Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise, Motion sickness, Respiratory disorder, Vaccination site reaction
Clinical narrative: Lingering respiratory issue; Dizzy; Motion sickness; COVID-19; COVID-19; Sick; Flare up of Ulcerative Colitis; Not felt well since first vaccination; Had reaction with all three COVID vaccinations; 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): 22K-163-4260526-00 (Agency).  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single, intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for colitis ulcerative. Relevant medical history included: "Device issue", start date: 2018 (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset Feb2021, outcome "unknown", described as "Flare up of Ulcerative Colitis"; DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "not recovered" and all described as "COVID-19"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "Lingering respiratory issue"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; MOTION SICKNESS (non-serious), outcome "unknown", described as "Motion sickness"; MALAISE (non-serious) with onset Feb2021, outcome "unknown", described as "Not felt well since first vaccination"; VACCINATION SITE REACTION (non-serious) with onset Feb2021, outcome "unknown", described as "Had reaction with all three COVID vaccinations"; ILLNESS (non-serious) with onset Dec2021, outcome "recovering", described as "Sick". The action taken for adalimumab was unknown. Clinical course: In 2018, the patient experienced three previous HUMIRA pen misfires. on 31Jan2022, the patient experienced HUMIRA Pen Misfire/Medication spilled on the skin.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of lingering respiratory issues, dizzy, motion sickness, not felt well since first vaccination, had reaction with all three covid vaccinations, sick with COVID onset in Dec2021, sick with COVID onset in Dec2021 and flare up of ulcerative colitis was not provided. The reporter's causality for the event(s) of three previous HUMIRA PEN MISFIRES and HUMIRA PEN MISFIRE/medication spilled on the skin with HUMIRA(ADALIMUMAB) (Device issue) was a reasonable possibility.   Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) Respiratory disorder was not reported. The reporter's causality for the event(s) of Dizzy, Motion sickness, Feeling unwell, Vaccination site reaction, Sickness, COVID-19, Colitis ulcerative aggravated was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and the suspect drug BNT162B2 cannot be completely excluded.