Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Oedema mouth, Pharyngeal oedema, Rash
Clinical narrative: Information has been received from a physician concerning a 25 year old female with a history of allergies and who has swelling with topical benzoyl peroxide who on 06-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot# 659055/1522U). Concomitant therapy included montelukast sodium, (dose, duration and indication not reported). Other concomitant therapy included ZYRTEC. On 06-DEC-2007 the patient experienced redness at injection site within seconds of receiving the injection, redness on face and neck and felt "weird". No shortness of breath was noted. The patient was taken by ambulance to the hospital. The doctor did not want the staff to give the patient an epi pen since he wanted to check her first. The patient's redness at injection site, redness on face and neck and feeling "weird" persisted. The patient sought unspecified medical attention. Additional information has been requested. Information has been received from a physician concerning a 25 year old white female with seasonal allergies and who has swelling with topical benzoyl peroxide who on 06-DEC-2007 at 1:10 pm was vaccinated IM into left deltoid with a first 0.5ml dose of GARDASIL (lot# 659055/1522U). Concomitant therapy included MSD, (dose, duration and indication not reported). Other concomitant therapy included ZYTREC. On 06-DEC-2007 at 1:10 pm, the patient experienced redness at injection site that was probably 10x10 cm. At 1:20 pm, after receiving the injection, the patient felt hot all over and experienced redness on her face and neck anad felt "weird." No shortness of breath was noted. Her pulse was in the 60s and her blood pressure was 110/80. The patient was taken by ambulance to the hospital. The doctor did not want the staff to give the patient an epi pensince he wanted to check her first. Upon arrival to the hospital, at 2:15 pm, the patient's vital signs were as follows: Temperature of  98.7, her pulse was 75/min, her respirations were 18/min, her blood pressure was 162/85 mm/hg and her pulse ox was 99% on room air. She rated her pain a 0 out of 10. At 2:13 pm, the patient's examination started. Her history and presentation was consistent with an acute allergic dermatitis. This was a new problem, with no prior history of similar episodes. No itching was present. The patient presented with a generalized non urticarial skin rash. She denied any trouble breathing, no nausea or vomiting. She did have an isolated localized skin rash. The patient complainted of feeling a lump in her throat, but no other airway or throat symptoms. It was reported that this reaction was due to the GARDASIL. The patient developed a trace sense of swelling in the back of the throat and mouth. No evidence of upper airway stidor, loss of voice, or trouble swallowing prior to the exam. Symptoms were currently rated as merely annoying. The patient denied any chest pain, trouble breathing or audible wheezing. A primary diagnosis of allergic reaction was made at the hospital. On 06-DEC-2007, the patient recovered and was discharged from the hospital. The primary care physician spoke to the patient at 16:40 and she was on her way home. She stated she felt better and that she received BENADRYL and steroids (PREDNISONE) at the hospital. (The patient was prescribed PREDNISONE 40 mg PO daily for 5 days). It was reported that the patient understood her after care instructions, the need for follow up and how to access follow up care and signs and symptoms to return to the emergency department. The patient also verbalized that she should not receive another GARDASIL injection. No product quality complaint was involved. Additional information is not expected.