Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Rash generalised, Streptococcus test, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse concerning an 11 year old male patient. The patient's medical history included hives as the reaction to unspecified penicillin. The patient did not have pertinent medical history. On 18-JAN-2016, the patient was vaccinated with a dose of GARDASIL 9 lot # L017407, expiration date 15-AUG-2017, intramuscularly (strength and dose were not provided). The patient did not take any concomitant medication. On 29-JAN-2016, the patient developed a rash and hives on the armpits and ankles that eventually spread over his entire body by an unspecified date in 2016. On an unspecified date in 2016, the patient received LOTRISONE cream as the treatment for the rash and hives. The patient recovered from the rash and hives on an unspecified date in 2016. Then, the treatment with LOTRISONE was discontinued on an unspecified date in 2016. On 25-MAR-2016, the patient was vaccinated with another dose of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, intramuscularly (strength and dose were not provided). On 28-MAR-2016, the patient developed a rash and hives on only the back of the arms and armpits. Then, on an unspecified date, the patient started on LOTRISONE cream therapy for this new case of rash and hives. At the time of the reporting, the patient was recovering from the new rash and hives. On an unknown date, the patient underwent "Strep test" but no result was provided. The patient sought medical attention via seeing the physician. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the registered nurse on 20-MAY-2016 concerning the male patient who was a student. There was no illness at time of vaccination. The assessments were reported as erythema multiforme (EM) minor and sore throat (onset date unknown, also reported as no sore throat). The onset of events had been acute. The duration had been 3 days. The patient had no fever, no rhinorrhea, no sore throat, no cough, no ear pain, no headaches, no abdominal pain, no vomiting and no diarrhea. The chief complaint was rash. The skin was positive for rash. The plans were reported strep culture (clinic collect) (for EM minor) and Point of Care Testing (POCT) rapid strep A antigen (for sore throat). EM minor and diff between major were discussed. The patient's mom would call if eye or mouth involvement triggered. BENADRYL was prescribed as treatment for the events. The rash was expected to come and go for next ten days possibly. Physician exam was reported as the following: constitutional: he appeared well, he was active, no distress; head: atraumatic; right ear: tympanic membrane and external ear normal; left ear: tympanic membrane and external ear normal; nose: nose normal; mouth/throat: mucous membranes were moist and definition was normal; eyes: conjunctivae and EOM were normal, pupils were equal, round, and reactive to light; neck: neck supple, no adenopathy; cardiovascular: normal rate, regular rhythm, S1 normal and S2 normal, pulses were palpable; pulmonary/chest: effort normal and breath sounded normal; abdominal: soft, bowel sounds were normal, he exhibited no distension and no mass, there was no tenderness; musculoskeletal: he exhibited no deformity; neurological: he was alert, he had normal strength and he exhibited normal muscle tone; skin: rash noted, rash was urticarial, no cyanosis and no pallor; multiple urticarial rings; erythema multiforme type rash; no eye or mouth involvement skin was warm. On 25-MAY-2016 at 11:45 AM, the patient was vaccinated with the second dose of GARDASIL 9 in his left arm at private doctor's office/hospital with private funds. The patient visited the emergency room/doctor and was diagnosed with erythema multiforme after the patient recovered from the event on an unknown date in 2016. Patient was seen today for rash. He was accompanied by his mother. It was reported that red blotches were all over body. Upon internal view, EM (on 26-JAN-2016 and on 28-MAR-2016) was considered to be medically significant. Additional information is not expected as all correspondence was received. Reporter information, patient information, labs, product, event and narrative were updated.