Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | OT |
Softball size swelling within a day after vaccination; This is a spontaneous report received from a Physician from a sales representative. A 54-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (medically significant), outcome "recovered", described as "Softball size swelling within a day after vaccination". Therapeutic measures were taken as a result of vaccination site swelling. Clinical course: Facility where vaccine was administered: Doctor's office/urgent care. Treated with Kelflex Ice and Benadryl. Causality for "softball size swelling within a day after vaccination" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event vaccination site swelling and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN). 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.