Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, SARS-CoV-2 test, Transient global amnesia
Clinical narrative: 72 hours post vaccine- admitted to (withheld) Hospital, (address withheld)-via the ER for dx of Transient Global Amnesia; other vaccine same date vaccine date: 27Sep2022; dose number 4/ Received Flu vaccine at same time of Pfizer Covid; other vaccine same date vaccine date: 27Sep2022; dose number 4/ Received Flu vaccine at same time of Pfizer Covid; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2022 as dose 4 (booster), single (Lot number: FMD173) at the age of 68 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Known allergy: Sulfa" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 27Sep2022, outcome "unknown" and all described as "other vaccine same date vaccine date: 27Sep2022; dose number 4/ Received Flu vaccine at same time of Pfizer Covid"; TRANSIENT GLOBAL AMNESIA (hospitalization) with onset 30Sep2022 at 11:00, outcome "recovering", described as "72 hours post vaccine- admitted to (withheld) Hospital, (address withheld)-via the ER for dx of Transient Global Amnesia". The patient was hospitalized for transient global amnesia (hospitalization duration: 1 day(s)). The event "72 hours post vaccine- admitted to (withheld) hospital, (address withheld)-via the er for dx of transient global amnesia" required emergency room visit. The patient underwent the following laboratory tests and procedures: covid tested post vaccination: (Covid test name post vaccination: covid-19 molecular (PCR/TMA)) SARS-CoV-2 test: (30Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of transient global amnesia. Patient did not receive other vaccine in four weeks. Other medications in two weeks: Received Flu vaccine at same time of Pfizer Covid. The adverse event resulted in: [Emergency room/department or urgent care, Hospitalization].; Sender's Comments: Based on the available information in the case, the causal association between the events 'Product use issue', 'Transient global amnesia' 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.