Sex: F
Vaccine: COVID19
Symptoms: Cataract, Diabetes mellitus, Insomnia, Macular degeneration, Musculoskeletal chest pain
Clinical narrative: Cataracts; Sleep difficult; Sciatic neuralgia; Rib pain; Diabetic; Musculoskeletal disorder; Macular degeneration; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-3902734-00 (AbbVie).  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 2016 (Batch/Lot number: unknown) at 40 mg (40 mg (40 mg, 2 in 1)) for crohn's disease. Relevant medical history included: "TOBACCO USE" (unspecified if ongoing), notes: No relevant medical history. Concomitant medication(s) included: B12 [CYANOCOBALAMIN] taken for product used for unknown indication. The following information was reported: MACULAR DEGENERATION (medically significant) with onset 2018, outcome "not recovered", described as "Macular degeneration"; CATARACT (medically significant), outcome "not recovered", described as "Cataracts"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "Diabetic"; MUSCULOSKELETAL DISORDER (medically significant) with onset 2021, outcome "not recovered", described as "Musculoskeletal disorder"; INSOMNIA (medically significant), outcome "not recovered", described as "Sleep difficult"; MUSCULOSKELETAL CHEST PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Rib pain"; SCIATICA (medically significant), outcome "not recovered", described as "Sciatic neuralgia". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of diabetes mellitus.  Clinical course: On 27Jan2022, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "MACULAR DEGENERATION" was amended to "EYESIGHT MACULAR DEGENERATION". The events of "PATIENT WAS GOING BLIND" and "VISION IMPAIRMENT/VISSION ISSUES" were removed. She had diabetic and was on flex pen. She was using unspecified eye drops for treatment. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality as per Mfr.(Drug/Vaccine) was no reasonable possibility for event Macular degeneration, Cataracts, Musculoskeletal disorder, Sleep difficult, Diabetic, Rib pain, Sciatic neuralgia for the drug HUMIRA. Causality as per reporter (Drug/Vaccine) was not reported for event Macular degeneration, Cataracts, Musculoskeletal disorder, Sleep difficult, Diabetic, Rib pain, Sciatic neuralgia for the drug HUMIRA. Causality as per reporter (Drug/Vaccine) was possible for event Macular degeneration for the drug PFIZER BIONTECH COVID-19. Causality as per reporter (Drug/Vaccine) was Not Reported for the event Cataracts, Musculoskeletal disorder, Sleep difficult, Diabetic, Rib pain, Sciatic neuralgia for the drug PFIZER BIONTECH COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Macular degeneration, Cataract, Diabetes mellitus, Musculoskeletal disorder, Insomnia, Musculoskeletal chest pain, Sciatica. 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