Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA4452 | IM / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 948422 | IM / LA |
Post COVID vaccine, suffering from acute pancreatitis; Vomiting; Abdominal pain; Back pain; Diarrhea; This spontaneous case initially received on 18-Dec-2025, was reported by a non health professional and concerns an adult female patient. Weight: 64.4 kg; Height: 155.44 cm Pfizer Covid-19 Vaccine, administered to patient on 29-Sep-2022 and 20-Sep-2023 (Lot number: GH9693). Administration of company suspect drug: On 08-Nov-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: 948422. Non-company suspect drugs: On 08-Nov-2025, the patient received Comirnaty (Tozinameran) for Indication not reported, Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical location: Left arm, Lot number: Not reported and would be requested upon follow up. Adverse reactions/events and outcomes: On 09-Nov-2025, post COVID vaccine, patient was suffering from acute pancreatitis (Hospitalized, Life-threatening, outcome: Not recovered / Not resolved). On an unknown date in 2025, the patient experienced Vomiting (outcome: Recovering / Resolving), Abdominal pain (outcome: Recovering / Resolving), Back pain (outcome: Recovering / Resolving), Diarrhea (outcome: Recovering / Resolving). Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter considered the event Post COVID vaccine, suffering from acute pancreatitis as serious (Hospitalized, Life-threatening) and did not provide the causality assessment. The primary reporter did not provide the seriousness and causality for the rest of the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering plausible temporal relationship for event acute pancreatitis (1 day post vaccination). However, the event is probably attributed to COVID-19 vaccine. Of note, concomitant administration of both vaccines (Flucelvax TIV and COVID-19) considered as confounder. Events vomiting, abdominal pain, diarrhea, back pain are attributed to (symptoms of) acute pancreatitis.
Comments: Pfizer Covid-19 Vaccine, administered to patient on 29-Sep-2022 and 20-Sep-2023 (Lot number: GH9693).