Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | B532G | SYR |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3A2KF | SYR |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 2 | Y010032 | SYR |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | 2052020 | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | B532G | — |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3A2KF | — |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 2 | Y010032 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | 2052020 | — |
CARDIAC ARREST; RESUSCITATION; Information has been received from Food and Drug Administration (agency number not provided) on 16-JUN-2025. This spontaneous report refers to a 33-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2025, the patient was vaccinated with second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (valid lot number 2052020, expiration date: 10-MAR-2026, obtained per internal review) with second dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (lot number Y010032, expiration date: 17-FEB-2027, obtained per internal review), with second dose of Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid (PEDIARIX) (lot number B532G) (Glaxo Smith Kline Biologicals), (expiration date was not reported) and with second dose of HIB vaccine conj (tet tox) (HIBERIX) (lot number 3A2KF) (Glaxo Smith Kline Biologicals), (expiration date was not reported) all for prophylaxis. On 11-APR-2025, the patient experienced a cardiac arrest at home while sleeping, ultimately achieved return of circulation in the emergency department (ED) after 30 plus minutes of Cardiopulmonary resuscitation (CPR). Concern for myocarditis as a potential cause of cardiac arrest. The patient died because of the events of resuscitation and cardiac arrest. It was unknown whether an autopsy was performed. The causal relationship between the events and the suspect vaccines were not provided. The agency considered the events resuscitation and cardiac arrest as serious due to the following criteria: death. Follow-up information has been received on 15-Jul-2025. Executive Summary: An Adverse Event Quality Investigation Report (AEQIR) was requested for Cardiac arrest; Resuscitation on ROTATEQ 2ML 10X1DOSE TUBE (PCI) package batch 2052020. A full investigation is required, and the following elements were assessed as part of this investigation: Retention Sample Evaluation and Testing, Batch Record Review, Logs, Deviation Review, Release Testing, Component and Raw Material Release Testing, Change Control Review, Stability Results, Information regarding warehousing/distribution, Design, Safety Assessment Statement, Potential Quality Issues Identified. This AEQIR did not identify any potential quality issues that would require further actions. Per the intake information, the sample is not expected to be returned. The subject AE-QIR investigation was not received as a Health Authority request. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. A packaging request was requested from MSD LLC in support of AE Quality Investigation for Complaint ID COMPLAINT-067602/ WP Lead Site Investigations INV-012043 for ROTATEQ 2ML 10X1DOSE TUBE (PCI); package batch 2052020 was packaged at MSD LLC, utilizing Fill Batch# 0001761189. Based on this completed investigation there were no potential quality issues identified. The PCI packaging process was found to be operating in a state of control.