Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
inadequate response to pneumococcal conjugated vaccine and PPSV23 booster; This literature spontaneous report was received from the authors of an article, titled as stated below, concerning a infant male patient. It was reported that by 20 months of age, the patient had experienced three episodes of otitis media requiring ear tube placement, occasional eczema flares, and loose stools. His eosinophil count was elevated at 1,200 cells/uL, and his IgE level was elevated for the first time to 2,329 IU/mL. On an unknown date, the patient was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (manufacturer unknown) and subsequently was vaccinated with a booster dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) as prophylaxis (dose, dose schedule, lot number, expiration date, route and site of administration were unknown). On an unknown date, although his total IgG was normal, the patient's response to Pneumococcal 15-valent Conjugate Vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) booster was inadequate (vaccination failure). The authors considered the event as related to Pneumococcal 15-valent Conjugate Vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Batch/Lot number is being requested and will be submitted if received. A copy of the published article is attached as further documentation of the patient's experience. Literature Report:
Medical History/Concurrent Conditions: Ear tube insertion; Eczema; Eosinophil count (remained elevated at 1,200 cells/uL); IgE (elevated for the first time to 2,329 IU/mL); IgG (Normal); Loose stools; Otitis media