Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site pruritus, Injection site rash, Irritability postvaccinal, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of injection site rash in 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included live attenuated human rotavirus;GlaxoSmithKline;unknown;unknown given on 26 April 2013. On 26 April 2013 the subject received 2nd dose of PEDIARIX (.5 ml, unknown route, left thigh). On 26 April 2013, "that evening" and less than one day after vaccination with PEDIARIX, the subject experienced injection site rash (described as a "sandpaper-like rash"), irritability after vaccines, injection site pruritus (described as "tried to scratch area") and pruritus of head (described as "rubbing his head like he was itching"). The subject's parents described the rash as "getting bigger and spreading out from the injection site." Per the physician, it was unknown if the immunization series was discontinued; however, the series was not delayed. The symptoms did not recur following subsequent administration. The lot number provided by the physician appears to be a partial lot number. An attempt was made to obtain the complete lot number; however, the receptionist stated that the lot number was shortened. At the time of reporting the outcome of the events were unknown. The physician considered the events were probably related to vaccination with PEDIARIX. Follow up information received from a healthcare professional (medical assistant) via Pfizer on 11 June 2013. Concurrent vaccinations included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus ;GlaxoSmithKline;unknown;unknown given on 22 February 2013; haemophilus influenzae type b  (non-gsk) ;Sanofi; intramuscular; unknown given in 2013; On 25 April 2013 (previously reported as 26 April 2013 by physician) after dose 2 of PEDIARIX, the patient experienced injection site rash. In 2013, the injection site rash was resolved. Follow up was received from a medical assistant on 16 July 2013. The medical assistant documented that this case has been reported to Regulatory Agency. The medical assistant reported that all adverse events were resolved on 28 April 2013, 3 days after vaccination with PEDIARIX. The medical assistant reported that PEDIARIX was reintroduced on 2 July 2013 as the subject received another PEDIARIX dose. The medical assistant reported that the symptoms did recur. In July 2013, the same month as vaccination with 3rd dose of PEDIARIX, subject experienced injection site rash, irritability after vaccines, injection site pruritus, and pruritis of head. The outcomes of the recurrent events were not reported. The medical assistant also reported that it was unknown if symptoms recurred following subsequent administration. The medical assistant did not consider this case to be serious. The reporter also documented that there was no congenital anomaly or birth defect. The medical assistant reported that the immunization series was not delayed or discontinued. Per the reporter, the subject has experienced adverse events following previous vaccinations with details of ACTHIB and PREVNAR 13. Follow up was received from medical assistant on 20 August 2013. The reporter documented that this case was reported to a Regulatory Agency. The reporter did not comment on the adverse events following the dose of PEDIARIX on 02 July2013. The reporter stated that the diagnosis from symptoms reported in April 2013 was not anaphylactic reaction. The reporter changed the onset and resolution dates of signs and symptoms of the events and added suspect vaccinations. Per the medical assistant, the 4-month-old experienced reactions following vaccination with PEDIARIX (GlaxoSmithKline), pneumococcal (non-gsk) and ACTHIB. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus ; GlaxoSmithKline;intramuscular;unknown given on 22 February 2013; haemophilus influenzae type b (non-gsk) ;Sanofi;intramuscular;unknown given in 2013; live attenuated human rotavirus ;GlaxoSmithKline;oral;unknown given on 26 April 2013. On 26 April 2013 the subject received 2nd dose of PEDIARIX (.5 ml, intramuscular, left thigh), on 26 April 2013 the subject received unspecified dose of pneumococcal (Non-GSK) (unknown details), and an unspecified dose of ACTHIB (unknown details). On 29 April 2013 (previously reported as the same day of vaccination), 3 days after vaccination with PEDIARIX, ACTHIB and pneumococcal (Non-GSK), the subject experienced injection site rash, irritability after vaccines, injection site pruritus and pruritus of head. On 3 May 2013 (previously reported as resolved on 28 April 2013, 2 days after onset), 3 days after adverse event onset, the medical assistant reported that the events of injection site rash, irritability after vaccines, injection site pruritis and pruritus of head had resolved. The medical assistant did not consider these events to be serious. The medical assistant documented that the relationship to the PEDIARIX was unknown and unrelated. The medical assistant reported that the events were not related to medical history, lack of efficacy, erroneous administration, or suspected transmission of infectious agent via a medicinal product. A biopsy was not performed. At the time of reporting, there was no relevant medical history. Per the reporter, the suspect drug(s) was reintroduced and symptoms did recur. The subject had received the suspect drug(s) before; however, did not provide details. Per the medical assistant the immunization series was not discontinued or delayed. The subject experienced the "same symptoms" when PEDIARIX was reintroduced. The medical assistant also documented that adverse events followed previous vaccinations with details of "only when given vaccines."