Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Diarrhoea, Dyspnoea, Immunisation, Influenza virus test
Clinical narrative: Diuresis; bad heart failure/ heart problems; diarrhoea; shortness of breath; 2 huge plural effusions; Dose Number: 3; Date of start of drug: 13-NOV-2021; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 90 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Nov2021 09:00 (Lot number: EW0217) at the age of 90 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "Tobacco use" (unspecified if ongoing). The patient did not receive any other vaccine on 13Nov2021. The patient did not have prior history of heart problems and covid prior to vaccination. The patient did not have any known allergy. Concomitant medication(s) included: BUSPAR; PEPCID AC; MOTRIN [IBUPROFEN]; MIRALAX; VENLAFAXINE; TRAZODONE. Vaccination history included: Pfizer covid mrna , lnp-s (pfizer sars-cov-2 vaccine) (Dose Number: 2, Batch/Lot No: ER2613, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 27Mar2021, when the patient was 90 years old, for COVID-19 Immunization; Pfizer covid mrna , lnp-s (pfizer sars-cov-2 vaccine) (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 06Mar2021, when the patient was 90 years old, for COVID-19 Immunization. It was unknown if the patient received any other vaccine in four weeks. The following information was reported: CARDIAC FAILURE (hospitalization, medically significant, life threatening) with onset 16Nov2021 09:00, outcome "not recovered", described as "bad heart failure/ heart problems"; DIARRHOEA (hospitalization, life threatening) with onset 16Nov2021 09:00, outcome "not recovered", described as "diarrhoea"; DYSPNOEA (hospitalization, life threatening) with onset 16Nov2021 09:00, outcome "not recovered", described as "shortness of breath"; PLEURAL EFFUSION (hospitalization, life threatening) with onset 16Nov2021 09:00, outcome "not recovered", described as "2 huge plural effusions"; POLYURIA (hospitalization, life threatening), outcome "unknown", described as "Diuresis"; IMMUNISATION (hospitalization, medically significant, life threatening) with onset 13Nov2021 09:00, outcome "unknown", described as "Dose Number: 3; Date of start of drug: 13-NOV-2021". The patient was hospitalized for cardiac failure, diarrhoea, dyspnoea, pleural effusion, polyuria, immunisation (start date: 27Nov2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: influenza virus test: (26Nov2021) negative, notes: Nasal Swab; sars-cov-2 test: (26Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac failure, diarrhoea, dyspnoea, pleural effusion, immunisation. Clinical course: As per doctor 3 days after vaccine, the patient developed diarrhea and shortness of breath. The patient was admitted to hospital on 11/27 in bad heart failure and had not prior history of heart problems. The patient had 2 huge plural effusions. The patient had been placed on hospice and was dying.  Follow-up attempts are not possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be 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.