Sex: U
Vaccine: COVID19, UNK
Symptoms: Respiratory disorder, Suspected COVID-19, Vaccination failure, Vaccination site reaction
Clinical narrative: Respiratory disorder; Dizzy; Motion sickness; COVID-19; COVID-19; Sickness; Colitis ulcerative aggravated; Feeling unwell; Vaccination site reaction; 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-163-4260526-00 (Company).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster),single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155267) at unk (citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset Feb2021, outcome "unknown", described as "Colitis ulcerative aggravated"; MALAISE (non-serious) with onset Feb2021, outcome "unknown", described as "Feeling unwell"; VACCINATION SITE REACTION (non-serious) with onset Feb2021, outcome "unknown"; VACCINATION FAILURE (medically significant), Suspected COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "Sickness"; DIZZINESS (non-serious) with onset 2022, outcome "unknown", described as "Dizzy"; MOTION SICKNESS (non-serious) with onset 2022, outcome "unknown"; RESPIRATORY DISORDER (non-serious), outcome "unknown". The action taken for adalimumab was unknown.  Clinical Course: It was reported that in 2018, the patient experienced three previous Humira pen misfires. In Feb2021, the patient experienced not felt well since first vaccination, had reaction with all three covid vaccinations and flare up of ulcerative colitis. In Dec2021, the patient experienced sick with covid. In 2022, the patient experienced dizzy and motion sickness. On 31Jan2022, the patient experienced Humira pen misfire/medication spilled on the skin. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "covid-19", "dizzy", "motion sickness", "feeling unwell", "vaccination site reaction", "colitis ulcerative aggravated" and "sickness" related to BNT162b2. The reporter's assessment of the causal relationship of "respiratory disorder" 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.  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) was a reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2 to all the reported events vaccination failure ,covid 19 , Colitis ulcerative , Respiratory disorder, Dizziness, Motion sickness , Malaise , Vaccination site reaction, Illness cannot be completely excluded based on temporal association and known drug safety profile