Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Amenorrhoea, Anti-Muellerian hormone level
Clinical narrative: constipation; post viral ileus; started vomiting, several times a day, severe abdominal pain, admitted with pancreatitis; distended abdomen; difficulty breathing; cough; extreme constipation; premature ovarian failure; strep throat; walking pneumonia; reactive airway disease; thoracic outlet syndrome; strep throat; chronic regional pain syndrome; strep throat; strep throat; strep throat; walking pneumonia; viral gastroparesis; visceral hyperalgesia; gastrointestinal dystress; This report was identified from a line listing obtained on request by the Company from the FDA under the Act. The information was obtained from a consumer concerning a 14-year old female patient. The patient had no any pertinent concurrent conditions or medical history, not known drug reactions/allergies, and no illness at the time of vaccination and up to one month prior.  On 19-JUL-2016 at 10:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # L043213, expiration date on 28-AUG-2017, dose 1, intramuscular in the right arm for prophylaxis.        On 24-AUG-2016, the patient started vomiting several times a day.   On 01-SEP-2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # M013636, expiration date on 15-FEB-2018, dose 2, intramuscular in the left arm for prophylaxis.         On unspecified date in September 2016, the patient continued with vomiting and went to the emergency room (ER) visit with severe abdominal pain. Subsequently she was admitted to hospital with pancreatitis, abdominal pain, constipation and post-viral ileus. After 8 days of stay, the patient was released from hospital. However, the patient continued with vomiting, abdominal pain, and gastrointestinal distress. The patient started seeing a Gastrointestinal (GI) specialist from 26-SEP-2016. On 04-OCT-2016, she went again to a GI specialist for post viral gastroparesis and visceral hyperalgesia. Later, she contracted a first episode of strep throat in November 2016 and developed walking pneumonia therefore.   On 05-JAN-2017, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # reported as M32650, expiration date not provided, dose 3, intramuscular in the right arm for prophylaxis.         In February 2017, she had a second episode of strep throat, and in June 2017 the patient had a third episode of strep throat. In October 2017, she had a fourth episode of strep throat and again developed walking pneumonia. In January 2018, the patient had a fifth episode of strep throat. The patient was given antibiotics (unspecified) for each strep throat episode and received albuterol and steroid inhalers for walking pneumonia. On 17-NOV-2017, the patient had a left arm pain mimicking heart attack but was confirmed as thoracic outlet syndrome. In January 2018, the patient started seeing a pulmonologist for reactive airway disease. Later, on unspecified date, the patient had an ER visit for distended abdomen, extreme constipation, difficulty breathing and cough. In March 2018, the patient experienced amenorrhea. On 04-AUG-2018 thyroglobulin antibodies resulted 9 (units not provided) and thyroid peroxidase antibodies resulted 38 (units not provided).  Later in September 2018, premature ovarian failure was suspected, subsequently confirmed in January 2019. The patient received estrogen therapy as treatment.   The following lab tests were also performed: On 04-JAN-2019 thyroid Peroxidase antibodies resulted 47 (high, units not provided). On 14-JAN-2019 Luteinizing hormone resulted 32.7 (units not provided); follicle stimulating hormone resulted 87.8 (units not provided) and anti Mullerian hormone resulted 0.02 (units not provided).  The reporter stated that patient's adverse events required doctor or other healthcare professional office/clinic visit; emergency room/department or urgent care; and all events were considered disability or resulted in permanent damage.  At the reporting time, the patient had not recovered from the events, and the causality assessment between the event and suspect therapy was not provided.  Lot number M32650 is 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 physician on 18-NOV-2019. The physician reported the correct lot # L043213 of third dose and expiration date not reported, but upon internal validation established as 28-AUG-2017.