Report #2836036

Overview

Sex

Female

Age

Age unknown

State

SC

Recovered

Not recovered

Vaccinated

Mar 26, 2025

Onset

Mar 26, 2025

Days to onset

0

Hospital days

—

Symptoms (3)

Symptom narrative

BLOOD PRESSURE DECREASED; PALPITATIONS; Information has been received from a health authority (agency # 2836036-1). This spontaneous report refers to a(n) 51-year-old female patient. The patient's medical history included Past Stroke and blood pressure control with triptans. The patient's concurrent conditions included Blood pressure control. Concomitant medications included Trazodone hydrochloride, Pantoprazole, Oxybutynin, Ropinirole, Famotidine, Meloxicam, Atorvastatin. On 26-MAR-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXVIVE) Injection, lot #Y019158, expiration date was not reported but upon internal validation was established as 20-MAY-2026, administered by Intramuscular route; Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot #M4834, administered by Intramuscular route (expiration date was not reported); along with Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX); all vaccines were administered for prophylaxis. On the same date, soon after vaccination but already at home, the patient experienced blood pressure went down and the hear stater racing (palpitations). On 09-APR-2025, the patient died due to the events. It was unknown whether an autopsy was performed. The causal relationship between the events of and the suspect vaccines were not reported. Executive summary received on 29-JUL-2025. Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V116 0.5ML 1DOSE SYR Batch number 0001791496 material number 2017970 at MSD which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. Due to the nature of this AE-QIR, a drug substance (DS) review was performed by DS manufacturing site MSD. The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of these Drug Substance batches. The investigation concluded that the Drug Substance batches conform to all release specifications. There have been no additional requests for information or additional testing relating to this Adverse Event.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2836036 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :; Reported Cause(s) of Death: BLOOD PRESSURE DECREASED; PALPITATIONS

Current illness

Blood pressure abnormal

Medical history

Medical History/Concurrent Conditions: Hypertension (Hypertension therapy); Stroke

Other medications

Trazodone; Pantoprazole; Oxybutynin ER; Ropinirole; Famotidine; Meloxicam; Atorvastatin