Received Jul 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LP4947 | — |
Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Inappropriate dose of vaccine administered; This is a spontaneous report received from a Nurse from a sales representative. An elderly patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, single (Lot number: GW7964) and as dose number unknown, single (Lot number: LP4947) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Oct2024, outcome "unknown", described as "Inappropriate dose of vaccine administered"; VACCINATION SITE ERYTHEMA (death, hospitalization), VACCINATION SITE SWELLING (death, hospitalization), VACCINATION SITE DISCOMFORT (death, hospitalization), outcome "fatal" and all described as "Redness, swollen, discomfort at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site discomfort. The patient date of death was unknown. Reported cause of death: "Redness, swollen, discomfort at the injection site". It was not reported if an autopsy was performed. Clinical course: Redness, swollen, discomfort at the injection site. At least two occurrences of this of late, one of which required hospitalization.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination site erythema, vaccination site swelling, and vaccination site discomfort; 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.; Reported Cause(s) of Death: Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site