Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperature was hot all the time; floaters; cramping; pain in his joints; stomach aches; double vision; He would sleep 15-17 hours a day but never felt rested.; dizzy; difficulty with his balance; Information has been received from a lawyer and refers to a 16-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot#, and expiry date was not reported) for prophylaxis. Patient's mother was exposed that vaccine was safe, prevented cancer, and teenagers must got it. Immediately after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, patient fainted and when he came to, he did not feel well. Also experienced complete exhaustion and developed chronic fatigue. He would sleep 15-17 hours a day but never felt rested. He could not stay awake. He developed pain in his joints and generally felt unwell. He complained of stomach aches and cramping, which caused him to use the bathroom often at school, and at home. He started drinking one and a half to three gallons of water daily. Everyday tasks became difficult, including picking out clothes, taking a shower, choosing foods to eat, and brushing his teeth. He started experiencing confusion, anxiety, and irritability. His body temperature was hot all the time. Upon standing, he got dizzy, he had difficulty with his balance, and his heart would race. His vision was affected, and he experienced floaters and double vision. Patient was evaluated and treated by numerous specialists, including gastroenterologists, internal medicine doctors, dermatologists, psychologists, psychiatrists, cardiologists, sleep medicine doctors, neurologists, chiropractors, acupuncturists, immunologists, and Ear Nose and Throat doctors. He also received brain scans to determine the cause of his symptoms. At the reporting time, the outcome of the events was not reported. Causality assessment was related. Upon internal review, the event of fainted was determined to be medically significant.