Received Oct 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Z007575 | OT |
Caller states a patient "vomited" during the administration of ROTATEQ.; The patient did not receive a full dose on that day; This spontaneous report was received from a Nurse practitioner and refers to a 3 month-old male patient. The patient's medical history, concurrent conditions, drug reactions were not reported. No know drug allergies reported. Concomitant therapies included vitamin D. On 27-Aug-2025, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #Z007575, expiration date: 24-Apr-2026) administered orally (strength not provided), as Prophylaxis. The reporter stated that the patient vomited during the administration of the vaccine; and that multiple attempts were made with the same dose and the patient kept vomiting; therefore, he did not receive a full dose, and it was unknown how much was actually received (accidental underdose). No other symptoms were reported since the administration. At the reporting time, the outcome of vomiting was unknown. The causal relationship between the event of vomiting and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not reported.
Vitamin D