Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hyperkeratosis, Infection, Sepsis, Skin ulcer
Clinical narrative: Sepsis; Broke out with shingles; Infections; Ulcerated corn; Ulcerated corn; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4209871.  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg, every 2 weeks), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neomycin for Drug use for unknown indication. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: SEPSIS (medically significant), outcome "unknown"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Broke out with shingles"; INFECTION (non-serious), outcome "unknown", described as "Infections"; HYPERKERATOSIS (non-serious), SKIN ULCER (non-serious), outcome "recovered" and all described as "Ulcerated corn". The event "ulcerated corn" required physician office visit. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "sepsis", "broke out with shingles", "infections" and "ulcerated corn" 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.  Clinical course: Solicited report by a consumer of an elderly female with events of sepsis, and non-serious broke out with shingles, infections, ulcerated corn, and ulcerated corn with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced ulcerated corn, ulcerated corn, infections, sepsis, broke out with shingles. On unknown date, ulcerated corn recovered/resolved. On unknown date, ulcerated corn recovered/resolved.It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Patient after starting the HUMIRA over the years, she had infections. She had sepsis at one point and had second covid injection which had her broke out with shingles. She had an ulcerated corn, podiatrist and was cleared up had covid booster and had no issues. Causalities: The reporter's causality for the event(s) of broke out with shingles, infections, sepsis, ulcerated corn unknown onset with Adalimumab Solution for Injection and Pfizer BioNTech COVID-19 vaccine was Not Provided. Opinion was that the causality for the event(s) of ulcerated corn unknown onset with Adalimumab Solution for Injection was No Reasonable Possibility. Opinion was that the causality for the event(s) of broke out with shingles, infections, sepsis, ulcerated corn unknown onset with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Opinion was that the causality for the event(s) of broke out with shingles, infections and sepsis with Adalimumab Solution for Injection was Not Assessable. Alternative Etiology for ulcerated corn with Adalimumab Solution for Injection: Most likely related to underlying Psoriasis. Alternative Etiology for ulcerated corn with Adalimumab Solution for Injection: Most likely related to underlying Psoriasis  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the events "sepsis", "broke out with shingles", "infections" and "ulcerated corn" could be possibly related to intercurrent medical condition/co-suspect drug adalimumab (HUMIRA). However a contributory role of Comirnaty cannot be completely excluded to the events as there is limited information 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 RAs, Ethics Committees, and Investigators, as appropriate.