Sex: F
Vaccine: HPV9, HPV9
Symptoms: Swelling face, Swollen tongue, Ultrasound thyroid normal, Urine analysis normal, X-ray gastrointestinal tract normal
Clinical narrative: could not eat because the food would not go down; food would not go down; her heart rate was 170 beats per minute which was very high for a young girl.; the patient had been up all night; stomach ulcers maybe burned a hole in her esophagus; stomach ulcers maybe burned a hole in her esophagus; severe chest pains/patient was having really bad chest pains again; Troubles breathing/felling like there was something stuck in her throat panicking because it was so hard to breathe; Black outs; Numbness In her fingers; severe back pain; Severe Headaches; Swelling In her face lips tongue and throat; Swelling In her face lips tongue & throat; Swelling In her face lips tongue & throat; Ribcage pain; felling like there was something stuck in her throat panicking because it was so hard to breathe; sore throat; antibiotics she was on created add reflux and stomach ulcers maybe burned a hole in her esophagus and possible bacterial Infection; possible bacterial Infection because strep and mono were negative as well; a lot of pain; Dizzy light headed near fainting; Information has been received from  the FDA (VAERS #: 800901) on 26-SEP-2019.  This spontaneous report refers to a 14 years old non pregnant female patient. The patient was perfectly healthy prior to the vaccine, other than the common flu ear infection that lead to ruptured ear.  Concomitant medication included birth control for several months and cefdinir (reported as cefdnor).  On 13-NOV-2018 at 15:45, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the left arm. On 19-NOV-2018, during a emergency room (ER) visit the patient complaint of severe chest pains, she could not breathe, severe back pain, felling like there was something stuck in her throat panicking because it was so hard to breathe, dizzy light headed near fainting, sore throat , swelling in her face lips and tongue, severe headache. Doctors in ER order upper gastro intestinal (GI), electrocardiogram (EKG), chest X-rays blood work for thyroid. Everything came back good. Doctors said antibiotics she was on created add reflux and stomach ulcers maybe burned a hole in her esophagus and possible bacterial Infection because strep and mono were negative as well. At this point the reporter was not even thinking about the shot she had a few days prior because they would think side effects would be 24 hours or so and doctors came back with bacterial Infection add reflux for medicine gave famotidine (PEPCID) and sent the patient home. On 27-NOV-2018, a follow up with the doctor she proscribed omeprazole (PRILOSEC) because the famotidine (PEPCID) was not working for acid reflux. Re tested for strep mono which both came back negative because the patient was not any better and in a lot of pain on going issue. So doctor ordered ultra sound of her thyroid all which came back normal nothing blocking her airway. On 13-DEC-2018, a call into the doctor the patient was having really bad chest pains again all of the above same symptoms doctor ordered 30 day heart monitor and to see ears, nose and throat (ENT). On 07-JAN-2019 we seen an ENT. On 16-JAN-2019 follow up with reg doc the heart monitor results not back yet continue what they were doing no PE still no change in the patient, health all of the above was still going on.  On 04-FEB-2019, they saw reg doctor, the patient had been up all night not being to breathe feeling like her air way was being blocked could not eat because the food would not go down, doctor done a chest a X-ray I, tested her urine for kidney Infection that was all normal no Infection. The test results were back for the heart monitor her heart showed stress her heart rate was 170 beats per minute which was very high for a young girl. These attacks would happen in the middle of the night sleeping during class, a heart rate that high should not happen when your sleeping or sitting, the school would contact them every time she would have one so they knew as the patient would report it through the monitor they gave her. Now the doc had ordered a computerized tomography (CT) scan with dye and we had to see a pediatric cardiologist on 15-FEB-2019.  Severe chest pains troubles breathing, black outs; dizziness, light headed, Numbness in her fingers, severe back pain, severe Headaches, swelling in her face lips tongue and throat, ribcage pain, the struggle was real they had lived at the doctors/hospital for months now the above dates were just high lights there was many others.  At the time of the report the outcome of gastric ulcer, dysphagia, hypophagia, insomnia, pain, high pulse rate,bacterial infection, gastrooesophageal reflux disease, oropharyngeal pain, sensation of foreign body, musculoskeletal chest pain, pharyngeal swelling, tongue oedema, face oedema, headache, back pain, hypoaesthesia, dizziness, loss of consciousness, dyspnoea, chest pain and oesophageal ulcer perforation was reported as not recovered. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review the events ulcer perforation and gastric ulcer were determined to be medically significant.  As of 18-DEC-2019, all telephone attempts to obtain follow up information have been unsuccessful.