Received Jul 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4929 | OT |
Cellulitis on their arms where they had to administer; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jul2025 as dose number unknown, single (Lot number: LN4929, Expiration Date: 31Jul2026) at the age of 59 years intramuscular, in arm for immunisation, Device Lot Number: LN4929, Device Expiration Date: 31Jul2026. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset Jul2025, outcome "unknown", described as "Cellulitis on their arms where they had to administer". The event "cellulitis on their arms where they had to administer" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (30Jun2025) unknown result, notes: 2 days before the vaccine was given. Therapeutic measures were taken as a result of vaccination site cellulitis. Causality for "cellulitis on their arms where they had to administer" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Clinical course: This was in regard to an adverse reaction that two patients had when they were vaccinated with Prevnar 20. What happened was the patients when they were vaccinated, they experience with what caller described as Cellulitis on their arms where they had to administer. The patients came back with an adverse reaction in their arm, they had what the caller describe as cellulitis on their arm. The reaction was severe enough, there were two people that were vaccinated with those Prevnar 20, they had to be administered antibiotic and or steroid treatment to prevent the infection on their arm. This was an adverse reaction because of the vaccine, the customer or rather caller would like to report that to know how to proceed with those patients. The reporter was a medical assistant at the doctor's office where the vaccine was administered. Site of administration was reported as Left right. Concomitant products, other medication and lab works: The patient was taking medication on a daily basis, and she did get blood work done 2 days before the vaccine was given. No further details about the medication. There was a treatment. After it was administrated, the vaccine she was seen 7 days letter. They prescribed Prednisone, a steroid medication. The indication was provided as pneumonia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500144744 Same reporter/vaccine/event, different patients;
Test Date: 20250630; Test Name: blood work; Result Unstructured Data: Test Result:unknown result; Comments: 2 days before the vaccine was given