Age: 15.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Metabolic function test, Metabolic function test normal, Syncope, Tremor, Urine analysis normal
Clinical narrative: Initial report was received on 15 December 2011 from another manufacturer (manufacturer control number WAES 1111USA02846). The following is verbatim from the report: "Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies who on 19-JAN-2010, was vaccinated with a first dose of GARDASIL (lot number not reported), on 08-APR-2010 was vaccinated with a second dose of GARDASIL (lot number not reported) and on 17-NOV-2011 was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL (669795/1317AA, expiration date 13-OCT-2013). There was no concomitant medication. The physician reported that on 17-NOV-2011 the patient felt well after receiving the third dose until late in the evening 8 hours after vaccine administration the patient experienced syncope, dizziness, weakness, shakiness and chest pain. The patient was seen in the office the following day (on 18-NOV-2011) her blood pressure was 138/80 and she was sweaty. The patient was sent to the emergency room where work up (blood tests, chest X-ray, electrocardiogram (EKG) was performed and all results were normal. A urine drug screen was also performed (results not provided). The patient continued to feel tired dizzy and had a noticeable tremor of the right hand (BP 120/80). The physician inquired about recommendations regarding treatment for syncope, dizziness, weakness, shakiness and chest pain related to the third dose of GARDASIL given to the patient. At the time of the report the patient's events persisted. No treatment was given for the events. A neurology consult was being requested. Follow up information has been received from the physician who reported that the patient was seen by a neurologist last week who felt that tremor might be related to the vaccine. The physician also reported that the patient was "back to normal"; the tremor resolved last Wednesday (23-NOV-2011), within 6 days of onset. Information was received from a physician and medical records concerning a 15 year old female (64.25 inches, 140 pounds) with no pertinent medical history, drug reactions or allergies who on 19-JAN-2010 was vaccinated with a first dose of GARDASIL (lot number not reported), on 08-APR-2010 was vaccinated with a second dose of GARDASIL (lot number not reported) and on 17-NOV-2011 was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL (669795/1317AA, expiration date 13-OCT-2013) into the left deltoid. Concomitant medication received on 17-NOV-2011 was a third dose of influenza vaccination (Sanofi-Pasteur) (Lot #U4476AD) intramuscularly into the left deltoid. On 17-NOV-2011, approximately eight and one half hours after receiving the vaccinations, the patient experienced dizzy, weak, tremor of upper extremity, and chest pain. On 18-NOV-2011, a chest x-ray, urinalysis, urine drug screen, comprehensive metabolic panel, and hematology profiles were all normal. The physician reported that the patient was recovered on 23-NOV-2011. Syncope, dizziness, shakiness, weakness, tired, sweaty, and chest pain were considered to be disabling by the physician. All available medical records will be provided upon request. Additional information has been requested." Note: the influenza vaccine, lot number U4476AD (invalid lot number), was reported by the other manufacturer as a sanofi pasteur product.