Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lyme disease, Psoriatic arthropathy
Clinical narrative: chronic lyme disease; psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4399185-00 (Agency).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 27Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset 2021, outcome "recovered", described as "psoriatic arthritis flare up"; LYME DISEASE (medically significant), outcome "unknown", described as "chronic lyme disease". The action taken for adalimumab was dosage not changed. Additional information: Solicited report by a consumer of an elderly female with events of non-serious chronic Lyme disease and psoriatic arthritis flare up with the covid vaccine with Humira (Adalimumab). There was no reported medical history. Concomitant drugs and dates of administration: Steroids (Steroids). Other relevant history: Not reported. On an unknown date the patient experienced chronic Lyme disease. In 2021, the patient experienced psoriatic arthritis flare up with the covid vaccination, On an unknown date psoriatic arthritis flare up with the covid vaccination resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Primary reporter contact for lot number information was unsuccessful.  Causality for Humira (Adalimumab): The reporter's causality for the event of Chronic Lyme disease was not provided. The reporter's causality for the event of psoriatic arthritis flare up with the covid vaccination with Humira (Adalimumab) was no reasonable possibility .  Causality for BNT162B2: 1) Lyme disease (Lyme disease) : Causality as per reporter (Drug/Vaccine): Not reported. 2) Psoriatic arthritis aggravated (Psoriatic arthropathy). Causality as per reporter (Drug/Vaccine): Probable The reporter's assessment of the causal relationship of "chronic lyme disease" with the suspect product(s) BNT162b2 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. The reporter considered "psoriatic arthritis flare up" 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 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 cannot be totally 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.