Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired healing, Localised infection, Vaccination site pain
Clinical narrative: infected tissue; felt humira hindered the healing; sore arm with each covid vaccine; 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-163-4300183-00. A 25 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). Relevant medical history included: "surgery to remove infected tissue" (unspecified if ongoing), notes: patient had a surgery to remove infected tissue; "surgery to remove infected tissue", start date: 2020, stop date: 2020, notes: patient had a surgery to remove infected tissue. The patient's concomitant medications were not reported. The following information was reported: LOCALISED INFECTION (medically significant), outcome "unknown", described as "infected tissue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore arm with each covid vaccine"; IMPAIRED HEALING (non-serious), outcome "unknown", described as "felt humira hindered the healing". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of localised infection. Clinical course reported as Solicited report from a consumer of an adult male with events of Infected tissue and non-serious sore arm with each covid vaccine, chills, felt humira hindered the healing, felt dehydrated and body aches with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced infected tissue, sore arm with each covid vaccine, chills, felt humira hindered the healing, felt dehydrated and body aches. In 2020 and Oct2021 patient had a surgery to remove infected tissue and he felt that Humira hindered the healing. States that he got a skin flap at the same time. He had sore arm with each vaccine and felt dehydrated following the second dose chills, body aches with the booster. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Localised infection which cannot be fully assessed/excluded. 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.