Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Gallbladder disorder, Vaccination site irritation
Clinical narrative: shortness of breath; Injection site irritation; gall bladder removed; 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-163-4375489-00 (Agency).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization, medically significant) with onset Nov2021, outcome "recovered", described as "shortness of breath"; VACCINATION SITE IRRITATION (medically significant) with onset Apr2022, outcome "recovered" (2022), described as "Injection site irritation"; GALLBLADDER DISORDER (medically significant) with onset Apr2022, outcome "unknown", described as "gall bladder removed". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of dyspnoea, gallbladder disorder.  The reporter considered "shortness of breath" related to BNT162b2. The reporter's assessment of the causal relationship of "gallbladder removed", "injection site irritation" and "gall bladder removed" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Solicited report from by a consumer of an adult female with events of Shortness of breath and gall bladder removed and non-serious irritation at Injection site with HUMIRA (ADALIMUMAB). There was no reported medical history. In Nov2021, the patient experienced Shortness of breath. In Apr2022, the patient experienced PAIN. On 01Mar2022, the patient experienced gall bladder removed and irritation at Injection site. On unknown dates, Shortness of breath and irritation at Injection site resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 01Nov2021, the patient received booster dose of Pfizer vaccine. After receiving the Pfizer vaccine booster dose she was hospitalized for shortness of breath and had to use continuous positive airway pressure and Bilevel positive airway pressure machine to assist in breathing. In Apr2022, she had gallbladder removed and local irritation at injection site right after injection that lasted for 2-3 days. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of SHORTNESS OF BREATH, GALLBLADDER REMOVED and IRRITATION AT INJECTION SITE was not provided. Agency's opinion is that there is no reasonable possibility that the events of SHORTNESS OF BREATH and GALLBLADDER REMOVED are related to HUMIRA(ADALIMUMAB). Agency's opinion is that there is a reasonable possibility that the event of IRRITATION AT INJECTION SITE is 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: Based on the available reported information, the causal association between the events gall bladder disorder, vaccination site irritation and dyspnoea 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.