Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Irritability, Product quality issue, Pyrexia, Rash, Skin lesion
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of an unspecified adverse event in a 5-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-GSK manufacturer) given on 20 July 2011; PREVNAR (non-GSK manufacturer) given on 20 July 2011. On 20 July 2011 the subject received unspecified dose of PEDIARIX (details unknown). On 20 July 2011, less than one day after vaccination with PEDIARIX, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up received from physician, via GSK representative, on 21 July 2011: The subject had received her 1st dose of PEDIARIX at 2 month-old with no adverse events. On 20 June 2011, at 4 months-old, the subject received a 2nd dose of PEDIARIX. On 20 June 2011, less than one day after vaccination with PEDIARIX, the subject experienced low grade fever. She was treated with TYLENOL. It was noted that the subject had received TYLENOL in the past and had tolerated it. On the night of 21 June 2011, the subject experienced small hives on her arms and legs. When she awoke on 22 June 2011, she had enlargement and increased redness of the lesions. By 23 June 2011, the subject had the lesions on her face, torso, arms and legs. She was also cranky and crying a lot during those days. The subject did not appear to scratch the lesions. She also experienced loose stools and a few spitting up episodes, but was not dehydrated and the stools were self-limiting. The subject was seen at a physicians office. The lesions began to have central clearing and then were target like and then became more confluent and serpiginous. On 25 June 2011 the rash disappeared and then 2 hours later it reappeared as severely as the 3rd day. The rash subsided on 28 June 2011 and at the time of reporting, the events were resolved. This case was reported as a product complaint because the physician considered that the subject reacted differently to the 1st PEDIARIX dose in comparison with the 2nd PEDIARIX dose. The physician considered that there may have been something "defective" in the 2nd PEDIARIX dose. The reporting physician an allergist in charge of finding out if the subject had developed an allergy to PEDIARIX, or if that particular lot number of vaccine administered for the 2nd dose was defective. An investigational report was received via GlaxoSmithKline Biologicals Quality Assurance on 05 August 2011. No sample was returned. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. Follow-up received on 24 August 2011 from physician: The subject had previously received PEDIARIX, PREVNAR, ACTHIB and rotavirus vaccine (unknown manufacturer) on 20 April 2011 with no reaction. On 20 June 2011, the subject received the same vaccines again and a reaction developed. The subject had received no medications and had no viral or infectious symptoms in the 2 weeks preceding the events and no fever. The physician confirmed that the onset date of earliest signs or symptoms was 20 June 2011. The physician considered the events were clinically significant (or requiring intervention). The subject was taken to the emergency room on 27 June 2011. She was also treated with diphenhydramine hydrochloride. The events resolved on 28 June 2011. The physician reported that the second exposure to the vaccines may have lead to a delayed Type IV reaction. The suspect product was identified as PEDIARIX, but no causality assessment was provided. The physician reported that the vaccination series was likely to be delayed due to the events as skin prick tests were pending. The subject had presented to the physician's office on 06 July 2011 for allergy evaluation.