Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
02/27/2025 at her pharmacy. The caller stated that she noticed a bruise forming underneath the bandage. The next day on 02/28/2025, she removed the bandage and there was a large bruise at the injection site.; On 03/04/2025, the caller took a photo of her arm and stated that the bruise was still "huge" and tender.; This spontaneous report was received from a patient reporting on herself as a 77-year-old female patient. Her medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included Xarelto (Rivaroxaban.) On 27-Feb-2025, at her pharmacy, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine solution for injection (CAPVAXIVE) 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) administered as prophylaxis. On the same date, the patient noticed a bruise forming underneath the bandage (vaccination site bruising). The next day on 28-FEB-2025, she removed the bandage and there was a large bruise at the injection site. On unspecified date in 2025, she experienced vaccination site pain. On 04-MAR-2025, she took a photo of her arm and stated that the bruise was still "huge" and tender. On 11-MAR-2025, (also reported as "yesterday"), she stated that she went back to the pharmacy to show the pharmacist. It was also stated that she read that this was only supposed to last for a few days, but it had been 2 weeks at that point. She had not spoken to her health care professional (HCP) about this. No further details provided. She had not recovered from the events, as at the reporting time (reported as "today"), her arm was still very bruised and tender at the injection site. The reporter considered vaccination site bruising and vaccination site pain to be related to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), considering that she had had many vaccines before including a flu shot about a month ago, and she had never had this reaction before and believed that she was having a reaction to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) vaccine itself. Lot # is being requested and will be submitted if received.
XARELTO