Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Crohn's disease, Fatigue, Myalgia
Clinical narrative: Crohn's Disease Flare; Crohn's Disease Flare/Related It to Stress after Losing Grandmother; Temperature elevation; Stress; Fatigue; Muscle pain; This is a solicited report based on information received by Pfizer from (Mfr. Control No.: 21K-163-3846093-00). A contactable consumer (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on Mar2021 (at age of 32 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free, then via subcutaneous from 18Dec2020 (Batch/Lot number was not reported) to an unspecified date, at Increased dosage Citrate free (1 in 1 wk) for Moderate to Severe Adult Crohn's Disease. Medical history included cerebral palsy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on Feb2021 (at age of 32 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. In 2021, the patient experienced Stress, Fatigue, Muscle Pain and Temperature elevation after Got Covid Vaccine. On 21Mar2021, the patient experienced Crohn's Disease Flare/Related It to Stress after Losing Grandmother with HUMIRA (ADALIMUMAB). In 2021, The Crohn's Disease Flare/Related It to Stress after Losing Grandmother resolved. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 21Aug2021, the patient experienced Crohn's Disease Flare with HUMIRA (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The outcome of the event "Crohn's disease aggravated (onset date 21Mar2021)" was recovered in 2021. The outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product ADALIMUMAB and BNT162B2 was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Crohn's disease flare up and other reported events and the suspect drug BNT162B2.   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.