National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

This is VAERS ID 789365

Case Details

VAERS ID: 789365 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infanrix hexa; Synflorix; Rotavirus vaccine; Bexsero; Infanrix hexa; Synflorix; Rotavirus vaccine
Current Illness:
Preexisting Conditions: Comments: none
Diagnostic Lab Data:

Write-up: This case was reported by a physician via call center representative and described the occurrence of cardiopulmonary arrest in a 5-month-old male patient who received BEXSERO (batch number ABX776AA, expiry date July 2020) for prophylaxis. Additional patient notes included none. Concomitant products included INFANRIX HEXA, SYNFLORIX, Rotavirus vaccine, BEXSERO, INFANRIX HEXA, SYNFLORIX and Rotavirus vaccine. On 19th November 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 20th November 2018, 1 days after receiving BEXSERO, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant), cyanosis (serious criteria death) and rigidity (serious criteria death). On an unknown date, the outcome of the cardiopulmonary arrest, cyanosis and rigidity were fatal. The patient died on 20th November 2018. The reported cause of death was cardiopulmonary arrest, cyanosis and rigidity. The reporter considered the cardiopulmonary arrest, cyanosis and rigidity to be unrelated to BEXSERO. Additional details were provided as follows: This case was found to be a duplicate of the regulatory case IT-MINISAL02-512448 and all the future corresponding information would be submitted to IT2018GSK214015 (case of record). The Authority reference number for the duplicate case IT-MINISAL02-512448. The patient was born in good clinical conditions, born at term (birth weight as 3.2kg), medical history was negative. In August 2018, the patient received according to National Immunization plan, first doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. No adverse events were reported following these vaccinations. On 20th September 2018, the patient received the first dose of the BEXSERO. On 15th October, 2018, the patient received second doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. Also, after these vaccinations no adverse event were reported. The patient received BEXSERO (not known the precise administration''s hour). The patient came home with his parents and was fine. During the night between 19th and 20th November 2018, the patient''s mother went to his room and realized that the patient was cyanotic and that he was already dead. At night that the parents found the baby in bed cyanotic without breathing. The doctors from emergency diagnosed cardiorespiratory arrest with presence of rigor. CPR until arrival in hospital. The patient''s mother tried to do a cardiac massage, without success, the patient was then taken to the hospital, but he had already passed away. The reporter would inform GlaxoSmithKline of any further detail as soon as they become aware. On 27th November 2018, during follow up from press review the patient demographic details were updated. The press reports that, according to experts who were investigating on the case, the patient''s death was due, at the moment, to the infant''s sudden death syndrome. The expert reports no correlation between the suspect product and the death. Reported Cause(s) of Death: Cardiorespiratory arrest; Cyanosis; Rigidity.

New Search

Link To This Search Result:

Copyright © 2020 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166