Reporte zur Charge N020353

Symptomtext

anxiety.; eyes rolled back and she appeared to be having a mild seizure; lethargic; nauseated; syncopal episode/passed out/loss of consciousness; Information has been received from the Food and Drug Administration (FDA) (Vaccine Adverse Experience Report on 04-SEP-2020. This spontaneous report was received from a registered nurse and refers to a 15-years-old, non-pregnant female patient. It was unknown if she took any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at the time of vaccination. She had no allergies to medications, food or other products. It was not reported if she had other illnesses at the time of vaccination and up to one month prior, and no chronic or long-standing health conditions. The patient's mother verbalized no known previous reactions to any vaccines. On 19-SEP-2019 at 11:20, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administrated intramuscularly into the left arm (dose was not provided; lot # N020353 was confirmed to be valid; expiration date was not reported but upon internal validation process, it was established as 28-APR-2020) for prophylaxis. On the same date, she also received the first dose of hepatitis a virus vaccine inactivated (HAVRIX) into right arm (lot number PA99T; dose, strength and expiration date was not provided); diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) into left arm (lot number U6378AA; dose, strength and expiration date was not provided), and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) also into right arm (lot number U6543AA; dose, strength and expiration date was not provided). All vaccines were administrated intramuscularly for prophylaxis. During administration of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and hepatitis a virus vaccine inactivated (HAVRIX) vaccines the patient was conversing with the reporter and her mother throughout but was showing some anxiety. After that, the left arm vaccines were given of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL). Shortly after completed with left arm vaccinations, the patient's eyes rolled back and she appeared to be having a mild seizure. She laid back on a table. She passed for around 15 seconds, she sat up with help but was very lethargic. She said she was nauseated. the patient's mother went to waiting room to get family member while the nurse stayed with the patient. On return they discussed visiting her doctor or the emergency room. The patient family member attempted to carry her out and she passed out again in hallway. She was held and eased down to floor by family. the patient was not harmed during transfer. The nurse called 911 to have patient evaluated for safety purposes. No allergic reaction evident, no redness, hives or breathing issues, just what appeared as a mild initial seizure and fainting episodes. the patient was evaluated by emergency medical services (EMS). Blood sugar and vitals were within normal limits. She was transported to local emergency room (ER) for evaluation. The reporter has provided vaccination Information and her contact information to the patient's mother. It was unknown if the patient recovered from the adverse events. The relatedness between the aforementioned events and the suspect vaccines was not provided. The case was assessed by the FDA as non-serious. Follow up information has been received from the registered nurse on 25-JAN-2021 via questionnaire. The patient had no previous reactions to vaccines. On 19-SEP-2019, the patient was vaccinated with 4 vaccines hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # U6378AA (conflicting information, previously reported as N020353 which was valid lot # for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # U6378AA is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number U6378AA does not match any Company product as confirmed by Lot Verification team), therapies included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) lot # PA99T (conflicting information, previously reported as U6378AA), hepatitis a virus vaccine inactivated (HAVRIX) lot # N020353 (conflicting information, previously reported as PA99T) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA). Previously reported events were further described. On the same date, once completed vaccinations, while the patient was sitting on an exam table, the patient became lethargic, eye-rolling, than syncopal episode (also reported as loss of consciousness). The nurse called for ambulance, and the patient was taken to ER to be evaluated and to rule out seizure or reaction to vaccines. The nurse reported possible seizures, but it was reported that the ER physician assessed the event not a seizure, only severe anxiety and not a vaccine reaction, therefore event seizure was deleted. The nurse talked with the patient's mother 2 hours after the event, and she stated that the patient was doing well, and the outcome of became lethargic, eye-rolling and syncopal episode was reported as recovered. The patient was sent home from the ER. The causality assessment between the events and the suspect vaccines was not provided. Upon internal review the events of syncope was determined to be medically significant.