Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Crying, Dizziness, Dysstasia, Nervousness
Clinical narrative: started to cry; unable to stand; feeling weak; dizzy; This spontaneous report was received from a healthcare professional on 18-AUG-2020 and refers to an 11-year-old, male patient. The patient had no known allergies, no illness at the time of vaccination and up to one month prior, and no chronic or long-standing health conditions. He had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. The patient was feeling well at first. He was not talkative and expressed being nervous about vaccines. He denied any side effects from vaccines in the past. The patient was reminded to tell father or nurse if he was not feeling well. He nodded and agreed. The patient was reminded to relax and practice deep breathing during administration of vaccines.  On 23-AUG-2019 at 10:00, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R016971, expiration date was not reported but upon internal validation established as 22-MAR-2021, intramuscularly in the right arm (dose was not reported), first dose of meningococcal acyw conj vaccine (crm197) (MENVEO) lot number amva152a, intramuscularly in the right arm (dose and expiration date were not reported), first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number R033656, expiration date was not reported but upon internal validation established as 20-NOV-2020, subcutaneously in the left arm (dose was not reported), the second dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) lot number 97nl3, intramuscularly in the right arm (dose and expiration date were not reported) and first dose of hepatitis a virus vaccine inactivated (HAVRIX) lot number 2gy7e, intramuscularly in the left arm (dose and expiration date were not reported), all for prophylaxis (also reported as patient was administered 3 vaccines on each arm).  On 23-AUG-2019 at 10:02, once the vaccine administration was finished, the patient was asked if he was feeling well, he shook his hand and started to cry. The patient was unable to stand. He reported feeling weak and dizzy. He was kept in an exam room to monitor symptoms. He denied eating that morning. He was given an ice pack to use on back of neck and forehead. The patient's father was with him during entire time of nurse visit. The patient stayed in clinic for at least 20 minutes to monitor symptoms. He was feeling better and was able to walk by himself. He reported feeling a lot better after resting in exam room. There were no medical tests and laboratory results related to the adverse events. The outcome of the events was reported as recovered/resolved. The relatedness between the events and the suspect therapies was not provided.  Follow-up information has been received from a registered nurse on 21-SEP-2020. It was reported that the reporter was not able to provide additional information regarding the events because of limited demographics to identify the patient. 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: R016971; expirationdate: 22-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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