Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4930 | — |
had a big ball and swelling very badly/these symptoms occurred at the injection site; Itching/these symptoms occurred at the injection site; spread everywhere like a rash/these symptoms occurred at the injection site; sharp shooting pain inside/these symptoms occurred at the injection site; Headache; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Sep2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: Jul2026) for immunisation, Device Lot Number: LN4930, Device Expiration Date: Jul2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Sep2025, outcome "recovered"; VACCINATION SITE PRURITUS (non-serious) with onset 22Sep2025, outcome "recovering", described as "Itching/these symptoms occurred at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 22Sep2025, outcome "recovering", described as "had a big ball and swelling very badly/these symptoms occurred at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2025, outcome "recovering", described as "sharp shooting pain inside/these symptoms occurred at the injection site"; VACCINATION SITE RASH (non-serious) with onset 22Sep2025, outcome "recovering", described as "spread everywhere like a rash/these symptoms occurred at the injection site". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pruritus, vaccination site rash, vaccination site pain. Additional information: The patient reported that she took a shot and had a very bad reaction that has been going on for about a week. Clarified that she had a big ball and swelling very badly and was itching. She stated that it spread everywhere like a rash. The patient clarified that these symptoms occurred at the injection site. The big ball and swelling very badly was worse every single day, but today (29Sep2025) she was feeling a bit better. The patient reported that she had itching, a sharp shooting pain inside, and had swelling and rash the night of the injection. Stated that she took Tylenol. Her symptoms were getting worse and said she put an ice pack on the site. After 2 days, it was a little bit better. The patient also reported that she had a little headache everyday but today she was fine.