chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Laboratory test, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no medical history and an allergy to sulfa medications who on 17-May-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (no lot number provided). On 20-JUN-2008 the patient received the second 0.5 ml dose of GARDASIL vaccine (yeast) (no lot number provided). Other therapy included "SYMBIAX". Since receiving the second dose on 20-JUN-2008 she has had a fever and was extremely tired. The patient's fever and extremely tired persisted. Laboratory diagnostics studies performed reported as "lab." At time of reporting patient had not recovered. Unknown medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Urine analysis
Clinical narrative: Information has been received from an 18 year old female consumer who on 20-JUN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (yeast) (lot # not reported). Concomitant therapy included "birth control pills" (hormonal contraceptives (unspecified)). the patient states that she "experienced stomach pains after getting vaccinated" (onset reported as 22-JUNE-2008). The patient sought unspecified medical attention and provided a urine sample (nor further specified). The patient reported that she was recovering from the stomach pains. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 19-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (route and administrating site not reported) (lot# 660393/0067X). Following her second dose of GARDASIL vaccine (yeast) the patient experienced nausea and vomiting for three hours. Subsequently the patient recovered from the nausea and vomiting. The patient sought unspecified medical attention. Additional information has been requested.   This is in follow-up to report(s) previously submitted on 7/15/2008.  Follow-up information was received from the physician.  The patient had itching around site of IMPLANON for 4 weeks.  She was treated with an antihistamine.  The outcome was not provided.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who was vaccinated with the first and second doses of GARDASIL vaccine (yeast). The patient experienced feeling faint, with vomiting, dizziness, and an injection site reaction with swelling and redness after each dose. The patient recovered from feeling faint, with vomiting, dizziness, and an injection site reaction with swelling and redness. Injection were administered at another location. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a 25 year old female patient with no allergies and a history of three surgical procedures to remove skin cancer and gall bladder removed who on 02-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant therapy. The patient was pregnant. The patient experienced the only adverse side effect as some pain in her arm in the area of the injection site. There was no fever or sickness. This only lasted fro a few days and the patient was fine now. The patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness postural, Headache
Clinical narrative: Information has been received from a licensed visiting nurse (LVN) concerning a 15 year old female with allergic rhinitis and a history of headache and meningitis (at 7 years of age) who on 25-MAR-2008 (Lot 659657/1487U), 10-JUN-2008 and 24-JUN-2008 (Lot #660391/0063X) was vaccinated IM with 0.5 mL doses of GARDASIL vaccine (yeast). Concomitant therapy included mometasone furoate (NASONEX). On 24-JUN-2008, after vaccination, the patient became dizzy/lightheaded upon standing and also developed a headache. The patient was treated with ibuprofen (MOTRIN) 800 mg for the headache. The patient did not require hospitalization, but was seen in the office. At the time of this report, the patient's dizziness/lightheadedness and headache persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Autoimmune disorder, Cardiac disorder, Cardiac stress test
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with chronic asthma who on 14-APR-2008 or on 16-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included montelukast sodium (MSD). The consumer reported that her daughter developed cardiac and auto immune issues after getting the first dose of GARDASIL vaccine. The patient was taken to the ER but not hospitalized. The patient had already seen a cardiologist and would be seeing a rheumatologist. On an unspecified date the patient had a stress test done (results not provided). The patient sought medical attention. Additional information has been requested. 9/17/08-cardiology consult notes received for DOS 6/11/08-Impression:rare, uniform premature ventricular contractions (PVCs). Mild mitral valve regurgitation without prolapse. Referred for C/O premature ventricular contractions. Over past two months C/O severe fatigue.  On 5/23/08 episode of shakiness, dizziness and shortness of breath. Presyncope, headaches and pallor. 9/23/08-records received for DOS 1/28/08-well visit with PMH asthmatic. 4/29/08-chest congestion face swelling with puffy eyelids. Assessment sinusitis. 5/1/08-asthma attack, asthma exacerbation. 5/7/08-seen for C/O low right side of head pain possible muscle spasm in neck. Mild hyperplasia. Swollen nasal mucosal. Received first Gardasil vaccine. 5/22/08-C/O feeling weak, fatigue, lack of energy.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a female who on unspecified dates was vaccinated with the three doses of GARDASIL vaccine (yeast). The physician reported that the patient tested negative twice for HPV before receiving GARDASIL vaccine. After her three injections, the patient tested positive for HPV. On an unspecified date the patient had a "Reflex Test" with WCP lab; which revealed she was a patient that had "ASCUS (abnormal undetermined cells)". The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no relevant medical history who on 10-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number 660387/1967U) by intramuscular injection (injection site not reported). There was no concomitant medication. On 10-JUN-2008, after receiving the vaccine, the patient became dizzy. It was reported that the patient's dizziness improved after stopping therapy and that the patient had recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with a history of Raynaud's Syndrome who on 23-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number 659439/1267U) (injection site and route not reported). Concomitant therapy included amphetamine aspartate/amphetamine SO4/dex (ADDERALL TABLETS), lisdexamfetamine dimesylate (VYVANSE) and desogestrel/ethinyl estradiol (MIRCETTE). After receiving the first dose of vaccine, the patient developed a fever and "felt sick". Subsequently the patient recovered from the events. On 16-JUN-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml by intramuscular injection (injection site not reported). Five minutes after the second dose, the patient developed a three inch round, red, swollen area at injection site. Unspecified medical attention was sought. Subsequently, the patient recovered from the event. Additional  information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with no pertinent medical history and no allergies who in December 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). In February 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient's mother asked if there have been reports of increase of frequency in the menstrual cycle. The patient's cycle was usually every 32 to 35 days but now it was every 27 days. On 25-JUN-2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). The patient's increase of frequency in the menstrual cycle persisted. The patient sought medical attention in office. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Breath sounds, Cardiovascular evaluation, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with penicillin allergy who consumes alcohol and has no other pertinent medical history who on 24-JUN-2008 was vaccinated with third dose of GARDASIL vaccine 1 dose. On 24-JUN-2008, the patient experienced black out. On 25-JUN-2008 morning, the patient was not feeling right and felt dizzy. The patient was bending over at work and then fainted. The patient came to the office 1/2 hour after fainting with a chief complaint of fatigue, myalgia, headache and dizziness. The patient had no symptoms in the office and was not treated. On 25-JUN-2008, the patient recovered from black out, not feeling right, faint, fatigue, myalgia, headache and dizziness. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Loss of consciousness, Myalgia, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with penicillin allergy who consumes alcohol and has no other pertinent medical history who on 24-JUN-2008 was vaccinated with third dose of GARDASIL vaccine 1 dose. On 24-JUN-2008, the patient experienced black out. On 25-JUN-2008 morning, the patient was not feeling right and felt dizzy. The patient was bending over at work and then fainted. The patient came to the office 1/2 hour after fainting with a chief complaint of fatigue, myalgia, headache and dizziness. The patient had no symptoms in the office and was not treated. On 25-JUN-2008, the patient recovered from black out, not feeling right, faint, fatigue, myalgia, headache and dizziness. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a certified medical assistant concerning a female who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (lot# 66039/1968U) at 10:30.. The patient had "trouble getting shots." Post vaccination the patient was monitored for approximately 15 minutes and when the patient walked around to check out window and passed out falling through the window. The patient was put into wheelchair and was given lemonade. The patient awoke and was responsive. On 16-JUN-2008 the patient recovered from faint. The patient sought medical attention at the office. This is one of several reports from the same source. Additional information ahs been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies reported who on  22-MAY-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 657736/0389U) 0.5 mL IM. The patient, on 02-OCT-2007 was vaccinated with a second dose of GARDASIL vaccine (lot# 658558/1061U) 0.5 mL IM. On 25-JUN-2008, the patient became dizzy, pale and diaphoretic after a third dose of GARDASIL vaccine (lot# 660555/0279X) 0.5 mL IM. Subsequently, the patient recovered from dizzy, pale and diaphoretic. The patient sought medical attention in the office, the events occurred in the physician's office. Additional information has been requested. This is one of several reports from the same source.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 25 year old female who on 23-JUN-2008 was vaccinated with a first dose of GARDASIL VACCINE 0.5 mL IM. The patient started getting a rash on her arms, but not around the injection site. On 25-JUN-2008, the patient called the office to report that the rash was all over her body and progressing. BENADRYL was recommended to the patient to treat the rash; however she reported that it did not seem to help. The patient was scheduled to be seen in the office on 26-JUN-2008 for an unrelated reason (sonogram). The patient's rash persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008.  Information has been received from a medical assistant concerning a 25 year old female who at 1pm on 23-JUN-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in her upper left arm (lot# 660553/0070X).  Thirty minutes after the injection, the patient started getting a rash on her arms and stomach but not around injection site and she felt light headed which lasted one hour.  One hour after the injection.  The patient experienced itching and a rash of small white bumps all over her body with no fever.  On 25-JUN-2008 the patient called the office to report that the rash was all over her body and progressing.  BENADRYL was recommended to the patient to treat the rash;  however she reported that it di not seem to help.  The patient was scheduled to be seen in the office on 26-JUN-2008 for an unrelated reason (sonogram and no result reported.  Subsequently, the patient recovered from the rash which lasted 7 days.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female who on 23-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and included hepatitis A virus vaccine (manufacturer unknown). The physician assistant reported that the patient received the first vaccination with GARDASIL VACCINE on 23-MAY-2008 and passed out. The patient became pale in color and passed out while sitting on the examination table. The patient was treated with cold compresses and recovered after an unspecified time frame. The patient was asked to wait in the office after recovery, but mother needed to leave. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician's assistant concerning a 14 year old female who on 04-DEC-2007 was vaccinated with the first dose of GARDASIL vaccine, on 07-FEB-2008 was vaccinated with the second dose of GARDASIL vaccine and on 23-JUN-2008 was vaccinated with the third dose of GARDASIL vaccine. There was no concomitant medication. The patient had no problems reported with the first or second dose of GARDASIL vaccine, but on 23-JUN-2008 while walking out the waiting room following the third dose passed out. The patient did not hit her head and was not passed out for very long. The patient was treated with cold compresses. No other supportive measurements were needed. The patient recovered at the office after an unspecified time. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Tenderness, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 24 year old old female who on 06-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (lot # not reported). On 06-MAR-2008, the patient was vaccinated intramuscularly with a second dose of GARDASIL vaccine (lot # not reported). The physician reported that "the patient received two doses of GARDASIL vaccine and experienced swelling of her jaw the night of vaccine both times. The 1st dose was given when she was 24 year sold and the 2nd dose was given when she was 25 years old. The swelling resolved in a few days without treatment for both instances." The patient sought unspecified medical attention during an office visit. No other details were reported by the physician. Additional information has been requested. Follow-up information was received from a physician, concerning the now 25 year old white female patient with no previous medical history and pre-existing allergies reported. The physician reported that on 06-MAY-2008, the patient was vaccinated with the second dose of GARDASIL. The next morning the patient had noted swelling and tenderness of right jaw. The patient were to the reporter's office later on 07-MAY-2008, and still had mild fullness at right jaw area, but no mass or oro-pharyogeal swelling. Left deltoid injection site was not swollen. Swelling jaw improved during the course of the day. The patient indicated similar swelling of jaw "a few days after" her first dose of GARDASIL. In both cases, swelling resolved spontaneously. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Sexual abuse
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who on an unspecified date in June 2007, reported as "about 1 year ago," was vaccinated with a first dose of GARDASIL vaccine (lot # not reported). It was reported that, on an unspecified date post first vaccination, the patient was sexually assaulted after her first dose of GARDASIL vaccine. "No adverse effect" was reported. Patient outcome was not reported. Additional information has been requested. Initial and follow up information has been received from a nurse practitioner and the physician's office concerning a female who on an unspecified date in june 2007, reported as "about 1 year ago", was vaccinated with a first dose of GARDASIL (lot # not reported). It was initally reported that the patient on approximately "25 or 25-JUN-2008", was vaccinated with a second dose of GARDASIL (lot # not reported) and on an unspecified date post first vaccination, the patient was sexually assaulted after her first dose of GARDASIL. "No adverse effect" was reported. Patient outcome was not reported. In follow up it was reported that there was no adverse drug related event. It was reported that the patient did not receive the second or third dose as scheduled. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Muscle spasms, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a 26 year old female with no history of drug reactions or allergies and a history of light cramping when menstrual period starts who in November 2007 was vaccinated with the first dose of GARDASIL vaccine and in January 2008 was vaccinated with the second dose of GARDSIL vaccine. About 2 weeks ago (on approximately 12-JUN-2008), the patient experienced cramping, which is "stronger than the usual light cramping" she had before her period starts." This cramping did not fade away, but is "off and on." On 25-JUN-2008, the patient was vaccinated with the third dose of GARDASIL vaccine 0.5 mL (lot 655327/1287U). There was no concomitant medication. On 26-JUN-2008, the patient found out that she was pregnant by a pregnancy test. On 26-JUN-2008, the patient was approximately five weeks gestation. Last menstrual period was approximately 20-MAY-2008, estimated due date 24-FEB-2009. She will not get any more doses. The patient's cramping persisted. The patient sought medical attention with a telephone call. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who in the summer of 2007, was vaccinated with a first dose of GARDASIL vaccine (lot number, injection site and route not reported). On 20-MAR-2008, the patient was vaccinated with a second dose of GARDASIL vaccine (lot number, injection site and route not reported). After receiving the 2 doses of vaccine, the patient developed a abnormal PAP smear. Unspecified medical attention was sought. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood test, Syncope
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with sulfonamide allergy who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine. At the same time the patient was vaccinated with the second dose of varicella virus vaccine live (MSD). The consumer reported that the patient had blood drawn for routine blood work after receiving the vaccinations and the patient fainted approximately 20 minutes immediately after the blood was drawn. Subsequently, the patient was recovered. The patient sought unspecified medical attention at the office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with type 1 diabetes mellitus and no known drug allergies who on 13-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine. On 16-JUN-2008 the patient was vaccinated with the second dose of GARDASIL vaccine. The patient was vaccinated at another facility. On 18-JUN-2008, the patient experienced vomiting. Subsequently, the patient recovered from vomiting. The patient sought unspecified medical attention. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Gingival erythema, Gingival swelling, Herpes simplex, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old female with seasonal allergies and a sulfonamide allergy who on 14-APR-2008 was vaccinated with the first dose of GARDASIL vaccine, lot # not specified. Concomitant therapy included ALLEGRA and VYVANSE. On an unspecified date in April 2008, the patient experienced low grade fever and sores on tongue after receiving her first dose of GARDASIL vaccine. The patient did not seek medical attention related to this and recovered at an unspecified time. On 16-JUN-2008, the patient received her second dose of GARDASIL vaccine, lot # not reported. The day after receiving the vaccine the patient developed a fever that lasted 3 - 4 days, a sore throat, sores on her mouth, tongue and inside of her lips, and red swollen gums. The patient was evaluated in the office and is recovering. Additional information has been requested. Followup phone call information was received from a nurse who reported that the patient was diagnosed with Herpes Type 1. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Stomatitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female with seasonal allergies and a sulfonamide allergy who on 14-APR-2008 was vaccinated with the first dose of GARDASIL vaccine, lot # not specified. Concomitant therapy included ALLEGRA and VYVANSE. On an unspecified date in April 2008, the patient experienced low grade fever and sores on tongue after receiving her first dose of GARDASIL vaccine. The patient did not seek medical attention related to this and recovered at an unspecified time. On 16-JUN-2008, the patient received her second dose of GARDASIL vaccine, lot # not reported. The day after receiving the vaccine the patient developed a fever that lasted 3 - 4 days, a sore throat, sores on her mouth, tongue and inside of her lips, and red swollen gums. The patient was evaluated in the office and is recovering. Additional information has been requested. Followup phone call information was received from a nurse who reported that the patient was diagnosed with Herpes Type 1. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with amoxicillin allergy and no pertinent medical history who on 10-SEP-2007, 12-NOV-2007 and 14-MAR-2008 was vaccinated with a first, second and third 0.5 mL doses, respectively, of GARDASIL vaccine (Lot #658488/0930U, 658558/1061U, 658488/1264U respectively). There was no concomitant medication. After receiving the third dose of GARDASIL vaccine the patient experienced unnamed symptoms. Subsequently, the symptoms cleared and then after an unknown time she experienced the symptoms again. Her family doctor diagnosed shingles for both occurrences. At the time of the report, the patient had recovered from shingles. The patient was seen in office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who on 23-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine. There was no concomitant medication. "3 days later," on 26-JUN-2008 the patient called the office to report she was dizzy. At the time of the report, the patient was recovering from being dizzy. The patient sought medical attention by calling the office. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female patient with no pertinent medical history and no allergies who was vaccinated with GARDASIL vaccine (yeast). There was no concomitant medication. The patient has been experiencing "spotting" during menstrual cycle. The pharmacist did not know the history of the "spotting". The patient is not known to be on birth control. The patient's spotting during menstrual cycle persisted. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeas). On 25-JUN-2008 the patient experienced periodic numbness in arm after vaccination. The patient experienced three episodes of numbness in the arm that received the vaccine. The patient recovered from periodic numbness in arm. The patient sought medical attention by telephone call. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female between 16-20 years of age, who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). The nurse practitioner reported that within the last 4-6 months the patient had experienced fainting and dizziness after receiving GARDASIL vaccine (yeast). It is unclear if the fainting occurred after all three dose or not. At the time of the report the patients had recovered; she was fine before leaving the office after receiving the vaccine. The patient did not seek medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 25-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) in the deltoid region of her arm. On 26-JUN-2008 the patient developed a rash from the wrist to the elbow on the arm in which she received the GARDASIL vaccine (yeast). The patient was treated with diphenhydramine hydrochloride (BENADRYL). The patient sought medical attention by telephone call. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female between 16-20 years of age, who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). The nurse practitioner reported that within the last 4-6 months the patient had experienced fainting and dizziness after receiving GARDASIL vaccine (yeast). It is unclear it the fainting occurred after all three dose or not. At the time of the report the patients had recovered; she was fine before leaving the office after receiving the vaccine. The patient did not seek medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Malaise, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nurse concerning her daughter, an 18 year old female who on approximately 26-DEC-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (route and administrating site not reported). The patient experienced soreness, redness and swelling in her arm as well as a fever that lasted for a few days. It was noted that the patient did not feel well for a period of approximately one week. Subsequently, the patient recovered from soreness, redness and swelling in her arm and fever. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Eye rolling, Muscle rigidity, Nervousness, Syncope, Tremor
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no known drug allergies who on 26-JUN-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 660393/0067X). At the same time the patient was vaccinated with hepatitis A vaccine (inactive) (HAVRIX). The patient told the nurse that she was nervous about shots. The patient was sitting on the table and a few minutes after GARDASIL vaccine (yeast) was administered the patient slumped down onto the table and her legs and arms were rigid and shaking. The patient's sister said her eyes rolled to the back of her head, The patient fainted and her hair was over her face. The patient was out for approximately two to three minutes. When the patient came to she said to nurse "did I fall asleep?" The patient was monitored at the office and fully recovered. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial information has been received from a nurse and follow-up information was received from a physician concerning a 14 year old female with no known drug allergies who on 26-JUN-2008 at 10:30 AM was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL (lot no. 660393/0067X). At the same time the patient was vaccinated with HAVRIX (lot no. AHAVB248AA). The patient told the nurse she was nervous about shots. The patient was sitting on the table and a few minutes after GARDASIL was administered the patient slumped down onto the table and her legs and arms were rigid and shaking. The patient's sister said her eyes rolled to the back of her head. The patient fainted and her hair was over her face. The patient was out for approximately two to three minutes. When the patient came to she said to nurse "did I fall asleep?". The patient was monitored at the office and fully recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Headache, Local reaction, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) (route and administrating site not reported). The patient experienced arm pain, weakness, headache and local reaction after administration. The patient's sister also had an adverse experience after vaccination with GARDASIL vaccine (yeast) (WAES# 0806USA08872). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning her daughter who was vaccinated with a first dose of GARDASIL vaccine. Subsequently, the patient experienced arm soreness. Subsequently, the patient recovered from arm soreness. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Stomach discomfort
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (lot not reported). Subsequently, the patient felt sick to her stomach but did not faint. The patient's status was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Headache, Local reaction, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced arm pain, weakness, headache and local reaction. At the time of report, no outcomes were reported. The physician also reported that the patient's sister experienced the same symptoms after received GARDASIL vaccine (yeast) (WAES# 0806USA08863). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a female who in June 2008 was vaccinated with the second dose of GARDASIL vaccine. The patient had "trouble getting shots or giving blood." The patient laid down for 15 minutes post vaccination and was monitored. When the patient walked down the hall way the patient fainted, and it took the patient about 30 second to revive. Smelly salts were place under the patient's nose. Subsequently, the patient recovered from faint. The patient sought medical attention at the office. This is one of several reports from the same source. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a certified medical assistant concerning a 15 year old female who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (lot# 659182/1757U) at 1900. On 19-JUN-2008 the patient was vaccinated with the second dose of GARDASIL at 10:00. The patient attempted to leave and started to feel nauseated after the second dose at 10:00 on 19-JUN-2008. The patient ran into the wall and passed out. The patient was put on floor and it took the patient about 30 second to revive. Smelly salts were placed under the patient's nose. Subsequently, the patient recovered from faint but still nauseated. The patient did not eat anything prior to shot. The patient was advised to eat prior to the last shot. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients who were vaccinated with a first dose of GARDASIL vaccine. The patients became dizzy, pale and diaphoretic after receiving a dose of GARDASIL vaccine. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 7/15/2008. Follow up information was received from a registered nurse indicating she would not be able to provide the exact number of patients or patient identifiers. This is one of several reports from the same source
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician and an office manager concerning an approximately 20 year old female who on an specified date was vaccinated intramuscularly with a first 0.5 mL dose of GARDASIL vaccine (Lot #660555/0279X). After receiving GARDASIL vaccine the patient fainted. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information ahs been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 23 year old female who on approximately 21-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (dose, route, and lot # not specified). On approximately 21-JUN-2008, the patient developed itching, redness, swelling, and inflammation at the injection site that went away on an unspecified date. On an unspecified date the injection started swelling again and spread to the elbow from the upper arm. The patient sought medical attention by phone call to the office. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received regarding a case in litigation. An X-ray technician reported that her colleague with no relevant medical history or allergies in October 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). In November 2007, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). In February 2008, also reported as soon after third dose, the patient had a positive PAP with abnormal cells. The patient sought unspecified medical attention. The patient's positive PAP with abnormal cells persisted. This is case 2 of 2. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Myalgia, Pain, White blood cell count decreased
Clinical narrative: Information has been received from a nurse, who is the mother of the patient, concerning her 16 year old daughter who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. On 10-JUN-2008, she was vaccinated with the second dose of GARDASIL vaccine, (lot # not reported), IM. Concomitant therapy included MENACTRA. The nurse reported that her daughter developed headache, muscle aches and pain on 25-JUN-2008. On 29-JUN-2008, she had taken her daughter the patient to a urgent care facility because she still wasn't feeling well. The nurse reported that her daughter had blood work performed and it was determined that she had a low white blood count; it was suspected she could have a virus, but they were not sure. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Libido decreased
Clinical narrative: Information has been received from a 24 year old female consumer with PAXIL allergy and no pertinent medical history who on 06-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 mL IM. There was no concomitant therapy. The patient experienced a diminished sex drive soon after starting therapy. On 06-MAY-2008, the patient was vaccinated with the second dose of GARDASIL vaccine 0.5 mL IM. There was no concomitant medication. On 06-MAY-2008, the patient experienced diminished sex drive much more soon after starting therapy. The patient's diminished sex drive persisted. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female (age unreported) who was vaccinated with a dose of GARDASIL vaccine (yeast), lot number not reported. Within five minutes the patient passed out for an extended period of time, hit her head on the wall and went to the emergency room. This is one of 2 reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: Information has been received from a consumer concerning her daughter a 13 year old female patient with type 1 diabetes mellitus, who at 30-JUN-2008 8:45 AM was vaccinated with the first dose of GARDASIL vaccine. Concomitant therapy included HUMALOG and LANTUS. On 30-JUN-2008, the patient experienced an elevation of blood glucose level (270mg/dl at 10 AM) (Home monitor). The patient had eaten usual breakfast prior to receiving vaccine in the morning. The patient did not seek medical attention, but would call physician. Additional information has been requested. This is in follow-up to report (s) previously on 7/15/2008.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypoaesthesia, Injection site anaesthesia, Paraesthesia
Clinical narrative: Information has been received from staff from a physician's office concerning an 18 year old female with severe allergies to numerous things (dogs, cats, doxycycline, sulfa, CEFZIL and ADACEL) who on 29-MAY-2008 was vaccinated with a first dose of GARDASIL by intramuscular injection in the arm (lot number not reported). Concomitant therapy included YASMIN, ZYRTEC and SUDAFED. Almost immediately after receiving the vaccine, the patient experienced numbness and tingling in her arm where the injection was given. The patient also experienced redness underneath her eyes which described as red streaks (one going vertically and the other horizontally). The patient also had a reaction to ADACEL, but specifics were unknown. Unspecified medical attention was sought. Subsequently, the patient recovered from all the events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with allergy to VICODIN who on 08-JAN-2008 was vaccinated with the third 0.5 mL dose of GARDASIL vaccine. It was unknown when she received the first and second 0.5 mL doses of GARDASIL vaccine. There was no concomitant medication. The patient began to experience back pain after receiving the second dose. At the time of this report, the patient's back pain persisted. The patient sought unspecified medical attention at the practice. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning an approximately 17 year old female with allergy to FLONASE who in April 2008, was vaccinated with the first 0.5 mL dose of GARDASIL vaccine. Concomitant therapy included diclofenac. The patient complaint of pain during administration of her first dose. The outcome was not reported. The patient sought unspecified medical attention during office visit. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning her 19 year old female cousin who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine. Concomitant medications were not reported. A nurse reported that her cousin received the first dose of GARDASIL vaccine and fainted in the waiting room. She recovered in 5 minutes. She had no reaction to her second vaccination with GARDASIL vaccine. Medical attention was sought: in office. There is no product quality complaint. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Follow up information was received from a nurse concerning her 20 year old female cousin with no medical history and no known allergies, who on 18-DEC-2007, at noon, was vaccinated with a first dose of GARDASIL (Lot # 653735/0688F) intramuscularly into the left deltoid. The patient fainted 5-10 minutes post vaccination. The patient recovered the same day. There was no illness at the time of vaccination. No relevant diagnostic/laboratory tests were performed. It was reported that two subsequent doses of GARDASIL caused no adverse effects. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with GARDASIL vaccine. It was unknown how many doses of GARDASIL vaccine the patient had received. The patient who had a normal PAP prior to vaccination had an abnormal PAP and was positive for HPV. At the time of this report, the patient was not recovered. The patient sought unspecified medical attention at office. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a female with a history of hives from penicillin who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. Later in that day the patient developed a rash, slightly raised if scratched, pruritic, over her trunk and arms. Subsequently, the patient recovered from rash which lasted for 5 to 7 days. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female between 16-20 years of age, who on an unspecified date was vaccinated with GARDASIL vaccine. The nurse practitioner reported that within the last 4-6 months the patient had experienced fainting and dizziness after receiving GARDASIL vaccine. It is unclear if the fainting occurred after all three doses or not. At the time of the report the patient had recovered; she was fine before leaving the office after receiving the vaccine. The patient did not seek medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a licensed practical nurse concerning a female in her "late 30's or early 40"s" who was vaccinated with a dose of GARDASIL vaccine. The nurse reported that the patient "may have Guillain-Barre syndrome." The patient contacted the office by phone. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review possible Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested. 12/19/08-records received-C/O weakness of muscles on 5/16/08 after Gardasil vaccine. 2/28/08 C/O increase in urge and frequency of urination for 24 hours. Suprapubic pain. DX UTI.  8/13/07 C/O foot pain/blisters after walking Gardasil vaccine adminsitered 11/15/07 lot #0955F left deltoid., 1/7/08 2nd Gardasil lot#0955F left deltoild and 3rd on 5/5/08 lot#1446U left deltoid.