Received Jul 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | UNK | Z005994 | OT |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 53HF9 | OT |
No additional AE; ROTATEQ and VAXNEUVANCE stored in refrigerator that experienced an excursion; This Spontaneous report was received from a health professional and referred to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. Medical assistant reported rotavirus vaccine, live, oral, pentavalent oral solution (ROTATEQ) and 15-Valent Pneumococcal Conjugate Vaccine (CRM197) (VAXNEUVANCE) stored in refrigerator that experienced an excursion on 13-May-2026. Temperature excursion -0.8C and time frame 0 Hours 15 Minutes 0 Seconds. No previous temperature excursion. On 15-May-2026, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent oral solution (ROTATEQ) at dose of 1.50 mL lot number 53HF9 and expiration date 03-Jul-2027 via oral and 15-Valent Pneumococcal Conjugate Vaccine (CRM197) (VAXNEUVANCE) at dose of 0.50 mL lot number Z005994 and expiration date of 02-Oct-2027 via intramuscular both for prophylaxis (anatomical location was not reported). No symptoms reported. Medical assistant confirmed products were not administered to any other patients.