Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fluid intake reduced, Immunisation reaction, Syncope, Weight increased
Clinical narrative: Vaccination adverse reaction/Covid vaccine metabolism; Fainting; Fainting; Weight gain; Fluid intake reduced; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4458886-00 (Agency).  A 66-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset May2022, outcome "recovered" (2022), SYNCOPE (medically significant) with onset Jun2022, outcome "unknown" and all described as "Fainting"; FLUID INTAKE REDUCED (non-serious) with onset 2022, outcome "unknown"; WEIGHT INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Weight gain"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "Vaccination adverse reaction/Covid vaccine metabolism". The patient underwent the following laboratory tests and procedures: Weight increased: (2022) about ten pounds. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had Weight gain about ten pounds, covid vaccine changed metabolism, not drink enough water and fainting with Humira. On an unknown date, the patient experienced Covid vaccine metabolism.  The reporter's assessment of the causal relationship of "fainting", "weight gain" and "fluid intake reduced" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "vaccination adverse reaction/covid vaccine metabolism" related to BNT162b2.  Causality for Humira(adalimumab): The reporter's causality for the event(s) of Weight gained about ten pounds, Covid vaccine changed metabolism, Not drink enough water, fainting onset in May2022 and fainting onset in Jun2022 was not provided.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events syncope, fluid intake reduced, weight increased, immunisation reaction and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.