Age: 6.0
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Nausea, Pruritus
Clinical narrative: Initial report was received 18 March 2013 from another manufacturer under reference number A1011108A. The following is verbatim per the report: "This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included dtpa vaccine (non-gsk); sanofi; unknown; unknown given in December 2012. In December 2012, the subject received a dose of ENGERIX B (unknown details). Within months of vaccination with ENGERIX B, the subject experienced allergic reaction. The nurse was contacted by an allergist "to report that the patient had an unknown allergic reaction to ENGERIX B." The allergist was requesting the lot number from the nurse; however the nurse was able to locate the information for this report. At the time of reporting the outcome of the event was unspecified. Follow up was received from nurse on 07 March 2013. The nurse reported that the subject was a 6-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and DAPTACEL (non-gsk). The subject's medical history included influenza. The subject "had just gotten over the flu" a "week or so before vaccination". Concurrent vaccination included DTaP vaccine; manufacturer unspecified; unknown; unknown given in August 2012 and the nurse reported no reaction with this dose. Concurrent medications included TAMIFLU a "week or so before vaccination." Per the nurse, on 18 December 2012 the subject received a dose of ENGERIX B (unknown details), 2nd dose of DAPTACEL (unknown details). The nurse did not report what site each vaccine was administered. On 19 December 2012, 1 day after vaccination with DAPTACEL and ENGERIX B described as "the very next day", the subject experienced allergic reaction, fever, swelling of tongue, itching, arm swelling (injection site), injection site redness, injection site hot to touch, injection site movement impairment ("could not move arm"), lethargy, nausea and hard to breathe. The subject's mother told the nurse on 1 March 2013 that the subject "became lethargic and his tongue was swelling". Per the nurse, the subject's mother also stated that the subject's arm was a little red and swollen post immunization. The nurse described the swelling as "half baseball size." The mother told the nurse that she treated the subject with "MOTRIN and alternated warm and cold compresses." The "very next day" (19 December 2012) the subject complained of nausea and said it was hard from him to breathe and his temperature kept going up even post MOTRIN." The subject was given BENADRYL and was taken by ambulance to the emergency room. "Within 20 minutes of giving BENADRYL" the subject was getting better. The emergency room placed the subject on steroids for a total of 5 days. Per the nurse, the subject was "tested again for the flu due to high fever 102 and greater and it was negative." The subject was treated with heat therapy (Hot compress), cool compress (Cold compress), MOTRIN, BENADRYL and Steroids. The nurse considered the events were life threatening and clinically significant (or requiring intervention) and the case was upgraded to serious. At the time of reporting, the events were resolved. It was unknown if the immunization series was discontinued or delayed. The nurse documented that the symptoms recurred following subsequent administration. The nurse documented that there had been no adverse events following previous vaccinations and "mom is behind on "immunizations." The nurse also documented that the subject was sent to an allergist. The allergist, per the subject's mother, said "it was a adverse reaction to vaccine and would like to do allergy testing." The subject's insurance would not pay for extensive testing."