Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Febrile convulsion, Injection site abscess sterile, Lymphocyte count normal, Muscle twitching, Neutrophil percentage
Clinical narrative: This case was reported in a literature article and described the occurrence of febrile convulsion in a 3-month-old female subject who received DTPa-HBV-IPV vaccine. Co-suspect products included ACTHIB, PREVNAR and ROTATEQ. Concomitant products included PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. On 18th June 2008, 1 days after receiving DTPa-HBV-IPV vaccine, ACTHIB, PREVNAR and ROTATEQ, the subject developed crying. Serious criteria included hospitalization. Additional event(s) included febrile convulsion with serious criteria of hospitalization and GSK medically significant, seizure with serious criteria of hospitalization and GSK medically significant, muscle twitching with serious criteria of hospitalization, injection site abscess sterile with serious criteria of hospitalization, fever with serious criteria of hospitalization and jerkiness with serious criteria of hospitalization. The outcome of crying was unknown. The outcome(s) of the additional event(s) included febrile convulsion (recovered/resolved), seizure (recovered/resolved), muscle twitching (recovered/resolved), injection site abscess sterile (recovered/resolved), fever (recovered/resolved) and jerkiness (recovered/resolved). The investigator considered the crying, jerkiness, febrile convulsion, seizure, muscle twitching and fever to be possibly related to DTPa-HBV-IPV vaccine, ACTHIB, PREVNAR and ROTATEQ. The investigator considered the injection site abscess sterile to be possibly related to DTPa-HBV-IPV vaccine. Diagnostic results (unless otherwise stated, normal values were not provided): In June 2008, Blood culture result was no growth unknown, Body temperature result was 103.3 unknown, Culture urine result was no growth unknown, Electroencephalogram result was normal unknown, Lymphocyte count result was 2937 unknown, Neutrophil percentage result was 56.2% and White blood cell count result was 17.8%. Additional information was provided. This case was reported in a literature article and described the occurrence of seizure; febrile convulsion; injection site sterile abscess; muscle twitching; pyrexia in a 0.3-year-old female who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur), PREVNAR (Pfizer/Wyeth), ROTATEQ (Merck). The patient was part of the systematic review of both the literature and the Vaccine Adverse Event Reporting System (VAERS) database in an effort to better characterize the phenomenon of sterile abscess formation following immunization with aluminum-containing vaccines. A literature search was performed on June 21, 2016 using the terms "Vaccine" and "Sterile abscess" with no restrictions other than the English language. Reports of vaccines not used in children (eg, bacilli Calmette-Guerin) were eliminated. The search of the VAERS database produced 30 reports dated from September 2002 to April 2015. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On 17 June 2008, at the age of 0.3 year, the patient received intramuscularly 2nd dose of each of PEDIARIX (in left thigh; AC21B149AA), ACTHIB (left thigh; UF260AA), PREVNAR (right thigh; C68306) and 2nd dose of peroral ROTATEQ (0207X). The vaccine was purchased and administered by private. On 17 June 2008, that evening after the vaccination, the patient went to the emergency room (ER) for seizure and strange muscle twitching. The patient was admitted to the hospital with pyrexia-fever 103.3 (unit unspecified), sterile abscess to left leg and febrile seizure. On 18 June 2008, the patient was diagnosed with immunization reaction. The patient had subjective fever, crying and jerking that morning. Small sterile abscess in right upper thigh. The patient was hospitalised for 1 day. The patient's electroencephalogram (EEG) was normal. White blood cells (WBC) were at 17.8%, neutrophils at 56.2%, lymphocytes at 2937 (units and normal range not provided for all), blood and urine cultures revealed no growth. This case has been considered serious due to hospitalisation. Treatment was unknown. The patient recovered in 18 hour to date of reporting. The authors considered the event of possibly related to aluminum adjuvant in the vaccine. The authors stated "Aluminum may be viewed as a repository adjuvant, facilitating a delayed release of antigen at the site of injection, thus prolonging contact with antigen presenting cells. In theory, this may lead to an accumulation of macrophages and immune cells at the site of injection, which may incidentally trigger the formation of sterile abscesses. Tdap, PREVNAR 13, DAPTACEL, PREVNAR 7, and PENTACEL all utilize aluminum phosphate, while GARDASIL, VAQTA, and the COMVAX vaccines utilize aluminum hydroxyphosphate sulfate. 4 Sterile abscess formation has been reported to complicate all of these immunizations, in addition to vaccines utilizing aluminum hydroxide adjuvants. The primary limitation to our data is the risk of an underreporting of cases, either due to a publication bias as related to our literature search or due to the use of passive reporting by the VAERS system. We are also unable to exclude the possibility that an allergic reaction to a compound other than aluminum may have been present in cases (eg, sorbitol). However, given the variety of different immunizations reported sharing the common use of an aluminum adjuvant, this was more than likely the responsible agent in the majority of cases". The authors concluded "Sterile abscess formation may rarely complicate immunization with vaccines containing aluminum adjuvants. Such reactions may exhibit a delayed response following immunization of several weeks, and may occur only after multiple doses of the vaccine have been previously received without incident. An awareness of this phenomenon may be helpful for those health care providers involved with the immunization of children. This is 1 of the 8 valid cases in the same literature article.