Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4508934-00. A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as (citrate free) (Lot number: 1163673) subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE OPERATION (medically significant), outcome "unknown", described as "Knee surgery NOS"; CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease aggravated"; CONSTIPATION (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "recovering"; DYSPHONIA (non-serious), outcome "recovering", described as "Hoarseness"; STRESS (non-serious), outcome "unknown". The action taken for adalimumab was unknown. The patient had Crohns flare up, due to stress either it was diarrhea or constipation, not in between. She had side effects of chills and hoarse after fourth Covid vaccination. She did not agree to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's assessment of the causal relationship of "knee surgery NOS", "Crohn's disease aggravated", "constipation" and "stress" 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 "chills" and "hoarseness" related to BNT162b2. Causality for PFIZER BIONTECH COVID-19 VACCINE: Causality as per reporter (Drug/Vaccine): Not Related for Knee surgery NOS, Crohns disease aggravated, constipation, stress and possible for chills, hoarseness. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Knee Surgery, Crohn's Disease Flare Up Due to Stress Unknown Onset, Constipation, Chills, Hoarse and Crohn's Disease Flare Up Due to Stress unknown onset was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of Knee Surgery, Crohn's Disease Flare Up Due to Stress unknown onset, Constipation, Chills, Hoarse and Crohn's Disease Flare Up Due to Stress unknown onset are related to HUMIRA (ADALIMUMAB). 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 events Crohn's disease, chills, constipation, dysphonia with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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. The causal association between the event knee operation and suspect product BNT162B2 assessed as unrelated as it could be due to underlying disease condition .