Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Colitis ulcerative, Herpes zoster, Illness, Immunodeficiency
Clinical narrative: Ulcerative colitis flare up; Possible lowered immune system; More pain in joints; Stinging with injections; Pain; Sickness; Shingles; Sickness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4483295-00.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at citrate free and second regimen (Batch/Lot number: unknown), all subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered", ILLNESS (non-serious) with onset 2022, outcome "unknown" and all described as "Sickness"; HERPES ZOSTER (non-serious) with onset Oct2021, outcome "recovered", described as "Shingles"; COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "Ulcerative colitis flare up"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Possible lowered immune system"; ARTHRALGIA (non-serious), outcome "not recovered", described as "More pain in joints"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Stinging with injections"; PAIN (non-serious), outcome "not recovered". The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced more pain in joints, stinging with injections, symptoms of pain have returned, ulcerative colitis flare up and possible lowered immune system. In 2021, the patient experienced sick. In Oct2021, the patient experienced shingles. In 2022, the patient experienced sick. On unknown dates, stinging with injections, shingles and sick resolved. Pfizer Biontech COVID-19 Vaccine (Tozinameran) and Moderna COVID-19 Vaccine (Elasomeran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "ulcerative colitis flare up", "possible lowered immune system", "more pain in joints", "stinging with injections", "shingles", "pain" and "sickness" 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.  The reporter's causality for the event(s) of more pain in joints, stinging with injections, shingles, symptoms of pain have returned and sick onset in 2021 with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of ulcerative colitis flare up, sick onset in 2022 and possible lowered immune system was not provided.   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, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of ulcerative colitis, Immunodeciciency, Arthralgia, Vaccination site pain, shingles, pain and illness. 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.