Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4930 | — |
cellulitis; extreme redness; swelling; This is a spontaneous report received from an Other HCP. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4930) for immunisation, Device Lot Number: LN4930. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "unknown"; ERYTHEMA (medically significant), outcome "unknown", described as "extreme redness"; SWELLING (medically significant), outcome "unknown". The events "cellulitis", "extreme redness" and "swelling" required emergency room visit. Clinical course: It was reported that they have a lot number that gave some patients what the doctor was considering abnormal reactions. Reporter stated they have another 16 doses of the same lot they just found that was affected. Stated that about 7 patients were involved with the previous report. Caller didn't have patient details to provide. Clarified abnormal reactions - stated the email she received states cellulitis, extreme redness, and swelling with one patient that went to the ER. States she not reporting anything new, just updating they have 16 doses of the same lot number that they found and quarantined. Confirms not administered to patients. She was looking to replace the 16 doses. The product sample was available to be returned. Packaging was sealed and intact. Causality for "cellulitis", "extreme redness" and "swelling" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: As there is limited information in the case provided, the causal association between the events cellulitis, erythema, and swelling; and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. 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.