Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diabetes mellitus, Pain, Psoriatic arthropathy, Vaccination site pain
Clinical narrative: Diabetic; Psoriatic arthritis aggravated; Ache; Vaccination site pain; This is a solicited report from a contactable consumer (patient) received by Pfizer from AbbVie Inc. (Mfr.Control No: 21K-163-4044346-00). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 01Apr2021 (Batch/Lot number was not reported) (at age 63-years-old) as dose 1, single, then via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriatic arthropathy. The patient medical history was not reported. There were no concomitant medications. On unknown dates, the patient experienced diabetic, psoriatic arthritis flare up/plaques on lower left leg and felt achy. On 22Apr2021, the patient experienced reaction/had covid-19 vaccination and had a sore arm. In April 2021, the reaction/had covid-19 vaccination and had a sore arm resolved on Apr2021. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Outcome of ache was unknown and for the remaining events was not recovered.   The reporter's causality for the event(s) of reaction/had covid-19 vaccination and had a sore arm and diabetic with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis flare up/plaques on lower front left leg with HUMIRA (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt achy was not provided. The reporter's causality for the event(s) of reaction/had covid-19 vaccination and had a sore arm with PFIZER BIONTECH COVID-19 VACCINE was no reasonable possibility while for the remaining events was not provided.   The reporter's assessment of the causal relationship of the events with the suspect product 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.  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 available information the reported event of Diabetes Mellitus, Psoriatic arthritis, pain is considered as unrelated  to  suspected vaccine and more likely to ongoing medical condition of Psoriasis and also elderly age, The reported event of Vaccination site pain is considered as related to suspected vaccine BNT162B2  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.