Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Fatigue, Osteoarthritis, Osteoporosis
Clinical narrative: 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 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and intramuscular, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2017 (Lot number: 1130421) to 27Sep2017 at 40 mg (40 mg (citrate free 40 mg,1 in 2 wk.)), second regimen subcutaneous since Jan2018 (Lot number: 1137002) at 40 mg (40 mg (citrate free 40 mg,1 in 2 wk.)) and third regimen subcutaneous since 2021 (ongoing) (Lot number: 1158969) at 40 mg (40 mg (citrate free 40 mg,1 in 2 wk.)) for psoriatic arthropathy. Relevant medical history included: "Ex-Smoker/Cigarette", start date: 1989 (unspecified if ongoing); "female breast cancer", start date: 27Sep2017, stop date: 2020; "right mastectomy", start date: 04Nov2017 (unspecified if ongoing); "Drank socially", start date: 1989 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "fatigue"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis aggravated"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Hand pain"; OSTEOPOROSIS (non-serious), outcome "not recovered", described as "Osteoporosis"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Balance disorder"; OSTEOARTHRITIS (non-serious), outcome "not recovered", described as "Osteoarthritis"; FALL (non-serious), outcome "not recovered", described as "Fall"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for adalimumab was dosage not changed. Reporter's causality assessment for BioNTech Vaccine (BNT162B2): The reporter's assessment of the causal relationship of the Fatigue, Psoriatic arthritis aggravated, Hand pain, Osteoporosis, Balance disorder, Osteoarthritis, Fall, Psoriasis flare-up 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. Reporter's causality assessment for Humira: The reporter assessed the causality between Fatigue, Psoriatic arthritis aggravated, Hand pain, Osteoporosis, Balance disorder, Osteoarthritis, Fall, Psoriasis flare-up and Humira as no reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events Fatigue, Psoriatic arthritis aggravated, Hand pain, Osteoporosis, Balance disorder, Osteoarthritis, Fall, Psoriasis flare-up 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.