Sex: M
Vaccine: HPV9
Symptoms: Hormone analysis, Impaired gastric emptying, Inappropriate schedule of product administration, Laboratory test, Malnutrition
Clinical narrative: Patient diagnosed with gastroparesis; Low heart rate; Patient misdiagnosed with other mental illnesses; Patient misdiagnosed with an eating disorder; First dose administered on 12-OCT-2020 and second dose administered on 19-OCT-2021; This spontaneous report was received from a consumer (patient's mother), referring to her 16 year-old son. The patient did not have any medical history or drug reactions/allergies (reported as none), and his concomitant medications were not provided (also reported as his concomitant medications included erythromycin and ondansetron (ZOFRAN); conflicting information).  On 12-OCT-2020, 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) injection, lot #1687292 (expiration date not provided but upon internal validation established as 25-AUG-2022; route of administration and anatomical location were not provided), and on 19-OCT-2021 received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1687293 (expiration date not provided but upon internal validation established as 30-APR-2023; route of administration and anatomical location were not provided) (inappropriate schedule of product administration). Both vaccines were administered for prophylaxis.  Later, on an unknown date (reported as about 2 to 3 weeks after receiving the vaccine), the patient started throwing up after eating, not wanting to eat, and losing weight leading to poor nutrition. It was reported that the patient was misdiagnosed with an eating disorder and other mental illnesses, so he was checked for hormonal imbalances through blood tests (results not provided) and growth disorders by checking growth plates (results not provided). Additionally, on unknown dates, the patient developed low heart rate. Then, after having several tests done (including an upper gastrointestinal scope and a gastric emptying test (results not provided for both)) over the course of few months (unspecified dates), the patient was diagnosed with gastroparesis on 17-JUL-2023 and was prescribed erythromycin and ondansetron (ZOFRAN) as treatment. The patient sought medical attention through doctors' visits and was considered of high risk due to low heart rate and poor nutrition.  The reporter stated that after treatment her son seemed to be eating a bit more but thought it was topo early to "tell and that it could be a placebo". Additionally, she stated that they would visit patient's primary care doctor on 11-AUG-2023 for a check up and to access if the medication was working. By the end of the report, the reporter stated that patient's health care professional had pushed hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but she had been hesitant to agree to it.  By the time of the report, the patient had not recovered from the gastroparesis and low heart rate. The outcome of eating disorder and other mental illnesses was not provided.  The reporter's causality assessment between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event gastroparesis was determined to be medically significant.