Sex: M
Vaccine: COVID19, FLUX, UNK
Symptoms: Feeling abnormal, Nephrolithiasis
Clinical narrative: Kidney stone; Feeling bad; 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-163-4499349-00 (AbbVie).  A 34-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 30Mar2022 (Batch/Lot number: unknown), subcutaneous for hidradenitis; influenza vaccine (INFLUENZA VACCINE), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "feeling nauseous" (unspecified if ongoing), notes: last month he was feeling nauseous; "a lot of abdominal pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 21Apr2021, when the patient was 33-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 12May2021, when the patient was 33-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 20Jun2022, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "recovered", described as "Feeling bad"; NEPHROLITHIASIS (hospitalization, medically significant) with onset 28Jul2022, outcome "recovered" (29Jul2022), described as "Kidney stone". The patient was hospitalized for nephrolithiasis (start date: 28Jul2022, discharge date: 29Jul2022, hospitalization duration: 1 day(s)). The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of nephrolithiasis.  The reporter's assessment of the causal relationship of "kidney stone" and "feeling bad" 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's causality for the event(s) of "kidney stone" with adalimumab was a reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that the events of kidney stone and felt horrible after covid and flu vaccine are related to 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 information in the case report and a plausible temporal relationship, a possible causal association between the reported events nephrolithiasis, feeling abnormal  and suspect 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.