Received Apr 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LX4483 | — |
Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; This is a spontaneous report received from a Nurse. A 59-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Apr2025 as dose number unknown, single (Lot number: LX4483, Expiration Date: Feb2026) at the age of 59 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE OEDEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Apr2025, outcome "recovering" and all described as "Erythema, edema, and pain at the injection site.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site oedema, vaccination site pain. Additional information: The patient did not receive any other vaccines on the same date as the vaccine which is reported. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine which is reported. The patient was taking any other medications within 2 weeks of the event starting. Reporter seriousness for erythema, pain and edema at injection site was not Serious. She reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physican stated a patient recently reported a side effect that came from one batch, the same lot number. Wanted to know what to do with that lot. They have it quarantined and out of patient circulation. Stated the physician was not comfortable using that lot. Stated she has confirmation numbers for the patients. She also has one patient that had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that was a different lot. Patient called and said kind of noticed erythema, pain and edema at injection site the same day into the next day. Caller stated she would say 19Apr2025.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086589 same reporter/product/event, different patient.;