Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | LN4930 | — |
Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 30Jun2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis 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.,Linked Report(s) : US-PFIZER INC-202500159636 same drug/event, different patient;