Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 3 | Y010032 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | — | OT |
DEATH; INFANT IRRITABILITY; UNRESPONSIVE TO STIMULI; DECREASED APPETITE; PYREXIA; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (Agency #2839201-1) on 17-JUL-2025. This spontaneous report and refers to an infant (age reported as 0.75-year-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2025, the patient was vaccinated with the third dose of pneumococcal 15-valent conjugate vaccine (VAXNEUVANCE) suspension for injection, administered intramuscularly in left leg, lot #Y010032, expiration date was not reported, however upon internal validation determined as 17-FEB-2027, for prophylaxis (exact dose was not reported); on the same day, she was vaccinated with 3rd dose of diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (MRC 5) (+) tetanus vaccine toxoid) (PENTACEL), administered intramuscularly in right leg, lot #UK196AA, for prophylaxis (exact dose and expiration date were not reported). On 09-APR-2025, in the evening, the child had fever and fussiness; fever resolved on 10-APR-2025 (discrepancy, outcome reported as fatal), however, her fussiness persisted, and child's appetite was poor. Given child's fussiness the evening of 10-APR-2025, her mother reported that the child slept in her parent's bed. Her parents awakened to find her non-responsive on the morning of 11-APR-2025 and they activated Emergency Medical Services (EMS). Child was transported to hospital. She did not survive and was pronounced dead in the hospital (conflicting information, the onset date of the events of infant irritability, decreased appetite, pyrexia, unresponsive to stimuli, and death was reported as 11-APR-2025; she was treated at emergency room and hospitalized due to the events; she was also treated at emergency room/department or urgent care). The patient died because of the events of infant irritability, unresponsive to stimuli, decreased appetite, and pyrexia. It was unknown whether an autopsy was performed. Causality assessment was not provided. Follow up information has been received on 21-AUG-2025. Investigation summary for VAXNEUVANCE, Batch/Lot #Y010032: Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V114 0.5ML 1DOSE SYR Batch number 0001759288 material number 2016658 at MSD Carlow which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. A supporting investigation was requested from the drug substance (DS) manufacturing site MSD (Inv-012951). The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of the Drug Substance batches consumed in Drug product batch 0001759288. The investigation concluded that the Drug Substance batches conform to all release specifications. A supporting investigation was also completed by the MSD packaging site (Inv-012952). Based on their investigation, no systemic packaging inadequacy of package batch Y010032 were identified at the Merck manufacturing facility that could impact the quality attributes of the product. 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. There have been no additional requests for information or additional testing relating to this Adverse Event.; Reported Cause(s) of Death: DECREASED APPETITE; INFANT IRRITABILITY; PYREXIA; UNRESPONSIVE TO STIMULI