chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 26 year old female who was vaccinated with the first dose of GARDASIL (route and lot number not reported).  The physician reported that " about 6 weeks ago", the patient developed cellulities on the right deltoid.  It was reported that the cellulities grew for two weeks so the patient was given an antibiotic (name and manufacturer unspecified) and the cellulites resolved (date unspecified)".  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Palpitations
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 09-JAN-2009 was initial vaccinated with the dose of GARDASIL (LOT# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 09-JAN-2009, the patient experienced dizziness and palpitations after vaccination. On an unspecified date, the symptoms recovered spontaneously without treatment. Follow-up information has been received from the nurse who reported that the 24 year old female on 09-JAN-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (LOT# not reported). Other concomitant therapy included TRI-SPRINTEC. On 09-JAN-2009, the patient experienced heart compression and dizziness after vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered from heart compression and dizziness. The patient went to office on 13-MAR-2009 to receive the second dose of GARDASIL but nurse didn't give her the second dose due to the AE from the first dose. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Human papilloma virus test positive, Loop electrosurgical excision procedure, Papilloma viral infection
Clinical narrative: Information has been received from a physician assistant concerning a female patient with a history of loop electrosurgical excision procedure (LEEP) in 2005 who on unspecified dates was vaccinated with the series of GARDASIL. On unknown date, the patient had a PAP (Papanicolaou) smear test that showed that the HPV positive was at high risk. At the time of the report, the patient's outcome was unknown. Follow-up information has been received a registered nurse concerning a 26 year old female patient with no pre-existing allergies, birth defects, medical conditions and a history of loop electrosurgical excision procedure (LEEP) and COLPO CIN who on 18-AUG-2006, 09-MAR-2007 and 07-SEP-2007 was vaccinated with the first dose (lot# 653650/0696F), second dose (lot# 654741/0013U) and third dose (lot# 654539/0742U) of GARDASIL in her thigh, respectively. Subsequently, the patient had recurrence of HPV after being vaccinated. On 16-NOV-2009, the patient had abnormal PAP (Papanicolaou) cervical Intraepithelial neoplasia (CIN) I & II after she completed all 3 doses of GARDASIL which required treatment in 2010. In April 2010, the patient underwent colposcopy + loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN). This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician assistant concerning a female patient with a history of loop electrosurgical excision procedure (LEEP) in 2005 who on unspecified dates was vaccinated with the series of GARDASIL. On unknown date, the patient had a PAP (Papanicolaou) smear test that showed that the HPV positive was at high risk. At the time of the report, the patient's outcome was unknown. Follow-up information has been received a registered nurse concerning a 26 year old female patient with no pre-existing allergies, birth defects, medical conditions and a history of loop electrosurgical excision procedure (LEEP) and COLPO CIN who on 18-AUG-2006, 09-MAR-2007 and 07-SEP-2007 was vaccinated with the first dose (lot# 653650/0696F), second dose (lot# 654741/0013U) and third dose (lot# 654539/0742U) of GARDASIL in her thigh, respectively. Subsequently, the patient had recurrence of HPV after being vaccinated. On 16-NOV-2009, the patient had abnormal PAP (Papanicolaou) cervical Intraepithelial neoplasia (CIN) I & II after she completed all 3 doses of GARDASIL which required treatment in 2010. In April 2010, the patient underwent colposcopy + loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female patient who on 23-APR-2010 was vaccinated with a dose of GARDASIL. Right after getting the vaccine, the patient became dizzy, and called the physician next day still experiencing dizziness. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash, Rash erythematous, Rash pruritic, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on 03-MAR-2010 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number was not provided). Subsequently the patient "started getting itchy red rash on her arms that spread to her legs and her feet. The patient was also dizzy and vomiting". On an unspecified date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial
Clinical narrative: Information has been received from a pharmacist concerning a 23 year old female who on 22-APR-2010 was vaccinated with the first dose of GARDASIL and the patient developed facial numbness. The patient was given BENADRYL and would be going to an unspecified emergency room on 23-APR-2010. The patient's facial numbness persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no drug reactions or allergies who on 19-APR-2010 was vaccinated with the third dose of GARDASIL (lot # 661766/0652X) 0.5 mL, IM. There was no concomitant medication. The physician reported that 18 hours later, the patient's mother called the office and stated that her daughter experienced dizziness. The physician suggested taking fluids and had not heard from the patient since. The patient sought unspecified medical attention. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received concerning a 10 year old female who on 31-JUL-2009 was vaccinated IM with 0.5 ml a first dose of GARDASIL (lot number: (661841/0653X). On 25-NOV-2009, the patient received the second dose of GARDASIL, IM, 0.5 ml (lot number: 663454/0672Y). Concomitant therapy included CLARITIN and ADVAIR. The physician reported that the patient noticed that her hair had been thinning after receiving GARDASIL. No laboratory test was performed. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention . Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Nurse Practitioner concerning an 18 year old female patient who on 17-MAR-2010 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot # 0981Y). Concomitant therapy included LOESTRIN 24 FE. On 01-APR-2010, the patient developed a lump on her arm and it was hot and red and it was the size of an egg. The patient went to the office on 20-APR-2010 for treatment and was also experienced pain and had limited rage of motion. At the time of the report the patient had not recovered. Follow up information has been received from a Nurse Practitioner who reported that on 01-APR-2010, the student developed a lump on the left deltoid at the injection site. There was swelling and sensitivity. The patient also had pain and arm raises. The patient was treated with KEFLEX 500 mg twice a day for 10 days and with MOTRIN 800 mg every 8 hours per necessity. At the time of the report it was unknown if the patient recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a Nurse Practitioner concerning an 18 year old female patient who on 17-MAR-2010 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot # 0981Y). Concomitant therapy included LOESTRIN 24 FE. On 01-APR-2010, the patient developed a lump on her arm and it was hot and red and it was the size of an egg. The patient went to the office on 20-APR-2010 for treatment and was also experienced pain and had limited rage of motion. At the time of the report the patient had not recovered. Follow up information has been received from a Nurse Practitioner who reported that on 01-APR-2010, the student developed a lump on the left deltoid at the injection site. There was swelling and sensitivity. The patient also had pain and arm raises. The patient was treated with KEFLEX 500 mg twice a day for 10 days and with MOTRIN 800 mg every 8 hours per necessity. At the time of the report it was unknown if the patient recovered. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Ultrasound abdomen
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 22-JAN-2010 was vaccinated with the first dose of GARDASIL, IM (lot# 1702X). On 22-MAR-2010, the patient was vaccinated with the second dose of GARDASIL, IM. It was reported that on an unspecified date, the patient experienced "stomach issues" such as abdominal pain with uncertain causation. An abdominal ultrasound of the "abdominal and bladder area" was performed (no results were provided). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with all three doses of GARDASIL. Subsequently the patient had developed HPV. The physician stated that the patient's HPV was high risk. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with no pertinent medical history and no drug reactions/allergies who in 2007 was vaccinated with GARDASIL series. Concomitant therapy included SPRTINTEC, ZANTAC and GAVISCON. On 12-APR-2010 the patient had an abnormal PAP screening, positive for HPV. The patient sought medical attention. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a female (between ages of 14-17) who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot# not reported). "Within a day or two after vaccine was given", the patient experienced migraines. Physician treated the patient in the emergency room however it was unknown if the patient was hospitalized. The patient was reported to have recovered within the day of the migraine beginning. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with all three doses of GARDASIL (lot #s not reported). Subsequently, the patient had an abnormal pap test. The physician mentioned that the patient completed her GARDASIL series before she became sexually active. The patient went to the physician's office. It was reported that the patient either did or was going to do a COPO test. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache
Clinical narrative: Information has been received from a registered nurse, concerning a 25 year old female who on an unspecified date was vaccinated with a third dose of GARDASIL (lot no. not reported). The nurse, who is the friend of the patient, reported that "after the patient received the third dose of GARDASIL she started to experience a headache and the patient stated that it was the worst headache she ever had. The nurse also reported that she followed up with the patient who stated that the headache has gone away but now she is extremely tired". Patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female patient who on 31-MAR-2010 was vaccinated with the second dose of GARDASIL. On 01-APR-2010 the patient woke up with itching, swelling of the fingers and hives all over. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with the second 0.5 mL dose of GARDASIL (route and LOT# not reported). The patient experienced immediate pain with the insertion of needle and a dome shaped swelling at the injection site. The swelling went down after 10 minutes, however later the patient developed a bruise at the site. No laboratory or diagnostic studies were performed. Unspecified medical attention was sought. No further information is available at this time of reporting. Follow-up information has been received from the nurse practitioner. The nurse practitioner told that the patient was vaccinated at public health clinic/hospital. And she had no additional information to share. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a "young lady" who on 02-APR-2010 was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL. 48 hours later, on 04-APR-2010 the patient presented with a systemic rash (all over the trunk of her body). The patient sought medical attention. The patient was told to take BENADRYL (manufacturer unspecified). At the time of the report, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient with unspecified medical history, drug reactions or allergies, who on 17-DEC-2009 was vaccinated with a first dose of GARDASIL (route and lot # unknown). Concomitant medication was unspecified. On 18-DEC-2009, the patient experienced a headache that lasted for a month. The Licensed Practical Nurse reported that the patient decided not to complete the rest of the GARDASIL series and she ended up having to take ADVIL for one month as needed for the headache. It was unspecified if lab diagnostic studies were performed. The patient did not seek medical attention. At the time of the report the patient recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Immediate post-injection reaction, Malaise, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse, concerning a 24 year old female patient, with no pertinent medical history and not known drug reactions or allergies, who on 26-MAR-2010, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number 662299/1099Y). There was no concomitant medication. The nurse reported that within second of receiving the vaccine, the patient had a warm sensation and then fainted. The patient was lowered to the floor and was not injured. The patient was unresponsive for 30-60 seconds. The patient laid down for 15 minutes and was then able to leave the office. The patient sought unspecified medical attention. No labs or diagnostics studies were performed. At the time of the report, the outcome of warm sensation was not reported. Follow-up information has been received from a registered nurse, concerning the female patient who on 26-MAR-2010, at 9:00AM, received in the left deltoid the first dose of GARDASIL. The registered nurse stated that on 26-MAR-2010, at 9:00AM, within minutes of receiving GARDASIL, the patient complained of not feeling well, asked for water and then fainted. The patient came to in approximately 1 minute. The patient was taken to exam room to lie down for 15 minutes. At the time of reporting, the patient had recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Antiphospholipid syndrome
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). Subsequently the patient developed an antiphospholipid antibody syndrome. The patient required a visit to the office. The patient's antiphospholipid antibody syndrome persisted. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient, who on unknown date, received the 1st and 2nd doses of GARDASIL (routes and lot numbers not provided), with no reactions reported. On 16-FEB-2010, the patient was vaccinated with the third dose of GARDASIL (lot number 662304/1013Y) (route not provided). A TB skin test was performed on the same day but different site, and the results were not provided. On 23-FEB-2010, "1 week after the third dose was given", the patient had an injection site reaction. The physician stated that the patient started with a "sore arm". The patient was treated with KEFLEX but still had an arm that was "swollen, warm and had a rash". On 17-MAR-2010, the patient was seen by the physician, and the patient was still presenting with "shoulder pain, redness and swelling". A TB skin test was performed on the same day but different site, and the results were not provided. At the time of reporting, the patient had not recovered. Follow-up information has been received from a physician concerning a 22 year old female with hypersensitivity to morphine and codeine, that produce vomiting and nausea, and, no illness at time of vaccination, was vaccinated with the third dose of GARDASIL on 16-FEB-2010. After vaccination, the patient experienced cellulitis of the left upper arm. The patient also experienced pain with movement and palpating. One month post immunization, the patient had a red circle of 4 inches. Physician reported that the patient recovered on an unspecified date. On an unknown date, an ultrasound of lower extremity/non vascular was performed, however the result was not provided. No additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Tenderness, Ultrasound scan
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient, who on unknown date, received the 1st and 2nd doses of GARDASIL (routes and lot numbers not provided), with no reactions reported. On 16-FEB-2010, the patient was vaccinated with the third dose of GARDASIL (lot number 662304/1013Y) (route not provided). A TB skin test was performed on the same day but different site, and the results were not provided. On 23-FEB-2010, "1 week after the third dose was given", the patient had an injection site reaction. The physician stated that the patient started with a "sore arm". The patient was treated with KEFLEX but still had an arm that was "swollen, warm and had a rash". On 17-MAR-2010, the patient was seen by the physician, and the patient was still presenting with "shoulder pain, redness and swelling". A TB skin test was performed on the same day but different site, and the results were not provided. At the time of reporting, the patient had not recovered. Follow-up information has been received from a physician concerning a 22 year old female with hypersensitivity to morphine and codeine, that produce vomiting and nausea, and, no illness at time of vaccination, was vaccinated with the third dose of GARDASIL on 16-FEB-2010. After vaccination, the patient experienced cellulitis of the left upper arm. The patient also experienced pain with movement and palpating. One month post immunization, the patient had a red circle of 4 inches. Physician reported that the patient recovered on an unspecified date. On an unknown date, an ultrasound of lower extremity/non vascular was performed, however the result was not provided. No additional information is expected.
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a female patient with latex allergy who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). Suspect secondary therapy included DTaP (unspecified) (manufacturer unknown). On an unspecified date the patient experienced anaphylactic reaction after receiving multiple vaccines including GARDASIL. Follow up information has been received on 09-APR-2010 via telephone call from a physician who was peripherally involved in this case. He explained that the patient's primary care physician (PCP) had consulted him because he was an allergist. The physician stated that he had originally called to inquire the GARDASIL "components". The physician stated that GARDASIL was definitely not involved in this report. The physician refused to give the patient's primary care physician name or contact information. The physician refused to given the patient's primary care physician name or contact information. The physician stated that he suspected that a DTaP (manufacturer unknown) vaccine was related to the patient's anaphylactic reaction. The DTaP (manufacturer unknown) had a latex stopper and the patient was allergic to latex. The patient had recovered. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient tested positive as "high risk" HPV infection. The patient sought unspecified medical attention. At the time of the report the patient's outcome was not specified. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Rash, Swelling, Urticaria
Clinical narrative: Information has been received from a parent of a 20 year old daughter with no medical history, drug reactions or allergies who in February 2010, was vaccinated with a dose of GARDASIL (dose and lot number not reported). Concomitant therapy included LOESTRIN. Consumer reported that her daughter had a really bad rash 9 to 10 days after getting the vaccine shot from the waist up, mainly in her arms and her belly. It was reported that was "welty and swollen". On an unknown date, a blood work was performed (results not provided). The outcome was not reported. Patient sought unspecified medical attention. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Decreased appetite, Dizziness, Myalgia, Nausea
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old female patient with a chronic yeast infection an no drug reactions/allergies, who in 2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 655327/1287U). On 26-MAR-2010, the patient was vaccinated with the second dose of GARDASIL (lot # 663559/1178Y). Concomitant therapy included ESTROSTEP. On 28-MAR-2010, the patient experienced dizziness, loss of appetite, was achy, had a high temperature, minor nausea, cough and congestion. The patient recovered from these symptoms. On 05-APR-2010 the patient developed a rash. At the time of the report, the patient had not recovered from the rash. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from a licensed practical nurse who indicated that the patient with no illness at the time of vaccination and no medical conditions (previously reported as chronic yeast infection) who was vaccinated IM with a dose of GARDASIL in her right deltoid. On 28-MAR-2010 the patient experienced achy muscles. On 05-MAY-2010 the patient developed rash on her trunk. On an unknown date the patient recovered. Additional information is not expected. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old female patient with a chronic yeast infection an no drug reactions/allergies, who in 2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 655327/1287U). On 26-MAR-2010, the patient was vaccinated with the second dose of GARDASIL (lot # 663559/1178Y). Concomitant therapy included ESTROSTEP. On 28-MAR-2010, the patient experienced dizziness, loss of appetite, was achy, had a high temperature, minor nausea, cough and congestion. The patient recovered from these symptoms. On 05-APR-2010 the patient developed a rash. At the time of the report, the patient had not recovered from the rash. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from a licensed practical nurse who indicated that the patient with no illness at the time of vaccination and no medical conditions (previously reported as chronic yeast infection) who was vaccinated IM with a dose of GARDASIL in her right deltoid. On 28-MAR-2010 the patient experienced achy muscles. On 05-MAY-2010 the patient developed rash on her trunk. On an unknown date the patient recovered. Additional information is not expected. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced an unknown reaction. It was reported that "this reaction occurred sometime in the past few months". The patient would not receive any other doses. The patient recovered from the unknown reaction. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the physician who reported that the vaccine was advised/provided by the patient's gynecologist. Details were completely unknown. The reporting physician did not administer the vaccine or treated patient. The physician only heard about it. The physician did not even know if the patient's symptoms were from vaccine. The patient was not under the reporting physician's medical care. Follow up information has been received from the physician who reported that this was not his patient. The physician did not administered GARDASIL. The physician did not have details about this event. No further information is available.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient experienced headaches. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. The patient's sibling also experienced headaches following vaccination with GARDASIL (MSD WAES# 1003USA01957). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Flank pain, Menstruation irregular
Clinical narrative: Information has been received from a mother concerning her 14 year old daughter with asparaginase, ceftazidime, ZOSYN allergies and a history of acute lymphoblastic leukaemia, who was vaccinated with the first "recommended" dose of GARDASIL "2 or 3 months ago'. There was no concomitant medication. At that evening the patient had side pain, a month of irregular period and had skipped her last 2 periods. There were no labs or diagnostic tests performed. The patient called the physician for medical attention. The patient had not recovered at time of reporting. Follow up information received from a physician concerning a 17 year old female patient with penicillin, cephalosporins allergies and a history of aspergillosis and acute lymphoblastic leukaemia, mental retardation, who was vaccinated with the first dose of GARDASIL (lot # 665768/1354Y) in the right deltoid on 01-FEB-2010. She received her second dose (lot # 662299/1099Y) in the right deltoid on 26-APR-2010. The patient had side pain the night after the first vaccination on 01-FEB-2010 and missed her periods. The reporter felt that this was due to the vaccination. The patient had the second dose without reported side effects. The outcome was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood glucose normal, Blood test normal, Fatigue, Madarosis
Clinical narrative: Information has been received from a 14 year old female consumer who in August 2009 was vaccinated with a first dose of GARDASIL. In August 2009 the consumer noticed that her hair was falling out a little. In October 2009 the consumer received a second dose of GARDASIL. In February 2010 the consumer received a third dose of GARDASIL and noticed a lot of hair loss. It was reported that about half of the consumer's hair was gone. The consumer saw a physician on 05-APR-2010 and had "bloodwork" done on 06-APR-2010, no results provided. At the time of the report, the consumer had not recovered. Follow-up information has been received from a physician concerning the 14 year old female patient, with no pertinent medical history and no known drug reactions or allergies, who on 13-JUL-2009, received intramuscularly the first 0.5 mL dose of GARDASIL (lot number 661954/1131X). On 15-SEP-2009 (previously reported as October 2009), the patient received intramuscularly the second 0.5 mL dose of GARDASIL (lot number 662300/1674X) and on 19-FEB-2010, the patient received intramuscularly the third dose of GARDASIL (lot number 662300/1674X). There was no concomitant therapy. The physician reported that the patient experienced hair loss and eyelash loss. The hair loss started around the time of the third dose (previously reported as August 2009) and was coming out in clumps. The patient had thinning of hair at the time of reporting. The physician stated that it was unknown if the hair was growing back. The physician stated that no eye irritation was noted but each morning she had 3-4 eyelashes that have fallen. The patient also had polydipsia. Blood tests were performed and the results were negative for diabetes (glucose) and thyroid. Blood test for chemistry panel was also performed and the results were not provided. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician, who reported that the 13 year old (previously reported as 14 year old) female patient, received on 19-FEB-2010, the third dose of GARDASIL at around 14:00h. The physician reported that on 01-MAR-2010, the patient started to experience hair loss and fatigue for a month. No treatment was followed. The physician reported that the experienced required a doctor visit. There were ordered labs but the patient never completed them. The patient's outcome was unknown at the time of reporting. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Polydipsia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 14 year old female consumer who in August 2009 was vaccinated with a first dose of GARDASIL. In August 2009 the consumer noticed that her hair was falling out a little. In October 2009 the consumer received a second dose of GARDASIL. In February 2010 the consumer received a third dose of GARDASIL and noticed a lot of hair loss. It was reported that about half of the consumer's hair was gone. The consumer saw a physician on 05-APR-2010 and had "bloodwork" done on 06-APR-2010, no results provided. At the time of the report, the consumer had not recovered. Follow-up information has been received from a physician concerning the 14 year old female patient, with no pertinent medical history and no known drug reactions or allergies, who on 13-JUL-2009, received intramuscularly the first 0.5 mL dose of GARDASIL (lot number 661954/1131X). On 15-SEP-2009 (previously reported as October 2009), the patient received intramuscularly the second 0.5 mL dose of GARDASIL (lot number 662300/1674X) and on 19-FEB-2010, the patient received intramuscularly the third dose of GARDASIL (lot number 662300/1674X). There was no concomitant therapy. The physician reported that the patient experienced hair loss and eyelash loss. The hair loss started around the time of the third dose (previously reported as August 2009) and was coming out in clumps. The patient had thinning of hair at the time of reporting. The physician stated that it was unknown if the hair was growing back. The physician stated that no eye irritation was noted but each morning she had 3-4 eyelashes that have fallen. The patient also had polydipsia. Blood tests were performed and the results were negative for diabetes (glucose) and thyroid. Blood test for chemistry panel was also performed and the results were not provided. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician, who reported that the 13 year old (previously reported as 14 year old) female patient, received on 19-FEB-2010, the third dose of GARDASIL at around 14:00h. The physician reported that on 01-MAR-2010, the patient started to experience hair loss and fatigue for a month. No treatment was followed. The physician reported that the experienced required a doctor visit. There were ordered labs but the patient never completed them. The patient's outcome was unknown at the time of reporting. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep study, Syncope
Clinical narrative: Information has been received from an office manager concerning her 19 year old daughter with no pertinent medical history who on an unspecified date in 2008 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# not reported). On unspecified dates, the patient was vaccinated intramuscularly with the second and the third 0.5ml dose of GARDASIL (lot#s not reported). There was no concomitant medication. It was reported that the patient experienced syncope several times between the second and third dose of GARDASIL. Unspecified medical attention was sought. Sleep studies were performed with no results reported. At the time of this report, the patient had recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Chest pain
Clinical narrative: Information has been received from a Registered Nurse concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). The Registered Nurse reported that 1 month after receiving the vaccine, the patient experienced chest pain. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with no pertinent medical history and no drug allergies, who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 662529/1317Y). There was no concomitant medication. "6 hours after vaccination" the patient experienced nausea, fever and joint pain. There were no labs or diagnostic tests performed. The patient did not seek medical attention. The patient recovered 24 hours after vaccination. Follow up information has been received from a nurse practitioner concerning a 23 year old female patient with no illness at time of vaccination, who on 14-JAN-2010 at 10:00 a.m. was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 662529/1317Y) in the left deltoid. Approximately 6 hour after vaccination, at 4:00 p.m. on 14-JAN-2010 the patient experienced nausea, fever and joint pain. There were no labs or diagnostic tests performed. No OTC medication nor "thermomet" to continue the fever. The patient recovered on 15-JAN-2010. No further information is available.
Age: 39.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Unevaluable event
Clinical narrative: Information has been received from a consumer concerning his approximately 39 year old wife with no pertinent medical history and no known drug reactions/allergies who in approximately January 2008, "in the early part of 2008", was vaccinated with an IM dose of GARDASIL (Lot# not reported). Concomitant therapy included ROBAXIN. In April and June of 2008 the patient went for a pap smear test which was positive. The patient took both a regular and a high-risk screening pap smear and they were positive. The reporter stated that up to that point his wife always had negative readings. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Information has been received from an office manager concerning a 25 year old female patient with no pertinent medical history and no drug reactions/allergies who on 21-JAN-2010 was vaccinated with the first 0.5mL dose of GARDASIL (lot# 662529/1317Y) IM. Concomitant therapy included hormonal contraceptives (unspecified). 2-3 days after the first dose of vaccination, on approximately 23-JAN-2010 the patient developed left-sided cervical, axillary and inguinal lymphadenopathy, as well as redness at the injection site. The lymphadenopathy resolved without requiring treatment. The patient reported the adverse symptoms when she arrived at the office on 12-APR-2010 for her second dose of GARDASIL. The patient sought unspecified medical attention. No laboratory test was performed. At the time of the report, the patient recovered on an unspecified date. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, No reaction on previous exposure to drug, Rash, Swelling face, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 30-MAR-2010 was vaccinated on left deltoid with the second 0.5 ml dose of GARDASIL (lot# 663454/0672Y). Concomitant therapy included PROMETRIUM. On 31-MAR-2010 the patient experienced rash, face swollen and hot. The patient didn't experience any AE on first dose. The patient sought unspecified medical attention. At the time of report the outcome was unknown. Follow up information was received from a Registered Nurse concerning the 22 year old female with no medical history or concurrent conditions who on 30-MAR-2010 at 9:00 AM (also reported as 10:00 AM) was vaccinated IM on left deltoid with the second 0.5 ml dose of GARDASIL (lot# 663453/0672Y). Concomitant therapy included PROMETRIUM 200 mg. There was no illness at the time of vaccination and adverse event following prior vaccination. It was reported that the patient woke up in the morning of 31-MAR-2010 at 7:30 AM (also reported as 7:00 AM) with rash, swollen face and felt "hot". She was having her normal breakfast food, nothing new and denied any new soaps, detergents, or perfumes. The patient was instructed to take BENADRYL and to go to emergency room if she had difficulty in breathing/swelling. The patient stated that she felt fine except swollen and hot. At 2:00 PM on that day the patient stated that symptoms were improving. She still had hives on back of neck and shoulders but no more face swelling or body rash (It was also reported that at 3:00 PM the patient's rash continued, swelling of face recovered and hives on back of neck and shoulders continued). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Activities of daily living impaired, Headache
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient who on 13-AUG-2008 was vaccinated with a dose of GARDASIL (lot # not reported). It was reported that the patient might have received a dose of TDAP (lot # not reported). On 13-AUG-2008 the patient developed persistent, significant severe headaches. Unspecified medical attention was sought. Therapy with human papillomavirus vaccine was discontinued. The patient still had the headaches. Follow up information has been received from the medical assistant concerning the patient who had headaches everyday to the point of having to go to bed on taking ibuprofen 800 mg tid. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient who on 17-JUL-2007 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #655617/1447F). On 18-JUL-2008, the patient was vaccinated with the second and third dose of GARDASIL respectively. It was reported that the patient had high risk PAP smear after getting all three doses of GARDASIL. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information received from a nurse practitioner via medical records indicated that the patient was a female student. On 17-JUL-2007 the patient was vaccinated with first dose of GARDASIL (lot # 655617/1447F), intramuscularly into her right arm. On the same date the patient was vaccinated with a first dose of MENACTRA (lot # U2182AA), intramuscularly into her left arm. On 18-SEP-2007 the patient received a second dose of GARDASIL (lot # 658563/1063U), intramuscularly into her left arm. On 21-JUL-2008 the patient received a third dose of GARDASIL (lot # 660391/063X), intramuscularly into her left arm and a second dose of varicella vaccine (Merck), (lot #659227/1510U), subcutaneously into her right arm. On 24-FEB-2010 the patient had a cervical HPV, high risk smear which came back positive for high/intermediate risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68. The patient's immunization record included three doses of HEP B vaccine (manufacturer unknown) on 30-JUN-1994 and 27-MAR-1995, a first dose of varicella vaccine (Merck) (manufacturer unknown) on 31-MAR-2004, four dosed of POLIO (unspecified) on 23-AUG-1994,  23-NOV-1994, 25-JAN-1995 and 07-SEP-1999, two doses of MMR vaccine (manufacturer unknown) on 08-SEP-1995 and 07-SEP-1999, a dose of DTAP on 14-JUL-2006, three doses of influenza (unspecified) (manufacturer unknown) on 23-AUG-1994, 23-NOV-1994 and 25-JAN-1995; and five doses of DTP on 23-AUG-1994, 23-NOV-1994, 25-JAN-1995, 22-DEC-1995 and on 07-SEP-1999. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy colon, Colonoscopy, Syncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient, who on 05-MAR-2010 was vaccinated with the first 0.5 mL dose of GARDASIL (route and lot number not reported). On 05-MAR-2010, the patient experienced syncope after getting the first dose of GARDASIL. It was also reported that the patient visited the office for a "colonoscopy with biopsy". The patient sought unspecified medical attention. The adverse event improved, but the patient's outcome was unknown at the time of reporting. All telephone attempts to contact the reporter have been unsuccessful. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with allergic reaction to AUGMENTIN who on 220DEC-2009 was vaccinated with the first dose of GARDASIL (lot # not reported). On 23-FEB-2010 the patient was vaccinated with the second dose GARDASIL (lot# not reported). It was reported the patient experienced swelling, stiffness and stinging at the injection site after each of the two doses of GARDASIL. No medical attention was sought. Vaccination with GARDASIL was continued. At the time of this report, the patient had recovered after being on therapy. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain upper, Asthenia, Lethargy, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 16 year old female patient with no relevant past drug history or concomitant medications who in December 2009, was vaccinated with the first dose of GARDASIL. There were no side effects after received the first dose. On 11-MAR-2010, the patient was vaccinated with the second dose of GARDASIL and also was vaccinated with a dose of unknown meningococcal vaccine (unspecified). It was reported that within one hour of getting her second dose of GARDASIL, on 11-MAR-2010, the patient experienced fever, lethargy, no energy and stomach cramping. The patient notified her physician of the events who advised her to monitor it for a few days. There were no lab tests performed. As a 14-MAR-2010, it was unknown if the patient would continue to receive the GARDASIL or meningococcal vaccine (unspecified). At the time of the report, the fever, no energy and stomach cramping persisted.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 23 year old female consumer who on 10-SEP-2009 was vaccinated with the first dose GARDASIL (lot# not reported). Since the patient was vaccinated, the patient had been experiencing pain in upper left arm ever. Therapy with human papilloma virus vaccine was discontinued. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.