Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Eczema, Electroencephalogram, Haemorrhage, Rash generalised, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 2-month-old female patient who received PEDIARIX. Co-suspect products included Hib vaccine, Rotavirus vaccine, PEDIARIX, Hepatitis B vaccine and pneumococcal vaccine. Concomitant products included PEDIARIX. In February 2008, the patient received the 1st dose of PEDIARIX, Hib vaccine and Rotavirus vaccine (oral). On an unknown date, the patient received the 3rd dose of PEDIARIX. On 4th December 2007, the patient received Hepatitis B vaccine. In February 2008, the patient received pneumococcal vaccine. On an unknown date, not applicable after receiving PEDIARIX, 213 days after receiving Hib vaccine and Rotavirus vaccine, 91 days after receiving PEDIARIX and 274 days after receiving Hepatitis B vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), generalized rash, eczema and skin reaction. The patient was treated with cannabidiol. On an unknown date, the outcome of the seizure was not recovered/not resolved and the outcome of the generalized rash, eczema and skin reaction were recovered/resolved. The reporter considered the generalized rash to be almost certainly related to PEDIARIX. It was unknown if the reporter considered the eczema and skin reaction to be related to PEDIARIX, Hib vaccine, Rotavirus vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the seizure and generalized rash to be related to Hib vaccine, Rotavirus vaccine and Hepatitis B vaccine. The reporter considered the seizure to be almost certainly related to PEDIARIX. Additional details were provided as follows: The patient's mother did chat for inquiry requesting data on the administration of PEDIARIX and skin rash and seizures. At birth, the patient received hepatitis B and further vaccination continued with PEDIARIX. In February 2008, at 2 months vaccination, the patient received PEDIARIX, Hib vaccine Rotavirus vaccine, PREVENAR and within 1 week she experienced rash on all over body and within 3 weeks she experienced bloody eczema on the face and elbow crease. The mother reported that according to package insert PEDIARIX not to vaccinate further with PEDIARIX if skin reaction occurs, indeed the patient was vaccinated with PEDIARIX further at 4 month and 6 months. The patient experienced seizure at 9 months of age. The patient was hospitalized in December 2008, February 2009, and September 2009 for seizures. She also had several EEGs (Electroencephalograms). According to the reporter the safety of receiving 4 Hepatitis B vaccines had not been studied. The reporter stated about the skin conditions of patient that the physician did not see the correlation between her symptoms and the vaccine, rather stated that her symptoms are based on genes (or genetics). At the time of reporting, within the last year, the patient skin issues had resolved but she continued to had seizures. The reporter stated that they had tried different medications and it was uncertain if they had worked. At the time of reporting, they were trying CBD (cannabidiol) treatment, which reporter did not provide a full description of. The contact details of the physician was provided by the reporter, however she (reporter) also advised not to contact the physician.