Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a consumer (subject's mother) and healthcare professional and described the occurrence of red bump at injection site in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included red bump. Concurrent medical conditions included skin sensitivity. The mother reported that she expected some level of reaction because the subject has sensitive skin and in the past has had a small red bump with other unspecified injections. On 18 July 2012 at 09:00 the subject received a dose of KINRIX (unknown route, left arm). On 18 July 2012, less than one day after vaccination with KINRIX, the subject experienced red bump at injection site and on approximately 19 July 2012, one day after vaccination with KINRIX, the subject experienced injection site hot to touch, discoloration of skin at injection site, injection site discomfort, injection site redness, hardness injection site and injection site infection. This case is associated with a pharmaceutical product complaint. The mother of the subject believed the vaccine was contaminated; however, the healthcare professional believed the events were a local site reaction and not the result of contamination. The mother requested that the vaccine be tested. The mother reported that the day of the vaccination, the subject experienced small red bump at injection site and more pronounced the next day. The subject went to daycare and the mother was contacted to pick up the child due to the bump being more raised and by the time the subject reached the physician's office her entire upper arm was swollen, hot to touch and seem bothersome (injection site discomfort). According to the mother, the physician said it was an infection and prescribed BACTRIM along with BENADRYL and MOTRIN. The mother reported that the physician drew a circle around the swelling for determining potential continuous swelling. On Friday [20 July 2012], the swelling had not increased, but the subject was not better. On 21 July 2012, Saturday, the subject was seen by a physician again. The mother noted that the subject was 'pretty much the same with the exception of the area not being as hot to touch". The physician prescribed prednisone to take with ZYRTEC and by 22 July 2012, Sunday, there was "visual improvement (not as swollen, red, or hot to touch), but the bump was still hard". As of 23 July 2012, the mother stated there was "slight discoloration of the skin, not hard and non-irritation". At the time of reporting the red bump at injection site including swelling at injection site, injection site hot to touch, hardness at injection site, injection site discomfort and injection redness were resolved and discoloration of skin at injection site was improved. The outcome of the infection was unspecified. The mother stated that there were other children with the same reaction. The healthcare professional (nurse) conferred with the physician and they believed that the subject had a local reaction instead of a systemic. The healthcare professional reported that there were a total of three subjects (including this subject) with local reactions, but not confirmed to be systemic and the other two were with different lot numbers. See cases A0989130A and A09891333A for details involving the other two subjects. Quality Assurance (QA) results received on 08 August 2012. Based on the fact that no precise technical problem was reported, no technical investigation has been performed accordingly. The lot was produced in compliance with Good Manufacturing Practices and met the requirements of our specifications. This lot was checked by GlaxoSmithKline (GSK) Biologicals Quality Assurance and Quality Control according  to our procedures. GSK Biologicals considered the product complaint as unsubstantiated.