Received May 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Z012201 | OT |
the patient started gaging and vomiting a little after the administration of the ROTATEQ vaccine; the taste of the ROTATEQ vaccine could have contributed to the vomiting / HCP stated that she could not confirm the taste of the ROTATEQ vaccine; the patient did not receive the full dose of the ROTATEQ vaccine / Was the dose administered? Yes, but it was an incomplete dose; Related to appearance of product? yes; the patient started gaging and vomiting a little after the administration of the ROTATEQ vaccine; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a 2-month-old patient of unknown gender. The patient's medical, past medications and concomitant medications were not reported. On 27-Apr-2026, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml oral solution, orally, lot# Z012201, expiration date: 25-Apr-2027 (exact dose and dose number were not reported), for prophylaxis. On the same date (27-Apr-2026), a little after the administration of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient started gagging and vomiting. The reporter stated that the taste of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine could have contributed to the vomiting, and the patient ate right before the administration of the vaccine (Product use complaint). The reporter stated that the patient did not receive the full dose of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine (Underdose). It was also noted: "Related to appearance of product? Yes" (Liquid product physical issue). The outcome of the events was not provided. The action taken with the suspect vaccine regarding events was not reported but assessed as not applicable. The reporter considered vomiting to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The causality assessment between gagging and the suspect vaccine was not provided.