Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 4 | — | OT |
Polymicrobial Pneumonia; This Spontaneous report was received from 2 Physicians via a company representative and referred to a 2 -year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, patient was vaccinated with 15-Valent Pneumococcal Conjugate Vaccine (CRM197) (Vaxneuvance) Suspension for injection. The patient had been vaccinated with Vaxneuvane with a full 4 shot schedule. Route of administration, anatomical site, lot# and expiration date were not reported for any dose. All of them for prophylaxis. On an unknown date, the patient experienced "Polymicrobial Pneumonia" (Pneumonia). On approximately 14-Feb-2026, reported as "17 days ago", the patient was admitted to the hospital due to the event. The reporter stated that it could have been a serotype that vaccination could/should have caught, but because the baby's infection was not serotyped early enough, they did not know At the time of this report, the patient still hospitalized in serious condition. The Physicians did not provide the causal relationship between the event and Pneumonia to 15-Valent Pneumococcal Conjugate Vaccine (CRM197) (Vaxneuvance). Batch/Lot number is being requested and will be submitted if received. The hospital shared with the physicians that they currently have 7 cases of the same in their care (Case#2390396 - Invalid case due to lack of patients' identifiers).