Age: 2.0
Sex: U
Vaccine: HEPA, PNC
Symptoms: Ascites, Bacteraemia, Beta haemolytic streptococcal infection, Cellulitis, Cyanosis
Clinical narrative: This case was reported in a literature article and described the occurrence of septic shock in a 2-year-old subject who received Hepatitis A vaccine. Co-suspect products included PREVNAR. On 2nd November 2001, 8 hrs after receiving Hepatitis A vaccine, the subject developed cellulitis. Serious criteria included death and GSK medically significant. Additional event(s) included fever on 2nd November 2001, mobility decreased on 4th November 2001, skin lesion on 4th November 2001, septic shock on 5th November 2001 with serious criteria of death and GSK medically significant, streptococcal meningitis on 5th November 2001 with serious criteria of death and GSK medically significant, bacteremia on 5th November 2001 with serious criteria of death and GSK medically significant, beta hemolytic streptococcal infection on 5th November 2001 with serious criteria of GSK medically significant, skin discoloration on 5th November 2001, tachycardia on 5th November 2001, cyanosis on 5th November 2001, purpura on 5th November 2001, coldness of skin on 5th November 2001, mucosal hemorrhage in 5th November 2001, puncture site hemorrhage on 5th November 2001, swelling of legs on 5th November 2001, lung congestion in November 2001 with serious criteria of GSK medically significant, pulmonary edema in November 2001 with serious criteria of GSK medically significant, ascites on November 2001 with serious criteria of GSK medically significant, hydrothorax in November 2001 with serious criteria of GSK medically significant, petechial rash in November 2001 and gastroenteritis eosinophilic in November 2001. The outcome of cellulitis was fatal. The outcome(s) of the additional event(s) included septic shock (fatal), streptococcal meningitis (fatal), bacteremia (fatal), beta hemolytic streptococcal infection (unknown), lung congestion (unknown), pulmonary edema (unknown), ascites (unknown), hydrothorax (unknown), fever (unknown), mobility decreased (unknown), skin lesion (unknown), skin discoloration (unknown), tachycardia (unknown), cyanosis (unknown), purpura (unknown), coldness of skin (unknown), mucosal hemorrhage (unknown), puncture site hemorrhage (unknown), petechial rash (unknown), gastroenteritis eosinophilic (unknown) and swelling of legs (unknown). The subject died on 5th November 2001. The reported cause of death was septic shock, bacterial meningitis, bacteremia and cellulitis. The investigator considered that there was a reasonable possibility that the cellulitis, septic shock, streptococcal meningitis, bacteremia and beta hemolytic streptococcal infection may have been caused by Hepatitis A vaccine. It was unknown if the investigator considered the fever, mobility decreased, skin lesion, skin discoloration, tachycardia, cyanosis, purpura, coldness of skin, mucosal hemorrhage, puncture site hemorrhage, swelling of legs, lung congestion, pulmonary edema, ascites, hydrothorax, petechial rash and gastroenteritis eosinophilic to be related to Hepatitis A vaccine. Relevant Tests: Lab tests performed on 05-Nov-2001 Diagnostic laboratory data showed that blood cerebrospinal fluid (CSF) and skin scraping from right leg: all positive for group A Beta Hemolytic Streptococcus. Pathologic diagnosis revealed cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, meningitis due to: Streptococcus pyogenes, Group A, Betahemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. Diagnostic results (unless otherwise stated, normal values were not provided): On 5th November 2001, Blood test result was see text unknown, Body temperature result was 39.3 degree C, CSF test result was see test unknown, Pathology test result was see text unknown and skin test result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of septic shock and bacterial meningitis due to bacteremia due to cellulitis in a 2.5-year-old patient of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline Biologicals) and PREVNAR (Pfizer/Wyeth). This case corresponds to table 8 in this literature article with VAERS ID: 183258. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On 2 November 2001, the patient received HAVRIX (lot no. 697A2) and PREVNAR (lot no. 477553) intramuscularly in left arm (dosages unknown for both). On 2 November 2001, 8 hours after vaccination, the patient experienced persistent fever as reported by medical doctor. On 4 November 2001, the patient experienced decreased mobility. Mosquito bite looking lesion on right lower leg. On 5 November 2001, the patient's right lower leg was discolored and swollen. The patient visited the emergency room (ER). On admission to ER, the patient temperature was 39.3 deg. C, had tachycardia, right lower leg was cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral, others were absent. The patient was bleeding profusely from mucous membranes and puncture sites. The patient deteriorated rapidly and despite very aggressive cardiopulmonary resuscitation, the patient expired on 5 November 2001. The cause of death was diagnosed as septic shock and bacterial meningitis due to bacteremia due to cellulitis. It was unknown if autopsy was performed. Diagnostic laboratory data showed that blood, cerebrospinal fluid (CSF) and skin scraping from right leg: all positive for group A Beta Hemolytic Streptococcus, Pathologic diagnosis revealed cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, meningitis due to: Streptococcus pyogenes, Group A, Betamolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. This case has been considered serious due to death. The authors did not comment on the relationship of septic shock and bacterial meningitis due to bacteremia due to cellulitis with HAVRIX. The authors concluded that "Evidence based medicine has been championed as a paradigm which results in improved medical practice. However, it is evident from the body of data collated in this review that very large randomized trials would be needed adequately address the issue of skin disinfection prior to vaccine administration and the prevention of sepsis. Consequently, a new paradigm118 might be evoked to cover this clinical issue, namely the use of a very low cost intervention (disposable skin swab) to prevent a very low prevalence event (sepsis related to parenteral vaccination) of high cost (medical attention including hospitalization with morbidity/mortality)". This is 1 of the 7 valid cases reported in the same literature article.