Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Acute recurrent pancreatitis/Acute mild pancreatitis; This is a literature report for the following literature source(s). A 12-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic pancreatitis" (unspecified if ongoing), notes: 17mo prior; "viral infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PANCREATITIS RELAPSING (medically significant), 11 days after the suspect product(s) administration, outcome "unknown", described as "Acute recurrent pancreatitis/Acute mild pancreatitis". Therapeutic measures were taken as a result of pancreatitis relapsing which included IV fluids, Famotidine, and Maalox.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pancreatitis relapsing and 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.
Medical History/Concurrent Conditions: Idiopathic pancreatitis (17mo prior); Viral infection