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This is VAERS ID 845516

Case Details

VAERS ID: 845516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB855AM / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Autopsy, Cardiac arrest, Death, Diarrhoea, Peritonitis, Rash, Rhinitis, Sepsis, Toxic shock syndrome streptococcal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infanrix hexa
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteomalacia; Petechia (of small bowels); Pyothorax
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201919

Write-up: Cardiac arrest; Acute peritonitis; Sepsis; Streptococcus pyogenes toxic shock syndrome; Coryza; Rash; Abdominal distension; Diarrhoea; This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 3-month-old female patient who received Rota (Rotarix liquid formulation) (batch number AROLB855AM, expiry date unknown) for prophylaxis. The patient''s past medical history included pyothorax, osteomalacia and petechia (of small bowels). Concomitant products included DTPa-HBV-IPV+Hib (Infanrix hexa). On an unknown date, the patient received Rotarix liquid formulation (oral). On an unknown date, less than 4 months after receiving Rotarix liquid formulation, the patient experienced cardiac arrest (serious criteria death, GSK medically significant and other: Serious as per reporter), acute peritonitis (serious criteria death, GSK medically significant and other: Serious as per reporter), sepsis (serious criteria death, GSK medically significant and other: Serious as per reporter), streptococcus pyogenes toxic shock syndrome (serious criteria death, GSK medically significant and other: Serious as per reporter), coryza (serious criteria death and other: Serious as per reporter), rash (serious criteria death and other: Serious as per reporter), abdominal distension (serious criteria death and other: Serious as per reporter) and diarrhoea (serious criteria death and other: Serious as per reporter). On an unknown date, the outcome of the cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhoea were fatal. The reported cause of death was cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea. An autopsy was performed. It was unknown if the reporter considered the cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhoea to be related to Rotarix liquid formulation. Additional details: The age at vaccination was not reported. However, patient could be 2 or 3 month at the time of vaccination. Initial information was received from a Physician via regulatory authority on 31st October 2019: Cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea. Note: The outcome for the events acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea was reported as not recovered not resolved, but the seriousness criteria was reported as death so the outcome of the events was change to fatal and the events acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea was also capture as cause of death.; Reported Cause(s) of Death: Cardiac arrest; acute peritonitis; Sepsis; streptococcus pyogenes toxic shock syndrome; coryza; Rash; abdominal distension; Diarrhoea


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