Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: unusual pneumonia on both sides; haven't felt well; pain in her upper back; exhaustion; falling asleep; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-FIB" (unspecified if ongoing); "Minor rheumatoid arthritis" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The following information was reported: FATIGUE (non-serious) with onset 18May2022 at 12:00, outcome "unknown", described as "exhaustion"; SOMNOLENCE (non-serious) with onset 18May2022 at 12:00, outcome "unknown", described as "falling asleep"; MALAISE (non-serious) with onset 18May2022 at 12:00, outcome "unknown", described as "haven't felt well"; BACK PAIN (non-serious) with onset 18May2022 at 12:00, outcome "unknown", described as "pain in her upper back"; PNEUMONIA (death, hospitalization) with onset 02Jun2022, outcome "fatal", described as "unusual pneumonia on both sides". The patient was hospitalized for pneumonia (hospitalization duration: 8 day(s)). The events "unusual pneumonia on both sides", "haven't felt well", "pain in her upper back", "exhaustion" and "falling asleep" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results, notes: Biopsies/samples were sent to (Clinic name); Computerised tomogram: Unknown results; Fungal test: Negative, notes: all labs negative for fungus; Pneumonia legionella: Negative, notes: all labs negative for legionnaires; Oxygen saturation: 86 %, notes: 7 days hospitalized with Oxygen at 86%; SARS-CoV-2 test: Negative, notes: COVID tests were negative. Therapeutic measures were taken as a result of pneumonia, malaise, back pain, fatigue, somnolence and included different antibiotics and prednisone. It was reported that treatment included "everything possible".  The patient date of death was 02Jun2022. Reported cause of death: "Pneumonia 2 recent secondary covid booster". No autopsy was performed. It was reported that the patient was not tested for COVID-19 post vaccination. The clinical course was reported as follows: "She died. Injected at her annual exam, her second Pfizer booster in excellent health. 5 days later complained of pain in her upper back she thought was tension and she had not felt well since she had that booster. 6 days utter exhaustion, falling asleep. 7 days hospitalized with oxygen at 86 percent and antibiotics and unusual pneumonia on both sides per ED doc. The next morning in ICU after CT scan. She stayed in ICU for a week, needing increasing oxygen. 2 days before she died, she was intubated. Biopsies/samples were sent to (clinic withheld) Clinic and she was treated with everything - all labs negative for legionnaires, fungus, etc, different antibiotics, prednisone. Secretions suctioned were bloody and tissue-like, very abnormal per staff. Death certificate said booster a contributing factor because ICD-10 did not have a code for adverse vaccine reactions, it WAS the cause. More alarming, no hospital policy/requirement to report it. How could you say this is based on science without data." The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: Pneumonia 2 recent secondary covid booster