Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y011819 | OT |
Blood work was done to address serotype findings. These were not at the level that the patient was expecting based on review of clinical data.; This spontaneous report was received from a male patient of unknown age reporting on himself via company representative. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) (lot #Y011819, expiration date: 01-Oct-2025) administered by unknown route as prophylaxis. Post administration of the vaccine, on 04-Feb-2025, blood work was done to address serotype findings. These were not at the level that the patient was expecting based on review of clinical data (antibody test abnormal). On this date, S Pneumoniae IgG serotype 1 was 30 ug/mL, S Pneumoniae IgG serotype 33F was 1.6 ug/mL, S Pneumoniae IgG serotype 9V was 0.3 ug/mL, S Pneumoniae IgG serotype 19A was unable to perfor due to a reagent issue, S Pneumoniae IgG serotype 18C was 0.5 ug/, S Pneumoniae IgG serotype 15B was 1.1 ug/mL, S Pneumoniae IgG serotype 7F was 3.7 ug/mL, S Pneumoniae IgG serotype 11A was 1.1 ug/mL, S Pneumoniae IgG serotype 10A was 0.2 ug/mL, S Pneumoniae IgG serotype 6B was 1 ug/mL, S Pneumoniae IgG serotype 23F was 0.1 ug/mL, S Pneumoniae IgG serotype 22F was 0.6 ug/mL, S Pneumoniae IgG serotype 20 was 0.5 ug/mL, S Pneumoniae IgG serotype 19F was 0.3 ug/mL, S Pneumoniae IgG serotype 17F was 3.6 ug/mL, S Pneumoniae IgG serotype 14 was 3.9 ug/mL, S Pneumoniae IgG serotype 12F was 0.2 ug/mL, S Pneumoniae IgG serotype 8 was 3.6 ug/mL, S Pneumoniae IgG serotype 4 was 0.1 ug/mL, S Pneumoniae IgG serotype 3 was 0.1 ug/mL, S Pneumoniae IgG serotype 2 was 2.2 ug/mL, S Pneumoniae IgG serotype 5 was less than 0.1 ug/mL, S Pneumoniae IgG serotype 9N was 37.1 ug/mL. At the reporting time, the outcome of this event was unknown. The causal relationship between the event and the suspect vaccine was not provided.
Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 1; Result Unstructured Data: 30 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 33F; Result Unstructured Data: 1.6 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 9V; Result Unstructured Data: 0.3 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 18C; Result Unstructured Data: 0.5 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 15B; Result Unstructured Data: 1.1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 7F; Result Unstructured Data: 3.7 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 11A; Result Unstructured Data: 1.1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 10A; Result Unstructured Data: 0.2 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 6B; Result Unstructured Data: 1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 23F; Result Unstructured Data: 0.1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 22F; Result Unstructured Data: 0.6 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 20; Result Unstructured Data: 0.5 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 19F; Result Unstructured Data: 0.3 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 17F; Result Unstructured Data: 3.6 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 14; Result Unstructured Data: 3.9 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 12F; Result Unstructured Data: 0.2 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 8; Result Unstructured Data: 3.6 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 4; Result Unstructured Data: 0.1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 3; Result Unstructured Data: 0.1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 2; Result Unstructured Data: 2.2 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 5; Result Unstructured Data: 0.1 ug/mL; Test Date: 20250204; Test Name: S Pneumoniae IgG serotype 9N; Result Unstructured Data: 37.1 ug/mL