Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Malaise, Psoriasis, SARS-CoV-2 test, Upper limb fracture
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. Other Case identifier(s): 22K-163-4221428-00 (RA). A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) at the age of 85 years as dose 2, single and intramuscular, administration date 01Jan2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at citrate free and second regimen subcutaneous (Batch/Lot number: unknown) at 40 mg for psoriasis, psoriasis. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: UPPER LIMB FRACTURE (medically significant) with onset Dec2021, outcome "unknown", described as "broken shoulder"; SURGERY (non-serious), outcome "unknown", described as "surgery"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "feeling ill"; AMNESIA (non-serious), outcome "unknown", described as "terrible memory loss"; PSORIASIS (non-serious), outcome "unknown", described as "psoriasis flare up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. The action taken for adalimumab was unknown. Additional Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Causality for HUMIRA (ADALIMUMAB). The reporter's causality for the event(s) of surgery, feeling ill, broken shoulder, terrible memory loss and psoriasis flare up was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of surgery, feeling ill, broken shoulder, terrible memory loss and psoriasis flare up are related to HUMIRA- (ADALIMUMAB). Causality for HUMIRA 40MG/0.8ML (ADALIMUMAB): The reporter's causality for the event(s) of surgery, feeling ill, broken shoulder, terrible memory loss and psoriasis flare up was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of surgery, feeling ill, broken shoulder, terrible memory loss and psoriasis flare up are related to HUMIRA .40MG/0.8ML (ADALIMUMAB). Causality for all events as per the reporter (Drug/Vaccine): Not Reported and Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. For SUSPECT DRUG(S) (include generic name) Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran), Causality for all events as per the reporter (Drug/Vaccine) was Possible. The reporter considered "broken shoulder", "feeling ill" and "terrible memory loss" not related to bnt162b2. 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 information available and know safety profile of suspect drug a causal association between bnt162b2 and the reported event malaise cannot be excluded and the events upper limb fracture, amnesia and psoriasis are assessed as not related to suspected product bnt162b2.