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This is VAERS ID 393523

Case Details

VAERS ID: 393523 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-07
Onset:2008-11-28
   Days after vaccination:21
Submitted: 2010-07-23
   Days after onset:601
Entered: 2010-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA021AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Autopsy, Bronchopneumonia, Cardiac arrest, Cough, Death, Dyspnoea, Endotracheal intubation, Generalised oedema, Hypotension, Inflammation, Lower respiratory tract infection, Mechanical ventilation, Mediastinitis, Necrosis, Oedema, Pleural effusion, Pleurisy, Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Skin oedema, Speech disorder, Streptococcal sepsis, Streptococcus test positive, Tachycardia, Tachypnoea, Tracheitis, Upper respiratory tract infection, Upper respiratory tract inflammation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-28
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body height, 02Dec2008, 172cm; Respiratory rate, 28Nov2008, 60 (at admission); Weight, 02Dec2008, 59kg; 02 Dec 2008: Bacterial test B haemolytic strep group B. 02 Dec 2008: Viral test. Nasal swab: respiratory syncytical virus.
CDC Split Type: B0554054A

Write-up: This case was reported by the Medicines and Healthcare products Regulatory Agency (GB-MHRA-ADR 20357549) and described the occurrence of streptococcal septicemia in a 12-year-old female subject who was vaccinated with CERVARIX. Previous vaccinations included 1st dose CERVARIX given 07 October 2008, smallpox vaccine 1996 and November 2000, Meningococcal c vaccine 22 November 2000, MMR vaccine 22 November 2000, Diphtheria toxoid 1996 and November 2000, Hib vaccine 1996 and November 2000, bacillus clostridium tetani 1996 and November 2000, whooping cough vaccine 1996 and November 2000 and poliomyelitis vaccine 1996 and November 2000. On 7 November 2008 the subject received unspecified second dose of CERVARIX (.5 ml, intramuscular, batch AHPVA021AA). At an unspecified time after vaccination with CERVARIX, the subject experienced streptococcal septicemia. The subject died on 30 November 2008 from streptococcal septicemia. It was unknown whether an autopsy was performed. MHRA Verbatim Text: Patient died 3 weeks following 2nd HPV Vaccination. Reported to have died due to Streptococcal A Septicemia. Still awaiting coroners verdict. Follow-up information received on 14 July 2010 from the MHRA: The patient had a cough for one week and then developed fever for three days. Patient was admitted to hospital three weeks after CERVARIX vaccination when the cough got worse and they developed difficulty breathing. On admission the respiratory rate was 60 per minute and they were distressed. They became so distressed they were unable to speak. The patient was transferred to the high dependency unit. On 28 November 2008 the patient then became tachycardic and a chest infection was diagnosed and the patient was taken to the theatre and intubated and ventilated. The patient crashed an hour later and had arrests characterized by very severe hypotension. The patient became asystolic. Despite all efforts the decision that further attempts were futile was made and the patient died on 28 November 2008. The cause of death was streptococcal septicemia. The coroner states that there is no doubt death was due to a group A streptococcal septicaemia. There was active inflammation of the upper respiratory tracts, the mediastinum, and focally the lungs. Group A streptococcus was cultured from multiple sites both at post-mortem and during the short terminal illness. It was noted that a respiratory syncytial virus was identified from the nose swab. According to the coroner it was probable that an upper respiratory tract infection was the portal of the devastating bacterial infection that caused death and it was possible that the respiratory syncytial virus was significant here. Post mortem results: A post mortem was carried out and there was found to be a considerable degree of generalized subcutaneous oedema. Both pleural cavities contained approximately 150mls of turbid yellow fluid. The lungs were found to have a necrotizing pleuritis with some extension of acute inflammation into the pulmonary parenchyma that is immediately adjacent to the pleural surface, though extensive pneumonia is not identified. Some inflammation and oedema extends into the pulmonary interstitium in the areas close to the pleural and mediastinal surface of the lungs. Some areas of bronchopneumonia are identified. The pericardial cavity contains approximately 50ml of clear liquid and the peritoneal cavity contains approximately 250-300ml of clear yellow fluid. The trachea shows evidence of an acute tracheitis with mediastinitis of the upper mediastinum. The larynx shows evidence of an upper respiratory tract infection. The thymus shows marked oedema, and the presence of scattered inflammatory cells.


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