Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Dyspnoea, Illness, Interchange of vaccine products
Clinical narrative: Pfizer covid (5-11y) vac (eua), moderna covid (12y up)vac(eua); she got sick from the covid vaccine; congestive heart failure; Atrial fibrillation; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (Unknown).  An 86-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "wild-type transthyretin-relat attr amyloidosis" (unspecified if ongoing), notes: wild-type transthyretin-relat attr amyloidosis; "Allergy to wasp venom" (unspecified if ongoing), notes: Allergy to wasp venom treatment kit; "Allergy to wasp venom" (unspecified if ongoing), notes: Allergy to wasp venom treatment kit. Concomitant medication(s) included: ELIQUIS; FUROSEMIDE; ZOLPIDEM TARTRATE; HYDROXYZINE HYDROCHLORIDE; LATANOPROST; OMEPRAZOLE; METOPROLOL TARTRATE. The following information was reported: ILLNESS (hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "she got sick from the covid vaccine"; CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "congestive heart failure"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), outcome "unknown", described as "Pfizer covid (5-11y) vac (eua), moderna covid (12y up)vac(eua)"; ATRIAL FIBRILLATION (medically significant), outcome "unknown"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath". Therapeutic measures were taken as a result of atrial fibrillation. The patient received unspecified treatment on 12Jul2021 for atrial fibrillation  Clinical course: It was stated she could only go a block then gets short of breath. She had heart failure with preserved ejection fraction. In Mar2021 she got sick from the covid vaccine and ended up in the hospital for congestive heart failure. In Aug2021 she got the covid booster and went to the hospital for 5 days and had a partial collapsed lung. Vyndamax start date was unknown, reported as 1.5 years ago. No additional information available. Reporter did not consider event (Shortness of breath) caused by suspect product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.