S g/dL), with the nadir recorded on hospital day 26. Vaccine-strain VZV in skin and bronchial lavage specimens was identified by real-time PCR targeting 4 vaccine associated single nucleotide polymorphisms at open reading frame (ORF) 3S, ORF 54, and ORF 62. A copy of the published article is attached as further documentation of the patient''s experience. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 18-OCT-2013 which reported that, a phone call was received from a physician in regards to Literature Article. The physician was unable to provide any patient or medical information. The physician stated there was no copy of the patients'' Death Certificate and/or a copy of the patient''s Autopsy Results available for her to share, at this time. Additional information has been requested. Follow-up social media report has been received from an unspecified reporter via a journal published. The patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) reconstituted with sterile diluent (lot # and expiration date were unknown). Causality assessment of sterile diluent with all the events was related. It has been determined that case # {US-009507513-2001USA005128} is a duplicate of case # {US-009507513-1210USA006581}. Therefore, case # {US-009507513-2001USA005128} is being deleted from our files and the cases are consolidated into case # {US-009507513-1210USA006581}.; Reported Cause(s) of Death: multisystem organ failure; acute respiratory distress; sepsis; varicella lesions; varicella pneumonitis


VAERS ID: 858990 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: Death; Respiratory failure; GBS(Guillain Barre syndrome ); This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant), respiratory failure (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the respiratory failure and guillain barre syndrome were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, respiratory failure and guillain barre syndrome to be related to Shingrix. Additional information: The patient had death claim involving GBS and respiratory failure.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 860135 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2020-01-29
Onset:2020-02-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR UJ230AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS LR537 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CG9017 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1660693 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 2mg
Current Illness: GERD
Preexisting Conditions: GERD
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away on 2/1/2020 ED diagnosis- cardiac arrest


VAERS ID: 860822 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Unknown  
Vaccinated:2019-11-08
Onset:2020-02-06
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2020-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2LL97 / N/A RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Influenza A virus test positive, Lung assist device therapy, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-09
   Days after onset: 3
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: Influenza A positive
CDC Split Type:

Write-up: Patient was diagnosed with Influenza A and had severe respiratory distress. Was placed on ECMO


VAERS ID: 860962 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2020-01-28
Onset:2020-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2020-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ310AB / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 7RK7K / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac arrest, Death, Hypoxia, Influenza, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-04
   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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unlnown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client passed away on 2/4/2020 at 0832 AM. Cause of death states hypoxia, respiratory failure, cardiac arrest and influenza. Unknown if the vaccines were linked to death in anyway. Reported due to close timing the vaccines were administered to death.


VAERS ID: 861937 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2019-04-01
Submitted: 0000-00-00
Entered: 2020-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Analgesic drug level therapeutic, Aspartate aminotransferase increased, Asthenia, Bilirubin conjugated increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood ethanol normal, Death, HIV test negative, Hepatitis A, Hepatitis A antibody positive, Hepatitis B DNA assay negative, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Hepatitis C RNA negative, Hepatitis C antibody negative, Hepatitis E antibody negative, Hepatorenal syndrome, Hospice care, International normalised ratio increased, Jaundice, Polymerase chain reaction, Transaminases increased, Vaccination failure
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcoholic; Hepatic cirrhosis
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis A
Allergies:
Diagnostic Lab Data: Test Date: 201904; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: 1813, Test Result Unit: unknown; Test Date: 2019; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: 39, Test Result Unit: unknown; Test Date: 201904; Test Name: Acetaminophen; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 201904; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: 933, Test Result Unit: unknown; Test Date: 2019; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: 35, Test Result Unit: unknown; Test Date: 201904; Test Name: Bilirubin direct; Result Unstructured Data: Test Result: 11.94, Test Result Unit: unknown; Test Date: 2019; Test Name: Bilirubin direct; Result Unstructured Data: Test Result: more than 14.00, Test Result Unit: unknown; Test Date: 201904; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result: 225, Test Result Unit: unknown; Test Date: 2019; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result: 90, Test Result Unit: unknown; Test Date: 201904; Test Name: Bilirubin total; Result Unstructured Data: Test Result: markedly elevated, Test Result Unit: unknown; Test Date: 201904; Test Name: Bilirubin total; Result Unstructured Data: Test Result: 19.97 (On day of admission), Test Result Unit: unknown; Test Date: 2019; Test Name: Bilirubin total; Result Unstructured Data: Test Result: 55.04, Test Result Unit: unknown; Test Date: 201904; Test Name: Ethanol; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 201904; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result: non-reactive for HEV-IgG, Test Result Unit: unknown; Test Date: 201904; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result: reactive for hepatitis A virus (HAV) IgG, Test Result Unit: unknown; Test Date: 201904; Test Name: Blood immunoglobulin M; Result Unstructured Data: Test Result: non-reactive for HEV-IgM, Test Result Unit: unknown; Test Date: 201904; Test Name: Blood immunoglobulin M; Result Unstructured Data: Test Result: reactive for hepatitis A virus (HAV) IgM, Test Result Unit: unknown; Test Date: 201904; Test Name: Hepatitis B core antibody; Result Unstructured Data: Test Result: non-reactive, Test Result Unit: unknown; Test Date: 201904; Test Name: Hepatitis B surface antibody; Result Unstructured Data: Test Result: non-reactive, Test Result Unit: unknown; Test Date: 201904; Test Name: Hepatitis B surface antigen; Result Unstructured Data: Test Result: non-reactive, Test Result Unit: unknown; Test Date: 201904; Test Name: Hepatitis C antibody; Result Unstructured Data: Test Result: non-reactive, Test Result Unit: unknown; Test Date: 201904; Test Name: International normalized ratio; Result Unstructured Data: Test Result: markedly elevated, Test Result Unit: unknown; Test Date: 201904; Test Name: International normalized ratio; Result Unstructured Data: Test Result: 2.18 (On day of admission), Test Result Unit: unknown; Test Date: 2019; Test Name: International normalized ratio; Result Unstructured Data: Test Result: 3.11, Test Result Unit: unknown; Test Date: 201904; Test Name: Physical examination; Result Unstructured Data: Test Result: unremarkable aside from generalized jaundice, Test Result Unit: unknown; Test Date: 201904; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201904; Test Name: Transaminases; Result Unstructured Data: Test Result: markedly elevated, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: Vaccination failure; Hepatitis A virus infection; Generalized weakness; Jaundice; Death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 58-year-old male patient who received Hepatitis A vaccine for prophylaxis. The patient''s past medical history included hepatitis a. Concurrent medical conditions included hepatic cirrhosis and alcoholic. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose. In April 2019, unknown after receiving Hepatitis A vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), hepatitis a (serious criteria hospitalization), weakness generalized (serious criteria hospitalization) and jaundice (serious criteria hospitalization). On an unknown date, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, hepatitis a, weakness generalized and jaundice were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, hepatitis a, weakness generalized and jaundice to be related to Hepatitis A vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a male patient aged 58-year-old who was vaccinated with unspecified hepatitis A vaccine (manufacturer unknown) for prophylaxis. The patient had a history of liver cirrhosis and Hepatitis A virus (HAV) infection. The patient had daily alcohol use. The patient was negative for human immunodeficiency virus (HIV). No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified hepatitis A vaccine one time (administration route and site unspecified; batch number not provided). The age at vaccination was not provided. On an unspecified date in April 2019, unknown period after vaccination, the patient presented to the emergency department (ED) with generalized weakness and jaundice for one week. The patient denied recent travel or drug use, however, admitted to daily alcohol use. The patient''s vital signs were normal. Physical exam was unremarkable aside from generalized jaundice. Laboratory results were relevant for markedly elevated transaminases, international normalized ratio (INR) and total bilirubin. On day of admission, the patient''s lab test showed alanine aminotransferase (ALT) at 1813, aspartate aminotransferase (AST) at 933, total bilirubin at 19.97. direct bilirubin at 11.94, INR at 2.18 and alkaline phosphatase at 225 (normal range and units not reported for all). In April 2019, from admission, Ethanol and acetaminophen levels were negative, polymerase chain reaction (PCR) did not detect hepatitis B virus deoxyribonucleic acid (HBV DNA) and hepatitis C virus ribonucleic acid (HCV RNA), but viral hepatitis serologies was non-reactive for hepatitis B core antibody (HBcAB), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepaitis C virus antibody (HCV-AB), hepatitis E virus (HEV immunoglobulin G)-IgG and HEV-IgM, but was reactive for hepatitis A virus (HAV) IgM and IgG, despite prior immunity to HAV two years ago in May 2017 when the patient was only reactive for HAV-IgG and non-reactive for HBcAB, HBsAg, HBsAb and HCV-AB. Supportive treatment was started. The patient''s hospital stay was complicated by fulminant liver failure and hepatorenal syndrome. The patient was not a candidate for liver transplant due to continued alcohol use. On last day, prior to expiration date, the patient''s lab tests showed ALT at 39, AST at 35, total bilirubin a 55.04, direct bilirubin at more than 14.00, INR at 3.11 and alkaline phosphatase at 90. The patient pursued hospice care and later expired. This case was considered as suspected vaccination failure since time to onset was unknown. This case was considered as serious due to death, vaccination failure and hospitalization. The authors commented "Immunity to HAV occurs after exposure to its antigen (Ag) confirmed by a positive IgG. Vaccination should offer lifelong immunity. T-cells play a main role in Ag presentation, cytokine induction and B cell differentiation. However, patients with a compromised immune system often experience T-cell dysfunction, hindering a proper immune response. Immunocompromised states, such as HIV infection, affect seroconversion rates after vaccination. One study showed 4% of patients with HAV infection were HIV positive and 55% were previously vaccinated. Our patient was negative for HIV but had a history of liver cirrhosis. The liver is the first organ in contact with the HAV Ag, delivered from the gut via the portal vein. Liver macrophages prevent systemic spread of Ag and hepatocytes synthesize complement. Both are essential for a robust immune response. This case highlights the risk of reinfection with HAV in cirrhotic patients, even with prior immunization. We suggest consideration for booster immunization in this population similar to that suggested for HIV patients". Lab Comments: The patient''s vital signs were normal. Polymerase chain reaction (PCR) did not detect hepatitis B virus deoxyribonucleic acid (HBV DNA) and hepatitis C virus ribonucleic acid (HCV RNA), but viral hepatitis serologies was non-reactive for hepatitis B core antibody (HBcAB), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepaitis C virus antibody (HCV-AB), hepatitis E virus (HEV immunoglobulin G)-IgG and HEV-IgM, but was reactive for hepatitis A virus (HAV) IgM and IgG, despite prior immunity to HAV two years ago in May 2017 when the patient was only reactive for HAV-IgG and non-reactive for HBcAB, HBsAg, HBsAb and HCV-AB. On last day in 2019, prior to expiration date, the patient''s lab tests showed ALT at 39, AST at 35, total bilirubin a 55.04, direct bilirubin at more than 14.00, INR at 3.11 and alkaline phosphatase at 90; Reported Cause(s) of Death: Death NOS


VAERS ID: 862665 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: North Carolina  
Vaccinated:2018-12-11
Onset:2018-12-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 4ZH95 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R014261 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X35262 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R015433 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-13
   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: none
Current Illness: eczema
Preexisting Conditions:
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away 12/13/18. Per parent report he has a seizure and died.


VAERS ID: 862890 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Male  
Location: Unknown  
Vaccinated:2020-01-29
Onset:2020-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Adenovirus infection, Adenovirus test positive, Arthropathy, Cellulitis, Culture negative, Cytomegalovirus infection, Cytomegalovirus test positive, Endotracheal intubation, Epiglottitis, Epstein-Barr virus infection, Epstein-Barr virus test positive, Herpes simplex, Herpes simplex test positive, Immunodeficiency, Immunoglobulin therapy, Immunology test, Incisional drainage, Lung assist device therapy, Lymphadenitis, Morbillivirus test positive, Multiple organ dysfunction syndrome, Otitis media, Polymerase chain reaction positive, Respiratory failure, Respiratory syncytial virus test positive, Roseolovirus test positive, Stridor, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (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), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-22
   Days after onset: 23
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: measles vaccine strain positive from NP and urine, resulted 2/21
CDC Split Type:

Write-up: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine. Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon. Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis. Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.


VAERS ID: 862933 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, General physical health deterioration, Organ failure, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sterile Diluent
Current Illness: Pulmonary hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132002USA009134

Write-up: RENAL FAILURE; ORGAN FAILURE; Deterioated quickly; This spontaneous report was received from a nurse via company representative refers to a 40 year old female patient (nurse''s cousin). The patient''s concurrent condition included pulmonary hypertension. The patient''s medical history, concomitant medication, drug reactions and allergies were not reported. It was reported that the patient was awaiting for a heart and double lung transplant. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and hepatitis a vaccine, inactivated (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot# and expiration date was not reported for both the suspect therapies) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, indication, route of administration, lot# and expiration date was not reported). On an unknown date after receiving the vaccines, the patient experienced quick deterioration and went into organ and renal failure (organ failure, general physical health deterioration and renal failure). On 10-FEB-2020, the patient died. It was unknown if an autopsy was performed. The cause of death was not reported. Causality was not reported. No product quality complaint (PQC) was involved with this report. Upon internal review, the event of renal failure was determined to be medically significant.


VAERS ID: 863114 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Kentucky  
Vaccinated:2019-12-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS D93B4 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ099AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AL8456 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S010702 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no meds
Current Illness: No illness
Preexisting Conditions: Prematurity, poor weight gain, GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None noted, called parent to reschedule 6 month WCC and mother told us baby had passed away. Did not give reason why.


VAERS ID: 863170 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2020-02-20
Onset:2020-02-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR U6397AB / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AT5497 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1658256 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Laboratory test, Pathology test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-21
   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: Nasal Saline PRN Simethicone PRN
Current Illness: Bronchilitis/Viral syndrome (rsv/flu negative) 2/1/20
Preexisting Conditions: 34 4/7 week prematurity due to pre-eclampsia with associated hyperbili and hypothermia; resolved social discord
Allergies: None
Diagnostic Lab Data: Autopsy pending with associated lab/pathology
CDC Split Type:

Write-up: Infant received vaccines morning of 2/20. At some point overnight between 2/20 and 2/21 the infant expired at home and was found deceased by his mother in the morning. We do not have further details but the death is being investigated by the Coroner''s office.


VAERS ID: 863176 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-01-15
Onset:2020-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Biopsy, Death, Diarrhoea, Graft versus host disease in gastrointestinal tract, Muscle spasms
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-09
   Days after onset: 25
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: Patient also had developed odd myalgias shortly after transplant that improved with steroids.
Allergies:
Diagnostic Lab Data: Upper GI Endoscopic Biopsy, 22-Jan-2020, Severe acute GVHD
CDC Split Type:

Write-up: Patient received the Fluarix Quadrivalent vaccination on 01/15/2020, approximately 6 months after his stem cell transplant. The next day he developed diarrhea that progressed over the weekend with abdominal pain and cramping requiring hospital admission. Upon admission he was found to have acute graft-versus-host disease (GVHD) of the GI tract, potentially incited by the immune activation from his influenza vaccination. Unfortunately the patient''s GVHD was refractory to multiple lines of therapy and led to his death less than a month after presentation.


VAERS ID: 863284 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Complications of transplanted kidney, Death, Product use in unapproved indication, Skin papilloma
SMQs:, Medication errors (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: Flat warts
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131912USA012731

Write-up: HPV vaccine for chest, back and extremities warts (flat warts); This literature marketed report has been received from the authors of the published article, concerning a 51 year old male patient. The patient''s pertinent medical history included a renal transplant and therapy with liquid nitrogen, tazarotene (TAZORAC) and imiquimod. The patient''s current conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) chest, back and extremities warts (flat warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient died due to complications related to the renal transplant. A copy of the published article is attached as further documentation of the patient''s experience. This is one of several reports received from the same literature.


VAERS ID: 863494 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: North Carolina  
Vaccinated:2020-02-27
Onset:2020-02-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ125AB / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AT8585 / 1 LA / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R016791 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: found unresponsive in crib, unresponsive to resuscitation. deceased. autopsy pending


VAERS ID: 863564 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: North Carolina  
Vaccinated:2020-02-21
Onset:2020-02-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LL / SYR
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LL / SYR
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK OT / SYR
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK RL / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Resuscitation, Rhinorrhoea
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-23
   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:
Allergies:
Diagnostic Lab Data: She is currently at medical center at at the medical examiner''s office they said it is a 90-day process for their test results to come back to say what the cause of death is or the results on their test and laboratory results
CDC Split Type:

Write-up: My daughter got her 4 months old vaccine shots on February 21st 20/20 we came home and stayed home. the next day Saturday we slept in late I didn''t notice anything strange about her it was my day off. we spent the whole day playing and loving each other and we went to bed early Sunday morning at about 3 A.m. of course she had naps throughout the day but when I finally went to sleep with her it was 3 in the morning. During the night after bed I noticed that her nose is running .I wiped her nose I went back to sleep and when I woke back up I noticed her nose was running a lot I thought she had a bad cold it had just snowed a few days ago even though she didn''t go in the snow I just thought maybe she had a running nose . but I noticed her chest wasn''t moving when I went to pick her up a whole bunch of fluid just rushed out of her face. I ran to my roommate we got into the car went to the hospital and they could not resuscitate my baby. nothing changed in her routine except for all those vaccine shots she got on that Friday the day before.


VAERS ID: 864321 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Colorado  
Vaccinated:2019-11-16
Onset:2019-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ293AA / UNK UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute cardiac event, Asthenia, Dehydration, Diarrhoea, Gastrointestinal disorder, Nausea, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-19
   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: acidophilus, famotidine, potassium chloride ER, quetiapine, Ativan, tums
Current Illness: Was hospitalized for acute urinary retention, low grade fever with initial suspicion for pneumonia that was subsequently ruled out. Patient was discharged on 11/18/2019. During the hospital stay she had an influenza vaccine administered, Fluzone high dose lot #UJ293AA on 11/16/2019. She developed nausea, vomiting and diarrhea that her physician, MD was concerned could be related to the vaccine. The patient died suddenly at her assisted living facility while on the toilet on 11/19/2019. This was thought to be an acute cardiac event, possibly an arrhythmia related to dehydration she sustained due to the gastrointestinal symptoms she was experiencing.
Preexisting Conditions: hypertensive heart disease, cardiomegaly, GERD, anxiety, dementia, iron deficiency anemia
Allergies: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Nausea, vomiting and diarrhea 48-72 hours after administration of the vaccine. Unknown whether this was the result of the vaccination or something else. The patient was frail, had underlying heart conditions and died of a cardiac event which likely was related to dehydration sustained from these symptoms.


VAERS ID: 865545 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2018-12-01
Submitted: 0000-00-00
Entered: 2020-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adrenal gland cancer metastatic, Asthenia, Atelectasis, Back injury, Blood test abnormal, Bone cancer metastatic, Bronchoscopy abnormal, Cellulitis, Central nervous system lesion, Chest X-ray abnormal, Cough, Death, Dyskinesia, Dyspnoea, Epidural analgesia, Extradural abscess, Fall, Feeling abnormal, General physical health deterioration, Haemorrhage, Hyperhidrosis, Laboratory test, Lung carcinoma cell type unspecified stage IV, Lung infiltration, Magnetic resonance imaging, Malaise, Mobility decreased, Muscle twitching, Oxygen saturation decreased, Pain, Pallor, Pneumonia, Pneumothorax, Productive cough, Pulmonary embolism, Pyrexia, Radiotherapy, Rash, Surgery
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-24
   Days after onset: 204
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 201812; Test Name: oxygen levels; Result Unstructured Data: Lab result: 82-83 percent
CDC Split Type: US0095075132003USA006263

Write-up: was getting weaker and weaker, and could not breathe; rash in his groin; the patient had a fever of 101F, the doctor state d to go back to the hospital; the patient had fallen into the bathtub; patient had an "MRl and patient had an epidural abscess".; the patient was diagnosed with stage 4 lung cancer, that was also in his bones, adrenal glands, and the patient had 10 lesions on his brain; the patient had a collapsed lung; the patient was getting weaker and weakerand couldn''t breath;; declined rapidly, and then died on 6/24/2019 from an unspecified cause; pneumonia and was on a nebulizer treatment multiple times a day; was coughing up copious amounts of mucous; his oxygen level were 82-83%; he was swating; the patient was coughing; the patient had magnetic resonance imaging (MRI) fo unspecified cause and needed an epidural.; twiches in the face and jerking movements in body; the patient ws in pain and could not get out of bed; on an unspecified date in 2018 the patient was at the gym and hurt his back; needed an epidural.; he was swating and pale; the patient was not feeling well; the patient had blood clots in his lungs; was diagnosed "with cellulitis, and was started on an unspecified intravenous antibiotic; twitches in the face and jerking movements in body; The Physician thought he had some kind of bleed; This spontaneous report was received from a patient''s wife and refers to a 75-year-old male patient. There was no information about the patient''s concurrent conditions, allergies, drug reactions, concomitant therapies provided. Medical history included prostate cancer diagnosed in year 2001, it was unknown if the patient received any treatment. On unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, dose number, lot #, expiration date and route of administration were not reported) for prophylaxis. On unspecified date in 2018, the patient was at the gym and hurt his back which was treated with unspecified pain injections. On unknown date, reported as unspecified Tuesday, the patient had magnetic resonance imaging (MRI) to unspecified cause and needed an epidural. On unknown date, reported as Saturday after getting epidural, the patient was running a temperature. After contact with physician the patient was admitted to the hospital. The patient had an MRI and was diagnosed with epidural abscess, treated with surgery on 01-OCT-2018. On an unspecified date in 2018, unspecified amount of time after the surgery, the patient started ertapenem sodium (INVANZ) injection, intravenously (strength, dose, frequency, indication, lot # and expiration date were not reported) therapy and developed twitches in the face and jerking movements in body. The patient was also in pain and could not get out of bed. He had many unspecified tests done, was seeing neurologists, was getting tested for seizures, and tests to see if the patient had a stroke, but no results were provided. The patient was in the hospital for three weeks, and then went to an unspecified rehabilitation center for three weeks and then, on an unspecified date, was discharged home. On unknown date, approximately in 2018, the patient was not feeling well, was coughing and on unknown date, he had fallen into the bathtub. The home nurse called the ambulance and he went to an unspecified hospital. Blood tests were performed and the physician thought that the patient had some kind of bleeding. The patient was pale and sweating and was released from the hospital. On the same day, in the evening, he developed fever of 101 degrees of Fahrenheit (F). The infectious doctor was called, and referred the patient back to the hospital. Chest radiograph (x-ray) and blood work were performed and results showed that there were blood clots in his lungs. Treatment with an unspecified blood thinner was started and the patient went to an unspecified rehabilitation facility for three weeks in November 2018. On unknown date in November 2018 (reported as around Thanksgiving 2018), the patient experienced rash in his groin and was admitted to hospital. Cellulitis was diagnosed (date not provided), and as a treatment an unspecified intravenous antibiotic was administered. After discharge, the treatment was changed to unspecified antibiotic pills. On unspecified date, in December 2018, the patient developed pneumonia and was on a nebulizer treatment multiple times a day. He was coughing up copious amounts of mucous and his oxygen levels were 82-83%. The patient was getting weaker and weaker, and could not breathe. On unknown date, within four days of starting the breathing treatments, the patient was admitted to the hospital for both lungs being infiltrated. On unspecified date, he had a collapsed lung and Atelectasis, and unspecified intravenous antibiotic was administered. On unspecified date, the patient had a bronchoscopy, and was diagnosed with stage 4 lung cancer, that was also in his bones, adrenal glands, and the patient had 10 lesions on his brain. While being in the hospital, he was coughing and was miserable. There was many consultation with specialist physicians. On unknown date, in one week, the patient received 5 radiation treatments on his brain. On the same week (start date was not provided), he received one dose of pembrolizumab (KEYTRUDA) injection (formulation, strength, (dose, frequency, route of administration, indication, lot # and expiration date were not reported) treatment. On unknown date, the patient declined rapidly, and then died on 24-JUN-2019 from an unspecified cause. It was unknown if autopsy was performed. Therapy with ertapenem sodium (INVANZ) was discontinued. The outcome of back injury, lung cancer metastatic, some kind of bleed, coughing up copious amounts of mucous, getting weaker and weaker, oxygen level of 82-83%, collapsed lung, breathing difficulty, pneumonia, cellulitis, rash, clots in lungs, fever, sweating, pallor of skin, fall, cough, malaise, pain, twitches in the face, jerking movements in body, extradural abscess was unknown. The causality assessment between the events and suspect therapies was not provided. Upon internal review the events of epidural abscess, some kind of bleed, clots in his lungs, cellulitis, pneumonia, collapsed lung, stage 4 lung cancer were considered to be medically significant.


VAERS ID: 865771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:2010-12-29
Onset:2014-02-10
   Days after vaccination:1139
Submitted: 0000-00-00
Entered: 2020-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Death, Herpes zoster, Pain, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132003USA007813

Write-up: Pt had suffered significant medical expenses, and pain and suffering, and damages until her death; Chronic pain; Pt was treated for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-DEC-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) in a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 10-FEB-2014, pt was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. Patient was prescribed with valacyclovir (VALTREX), lidocaine, gabapentin and hydrocodone (+) acetaminophen (VICODIN) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient had suffered significant medical expenses, and pain and suffering, and other damages until her death. The cause of death and if an autopsy was performed was unknown. The outcome of herpes zoster and chronic pain was unknown. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 866693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2018-01-01
Onset:2018-03-30
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2020-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: US0095075132003USA009956

Write-up: heart attack; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt''s medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified day in approximately January 2018, the pt was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for the prevention of shingles. On 30-MAR-2018 (also reported as shortly after receiving the vaccine), the pt suffered a fatal heart attack as a direct and proximate result of the zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt suffered painful injuries, damages, and wrongful death. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company''s wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury and wrongful death. It was reported that the pt incurred and would continue to incur medical expenses and other economic harm as a direct result of use of zoster vaccine live (ZOSTAVAX). The causal relationship between the event was reported as related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: heart attack


VAERS ID: 867480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Biopsy mucosa abnormal, Blister, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Chapped lips, Complement factor C3, Death, Duodenal ulcer perforation, Dysphagia, Erythema, Fatigue, Haemorrhage, Herpes simplex test negative, Lip blister, Lip haemorrhage, Mouth swelling, Mouth ulceration, Polymerase chain reaction, Rash, Scab, Sepsis, Stevens-Johnson syndrome, Stomatitis, Tongue ulceration, Viral test
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal perforation (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pembrolizumab
Current Illness: Adenocarcinoma lung (treated with lobectomy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Immunoglobulins; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Mucosal biopsy; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: not detected herpes simplex virus, Test Result Unit: unknown; Test Name: Virus culture; Result Unstructured Data: Test Result: not detected herpes simplex virus, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: Stevens-Johnson syndrome like eruptions; perforated duodenal ulcer; sepsis; multiple small oral ulcers; fatigue; oral mucositis; tongue ulcer; difficulty swallowing; a non-pruritic and non-tender rash in the upper back and upper extremities; lip ulcer; hemorrhagic crust more prominent in the lower lip, showing cracking and fissuring with blood encrustation; hemorrhagic crust more prominent in the lower lip, showing cracking and fissuring with blood encrustation; extensive vesicles/vesicles with erythematous borders scattered in hard palate, mucosa, and gums; lip, showing cracking and fissuring; vesicles with erythematous borders scattered in hard palate, mucosa, and gums; death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 80-year-old female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. Co-suspect products included pembrolizumab for adenocarcinoma lung. Previously administered products included chemotherapy, pembrolizumab (5 doses received on an unspecified date) and immunotherapy. Concurrent medical conditions included adenocarcinoma lung (treated with lobectomy). On an unknown date, the patient received the 1st dose of Herpes Zoster vaccine and pembrolizumab at an unknown dose and frequency. On an unknown date, unknown after receiving Herpes Zoster vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), stevens johnson type reaction (serious criteria hospitalization and GSK medically significant), duodenal ulcer perforation (serious criteria hospitalization and GSK medically significant), sepsis (serious criteria hospitalization and GSK medically significant), mouth ulcer (serious criteria hospitalization), fatigue (serious criteria hospitalization), mucositis oral (serious criteria hospitalization), tongue ulceration (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), rash (serious criteria hospitalization), lip ulcer (serious criteria hospitalization), lip hemorrhage (serious criteria hospitalization), crust (serious criteria hospitalization), vesicles (serious criteria hospitalization), cracked lips (serious criteria hospitalization) and erythema (serious criteria hospitalization). The patient was treated with acyclovir, prednisone and antiseptics (nos) (Antiseptic). Pembrolizumab was discontinued. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the stevens johnson type reaction was recovering/resolving and the outcome of the duodenal ulcer perforation, sepsis, mouth ulcer, fatigue, mucositis oral, tongue ulceration, swallowing difficult, rash, lip ulcer, lip hemorrhage, crust, vesicles, cracked lips and erythema were unknown. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death, stevens johnson type reaction, duodenal ulcer perforation, sepsis, mouth ulcer, fatigue, mucositis oral, tongue ulceration, swallowing difficult, rash, lip ulcer, lip hemorrhage, crust, vesicles, cracked lips and erythema to be related to Herpes Zoster vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Stevens-Johnson syndrome (SJS) like eruptions in an 80-year-old female patient, who was vaccinated with unspecified recombinant zoster vaccine (RZV) (manufacturer unknown) for prophylaxis. The patient was woman. The patient had a 13-year history of lung adenocarcinoma. The patient was treated with lobectomy. Despite several surgeries and chemotherapy, progression to advanced lung adenocarcinoma with invasion of the visceral pleura occurred. Based on biomarker testing (PD-L1 positive, EGFR/ALK negative), 15 weeks before the presentation, the patient received immunotherapy with a single-agent pembrolizumab that resulted in improvement of disease progression. There were no other new medications recorded either previous experience with other immunotherapy agents or corticosteroids. No information on patient''s family history was provided. On an unspecified date, the patient received 1st dose of unspecified recombinant zoster vaccine (RZV) (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided but it could be 79 years or 80 years. On an unspecified date, the patient received 6st dose of pembrolizumab. The patient received a total of 6 doses of pembrolizumab before presentation. On an unspecified date, 2 days after the 6th dose of pembrolizumab and 7 days after 1st dose of recombinant zoster vaccine, the patient presented with a 2-day history of multiple small oral ulcers. Associated symptoms included fatigue. The oral mucositis was considered nonspecific; thus, an antiseptic solution was prescribed. After 2 days, the patient developed new ulcers in the tongue associated with difficulty swallowing solids. The patient received treatment with acyclovir without improvement. Subsequently, the patient exhibited worsening of ulcers over the lips and a non-pruritic and non-tender rash in the upper back and upper extremities. The physical examination revealed hemorrhagic crust more prominent in the lower lip, showing cracking and fissuring with blood encrustation. Oral mucosa examination showed extensive vesicles with erythematous borders scattered in hard palate, mucosa, and gums. The tongue was denuded, with prominent taste buds and a rough surface appearance. Some scabs were noticed in the upper extremities and upper back without any surrounding erythema. A buccal mucosa biopsy revealed focally ulcerated mildly parakeratotic stratified squamous epithelium overlying fibrovascular connective tissue. The ulcer bed was covered by a fibrin clot composed of enmeshed erythrocytes, neutrophils, and lymphocytes. Numerous ectatic endotheliallined vascular channels were noticed throughout the subjacent connective tissue stroma, which exhibits a diffuse acute and chronic inflammatory cell infiltrate. No immunoreactants (C3, immunoglobulin [Ig] G, IgA, IgM) were detected. The viral culture and polymerase chain reaction did not detect herpes simplex virus. Although the histopathologic findings were nonspecific, when correlated with the clinical presentation and onset of new medications, the findings were compatible with the diagnosis of SJS-like eruption. The patient received prednisone, which slowed the progression of her lesions. The patient had not been maintained on steroid therapy prior. The patient did not receive the second dose of RZV and pembrolizumab was discontinued. At a 1-month follow-up appointment, her initial eruptions improved. Unfortunately, the patient subsequently presented to the hospital with severe sepsis from a perforated duodenal ulcer. On an unspecified date, the patient was died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death and hospitalization. The author commented, "SJS is a rare blistering disorder with high mortality rate and significant morbidity. Stevens-Johnson syndrome (SJS) is a life-threating mucocutaneous reaction predominantly induced by drugs. Causes include drugs, herpes viruses, and immunization. The timing of the eruption soon after the receipt of recombinant zoster vaccine suggests a role of vaccination in our patient, yet patients receiving cancer immunotherapy may develop late-onset skin toxicity. Targeted cancer therapies such as pembrolizumab, which has been approved for the treatment of metastatic malignancy, can cause severe skin toxicities, including SJS. They are rare and inconsistently reported. Therefore, we recommend long-term monitoring for mucocutaneous reactions after initiation of pembrolizumab. It is possible that the corticosteroids given for her SJS-like syndrome contributed to her death. The most common drugs associated with SJS are sulfonamide antibiotics, anticonvulsants, nonsteroidal anti-inflammatory drugs, and corticosteroids. Other etiologies, such as viruses (i.e., herpes simplex virus) and vaccinations, have been implicated as a cause of SJS. Some predisposing factors, namely, drug-specific T-cell-mediated cytotoxicity, and genetic susceptibility of the patient (human leukocyte antigen [HLA] and non-HLA genes) may play a role in its pathogenesis. Our patient developed SJS-like eruptions in oral mucosa after 15 weeks of exposure of pembrolizumab (6 doses) and 7 days after 1 dose of RZV. SJS only rarely occurs 8 weeks following suspected drug exposure, but late onset in patients receiving immunotherapy has been reported. Pembrolizumab is usually a well-tolerated therapy for metastatic cancers. The most common immune-related skin lesions reported are lichenoid reaction, eczema, and vitiligo. Pembrolizumab rarely causes skin reactions, but severe responses such as SJS can occur. The latent period between pembrolizumab exposure and onset of symptoms in SJS varies from 7 to 140 days. In addition, gene expression profiles from skin lesions caused by anti-programmed death-1 (anti-PD-1) antibody therapy and SJS has similarities. These findings suggests that anti-PD-1 antibody can induce SJS-like adverse reactions. Furthermore, cases of SJS following herpes zoster vaccination are exceedingly rare. In a recent systematic review, there were 2 post-marketing surveillance studies implicating live-attenuated varicella vaccine with SJS. The immunologic theory behind vaccine-induced cutaneous hypersensitivity states that antigens in the vaccine are expressed on the surface of keratinocytes, generating a CD8+ T lymphocyte immune response against epidermal cells. This leads to apoptosis of keratinocytes and detachment of the dermal-epidermal junction. Our patient received the new vaccine RZV that promotes strong CD4+ T-cell and humoral immune response against recombinant proteins. It is difficult to ignore the appearance of her severe mucocutaneous eruption shortly after she received zoster vaccine, suggesting that herpes virus antigens, perhaps in combination with her immunotherapy, may have induced the cytotoxic skin reaction. However, immunotherapies require time to induce immune responses, and skin immune-mediated adverse effect may take longer to appear compared with cytotoxic therapies." This article corresponding to this case is not available for regulatory submission due to copyright restriction. Lab Comments: On an unspecified date, lab test were performed. The patient''s oral mucosa examination showed extensive vesicles with erythematous borders scattered in hard palate, mucosa, and gums. The tongue was denuded, with prominent taste buds and a rough surface appearance. Some scabs were noticed in the upper extremities and upper back without any surrounding erythema.A buccal mucosa biopsy revealed focally ulcerated mildly parakeratotic stratified squamous epithelium overlying fibrovascular connective tissue. The ulcer bed was covered by a fibrin clot composed of enmeshed erythrocytes, neutrophils, and lymphocytes. Numerous ectatic endotheliallined vascular channels were noticed throughout the subjacent connective tissue stroma, which exhibits a diffuse acute and chronic inflammatory cell infiltrate. The histopathologic findings were nonspecific, when correlated with the clinical presentation and onset of new medications, the findings were compatible with the diagnosis of SJS-like eruption. No immunoreactants. (C3, immunoglobulin [Ig] G, IgA, IgM) were detected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 867687 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: California  
Vaccinated:2019-10-09
Onset:2020-01-17
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2020-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Albumin CSF, CSF immunoglobulin G index, CSF test, Death, Encephalitis, Hypoxic-ischaemic encephalopathy, Magnetic resonance imaging, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-01-25
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI CSF, Albumin CSF, IgG CSF encephalitis, meningitis panel
CDC Split Type:

Write-up: Acute bilateral cerebellitis, respiratory failure, anoxic encephalopathy, death. Presented to Hospital on 1/17/2020, expired 1/25/2020.


VAERS ID: 867691 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Tennessee  
Vaccinated:2020-04-06
Onset:2020-04-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ157AA / 2 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Crying, Cyanosis, Death, Dyspnoea, Endotracheal intubation, Hypotonia, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril 1 mg/ml 0.25 ml po bid Levothyroxine .025 tab q day liquid multivitamin with iron Nystatin oral susp 100,000 U/ 1 ml 1 ml qid fpr 10 days
Current Illness: thrush
Preexisting Conditions: ex 26 weeker- 1 lb 13 oz 4 mo post op from bowel perforation at DOL 5 bronchopulmonary dysplasia- on 1/4 L/min O2 HTN- previous LV functon at 45- 50 %- improved with enalapril hypothyroidism
Allergies: None
Diagnostic Lab Data: Patient arrived DOA at the ER. Medical examiner was called and saw baby. The baby was sent for autopsy.
CDC Split Type:

Write-up: Baby had been in the office for a new patient well baby check and needed vaccine. Baby had been fine for the 48 hrs prior to event. Mom heard baby crying about 11: 30 on 4/8/2020. She went in to get him . She picked him up and heard a gasp. He then went limp and turned blue. She started CPR and grandmother called 911. Paramedics found the baby in asystole. They intubated the baby but never got a heart beat . The medical examiner was called. She sent the baby for autopsy. She started that on her exam she could find nothing obviously wrong with the baby.


VAERS ID: 867981 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Missouri  
Vaccinated:2020-04-08
Onset:2020-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ148ABA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AT8661 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1660972 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: None
Allergies: none
Diagnostic Lab Data: not that I know of
CDC Split Type:

Write-up: Was seen in the morning at my office for 2 month check, exam normal. Gave immunizations at the end of the visit. Was called by ER at about 1:30 PM that the patient arrived in the ER deceased.


VAERS ID: 868384 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Michigan  
Vaccinated:2020-01-16
Onset:2020-01-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 604800035514 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram, Death, Electroencephalogram, Laboratory test, Magnetic resonance imaging, Myocardial infarction, Resuscitation, Stent placement
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-26
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin 81mg, Metoprolol Succ. 50 mmm, Atorvastatin 20mg
Current Illness: None
Preexisting Conditions: HX; Previous Atrial Fib episode, Elevated Cholesterol
Allergies: None
Diagnostic Lab Data: CAT scan, labs, MRIs and EEG throughout his stay in the hospital.
CDC Split Type:

Write-up: Patient received the vaccine on 1/16/20 in the afternoon. The following morning he had a massive heart attack and had to be resuscitated multiple times. He was sent to Hospital where he received two stents. There we were informed that he also had multiple strokes and passed away on 1/26/20.


VAERS ID: 868993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Oregon  
Vaccinated:2012-06-15
Onset:2012-07-15
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2020-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autism spectrum disorder, CDKL5 deficiency disorder, Constipation, Death, Electroencephalogram, Epilepsy, Gait inability, Gastrooesophageal reflux disease, Infantile spasms, Laboratory test, Petit mal epilepsy, Speech disorder developmental
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-04
   Days after onset: 1815
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: Healthy pregnancy and delivery
Preexisting Conditions: After vaccination: seizures started 2-4 weeks after vaccination, she was vaccinated per the CDC recommended guidelines despite having seizures. She was diagnosed with: epilepsy, infantile spasms, CDKL5, severe autism spectrum disorder symptoms, severe constipation, she never walked or talked, and she died at age 5.
Allergies: Dairy
Diagnostic Lab Data: Many years of hospitalizations, lab tests, EEGs, physical, speech, vision, & occupational therapies. She received A,B, & C line drugs to try to stop the seizures.
CDC Split Type:

Write-up: Severe reflux and absence Seizures started between 2-4 weeks of age. Sandifer Syndrome was ruled out, she was treated for reflux and eventually did a series of EEGs. Diagnosed with epilepsy and started on Kepra. She was vaccinated per the CDC guidelines despite having epilepsy and symptoms continued to worsen. She received further diagnoses of CDKL5, infantile Spasms, and a large number of severe autism spectrum symptoms.


VAERS ID: 869232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2018-11-06
Submitted: 0000-00-00
Entered: 2020-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Epilepsy, Generalised tonic-clonic seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: was diagnosed with epilepsy; grand mal seizure took patient''s life; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a female patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On 6th November 2018, unknown after receiving Bexsero, the patient experienced grand mal seizure (serious criteria death and GSK medically significant). On an unknown date, the patient experienced epilepsy (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was fatal and the outcome of the epilepsy was unknown. The patient died on 6th November 2018. The reported cause of death was grand mal seizure. The reporter considered the grand mal seizure and epilepsy to be possibly related to Bexsero. Additional details were provided as follows: The age at vaccination was not reported. The patient was healthy her whole life until her physician recommended she get the meningitis shot. Shortly after the vaccination, the patient was diagnosed with epilepsy. On 6th November, 2018, a grand mal seizure took patient''s life. It was reported that young woman was killed by the meningococcal vaccine. The case was linked with the case US2020AMR069851 reported by same reporter; Reported Cause(s) of Death: Grand mal seizure


VAERS ID: 870136 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Florida  
Vaccinated:2020-01-01
Onset:2020-01-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2020-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-28
   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: Blood pressure Gabepentin Baby aspirin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 872246 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Texas  
Vaccinated:2020-02-24
Onset:2020-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK LG / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LG / UN

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Crying, Decreased appetite, Discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-27
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: No
CDC Split Type:

Write-up: After my baby received the vaccines, he got fever at 100.94F at Feb 25 ,2020, 2:00AM. I gave him the infant Tylenol oral suspension. Then he temperature back to normal after he received the 1.25ml does. At Received the vaccine 48 hours , my baby feet weak and lost appetite . cried a lot than usual. At two days later after 48 hours period time, my baby feel uncomfortable, cried lots ,lost appetite.


VAERS ID: 872438 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Unknown  
Vaccinated:2019-12-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS D93B4 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. S016890 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AL3577 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S004399 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: First Omeprazole 2mg/ml, Levothyroxine 25mcg
Current Illness: See Tracheoesophageal Fistula Repair 11/18/19
Preexisting Conditions: Yes, see problem list attached
Allergies: NKA
Diagnostic Lab Data: Coroner''s Report
CDC Split Type:

Write-up: None stated.


VAERS ID: 872739 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Female  
Location: Florida  
Vaccinated:2020-04-08
Onset:2020-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Decreased activity, Epistaxis, Feeling abnormal, Incoherent, Laboratory test, Pulse absent, Pyrexia, Respiration abnormal, Respiratory arrest, Somnolence
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: A week after her 3 month shots she was diagnosed with pertussis and hospitalized
Other Medications: Nexium 5 mg, Albuterol, Inhaler
Current Illness: Upper Respiratory Infection
Preexisting Conditions: Gastrointestinal Reflux
Allergies: Milk Protein Allergy
Diagnostic Lab Data: Autopsy Report and labs not in yet
CDC Split Type:

Write-up: My daughter was fine and her normal self at 1:30 pm was her appointment they did her shots around 2 pm as soon as we left the dr office she fell asleep and slept a while. The rest of the day she wasn?t really her playful she had a slight fever so I gave her infant Tylenol the was around 4 pm. Around 10:30 she dozed off and woke up like 5 minutes later breathing funny and acting dazed like none coherent so me, her godmother, her son, my son and another friend just stood watching her for about 30 minutes talking to her and looking at her chest and breathing pattern. She finally started acting normal and breathing good. So my friend was like take her home give her a breathing treatment and watch her. When we got in the car I gave her her inhaler and buckled her in and we left. Me and my son who is 11 left and it took us all of 15 minutes to get home so we were home around 11:30 my timing may be a little off but we got home got out I grabbed her bag and car seat thinking she was sleep. Went in the house sat the car seat down unbuckled her and it looked like her nose was running so I took her baby rag wiped her nose and noticed blood so I grabbed her up so fast and ran in my brother room and said she has blood coming out her nose he then asked was she breathing I said no and called 911 he said we not waiting cause the hospital up the road so we left she had no heartbeat when we got there and they tried everything possible They pronounced her dead at 12 something am April 9th


VAERS ID: 873474 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Male  
Location: Wisconsin  
Vaccinated:2020-06-11
Onset:2020-06-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2020-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2KD4D / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CN5850 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1660666 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-06-15
   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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Suffered Cardiac Arrest at Home and died. (Sudden unexplained infant death)


VAERS ID: 873566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: USPFIZER INC2020233127

Write-up: pneumonia; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for pneumonia vaccine. The patient''s medical history and concomitant medications were not reported. The reporter reported for his late wife was convinced by her doctor to take Prevnar 13. Prevnar 13 was administered to his late wife a week or so before she passed away. She passed away within two weeks of pneumonia. Prevnar 13 obviously did not work and that colors his assessment of the drug. The patient died of pneumonia on an unspecified date. It was not reported if an autopsy was performed. Information regarding batch/lot number has been requested.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 873618 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UJ306AA / UNK AR / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac failure congestive, Condition aggravated, Death, Dementia, Dysstasia, Fall, Feeling abnormal, Feeling hot, Gait disturbance, Intensive care, Malaise, Mobility decreased, Muscular weakness, Peripheral swelling, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-04-27
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin; Glimepride; Magnesium; Carvedilol; simvastin; low dose aspirin; Lorsartan; Furosemide; Omeprazole; Azopt; Timolol Maleate; Latanoprost; WARFARIN; LASIK; He had finished anti-biotic for pneumonia a few days before and was given me
Current Illness: PNEUMONIA, CHF,
Preexisting Conditions: Congestive heart FAILURE, DEMENTIA, DIABETICES, PROSTATE CANCER
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.''s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn''t stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn''t walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.


VAERS ID: 873934 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: New York  
Vaccinated:2020-05-21
Onset:2020-05-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2020-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS F4H92 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. S016870 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CN0614 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1660941 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-26
   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: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Done in the ED
CDC Split Type:

Write-up: Pt was taken to ED with sudden unexplained infant death


VAERS ID: 875042 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Alabama  
Vaccinated:2019-11-26
Onset:2019-11-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Death-Sudden Undetermined Death


VAERS ID: 875072 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: New York  
Vaccinated:2020-02-05
Onset:2020-02-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2020-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS D93B4 / UNK LL / SYR
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 77A5T / UNK LL / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AL8457 / UNK RL / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S017635 / UNK - / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-13
   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: Oseltamivir 6mg
Current Illness: Influenza A
Preexisting Conditions:
Allergies: N.K.D.A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fatal


VAERS ID: 875384 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Deep vein thrombosis, Meningitis, Thrombosis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: deep vein thrombus; Suspected vaccination failure; Meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of deep vein thrombosis in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, more than 2 years after receiving Meningococcal B vaccine, the patient experienced deep vein thrombosis (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the deep vein thrombosis was fatal and the outcome of the vaccination failure was unknown and the outcome of the meningitis was recovered/resolved. The reported cause of death was deep vein thrombosis. It was unknown if the reporter considered the deep vein thrombosis, vaccination failure and meningitis to be related to Meningococcal B vaccine. Additional details were provided as follows: After receiving Meningococcal B vaccine, the patient got meningitis at the age of 17 years. The patient recovered however the doctors made mistakes in the process and a blood clot went into his heart and he passed away of that. The cause of death was deep vein thrombus. It was unknown which type of meningitis the patient had. The patient was in his senior year of high school. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for Meningococcal B vaccine and type of meningitis and laboratory confirmation for meningitis were not provided.; Reported Cause(s) of Death: Deep vein thrombosis


VAERS ID: 875595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: died; This case was reported by a consumer via interactive digital media and described the occurrence of death in a 5-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to DTPa vaccine. Additional case details were reported as follows: The reporter was patient''s grandparent. The age at vaccination was not reported. The patient died from a DTP vaccine. Further information would not be available.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 875633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2008-08-20
Onset:2008-10-22
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2020-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3355A / UNK - / OT
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Capillary nail refill test abnormal, Cardio-respiratory arrest, Condition aggravated, Confusional state, Congenital HIV infection, Death, Dehydration, Depressed level of consciousness, Diarrhoea, Disseminated varicella zoster vaccine virus infection, Dry skin, Ear pain, End stage AIDS, Generalised tonic-clonic seizure, Hypophagia, Hypopnoea, Lethargy, Mental status changes, Mydriasis, Pallor, Pupillary reflex impaired, Tachycardia, Varicella post vaccine, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (narrow), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-28
   Days after onset: 402
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: EPIVIR; RETROVIR; BACTRIM; ZIAGEN; KALETRA; didanosine; emtricitabine; fluconazole; calcium (unspecified); folic acid; cyclosporine; ethambutol; moxifloxacin; pyridoxine; vitamins (unspecified); nelfinavir; valganciclovir hydrochloride; fam
Current Illness: Asplenia; Drug allergy; End stage AIDS; Facial rash; Human immunodeficiency virus status; Mycobacterium avium intracellulare infection; Prophylactic vaccination; Sinusitis
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrostomy tube insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132007USA001966

Write-up: TACHYCARDIA; PUPILS DILATED; PUPILS SLUGGISH AND EQUAL; ALTERED MENTAL STATUS; LETHARGIC; CONFUSION; DECREASED LEVEL OF CONSCIOUSNESS; CAPILLARY REFILL DELAYED; SHALLOW BREATHING; VOMITING; DIARRHEA; DECREASED PO INTAKE / UNABLE TO ACCEPT FEEDINGS; SKIN PALE; SKIN DRY / MEMBRANES / TURGOR DRY; "END STAGE AID"; CARDIOPULMONARY ARREST; CONGENITAL HIV; DEHYDRATION; SEIZURES (TONIC / CLONIC); CHICKENPOX / DISSEMINATED VARICELLA; EAR ACHE; Information has been downloaded from Agency (US-1577272925-2009-05439). This spontaneous report was received from a healthcare professional concerning a male patient of unknown age. The patient''s concurrent conditions included human immunodeficiency virus (hiv) test, end stage aids, mycobacterium avium complex infection, asplenia, drug hypersensitivity, sinusitis and rash. The patient''s medical history included gastrostomy and the patient''s concomitant medications included lamivudine (EPIVIR), zidovudine (RETROVIR), sulfamethoxazole (+) trimethoprim (BACTRIM), abacavir sulfate (ZIAGEN), lopinavir (+) ritonavir (KALETRA), didanosine, emtricitabine, fluconazole, calcium (unspecified), folic acid, cyclosporine, ethambutol, moxifloxacin, pyridoxine, vitamins (unspecified), nelfinavir, valganciclovir hydrochloride, famotidine (reported as FLAMOTADINE ) and levocarnitine (reported as PEROCARNITINE). On an unknown date, the patient started therapy with ferrous sulfate (strength, dose, frequency, route of administration, lot number, expiration date and indication were not provided). On 20-AUG-2008, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), for immunization (route of administration was reported as unknown; lot number was reported as 0630X410, strength, dose, frequency and expiration date were not provided). On 16-SEP-2008, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) for immunization (route of administration was reported as unknown and lot number was reported as C3355A; strength, dose, frequency and expiration date were not provided). On an unknown date the patient experienced end stage aids, skin dry-membranes and turgor dry (dry skin), skin pale (pallor), decreased oral intake ? unable to accept feedings (hypophagia), diarrhea, vomiting, shallow breathing (hypopnea), capillary refill delayed (capillary nail refill test abnormal), decreased level of consciousness (depressed level of consciousness), confusion (confusional state), letargic (lethargy), altered mental status (mental status changes), pupils dilated (mydriasis), pupils sluggish and equal (pupillary reflex impaired ), tachycardia, dehydration, congenital hiv infection and cardiopulmonary arrest (cardio-respiratory arrest). On an unspecified date in 2008, the patient experienced ear ache (ear pain). On 22-OCT-2008 the patient experienced chicken ports and disseminated varicella (varicella). On 28-NOV-2009 the patient experienced seizures tonic-clonic (generalised tonic-clonic seizure). It was reported that the patient was hospitalized due to the events on an unspecified date. The outcome of end stage aids, varicella, dehydration, congenital hiv infection and cardio-respiratory arrest was reported as fatal and the outcome of generalised tonic-clonic seizure, ear pain, dry skin, pallor, hypophagia, diarrhoea, vomiting, hypopnoea, capillary nail refill test abnormal, depressed level of consciousness, confusional state, lethargy, mental status changes, pupillary reflex impaired, mydriasis and tachycardia was unknown. Therapy with varicella virus vaccine live (oka/merck)(VARIVAX) was restarted and pallor did not recur. The patient died on 28-NOV-2009. The cause of death and if an autopsy was performed was not reported. The causality assessment between the suspect drugs and the events occurrence was not provided. Lot number 0630X410 is an invalid lot number for varicella virus vaccine live (oka/merck).


VAERS ID: 877469 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Florida  
Vaccinated:2020-07-26
Onset:2020-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9974P / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Death, Myocardial infarction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-07-01
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: alprazolam
Current Illness: none noted
Preexisting Conditions: none noted
Allergies: none aware
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Morning after administration, husband called pharmacy and reported patient had been up all night vomiting and had severe stomach pain. Vomiting had subsided (stomach was empty) but still nausea and not able to keep anything down. Patient was recommended to treat hydration with pedialyte and try to eat non-irritating foods such as saltines. She was considering self treating pain with medical marijuana. Next encounter with patient ws 2 days later, husband called pharmacy staff to inform patient had a heart attack and passed away. It is unknown if related to vaccine administration.


VAERS ID: 878077 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202014

Write-up: my 6 year old brother died of meningitis within a few days of receiving a vaccine for it; This case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a 6-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. The patient''s past medical history included immunodeficiency. On an unknown date, the patient received Bexsero. On an unknown date, couple of days after receiving Bexsero, the patient experienced meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the meningitis was fatal. The reported cause of death was meningitis. The reporter considered the meningitis to be related to Bexsero. Additional details were reported as follows: The age at vaccination was not reported. The patient died on an unknown date. The reporter stated that, my two years old had never received a vaccine because my 6 years old brother died of meningities within a few days of receiving a vaccine. for it that''s a story it''s short but its truth he should not have received it he had an immune deficiency already it was just too much this was exactly why they should not force anything, everyone reacts differently.; Reported Cause(s) of Death: Meningitis


VAERS ID: 878242 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Indiana  
Vaccinated:2019-03-06
Onset:2019-03-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. UNKNOWN / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH UNKNOWN / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Ascites, Autopsy, Death, Decreased interest, Intestinal infarction, Intestinal ischaemia, Mesenteric arterial occlusion, Volume blood decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: Mother reported concern that infant was gassy and not sleeping well.
Preexisting Conditions: None reported.
Allergies: None reported
Diagnostic Lab Data: Autopsy Results Preliminary Anatomic Findings: 1.) Ischemic bowel in distribution of superior mesenteric artery 2.) Depleted intravascular blood volume 3.) Mild ascites Cause of Death: Infarcted bowel due to mesenteric artery occlusion Manner of Death: Natural
CDC Split Type:

Write-up: Per report by mother, infant stopped showing interest in eating approximately 6 hours after immunizations. Infant was pronounced deceased on March 08, 2019. Preliminary Anatomic Findings: 1.) Ischemic bowel in distribution of superior mesenteric artery 2.) Depleted intravascular blood volume 3.) Mild ascites Cause of Death: Infarcted bowel due to mesenteric artery occlusion


VAERS ID: 878656 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Arkansas  
Vaccinated:2019-02-14
Onset:2019-02-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-15
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found deceased next morning (02/15/2019 at 0600).


VAERS ID: 879083 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Unknown  
Vaccinated:2019-12-01
Onset:2020-07-26
   Days after vaccination:238
Submitted: 0000-00-00
Entered: 2020-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-07-26
   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: USGLAXOSMITHKLINEUS2020AM

Write-up: patient passed away; This case was reported by a consumer via patient support programs and described the occurrence of unknown cause of death in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2019, the patient received the 1st dose of Shingrix. On 26th July 2020, less than 9 months after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 26th July 2020. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be unrelated to Shingrix. Additional details were provided as follows: The reporter stated that, after vaccination with Shingrix 1st dose on December 2019, the patient passed away on 26th July 2020. The reporter stated that, cause of death was undisclosed. There was no product complaint. The reporter consented to follow up; Reported Cause(s) of Death: Death NOS


VAERS ID: 25010 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: Foreign  
Vaccinated:1989-10-29
Onset:1989-12-01
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 1990-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. A2223P / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Bronchitis
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: ~ ()~~~In patient
Other Medications: Promethanzine HCL given 21Dec89-21Dec89
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Dianostic test - Autopsy, Date Dec89 , comment - Streptococcal tracheobronchitis
CDC Split Type: WAES90060362

Write-up: 17 mon. male, received 29Oct89 MMR vaccine 1 dose. 21Dec89 received therapy w/ Promethazine HCL, HS. 22Dec89 infant found dead. Post mortem revealed acute Streptococcal tracheobronchitis.


VAERS ID: 25066 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:1988-07-13
Submitted: 1988-10-26
   Days after onset:105
Entered: 1990-07-09
   Days after submission:621
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MM: MEASLES + MUMPS (MM-VAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Bradycardia, Pyrexia, Tachycardia, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: no relevant history
Allergies:
Diagnostic Lab Data: CSF 973 mg/dl comment protein
CDC Split Type: ARR47.344

Write-up: Pt vaccinated w/ MMVAX, developed fever, weight loss, vomiting, apena, tachycardia, bradycardia & subsequently died.


VAERS ID: 25907 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:1988-10-18
Onset:1988-10-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 1990-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Hyperhidrosis, Infection, Jaundice, Lymphadenopathy, Pyrexia, Right ventricular failure, Splenomegaly
SMQs:, Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1988-10-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Chlorambucil; Prednisolone; Atenolol
Current Illness:
Preexisting Conditions: Hypertension; Non-Hodgkins lymphoma; Splenomegaly
Allergies:
Diagnostic Lab Data: Hemoglobin - 17OCT88- 9.3g/dl; Hemoglobin - 21OCT88 4.2 g/dl; Hemoglobin - 22OCT88 6.2 g/dl; Autopsy Oct 88
CDC Split Type: WAES89110278

Write-up: Pt vaccinated with Pneumovax 23 developed fever, diaphoresis, weakness, and jaundice, and was hospitalized. Decreased hemoglobin was confirmed by lab analysis which revealed hemoglobin 4.2. Dx with autoimmune hemolytic anemia.


VAERS ID: 31739 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1991-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection
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: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: EBW918026

Write-up: Pt recd vax & died due to a fulminant Hep D infect; Additional details are currently not available;


VAERS ID: 34138 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:1991-08-09
Onset:1991-08-11
   Days after vaccination:2
Submitted: 1991-08-16
   Days after onset:5
Entered: 1991-08-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PROHIBIT) / CONNAUGHT LABORATORIES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO3923

Write-up: Died 2 days p/vax; A few hrs p/receiving vax devel temp & vomiting;


VAERS ID: 35528 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:1990-10-17
Onset:1990-10-31
   Days after vaccination:14
Submitted: 1991-10-10
   Days after onset:343
Entered: 1991-10-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 4919P2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-11-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO3956

Write-up: Pt died on 8NOV90; admitted to Hosp 31OCT90 w/rt sided weakness; Family requested that no heroic measures be used; condition rapidly progressed w/subsequent death; dx GBS; hx of alcohol abuse;


VAERS ID: 36592 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:1991-10-21
Onset:0000-00-00
Submitted: 1991-11-21
Entered: 1991-11-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Drug ineffective, Haemolytic anaemia, Hepatitis, Immune system disorder, Infection, Jaundice, Splenic rupture
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Bone marrow biopsy confirmed a hemolytic process & was consistent w/auto-immune hemolytic anemia; 04NOV91: hemoglobin appr 2 mg/dl;
CDC Split Type: EBW918077

Write-up: P/2nd dose pt had no initial sx other than residual arm soreness; 31OCT91 MD found pt to be jaundiced w/palpable liver & dark colored urine; MD felt pt had hepatitis infect; pt exp a cardiac arrest & died; autopsy revealed splenic rupture;


VAERS ID: 37898 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1991-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Encephalitis, Headache, Meningitis, Stupor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: No relevant hx
Allergies:
Diagnostic Lab Data: CSF-Microscopy, unremarkable; Post mortem investigations subsequently revealed evidence of past mumps infection; Only virus isolated was an echovirus type 25 from nasopharyngeal secretions; MD felt pts meningoencephalitis & death not re:vax
CDC Split Type: WAES91120207

Write-up: 10 days following vax pt devel vomiting & h/a; 72 hrs following these sx, pt was hospitalized; On admission pt was afebrile & semiconscious; 48 hrs following hospitalization pt died; Post mortem investigations past mumps infection;


VAERS ID: 38079 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1991-12-17
Entered: 1991-12-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills
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: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: requested
CDC Split Type: CO4045

Write-up: Devel chills early evening p/flu shot; expired sometime that evening;


VAERS ID: 39360 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:1990-01-31
Onset:1990-01-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1992-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness:
Preexisting Conditions: No relevant hx
Allergies:
Diagnostic Lab Data: Autopsy performed-results not yet available;
CDC Split Type: WAES90021194

Write-up: Pt recvd MMR/DT/Polio vax 31JAN90 @ 10AM; @ noon pt ate lunch & was sent to bed; @ 3PM pt was found dead; autopsy was performed; MD felt uncertain regarding the causality of vax;


VAERS ID: 40512 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:1991-10-11
Onset:1991-11-25
   Days after vaccination:45
Submitted: 1992-02-20
   Days after onset:87
Entered: 1992-03-23
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
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: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: pulmonary infiltration "inactive" lymphoma type II diabetes;
Allergies:
Diagnostic Lab Data: No autopsy was performed;
CDC Split Type: CO4139

Write-up: Pt had a hx of chronic pulmonary problems; pt died;


VAERS ID: 40513 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:1991-11-13
Onset:1991-11-27
   Days after vaccination:14
Submitted: 1992-02-20
   Days after onset:85
Entered: 1992-03-23
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Respiratory failure (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: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO4140

Write-up: Died of cardio-respiratory arrest;


VAERS ID: 42584 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:1988-07-01
Onset:1988-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1992-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Infection, Meningitis, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: Splenectomy; Hodgkins disease
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES92050943

Write-up: Pt recvd Pneumovax vax JUL88 & 29MAR89 pt devel meningitis & pneumococcal sepsis; On 6APR89 pt died due to pneumococcal infect; reporting MD felt pneumococcal sepsis was poss related to lack of response to vax;


VAERS ID: 44547 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:1991-09-30
Onset:1991-09-30
   Days after vaccination:0
Submitted: 1992-08-19
   Days after onset:324
Entered: 1992-08-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 5181P2 / 6 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Hypotension, Myocardial infarction, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-09-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Cadizem, Lanoxin, Diabetias;
Current Illness:
Preexisting Conditions: diabetes & long hx of heart disease;
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO4401

Write-up: found sitting in chair not breathing; pale & no pulse; ambulance attendants performed CPR because they found pulse; not successful; cause of death as listed on certificate is acute myocardial infarction; not related to vax;


VAERS ID: 46254 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:1992-02-06
Onset:1992-08-22
   Days after vaccination:198
Submitted: 1992-10-13
   Days after onset:52
Entered: 1992-10-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Infection, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1992-08-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO4473

Write-up: dx of Haemophilus-influenzae sepsis recvd 2 doses of vax; 18DEC91 & 6FEB92; no further details available;


VAERS ID: 46330 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:1992-08-29
Onset:1992-09-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 1992-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MM: MEASLES + MUMPS (MM-VAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bradycardia, Brain oedema, Encephalitis, Febrile convulsion, Infection, Laryngitis, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1992-09-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: HIB AUG92
Current Illness:
Preexisting Conditions: no relevant hx
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES92100500

Write-up: pt recvd MMR/HIB vax & 10 days later devel fever & pharyngolaryngitis; 8SEP92 devel febrile convuls & was hospitalized; following morning 9SEP92 pt devel bradycardia & pt died; cause of death was identified as brain edema;


VAERS ID: 46452 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1992-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: no relevant history
Allergies:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES92020097

Write-up: Pt recvd Hep B vax & subsequently found to be 4 wks pregnant; pt had a missed abortion @ 12 wks gestation; No additional info is expected;


VAERS ID: 47510 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:1992-07-15
Onset:1992-10-25
   Days after vaccination:102
Submitted: 1992-10-28
   Days after onset:3
Entered: 1992-11-30
   Days after submission:33
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / 1 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Sudden infant death syndrome
SMQs:, Lack of efficacy/effect (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1992-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: NA
Current Illness: healthy
Preexisting Conditions: well pt visits @ 2 & 4 mos of age were nl;
Allergies:
Diagnostic Lab Data: presumptive cause of death is SIDS; an autopsy was not performed;
CDC Split Type: 920365901

Write-up: clinical trial report from germany of a pt who was vaxed w/DTaP 15JUL92 @ 4mos & died 25OCT92; dx SIDS; pt discont study early because of bordetella pertussis (nasophryngeal swab pos on 21AUG);


VAERS ID: 49270 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1993-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Endocarditis, Infection
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: no relevant hx
Allergies:
Diagnostic Lab Data: Autopsy=congenital anomaly;
CDC Split Type: WAES93010841

Write-up: pt recvd vax & died; autopsy by a forensic center revealed cause of death as unspecified congenital anomaly which was unrelated to vax w/hep B; addtl info has been requested;


VAERS ID: 49808 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:1992-09-25
Onset:1992-09-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 1993-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coagulopathy, Encephalitis, Haemorrhage, Hepatic function abnormal, Hepatomegaly, Hyperbilirubinaemia, Pallor
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: 1992-09-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ENG6522

Write-up: DEC92 3 days p/receiving a dose of vax pt died; suspected cause of death was mentioned to be coagulopathy encephalitis;


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