Age: 66.0
Sex: M
Vaccine: COVID19, UNK, VARZOS
Symptoms: Drug level decreased, Drug specific antibody present, Fistula, Gastrointestinal mucosa hyperaemia, Gastrointestinal tract irritation
Clinical narrative: completed colonoscopy and noticed slight redness and irritation; completed colonoscopy and noticed slight redness and irritation; sore arm from the covid vaccine/covid-19 vaccine made arm hurt at injection site; shingles vaccine had reaction at injection site; levels of humira had been low; pimples around face and anus; fistula; hemoglobin low; anemia/iron levels were low; stiffness in joints; the event of antibodies for humira; FACILITATED COLLECT  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): 21K-163-4006465-00 (Agency), US-PFIZER INC-202200248616 (Pfizer).  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single, intramuscular, administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154253) at citrate free (1 in 1 wk) for crohn's disease; varicella zoster vaccine rge (cho) (SHINGRIX) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Surgery", start date: 2020 (unspecified if ongoing), notes: He had surgery in last fall 2020.; "Mouth sores", start date: 2020 (unspecified if ongoing), notes: In 2020, he was on weekly dosing of HUMIRA and took another medication simultaneously and had experienced mouth sores. The patient's concomitant medications were not reported. The following information was reported: GASTROINTESTINAL TRACT IRRITATION (medically significant), outcome "unknown", GASTROINTESTINAL MUCOSA HYPERAEMIA (medically significant), outcome "not recovered" and all described as "completed colonoscopy and noticed slight redness and irritation"; VACCINATION SITE PAIN (medically significant), outcome "recovered", described as "sore arm from the covid vaccine/covid-19 vaccine made arm hurt at injection site"; VACCINATION SITE REACTION (medically significant), outcome "recovered", described as "shingles vaccine had reaction at injection site"; DRUG LEVEL DECREASED (medically significant), outcome "unknown", described as "levels of humira had been low"; ACNE (medically significant), outcome "unknown", described as "pimples around face and anus"; FISTULA (medically significant), outcome "unknown", described as "fistula"; HAEMOGLOBIN DECREASED (medically significant), outcome "unknown", described as "hemoglobin low"; IRON DEFICIENCY ANAEMIA (medically significant), outcome "not recovered", described as "anemia/iron levels were low"; JOINT STIFFNESS (medically significant), outcome "unknown", described as "stiffness in joints"; DRUG SPECIFIC ANTIBODY PRESENT (medically significant), outcome "not recovered", described as "the event of antibodies for humira". The patient underwent the following laboratory tests and procedures: blood iron: low; blood test: little high, notes: Antibodies for Humira was little high; little low, notes: Antibodies for Humira was little low; colonoscopy: slight redness and irritation, notes: Noticed slight redness and irritation but not usual Crohn's inflammation; drug level: low, notes: levels of HUMIRA  had been low; haemoglobin: low. The action taken for adalimumab was unknown. Solicited report from a male with events of non-serious Completed colonoscopy and noticed slight redness and irritation, mouth sores, sore arm from the COVID Vaccine/covid-19 vaccine made arm hurt at injection site, shingles vaccine had reaction at injection site, levels of HUMIRA  had been low, pimples around face and anus/thought might be side effects of Crohn's, fistula, Hemoglobin low, anemia/iron levels were low, stiffness in joints and antibodies for HUMIRA was just a tad bit Off, on the high side with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced completed colonoscopy and noticed slight redness and irritation, sore arm from the COVID vaccine/covid-19 vaccine made arm hurt at injection site, shingles vaccine had reaction at Injection site, levels of HUMIRA had been low, pimples around face and anus/thought might be side effects of Crohn's, fistula, hemoglobin low, anemia/iron levels were low, stiffness in joints and antibodies for HUMIRA was just a tad bit off, on the high side. In 2020, the patient experienced surgery and mouth sores. On unknown dates, sore arm from the COVID VACCINE/COVID-19 VACCINE made arm hurt at injection site and shingles vaccine had reaction at injection site resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The physician completed a colonoscopy and noticed slight redness and irritation but not the patients usual Chron's inflammation. He was doing very well overall. He had surgery in last fall 2020. In 2020, he was on weekly dosing of HUMIRA and took another medication simultaneously and had experienced mouth sores. His levels of HUMIRA had been low, so the physician bumped him up to weekly dose again. Unspecified shingles vaccine was considered as co-suspect. Another medication was considered as co-suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "completed colonoscopy and noticed slight redness and irritation", "sore arm from the covid vaccine/covid-19 vaccine made arm hurt at injection site", "shingles vaccine had reaction at injection site", "levels of humira had been low", "pimples around face and anus", "fistula", "hemoglobin low", "anemia/iron levels were low", "stiffness in joints" and "the event of antibodies for humira" not related to bnt162b2, Humira and not reported for Shingrix.  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 current available limited information in the case provided, the causal association between the event's Gastrointestinal tract irritation, Gastrointestinal mucosa hyperemia, Vaccination site pain, Acne Fistula, Hemoglobin decreased, Iron deficiency anemia, Joint stiffness and the use of suspect product BNT162B2 cannot be fully excluded. However, based on the information provided in narrative, Vaccination site reaction is directly due to shingle vaccine and Drug level decreased and Drug specific antibody present is directly related to Humira, hence unrelated to BNT162B2. The case will be reassessed once further information is 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.