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VAERS ID: 1000475

AGE: 25| SEX: M|State: FR

Description

Sudden death; This case was reported by a physician via regulatory authority and described the occurrence of sudden death in a 25-year-old male patient who received HAB (Twinrix adult) (batch number AHABB418AC, expiry date unknown) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis and HUMAN PAPILLOMAVIRUS 9-VALENT-VACCINE (GARDASIL 9) (batch number S035693, expiry date unknown) for prophylaxis. On 28th October 2020 11:41, the patient received the 3rd dose of Twinrix adult (intramuscular). On 28th October 2020, the patient started hepatitis A and hepatitis B vaccine pre-filled syringe device. On 28th October 2020 11:41, the patient received the 3rd dose of GARDASIL 9 (intramuscular). On 28th October 2020, less than a day after receiving Twinrix adult and hepatitis A and hepatitis B vaccine pre-filled syringe device, the patient experienced sudden death (serious criteria death and GSK medically significant). On 28th October 2020, the outcome of the sudden death was fatal. The patient died on 28th October 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the sudden death to be related to Twinrix adult and hepatitis A and hepatitis B vaccine pre-filled syringe device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details : The patient was vaccinated with Twinrix adult and GARDASIL 9 on an left arm. The Regulatory Authority causality assessment was reported as not assessed in association with reported suspect vaccine and events. The time to onset was reported as 1 day in drug event mapping, however based on vaccination date and event onset date it was captured as less than a day. The time to onset for events sudden death with Gardasil 9 was reported as 1 day however based on vaccination date and event onset date it was captured as less than a day. The duration for event sudden death was reported as 1 day, However looking of the nature of event the duration was not captured in duration field. It was unknown if the reporter considered the sudden death to be related to gardasil 9. Initial information was received from a physician via regulatory authority on 1st February 2021: Sudden death Reporter's comment: 26.01.2021 Regulatory Authority has requested additional information, This is a preliminary report Sender's comment: Reported Cause(s) of Death: Unknown cause of death

Symptoms

Sudden death

Vaccines

VAX DATE: 27 October 2020 | ONSET DATE: 27 October 2020 | DAYS TO ONSET: 0
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • HEPAB
  • HPV9
  • GLAXOSMITHKLINE BIOLOGICALS
  • MERCK & CO. INC.
  • HEP A + HEP B (TWINRIX)
  • HPV (GARDASIL 9)
  • 3
  • IM
  • LA
  • AHABB418AC
  • S035693

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
27 October 2020
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
V_ADMINBY:
UNK
OTHER_MEDS:
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:
NOGLAXOSMITHKLINENO202102
FORM_VERS:
2
TODAYS_DATE:
02 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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