Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | — | — |
headache; diarrhea committing; swelling; This is a spontaneous report received from an Other HCP from a sales representative. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 01May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01May2025, outcome "recovered"; DIARRHOEA (non-serious) with onset May2025, outcome "recovered", described as "diarrhea committing"; SWELLING (non-serious) with onset May2025, outcome "recovered". It was unknown if therapeutic measures were taken as a result of headache, diarrhoea, swelling. Additional information: patient reported headache one hour after administration followed by 3 days of diarrhea committing and swelling. Eventually recovered. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.