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: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other health professional (physician's assistant) received by Pfizer from GlaxoSmithKline (Manufacturer Report No. A1056364A). A 10-week-old male patient received the first dose of PREVENAR 13 (Lot Number G47423) (initially reported as PREVENAR); the first dose of PEDIARIX (Lot Number 749CT, manufactured by GlaxoSmithKline) administered via an unspecified route into the thigh (initially reported as generic diphtheria, tetanus and acellular pertussis); the first dose of ROTATEQ (Lot Number J008932, manufactured by Merck) orally (initially reported as generic live attenuated human rotavirus vaccine); and the first dose of ACTHIB (Lot Number UH770A12, manufactured by Sanofi) (initially reported as generic Haemophilus influenza type b vaccine) all on 15Aug2013 (initially reported as 17Aug2013) (hepatitis b vaccine and poliomyelitis vaccine inactivated were not received as separate vaccines as initially reported). Relevant medical history included premature baby 26 to 32 weeks; born at 27 weeks (birth weight of 1kg) with routine referral to cardiologist, pulmonary, and eye doctors due to premature birth. Concurrent medications included unspecified vitamin and TYLENOL child formulation. The patient had no known allergies and had not received any previous vaccinations (this was the patient's first set of vaccinations). On 17Aug2013, 2 days after immunizations were received, the patient experienced rash and on 18Aug2013, the patient experienced erythema multiforme, hives, urticaria, fever, throat swelling (per the mother, but not per the hospital) and target lesion [bull's eye-skin lesion] (initially, anaphylaxis had incorrectly been reported). Clinical course was as follows: The patient presented with skin rash/contact dermatitis after having received the vaccinations. The patient was taken to the emergency room on 17Aug2013 for a rash and administered intravenous (IV) steroids. The patient was discharged from the emergency room the same day on oral steroids. The oral steroid prescription was not filled. The patient's rash worsened and he developed a fever up to 101 degrees Fahrenheit. Subsequently, he was admitted to the hospital on 18Aug2013 for erythema multiforme, hives, urticaria, fever, throat swelling (per the mother, but not per the hospital) and target lesion [bull's-eye skin lesion] and the treating physician considered the events life-threatening. According to a copy of the patient's hospital admission note on 18Aug2013: 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 has normal male genitalia, uncircumcised. Descended testes. Extremities: warm and well-perfused. The examination of the patient's skin: "he has varied size erythematous, target-like lesion most of his body including the face, trunk, legs and arms as well. It does not seem to be bothering the patient at this moment." Lab data on 18Aug2013 was as follows (no units reported): Alkaline phosphatase, 516; blood neutrophil count, 9; bicarbonate, 22; blood urea nitrogen, 14; C-reactive protein, 2.5; chloride, 104; creatinine, 0.22; hematocrit, 29; hemoglobin, 10; platelet count, 254; potassium, 6.2; segmented neutrophil count, 11; sodium, 135; white blood cell count, 9. The patient also had lumbar puncture (LP) performed; however, it was a bloody tap per the attending physician in the emergency room. Urine analysis (UA), urine culture, cerebrospinal fluid (CSF) culture, and blood culture were pending. There were no imaging studies done. The assessment and plan was as follow: 1) Admitted to general pediatric floor; 2) Continued on ceftriaxone 50mg per kg twice per day until cultures obtained; 3) Given TYLENOL for fever as needed; 4) The CMP was to be repeated for the high potassium the next morning and patient was allowed to have regular formula diet as he did not seem to be dehydrated; 5) Steroids started as the erythema multiforme seemed to be restrained to the patient's skin. His mucosal membranes were not affected and the patient was feeding well. Topical hydrocortisone for itchiness. The patient was discharged on 20Aug2013. The events of erythema multiforme, hives, urticaria, fever, throat swelling (per the mother, but not the hospital) and target lesion [bull's-eye skin lesion] resolved on an unspecified date. The outcome of the events elevated potassium and elevated alkaline phosphatase were unknown. Immunization series with PREVENAR 13; PEDIARIX; ROTATEQ; and ACTHIB were discontinued and the patient was referred to an allergist for allergy testing to determine which vaccine may have caused the reaction before administering any additional vaccines to this patient. The reporting physician's assistant considered the events were clinically significant (or requiring intervention) and required the patient to be hospitalized, but were not disabling or life-threatening (as initially reported). The reporting physician's assistant considered the events erythema multiforme, hives, urticaria, fever, throat swelling (per the mother, but not per the hospital), target lesion [bull's-eye skin lesion], elevated potassium and elevated alkaline phosphatase to be possibly related to vaccination with PREVENAR 13; PEDIARIX; ROTATEQ; and ACTHIB. 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. Follow-up (10Apr2014): Follow-up attempts completed. No further information expected. Follow-up (05May2014): New information reported by a contactable other health professional (physician's assistant) received from GlaxoSmithKline (Manufacturer Report No. RC/A1056364A) includes: Drug data (removed hepatitis b vaccine and poliomyelitis vaccine inactivated as separate suspect vaccines and changed date of administration for all suspect vaccines to 15Aug2013), concomitant medications, reaction data (changed event "anaphylaxis" to "erythema multiforme" and added events "blood potassium increased" and "blood alkaline phosphatase increased" and clinical details), outcome (erythema multiforme: recovered/resolved; blood potassium increased and blood alkaline phosphatase increased: unknown), causality (possibly related), and seriousness (medically significant and hospitalized).