Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
partial Bell's palsy; scalp numbness; fever; This is a spontaneous report received from a Physician from a sales representative. An adult female patient (unknown if pregnant) 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: BELL'S PALSY (medically significant), outcome "recovered", described as "partial Bell's palsy"; HYPOAESTHESIA (non-serious), outcome "recovered", described as "scalp numbness"; PYREXIA (non-serious), outcome "recovered", described as "fever". Therapeutic measures were taken as a result of bell's palsy, hypoaesthesia, pyrexia. Additional infirmation: The patient experienced scalp numbness and partial Bell's palsy with a fever 2-3 days post vaccination with Prevnar 20. 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: Based on the available information the company considers that there was not a reasonable possibility that the event Bell's palsy was related to pneumococcal 20-val conj vac. There is no compelling evidence to implicate suspect drug with the event and more likely related to underlying/intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer drug 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