Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | — | OT |
patient missed their second dose of ROTATEQ; green poop; This spontaneous report was received from a consumer referring her son as a 2-month-old male patient. His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 11-NOV-2024, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral liquid, dose number 1, 1 dosage form administered by Oral route (po) (lot # and expiration date were not reported) as prophylaxis (reported as "rotavirus.") On unspecified date in November 2024, the patient had "green poop" (faeces discoloured) following first vaccination, which lasted for "about a week or two". Then on an unspecified date in November 2024, he recovered from the event. Patient's mother reported that the patient missed his second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) on 11-JAN-2025 (product dose omission issue). No symptoms or side effects were reported by the patient's mother for the patient missing the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). No further information reported by the patient's mother. The causal relationship between faeces discoloured and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown as patient's mother was unsure if that was because of the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ.) Additional information was not expected.