Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y014324 | — |
No additional AE/No PQC.; HBP called regarding T/E for ROTATEQ and GARDASIL-9. HBP noted that ROTATEQ was administered to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-Jun-2025, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vials 0,5 mL (lot #Y014324 and expiration date reported as 21-Feb-2026) administered for prophylaxis. The reporter called regarding a temperature excursion (T/E) for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (low TE; duration of temperature excursion: (35.4F) for 1 hour 0 minutes 0 seconds) and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9). No previous excursions were noted. It was noted that Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to a patient and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) was not administered to any patients (product storage error). No symptomatic events were reported (no adverse event). No additional adverse event (AE) and no product quality complaint (PQC) was noted. This case was considered to be invalid due to lack of patient's identifiers.