Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Oropharyngeal discomfort, Pruritus, Rash, Rash papular
Clinical narrative: feeling abnormal; pruritus/ Pt was itchy on the buttocks but no rash noted there; rash/ rash that they noticed 3-4 hours following his 1st HPV vaccine/ Fine, diffuse, red/pink papular rash located on forehead, outer ear, behind both ears, and faintly on upper back; rash pruritic/ Pruritic rash was located on the forehead and this morning, mom noticed that it had spread to the ears, behind the ears and upper back; throat "felt different", when swallowing; throat "felt different", when swallowing; This spontaneous report was received from a Regulatory Authority (Reference No. 742986) and refers to a 13-year-old male patient. The patient's chronic or long-standing health condition included shellfish allergy. The patient had not current illnesses, was not on other medications and had not any laboratory data. The patient's prior vaccinations were not provided.    On 02-APR-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022728, expiry date on 31-MAY-2020, intramuscularly, in the right arm (exact dose was not reported) for prophylaxis. On the same vaccination date, patient/parent reported 3-4 hours after first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, developed a pruritic rash located on his forehead  which then spread to his ears and behind his ears. Later, in the evening, complained his throat felt different when swallowing but it was not swollen, no tongue involvement, no cough or vomiting. The patient woke at morning with rash on his back and continued rash on forehead and ears. The patient also complained of his buttocks was itchy but no rash was noted. He was given diphenhydramine hydrochloride (BENADRYL) at that morning before assessment and parent noticed some fading. There was no rash at injection site (feeling abnormal, rash pruritic, rash and pruritus).  At the reporting time, the outcome of feeling abnormal, rash pruritic, rash and pruritus was unknown. The causality assessment between the aforementioned adverse events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information has been received from a registered nurse via the agency (Reference No. 742986) on 15-APR-2019 regarding the patient. The patient was allergic to penicillin. The vaccination date was updated to 02-APR-2018 at 16:11. The onset date of the events was updated to 02-APR-2018 at 19:00.  Follow up information was received from the registered nurse on 17-MAY-2019. The patient's concomitant medications included epinephrine hydrochloride (EPIPEN) and diphenhydramine hydrochloride (BENADRYL) (also reported as a treatment). The patient had allergy to penicillin V potassium (previously reported as penicillin), the drug reaction was hives.  The patient was vaccinated in the right deltoid (previously reported as in right arm). On 03-APR-2018 during the examination, the patient's pulse was 80 (units not provided), body temperature (axillary) was 98.6 Fahrenheit degree (37 Celsius degree), body weight was 187 Ib 9.6 oz (85.1 kg), oxygen saturation (SpO2) was 99%, the patient denied shortness of breath, fever, syncope. He stated that he did not eat anything usual, no recent yard work or time outdoors. No new soaps or detergents. His examination revealed: generally: well appearing, alert, no acute distress; head: normocephalic, atraumatic; eyes: conjunctiva clear, no discharge, eyelids within normal limits (wnl); ears: no rhinorrhea, no nasal congestion; oral: Moist mucous membranes. No lesion, no erythema, exudate or petechiae, tonsils 3+; neck: supple, no significant adenopathy; coronary: rubs, regular rate and rhythm (rrr), normal (nml) S1 and S2, no murmurs, or gallops; pulmonary: clear to auscultation, no grunting, flaring, or retracting; skin: fine, diffuse, red/pink papular rash located on forehead, outer ear, at behind both ears, and faintly on upper back, no rash injection site. The treatment of the events was diphenhydramine hydrochloride (BENADRYL) administered for 24 to 48 hours, followed by cetirizine hydrochloride (ZYRTEC) for one week. Duration of pruritic rash was 24 hours, the patient recovered on 03-APR-2018 at 19:00. Duration of throat "felt different" when swallowing was 72 hours, the patient recovered on 05-APR-2019 at 19:00.