Report #2834981

Received Apr 9, 2025

ER / ED visit

A note on interpretation. VAERS reports are unverified and may be incomplete or coincidental. A report does not establish that a vaccine caused an event, and counts should not be used to calculate incidence or infer causation. Full disclaimer

Overview

Sex: Female
Age: Age unknown
State: AZ
Recovered: Unknown
Vaccinated: —
Onset: —
Days to onset: —
Hospital days: —

Vaccines (1)

Type	Name	Manufacturer	Dose	Lot	Route / Site
PNC21	PNEUMO (CAPVAXIVE)	MERCK & CO. INC.	UNK	—	OT

Symptoms (6)

Confusional stateFatigueLethargyNeurological symptomPneumococcal infectionProduct use in unapproved indication

Symptom narrative

stroke-like symptoms; indication : Pneumococcal Disease; confusion; fatigue; severe lethargy; This spontaneous report was received from a medical assistant via company representative and refers to a female patient in her 50's. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, she was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) 168 mcg/ml injection, 0.5 ml intramuscularly (lot # and expiration date were not provided) for "Pneumococcal Disease" (Product use in unapproved indication). On an unknown date, the patient experienced severe lethargy, fatigue, confusion, and stroke-like symptoms. She went to the emergency department. The outcome of the events was not provided. Causality assessment was not reported. Upon internal review, the event of stroke-like symptoms was considered to be medically significant. Lot # is being requested and will be submitted if received.