Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccination site bruising, Vitreous floaters
Clinical narrative: covid-19; covid-19; Gas pain; Injection site bruising; upset stomach; diarrhea; Eye floaters; Uveitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4272751-00 (AbbVie).  A 15-year-old male patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 06Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 14 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: UVEITIS (medically significant) with onset 13Jul2021, outcome "not recovered"; VITREOUS FLOATERS (non-serious) with onset 21Jul2021, outcome "not recovered", described as "Eye floaters"; FLATULENCE (non-serious) with onset Jan2022, outcome "not recovered", described as "Gas pain"; VACCINATION SITE BRUISING (non-serious) with onset Jan2022, outcome "recovered" (2022), described as "Injection site bruising"; DIARRHOEA (non-serious) with onset Jan2022, outcome "not recovered", described as "diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset Jan2022, outcome "not recovered", described as "upset stomach"; VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Feb2022) and all described as "covid-19". The action taken for adalimumab was dosage not changed.  The reporter considered "uveitis" and "eye floaters" related to BNT162b2. The reporter's assessment of the causal relationship of "covid-19", "gas pain", "injection site bruising", "upset stomach" and "diarrhea" 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.  Causality for Humira (Adalimumab): The reporter causality for the events of  uveitis, upset stomach, gas pain , Covid-19, and diarrhea was not provided, bruise at injection site with Humira (Adalimumab) was a reasonable possibility. Causality for BNT162B: The reporter(s) causality for the events of  Uveitis (Uveitis) and Eye floaters (Vitreous floaters)  was Possible, Covid-19 (Covid-19)  Gas pain (Flatulence ) Injection site bruising (Injection site bruising) ) Upset stomach (Abdominal discomfort) Diarrhea (Diarrhea) With BNT162B2 was not reported  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, uveitis, vitreous floaters, flatulence, vaccination site bruising, diarrhea, abdominal discomfort, vaccination failure, covid 19 cannot be completely ruled out. 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.