Reporte zur Charge 46204AA

Symptomtext

Dehydration; "Gray" face; WBC count was elevated; Continued flu; Became hot; Weak; Information has been received from agency (VAERS 829730) on 04-SEP-2020. This spontaneous report was received from a registered nurse concerning a 11-year-old male patient. The patient's concurrent conditions included asthma (being evaluated for cough x 24 since "he had none"). The patient's medical history and concomitant medications were not reported. On 08-AUG-2019, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), in the right arm, lot number reported as R025651 for prophylaxis (route of administration was not provided). On the same date, the patient also received the first dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), in the right arm, lot number reported as 46204AA and the sixth dose also reported as "5 previous doses" of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, in the right arm, lot number reported as 91NL3; both for prophylaxis. The patient did not receive other vaccines within 4 weeks prior to these vaccinations. On the same date, approximately 1 hour after vaccination, the patient became hot, weak and mother stated that had "gray face", an ambulance was called and he was seen in ER (emergency department); the patient received IVF (intravenous fluids) for dehydration and also was noted that WBC (white blood cell) count was elevated. Additionally, was reported that the patient was having continued flu and "PND". The patient had no illness at the time of vaccination and did not have adverse events following prior vaccinations. At the reporting time, the patient recovered from the reported events on unspecified dates. The reporter did not provide a causal assessment between the reported events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. Lot number R025651 was confirmed as an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow-up information has been received from the registered nurse on 07-MAY-2021. The lo# of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was provided as R032768, expiration date not reported, upon internal validation established as 31-AUG-2021. 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: R032768; expirationdate: 31-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent