Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
Pneumonia; Pneumothorax; A hole in the lung; This is a spontaneous report received from a Physician. A male 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: PNEUMONIA (medically significant), 48 hrs after the suspect product(s) administration, outcome "unknown"; PNEUMOTHORAX (medically significant), 48 hrs after the suspect product(s) administration, outcome "unknown", described as "Pneumothorax; A hole in the lung". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event pneumonia and pneumothorax based on the known safety profile 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.