Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered at inappropriate site, Erythema multiforme, Laboratory test, Rash
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had a "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot number, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot number 749CT, 0.5 ml, unknown route, left arm) and experienced vaccine administered at inappropriate site. The preferred administration site for PEDIARIX was the anterolateral aspect of the thigh for children younger than 1 year. Concomitant therapies included vitamin (unspecified) and CHILDRENS TYLENOL. On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up has been received on 08-MAY-2014 from a physician's assistant via another company (GlaxoSmithKline, manufacturer control number: A1056364A). The patient age was reported as 10 weeks old (previously reported as 2 months old), he was born at 27 weeks (previously reported as 31 weeks), had no known allergies. No adverse events occurred with previous vaccinations. The patient's birth weight was 1 kg. On 15-AUG-2013 the patient was vaccinated with a first dose of ROTATEQ (expiration date, strength and frequency were not reported), orally. Lot number J008932 is an invalid lot number for ROTATEQ. Other suspect therapies that were administered on the same day (15-AUG-2013) included: a first dose of ACTHIB (lot number UH770A12), a first dose of PREVNAR 13 (lot number G47423) and a first dose of PEDIARIX (lot number 749CT, 0.5 ml, unknown route, thigh (also reported as left arm, which was an event of vaccine administered at inappropriate site) vaccine. Illness at the time of vaccination was reported as premature baby 26 to 32 weeks. It was reported that the patient had no concomitant medications, also reported that other medications included unspecified vitamin and CHILDRENS TYLENOL. On 17-AUG-2013, 2 days after vaccination with ACTHIB, PEDIARIX, PREVNAR 13 and ROTATEQ, the subject experienced erythema multiforme, hive, urticaria, fever, throat swelling (per the mother, but not the hospital) and target lesion [bull's-eye skin lesion]. The subject presented with was skin rash/contact dermatitis. The reaction occurred after receiving one dose of vaccines. The subject was managed with prednisone and ceftriaxone. The duration of the reaction was unknown but the subject made a full recovery. Laboratory tests were performed; biopsy was not. There was no other history with drugs or allergic reactions. The patient was taken to the emergency room on 17-AUG-2013 for a rash and discharged the same day on oral steroids. Intravenous (IV) steroids were given prior to discharge. The oral steroid prescription was not filled. The subject's rash worsened and he developed a fever up to 101 degrees Fahrenheit. Subsequently, he was admitted to the hospital on 18-AUG-2013. He was treated with ceftriaxone and discharged on 20-AUG-2013. According to a copy of the patient's hospital admission note on 18-AUG-2013: History and Physical: Cardiovascular: regular rate and rhythm. No murmurs. Lungs: Clear to auscultation bilaterally. Abdomen: soft, non-tender, non-distended: No hepatosplenomegaly. Genitourinary: he had normal male genitalia, uncircumcised. Descended testes. Extremities: warm and well-perfused. The examination of the subject's skin: "he had varied sized erythematous, target-like lesion most of his body including the face, trunk, legs and arms as well. It did not seem to be bothering the patient at this moment". Laboratory examination: the patient had had a CBC (complete blood count) done that shows a white count of 9, H and H (hemoglobin and hematocrit) of 10 and 29, platelet count of 254 with 9 bands and 11 segs. CRP (C-reactive protein) is 2.5. His BMP (basic metabolic panel): sodium 135, potassium 6.2, chloride 104, bicarbonate 22, BUN (blood urea nitrogen) 14, creatinine 0.22. The rest of his CMP (complete metabolic profile), he has an elevated alkaline phosphatase of 516. The patient also had an LP (lumbar puncture) done; however, it was a bloody tap per the attending physician in the emergency room. We had urine analysis (UA), urine culture, CSF (cerebrospinal fluid) culture and blood culture pending at this moment. There were no imaging studies done. Assessment and plan: this was a 10-week old male at 27 weeks premature that presented with fever and erythema multiforme. The plan for him was: 1) Admit to general pediatric floor. 2) Continue on ceftriaxone 50mg per kg bid until cultures are obtained. 3) Give TYLENOL for fever prn (when needed). 4) Repeat the CMP in the morning for the high potassium. Allow the patient to have regular formula diet at this moment as he does not seem to be dehydrated. 5) We would not start steroids at this time, as the erythema multiforme seems to be restrained to the patient's skin. His mucosal membranes are not affected and the patient is feeding well. He can have topical hydrocortisone for itchiness. No further recommendations at this time. At the time of reporting the events were resolved; resolution date was unknown. The outcome of the elevated potassium and elevated alkaline phosphatase was unknown. Immunization series with ACTHIB, PEDIARIX, PREVNAR 13 and ROTATEQ were discontinued. The reporting physician's assistant considered the events were clinically significant (or requiring intervention) and required hospitalized but were not disabling or life threatening; and possibly related to vaccination with ACTHIB, PEDIARIX, PREVNAR 13 and ROTATEQ. The physician's assistant also associated the events to medical history/concurrent illness of "premature infant, multiple vaccines given, fever indicates a possible underlying infection." Additional information has been requested.