Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | — | — |
more gassy; Constipation aggravated; Fussy; This Spontaneous report was received from the patient's parent and referred to a Male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unknown date, the patient received one dose of Rotavirus Vaccine, Live, Oral, Pentavalent Oral solution (ROTATEQ) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after the Rotavirus Vaccine, Live, Oral, Pentavalent Oral solution (ROTATEQ) dose the patient was gassier and fussier for few days (Flatulence and Irritability). The patient suffered with constipation and the rotavirus vaccine, live, oral, pentavalent oral solution (ROTATEQ) made it worse for a few days. The outcome of the events flatulence, irritability and constipation was not provided. The reporter considered the events to be related to rotavirus vaccine, live, oral, pentavalent oral solution (ROTATEQ). Additional information is not expected.
Constipation