Received Apr 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LX4483 | OT / LA |
Rash (small bumps) around the injection site, redness, inflammation; Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site; Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site; This is a spontaneous report received from a Nurse. A 61-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Apr2025 as dose number unknown 0.5 ml, single (Lot number: LX4483, Expiration Date: 20Feb2026) at the age of 61 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 15Apr2025, outcome "recovering", described as "Rash (small bumps) around the injection site, redness, inflammation"; VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Apr2025, outcome "recovering" and all described as "Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site". Therapeutic measures were taken as a result of vaccination site inflammation, vaccination site rash, vaccination site erythema. Additional information: The patient did not received any other vaccines on the same date as the vaccine. The patient did received any other vaccines within 4 weeks PRIOR to the vaccine. The patient was taking other medications within 2 weeks of the event starting. Nurse reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physician stated a patient recently reported a side effect that came from one batch, the same lot number. She has done reporting on Pfizer portal and VAERS. Wants to know what to do with that lot. They have it quarantined and out of patient circulation. They purchase through a distributor, and she wants to see what we recommend from manufacturer; she had contacted the distributor to see if they need return it, wait for it to expire or if they can get credit. States the physician is not comfortable using that lot. States 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 is a different lot.