Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Myalgia, Nausea, Necrotising fasciitis, Pain, Pain in extremity
Clinical narrative: This case was reported in a literature article and described the occurrence of septic shock in a 11-year-old female subject who received Tdap vaccine. Co-suspect products included GARDASIL and MENACTRA. Concurrent medical conditions included swelling of feet, sickle cell trait and sore throat. On 30th March 2009, less than a day after receiving Tdap vaccine. and Hepatitis A vaccine and less than a day after receiving Tdap vaccine. and Hepatitis A vaccine, the subject developed necrotizing fasciitis. Serious criteria included death and GSK medically significant. Additional event(s) included fever on 30th March 2009, pain in hip on 30th March 2009, bacterial infection due to streptococcus, group A on 1st April 2009 with serious criteria of GSK medically significant, viral syndrome on 1st April 2009, tenderness on 1st April 2009, septic shock on 3rd April 2009 with serious criteria of death and GSK medically significant, infective myositis on 3rd April 2009, nausea on 3rd April 2009, vomiting on 3rd April 2009, rash on 3rd April 2009, polymyalgia on 3rd April 2009, swelling on 3rd April, insomnia on 3rd April 2009, vaccination adverse reaction on 3rd April 2009, hypotension on 3rd on April 2009 and instability cardiovascular on 3rd April 2009. The subject was treated with analgesic. The outcome of necrotizing fasciitis was fatal. The outcome(s) of the additional event(s) included septic shock (fatal), bacterial infection due to streptococcus, group A (unknown), infective myositis (unknown), fever (unknown), pain in hip (unknown), viral syndrome (unknown), tenderness (unknown), general body pain (unknown), walking disability (unknown), leg pain (unknown), nausea (unknown), vomiting (unknown), rash (unknown), polymyalgia (unknown), swelling (unknown), insomnia (unknown), vaccination adverse reaction (unknown), hypotension (unknown) and instability cardiovascular (unknown). The subject died on 3rd April 2009. The reported cause of death was septic shock and necrotizing fasciitis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the necrotizing fasciitis, bacterial infection due to streptococcus, group A, viral syndrome, septic shock, infective myositis and vaccination adverse reaction may have been caused by Tdap vaccine. and Hepatitis A vaccine. It was unknown if the investigator considered the fever, pain in hip, tenderness, general body pain, walking disability, leg pain, nausea, vomiting, rash, polymyalgia, swelling, insomnia, hypotension and instability cardiovascular to be related to Tdap vaccine. and Hepatitis A vaccine. Relevant Tests: Lab tests performed on 01-Apr-2009 and 03-Apr-2009. Physical examination was positive for tenderness over Left anterior thigh. UA was positive for reducing substance. Chest X-ray (CXR) was questionable with either bronchitis or atypical pneumonia Diagnostic results (unless otherwise stated, normal values were not provided): On 1st April 2009, Blood test result was group A streptococcus infection unknown, Lymphocyte count result was 13.1 %, Monocyte count results was 12.6 %, Physical examination result was see text unknown, Urine analysis result was within normal limits unknown and White blood cell count result was 11.1 73 %. On 3rd April 2009, Alanine aminotransferase result was 90 unknown, Aldolase result was 22.3 unknown, Anion gap result was 21.5 unknown, Aspartate aminotransferase result was 132 unknown, Blood albumin result was 3.3 unknown, Blood chloride result was 94 unknown, Blood creatine phosphokinase result was 116 unknown, Blood culture result was positive for Streptococcus pyogenes Group A unknown, Blood glucose result was 170 unknown, Blood lactate dehydrogenase result was 389 unknown, Blood potassium result was 3.1 unknown, Blood sodium result was 131 unknown, Body temperature result was 102 degree F, Carbon dioxide result was 18.6 unknown, Chest X-ray result was see text unknown, Culture urine result was positive for Streptococcus pyogenes Group A unknown, Globulin result was 4.2 unknown. Glucose urine result was 100 unknown, Haematocrit result was 33.6 unknown, Haemoglobin result was 11.1 unknown, Lymphocyte count result was 12 %, Mean cell haemoglobin result was 23.4 unknown, Mean cell volume result was 70.3 unknown, Red blood cell morphology result was abnormal unknown, Urobilinogen urine result was 8.0 unknown and White blood cell count result was 8.4 with 16 %. Additional information was provided. This case was reported in a literature article and described the occurrence of necrotizing fasciitis (Gram (+) with septic shock in a 11-year-old female patient who was vaccinated with BOOSTRIX (GlaxoSmithKline Biologicals), HAVRIX (SmithKline Beecham), VAQTA (Merck), GARDASIL (Merck and CO. INC.), MENACTRA (Sanofi Pasteur). This case corresponds to table 8 in this literature article with VAERS ID: 344160. The patient's preexisting conditions included foot swelling and sickle-cell trait. The patient's concurrent illness included sore throat with no other medical conditions. No information on patient's family history was provided. Patient complained about sore throat a week prior to vaccination. On 30 March 2009, the patient received BOOSTRIX (lot no. AC52B029AA) intramuscularly in the left arm (dosages unknown), HAVRIX (lot no. AHAVB262A), MENACTRA (lot no. U2670AA) (administration route and site unspecified; dosages unknown for both) and 1st dose of GARDASIL (lot no. 0570X) concomitantly (administration route and site unspecified). On 30 March 2009, an unknown period after vaccination with BOOSTRIX, VAQTA, MENACTRA and after getting the 1st dose of GARDASIL, the patient presented to emergency room (ER) with fever and pain in the hip. The patient sought unspecified medical attention. On 1 April 2009, the patient was diagnosed with pediatric viral syndrome. Physical examination was positive for tenderness over Left anterior thigh. The patient was treated with analgesic and discontinued. Diagnostic laboratory data revealed a group A streptococcus in the blood. On 1 April 2009, complete blood count (CBC) with white blood cells (WBCs) at 11.1 73% segs, lymphocytes at 13.1%, monocytes at 12.6%. Urine analysis (UA) was within normal limits. On 3 April 2009, the patient presented again to ER with fever of 102 deg. F, body aches, inability to walk 2 inch, leg pain, nausea, vomiting, rash and polymyagias. Physical examination was positive for extremity pain and swelling, rash, as well as not sleeping and acting differently. Subsequently, the patient was transferred to higher level of care. On 3 April 2009, Laboratory tests revealed, creatine kinase (CK): 116, lactate dehydrogenase (LDH): 389, Na+ 131, K 3.1, Cl 94, CO2 18.6, Anion gap 21.5, Glucose 170, Albumin 3.3, Globulin 4.2, aspartate aminotransferase (AST)132, alanine aminotransferase (ALT) 90, Aldolase 22.3, WBCs at 8.4 with 16% bands, lymphocytes at 12%. Abnormal red bloods cells (RBCs) morphology. Haemoglobin: 11.1, Hematocrit (Hct): 33.6. Mean corpuscular volume (MCV) 70.3. Mean corpuscular haemoglobin (MCH) 23.4. UA was positive for Glucose at 100, urobilinogen 8.0 , positive reducing substance. Urine and blood culture were positive for Streptococcus pyogenes Group A. Chest X-ray (CXR) was questionable with either bronchitis or atypical pneumonia. The patient was diagnosed with post-vaccination reaction. Later, the patient was admitted from local facility for evaluation of fever with difficulty ambulating. Neurologic/orthopaedic consults on arrival with probable diagnosis of infectious myositis. The patient was treated intravenously (IV) with antibiotics (ABX) however IV access was lost and patient became hypotensive with evidence of septic shock with cardiovascular instability. The patient was intubated and despite extensive resuscitation efforts, the patient expired on 3 April 2009. Autopsy report revealed the cause of death as necrotizing fasciitis (Gram (+)) with septic shock. This case has been considered serious due to death. The authors considered the event of necrotizing fasciitis (Gram (+) with septic shock with BOOSTRIX; HAVRIX; GARDASIL and MENACTRA. 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 collected in this review that very large randomized trials would be needed to 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 hospitalisation with morbidity/mortality)". This is 1 of the valid cases reported in the same literature article.