Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Skin exfoliation, Skin lesion, Stevens-Johnson syndrome, Tinea infection, Tonsillar hypertrophy
Clinical narrative: Information received on 30 July 2014 from a consumer who is the patient's parent. A three year old male child, who is now four years old, but date of birth not reported, was administered FLUZONE on an unspecified date last year, batch, route and site of administration not reported. The patient experienced Stevens-Johnson Syndrome on an unreported date. The patient's medical history and concomitant medications were not reported. The patient was hospitalized on an unknown date for an unknown duration. Laboratory tests were not reported. The patient outcome was not reported and is unknown. Follow-up information was received from the physician on 04 September 2014, and included medical records. The patient was seen by his physician on 21 October 2013 for his three-year well visit, at which time he received FLUZONE (lot number UH921AA) 0.5 mL intramuscularly in the right leg, and a second dose of hepatitis A vaccine (manufacturer and lot number not reported). Relevant family history included erythromycin allergy (maternal). Concomitant medications included ibuprofen, albuterol, and PULMICORT. At the time of the visit he was noted to have a rash (described as dry, scaly area) on his anterior thighs, but physical exam otherwise was within normal limits. He had previously received FLUZONE (lot number UH921AA) on 18 March 2011 and 12 October 2011 with no adverse reactions. Temperature prior to vaccination was 37 C (98.6 F). Routine laboratory testing, including urinalysis and complete blood count, were performed. On 22 October 2013, i.e., one day post-vaccination, the patient presented to his physician with eyelid edema, according to his parent he had woken up that morning with his "eyes swollen shut". Additionally, a single ringworm lesion was noted on the right knee at that time. The patient was afebrile, and a physical exam was otherwise unremarkable; the patient was diagnosed with eyelid edema and tinea corporis and prescribed clotrimazole 1%. He was instructed to use cool compresses to the eyes, and BENADRYL elixir 5 ml every 6-8 hours as needed. He subsequently developed a rash and swelling of the neck, and the following morning refused to raise his arms per his mother. He was seen by his physician again on 23 October 2013, where erythema on the face, axilla, and groin was noted, with peeling of the face. Tonsils were enlarged with exudate present. The patient was transferred to the emergency room for acute tonsillitis and possible streptococcal or staphylococcal infection. Laboratory testing in the hospital was normal except for a lactate of 2.9 and low RBC indices. He was admitted to the hospital with skin rash, allergic reaction, and allergic dermatitis. Temperature on admission was 100.5 F, and intravenous fluids were initiated, in addition to acetaminophen, ibuprofen and intravenous SOLU-MEDROL. On 24 October 2013 he developed new vesicular eruptions; laboratory testing showed no evidence of bacterial infection, and he remained afebrile. On 25 October 2013 he developed worsening of facial lesions, with more perioral involvement, with desquamation, and was "miserable when moved due to skin tenderness". At that time he was transferred to another hospital in order to be followed by a dermatologist, due to concern for Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome. SOLU-MEDROL and acetaminophen were discontinued. Medical records for the second hospital were not provided. On 14 November 2013 the patient was seen for a follow-up visit with his pediatrician, and which time no symptoms were noted. He was instructed to follow-up with an allergist at that time. On 25 November 2013, the allergist's evaluation noted "resolved Stevens-Johnson syndrome, probable reaction to vaccine component". The recommendations were to obtain a detailed print-out of all ingredients used for Hepatitis A and Influenza vaccines, and avoid all ingredients in future vaccinations. The allergist also recommended avoiding Influenza and Hepatitis A vaccination in the future. Documents held by sender: Office notes, immunization records.