Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
became unresponsive for 1-3 minutes; turned dusky; This is a spontaneous report received from a Physician from Medical information team. A 3-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 3 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UNRESPONSIVE TO STIMULI (hospitalization, medically significant) with onset 14Sep2025, outcome "unknown", described as "became unresponsive for 1-3 minutes"; SKIN DISCOLOURATION (medically significant) with onset 14Sep2025, outcome "recovered" (14Sep2025), described as "turned dusky". The patient was hospitalized for unresponsive to stimuli (start date: Sep2025). The patient underwent the following laboratory tests and procedures: Body height: (04Aug2025) 23.5, notes: inches. Additional information: Caller wasn't there, would say medically significant from the story caller got from patient's mother. Clarified patient was taken to hospital, doesn't think anything was done, not given antibiotics or anything, was seen in emergency room and admitted overnight. Confirmed was admitted into the hospital, therefore seriousness selected in formal field as hospitalization. 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: A possible contributory role of the suspect products cannot be excluded for the reported events unresponsive to stimuli and skin discoloration based on the known safety profile and temporal association. However there is not enough information to make a medically meaningful assessment. 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.
Test Date: 20250804; Test Name: Height; Result Unstructured Data: Test Result:23.5; Comments: inches