Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2173920 | OT |
ear drainage; patient's mother was on immunosuppressant medication when she was pregnant/the patient's mother's OB facility guided them that the patient was not supposed to receive a vaccine until he was at leat 6-month-old; This spontaneous report was received from an administrator and referred to a 2-month-old male patient. The patient's medical history included foetal exposure during pregnancy (the patient's mother was on immunosuppressant medication when she was pregnant). The patient's pertinent medical history and concomitant medications were reported as none. No known drug allergies. The patient's past medications were not reported. On 18-Dec-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # 2173920, expiration date 08-Nov-2026), administered via oral route for prophylaxis of rotavirus by a health professional (dose and dose number were not reported). It was reported that the patient's mother's Obstetrics and gynaecology (OB) facility guided them that the patient was not supposed to receive a vaccine until he was at least 6-month-old. However, the vaccine was already administered (Product use issue). On 02-Jan-2026, the patient experienced ear drainage (Otorrhoea). The patient sought medical attention and was given amoxicillin 3 ml by mouth twice a day for 10 days. On an unknown date in 2026 (reported as now), the patient recovered from Otorrhoea. No other symptoms were reported. No additional adverse event (AE) or product quality complaint (PQC) was reported. The action taken with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) regarding otorrhoea was not applicable. The causality between the event otorrhoea and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not reported.
Medical History/Concurrent Conditions: Drug exposure in utero; Comments: No known drug allergies
Test Date: 20251207; Test Name: covid; Test Result: Negative ; Test Date: 20251207; Test Name: influenza; Test Result: Negative