Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
she also noticed redness and a rash; she also noticed redness and a rash; felt "some injection site discomfort" shortly after administration which "seemed typical"; This spontaneous report was received from a consumer and refers to herself, a 58-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included estrogens conjugated (PREMARIN), progesterone), pregabalin (LYRICA), rosuvastatin . On 08-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 0.5 mL administered by unknown route (vaccination site, lot # and expiration date were not reported) for pneumococcal conjugate vaccine. On 08-Jul-2025, the patient felt some injection site discomfort shortly after administration which seemed typical. On 15-jul-2025 (today), she also noticed redness and a rash. The patient reported to a health care professional (HCP) who recommended she took a picture, apply ice, and topical diphenhydramine (BENADRYL). HCP treating the adverse event (AE) provided permission to contact. The patient did have name of administering HCP at the time of the call. No additional AE and no product quality complaint (PQC) was noted. At the reporting time, the patient had not recovered from the reported adverse events. The causal relationship between the adverse events and the suspect vaccine was not reported. Lot # is being requested and will be submitted if received.
PREMARIN; PROGESTERONE; LYRICA; RASUVASTATIN