Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Eye swelling, Hypersensitivity, Local swelling, Productive cough, Pruritus
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of body hives in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 16 December 2011 at 16:30 the subject received unspecified dose of KINRIX (unknown). The next morning, on the morning of 17 December 2011, less than one day after vaccination with KINRIX, the subject was covered in hives from his neck down. The child was taken back to his physician who prescribed BENADRYL. After taking three doses of BENADRYL, the hives spread and moved around the subject's body. Within days of receiving KINRIX, he developed eye swelling, neck swelling, started to gag, and spit up about half of a cup of clear, yellow mucus. The subjects leg started trembling and he was taken to the emergency room where he received a steroid which got the reaction under control. The child's mother reported that an allergist thought the reaction was likely due to vaccination with KINRIX. At the time of reporting the outcome of the events was unspecified. Follow up information received from the subject's mother on 24 February 2012. Historic vaccination included HIB; manufacturer unspecified;unknown;unknown given on 21 January 2007, 23 March 2007, 5 July 2007 and 28 March 2008; DTAP, HIB and IPV; manufacturer unspecified;unknown;unknown given on 24 January 2007, 23 March 2007 and 5 July 2007; DTAP; manufacturer unspecified;unknown;unknown given on 1 July 2008; hepatitis A inactivated; manufacturer unspecified;unknown;unknown given on 20 November 2009 and 11 October 2010; MMR (non-gsk);non-GSK manufacturer;unknown;unknown given on 24 January 2007, 23 March 2007, 5 July 2007 and 28 December 2007; varicella virus vaccine (non-gsk); non-GSK manufacturer;unknown;unknown given on 25 August 2009. Concurrent vaccination included INFLUENZA; manufacturer unspecified;unknown;unknown given on 14 October 2011. The information provided by the mother indicated that the subject had an "acute relatively severe urticaria likely due to a hypersensitivity reaction to the DTAP-IPV vaccine virus versus less likely but questioning an inert ingredient". The subject had the KINRIX vaccination at about 16:00 on 16 December 2011 and developed the hives and pruritus "overnight" so it was unclear with the reported information if the hives and pruritus occurred on 16 December or 17 December 2011. "There are not other good severe inhalant allergy, drug allergy or any hidden acute or chronic infection or inflammatory disease that caused the "urticaria/rash". The subject's history did not suggest any primary dermatitis including atopic dermatitis nor any recurring acute upper respiratory infections (URI's) or any asthma. No allergy restrictions for food were recommended. It was recommended that food and drug diary be kept with any future reactions. The subject was given a medical kit with Epi-pen Jr, BENADRYL and ORAPRED for "just in case". Follow up information received from the subject's physician on 23 March 2012. The physician reported that the subject experienced the events on 16 December 2011 after receiving KINRIX. The physician considered the events as serious reporting that the events jeopardized the subject or required intervention. The physician noted that no action was taken with the KINRIX since the dose received was the subject's last dose. According to the physician, the subject has not experienced any adverse events following previous vaccinations.