Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse food reaction, Colitis ulcerative, Muscle spasms, Pain in extremity, Tooth extraction
Clinical narrative: Pain in arm; Cramps; Unevaluable event; Tooth extraction; Colitis ulcerative aggravated; Adverse food 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-163-4393407-00 (AbbVie).  A female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (from an unknown date and ongoing) (Batch/Lot number: unknown) at cf, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE FOOD REACTION (non-serious) with onset 18Jan2022, outcome "not recovered"; COLITIS ULCERATIVE (medically significant) with onset 18Jan2022, outcome "not recovered", described as "Colitis ulcerative aggravated"; TOOTH EXTRACTION (non-serious) with onset 03May2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in arm"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "Cramps"; UNEVALUABLE EVENT (non-serious), outcome "not recovered". The action taken for adalimumab was dosage not changed. The reporter's assessment of the causal relationship of "colitis ulcerative aggravated", "tooth extraction", "cramps", "unevaluable event" and "adverse food reaction" 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. The reporter considered "pain in arm" related to BNT162b2. Solicited report from the USA by a consumer of a female with events of Tooth extraction and non serious arm sore, certain foods fiber and uncooked cause ulcerative Colitis flare and cramps and frequency with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced arm sore and cramps and frequency. On 18Jan2022, the patient experienced certain foods fiber and uncooked cause ulcerative Colitis flare. On 03May2022, the patient experienced Tooth extraction. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab). The reporter's causality for the event(s) of Tooth extraction with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of arm sore was not provided. The reporter's causality for the event(s) of certain foods fiber and uncooked cause ulcerative Colitis flare onset 8Jan2022, cramps and frequency unknown onset, cramps and frequency unknown onset and certain foods fiber and uncooked cause ulcerative Colitis flare onset 18Jan2022 with Humira (Adalimumab) was a reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of Tooth extraction, arm sore, certain foods fiber and uncooked cause ulcerative Colitis flare onset 18Jan2022, cramps and frequency unknown onset, cramps and frequency unknown onset and certain foods fiber and uncooked cause ulcerative Colitis flare onset 18Jan2022 are related to Humira (Adalimumab).  Product-Reaction level: For product Humira the causality of the events Tooth extraction and Pain in arm causality as per reporter was Not Related, Causality as per Mfr was No reasonable possibility; Causality of the events Colitis ulcerative aggravated, Cramps, Unevaluable event and Adverse food reaction Causality as per reporter was Probable; Causality as per Mfr was No reasonable possibility. The causality as per reporter for product Pfizer Biontech Covid-19 Vaccine (Tozinameran) for all doses for events Tooth extraction, Colitis ulcerative aggravated (Colitis ulcerative), Cramps, Unevaluable event and Adverse food reaction was Not Reported. The causality as per reporter for Pfizer Biontech Covid-19 Vaccine (Tozinameran) for all doses for event Pain in extremity was reported as Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Colitis Ulcerative, tooth extraction, pain in arm, muscle spasm, unevaluable event, adverse food reaction and the suspect drug cannot be established, hence the causality was kept as Unrelated. The case will be reassessed once new information is available.