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This is VAERS ID 816276

Case Details

VAERS ID: 816276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-25
Onset:2019-04-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD309A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX785BB / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AA2786 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC064AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Epistaxis, Heart rate decreased, Hypopnoea, Loss of consciousness, Mydriasis, Pallor, Pulse abnormal, Rhinorrhoea, Skin discolouration, Sudden infant death syndrome, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-26
   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: BCG VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201909

Write-up: Sudden infant death syndrome; Loss of consciousness; Pale skin; Watery nasal discharge; Vomiting; Shallow breathing; Dilated pupils; Heart rate low; Watery nasal discharge; Pulse weak; Skin discoloration; This case was reported by a consumer via regulatory authority and described the occurrence of sudden infant death syndrome in a 8-week-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD309A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC064AA, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number ABX785BB, expiry date August 2020) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AA2786, expiry date March 2021) for prophylaxis. Concomitant products included BCG VACCINE. On 25th April 2019, the patient received Infanrix hexa (parenteral) .5 ml, Rotarix liquid formulation (oral) 1.5 ml, Bexsero (parenteral) .5 ml and PREVENAR 13 (parenteral) .5 ml. On 26th April 2019, 1 days after receiving Infanrix hexa, Rotarix liquid formulation and Bexsero, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant), loss of consciousness (serious criteria GSK medically significant), pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration. On 26th April 2019, the outcome of the sudden infant death syndrome was fatal. On an unknown date, the outcome of the loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, nasal discharge watery excessive, pulse weak and skin discoloration were not recovered/not resolved and the outcome of the heart rate low was unknown. The patient died on 26th April 2019. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome, loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration to be related to Infanrix hexa, Rotarix liquid formulation and Bexsero. Additional details: The age at vaccination was not reported, however the patient could be 7 to 8 weeks at the time of vaccination. The Infanrix hexa batch number was reported as A2HD309A . However based on a batch number review, it was change to A21CD309A. The Rotarix batch number was reported as AROLCO64AA. However based on a batch number review, it was change to AROLC064AA. Initial information was reported by a consumer via regulatory authority on 23rd May 2019: Sudden infant death syndrome, loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration.; Reported Cause(s) of Death: Sudden infant death syndrome


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