Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
has been continuing to get pneumonia; has been continuing to get pneumonia; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) 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: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "has been continuing to get pneumonia". Clinical course: Reporter like to know what is the level of efficacy of Prevnar 20 in preventing recurrent pneumonia (ex: he has a patient that had pneumonia, received Prevnar 20, and has been continuing to get pneumonia). Provider was asking if we had any information on the following questions: what is the rate of incidence of illness in the 9 serotypes found in PCV21 and not found in Prevnar 20. Wants to know that rate of incidence of illness in the serotypes found in Prevnar 20 vs. serotypes in PCV 21. He also would like to know what is the level of efficacy of Prevnar 20 in preventing recurrent pneumonia (ex: he has a patient that had pneumonia, received Prevnar 20, and has been continuing to get pneumonia). Provider was asking if we had any information on the following questions: what is the rate of incidence of illness in the 9 serotypes found in PCV21 and not found in Prevnar 20. Wants to know that rate of incidence of illness in the serotypes found in Prevnar 20 vs. serotypes in PCV 21. 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: The efficacy of a product varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product pneumococcal 20-val conj vac to the reported event 'has been continuing to get pneumonia' cannot be ruled out.