Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth haemorrhage, Rash
Clinical narrative: ITP; Brain dead; Brain hemorrhage; Blood in the mouth; Patches on legs; Back pain; D Dimer Very high; Her husband couldn't talk; bruise on arm; This is a spontaneous report from a contactable Nurse (patient's wife). A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 17Mar2021 16:00 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) as 2ND DOSE, SINGLE (at the age of 72 years) for covid-19 immunisation .  The patient received the first dose of BNT162B2 (Lot number: EL3246, Expiration date: Unknown) on 25Feb2021 16:30 in Arm (side not specified) as single dose (at the age of 72 years) for Covid-19 immunisation.  Medical history included blood cholesterol from an unknown date and unknown if ongoing, vascular graft from 2013 to an unknown date. Had flu shot and pneumonia shot. No problems. The patient received no other vaccine other than BNT162B2 within 4 weeks. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for vascular graft from 2013 to an unspecified stop date; metoprolol (METOPROLOL) taken for vascular graft, start and stop date were not reported.  6 weeks after the second vaccine, he had patches on legs and back pain. He went to hospital. They found generalized bleeding and ITP, and he passed away immediately. The patient experienced brain dead (death, hospitalization) on 09May2021 , brain hemorrhage (death, hospitalization) on 04May2021 , ITP (immune thrombocytopenia) (death, hospitalization) on an unspecified date , blood in the mouth  (death, hospitalization) on 03May2021 , back pain (death, hospitalization) on 2021 , patches on legs (death, hospitalization) on May2021 , D Dimer very high (death, medically significant) on an unspecified date , her husband couldn't talk (Her husband couldn't talk. She was calling his name. She asked him why he was not talking. She squeezed his hand and he squeezed back. He couldn't talk.) (death) on an unspecified date, bruise on arm (death) on 2021.  The patient was hospitalized from 03May2021 to 09May2021.  The patient underwent lab tests and procedures which included computerised tomogram abdomen: no active bleeding, no mass on 03May2021, computerised tomogram head: hemorrhage on 04May2021, fibrin D Dimer: very high on unspecified date.  Therapeutic measures were taken as a result of ITP, back pain.  With ITP, they started to do plasmapheresis. Wife stated that the doctor gave him medication Aleve, for back pain. He took 5 tablets only. Then she saw the spots. She told her husband not to take anymore and he did not. The patient died on 09May2021.  An autopsy was not performed.  Wife said that the doctor was not sure if they were related. The wife stated that she did feel that they were related.  The reporter stated events back pain, ITP, blood in the mouth, brain Hemorrhage, Patches on legs, were related to the suspect product.  Wife stated that before this, her husband did 2 miles running every other day or twice a week. He was healthy. He ate healthy foods. Her husband's cholesterol was always under 200. He had no issues. His bloodwork was done, and all was OK. He constantly went to the doctor. This case is not related to a study.; Sender's Comments: Based on the information currently available, the reported events are attributed to intercurrent or underlying medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: Brain dead; Brain hemorrhage; ITP; Blood in the mouth; Back pain; Patches on legs; bruise on arm; Her husband couldn't talk; D Dimer Very high