Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Spinal X-ray abnormal, Staphylococcus test negative, Stridor, Swelling, Swelling face
Clinical narrative: Wheezing; Anaphylactic reaction; Oxygen saturation decreased; Stridor; Swelling face; Swollen tongue; Tachycardia; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 21-year-old female patient. The patient's medical history included malfunction of ventricular shunt, multiple somatic complaints, mast cell activation, sleep apnea, idiopathic normal pressure hydrocephalus (INPH), allergy, insomnia, tachycardia, gastroesophageal reflux disease (GERD), shortness of breath, obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, neutrophilic leukocytosis, psychogenic nonepileptic seizure, vocal cord dysfunction, syncope, anaphylaxis, abnormal vision, pseudotumor cerebri, other headache syndrome, degeneration of lumbar or lumbosacral intervertebral disc, neck pain, shoulder pain, temporomandibular joint disorder, somatoform disorder, ankle pain, depressive disorder, auditory processing disorder, attention deficit hyperactivity disorder, knee pain, eczema, patellofemoral syndrome, sinusitis and asthma.  Before vaccine administration, the patient denied any problems with vaccines in the past, but "her mother came into room with reaction and rep". On 21-FEB-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N001533, expiration date 16-OCT-2019, intramuscularly in the right arm (dose was not reported). Concomitant therapies included acetaminophen (TYLENOL), ibuprofen (MOTRIN) and medical cannabis.  On 21-FEB-2018, the patient experienced anaphylactic reaction, swelling face, swollen tongue, tachycardia, oxygen saturation decreased, wheezing and stridor. The reactions started 8-10 min after administration and the patient was treated with epinephrine hydrochloride (EPIPEN) twice, oxygen and emergency was called with transport to the hospital. She was hospitalized due to the events. The outcome of anaphylactic reaction, wheezing, tachycardia, swollen tongue, swelling face, stridor and oxygen saturation decreased was reported as unknown.  The causal relationship between the events and the vaccine was not reported.   The Agency considered the events to be life-threatening.  Follow up information was received from a nurse on 15-APR-2019.  The patient was female, who was not pregnant at the time of vaccination. Previously reported medical history was also described as chronic or long-standing health conditions. Also as the patient's medical history were added anaphylactic reactions requiring hospitalizations, idiopathic anaphylaxis, left (L) ankle surgery, being obese, pseudotumor cerebri s/p verticulo-peritoneal (VP) shunt, sinus surgery with septoplasty and vocal cord disfunction was described as paradoxical vocal cord dysfunction with multiple onabotulinumtoxinA (BOTOX) injections. The patient drug allergies included acetaminophen (+) butalbital (+) caffeine (FIORICET) (on 07-JAN-2016, anaphylaxis high), lidocaine (on 17-JAN-2017, anaphylaxis high), methadone hydrochloride (on 07-JAN-2015, anaphylaxis high), phenylephrine hydrochloride (on 08-AUG-2017, anaphylaxis, hives, high), ophthalmic phenylephrine eye drops (unspecified) (anaphylaxis), metoclopramide hydrochloride (REGLAN) (on 11-JUN-2015, shortness of breath, allergy, burning sensation in chest), trazodone (on 24-JUL-2014, itching, rash, unspecified high allergy), tropicamide (on 28-FEB-2017, high shortness of breath, burning eyes), duloxetine hydrochloride (CYMBALTA) (on 06-FEB-2015, unspecified allergy, tachycardia), venlafaxine hydrochloride (EFFEXOR) (18-JAN-2016, urinary retention), heparin (on 23-JUL-2015, itching), ibuprofen (on 02-MAR-2016, allergic reactions), polyethylene glycol 3350 (on 24-FEB-2014, itching, allergy), tiotropium bromide (SPIRIVA HANDIHALER) (on 29-APR-2016, "chest popping"), topiramate, (on 06-JAN-2019, acidosis). The patient could not take tramadol combined with fluoxetine hydrochloride (PROZAC) or sertraline hydrochloride (ZOLOFT), because it provoked seizures to occur. There was also reported allergy to butalbital, enoxaparin sodium, tiotropium bromide, citalopram hydrobromide, duloxetine hydrochloride, sertraline hydrochloride and venlafaxine. The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 21-FEB-2018 at 11:15. The adverse events started on the same date at 11:25. On the same date, the patient was admitted to the hospital with vocal cord dysfunction and allergic reaction, pseudo-tumor cerebri. She developed shortness of breath (SOB), stridor and wheezing after vaccination. Emergency Medical Services were activated and she was transported to emergency room (ER) where she w3as given epinephrine, diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), despite normal oxygenation and capnometry. Arrival physical examination (PE) included tachycardia and anxiousness. She was complaining about itching. When the patient was observed from outside room, there was no respiratory issues, oxygen saturation within normal limits (WNL). When providers entered room, the patient was complaining about shortness of breath and made gasping respiratory noises. She was admitted to intensive care unit (ICU), where treatment (Tx't) included lorazepam (ATIVAN), diphenhydramine hydrochloride (BENADRYL), hydroxyzine, epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL) and histamine receptor blockers (unspecified). The treatment made significant improvement and the patient was transferred to the floor. She had 2 short episodes of stridorous breathing as well as anxiety, a few scattered wheals over abdomen and scratch marks to face and trunk. The patient intermittently held breath for prolonged periods (with oxygen saturation dropping to 80s and rapid return to 99 percent (%)) with return of breathing prior to receiving diphenhydramine hydrochloride (BENADRYL) methylprednisolone sodium succinate (SOLU-MEDROL). There was an otolaryngologist (ENT) consultation. During inpatient the labs diagnostics tests were performed which revealed white blood cell count (WBC) 15.7 1000/microliter (K/ul) (high), lymphocyte percentage (reported as lymphs) 6.6 % (low), monocyte percentage/count (reported as monos) 9.3 % and 1.1 K/ul (increased), neutrophil percentage/count (reported as neutros) 90 % (increased), 51 % (low) and 14.2 K/ul (low), red blood cell count (RBC) 4.04 millions per deciliter (M/dL) (low), hematocrit (Hct) 35.5 % (low), hemoglobin (Hgb) 11.4 gram per deciliter (g/dl) (high), blood urea (BUN) 25 milligram per deciliter (mg/dl) (high), creatinine 1.1 mg/dl (high), fasting glucose 133 mg/dl (high), blood magnesium (reported as Mg) 2.2 mg/dl (high), blood phosphorus (reported as PO4) 4.6 mg/dl (high), blood potassium (reported as K) 5.1 (high) and 3.3 (low) milliequivalent per liter (mEq/l) and blood sodium 134 mEq/l (low). There was also performed methicillin-resistant staphylococcus aureus test with a negative result. Neck X-ray showed marked soft tissue swelling obliterating supraglottic airway consistent with (c/w), angioedema, normal infraglottic airway. The Chest X-ray (CXR) was within normal limits  and an arterial blood gas test (ABGs) with an abnormal result. On 25-FEB-2018, the patient was sent home in good condition with treatment and follow up instructions.  The outcome of reported events was unknown.  Reported adverse events required doctor or other healthcare professional office/clinic visit, emergency room visit.  This is an amended report. For the event of wheezing there was added onset date 21-FEB-2018 at 11:25. For other encoded date there was added onset time at 11:25.  As of 02-JUL-2019, all telephonic attempts to obtain follow-up information have been unsuccessful.