Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Seizure like phenomena, Snoring, Tremor, Unresponsive to stimuli
Clinical narrative: Low blood sugar; snoring noises; clammy; pale skin; Vasovagal reaction with seizure like activity; Vasovagal reaction with seizure like activity; eyes rolled up; she was shaking; unresponsive; was feeling anxious about shot; Information has been received from Food And Drug Administration (Agency number: 824724) on 14-JUL-2020. This spontaneous report was received from a health care professional concerning a 22-year-old female non-pregnant patient. Allergy to sulfa drugs, reported from eye drops received for pink eye in childhood, the reaction was worsened with pink eye symptoms and swelling. None prescriptions, over the counter, medications, dietary supplements, or herbal remedies were taken at the time of vaccination. The patient's pertinent medical history and concurrent conditions were not reported. On 22-JUL-2019 at 09:20, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R021636, intramuscular in the left arm for prophylaxis. Expiration date (Lot No. R021636 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 12-MAY-2021). On the same date at 09:25, the patient had a vasovagal reaction (presyncope) with seizure like activity (seizure like phenomena) 5 minutes after receiving the second-round dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Reaction lasted 1-2 minutes, the patient was supported by staff in chair, eyes rolled up (eye movement disorder), and she was shaking (tremor) and unresponsive (unresponsive to stimuli), pulse was regular, and the patient was breathing, making 1-2 snoring noises (snoring). Clammy (cold sweat) and pale skin (pallor). The patient then became responsive and was lowered down to mat on floor. Apple juice and graham crackers were given. The patient reported issues with low blood sugar (blood glucose decreased), not having breakfast prior, and also was feeling anxious about shot. Vitals were within normal limits (WNL) respiratory rate (RR) 18 (unit not reported), blood pressure (BP) 103/83 (unit not reported), hearth rate (HR) 62 (unit not reported) at 09:36. The patient slowly returned to sitting then standing position and walked out of the clinic 20-30 minutes after adverse event. The outcome of presyncope, anxiety, blood glucose decreased, pallor, cold sweat, snoring, unresponsive to stimuli, tremor, eye movement disorder and seizure like phenomena was reported as recovered. The relatedness between the suspect therapy and the events was unknown.  Follow up information has been received from the registered nurse (previously described as a health care professional) on 28-JUL-2020. The patient's demographic details were provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Registered Nurse; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent