Received May 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Antibody test abnormal; This spontaneous report was received from a Physician and refers to an Elderly female patient in her 70's. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown) (lot #, expiration date, strength, route of administration, anatomical location not provided) as "routinely pneumonia" (pneumonia immunization). On an unknown date, the patient had low antibody results with the vaccine (Antibody test abnormal), as the test showed "low" for 20 of serotypes and "low-normal" for serotypes 34, 43 and 57. At the reporting time, the outcome of Antibody test abnormal was unknown. It was stated that was unclear if there were any other adverse effects. The causal relationship between the event of Antibody test abnormal and Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02794485-02794481 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZHRHRYA5|25042025160011|8489 , Central date : 2025-04-25 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2280124 , MNSC case number : 02794485 , MNSC interaction number : 02794481 , Integration log UniqueID : 500UW00000ZHRHRYA5|25042025160011|8489 , Service cloud CaseID : 500UW00000ZHRHRYA5
Test Name: Serotype test; Result Unstructured Data: showed low for 20 of serotypes and low-normal for serotypes 34, 43 and 57.