Age: 25.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Dehydration, Impaired healing, Localised infection, Pain
Clinical narrative: felt humira hindered the healing; felt dehydrated; body aches; Chills; skin flap; infected tissue; 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 15Apr2021 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). Relevant medical history included: "surgery to remove infected tissue" (not 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. Vaccination history included: Bnt162b2 (Dose: 01, Route of Administration: Intramuscular, felt humira hindered the healing), administration date: 25Mar2021, when the patient was 25 years old, for Covid-19 Vaccination, reaction(s): "felt humira hindered the healing", "infected tissue", "sore arm with each covid vaccine". The following information was reported: SKIN FLAP NECROSIS (medically significant), outcome "unknown", described as "skin flap"; 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"; DEHYDRATION (non-serious), outcome "unknown", described as "felt dehydrated"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown", described as "Chills". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of localised infection. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of infected tissue, sore arm with each covid vaccine, chills, felt Humira hindered the healing, felt dehydrated and body aches was not provided Causality for Covid 19: The reporter's causality for the event(s) of Localized infection, infected tissue and Impaired healing as not Reported, sore arm with each covid vaccine, chills, felt Humira hindered the healing, felt dehydrated and body aches was Possible.  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 events Skin flap necrosis and localized 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.