Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: he could "feel something go up my back"; About 15 minutes post vaccination he was standing next to the exam table and collapsed onto It,; he had urinary Incontinence; he was unconscious; color was pale to dusky; he appeared to move his arms and neck in a jerking motion; blood pressure (BP) 100/60; pulse 80s (units not provided).; he complained of his hands going numb; Information has been received from the agency on 25-SEP-2020.  This spontaneous report was received from a healthcare professional and refers to an 11-year-old male patient. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. He had no allergies to medications or food, however, he had some seasonal allergies to pollen. It was reported that the patient had seasonal allergies at the time of vaccination and up to one month prior were reported. The patient had no chronic or long-standing health conditions. However, it was stated by the reporter that he used albuterol sometimes when he had an upper respiratory infection (URI) for wheezing once or twice a year.  On 09-OCT-2019, at 11:15, 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 # R025726 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 26-MAY-2021, intramuscularly in the left arm (exact dose was not provided); the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) lot # reported as 429H5, intramuscularly in the right arm (expiration date and exact dose were not provided) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # reported as U6346AA, intramuscularly in the right arm (expiration date and exact dose were not provided); all for prophylaxis. On the same date, at 11:30 (also reported as about 5 minutes after the vaccination), he stated he could "feel something go up my back". The patient was standing next to an exam table and collapsed onto it; he was hold upright, he was unconscious; he appeared to move his arms and neck in a jerking motion, his color was pale to dusky, he opened his airway and slapped his face. The patient appeared to revive; he had an urinary incontinence. His vitals were rechecked: blood pressure (BP) 100/60 (units not provided), pulse 80s (units not provided). He was laid on the exam table. 911 was called. The patient was evaluated and oriented three times; by the time of ambulance arrival he was able to stand after sitting on side of the exam table. He did not want to go to emergency room (ER) so his parent took him home. He had fainted in the past but not the involuntary movement or incontinence. He also had complained of his hands going numb but the sensation returned. It was reported that the patient recovered from the events on 09-OCT-2019.  The relatedness between the aforementioned events and the suspect vaccines was not provided. The case was assessed by the agency as non-serious.  Follow up received from an unspecified reporter at physician's office via telephone call on 12-OCT-2020. It was reported the date of birth of the patient and she would inform the physician regarding this report. 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: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent