Age: 0.73
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Immediate post-injection reaction, Inappropriate schedule of drug administration, Injection site rash, Lymphocyte count increased, Lymphocytosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eczema in a 5-month-old female patient who received PEDIARIX. Co-suspect products included Rotavirus vaccine, PEDIARIX and PEDIARIX. On 15th May 2013, the patient received the 1st dose of PEDIARIX and Rotavirus vaccine. On 4th September 2013, the patient received the 2nd dose of PEDIARIX. On 11th December 2013, the patient received the 3rd dose of PEDIARIX. On 4th September 2013, not applicable after receiving PEDIARIX, Rotavirus vaccine and PEDIARIX, an unknown time after receiving PEDIARIX and not applicable after receiving PEDIARIX, Rotavirus vaccine and PEDIARIX, the patient experienced drug dose administration interval too long. On 11th December 2013, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced eczema, petechial rash, lymphocytes raised, lymphocytosis, neutrophil count low, neutropenia (serious criteria GSK medically significant), anisocoria, anaphylaxis (serious criteria GSK medically significant) and peanut allergy. On an unknown date, the outcome of the eczema was recovering/resolving and the outcome of the petechial rash, lymphocytes raised and neutrophil count low were recovered/resolved and the outcome of the lymphocytosis, neutropenia, anaphylaxis, peanut allergy, drug dose administration interval too long and drug dose administration interval too long were unknown and the outcome of the anisocoria was not recovered/not resolved. The reporter considered the eczema, petechial rash and lymphocytes raised to be probably related to PEDIARIX. It was unknown if the reporter considered the lymphocytosis, neutrophil count low, neutropenia and anisocoria to be related to PEDIARIX and Rotavirus vaccine. The reporter considered the eczema to be probably related to Rotavirus vaccine. It was unknown if the reporter considered the petechial rash and lymphocytes raised to be related to Rotavirus vaccine. It was unknown if the reporter considered the anaphylaxis and peanut allergy to be related to PEDIARIX. Additional details were provided as follows: The patient received first dose of PEDIARIX around age of 2 months. Immediately 24 hours after vaccination, the patient experienced eczema on folds of arms and legs described as a weeping rash. The patient's head was covered in cradle cap (related to eczema). Eczema remained but had improved. Petechial rash presented about 7-10 days after first dose of PEDIARIX, specific to legs, trunk and shoulder. Labs were drawn at that time showing normal WBC but elevated lymphocytes. Neutrophil count was abnormal. At 12-14 months, lab abnormalities resolved. Benign neutropenia was the final diagnosis. Benign anisocoria was diagnosed at 5 months of age as well (not resolved at this time). On 4th September 2013, the patient received 2nd dose of PEDIARIX, leading to lengthening of vaccination schedule. Anaphylaxis was mentioned after second DTAP administration, but reporter unable to provide further details. Also mentioned that patient initially tested negative for allergies but a peanut allergy was later discovered. On 11th December 2013, the patient received 3rd dose of PEDIARIX, leading to lengthening of vaccination schedule. Additional suspect product of ROTARIX added since patient received rotavirus pentavalent on 15th May 2013, reporter unable to provide brand of rotavirus vaccine. Patient also received pneumococcal and hepatitis vaccines 16th September 2013 and 19th March 2014, brand of vaccines unknown. Due to time constraints of reporter, she declined to provide further details during the call.