Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | 209662 | OT |
decreased oxygen saturation/additional oxygen support; experienced apnea; experienced bradycardia to a rate of 53; received a 2 mL dose but the chart noted a partial dose.; This spontaneous report was received from a pharmacist and refers to a 3-month male patient. The patient's concurrent conditions included Premature Baby, NICU, and oxygen support. Concomitant medications included Hepatitis B Vaccine (manufacturer unknown), Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) (PENTACEL), Pneumococcal vaccine (manufacturer un known) . On 06-APR-2025, the patient was vaccinated with a first dose of dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #209662, expiration date: 27-MAR-2026), dose: 2 mL, but it was reported that the baby received a 2 mL dose but the chart noted a partial dose(Underdose) , administered by Oral route for prophylaxis reported as Primary immunization. After being administered the vaccine, on the same day, the patient experienced apnea, bradycardia to a rate of 53 (units not provided), decreased oxygen saturation. The baby did not respond to suctioning or repositioning. The baby needed additional oxygen support. The hospitalization prolonged, on an unknown day in 2025. The baby was still admitted in hospital. The patient recovered from the events on the same day (on 06-APR-2025). It was mentioned that the reporter stated that he/she was undecided if patient would get second dose The causal relationship between the events and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown. The reporter considered, the events of experienced apnea bradycardia to a rate of 53 and decreased oxygen saturation/additional oxygen support to be medically significant.
Hospitalization; Oxygen therapy; Premature baby
PENTACIL vaccine; Hepatitis B vaccine; Pneumoccocal vaccine