chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female with Crohn's disease, sulfonamide allergy to nuts and environmental allergies who on 02-JAN-2008, 13-MAR-2008 and 25-AUG-2008, was vaccinated intramuscularly with her first, second and third 0.5 ml doses, respectively, of GARDASIL (Lot # of the third dose 659184/0843X). Concomitant therapy included ASACOL, SINGULAIR, ALLEGRA and 6-MP. On 25-AUG-2008, after receiving the third dose of GARDASIL, the patient developed a fever with a temperature of 102 degrees F. The patient was treated with MOTRIN and acetaminophen TYLENOL. At the time of the report, the patient was recovering from fever. Medical attention was sought via phone call. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with the second dose GARDASIL and fainted. The outcome was unknown. The patient sought unspecified medical attention in the office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Nuclear magnetic resonance imaging abnormal, Pelvic pain, Urinary tract infection
Clinical narrative: Information has been received from a registered nurse, concerning a 25 year old female patient with a history of psychiatric disorder, who on 11-JUL-2008 was vaccinated with 0.5 mL GARDASIL intramuscularly in the left arm. Concomitant therapy included EFFEXOR, XANAX and SYNTHROID. Approximately in August, a month after receiving the first dose of GARDAIL, the patient experienced pelvic pain and joint pain. On 18-AUG-2008, the patient sought treatment for abdominal pain from an emergency room and was treated for a urinary tract infection. On 20-AUG-2008, the patient underwent a magnetic resonance imaging that indicated there was abnormal abdominal tissue. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with her first dose of GARDASIL 0.5ml, IM. Concomitant therapy included INFANRIX received during the same visit. The patient experienced syncope after administration of her first dose. She was unconscious for 10 seconds. On unspecified date, the patient recovered from syncope. The patient sought medical attention via: office visit. She has since received her second dose of GARDASIL 0.5ml, IM and did not experienced any adverse event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a healthcare worker concerning a 22 year old female with no pertinent medical history and no allergies who no 12-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # 0152X). There was no concomitant medication. On 12-AUG-2008 the patient experienced itching in 4 hours of receiving the first dose. The patient took BENADRYL, but it did not help the itching. On 14-AUG-2008 the patient called office. On an unspecified date the patient recovered from itching. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 50 year old female who on 22-AUG-2008 was vaccinated with the first dose of GARDASIL. On 22-AUG-2008 the patient passed out within minutes after receiving a first dose. The patient fully recovered. The patient sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 13-AUG-2008, was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U). The physician reported that the patient received GARDASIL and then fainted. On an unknown date, the patient recovered. It is unknown if the patient sought medical attention. This is one of two reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with GARDASIL. The patient came down with mono within one month of getting the vaccine. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who in June 2008, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL. Concomitant therapy included oral contraceptive. "One week after administration of her first dose of GARDASIL", the patient developed generalized pruritic rash on her body. The patient took BENADRYL and then symptoms resolved when the patient woke up "the next morning". "One week later", the rash reappeared for the second time and resolved the next day after taking BENADRYL. The rash reappeared for the third time "one week later" and again symptoms resolved after taking BENADRYL. The patient was seen in office. These events were also reported as a "head to toe rash" that developed one week post vaccination which resolved the next morning after OTC BENADRYL use. The rash returned a second time about one week after the first rash appeared which again resolved after using OTC BENADRYL.  Follow-up information was received from the physician via phone call on 08-SEP-2008 indicating that the patient received the first dose of GARDASIL on 27-JUN-2008. The patient went to bed one night and woke up the next day with a total body rash one week after the injection. The patient took BENADRYL and the rash resolved. "One week later", the same total body rash reappeared. After taking hydrochloride BENADRYL, the rash resolved. "One week later", the same total  body rash reappeared for the third time. After taking BENADRYL, the rash resolved. So the patient had 3 episodes of total body rash that resolved with BENADRYL. On 27-AUG-2008 the patient returned for her second dose of GARDASIL and reported her experiences to the physician. As far as the physician knows, no further episodes had occurred. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Fatigue, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no pertinent medical history or drug allergies who on 24-JUL-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included ALLEGRA. It was reported that the patient was not feeling well, looked pale, and complained of fatigue and diaphoresis when she came in to get her GARDASIL. Labs done that day after she got GARDASIL came back that she is anemic and the mom was blaming the GARDASIL. On an unspecified date, the patient recovered. The patient was seen by doctor. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Loss of consciousness, Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning a 13 year old female with sulfonamide allergy who on 26-AUG-2008 was vaccinated with a first dose of GARDASIL (lot number 660557/0072X) intramuscularly (injection site not reported). After the vaccination, the patient "passed out,  her arms were shaking, and her eyes rolled back". The patient was sent to the emergency room but was not admitted. The patient was diagnosed with syncope and released. The physician also reported that the patient came to the physician's office for a "sick visit" and had symptoms of "not feeling well for one month, right knee pain, sore throat, and out of breath when running or in the pool." During the visit it was decided to give her the GARDASIL. The physician reports that "the father requested to start GARDASIL series." Subsequently on 26-AUG-2008, also reported as "yesterday", the patient recovered from syncope. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who on approximately 13-AUG-2008, "two weeks ago", was vaccinated with the second 0.5 ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 20-AUG-2008, "last week", the patient developed a rash over her body and it had become itchy and painful. At the time of this report, the patient's symptoms persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included MENACTRA and an unspecified vaccine. Immediately after injection, the patient experienced dizziness. The patient went to see the doctor. Subsequently the patient recovered from the event. The physician also reported that on an unspecified date the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). The patient felt fine after the vaccination. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female with no medical history and with penicillin allergy who on 26-AUG-2008 was vaccinated intramuscularly with 0.5 ml of GARDASIL (Lot # 0152X). There was no concomitant medication. Later that night, on 26-AUG-2008 the patient developed hives all over her body including in her throat. She took OTC BENADRYL and the symptoms resolved on 27-AUG-2008. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cystitis, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer, concerning her 22 year old daughter with no previous medical history reported, who was vaccinated with the complete series of GARDASIL (Lot # not reported). On beginning of summer 2008 (approximately 01-AUG-2008) the patient had her yearly pap smear and her physician advised her that she needs to come back to the office because she was positive for HPV. The reporter stated that the physician did not specify what type of HPV does the patient have. The patient also experienced bladder infection recently. As of 27-AUG-2008, the patient had not recovered. The patient sought medical attention with the physician. There was no product  quality complaint. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Familial risk factor, Injection site discolouration
Clinical narrative: Information has been received from a nurse practitioner concerning a female teenager who in 2007 was vaccinated with the first dose of GARDASIL and an unspecified dates was vaccinated with the second and the third dose of GARDASIL. Concomitant therapy included therapy unspecified. Following the second dose of GARDASIL the patient developed a small lighter skin discoloration at the injection site. The patient sought medical attention, office visit. At the time of the reporting, the patient was recovering. The reporter also indicated the patient's twin sister had the same symptoms after receiving the second dose of GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Neurological examination abnormal, Orthostatic hypotension, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 12 year old female who in May 2007, was vaccinated with the first dose of GARDASIL, in August of 2007 was vaccinated with the second dose of GARDASIL and in December of 2007 received the third dose of GARDASIL. The lot numbers were not known. On 22-JAN-2008, the patient experienced black out episodes 1&1/2 months after administration of her third dose of GARDASIL. The patient has been examined by a neurologist who diagnosed her with orthostatic hypotension. She has not had seizures or any episodes of syncope. She experienced visual disturbances but remains conscious at the time of reporting, the event persisted. The physician did not have any additional information because she is not her patient. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood immunoglobulin E increased, Eosinophilia, Platelet count increased, Thrombocythaemia
Clinical narrative: Information has been received from a hematologist concerning a 14 year old female with no pertinent medical history, nor drug reaction/allergies, who was vaccinated with the first two doses of GARDASIL. No concomitant medication reported. Subsequently, the patient developed thrombocytosis (platelet count 1,500,000) and eosinophilia after receiving the first two doses of GARDASIL. The immunoglobin E level was elevated at 2,600 too. At the time of the report, the patient had not recovered. Medical attention was sought at the physician's office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Infection, Ultrasound scan
Clinical narrative: Information has been received from a licensed practical nurse through the Merck Pregnancy registry concerning a 19 year old female with no previous pregnancies and no significant past medical history, who on an unspecified date during her first trimester of pregnancy was vaccinated (given by her primary care physician) with GARDASIL (lot number not reported). On 17-JUN-2008 the patient was treated with 1 gram of ZITHROMAX for infection. The patient was put on prenatal vitamins (unspecified) QD. On 22-JUN-2008 the patient underwent an ultrasound indicated for dating, which showed that she was 9 weeks and 3 days. On 12-JUL-2008 the patient underwent MSAFP which was negative. The reporter noted the patient's estimated delivery date as 22-JAN-2009. The patient's LMP was approximately 17-APR-2008. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on 13-Jun-2008 was vaccinated with the third dose of GARDASIL. On the same day, after receiving her third dose, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on 07-Aug-2008 was vaccinated with a dose of GARDASIL. On the same day, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vertigo
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. On the same day the patient experienced syncope and vertigo. Subsequently, the patient recovered fully from syncope and vertigo on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on 30-Jun-2008 was vaccinated with a dose of GARDASIL. On the same day, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on 19-FEB-2008 was vaccinated with the third dose of GARDASIL. On the same day, after receiving her third dose, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Lumbar puncture, Myalgia
Clinical narrative: Information has been received from a pharmacist who reported that his 18 year old daughter with no pertinent medical history and no drug reaction/allergies on 14-JUL-2008 was vaccinated with her third dose of GARDASIL. On 15-AUG-2008, the patient experienced muscle pains and joint pain and was hospitalized for 2 days. The patient's muscle pains and joint pain persisted. No adverse event was reported with the first and second dose of GARDASIL. Laboratory test include blood work and numerous other tests (results not provided). Follow-up information has been received from the patient's father who reported that his daughter had a spinal tap that did not confirm a specific diagnosis, and was negative for Guillain-Barre syndrome. The patient's muscle and joint pains persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chest X-ray, Epstein-Barr virus antibody positive, Full blood count, Headache
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in May 2008, was vaccinated with her first dose of GARDASIL. Subsequently the patient developed numbness of her feet about 2-3 months later. Then the numbness spread to the hands and tongue. She had fevers of up 103F, body aches, sore throat, stomach aches and headaches. The numbness of the tongue had gotten better and the numbness in the hands were less. She was seen by several physicians including her primary physician and OB/GYN. Physician thought that this could be from other causes. Numbness of feet, hands and tongue, fevers, body aches, sore throat, stomach aches and headaches were recovering. Laboratory diagnostic studies performed include: CBC, SMA-12, basic metabolic tests, positive epstein barr virus antibody, thyroid test, liver function tests, urinary tests and chest x-ray. No further information is available. 2/23/09-records received for DOS 8/31/08-9/5/08 DC DX: Guillain-Barre syndrome. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Sore throat and fatigue and with continued fatigue developed numbness of right fifth toe. PE demonstrated positive left Bell phenomenon. Deep tendon reflexes suprressed throughout. Treated with IVIG/9/7-9/19/08-DC DX: Gait disturbance and disability to due recent Guillain-Barre syndrome event. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Presented with C/O headache, nausea and vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Liver function test, Metabolic function test, Oropharyngeal pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in May 2008, was vaccinated with her first dose of GARDASIL. Subsequently the patient developed numbness of her feet about 2-3 months later. Then the numbness spread to the hands and tongue. She had fevers of up 103F, body aches, sore throat, stomach aches and headaches. The numbness of the tongue had gotten better and the numbness in the hands were less. She was seen by several physicians including her primary physician and OB/GYN. Physician thought that this could be from other causes. Numbness of feet, hands and tongue, fevers, body aches, sore throat, stomach aches and headaches were recovering. Laboratory diagnostic studies performed include: CBC, SMA-12, basic metabolic tests, positive epstein barr virus antibody, thyroid test, liver function tests, urinary tests and chest x-ray. No further information is available. 2/23/09-records received for DOS 8/31/08-9/5/08 DC DX: Guillain-Barre syndrome. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Sore throat and fatigue and with continued fatigue developed numbness of right fifth toe. PE demonstrated positive left Bell phenomenon. Deep tendon reflexes suprressed throughout. Treated with IVIG/9/7-9/19/08-DC DX: Gait disturbance and disability to due recent Guillain-Barre syndrome event. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Presented with C/O headache, nausea and vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Thyroid function test, Urine analysis
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in May 2008, was vaccinated with her first dose of GARDASIL. Subsequently the patient developed numbness of her feet about 2-3 months later. Then the numbness spread to the hands and tongue. She had fevers of up 103F, body aches, sore throat, stomach aches and headaches. The numbness of the tongue had gotten better and the numbness in the hands were less. She was seen by several physicians including her primary physician and OB/GYN. Physician thought that this could be from other causes. Numbness of feet, hands and tongue, fevers, body aches, sore throat, stomach aches and headaches were recovering. Laboratory diagnostic studies performed include: CBC, SMA-12, basic metabolic tests, positive epstein barr virus antibody, thyroid test, liver function tests, urinary tests and chest x-ray. No further information is available. 2/23/09-records received for DOS 8/31/08-9/5/08 DC DX: Guillain-Barre syndrome. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Sore throat and fatigue and with continued fatigue developed numbness of right fifth toe. PE demonstrated positive left Bell phenomenon. Deep tendon reflexes suprressed throughout. Treated with IVIG/9/7-9/19/08-DC DX: Gait disturbance and disability to due recent Guillain-Barre syndrome event. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Presented with C/O headache, nausea and vomiting.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a female patient who after receiving the first dose of GARDASIL in her left arm the left side of her body feels numb and tingling including her stomach. No further adverse event information provided. Consumer stated she was going into her physician and would call back with additional information. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL. A few weeks after receiving the second dose, the patient had broken out in genital warts. The patient had come into the office about the experience and the physician referred her to an Obstetrician/Gynecologist. The physician did not know at the time when the patient received the first dose because she received it in Texas. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no pertinent medical history or drug reactions or allergies who on 28-AUG-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659184/0843X). Concomitant therapy included LOESTRIN 24 FE. Subsequently the patient passed out when she was signing out at the front desk to leave.  The patient was observed and recovered and went home. On the same day, urine pregnancy test was performed and the result was negative. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with allergy to penicillin and amoxacillin and a history of cervical dysplasia who on 10-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 658556/1060U). On 12-AUG-2008 was vaccinated with the second dose of GARDASIL, (Lot # 660612/0229X), 0.5 mL, IM. The medical assistant reported that the patient experienced diarrhea after receiving the second dose of GARDASIL. The diarrhea began shortly after she received the second dose and has persisted. The numbness persisted. The patient sought medical attention, called the physician. Additional information has been requested.  11/21/08 Reviewed GYN medical records of 6/10-9/10/2008. FINAL DX: right arm myalgia from 2nd Gardasil shot Records reveal patient received HPV#1 on 6/10/08, lot # 1060U.  Experienced drowsiness & mild nausea which resolved.  RTC 8/12/08 for HPV #2, lot# 0229X, RA.  Had immediate numbness of right forearm & fingertips.  RTC 8/28 w/continued numbness & decreased right hand grip strength.  Referred to neuro.  RTC 9/10 w/same complaints.  Had not seen neuro yet.  No other records available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Familial risk factor, Injection site discolouration
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 years old female patient with no allergies and no medical history who on 24-APR-2007 was vaccinated with the first dose of GARDASIL (lot No. 653938/0954F) into the right deltoid and an unspecified dates was vaccinated with the second and the third dose of GARDASIL. Concomitant therapy included BACTRIM after the shot was given. Following the second dose of GARDASIL the patient developed a small lighter skin discoloration at the injection site. The patient sought medical attention, office visit. At the time of the reporting, the patient was recovering. The reporter also indicated the patient's twin sister had the same symptoms after receiving the second dose of GARDASIL. Follow up information was received reporting that at the time of vaccination the patient had bladder infection. On 11-DEC-2007 the patient experienced molluscum contagiosum. At the time of the reporting, the outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (route and administration site not reported) at another office. Subsequently the patient experienced an allergic reaction after receiving GARDASIL. Subsequently, the patient recovered from the allergic reaction. The patient sought medical attention by seeing a physician. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchitis, Chest X-ray abnormal, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 31-MAR-2008 was vaccinated with a first dose of GARDASIL (route and administration site not reported). The patient was healthy prior to her second dose of GARDASIL. On 05-JUN-2008 the patient was vaccinated with a second dose of GARDASIL (route and administration site not reported). On 05-JUN-2008 the patient experienced severe fatigue, shortness of breath and chest discomfort. She was seen in urgent care sometime between June 5th and 9th. She was treated with an inhaler. On 09-JUN-2008 she followed-up with her physician. Her chest X-ray showed bronchitis. She was prescribed MEDROL DOSEPAK and albuterol as needed. The patient was referred to a pulmonologist and an allergist. She saw the allergist on 11-JUN-2008, the allergist agreed that the patient had bronchitis. He treated her with Z-PAK and albuterol, then added CLARINEX, "Cymbicort" and prednisone (manufacturer unknown) 40 mg. The patient was followed-up on 17-JUN-2008 with her primary care physician and she diagnosed her with dyspnea. Another follow up visit was made on 05-AUG-2008, her shortness of breath was resolved, but she still complained of severe fatigue. Her blood work showed reactivation of Epstein-Barr Virus. A follow up visit was made on 25-AUG-2008 she still complained of chronic fatigue. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus infection, Epstein-Barr virus test positive, Fatigue, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 31-MAR-2008 was vaccinated with a first dose of GARDASIL (route and administration site not reported). The patient was healthy prior to her second dose of GARDASIL. On 05-JUN-2008 the patient was vaccinated with a second dose of GARDASIL (route and administration site not reported). On 05-JUN-2008 the patient experienced severe fatigue, shortness of breath and chest discomfort. She was seen in urgent care sometime between June 5th and 9th. She was treated with an inhaler. On 09-JUN-2008 she followed-up with her physician. Her chest X-ray showed bronchitis. She was prescribed MEDROL DOSEPAK and albuterol as needed. The patient was referred to a pulmonologist and an allergist. She saw the allergist on 11-JUN-2008, the allergist agreed that the patient had bronchitis. He treated her with Z-PAK and albuterol, then added CLARINEX, "Cymbicort" and prednisone (manufacturer unknown) 40 mg. The patient was followed-up on 17-JUN-2008 with her primary care physician and she diagnosed her with dyspnea. Another follow up visit was made on 05-AUG-2008, her shortness of breath was resolved, but she still complained of severe fatigue. Her blood work showed reactivation of Epstein-Barr Virus. A follow up visit was made on 25-AUG-2008 she still complained of chronic fatigue. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on an unspecified date was vaccinated with a dose of GARDASIL 0.5 ml IM. 30 to 40 minutes after the vaccination, the patient passed out and vomited in her car. Subsequently, the patient recovered from passing out and vomiting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Inflammation, Injected limb mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 25-JUL-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in her left arm. Other suspect therapy included a dose of RECOMBIVAX HB (MSD) which was received 2 weeks before 25-JUL-2008. On 25-JUL-2008 the patient developed soreness in the arm which was progressively worse. The patient developed difficulty raising the arm above the head. The patient was treated with the primary care physician. The physician ordered a MRI of the arm that indicated inflammation and the patient was prescribed prednisone. The patient's arm inflammation persisted. There were no other symptoms or treatment reported. The patient sought medical attention in the office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gallbladder disorder
Clinical narrative: Information has been received for the Pregnancy Registry for HPV vaccine from a nurse concerning a 19 year old female patient who in June 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included ADDERALL and PROZAC. The patient was pregnant when she was given the first dose of HPV vaccine in June 2008. Currently in approximately August 2008, the patient was having gall bladder problems, but no other symptoms reported. The patient's LMP was 02-FEB-2008 and EDD 08-NOV-2008. The patient sought medical attention. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who in approximately August 2008, also reported as last couple of weeks, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient had a delayed menstrual. The menstrual period was delayed by seven days.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Stomach discomfort
Clinical narrative: Information has been received from patient's mother who reported that her 17 year old daughter on 12-AUG-2008 was vaccinated with GARDASIL.  There was no concomitant medication.  On 14-AUG-2008, two days after her daughter was vaccinated she began to have an upset stomach which has been ongoing up until now.  The patient's mother said that the stomach discomfort has been occurring approximately 15 minutes after she eats or drinks something.  At the time of the report, the patient had not recovered from her upset stomach.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site haematoma, Pain in extremity
Clinical narrative: Information has been received from the patient's mother who reported that her 13 year old daughter with a history of idiopathic thrombocytopenic purpura when she was very young and has not had any problems since; on 17-JUN-2008 or 18-JUN-2008 was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The daughter's arm was painful and developed a bruise following vaccination.  The daughter's arm started to hurt 20 minutes after vaccination with GARDASIL and then developed a bruise at the injection site.  The daughter had trouble raising her arm for about one week after the vaccination.  Subsequently, on 25-JUN-2008 the patient recovered from arm was painful, bruise at injection site and trouble raising her arm.  No other information reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning 4 female patients who on an unspecified date were vaccinated with GARDASIL.  It was reported that all 4 patients fainted within the 15 minute period following vaccination.  No specifics known about the patients.  At the time of reporting, the patients had recovered.  The patients sought medical attention in the office.  Attempts are being made to obtain additional identifying information to distinguish the individual patients.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008.  Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with GARDASIL. It was reported that the patient fainted within the 15 minute period following vaccination. No specifics known about the patient. At the time of reporting, the patient had recovered. The patient sought medical attention in office. This is one of several patients received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia oral, Limb discomfort, Posture abnormal, Skin discolouration, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL.  The nurse reported that the patient had a fainting episode after receiving GARDASIL.  Soon after the vaccination, the patient complained that her arm felt "funny" and lips became numb.  Her skin color turned "dusky" and her hand became "postured".  The patient was then lowered to the floor.  She was sent to an emergency room and determined that she did have a fainting episode.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with obesity who on 23-JUN-2008, was vaccinated with the first dose of GARDASIL (lot # 660389/1968U), 0.5 ml intramuscularly.  There was no concomitant medication.  The physician reported that on 15-JUL-2008, the patient developed widespread urticaria.  The patient was treated with a course of prednisone and completely recovered.  On 21-AUG-2008, the patient was administered the second dose of GARDASIL (lot # 660612/0229X), 0.5 ml intramuscularly, and on 26-AUG-2008, she developed urticaria of the upper chest and upper extremities.  On 29-AUG-2008, the patient was prescribed a MEDROL dose pack.  At the time of the report, the patient had not recovered.  The patient sought medical attention at the physician's office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VPL vaccine (yeast) (lot number 660612/0229X) (injection site and route not reported).  Shortly after being vaccinated, the patient passed out in the waiting room.  Unspecified medical attention was sought.  The physician reported that the patient recovered in a short while and went home.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning her 17 year old daughter who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 18 VLP vaccine (yeast).  In November 2007 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  The patient experienced fever and flu like symptoms after both of the doses were given.  The third dose has not yet given to the patient.  Subsequently, the patient recovered from fever and flu like symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: It was reported in a published article, titled as above.  A 26 year old woman came to a family practice clinic to receive the first of three doses of GARDASIL.  She returned 5 days later with swollen lymph nodes in the left side of her neck.  The patient noticed enlarging lymph nodes 3 days after receiving the GARDASIL, which had been injected intramuscularly into her left deltoid muscle.  At this visit and all sequent clinic visits, the patient denied any recent upper respiratory infection, pharyngitis, cough, fever, or left upper extremity skin infections or rashes.  She also denied any significant medical or surgical history.  Her drug therapy only consisted of a daily oral contraceptive, and she denied recent antibiotic and nonsteroidal antiinfammatory treatment.  She had received no other immunizations recently and reported no previous vaccine-related lymphadenopathy.  The patient also denied any drug or seasonal allergies, asthma, or eczema.  Physical examination revealed normal vital signs and several palpable anterior cervical and supraclavicular subcentimeter lymph nodes on the left side of the patient's neck.  These were soft and fully mobile, without matting.  The remainder of her physical examination was normal with no other regional lymphadenopathy.  Due to the patient's lack of systemic symptoms, laboratory evaluation, pharmacologic therapy, and lymph node biopsy were not indicated.  The patient remained afebrile and exhibited no signs or symptoms of systemic infection over the next several days.  She was reevaluated at the family practice office 17 days after her initial vaccination.  The lymphadenopathy had completely resolved.  The patient received her second dose of GARDASIL 2 months after the initial immunization and experienced no associated lymphadenopathy.  This patient's lymphadenopathy was spatially and temporally related to administration of GARDASIL, given that it developed in the left side of her neck, ipsilateral to the vaccination site, within 3 days of immunization.  Her history and physical examination suggested no other possible etiology of lymphadenopathy such as infection, cancer, autoimmune disease, or immunocompromised status.  Therefore, one can reasonably conclude, congruent with the score derived from an adverse drug reaction probability scale, that the patient's unilateral cervical lymphadenopathy was most likely caused by the GARDASIL.  We concluded that withholding further GARDASIL immunization or any other recommended or indicated vaccines would not be necessary since lymphadenopathy is not a life-threatening adverse effect and poses no serious consequences.  Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication
Clinical narrative: Information has been received from an office manager who reported that the GARDASIL vaccine (Lot #655604/0052X) leaked out of the syringe onto the nurse's pants before it can be given to a patient. No adverse effect reported. SR number 1-3094846504. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a nurse concerning a female patient who on 11-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine, Lot #659657/1487U. It was reported that the patient was lightheaded, but she did not actually faint. The patient received the second dose of GARDASIL and was fine. The patient sought medical attention in office. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLUN3, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF
Symptoms: Areflexia, Asthenia, Axonal neuropathy, Blood immunoglobulin M, Blood test normal
Clinical narrative: FOLLOW UP VAERS (Original VAERS (Original VAERS #262657 filed on 9/6/2006. Updated information attached.  Discharged from the military and lost to follow up.  19 year-old male, retired due to Guillan-Barre syndrome. He presents today for periodic re-evaluation in accordance with orders. He was well until on/about 31 Aug 2006 when he initially-developed "achy" pain in his arms. Over the next 3 days, he developed rapidly progressive quadriparesis. At nadir, he could not lift his arms over his shoulders and could not walk without assistance. He presented to "medical center" for evaluation and was diagnosed with Guillain-Barre syndrome. EMG/NCS was consistent with a severe motor-greater-than-sensory mulitfocal peripheral neuropathy, felt-consistent. Early lumbar puncture had normal cell count, with a protein relatively elevated-for-age. He was treated with intravenous immunoglobulin. Subsequently, he had partial improvement in quadriparesis, but continued with moderate-severe distal weakness, so he was medically retired. He reports being at nadir for about 1-2 weeks, then had majority of improvement by Dec 2006. Since Dec 2006 he has continued at his current state. He reports generally feeling well. Seems not to have significant motor weakness. However, he reports a baseline fatigue/tiredness and general decease in energy level which remains functionally-limiting. As a result, he feels he cannot maintain a full-time job.
Age: 18.0
Sex: M
Vaccine: FLUN3, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF
Symptoms: Dyskinesia, Electromyogram abnormal, Extensor plantar response, Gait disturbance, Hypoaesthesia
Clinical narrative: FOLLOW UP VAERS (Original VAERS (Original VAERS #262657 filed on 9/6/2006. Updated information attached.  Discharged from the military and lost to follow up.  19 year-old male, retired due to Guillan-Barre syndrome. He presents today for periodic re-evaluation in accordance with orders. He was well until on/about 31 Aug 2006 when he initially-developed "achy" pain in his arms. Over the next 3 days, he developed rapidly progressive quadriparesis. At nadir, he could not lift his arms over his shoulders and could not walk without assistance. He presented to "medical center" for evaluation and was diagnosed with Guillain-Barre syndrome. EMG/NCS was consistent with a severe motor-greater-than-sensory mulitfocal peripheral neuropathy, felt-consistent. Early lumbar puncture had normal cell count, with a protein relatively elevated-for-age. He was treated with intravenous immunoglobulin. Subsequently, he had partial improvement in quadriparesis, but continued with moderate-severe distal weakness, so he was medically retired. He reports being at nadir for about 1-2 weeks, then had majority of improvement by Dec 2006. Since Dec 2006 he has continued at his current state. He reports generally feeling well. Seems not to have significant motor weakness. However, he reports a baseline fatigue/tiredness and general decease in energy level which remains functionally-limiting. As a result, he feels he cannot maintain a full-time job.
Age: 18.0
Sex: M
Vaccine: FLUN3, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF, FLUN3, HEPAB, IPV, TDAP, YF
Symptoms: Hypotonia, Immunology test, Lumbar puncture normal, Muscular weakness, Pain in extremity
Clinical narrative: FOLLOW UP VAERS (Original VAERS (Original VAERS #262657 filed on 9/6/2006. Updated information attached.  Discharged from the military and lost to follow up.  19 year-old male, retired due to Guillan-Barre syndrome. He presents today for periodic re-evaluation in accordance with orders. He was well until on/about 31 Aug 2006 when he initially-developed "achy" pain in his arms. Over the next 3 days, he developed rapidly progressive quadriparesis. At nadir, he could not lift his arms over his shoulders and could not walk without assistance. He presented to "medical center" for evaluation and was diagnosed with Guillain-Barre syndrome. EMG/NCS was consistent with a severe motor-greater-than-sensory mulitfocal peripheral neuropathy, felt-consistent. Early lumbar puncture had normal cell count, with a protein relatively elevated-for-age. He was treated with intravenous immunoglobulin. Subsequently, he had partial improvement in quadriparesis, but continued with moderate-severe distal weakness, so he was medically retired. He reports being at nadir for about 1-2 weeks, then had majority of improvement by Dec 2006. Since Dec 2006 he has continued at his current state. He reports generally feeling well. Seems not to have significant motor weakness. However, he reports a baseline fatigue/tiredness and general decease in energy level which remains functionally-limiting. As a result, he feels he cannot maintain a full-time job.