Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | LM2211 | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8515EA | OT / RA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y011819 | OT / LA |
an itchy, red, hot, and swollen arm that went down to her elbow; an itchy, red, hot, and swollen arm that went down to her elbow; itchy, red, hot, and swollen arm that went down to her elbow; itchy, red, hot, and swollen arm that went down to her elbow; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2232179. The previous case ID: 2412USA004213. Information has been received from FDA on 11-DEC-2024, regarding an 82-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-OCT-2024, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection (lot #Y011819 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 01-OCT-2025) intramuscularly in the left arm (strength and dose was not provided), tozinameran (PFIZER BIONTECH COVID-19 VACCINE) intramuscularly in the left arm (lot# LM2211, strength, formulation and expiry date were not provided) and influenza vaccine inact split 3v (FLUZONE HIGH DOSE) intramuscularly in the right arm (lot # U8515EA, strength, formulation and expiry date were not provided) all for prophylaxis. On 11-OCT-2024, the patient experienced an itchy, red, hot, and swollen arm that went down to her elbow. The patient called the doctor and they told her to go to urgent care and she was given an antibiotic and steroid to help. She also used cold compresses all weekend to help. She was told if it got worse, she was to go to the emergency room (ER) but that never happened. Outcome of all the events was recovered on an unknown date in 2024. Causality assessment was not provided. This is one of several reports from the same reporter. Executive Summary: Investigation summary for CAPVAXIVE Batch/Lot# Y011819 Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of CAPVAXIVE Batch number 0001774623 material number 2017970 at MSD which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. There have been no additional requests for information or additional testing relating to this Adverse Event.
Prophylaxis