Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / RA |
Swollen arm; Diarrhea; Kind of felt very drowsy; Patient lost his strength and then he was at the hospital for couple of days; This is a spontaneous report received from a Pharmacist. An 88-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Sep2025 as dose 1, 0.3ml single (Batch/Lot number: unknown) at the age of 88 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (hospitalization) with onset Sep2025, outcome "unknown", described as "Diarrhea"; SOMNOLENCE (hospitalization) with onset Sep2025, outcome "unknown", described as "Kind of felt very drowsy"; ASTHENIA (hospitalization) with onset Sep2025, outcome "unknown", described as "Patient lost his strength and then he was at the hospital for couple of days"; PERIPHERAL SWELLING (hospitalization) with onset Sep2025, outcome "unknown", described as "Swollen arm". The patient was hospitalized for peripheral swelling, diarrhoea, somnolence, asthenia (start date: 2025). Therapeutic measures were taken as a result of peripheral swelling, diarrhoea, somnolence, asthenia. Clinical course: The reporter (pharmacist) stated that the patient received the vaccine and think he had reaction, then days later the reporter was told that the patient kind felt he had a swollen arm, that's normal. Patient lost his strength and then he was at the hospital for couple of days. He had diarrhea. He lost his strength. Reporter thinks that made him to go to the hospital. So, he goes to an adult day care. So, the reporter went there to do like a clinic. So, the nurse has told the reporter days later that he had a swollen arm, that's normal, but he kind of felt very drowsy, but then again it was days later. The reporter doesn't know if it was related to vaccine or something else. Reporter is not sure about any other medical conditions or taking any other medication. When asked about treatment: Reporter stated, "Yes, it is okay now. This happened three months ago." Date of hospital: Reporter stated, "I am not hundred percent sure. I went there and the nurse told me like two weeks later." Discharge date: Reporter stated, "I don't know the discharge date." The patient did not receive any other vaccines on the same date as the Pfizer vaccine and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Patient is not allergic to any previous vaccination, medications, food or other products. Investigations: No. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Based on the current information available and an implied drug-event temporal association, a contributory role of suspect product- BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA), in the development of the reported serious events- "Swollen arm", "Diarrhea", "Kind of felt very drowsy", "Patient lost his strength and then he was at the hospital for couple of days", 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. This case will be reassessed should additional information become available.