Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Failure to thrive, Gastrointestinal haemorrhage, Headache, Inappropriate schedule of product administration
Clinical narrative: Several syncopal episodes; cva x 3; GI bleed; sick sinus syndrome; failure to thrive; severe headaches; Dose 1 and dose 2 administered on 04Nov2022; Dose 1 and dose 2 administered on 04Nov2022; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FF2590) intramuscular, in right arm and on 04Nov2021 as dose 2, single (Lot number: FH8030) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bradycardia" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing); "shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (death, hospitalization, medically significant, life threatening), OVERDOSE (death, hospitalization, medically significant, life threatening) all with onset 04Nov2021, outcome "fatal" and all described as "Dose 1 and dose 2 administered on 04Nov2022"; GASTROINTESTINAL HAEMORRHAGE (death, hospitalization, medically significant, life threatening) with onset 01Jan2022, outcome "fatal", described as "GI bleed"; SYNCOPE (death, hospitalization, medically significant, life threatening) with onset 01Jan2022, outcome "fatal", described as "Several syncopal episodes"; CEREBROVASCULAR ACCIDENT (death, hospitalization, medically significant, life threatening) with onset 01Jan2022, outcome "fatal", described as "cva x 3"; FAILURE TO THRIVE (death, hospitalization, medically significant, life threatening) with onset 01Jan2022, outcome "fatal"; HEADACHE (death, hospitalization, medically significant, life threatening) with onset 01Jan2022, outcome "fatal", described as "severe headaches"; SINUS NODE DYSFUNCTION (death, hospitalization, medically significant, life threatening) with onset 01Jan2022, outcome "fatal", described as "sick sinus syndrome". The patient was hospitalized for inappropriate schedule of product administration, overdose, syncope, cerebrovascular accident, gastrointestinal haemorrhage, sinus node dysfunction, failure to thrive, headache (hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: If covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of syncope, cerebrovascular accident, gastrointestinal haemorrhage, sinus node dysfunction, failure to thrive, headache. The patient date of death was 29Mar2022. Reported cause of death: "Several syncopal episodes", "severe headaches", "GI bleed", "sick sinus syndrome", "cva x 3", "failure to thrive", "Dose 1 and dose 2 administered on 04Nov2022". No autopsy was performed.  Clinical information: If other vaccine in four weeks: No. If covid prior vaccination: No. If treatment ae: Unknown.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "syncope", "cerebrovascular accident", "gastrointestinal hemorrahge", "sinus node dysfunction", "failure to thrive", headache", "overdose". 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: Several syncopal episodes; severe headaches; GI bleed; sick sinus syndrome; failure to thrive; Dose 1 and dose 2 administered on 04Nov2022; Dose 1 and dose 2 administered on 04Nov2022; cva x 3