Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Contusion, Device issue, Fibromyalgia, Immunisation
Clinical narrative: Ulcerative Colitis flare; Humira pen misfired and some liquid came out; Injection might had hit blood vessel because had a sore spot; Patient was not absorbing nutrients; Weight gain; Fibromyalgia; Round burise the size of a circle with pen; Injection might had hit blood vessel because had a sore spot; Booster; 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-163-4202627-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single, intramuscular, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 1 in 14 d for colitis ulcerative; adalimumab (HUMIRA) (Batch/Lot number: unknown) at 1 in 10 d for colitis ulcerative. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZATHIOPRINE taken for product used for unknown indication. The following information was reported: IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "Booster"; COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "Ulcerative Colitis flare"; DEVICE ISSUE (non-serious), outcome "unknown", described as "Humira pen misfired and some liquid came out"; VASCULAR INJURY (non-serious), INJECTION SITE PAIN (non-serious), outcome "unknown" and all described as "Injection might had hit blood vessel because had a sore spot"; MALABSORPTION (non-serious), outcome "unknown", described as "Patient was not absorbing nutrients"; WEIGHT INCREASED (non-serious), outcome "recovering", described as "Weight gain"; FIBROMYALGIA (non-serious), outcome "not recovered", described as "Fibromyalgia"; CONTUSION (non-serious), outcome "unknown", described as "Round burise the size of a circle with pen". The patient underwent the following laboratory tests and procedures: weight: 130 lbs; 200 lbs. The action taken for adalimumab and adalimumab was unknown. Therapeutic measures were taken as a result of fibromyalgia with Lyrica. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  The reporter considered "ulcerative colitis flare", "humira pen misfired and some liquid came out", "injection might had hit blood vessel because had a sore spot", "patient was not absorbing nutrients", "weight gain", "fibromyalgia" and "round burise the size of a circle with pen" related to bnt162b2.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Humira pen misfired and some liquid came out, Injection might had hit blood vessel because had a sore spot unknown onset, Patient was not absorbing nutrients, Weight gain, Round bruise the size of a circle with pen and Ulcerative Colitis flare and Injection might had hit blood vessel because had a sore spot unknown onset was not provided. The reporter's causality for the event(s) of Fibromyalgia with HUMIRA (ADALIMUMAB) was no reasonable possibility.   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 information available in narrative the reported  event of  Ulcerative colitis flare, Booster, Malabsorption, weight increased, fibromyalgia, is assessed as related to suspected vaccine BNT162B2. However the reported event of Device issue, vascular injury due to injection and injection site pain is assessed  unrelated to suspected vaccine as the narrative clearly indicates that the events were more likely due to concomitant medication and less likely due to vaccine