Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | — | OT |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 4 | Y005880 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | — | — |
The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an UNKNOWN ROTAVIRUS on 11/11/2024 and 12/12/2024. The patient received a dose of ROTATEQ on 2/25/2025; The parents brought the patient to a pediatric urgent care because they were being fussy. The patient has since completely recovered from being fussy and has not had any medical concerns since.; The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an UNKNOWN ROTAVIRUS on 11/11/2024 and 12/12/2024. The patient received a dose of ROTATEQ on 2/25/2025; This spontaneous report was received from a medical assistant and refers to a 5-month-old (also reported as 6-month-old, conflicting information) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Oct-2024, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), 2 mL / three dose series, administered by oral route as rotavirus vaccination (lot # and expiration date were not reported). Then the patient traveled where he (reported as they, conflicting information) received unknown rotavirus vaccine on 11-Nov-2024 (second dose, strength, dose, formulation, indication, expiration date, and lot # were not reported) and 12-Dec-2024, (third dose, strength, dose, formulation, indication, expiration date, and lot # were not reported). On 25-Feb-2025, the patient was vaccinated with the forth dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (lot #Y005880, expiration date: 19-Nov-2025), 2 mL / three dose series, administered by oral route as rotavirus vaccination (Interchange of vaccine products, Extra dose administered). Operator of device was health professional. On 25-Feb-2025, after the patient received Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), the parents brought the patient to a pediatric urgent care because they were being fussy. The Physician of the urgent care told the parents that the patient was ok and no medical treatments were necessary and to continue to monitor the patient. The patient had since completely recovered from being fussy and has not had any medical concerns since." Medical Assistant confirmed the patient had made a recovery from "being fussy", and was not provided any additional information. The action taken was not applicable. The causal relationship between the event of fussy and Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), unknown rotavirus vaccine was not reported. Lot # is being requested and will be submitted if received.