Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | — | — |
Pneumococcal meningitis; This is a spontaneous report received from a Physician. A 2-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: MENINGITIS PNEUMOCOCCAL (death), outcome "fatal", described as "Pneumococcal meningitis". The patient date of death was unknown. Reported cause of death: "Pneumococcal meningitis". It was not reported if an autopsy was performed. Clinical course: The patient passed away several months ago from pneumococcal meningitis. This is relevant because the parent reported back to the withheld that it was Sero-Type 15B that caused the fatal case of pneumococcal meningitis. ST-15B is not contained in PCV13 or PCV15 but it is contained in PCV20. According to doctor the medical clinics across (redacted) continued to use PCV13 for childhood vaccinations after PCV20 was approved and available in order to deplete PCV13 stock before ordering the newer PCV20 vaccine. The parents believe the child may not have died if the withheld had begun using PCV20 as soon as it was available instead of continuing to use PCV13. This is all reported second hand from doctor during the vaccines field medical interaction. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Pneumococcal meningitis with non PREVNAR 13 covered serotype (15B ) represents an intercurrent bacterial infection; no lack of efficacy with the suspect vaccine was evidenced. 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.; Reported Cause(s) of Death: Pneumococcal meningitis