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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EM0477 / 1||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Bradycardia, Death, Electrocardiogram, Face oedema, Oedema peripheral, Pulmonary arterial hypertension
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:
Write-up: Bradycardia; Pulmonary arterial hypertension; Edema extremities; Edema face; The patient died on 17Jan2021; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the European Medicines Agency DK-DKMA-WBS-0029225. A 74-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscular on 05Jan2021 at single dose for covid-19 immunization. Medical history included multiple hospitalization in 2020 due to pneumonia from 2020, ongoing wheelchair user, ongoing spasticity, ongoing cerebral palsy, ongoing polycythaemia, ongoing anaemia diagnosed in 2020. The patient was a non-smoker. Concurrent condition also included hypertension, incontinence, reflux gastritis, myeloproliferative disorder, insomnia, obstipation, anxiety, dyspepsia and depression, 2 cm gallbladder stone found in December in an unknown year. No surgery performed for the cholelithiasis. Concomitant medication included mirabegron (BETMIGA) from 16Feb2018 to 17Jan2021 for Incontinence, amlodipine besilate (AMLODIPIN ACCORD) from an unknown date to 17Jan2021 for hypertension, hydroxycarbamide (HYDREA) from 01Jan2011 to 17Jan2021 for Myeloproliferative disorder, sertraline hydrochloride (SERTRALIN ACCORD) from 16Feb2018 to 17Jan2021 for depression, algeldrate, alginic acid, calcium carbonate, magnesium trisilicate, sodium bicarbonate (GAVISCON) from 16Feb2018 to 17Jan2021 for Reflux gastritis, pantoprazole (PANTOPRAZOLE 2CARE4) from 09Jan2021 to 17Jan2021 for Dyspepsia, magnesium hydroxide (MAGNESIA MEDIC) for obstipation, sodium picosulfate (LAXOBERAL) from an unknown date to 17Jan2021 for Obstipation, pregabalin (PREGABALIN ACCORD) from 01Jan2011 to 17Jan2021 for Anxiety, oxazepam (OXAPAX) from 16Feb2018 to 17Jan2021 for Anxiety, ramipril (RAMIPRIL HEXAL) from 16Feb2018 to 17Jan2021 for hypertension, zopiclone (IMOZOP) from 16Feb2018 to 17Jan2021 for Insomnia, folic acid (FOLIMET) from 04Jan2021 to 17Jan2021 for Anaemia. There was no information regarding past medication. On 05Jan2021 the patient developed edema extremities and edema face. On 09Jan2021 the patient developed Bradycardia and Pulmonary arterial hypertension. The ADRs were by the physician reported as resulting in hospitalization. The patient was treated with Xarelto (Rivaroxaban). The patient was treated with high-spectrum antibiotics during hospitalization, after which an increase in white blood cells was seen. However, it was not known if the patient could have had an underlying infection, which suddenly manifested itself and was the cause of death. Cause of death was reported as unknown cause of death. The patient underwent lab tests and procedures which included electrocardiogram with result of decreased function of right ventricle. Bradycardia recovered on 13Jan2021. Edema extremities and Edema face recovered on 15Jan2021. Pulmonary arterial hypertension was not recovered. The patient died on 17Jan2021. The physician assumed that there was no causality between the vaccine and the cause of death. However, the physician cannot state the cause of death.; Sender''s Comments: Based solely on event-vaccine chronological association, contributory role of BNT162B2 (COMIRNATY) to event Death (unknown cause) cannot be completely excluded. The case will be reevaluated should additional information including the cause of death become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death
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