Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Respiratory failure
Clinical narrative: Her husband got sick after the vaccine; Respiratory failure; short of breath; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: diagnosed about 10 years ago; "Coronary artery disease" (unspecified if ongoing), notes: diagnosed over 10 years ago; "High cholesterol" (unspecified if ongoing), notes: diagnosed 28 years ago; "Pulmonary fibrosis" (unspecified if ongoing), notes: diagnosed with by-pass surgery, eight years ago; "Allergic rhinitis" (unspecified if ongoing), notes: diagnosed about 28 years ago; "Osteoporosis", start date: Jul2021 (unspecified if ongoing); "Erectile dysfunction" (unspecified if ongoing), notes: diagnosed 10 years ago; "Depression", start date: 2020 (unspecified if ongoing); "elevated lipid" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypertension; ASPIRIN [ACETYLSALICYLIC ACID] oral taken for coronary artery disease; LIPITOR oral taken for blood cholesterol increased; BREO ELLIPTA taken for pulmonary fibrosis; BUMEX oral; COZAAR oral taken for hypertension; FISH OIL oral taken for lipids increased; FLUTICASONE nasal taken for rhinitis allergic; FOSAMAX oral taken for osteoporosis; ARAVA oral taken for pulmonary fibrosis; METOPROLOL TARTRATE oral taken for coronary artery disease; POTASSIUM oral; PREDNISONE oral taken for pulmonary fibrosis; VENTOLIN [SALBUTAMOL] taken for pulmonary fibrosis; VIAGRA oral taken for erectile dysfunction; ZOLOFT oral taken for depression. Vaccination history included: Bnt162b2 (DOSE 1, single), for COVID-19 immunization, reaction(s): "None"; Bnt162b2 (DOSE 2, single), for COVID-19 immunization, reaction(s): "None"; Bnt162b2 (DOSE 3, single), for COVID-19 immunization, reaction(s): "None". The following information was reported: DYSPNOEA (hospitalization) with onset 21Mar2022 at 13:00, outcome "unknown", described as "short of breath"; RESPIRATORY FAILURE (death, hospitalization) with onset 01Apr2022 at 11:00, outcome "fatal"; MALAISE (hospitalization), outcome "unknown", described as "Her husband got sick after the vaccine". The patient was hospitalized for respiratory failure, dyspnoea, malaise (start date: 21Mar2022). The events "respiratory failure", "short of breath" and "her husband got sick after the vaccine" required emergency room visit. The patient date of death was 01Apr2022. Reported cause of death: "Respiratory failure". The autopsy was performed, and results were not provided. Clinical course: No additional vaccines administered on same date of the Pfizer suspect. No other vaccines prior vaccinations (within 4 weeks). No family medical history relevant to events. An internal medicine doctor reported he had a patient passed way in the hospital after receiving the booster (fourth dose) around 15:00 or 16:00 on 20Mar2022. Patient died at 11:00 on 01Apr2022. Autopsy results are pending. The patient's wife wanted to add, about 13:00 on 21Mar2022, the patient became short of breath, then it snow balled and ended in his death. Her husband got sick after the vaccine and was admitted to the hospital, died 10 days later. Less than twenty four hours after receiving the vaccine he became short of breath, breathing 30 times a minute, an ambulance was called and he was taken to the hospital on 21Mar2022. He was admitted to the hospital, and he was in the hospital until his death.  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 available reported information, the causal association between the events respiratory failure, dyspnea and malaise and the 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.; Reported Cause(s) of Death: Respiratory failure