Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immunoglobulin therapy, Kawasaki's disease, Lip dry, Occult blood positive, Oedema
Clinical narrative: This case was reported in a literature article and described the occurrence of vasculitis in a infant female patient who received PEDIARIX for prophylaxis. Co-suspect products included ROTARIX for prophylaxis, Haemophilus influenzae type b vaccine for prophylaxis, PREVNAR 13 for prophylaxis, PEDIARIX for prophylaxis, ROTARIX for prophylaxis and PREVNAR 13 for prophylaxis. On an unknown date, the patient received the 1st dose of PEDIARIX, the 1st dose of ROATRIX (oral), Haemophilus influenzae type b vaccine at an unknown dose, the 1st dose of PREVNAR 13, the 2nd dose of PEDIARIX, the 2nd dose of ROTARIX and the 2nd dose of PREVNAR 13. On an unknown date, less than a week after receiving PEDIARIX, ROTARIX and Haemophilus influenzae type b vaccine and not applicable after receiving PEDIARIX and ROATRIX, the patient experienced vasculitis (serious criteria hospitalization and GSK medically significant), viral sepsis (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), edema (serious criteria hospitalization), erythematous rash (serious criteria hospitalization), hypoperfusion (serious criteria hospitalization), kawasaki's disease (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), hemorrhagic diarrhea (serious criteria hospitalization and GSK medically significant), erythromacular rash (serious criteria hospitalization), lip dry (serious criteria hospitalization), cracked lips (serious criteria hospitalization), conjunctivitis (serious criteria hospitalization), pedal edema (serious criteria hospitalization), erythema of extremities (serious criteria hospitalization) and swelling of feet (serious criteria hospitalization). The patient was treated with Aspirin and Immunoglobulin. Rechallenge with ROTARIX was positive. Rechallenge with PREVNAR 13 was positive. On an unknown date, the outcome of the vasculitis, viral sepsis, fever, edema, erythematous rash, Kawasaki's disease, fever, hemorrhagic diarrhea, erythromacular rash, lip dry, cracked lips, conjunctivitis, pedal edema, erythema of extremities and swelling of feet were recovered/resolved and the outcome of the hypoperfusion was unknown. The reporter considered the vasculitis, viral sepsis, fever, edema, erythematous rash and hypoperfusion to be possibly related to PEDIARIX, ROTARIX and Haemophilus influenzae type b vaccine. The reporter considered the kawasaki's disease, fever, hemorrhagic diarrhea, erythromacular rash, lip dry, cracked lips, conjunctivitis, pedal edema, erythema of extremities and swelling of feet to be possibly related to Pediarix and ROTARIX. Additional information was provided. This case was reported in a literature and described the occurrence of suspected viral sepsis and Kawasaki disease (KD) in a female of unspecified age who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX (RV1) (GlaxoSmithKline), unspecified haemophilus influenzae type B (Hib) vaccine (manufacturer unknown) and PREVNAR 13 (Wyeth/Pfizer) for prophylaxis. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date at the age of 2 months, the patient received PEDIARIX, ROTARIX, unspecified haemophilus influenzae type B (Hib) vaccine and PREVNAR 13 (administration route and site unspecified, dosage unknown; batch number not provided for all). On an unspecified date, 1 week after vaccination, the patient was first admitted with fever, oedema and erythematous-purplish rash of the extremities. At presentation, the patient had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. On an unspecified date, at the age of 2 months, at the routine 4 months well child visit, the patient received PEDIARIX, ROTARIX and PREVNAR 13 (administration route and site unspecified, dosage unknown; batch number not provided for all). On an unspecified date at the age of 4 months, 12 hours after vaccination, the patient developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time the patient had a temperature of 39.4 deg.C, haeme-occult positive diarrhoea, and an erythematous macular rash on her torso. By DOI 7, the patient had dry, cracked lips, intermittent non-purulent conjunctivitis, and oedematous feet with red soles. KD was suspected based on standard agency criteria, laboratory data were notable for C-reactive protein 97.1 mg/L, haemoglobin 10.2 g/ dL, and albumin 2.8 g/dL (normal range not provided for all); viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 deg.C fever, the patient was given intravenous immunoglobulin (IVIG) and aspirin on DOI 9. The patient defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, the patient was at her clinical baseline at discharge on DOI 11. Subsequently, the patient received all expected 6 months vaccines except ROTARIX, and received measles-mumps-rubella (MMR) and Varicella vaccines at 12 months, all with no issues and had remained otherwise well through 15 months of age. This case has been considered as serious due hospitalisation. The authors stated, "The current patient's first presentation after vaccination, with widespread rash and oedema, was consistent with vasculitis; her second met the criteria for KD, and the prompt response to IVIG corroborated this diagnosis. The rapidity of symptoms after the second round of vaccinations suggested the possibility of antigen sensitization with her previous exposure and an immune-mediated phenomenon. It is worth noting that the patient's personal contacts all lacked any illnesses around the time of diagnosis, and there were no other KD cases in the present hospital for 4 weeks before or after. Given an absence of issues after the 6 month immunizations when ROTARIX was omitted, we suspect that this vaccine was the precipitating agent; nevertheless, an independent or combined effect with a concomitantly received immunization remains possible". The authors concluded, "vaccines may potentially be associated with vasculitides, including KD, in individual children, and ongoing, systematic surveillance of such events is warranted, particularly for newer immunizations". Lab Comments: Lab tests were performed on an unspecified dates. At the age of 2 months, all cultures were normal/negative. At the age of 4 months, the patient had haeme-occult positive diarrhoea.