Sex: F
Vaccine: COVID19
Symptoms: Bone loss, Crohn's disease, Hypophagia
Clinical narrative: Crohn's flare up; bone loss in elbow; Can not eat anything; This is a solicited report from a non-interventional study (FACILITATED COLLECT) based on information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4060317-00).  Solicited report by a consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (lot number and expiry date: unknown) to an unspecified date, at unspecified dose for Moderate to severe Adult Crohn's disease; alprazolam, route of administration, start and stop date, lot number and dose were not reported for anxiety; infliximab (REMICAIDE), route of administration, start and stop date, lot number and dose were not reported for product used for unknown indication; miconazole nitrate (MONISTAT), route of administration, start and stop date, lot number and dose were not reported for product used for unknown indication; benzylpenicillin potassium, benzylpenicillin sodium (PENICILLIN [BENZYLPENICILLIN POTASSIUM;BENZYLPENICILLIN SODIUM]), route of administration, start and stop date, lot number and dose were not reported for product used for unknown indication. Medical history included no-tobacco user, abstains from alcohol, Penicillin allergy manifested by rash, Sulfa drugs allergy manifested by rash, Crohn's disease, and migraine. Concomitant medications included dexlansoprazole (DEXILANT) taken for Crohn's disease, start and stop date were not reported; and galcanezumab (EMGALITY [GALCANEZUMAB]) taken for migraine, start and stop date were not reported. The patient previously took Remicaide and experienced anaphylactic shock, monistat and experienced infections gets worse, and tryptan and experienced erratic heartbeat. On unknown date, the patient experienced Cannot eat anything, Bone loss in elbow and Crohns flare up. On an unknown date, Bone loss in elbow resolved. ALPRAZOLAM, PENICILLIN (BENZYLPENICILLIN POTASSIUM; BENZYLPENICILLIN SODIUM), REMICAIDE (INFLIXIMAB) and MONISTAT (MICONAZOLE NITRATE) were also considered suspect. The patient was hospitalized for two days because of Crohn's flare up. She experienced stomach pain, throwing up and could not eat anything in Aug2021. She was treated with concomitant drug Dexilant for Crohn's disease, Emeality for migraine, Alprazolam for anxiety. She had blood in stool, diarrhea. She had bone loss and elbow surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received COVID-19 Vaccine manufactured by Pfizer. Outcome of the event Crohn's flare up was recovering, for bone loss in elbow was recovered on unspecified date, while for event Can not eat anything was unknown.  The reporter's causality for the events of Cannot eat anything and Bone loss in elbow with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of Crohn's flare up was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of Cannot eat anything, Bone loss in elbow and Crohn's flare up are related to HUMIRA (ADALIMUMAB). Causality between the events and the remaining suspect drugs were not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: 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.