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From the 9/17/2021 release of VAERS data:

Found 46 cases where Patient Died and Vaccination Date from '2020-01-01' to '2020-03-31'



Case Details

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VAERS ID: 1085019 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Washington  
Vaccinated:2020-03-03
Onset:2021-03-05
   Days after vaccination:367
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006M20A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Death
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi vitamin, promethazine 25 mg, omeprazole 20 mg, cyclobenzaprine, 10 mg, oxycodone/APAP 5/325mg, gabapentin 800 mg, simvastatin 20 mg tab, metformin 1000 mg tab, nortriptyline 50 mg cap, zolpidem 10 mg tab, Ketorolac 60 mg injection 2 t
Current Illness: Chronic pain, HTN, DM, Cervicalgia, nausea, insomnia
Preexisting Conditions: Tobacco abuse, HTN, Diabetes mellitus, DJD, Cervicalgia, osteoarthritis, chronic pain, opioid use, diabetic polyneuropathy, carpal tunnel syndrome bilaterally, atopic dermatitis, bursitis , history of DVT, LE edema, chronic nausea, hyperlipidemia, insomnia,
Allergies: Benzodiazepines, celecoxib, codeine, diphenhydramine HCL, inositol Niacinate, Metaxalone, Niacinamide, oxycodone HCL, ASA, horse/equine containing products,, erythromycin base products, shellfish derived, bee venom
Diagnostic Lab Data: Unknown if autopsy will be performed.
CDC Split Type:

Write-up: Had vaccine on 3/3/2021 at approximately 1 PM. She was found on her couch deceased on 3/8/2021. Possible death on 3/5/2021. She called her sister and told sister that back hurt worse than usual and she would lay on the couch and rest. This is where she was found. Unknown if from vaccine, but due to vaccination on Wednesday proceeding her death, report is being filed.


VAERS ID: 1099326 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2020-03-18
Onset:2021-02-23
   Days after vaccination:342
Submitted: 0000-00-00
Entered: 2021-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Cough, Death, Gastrooesophageal reflux disease
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bepreve; Betoptic; Alphagan; Rocklatan; SystaineZaditor; Systane complete;Spiriva hand haler
Current Illness: None
Preexisting Conditions: COPD; Dystonia
Allergies: only seasonal allergies
Diagnostic Lab Data: Patient dies on March 5, 2021.
CDC Split Type: unKnown

Write-up: A few days after vaccination patient had an unusual dry cough/ and then a pain in his chest, He called our Doctor she said call your cardiologist now, patient called Dr and told him he wanted to go to his office, explained the pain he was experiencing - the doctor told him said he couldn''t see him wanted to do a telemed exam. and proceeded to tell patient to see an gastro entomologist, take Tums, no tomatoes, no coffee and a few other foods and that patient was suffering from Acid Reflux and to call him back net week.


VAERS ID: 1157437 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Florida  
Vaccinated:2020-01-07
Onset:2020-01-23
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Death, Dementia, Encephalopathy, Parkinson's disease
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (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: 2020-03-18
   Days after onset: 54
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: Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2021GS

Write-up: Parkinson''s Disease; mild dementia; Encephalopathy; This case was reported by a lawyer and described the occurrence of parkinson''s disease in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. The patient''s past medical history included parkinson''s disease. On 7th January 2020, the patient received Shingrix (intramuscular) 50 mcg. On 23rd January 2020, more than 2 weeks after receiving Shingrix, the patient experienced encephalopathy (serious criteria GSK medically significant). On an unknown date, the patient experienced parkinson''s disease (serious criteria death and GSK medically significant) and dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the parkinson''s disease was fatal and the outcome of the encephalopathy and dementia were unknown. The patient died on 18th March 2020. The reported cause of death was parkinson''s disease. An autopsy was not performed. It was unknown if the reporter considered the parkinson''s disease, encephalopathy and dementia to be related to Shingrix. The initial information was received on 31 March 2021 via medical record (case is medically confirmed). As per pharmacy record, the patient ingested Shingrix 50mcg injection administered 0.5 ml in the muscles as directed on 07 January 2020. As per death certificate, patient died on 18 March 2020, the cause of death was Parkinson''s Disease. The autopsy was not performed. The manner of death was natural. The patient had parkinsonism by September 2015. Patient has had evidence of parkinsonism and mild dementia. The patient experienced Encephalopathy diagnosed on 23 January 2020. He was hospitalized a day after shingles vaccine at which point he was noted to be encephalopathic. He remains encephalopathic although better than when in hospital.; Reported Cause(s) of Death: Parkinson''s Disease


VAERS ID: 1202967 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Unknown  
Vaccinated:2020-03-20
Onset:2021-04-08
   Days after vaccination:384
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Exposure to SARS-CoV-2, Pulse absent, Respiratory arrest, SARS-CoV-2 test positive, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Tested positive for COVD on 4/1
CDC Split Type:

Write-up: Death Narrative: Patient had Pfizer COVID vaccine dose #1 on 3/20/21. He called his provider on 3/30 to report known exposure to COVID that occurred on 3/27 and 3/28. On 4/1 he tested positive for COVID swabbed at the facility and sent to the main facility for processing. He was notified of positive result on 4/1 at 4pm. He was advised to quarantine and to call facility call center/triage should he develop any fever, shortness of breath, and other Covid-related symptoms. Provider received a phone call from PD on 4/8 notifying of patient unattended death. According to EMS report neighbors were aware of patients COVID positive status. No one had seen or heard from the patient in 3 days so they contacted PD for wellness check. Entry was forced into apartment and patient was found deceased, sitting on the couch. Not breathing ashen color. Pt has ringer and no Pulse. PMH: Quit tobacco 5-15 yrs ago Hyperlipidemia Hyperglycemia Obesity Allergic rhinitis, stable Hx AAA and Right ICA aneurysm, S/P Open repair in 2013 Patient had no prior history of COVID before 4/1 diagnosis. He was not having any symptoms between 4/1 when he tested positive and he did not call to report any symptoms between 4/1 diagnosis and death. There was no communication after 4/1 positive covid test. Patient was scheduled for a phone call with RN on 4/8 the date he was found deceased. Cause of death is not mentioned, but suspected to be due to COVID infection. There were no reported side effects to COVID Vaccine administration.


VAERS ID: 1378167 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: California  
Vaccinated:2020-02-01
Onset:2020-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 AR / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bedridden, Blindness, Cough, Decreased appetite, General physical health deterioration, Mobility decreased, Pulmonary thrombosis, Pyrexia, Thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-31
   Days after onset: 119
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 95 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Stage 4 lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The night after receiving the vaccine, the patient began having continuous fevers and coughs. It was later discovered that there were blood clots in the lung and legs. Patient health rapidly declined during hospitalization period. Mobility, apetite and overall strength and energy decreased. Patient was fully bedridden and soon lost eye sight.


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

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

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

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


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

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

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

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


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

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

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

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


VAERS ID: 863006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-09
Onset:2020-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X63656 / 1 RL / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Crying, Cyanosis, Death, Dehydration, Dyspnoea, Gastroenteritis adenovirus, Hypotonia, Laboratory test, Meningitis, Moaning, Otitis media, Pulse absent, Purulent discharge, Pyrexia, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-11
   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: IBUM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dehydration (Hospitalization 06-16.12.2019); Enteritis due to adenovirus (Hospitalization 01-05.12.2019); Urinary tract infection, site not specified (Hospitalization 06-16.12.2019)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5-38.9, Test Result Unit: Centigrade
CDC Split Type: PLPFIZER INC2020079748

Write-up: Purulent meningitis secondary to otitis media (left ear); Purulent meningitis secondary to otitis media (left ear); Cardiac arrest; Moaning; No muscle tone; Respiratory arrest; Crying; Cyanosis; Fever lasting up to 48 hours; This is a spontaneous report downloaded from the regulatory authority PL-URPL-3-86-2020, Sender Type: Agency, Sender''s Organisation: from a contactable Physician received from the Regulatory Authority. The Regulatory Authority report number is PL-URPL-3-86-2020. The reporter is contactable. A 3-months-old male patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot. X63656, exp. Oct2020) via intramuscular in right thigh on 09Jan2020 13:30 at 0.5 ml, single for immunization. Medical history included Urinary tract infection, site not specified (Hospitalization 06-16.12.2019), dehydration (Hospitalization 06-16.12.2019), Enteritis due to adenovirus (Hospitalization 01-05.12.2019). Concomitant medication included ibuprofen (IBUM) from 11Jan2020 13:30, paracetamol from 11Jan2020. The patient experienced no muscle tone on 11Jan2020, respiratory arrest on 11Jan2020, crying on 11Jan2020, purulent meningitis secondary to otitis media (left ear) on unknown date, cardiac arrest on 11Jan2020, moaning on 11Jan2020, fever lasting up to 48 hours on 10Jan2020, cyanosis on 11Jan2020. The events were all fatal and event crying was also medically significant. The patient underwent lab tests and procedures which included body temperature: 38.5-38.9 degree celsius on unknown date. The patient died on 11Jan2020. It was not reported if an autopsy was performed. SENDER COMMENT: Fever and crying are the expected adverse reactions listed in point 4.8. Summary of Product Characteristics for Prevenar 13. Continuous crying is not mentioned in section 4.8. SmPC. Until 28 January 2020 470 cases of persistent crying after the Prevenar 13 vaccine were reported in the regulatory authority database. Cyanosis, "moaning", shortness of breath, lack of heart rate and muscular tone were not mentioned in section 4.8. SmPC of Prevenar 13. Purulent meningitis is an unexpected adverse reaction not mentioned in section 4.8. Summary of Product Characteristics of Prevenar 13. ''In most cases caused by Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae b, and in older children by N. meningitidis, S.pneumoniae and in special circumstances by other bacteria (...) or by other pathogens in children in states of immunosuppression. The disease begins suddenly with fever, vomiting and anxiety; emboli emphysema eruptions occur on the skin in meningococcal septicemia (...). Mortality from purulent meningitis is 20% in newborns and up to 10% in infants. Until 6 February 2020 70 cases of meningitis after vaccination with Prevenar 13 were reported in the regulatory authority database, including fatalities. Due to the lack of detailed information on the etiology of purulent meningitis, Prevenar 13 cannot be clearly identified as responsible for the occurrence of adverse reactions. Due to the hospitalization of the child twice for infectious reasons and his prematurity, it cannot be excluded that the reason for the above symptoms could be a factor other than the vaccine. If additional information is obtained, a follow-up will be performed. The person reporting unexpected post vaccination reaction qualified it as serious (death). Due to the patient''s death, the nature of adverse reactions (continuous crying) and the assessment of the reporting person (serious), regulatory authority classified unexpected post vaccination reaction as serious. Prevenar 13: Other Assessment: Agency,WHO,Possible. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: No muscle tone; Respiratory arrest; Crying; Cardiac arrest; Moaning; Fever lasting up to 48 hours; Cyanosis; Purulent meningitis secondary to otitis media (left ear); purulent meningitis secondary to otitis media (left ear)


VAERS ID: 864267 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-02-21
Onset:2020-02-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B331AI / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT202003

Write-up: Fetal exposure during pregnancy; Intrauterine death; This retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of intra-uterine death in a patient exposed to DTPa (Reduced antigen) (Boostrix) (batch number AC37B331AI, expiry date unknown) in utero. The mother received the product for prophylaxis. The parent''s medical history included anemia and hypothyroidism. On 21st February 2020, the 20-year-old mother received Boostrix. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to Boostrix at an unknown time during the pregnancy. The patient was diagnosed with intra-uterine death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced fetal exposure during pregnancy. On an unknown date, the outcome of the intra-uterine death was fatal and the outcome of the fetal exposure during pregnancy was unknown. It was unknown if the reporter considered the intra-uterine death to be related to Boostrix. Additional details were provided as follows: The patient received Boostrix by transplacental route. The reporter stated that, after vaccination, the patient experienced intra-uterine death and fetal exposure during pregnancy.


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