Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Oral pain
Clinical narrative: painful to eat; crohn's flare up; 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-163-4348658-00 (AbbVie).  A 56-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster), Route of Admin: Intramuscular), for Covid-19 immunization; Bnt162b2 (Dose 2, Route of Admin: Intramuscular), for Covid-19 immunization; Bnt162b2 (Dose 1, Route of Admin: Intramuscular), for Covid-19 immunization. The following information was reported: ORAL PAIN  with onset Mar2022, outcome "recovered" (2022), described as "painful to eat"; CROHN'S DISEASE  with onset 2022, outcome "unknown", described as "crohn's flare up". The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "crohn's flare up" and "painful to eat" 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. Additional information: Suspect Drug information: Suspect Drug: Rinvoq (Upadacitinib), Not Available Route of Administration: Oral, Indication for use: Moderate to severe Rheumatoid Arthritis, Therapy Dates: Unk  Suspect Drug: Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown, Daily Dose: 1 in 1 D, Route of Administration: Intramuscular, Indication for use: Covid-19 vaccination, Therapy Dates: Unk, Reaction onset: 2022. Did Event Abate after stopping drug; NA. Concomitant Drugs and dates of administration: Concomitant Drugs Not Reported. Other Relevant History: Not reported. Reaction Information: Reaction: Vaccination site pain. Describe reaction: Pain (Pain) - Recovered/resolved, Crohn's aggravated (Crohn's disease) - Unknown  Solicited report from by a consumer of a 56-year-old female with events of non-serious painful to eat after her fourth covid 19 booster vaccine and Crohn's Flare up with Rinvoq (Upadacitinib). There was no reported medical history. In 2022, the patient experienced Crohn's flare up. In Mar2022, the patient experienced painful to eat after her fourth covid 19 booster vaccine. On an unknown date, painful to eat after her fourth covid 19 booster vaccine resolved. Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) was also considered as suspect. Patient had too painful to eat after her fourth covid 19 booster vaccine on 04Mar2022 and also caused her Crohn's flare up for two days. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Primary reporter contact for lot number information was not available.  Causality for Rinvoq (Upadacitinib); The reporter's causality for the event (s) of painful to eat after her fourth covid 19 booster vaccine with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event (s) of Crohn's flare up was not provided. Product-Reaction level: Seq. No. 1, Drug: Rinvoq (Upadacitinib), Causality: Pain (Pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. Crohn's aggravated (Crohn's disease), Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported. Dechallenge: N/A Seq. No. 2, Drug: Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown, Daily Dose: Booster dose (1 in 1 D), 4th Covid-19 booster. Route of admin: Intramuscular, Intramuscular, Intramuscular, Therapy Dates/Duration: 04Mar2022 - 04Mar2022 Causality: Pain (Pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: N/A. Crohn's aggravated (Crohn's disease), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Chrons disease , oral pain and the suspect drug BNT162B2 cannot be excluded. 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