Received Feb 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MJ3263 | — |
She is calling about a Prevnar 20 prefilled syringe that has white floaties and black mold inside the vaccine (No patient involved); The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 19Feb2026, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MJ3263, Expiration Date: 28Feb2027) for immunisation. The following information was reported: PRODUCT CONTAMINATION (non-serious), outcome "unknown", described as "She is calling about a Prevnar 20 prefilled syringe that has white floaties and black mold inside the vaccine (No patient involved)". The reporter considered "she is calling about a prevnar 20 prefilled syringe that has white floaties and black mold inside the vaccine (no patient involved)" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "she is calling about a prevnar 20 prefilled syringe that has white floaties and black mold inside the vaccine (no patient involved)" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Based on the given information, the Company confirms that the event product contamination is unrelated to the suspected drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) and most likely a product quality complaint associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).