chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 20 year old female who developed rash (unspecified type) around the injection site after receiving the first and second 0.5 mL doses of GARDASIL (lot# was not available). The patient received the second dose of vaccine on 13-OCT-2009 and she called the nurse later and reported her reaction. The outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Depression
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with the second dose of GARDASIL. The reporter mentioned she believed her daughter had anxiety and depression for a whole week after received the vaccine. At the time of reporting the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with three doses of GARDASIL on unspecified dates and recently had an abnormal PAP test positive for HPV. The date of PAP test was unknown. At the time of report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Bone neoplasm
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). The physician heard from one of his patients that a girl developed a bone tumor after receiving GARDASIL. At the time of this report the patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in jaw
Clinical narrative: Information has been received from a receptionist concerning a female patient who was vaccinated with a dose of GARDASIL (lot # not specified). On 12-OCT-2009 her jaw started to hurt. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Muscle spasms
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning an "18 year old" female who on 19-OCT-2009 was vaccinated with the second dose of GARDASIL (unspecified when the first dose was given) and was approximately 4 weeks pregnant at the time of reporting. The patient was currently had "cramping". The patient's estimated conception date was 07-OCT-2009, and estimated delivery date was 14-JUL-2010. The patient called the physician's office for medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from a consumer concerning her currently 24 year old daughter who in approximately 2007 was vaccinated with series of GARDASIL (lot#, route and site of administration not reported). It was reported that the patient had been diagnosed with cervical dysplasia. The patient had not had multiple sex partners and had had yearly Pap smears. The consumer was wondering if cervical dysplasia was related to GARDASIL. At the time of this report, the patient's outcome was unknown. No further information is available.
Age: 4.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 4 year old female who on 27-AUG-2009 was inadvertently vaccinated with the first dose of GARDASIL (IM, 0.5ml) instead of "IVP" (human error not PQC). No adverse effects reported. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with no pertinent medical history who on 06-OCT-2009 was vaccinated with the first dose of GARDASIL (lot # 663552/1350Y). There was no concomitant medication. Subsequently, the patient experienced arm numbness as soon as the vaccination. The patient recovered on 06-OCT-2009. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site erythema, Injection site exfoliation, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with no known allergies or pertinent medical history who on 12-AUG-2009 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 662300/0100Y). There was no concomitant medication. The physician reported that the patient received the first dose of GARDASIL and later experienced swelling and redness with a raised scaly border at the injection site. On 25-AUG-2009 the patient's mother called the office to report that she thought the child had ringworm and had been applying hydrocortisone cream (manufacturer unknown) to the affected area. On 13-OCT-2009, the patient was seen in the office with a hypopigmented 2 cm around the injection site. The area had a small induration that remained. At the time of the report that patient was recovering. On 13-OCT-2009, the female patient with hyperhidrosis and chronic foot dermatitis was scheduled to be vaccinated with the second dose of GARDASIL (Lot number not reported). (It was not reported if the patient actually received the second dose). The patient reported that she had a rash on the area where she received her last dose of GARDASIL that had been there since the vaccine, it is not going away. The patient reported that it had loss of pigment circumferentially around site. On 12-AUG-2009, the patient was treated with HYTONE and DRYSOL, on 13-OCT-2009, treated with triamcinolone acetonide 0.5%. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with no known allergies or pertinent medical history who on 12-AUG-2009 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 662300/0100Y). There was no concomitant medication. The physician reported that the patient received the first dose of GARDASIL and later experienced swelling and redness with a raised scaly border at the injection site. On 25-AUG-2009 the patient's mother called the office to report that she thought the child had ringworm and had been applying hydrocortisone cream (manufacturer unknown) to the affected area. On 13-OCT-2009, the patient was seen in the office with a hypopigmented 2 cm around the injection site. The area had a small induration that remained. At the time of the report that patient was recovering. On 13-OCT-2009, the female patient with hyperhidrosis and chronic foot dermatitis was scheduled to be vaccinated with the second dose of GARDASIL (Lot number not reported). (It was not reported if the patient actually received the second dose). The patient reported that she had a rash on the area where she received her last dose of GARDASIL that had been there since the vaccine, it is not going away. The patient reported that it had loss of pigment circumferentially around site. On 12-AUG-2009, the patient was treated with HYTONE and DRYSOL, on 13-OCT-2009, treated with triamcinolone acetonide 0.5%. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Drug screen positive, Fungal infection, Ultrasound scan normal
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number 661046/0381X) while she may have been pregnant. The last menstrual period reported as 06-JUL-2009. There were no adverse reactions reported. The patient saw a physician in the office. On 03-SEP-2009 a urine drug screen was performed and resulted for Cannabis. On 03-SEP-2009, the patient was given ZITHROMAX. At the time of the report, the outcome of the patient was not reported. Follow-up information has been received from the medical assistant concerning the 22 year old female with a history of one previous pregnancy and one full term delivery who on 28-JUL-2009, at 11:00 AM was vaccinated with the first dose of GARDASIL (lot number 661046/0381X) in the right arm. Prenatal vitamins were used daily since pregnancy. On 01-SEP-2009 an ultrasound was performed for the estimated date of conception. The result was normal intrauterine pregnancy. On 20-JAN-2010, the patient was vaccinated with a 0.5 ml dose of H1N1 (manufacturer unspecified). On an unspecified date, the patient developed yeast infection and was treated on 01-APR-2010 with TERAZOL 7 vaginal cream 0.4% for one time. On 08-APR-2010 the patient gave birth to a normal baby boy. The boy was 8 pounds and 8 ounces weight and 20.75 inches long. There was no complication during pregnancy and labor/delivery. There were no congenital anomalies or other complications with the infant. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Joint swelling, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no medical history or drug allergies who on 26-AUG-2009 was vaccinated with the first dose injection of GARDASIL (lot number not reported). There was no concomitant medication. On approximately 28-AUG-2009 (also reported as about 36 to 48 hours after receiving the vaccination) the patient experienced hives all over her body and started to have joint swelling. The patient took BENADRYL but that did not help, so the patient then saw her physician and was given MEDROL DOSEPAK and cortisone shot and by 01-SEP-2009 the patient had recovered. The consumer reported that the physician stated the patient had an allergic reaction to GARDASIL and she should not get anymore doses. There were no laboratory diagnostic studies performed. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bruxism, Gaze palsy, Musculoskeletal stiffness, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a "15 year old" female who on an unspecified date was vaccinated with a second 0.5ml dose of GARDASIL (lot # 663453/0249Y) IM. The physician stated that "a patient developed a vasovagal reaction, including staff hands and her eyes rolled back into her head after receiving GARDASIL on 06-OCT-2009." "The nurse stated that she did not believe GARDASIL was the cause of this, but rather the patient had been very nervous about receiving the vaccine, the patient did not eat anything that day before receiving the vaccine, and she was just recovering from the flu." The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who on 04-AUG-2009 at 3:30 pm was vaccinated with the first dose of GARDASIL (lot # 663451/0216Y) IM and on 06-OCT-2009 at 4:30 pm with the second dose (lot # 663453/0249Y) IM. The father stated that the patient had been sick with "flu" the week prior to the vaccine. On 06-OCT-2009 at 4:30 pm to 4:45 pm, the patient appeared to have a vasovagal response. She got pale and her eyes rolled back. Her teeth clinched and she was unresponsive for 3 to 5 seconds. It was noted that the patient had not eaten all day and had been sick with "flu". The patient was also very nervous about the shot. PHENERGAN suppository was given due to nausea. There were no labs and diagnostic tests performed. The patient was watched for 45 minutes with the doctor present. Subsequently, the patient recovered on 06-OCT-2009 and left with her father. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a "15 year old" female who on an unspecified date was vaccinated with a second 0.5ml dose of GARDASIL (lot # 663453/0249Y) IM. The physician stated that "a patient developed a vasovagal reaction, including staff hands and her eyes rolled back into her head after receiving GARDASIL on 06-OCT-2009." "The nurse stated that she did not believe GARDASIL was the cause of this, but rather the patient had been very nervous about receiving the vaccine, the patient did not eat anything that day before receiving the vaccine, and she was just recovering from the flu." The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who on 04-AUG-2009 at 3:30 pm was vaccinated with the first dose of GARDASIL (lot # 663451/0216Y) IM and on 06-OCT-2009 at 4:30 pm with the second dose (lot # 663453/0249Y) IM. The father stated that the patient had been sick with "flu" the week prior to the vaccine. On 06-OCT-2009 at 4:30 pm to 4:45 pm, the patient appeared to have a vasovagal response. She got pale and her eyes rolled back. Her teeth clinched and she was unresponsive for 3 to 5 seconds. It was noted that the patient had not eaten all day and had been sick with "flu". The patient was also very nervous about the shot. PHENERGAN suppository was given due to nausea. There were no labs and diagnostic tests performed. The patient was watched for 45 minutes with the doctor present. Subsequently, the patient recovered on 06-OCT-2009 and left with her father. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Hypersensitivity, Ultrasound scan abnormal
Clinical narrative: Information has been received from a 23 year old female patient, for GARDASIL, a Pregnancy Registry product, who on 11-SEP-2009 was vaccinated intramuscularly with the third dose of 0.65 ml GARDASIL. Concomitant therapy included SYMBICORT and prenatal vitamins. The patient had been pregnant for 7 weeks when she was given her third dose of GARDASIL. Blood work was performed (result not reported). The patient's date of last menstrual period was approximately on 24-JUL-2009 and estimated delivery date was on 30-APR-2010. No adverse event reported. Medical attention had been sought. Follow up information was received from a registered nurse, for GARDASIL, a Pregnancy Registry product, which reported that on 11-SEP-2009, the female patient with asthma and with a history of 1 previous pregnancy and 1 previous full term delivery was vaccinated with the third dose of GARDASIL (lot # 663453/0249Y) while she was pregnant. Concomitant therapy included SYMBICORT, prenatal vitamins and PULMICORT. Her LMP was on approximately 24-AUG-2009, the estimated conception date was on approximately 07-SEP-2009, and EDD was on approximately 03-JUN-2010. On an unspecified date, the patient developed allergies. She was given EQUATE ALLERGY MEDICATION daily to treat allergies. On 15-OCT-2009, ultrasound was performed for dating which was ok, the patient was 6 weeks and 6 days of pregnancy and there was fetal heart rate (FHR). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis atopic, Rash
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no pertinent medical attention who on 23-FEB-2009 and 14-SEP-2009 was vaccinated IM with the first and second (lot# 0670Y) 0.5ml doses of GARDASIL. There was no concomitant medication. The patient developed a dermatologic reaction after the first dose of GARDASIL. The patient was taking oral prednisone for eczema as of April 2009. In July 2009 and August 2009 the patient was examined by a dermatologist and treated for atopic dermatitis. The patient developed a rash (worse than prior reaction) 3 days after the second dose of GARDASIL. The patient was examined by dermatologist in September 2009 and treated with a topical steroid cream. The patient sought medical attention through a telephone call. On 22-OCT-2009, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female patient with no known drug reactions/allergies or pertinent medical history who on 25-FEB-2009 was vaccinated with the first dose of GARDASIL. On 05-OCT-2009 the patient was vaccinated with the third dose of GARDASIL. The medical assistant reported that as soon as the third dose of GARDASIL was administered the patient experienced injection arm numbness. The injection arm numbness resolved before the patient left the office. It was reported that later the same date, on 05-OCT-2009, the patient called back to the office to report that her finger tips were numb. No lab tests were performed. On an unknown date, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot number not provided). The registered nurse reported that the patient said the injection was very painful. At the time of the report the patient had recovered. The patient sought medical attention in the office. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Heart rate irregular, Muscle spasms, Myalgia, Nausea, Rash
Clinical narrative: Information has been received from a physician who reported that a mother chose to stop her daughter's GARDASIL due to "bad press". The article was in the newspaper concerning three girls, who had experiences after receiving the vaccine. On an unspecified date the patient who was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date she experienced charley horse, spasms and pain in muscles with fainting, nausea, irregular heartbeat and rash since she received GARDASIL. The patient's outcome was not reported. This is one of three reports from the same source. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician who reported that a mother chose to stop her daughter's GARDASIL due to "bad press". The article was in the newspaper concerning three girls, who had experiences after receiving the vaccine. On an unspecified date the patient who was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date she experienced charley horse, spasms and pain in muscles with fainting, nausea, irregular heartbeat and rash since she received GARDASIL. The patient's outcome was not reported. This is one of three reports from the same source. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who on 06-NOV-2009 was vaccinated IM with the third 0.5 ml dose of GARDASIL. On 060-NOV-2009 the patient developed swelling and numbness at the injection site after receiving her GARDASIL. The numbness extended to the patient's elbow and she experienced tingling on her fingers on her left hand. It was reported to the representative that the patient had "recently" received FLUMIST. The patient had sought medical attention, office visit. At the time of report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Arrhythmia supraventricular
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with GARDASIL. Subsequently the patient experienced atrial arrhythmia and was scheduled to have ablation for correction of the arrhythmia could to be related to GARDASIL. There was no other information provided at this time and the health professional did not feel that this atrial arrhythmia was related to vaccination. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Presyncope
Clinical narrative: Information has been received from a patient's father concerning his 12 year old daughter, who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (lot # not provided). Subsequently the patient turned white and nearly fainted after getting the first dose of GARDASIL. At the time of the report the patient's outcome was unknown. No laboratory diagnostics studies were performed. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced a sore arm afterwards. On an unspecified date the patient was vaccinated with the second dose of GARDASIL in the hip, since she had a sore arm after the first dose. The nurse practitioner did not know if the vaccine was given intramuscular or not. On an unspecified date, the patient was given the third dose of GARDASIL in the arm. Medical attention was sought, the patient spoken to the nurse practitioner. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Heart rate irregular, Muscle spasms, Myalgia, Nausea, Rash
Clinical narrative: Information has been received from a physician who reported that a mother chose to stop her daughter's GARDASIL due to "bad press". The article " teens believe GARDASIL make them sick" was in newspaper on 29-OCT-2009 concerning three girls, known as the "GARDASIL Girls" had experiences after receiving the vaccine. On an unspecified date the patient who was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date she experienced charley horse, spasms and pain in muscles with fainting, nausea, irregular heartbeat and rash since she received GARDASIL. The patient's outcome was not reported. This is one of three reports form the same source. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician who reported that a mother chose to stop her daughter's GARDASIL due to "bad press". The article " teens believe GARDASIL make them sick" was in newspaper on 29-OCT-2009 concerning three girls, known as the "GARDASIL Girls" had experiences after receiving the vaccine. On an unspecified date the patient who was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date she experienced charley horse, spasms and pain in muscles with fainting, nausea, irregular heartbeat and rash since she received GARDASIL. The patient's outcome was not reported. This is one of three reports form the same source. No additional information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ear infection, Haematology test normal, Impaired work ability, Migraine
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient with amoxicillin and sulpha allergy who on 01-OCT-2009 was vaccinated with a first dose of GARDASIL 0.5 ml (Lot # 663453/0249Y). Concomitant therapy included a second dose of DEPO-PROVERA (manufacturer unspecified). On 04-OCT-2009 the patient woke up with dizzy spells, extreme muscle fatigue and nausea. The patient had experienced these symptoms chronically since 04-OCT-2009. The patient saw her primary care physician who pulled blood work, but all test showed no abnormalities. The primary care physician prescribed the patient prednisone (manufacturer unspecified) as treatment but the patient was still experiencing these symptoms. At the time of the report the patient had not recovered. Further information has been received from a licensed practical nurse concerning to this patient. The nurse confirmed that the patient on 01-OCT-2009 received a dose of GARDASIL and also her second dose of DEPO-PROVERA (manufacturer unspecified). The patient did not receive any concomitant vaccinations. On 20-OCT-2009, the patient contacted the physician and she complained of migraine headache, dizziness and her muscle felt sore. The patient was treated with ZOFRAN for nausea. The patient was able to go to work but stated that "it was hard to function". The patient "considered her condition to be a burden" and stated that she would not continue the therapy with GARDASIL. The patient was prescribed laboratory blood tests (blood tests unspecified). The blood test results were normal. Further follow-up has been received from a Licensed Practical Nurse concerning to this patient with amoxicillin, ROBITUSSIN allergies who was vaccinated on 01-OCT-2009 at 11:30 AM on left deltoid with a dose of GARDASIL. On 04-OCT-2009 the patient experienced dizzy spells, extreme muscle, fatigue and nauseated all the time since vaccination with GARDASIL. No abnormal blood work was performed. The primary care physician prescribed the patient prednisone (manufacturer unspecified). Additional follow up information has been received from a Licensed Nurse Practitioner concerning this patient. The nurse stated that on 04-OCT-2009, the patient woke up with a migraine, extreme nausea, dizziness and muscle fatigue. Patient saw her primary care physician and they ran test and everything was within normal limits. They gave her prednisone and treated her for an ear infection. Signs and symptoms never went away. The patient recovered from migraine, extreme nausea, dizziness and muscle fatigue on unspecified date. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle fatigue, Nausea
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient with amoxicillin and sulpha allergy who on 01-OCT-2009 was vaccinated with a first dose of GARDASIL 0.5 ml (Lot # 663453/0249Y). Concomitant therapy included a second dose of DEPO-PROVERA (manufacturer unspecified). On 04-OCT-2009 the patient woke up with dizzy spells, extreme muscle fatigue and nausea. The patient had experienced these symptoms chronically since 04-OCT-2009. The patient saw her primary care physician who pulled blood work, but all test showed no abnormalities. The primary care physician prescribed the patient prednisone (manufacturer unspecified) as treatment but the patient was still experiencing these symptoms. At the time of the report the patient had not recovered. Further information has been received from a licensed practical nurse concerning to this patient. The nurse confirmed that the patient on 01-OCT-2009 received a dose of GARDASIL and also her second dose of DEPO-PROVERA (manufacturer unspecified). The patient did not receive any concomitant vaccinations. On 20-OCT-2009, the patient contacted the physician and she complained of migraine headache, dizziness and her muscle felt sore. The patient was treated with ZOFRAN for nausea. The patient was able to go to work but stated that "it was hard to function". The patient "considered her condition to be a burden" and stated that she would not continue the therapy with GARDASIL. The patient was prescribed laboratory blood tests (blood tests unspecified). The blood test results were normal. Further follow-up has been received from a Licensed Practical Nurse concerning to this patient with amoxicillin, ROBITUSSIN allergies who was vaccinated on 01-OCT-2009 at 11:30 AM on left deltoid with a dose of GARDASIL. On 04-OCT-2009 the patient experienced dizzy spells, extreme muscle, fatigue and nauseated all the time since vaccination with GARDASIL. No abnormal blood work was performed. The primary care physician prescribed the patient prednisone (manufacturer unspecified). Additional follow up information has been received from a Licensed Nurse Practitioner concerning this patient. The nurse stated that on 04-OCT-2009, the patient woke up with a migraine, extreme nausea, dizziness and muscle fatigue. Patient saw her primary care physician and they ran test and everything was within normal limits. They gave her prednisone and treated her for an ear infection. Signs and symptoms never went away. The patient recovered from migraine, extreme nausea, dizziness and muscle fatigue on unspecified date. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Tongue exfoliation
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female who on 03-NOV-2009 was vaccinated with the second dose of GARDASIL (lot number was not available). Concomitant therapy included VALTREX and unspecified birth control medicine. On 03-NOV-2009 the patient developed a rash with no itch and her tongue started peeling a few hours after receiving her second dose of vaccine. The patient sought medical attention by visiting the nurse practitioner. The patient had recovered after stopping therapy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL. Subsequently the patient experienced syncope. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been received from an other health professional indicated that she could not fill out the form because she couldn't find the patient and the physician was no longer worked in the office. She would not return the form to Merck. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge, Vaginal odour
Clinical narrative: Information has been received from a nurse practitioner concerning a female who in June 2008 was vaccinated with the first dose of GARDASIL (route and LOT# not reported). At the time of the reporting, it was reported that the patient currently had an odorous vaginal discharge. On 12-NOV-2009, she would received the second dose of GARDASIL (route and LOT# not reported). Unspecified medical attention was sought in the office. The patient's outcome was not recovered. Follow-up information has been received from the nurse practitioner who indicated that the patient received the first dose of GARDASIL at another office and she planned to follow up with a primary care office. The nurse practitioner stated that they told her to get it as soon as possible. The culture test haemophilus influenza was performed on an unspecified date and results not provided. The patient was treated with METRONIDAZOLE. The nurse practitioner doubted the adverse events were related to GARDASIL. The patient's outcome was unknown. Follow-up information has been received from the nurse practitioner who reported that they had just called Merck and to see if it was too late for second vaccination. The patient had bacterial vaginosis at time of vaccination. The patient had not had the second vaccination and she would get the second and third vaccinations in 12 weeks. The patient was taken METRONIDAZOLE, 500 mg, BID X 7 (days) for foul smelling discharge. It was noted that foul smelling discharge was not related to vaccination. No further information is available.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse practitioner concerning a 30 year old female patient who on 15-OCT-2009 received her first dose of GARDASIL (dose and lot number not reported). According to the reporter, the patient called the office to report that her hair is falling out. The patient was scheduled to be seen in the office on 10-NOV-2009, but she failed to keep the appointment. The outcome for the patient's hair falling out was unknown. Follow up information has been received from the nurse practitioner concerning the 30 year old female patient without any illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions reported, who on 15-OCT-2009 received her first dose of GARDASIL, intramuscular route (lot #661846/1312X). No other known vaccines administered. The nurse practitioner reported that the patient called the next day after the vaccination and she reported that she was losing her hair after shot. the patient was to see a dermatologist. (The reporter felt that secondary unlikely caused by GARDASIL). At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Dermatitis, Drug exposure before pregnancy, Hepatic enzyme increased, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who on 03-MAR-2009 and 05-MAY-2009 was vaccinated IM with the first and second 0.5ml doses of GARDASIL (lot# not reported). Then the patient discovered that she was pregnant. No adverse effects noted. The patient sought unspecified medical attention. On 01-SEP-2009. a blood test was performed and it was positive for pregnancy. On 12-OCT-2009, an ultrasound was performed, and it showed normal prenatal ultrasound. The patient's last menstrual period was reported as 15-JUN-2009. The estimated delivery date would be 22-MAR-2010. This is one of several reports received from the same source. Follow-up information was received from a Nurse Practitioner who stated that the patient received GARDASIL. (Both doses were Lot number: 661846/1312X). It was reported that the patient was not sure of diagnosis but was having liver problems (elevated liver enzymes and dermatitis. The reporter stated that the same thing happened with a previous pregnant. It was performed an ultrasound on 01-SEP-2009 with a normal result. According of last week's ultrasound (on approximately 18-NOV-2009) the baby weighs 1 pound. It was also mentioned that the patient would be seen on 01-DEC-2009 by a specialist. The patient sought medical attention in office visit. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Molluscum contagiosum
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first 0.5 mL dose of GARDASIL. Subsequently, one month later after vaccination the patient developed "miluscumcontagiosum" (may be a molluscum contagiosum). The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from the physician concerning an approximately 13 year female old student with mood disorder who on 29-NOV-2009 was vaccinated intramuscularly with the first dose of GARDASIL (lot# 774170/0388Y). On 30-JAN-2008, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot# 1742U). Concomitant therapy included PROZAC. After receiving the two vaccinations, in 2008 the patient developed outbreak of molluscum contagiosum. It was also reported that the patient was told by a dermatologist that could not rule out GARDASIL as a trigger. The outcome of molluscum contagiosum was not reported. The patient refused the final dose. There was no illness at time of vaccination. No laboratory was performed. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with a history of positive human papilloma virus prior to starting GARDASIL series who on an unspecified was vaccinated with the third dose of GARDASIL. The physician reported that the patient developed fever, headache and flu like symptoms that persisted for 5 days after receiving the third dose of vaccine. The patient was due to receive her third dose in August 2009 but had delayed it because of that reaction. On an unspecified date the patient recovered from fever, headache and flu like symptoms. The patient sought medical attention at the office. Follow-up information has been received from a health care professional who indicated that the patient was a student with a history of abnormal papsmear. According to the reporter, on 17-APR-2009 the patient received intramuscularly her second dose of GARDASIL (Lot # 661954/1496X) into her right deltoid at 11:27 AM. There was no illness at the time of vaccination. The patient stated that she had fever and flu like symptoms with the second dose of GARDASIL (previously reported as third dose). No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Injection site urticaria, Lip swelling, No reaction on previous exposure to drug, Seasonal allergy
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient with asthma, seasonal allergies, allergies to sulfonamide, aspirin, ibuprofen and ALEVE who on 04-AUG-2009 and 06-OCT-2009 was vaccinated IM with a first and second 0.5ml doses of GARDASIL (lot# 661046/0381X for 1st and 2nd doses). Concomitant therapy included YAZ, albuterol inhaler as needed, XYVAL, SINGULAIR, and ALLERX dose back. Within one week of 06-OCT-2009, the patient developed hives on her legs and left hip and swelling on her lips after receiving her second dose of GARDASIL. The second dose of GARDASIL was administered in her left hip. The patient sought medical attention through an office visit. On unspecified date, the patient recovered. Follow up information has been received from the certified medical assistant concerning the 16 year old female patient who on 06-OCT-2009 at 14:00 was vaccinated IM into the left gluteal muscle with a second 0.5ml dose of GARDASIL (lot# 661046/0381X) (exp: 10-DEC-2010). There was no known illness at the time of vaccination and no known adverse event following prior vaccination. On 07-OCT-2009 at 9:11 AM the patient developed hives on her legs that were larger than quarters and she also developed swelling of her lips. Medical attention was sought, the patient saw the physician. Subsequently, the patient recovered on an unspecified date sought, the patient saw the physician. Subsequently, the patient recovered on an unspecified date. No further information was available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient with asthma, seasonal allergies, allergies to sulfonamide, aspirin, ibuprofen and ALEVE who on 04-AUG-2009 and 06-OCT-2009 was vaccinated IM with a first and second 0.5ml doses of GARDASIL (lot# 661046/0381X for 1st and 2nd doses). Concomitant therapy included YAZ, albuterol inhaler as needed, XYVAL, SINGULAIR, and ALLERX dose back. Within one week of 06-OCT-2009, the patient developed hives on her legs and left hip and swelling on her lips after receiving her second dose of GARDASIL. The second dose of GARDASIL was administered in her left hip. The patient sought medical attention through an office visit. On unspecified date, the patient recovered. Follow up information has been received from the certified medical assistant concerning the 16 year old female patient who on 06-OCT-2009 at 14:00 was vaccinated IM into the left gluteal muscle with a second 0.5ml dose of GARDASIL (lot# 661046/0381X) (exp: 10-DEC-2010). There was no known illness at the time of vaccination and no known adverse event following prior vaccination. On 07-OCT-2009 at 9:11 AM the patient developed hives on her legs that were larger than quarters and she also developed swelling of her lips. Medical attention was sought, the patient saw the physician. Subsequently, the patient recovered on an unspecified date sought, the patient saw the physician. Subsequently, the patient recovered on an unspecified date. No further information was available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Sinusitis, Syncope
Clinical narrative: Information has been received from a nurse concerning a 12 year old female patient with a history of a premature atrial contraction who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 661046/0381X). There was no concomitant medication. On 22-SEP-2209 the patient's mother called 911 and the patient was taken to the Emergency Room (ER) and diagnosed with syncope and sinusitis. The mother believed it was due to the vaccine; however the nurse did not think that it was. There as an about two month's delay, almost a three month between the injection and the syncope. The patient received AUGMENTIN. At the time of the report, the patient was doing well. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a teenaged female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Two or three months ago, the patient experienced syncopal episode. The patient fell and the reporter believed it was her head she hit on the table and the patient needed stitches. At the time of the report, the patient fully recovered. This is an amended report. The AE term of "head banging" was delete and the reporter term of "hit her head on table" was added to map to AE term of "head injury". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Laboratory test, Myalgia
Clinical narrative: Information has been received from a pharmacist concerning a female patient "in her early 20's" who "in early 2008" was vaccinated with 3 doses of GARDASIL (lot number not reported). The patient received her doses from another facility. About one year after dose 3 was administered, in 2009, the patient began to experience myalgia and tiredness. Unspecified medical contact was sought. The patient did have lab work done but the pharmacist doesn't know which ones. At the time of the report, the patient had not recovered. The Pharmacist contacted during telephone follow-up could no supply the following information patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of even and recovery status. The Pharmacist was waiting to speak with the doctor regarding these patients. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Malaise, Muscular weakness
Clinical narrative: Information has been received from a 26 year old female who in September 2009, was vaccinated with the first dose of GARDASIL. Subsequently, 4 days after the vaccination, the patient experienced malaise, muscle weakness and shortness of breath. The patient recovered from malaise, muscle weakness and shortness of breath after 5 days. The patient consulted to the general physician, and the physician did not find any abnormality in the exam. The patient felt that malaise, muscle weakness and shortness of breath were related to therapy with GARDASIL. The physician considered that the vaccination with GARDASIL was not related with these events. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a pregnant female patient who on an unspecified date in 2009 ("in the last couple weeks") was accidentally vaccinated with a 0.5ml dose of GARDASIL instead of flu vaccines. It was reported that the nurse had reached into her diebold dispenser to retrieve the flu vaccine syringes, but took out GARDASIL filled syringe instead. No adverse effect was reported. Unspecified medical attention was sought. The nurse pointed out that the patient was in her third trimester. This is one of several reports from the same source. No further information is available.
Age: 41.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy skin, Skin papilloma
Clinical narrative: Information has been received from a 41 year old male HIV and HPV positive (prior to vaccine) with an allergy/reaction to fluoroquinolone antibiotics who in "early 2008" was vaccinated with GARDASIL. Concomitant therapy included LIPITOR and allopurinol. The consumer reported that since "Spring 2009" he had 2 warts on his back and 13 warts on his chest after administration of GARDASIL. The patient stated that he never had warts in either area prior to receiving GARDASIL. At the time of the report the patient had not recovered. The consumer wanted to note that he was advised by his physician to receive the vaccine because he was a "gay man". The patient sought unspecified medical attention. On an unspecified date a skin biopsy with diagnosis of wart was performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with "at least one dose" of GARDASIL. The physician reported that on an unspecified date, when a Pap smear test was done, the patient had an abnormal result. The patient sought the physician for medical attention. At the time of the report, the patient's outcome was unknown. The physician stated that the patient will continue with the GARDASIL series. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 14-OCT-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot number 661846/1312X). Concomitant therapy in the same week included a dose of flu vaccine (manufacturer unspecified) and DEPO-PROVERA (manufacture unspecified). On 15-OCT-2009 the patient broke out in hives and a rash on her stomach, back, legs and neck. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient was recovering.  Follow-up information has been received from the 23 year old female patient who on 14-OCT-2009 at 13:30 pm was vaccinated IM in the right arm with the first dose of GARDASIL (lot number 661846/1312X). Concomitant therapy in the same week included a dose of flu vaccine (manufacturer unspecified) and on 15-OCT-2009 the second dose of DEPO-PROVERA (lot number I0901) in the left hip. On 15-OCT-2009, at 18:00 pm, the patient broke out rash/hives on stomach, back, legs and neck. The outcome of the patient was not reported. Additional information has been requested.