Reporte zur Charge N014945

Symptomtext

POTS; Dysautonomia; syncope; constipation; Arm/Shoulder/Joint pain; Sinus tachycardia; Information has been received from a consumer via the Administration (# 857405) on 17-AUG-2022, regarding a 14-year-old non-pregnant female patient (also reported as male, inconsistent information). The patient's concurrent conditions included asthma. Previous drug reactions, or allergies reported were bee venom (also reported as honey bee, inconsistent information) and strawberries. On 03-FEB-2018 at 15:00 (also reported as 15:36, inconsistent information), the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (strength, dose, frequency, anatomical location, indication, lot number, and expiration date were not provided) indicated as prophylaxis. On the same fay, the patient was vaccinated with 1 dose of hepatitis A vaccine, inactivated (VAQTA)(also reported as hep a (HAVRIX), inconsistent information) intramuscular in the right arm (lot number N014945 has been verified to be a valid lot number, expiry date 17-JUN-2019) also indicated as prophylaxis. On 06-MAR-2019 (also reported as 06-APR-2019, inconsistent information), the patient experienced POTS (postural orthostatic tachycardia syndrome), dysautonomia (autonomic nervous system imbalance), syncope, constipation, arm/shoulder/joint pain (arthralgia), and sinus tachycardia (hospitalization and disability criteria for ). Additional laboratory and diagnostical tests were performed: electrocardiogram (EKG), electroencephalogram (EEG), Holter Monitor 1 week; "Holter monitor" 30 days; medtronic LOOP monitor implant in chest wall; full laboratory panels, thyroid panels, genetics review and counseling to rule out potential for anything else that could have contributed. The outcome of the aforementioned events was reported as not recovered. The causality assessment was not provided. Follow-up information has been received via telephone call to the physician office on 01-SEP-202 An unspecified reporter, stated that they could not help without a name and date of birth of the patient. The reporter was unable to find a healthcare provider who was completed the adverse event report. Additional information was not expected, all scheduled correspondence was canceled.