Received Mar 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | OT |
was sick during this time as well; diarrhea 2 days after receiving her second dose of ROTATEQ which lasted a few days; also experienced diarrhea after first dose of ROTATEQ; This spontaneous report was received from a pharmacist (the patient's mother) via company representative and refers to an infant female patient (exact age was not provided). The patient's medical history, concurrent conditions, past medications and concomitant medications were not reported. On an unknown date, patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution, administered orally, indication: vaccination (exact dose, lot# and expiray date were not reported). On an unspecified date after vaccination, the patient experienced diarrhea (first occurrence). On an unknown date, at the age of 4 months old, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution, administered orally, indication: vaccination (exact dose, lot# and expiry date were not reported) and 2 days after the vaccination, she experienced diarrhea (second occurrence) which lasted a few days. The patient was also sick during that time as well. The outcome of diarrhea (first occurrence) and sick was not provided. The outcome of the event diarrhea (second occurrence) was considered to be recovered. The action taken with the suspect vaccine regarding events was not reported but assessed as not applicable. The causality assessment between events and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.