Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Fatigue, Immunisation, Off label use
Clinical narrative: She Received Fourth Dose Covid-19 Vaccine Manufactured By Pfizer; She Received Fourth Dose Covid-19 Vaccine Manufactured By Pfizer; fatigue; Fallen several times due to balance issues; Fallen several times due to balance issues; Osteoarthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since 2021 (ongoing) (Lot number: 1158969) at 40 mg ((citrate free) (1 in 2 wk)), second regimen subcutaneous since Jan2018 (Lot number: 1137002) at 40 mg ((citrate free) (1 in 2 wk)) and third regimen subcutaneous from 2017 (Lot number: 1130421) to 27Sep2017 at citrate free for psoriatic arthropathy. Relevant medical history included: "Female breast cancer", start date: 27Sep2017 (unspecified if ongoing); "EX-Smoker/Cigarette", start date: 1989 (unspecified if ongoing); "right mastectomy", start date: 04Nov2017 (unspecified if ongoing), notes: Right. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route: Intramuscular), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Fatigue", "Fallen seeral times due to balance issues", "Fallen seeral times due to balance issues", "Hand pain", "Osteoarthritis", "Psoriasis flare-up", "Psoriatic arthritis aggravated"; Bnt162b2 (Dose 2, Route: Intramuscular), administration date: 24Mar2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Fatigue", "Fallen seeral times due to balance issues", "Fallen seeral times due to balance issues", "Osteoarthritis", "Hand pain", "Psoriasis flare-up", "Psoriatic arthritis aggravated"; Bnt162b2 (Dose 3, Route: Intramuscular), administration date: 18Aug2021, when the patient was 64 years old, for COVID-19 Vaccination, reaction(s): "Fatigue", "Fallen seeral times due to balance issues", "Fallen seeral times due to balance issues", "Osteoarthritis", "Swollen lymph nodes on left side", "Sick with a cold", "Sick with a cold", "roof of mouth", "tongue raw", "runny nose", "slight fever"; Bnt162b2 (Dose 3, Route: Intramuscular), administration date: 18Aug2021, when the patient was 64 old, for COVID-19 Vaccination, reaction(s): "sore throat". The following information was reported: OFF LABEL USE (hospitalization, medically significant), IMMUNISATION (hospitalization, medically significant), outcome "unknown" and all described as "She Received Fourth Dose Covid-19 Vaccine Manufactured By Pfizer"; FATIGUE (hospitalization, medically significant), outcome "unknown", described as "fatigue"; FALL (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "Fallen several times due to balance issues"; OSTEOARTHRITIS (non-serious), outcome "unknown", described as "Osteoarthritis". The action taken for adalimumab was dosage not changed.  Causality assessment: The reporter's assessment of the causal relationship of the events off label use, immunization, fatigue, fall balance disorder, and osteoarthritis with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event 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.