Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
Nurse calling to request information on redosing a patient who received ROTATEQ and vomited/regurgitated the vaccine immediately after it was administered. She states the patient is a 6 month old female. Nurse did not provide additional information r; received ROTATEQ and vomited/regurgitated the vaccine immediately after it was administered; This spontaneous report was received from a nurse and refers to a 6-months-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Jul-2025, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), dose number 1, administered by Oral route (lot # and expiration date were not reported) as prophylaxis. On the same date (09-Jul-2025), the patient vomited/regurgitated the vaccine immediately after it was administered (accidental under dose). The reporting nurse was calling to request information on redosing a patient who received Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and did not provide additional information. At the reporting time, the outcome of the patient vomited/regurgitated was unknown. The causal relationship between the event and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided. Lot # is being requested and will be submitted if received.