Sex: M
Vaccine: COVID19, UNK
Symptoms: Dry mouth, Fall, Hip fracture, Vaccination site pain
Clinical narrative: Dry mouth; Hip fracture; Fall; Vaccination site pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4255025-00 (Agency).  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot number: unknown) to Jan2022 at citrate free for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, Route of Admin : 1)Intra-muscular), administration date: Feb2021, when the patient was 57 years old, for COVID-19 Immunization, reaction(s): "Dry mouth", "Fall", "Hip fracture", "Vaccination site pain"; Bnt162b2 (2nd dose of covid vaccine, Route of Admin : 1)Intra-muscular), administration date: Mar2021, when the patient was 57 years old, for COVID-19 Immunization, reaction(s): "Dry mouth", "Fall", "Hip fracture", "Vaccination site pain". The following information was reported: HIP FRACTURE (medically significant) with onset 21Jan2022, outcome "recovering", described as "Hip fracture"; FALL (medically significant) with onset 21Jan2022, outcome "recovering", described as "Fall"; DRY MOUTH (medically significant), outcome "unknown", described as "Dry mouth"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "recovered", described as "Vaccination site pain". The action taken for adalimumab was temporarily withdrawn on Jan2022. On an unknown date, the patient experienced dry mouth. In 2021, the patient experienced soreness at injection site after vaccination. On 21Jan2022, the patient experienced broke hip and fell. On an unknown date, soreness at injection site after vaccination resolved. The Patient was on Humira for three years now. He fell, and his hip was broke on 21Jan2022 and on 22Jan2022, he had a surgery to fix it. His Physician instructed him to stay off Humira for six to eight weeks. He asked if that was normal to do that or if that was the protocol. He had also dry mouth from the other medication which he was put on for his hip. He had soreness at injection site after vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of broke hip, fell, dry mouth and soreness at injection site after vaccination with humira(adalimumab) was no reasonable possibility.  The reporter's causality for the event(s) of broke hip, fell, and dry mouth was Not Reported and reporter's causality for the event soreness at injection site was Possible with BNT162B2  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and HIP FRACTURE, FALL, DRY MOUTH, VACCINATION SITE PAIN cannot be completely 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.