Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, SARS-CoV-2 antibody test, Suspected COVID-19, Therapeutic response shortened
Clinical narrative: Recurrent psoriatic arthritis/psoriatic arthritis symptoms returned; Difficulty sleeping/hard to sleep/up all night; Discomfort/uncomfortable; Ache; Wearing off effect; Sickness; sick again after got the booster; sick again after got the booster; 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): 22K-163-4293116-00 (AbbVie).  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 06Feb2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Verbatim: Covid-19), administration date: 27Feb2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: DRUG INEFFECTIVE(medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "sick again after got the booster"; PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Recurrent psoriatic arthritis/psoriatic arthritis symptoms returned"; INSOMNIA (non-serious), outcome "unknown", described as "Difficulty sleeping/hard to sleep/up all night"; DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort/uncomfortable"; PAIN (non-serious), outcome "unknown", described as "Ache"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Wearing off effect"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "Sickness". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (Aug2021) positive. The action taken for adalimumab was unknown. Clinical course: The patient stated that he experienced events of COVID and sick again after got the booster, hard to sleep/up all night, uncomfortable; She could always tell when it was time for injection patient starts to get achy and psoriatic arthritis symptoms returned with Humira (Adalimumab). Patient was on Humira and stated her symptoms are returned. She had Covid in Aug2021 and was in the hospital for one day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of covid, sick again after got the booster, hard to sleep/up all night, uncomfortable, when it was time for injection patient starts to get achy unknown onset, psoriatic arthritis symptoms returned and when it was time for injection patient starts to get achy unknown onset was not provided. Causality as per Mfr. (Drug): There was no reasonable possibility that the events of covid, sick again after got the booster, hard to sleep/up all night, uncomfortable, when it was time for injection patient starts to get achy unknown onset, psoriatic arthritis symptoms returned and when it was time for injection patient starts to get achy unknown onset are related to Humira (Adalimumab). Causality for BNT162B2 : The reporter's causality for the event(s) of Sickness was probable and the reporter's assessment of the causal relationship of the events COVID-19, Difficulty sleeping, Discomfort, Ache, Recurrent psoriatic arthritis and Wearing off effect with the suspect product 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported suspected COVID-19 after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Based on the current available limited information in the case provided, the causal association between the events Psoriatic arthropathy, Insomnia, Discomfort, Pain, Therapeutic response shortened and illness and the use of suspect product BNT162B2 cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.