Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Extra dose administered, Off label use, Psoriasis, Rheumatoid arthritis
Clinical narrative: Memory loss; Off label use/received third dose of BNT162B2; Extra dose administered/received third dose of BNT162B2; Rheumatoid arthritis flare up; Psoriasis; This is a solicited report received from a contactable consumer (patient) from marketing program based on the information received by Pfizer.   A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular on 23Aug2021 (at 63 years old) as dose 3, single for covid-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing, at an unknown dose and frequency (citrate free (as reported)) for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 on 06Apr2021 and then the second dose on 26Apr2021, both via intramuscular route as COVID-19 immunization (at the age of 63 years old). On 23Aug2021, the patient received third dose of BNT162B2 (off label use/extra dose administered). In Aug2021, the patient experienced rheumatoid arthritis flare up and psoriasis. On an unspecified date in 2021, patient had memory loss. The action taken in response to the events for bnt162b2 was not applicable, while for adalimumab was dose not changed. The outcome of the events reported was unknown.   A 63-year-old contactable female consumer (patient) reported for herself that: Describe reactions (including relevant test/lab data): Memory loss- Unknown; Psoriasis- Unknown; Rheumatoid arthritis flare up- Unknown: Solicited report by a consumer of a 63 year old female with events of non-serious normal memory loss, psoriasis on feet and rheumatoid arthritis flare up with humira (adalimumab). there was no reported medical history. on an unknown date, the patient experienced normal memory loss. in august 2021,the patient experienced psoriasis on feet and rheumatoid arthritis flare up.pfizer biontech COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 6Apr2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 26Apr 2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer. Describe Reaction(s)(Include relevant test/lab data): On 23Aug2021, patient received booster shot COVID-19 Vaccine manufactured by Pfizer.   The reporter's causality for the events of normal memory loss and rheumatoid arthritis flare up with humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of psoriasis on feet was not provided. The reporter's causality for the event of normal memory loss with BNT162B2 was not reported. The reporter's causality for the events of psoriasis on feet and rheumatoid arthritis flare up was probable.  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 limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events memory loss, psoriasis on feet and rheumatoid arthritis flare up cannot be totally excluded/assessed. However, role of co-suspect humira (adalimumab) cannot be denied. The case will be reassessed if additional information becomes available. 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.