Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis microscopic, Colitis ulcerative, Incorrect dose administered, Injection site haemorrhage, Lethargy
Clinical narrative: Colitis ulcerative aggravated; Colitis collagenous; Rheumatoid arthritis; Vaccination adverse reaction/lethargic reaction to covid vaccine; Injection site bleeding; Wrong injection technique; Inappropriate dose of drug administered; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). Other Case identifier(s): 21K-163-4186575-00 (AbbVie).  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg, 1 in 2 wk) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Colitis ulcerative aggravated"; COLITIS MICROSCOPIC (medically significant), outcome "not recovered", described as "Colitis collagenous"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis"; LETHARGY (non-serious), outcome "recovered", described as "Vaccination adverse reaction/lethargic reaction to covid vaccine"; INJECTION SITE HAEMORRHAGE (non-serious), outcome "recovered", described as "Injection site bleeding"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "Wrong injection technique"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of drug administered". This is a solicited report by a consumer of an adult male with events of non-serious flare of ulcerative colitis, collagenous colitis, rheumatoid arthritis, blood at injection site, lethargic reaction to covid vaccine and pen misfire/ clipped finger and medication leaked out of pen with HUMIRA (adalimumab). On unknown dates, the patient experienced flare of ulcerative colitis, collagenous colitis, rheumatoid arthritis, blood at injection site, lethargic reaction to covid vaccine and pen misfire/ clipped finger and medication leaked out of pen. On unknown dates, blood at injection site and lethargic reaction to covid vaccine resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer/ Biontech. The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "colitis ulcerative aggravated", "colitis collagenous", "rheumatoid arthritis", "vaccination adverse reaction/lethargic reaction to covid vaccine" and "injection site bleeding", "Wrong injection technique" and "Inappropriate dose of drug administered" related to bnt162b2 (reported as possible by reporter). The reporter considered "Colitis ulcerative aggravated", "Colitis microscopic", "Rheumatoid arthritis", "Injection site hemorrhage" was related to HUMIRA (reported as "Reasonable possibility" by reporter) and considered event "vaccination adverse reaction/lethargic reaction to covid vaccine" was not related to HUMIRA (reported as "No reasonable possibility" by reporter) and for events "Wrong injection technique" and "Inappropriate dose of drug administered" was not reported.   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 reported information ,a causal relationship between the events and suspected drug cannot be excluded.  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