Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Brain fog, Illness
Clinical narrative: brain fog; sick; This is a spontaneous report received from a Nurse from medical information team.  An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "polycystitis" (unspecified if ongoing), notes: diagnosed 10 or 11 years ago,still stable. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, NDC, lot, expiry: EK41710, confirmed with caller), administration date: 23Jan2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, NDC, lot, expiry: EL3302), administration date: 13Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, stated had a lot in 2021, NDC, lot, expiry: FC3183), administration date: 29Sep2021, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, NDC: Unknown, Lot: FK9895, Expiry: May2022), administration date: 12Apr2022, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Pfizer BIV, NDC: Unknown, Lot: GH9702, Expiry: Jun2023), administration date: 15Sep2022, for COVID-19 immunization; BNT162b2 omi xbb.1.5 (DOSE 6 (BOOSTER), SINGLE, NDC, lot, expiry: HG4665), administration date: 26Oct2023, for COVID-19 immunization; Flu shot (Caller knows wasn't from the flu shot, because caller takes the flu shot every year.). The following information was reported: ILLNESS (non-serious) with onset 14Sep2024, outcome "recovering", described as "sick"; BRAIN FOG (medically significant) with onset 16Sep2024, outcome "recovered" (Sep2024). The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.7, notes: Creatinine is about 1.7, units unknown, caller doesn't want it to get to 2. Additional information: The patient had the vaccine on a Friday, thinks 13Sep2024, then was sick Saturday, and noticed the brain fog the Monday after getting the vaccine. It was not ongoing, woke up the next Friday and was gone. Caller had brain fog with the COVID vaccine. Brain fog lasted one week, from Friday to Friday. She was also sick one day and then the next day she felt better but her brain didn't feel better until a week later. On the latter part, the caller also asked if she should take it again in the future or not but her experience was scary  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event brain fog and the suspect drug BNT162B2 OMICRON (KP.2) 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 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.