Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | 1 | Y016291 | OT / LA |
evaluated at the emergency room on 08/17/2025 with a fever of 104F and other unknown symptoms.; evaluated at the emergency room on 08/17/2025 with a fever of 104F and other unknown symptoms.; The patients mother called the office this morning, 08/18/2025, and reported the redness at the patient's injection site was shrinking and they were able to move their arm a little better.; The patients mother called the office this morning, 08/18/2025, and reported the redness at the patient's injection site was shrinking and they were able to move their arm a little better.; This spontaneous report was received from an office manager and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-Aug-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #Y016291 with expiration date reported as and upon internal validation confirmed to be 06-Dec-2026) 0.5mL/once administered intramuscularly in the left arm for Low IG levels vaccination (prophylaxis). On 17-Aug-2025, the patient was evaluated at the emergency room with a fever of 104F and other unknown symptoms (pyrexia; ill-defined disorder). It was reported that the patient sought medical attention and went to the emergency room (ER) over the weekend. On an unspecified date in august 2025, the patient experienced injection site erythema and injected limb mobility decreased. The treatment provided was as followed: cool compresses to left arm, initiated steroid taper, triamcinolone cream and zyrtec twice daily. On 18-Aug-2025 (this morning), the patients mother called the office and reported the redness at the patient's injection site was shrinking and they were able to move their arm a little better. No other details or information were able to be provided during the call. No additional adverse event (AE) and no product quality complaint (PQC) was reported. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was reported as not applicable. At the reporting time, the patient was recovering from the adverse events. The causal relationship between the reported adverse events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was reported as related. It was noted that the reporter called in to report the facility had four patients who reported adverse issues related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). This is one of several reports received from the same reporter.; Reporter's Comments: Keywords : MUL; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02858136-02858116 , CLIC number : , ESTAR number : , IRMS number : 500UW00000jA28KYAS|20082025120015|1284 , Central date : 2025-08-20 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2320678 , MNSC case number : 02858136 , MNSC interaction number : 02858116 , Integration log UniqueID : 500UW00000jA28KYAS|20082025120015|1284 , Service cloud CaseID : 500UW00000jA28KYAS
Test Date: 20250817; Test Name: body temperature; Result Unstructured Data: 104 [degF]