Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Dizziness, Headache, Immediate post-injection reaction, Joint injury
Clinical narrative: Information has been received from a nurse (R.N.) concerning a 17 year old male who in December 2010, was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). The patient experienced headache and felt lightheaded immediately after the injection in December 2010. The patient did not seek medical attention. At the time of reporting, the patient was recovering from headache and lightheaded. Follow up information has been received from a nurse and medical records concerning a 17 year old male with asthma and cat allergy and a history of trigger finger release (1999) and an unspecified head injury (27-MAY-2010) who on 20-DEC-2010 was vaccinated with the first dose of GARDASIL (lot #0766Z), (intramuscular, left deltoid). Patient reclined for twenty minutes, as per protocol. Ten minutes after injection, patient reported bad headache with tears in his eyes. After twenty minutes, patient still had headache but denied any other symptoms. Discussed with a nurse practitioner and patient was released from office. Mom advised not to let patient drive the rest of the day and that she would be contacted later with more information as to whether he should receive the second injection in two months. Reaction discussed with on-call nurse who asked about history of seizures which was negative. The Nurse stated that she wouldn't call this an adverse reaction, but it was probably a vasoconstrictive reaction. The nurse informed that if headache didn't clear within twenty-four hours or he had developed other symptoms, she would probably recommend not giving again. A message was left with patient's mom to call. On 04-FEB-2011, the nurse spoke with drug rep to see if there was any detailed information on GARDASIL and patients who had a history of a head injury. The patient's mother reported that the patient's headache lasted all day and he developed dizziness off and on for the rest of the day also. The nurse discussed with the patient's mother that headache was not contraindicated for any additional doses. On 21-FEB-2011, patient was seen in follow-up with and of episode of decreased consciousness at a wrestling meet after suffering a shoulder injury. His headaches had resolved, which the patient's mother thought was related to use of ZYRTEC. He had not had any further neurological symptoms or changes. Medical therapy included albuterol MDI HFA, FLONASE and QVAR for asthma and doxycycline. Assessment: headache, resolved. It was discussed with the patient and his mother the anticipated benefits of GARDASIL, as well as statements as recorded from discussion with drug rep on 20-DEC-2010 and 04-FEB-2011 and the CDC. Both the patient and his mother asked for him to get the vaccine. Permit was signed. Dose #2 of GARDASIL was given (no further information provided). All available medical records will be provided upon request. Follow up information has been received from the registered nurse who reported that the possible concomitant therapy included ZYRTEC, albuterol, FLONASE, OVARAS and doxycycline. The nurse did not know if the prescriptions were ever refilled by the patient and he was currently out of refills for all of the concomitant medications. No further information is available.