Age: 8.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Gastric infection, Gastritis, Juvenile idiopathic arthritis
Clinical narrative: Juvenile idiopathic arthritis flare; Gastritis; stomach bug; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4279910-00 (Agency).  A 8 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), intramuscular, administration date 19Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), first regimen subcutaneous (Batch/Lot number: unknown) till Dec2021 and second regimen subcutaneous from 10Feb2022 (Batch/Lot number: unknown) to 10Feb2022 for juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "COVID-19"; JUVENILE IDIOPATHIC ARTHRITIS (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "Juvenile idiopathic arthritis flare"; GASTRITIS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Gastritis"; GASTRIC INFECTION (non-serious) with onset 2022, outcome "recovered" (2022), described as "stomach bug". The events "gastritis" and "stomach bug" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: laboratory test: (unspecified date) stomach bug; sars-cov-2 test: (22Dec2021) positive. The action taken for adalimumab was dosage permanently withdrawn on 10Feb2022.  The reporter considered "covid-19", "juvenile idiopathic arthritis flare", "gastritis" and "stomach bug" related to bnt162b2.  Clinical course: The patient reported she had her second Covid-19 shot on 19Dec2021, first Covid-19 shot on an unknown date in 2021. However, on 22Dec2021 she was tested and results came back positive for Covid-19 felt and parents decided to skip Humira dose until she got better. She ended up receiving her Humira dose on 10Feb2022 after having Covid-19 and being hospitalized over the weekend from a flare up. She was taken to the emergency room and was there for a weekend due to severe diarrhea, gastritis, and unable to keep anything in. After several test it ended up being a stomach bug. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the events of Gastritis, stomach bug and polyarticular juvenile idiopathic arthritis flare was not provided; for the events of Covid-19 was no reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of gastritis, polyarticular juvenile idiopathic arthritis flare and Covid-19. Agency's opinion is that there is a reasonable possibility that the event of stomach bug is related to Humira (Adalimumab). Causality for BNT162B2: The reporter's causality for the events of Gastritis, Gastric infection, Juvenile idiopathic arthritis flare, Covid-19 was Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.