Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
Neutropenia; high fever; This is a spontaneous report received from a Physician. A 12-month-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUTROPENIA (hospitalization) with onset 2024, outcome "recovered"; PYREXIA (hospitalization) with onset 2024, 1 day after the suspect product(s) administration, outcome "recovered", described as "high fever". Neutropenia corrected in the following couple months. Patient was referred to hematologists. The reporter consider event as caused by suspect product. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported events neutropenia and fever was related to the suspect product event most likely due to patient underlying contributory factors. 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.