Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Incorrect dose administered, 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; Received Flu vaccine at same time of Pfizer Covid; Received Flu vaccine at same time of Pfizer Covid; dose number 5; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9693) 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: "hypothyroid" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FMD173, Vaccine location: Left arm), administration date: 27Sep2022, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Sep2022, outcome "unknown" and all described as "Received Flu vaccine at same time of Pfizer Covid"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 27Sep2022, outcome "unknown", described as "dose number 5"; 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: SARS-CoV-2 test: (30Sep2022) Negative, notes: Nasal swab. Therapeutic measures were not taken as a result of transient global amnesia. The facility where the vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination. The patient had tested for COVID-19 post vaccination. The patient received Flu vaccine at same time of Pfizer COVID vaccine.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and 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.