Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Injection site nodule, Swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of nodule injection site in an unknown number of subjects of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subjects received a dose of PEDIARIX (unknown volume and route, unknown thigh). At an unspecified time after vaccination with PEDIARIX, the subjects experienced nodule injection site ("knots in leg'). The nurse reported "multiple" subjects with "knots on their legs where the PEDIARIX injection was given." The nurse reported that the office gave the subjects "more than one vaccine injection in the same leg" but these vaccines were not known at the time of reporting. At the time of reporting the outcome of the event was unknown. The nurse reported that the "knots were still there" when the subjects returned to receive their next dose of PEDIARIX. Follow up received from nurse on 19 March 2013. The nurse stated that "all infants with whom they administer PEDIARIX to, are getting knots in their legs where PEDIARIX was administered." The nurse stated that PEDIARIX is the only vaccine administered into "their one thigh." The nurse also stated "they do not administer any other vaccines to these infants in the same thigh as PEDIARIX." Per the nurse, the knots were "still there 2 months later when the patient comes back for their next dose." On unspecified dates the subjects received a dose of PEDIARIX (unknown details, unknown thigh) and on unspecified dates the subjects received a dose of PENTACEL (unknown details, unknown thigh) and experienced interchange of vaccine products. The nurse stated that the office "switched the patients over the PENTACEL and administer PENTACEL instead of PEDIARIX." The reporter stated that when the subjects "get the PENTACEL injection, their patients do not get knots in their thighs like they do when they receive PEDIARIX." The office again switched back to using PEDIARIX, and "as soon as they went back to giving their patients PEDIARIX, the patients again experienced knots in their legs." The nurse stated that their office will no longer be using PEDIARIX. No further information was provided. Follow-up information was received on 03 May 2013 via healthcare professional who provided details on one subject who received PEDIARIX in the left thigh. The onset of events occurred on 01 March 2013 when the subject was approximately 6-months old. Treatment action taken with PEDIARIX included warm compression and massage. The series with PEDIARIX was not discontinued or delayed. The subject experienced adverse events with previous vaccinations; when the subject was 2-months old in approximately October 2012, PEDIARIX was administered and they experienced "little swelling and redness". The healthcare professional did not consider the events serious. The events were not attributed to medical history/concurrent illness, lack of efficacy, erroneous administration or transmission of infectious agent or medicinal product. An update outcome of the events was not provided.