Age: 22.0
Sex: F
Vaccine: HPV9, TDAP, HPV9, TDAP
Symptoms: Nausea, Oral pruritus, Pruritus, Rash, Swollen tongue
Clinical narrative: Anaphylactic reaction//difficulty breathing, wheezing, hives, sensation of tongue swelling after receiving tetanus and HPV; Dyspnoea/trouble breathing; Urticaria/hives; unspecified drug dispensing error; This report was identified from a line listing obtained on request by the Company from the Food and drug administration (FDA) under the Act (VAERS# 794687) from a patient's mother, regarding her 22-year-old daughter. The patient's drug allergies, concurrent conditions and concomitant medications were not reported. On 04-JAN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly in the left arm, lot # R021634, expiry date: 08-MAY-2021 (frequency not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL).   On 04-JAN-2019, about half an hour after the visit, the patient's mother called in and stated that they called ambulance due to patient having experienced anaphylactic reaction. The patient had trouble breathing and hives. The outcome of anaphylactic reaction, urticaria and dyspnoea was unknown. Causality of the events with respect to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.  Follow up information has been received on 03-JUL-2019 from a healthcare professional via FDA. The patient's concurrent conditions included allergy to peanuts, tree nuts, milk, shellfish and sulfa allergy. The patient was 22-year-old, non-pregnant, at the time of vaccination. It was reported that the patient received second doses of the suspect vaccines.   Follow up information has been received on 25-JUL-2019 from the medical assistant and a physician via medical records regarding patient. The patient was never a smoker, and did not use alcohol, or recreational drugs. Concurrent conditions included asthma and lactose allergy. Concomitant therapies included nortriptyline hydrochloride (PAMELOR), metformin hydrochloride, sertraline hydrochloride, spironolactone, cetirizine hydrochloride (ZYRTEC), epinephrine hydrochloride (EPIPEN), montelukast sodium (SINGULAIR), beclomethasone dipropionate (QVAR), albuterol sulfate (PROAIR) and sertraline hydrochloride (ZOLOFT). Her medical history included headaches including migraines, and an unspecified adverse event on 16-AUG-2007, when the patient was 11-year-old, following a vaccination with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Swelling was reported as adverse reaction to lactose, nut, shellfish, sulfa (described further as sulfonamide antibiotics), and tree nut allergies. The patient received hpv vaccination (provided as 1 previous dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the past and had no allergic reaction. On 04-JAN-2019 in the afternoon, 5 minutes after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL), sudden difficulty breathing, shortness of breath, wheezing, abdominal cramping, nausea, hives (urticaria), itchy mouth, and sensation of tongue swelling began. Immediately, the patient gave herself epinephrine (EPIPEN) injection, and her parents drove her to the emergency department for further evaluation. On 04-JAN-2019 (reported as at the time of the medication dispensing) an unspecified drug dispensing error occurred. The patient presented to emergency department with cough, abdominal pain, nausea, skin rash and itch. The patient reported that upon arrival in the ED, shortness of breath, wheezing, abdominal cramping and nausea resolved, but hives and sensation of tongue swelling continued. She was hospitalized due to anaphylactic reaction. It was reported that the patient denied fever, chills, eye pain, sore throat, chest pain, hemoptysis, vomiting, diarrhea, constipation, bloody stool, hematuria, dysuria, urinary frequency or urgency, back, neck, joint pain, or myalgia, headache, confusion, weakness, numbness, or bleeding. At 16:09, body temperature was 99.4 Fahrenheit (F), pulse rate was 125 H, respiratory rate was 20 (units not reported), blood pressure was 116/76 (units not reported), and oxygen saturation (O2 Sat) by pulse oximetry was 98 (units not reported). The physical exam was performed. The patient was alert, well appearing, with no acute distress, well developed, and had no signs of angioedema, or anaphylaxis. Head, eye, ear, nose and throat (HEENT) exam showed normal ear, nose and throat (ENT) inspection, normal pharynx, and lids, there were no signs of angioedema, uvula midline, no drooling or voice change was observed. Neck was supple, with no lymphadenopathy, meningism, or stridor. Respiratory exam showed no respiratory distress, chest was non-tender, and breath sounds were normal. Cardiovascular exam showed regular rate and rhythm (RRR), with no murmur or rub. Abdomen was non-tender, soft, there was no organomegaly, the bowel sounds were normal, and no rebound guarding or peritoneal sign was seen. Back was non-tender, with no midline, or costovertebral angle (CVA) tenderness. There was no extremity edema. Neurologically, she was alert, oriented x3, with no gross weakness. Psychologically, the mood/affect, and memory/judgment were normal. The skin was warm, dry, with no petechiae; however, urticarial to face, neck, and trunk was present, and Nikolsky sign was negative on bilateral arms. The physician had low suspicion of toxic shock syndrome, or toxic epidermal necrolysis.  Dexamethasone (DECADRON) and diphenhydramine hydrochloride (BENADRYL) were given for urticaria, and an additional dose of diphenhydramine hydrochloride (BENADRYL), and doses of famotidine (PEPCID) and normal saline to maintain pressure were administered to the patient. The patient and her family understood and agreed with the plan. On the same day at 18:30, the patient had re-evaluation assessment, which showed that the symptoms had improved. The patient reported resolution of sensation of tongue swelling, and had no further bouts of shortness of breath, wheezing, abdominal cramping or nausea. She was monitored for additional 90 minutes. At 20:05 on the same day, she had second re-evaluation assessment, which showed that the symptoms resolved. Resolution of urticaria was noted, lungs were clear to auscultation, there were no signs of angioedema, or anaphylaxis. The patient thought that she might have had allergic reaction to preservative, or bovine serum, a component of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). That possibility was discussed with the patient in the hospital. Diphenhydramine hydrochloride (BENADRYL) suspension every 6 hours for four days, and ranitidine hydrochloride (ZANTAC) or famotidine (PEPCID) suspension, reported as times 4 days were advised to be continued. Prednisolone suspension was prescribed to prevent rebound symptoms. The patient was advised to see her primary care provider in 3-5 days for reevaluation, and was given return precautions. The patient understood and agreed with the discharge plan, and on the same day, she was discharged home with her family, looking well, and in no apparent distress.  The reporter's causality assessment was not provided. All available medical records will be provided upon request.