chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a physician concerning a 29 year old female, for the Pregnancy Registry for GARDASIL, who on approximately 03-NOV-2009, "between week 4 and 5 of the patient's pregnancy", was vaccinated with a dose of GARDASIL (Lot No. not reported). The patient was between week 4 or 5 of her pregnancy and was supposed to receive a dose of Hepatitis B virus vaccine (manufacturer unspecified). The physician reported that on 16-DEC-2009 the patient was 10 weeks pregnant. The patient's LMP was on 08-OCT-2009 and her EDD was estimated to be 15-Jul-2010. There was no adverse event reported. Follow-up information was received from the Certified Nurse-Midwife on 17-NOV-2010 who reported that the patient went on to have a healthy, normal, baby, and she delivered at term. She added that the patient was also healthy and her pregnancy was uncomplicated. Follow up information has been received from an Advanced Practice Registered Nurse concerning the female patient with no infections or illnesses during pregnancy and with no concurrent medical condition or family history. The patient had a history of 4 previous pregnancies, 2 full term deliveries and 2 spontaneous abortions (miscarriages), with no birth defects or infant complications in the previous pregnancies. A serum alpha-fetoprotein test (AFP) was performed on 28-JAN-2010 result was negative. It was reported that on 15-JUL-2010, the patient delivered a female baby with 7 pounds and 1 ounces of weight, apgar score 8/9. The infant was normal. There were no congenital anomalies. There were no other complications or abnormalities. There were no complications during pregnancy or labor/delivery, it was reported that the mom and baby appeared fine. Additional information has been received from the patient. She stated that her baby was doing well, but the pediatrician was following the baby's hemangioma on her neck (from birth), and an MRI of the fontanel was scheduled for next week. Follow up information has been received from the nurse practitioner. She reported that the patient's post partum visit was 26-AUG-2010. The patient had the baby with her, and the nurse "played with the baby", and all seemed well with the baby, she confirmed that she had no baby information to report. The baby's congenital anomaly hemangioma was captured in WAES# 0912USA0199881. Follow up information from the physician indicated that the baby's hemangioma was a (subcutaneous hemangioma of the cervicothoracic junction (C7-T3), no extension into cervicothoracic spine) and was captured in WAES# 0912USA0199881. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Apgar score normal, Drug exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 29 year old female, for the Pregnancy Registry for GARDASIL, who on approximately 03-NOV-2009, "between week 4 and 5 of the patient's pregnancy", was vaccinated with a dose of GARDASIL (Lot No. not reported). The patient was between week 4 or 5 of her pregnancy and was supposed to receive a dose of Hepatitis B virus vaccine (manufacturer unspecified). The physician reported that on 16-DEC-2009 the patient was 10 weeks pregnant. The patient's LMP was on 08-OCT-2009 and her EDD was estimated to be 15-Jul-2010. There was no adverse event reported. Follow-up information was received from the Certified Nurse-Midwife on 17-NOV-2010 who reported that the patient went on to have a healthy, normal, baby, and she delivered at term. She added that the patient was also healthy and her pregnancy was uncomplicated. Follow up information has been received from an Advanced Practice Registered Nurse concerning the female patient with no infections or illnesses during pregnancy and with no concurrent medical condition or family history. The patient had a history of 4 previous pregnancies, 2 full term deliveries and 2 spontaneous abortions (miscarriages), with no birth defects or infant complications in the previous pregnancies. A serum alpha-fetoprotein test (AFP) was performed on 28-JAN-2010 result was negative. It was reported that on 15-JUL-2010, the patient delivered a female baby with 7 pounds and 1 ounces of weight, apgar score 8/9. The infant was normal. There were no congenital anomalies. There were no other complications or abnormalities. There were no complications during pregnancy or labor/delivery, it was reported that the mom and baby appeared fine. Additional information has been received from the patient. She stated that her baby was doing well, but the pediatrician was following the baby's hemangioma on her neck (from birth), and an MRI of the fontanel was scheduled for next week. Follow up information has been received from the nurse practitioner. She reported that the patient's post partum visit was 26-AUG-2010. The patient had the baby with her, and the nurse "played with the baby", and all seemed well with the baby, she confirmed that she had no baby information to report. The baby's congenital anomaly hemangioma was captured in WAES# 0912USA0199881. Follow up information from the physician indicated that the baby's hemangioma was a (subcutaneous hemangioma of the cervicothoracic junction (C7-T3), no extension into cervicothoracic spine) and was captured in WAES# 0912USA0199881. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with depression, Raynaud's syndrome and no drug reactions/allergies, who on 11-MAY-2010 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # not reported) and on 15-SEP-2010 was vaccinated with the second dose of GARDASIL (Lot # not reported). Concomitant therapy included APRI and fluoxetine. After the first dose, on 11-MAY-2010, the patient had some soreness at the injection site that resolved on 12-MAY-2010. The patient did not seek medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the registered nurse who indicated that the 24 year old student with not illness at the time of vaccination, migraines and a history of mild concussion in 2008 was vaccinated into the left deltoid with the first dose of GARDASIL  (Lot # 665266/1378Y, expiration date: 09-JUN-2010). The registered nurse reported that the patient tolerated well the vaccine on the day that she received. Next day, she felt muscle soreness at injection site. It did not alter her ADL's in any way. No follow up was sought. The patient did not report until returning for the second dose of GARDASIL (Lot # not reported) on 15-SEP-2010. There were not problems with the second vaccine, which was given by the same registered nurse. The patient had recovered 2 days post-injection (reported as 12-MAY-2010). Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with depression, Raynaud's syndrome and no drug reactions/allergies, who on 11-MAY-2010 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # not reported) and on 15-SEP-2010 was vaccinated with the second dose of GARDASIL (Lot # not reported). Concomitant therapy included APRI and fluoxetine. After the first dose, on 11-MAY-2010, the patient had some soreness at the injection site that resolved on 12-MAY-2010. The patient did not seek medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the registered nurse who indicated that the 24 year old student with not illness at the time of vaccination, migraines and a history of mild concussion in 2008 was vaccinated into the left deltoid with the first dose of GARDASIL  (Lot # 665266/1378Y, expiration date: 09-JUN-2010). The registered nurse reported that the patient tolerated well the vaccine on the day that she received. Next day, she felt muscle soreness at injection site. It did not alter her ADL's in any way. No follow up was sought. The patient did not report until returning for the second dose of GARDASIL (Lot # not reported) on 15-SEP-2010. There were not problems with the second vaccine, which was given by the same registered nurse. The patient had recovered 2 days post-injection (reported as 12-MAY-2010). Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy site unspecified normal, Laboratory test, Lymphadenopathy, Myalgia, Positron emission tomogram
Clinical narrative: Information has been received from an approximately 25 year old female patient with no medical history and drug reactions or allergies who in July 2010 and at the beginning of January 2011 was vaccinated with the first and the second dose of GARDASIL respectively (dose, route and lot # not reported). There was no concomitant medication. The patient reported that approximately August 2010 (about a month after receiving the first injection) she developed discomfort, in her neck, arm and chest area. In November 2010, the patient developed noticeable swelling in her lymph nodes. At the end of January 2011, the patient had outpatient surgery to remove the nodes. The nodes were biopsied. One of the biopsies returned an inconclusive result and two others were negative for cancer. The patient has been examined by her gynecologist, three different lymphoma specialists, the results of which were negative for cancer. The patient had a positron emission tomography (PET) scan in February 2011. The scan showed various lymph nodes, in her neck area and one between her lungs. The patient was still having discomfort in her upper arm, shoulder and neck. The patient received antibiotic (unspecified) for the condition. At the time of reporting, the patient was not recovered and her physicians were still trying to determine the cause of the swollen lymph nodes and a treatment for the condition. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from an approximately 25 year old female patient with no medical history and drug reactions or allergies who in July 2010 and at the beginning of January 2011 was vaccinated with the first and the second dose of GARDASIL respectively (dose, route and lot # not reported). There was no concomitant medication. The patient reported that approximately August 2010 (about a month after receiving the first injection) she developed discomfort, in her neck, arm and chest area. In November 2010, the patient developed noticeable swelling in her lymph nodes. At the end of January 2011, the patient had outpatient surgery to remove the nodes. The nodes were biopsied. One of the biopsies returned an inconclusive result and two others were negative for cancer. The patient has been examined by her gynecologist, three different lymphoma specialists, the results of which were negative for cancer. The patient had a positron emission tomography (PET) scan in February 2011. The scan showed various lymph nodes, in her neck area and one between her lungs. The patient was still having discomfort in her upper arm, shoulder and neck. The patient received antibiotic (unspecified) for the condition. At the time of reporting, the patient was not recovered and her physicians were still trying to determine the cause of the swollen lymph nodes and a treatment for the condition. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy lymph gland, Chest discomfort, Limb discomfort, Lymphadenectomy, Lymphadenopathy
Clinical narrative: Information has been received from an approximately 25 year old female patient with no medical history and drug reactions or allergies who in July 2010 and at the beginning of January 2011 was vaccinated with the first and the second dose of GARDASIL respectively (dose, route and lot # not reported). There was no concomitant medication. The patient reported that approximately August 2010 (about a month after receiving the first injection) she developed discomfort, in her neck, arm and chest area. In November 2010, the patient developed noticeable swelling in her lymph nodes. At the end of January 2011, the patient had outpatient surgery to remove the nodes. The nodes were biopsied. One of the biopsies returned an inconclusive result and two others were negative for cancer. The patient has been examined by her gynecologist, three different lymphoma specialists, the results of which were negative for cancer. The patient had a positron emission tomography (PET) scan in February 2011. The scan showed various lymph nodes, in her neck area and one between her lungs. The patient was still having discomfort in her upper arm, shoulder and neck. The patient received antibiotic (unspecified) for the condition. At the time of reporting, the patient was not recovered and her physicians were still trying to determine the cause of the swollen lymph nodes and a treatment for the condition. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal discomfort, Positron emission tomogram
Clinical narrative: Information has been received from an approximately 25 year old female patient with no medical history and drug reactions or allergies who in July 2010 and at the beginning of January 2011 was vaccinated with the first and the second dose of GARDASIL respectively (dose, route and lot # not reported). There was no concomitant medication. The patient reported that approximately August 2010 (about a month after receiving the first injection) she developed discomfort, in her neck, arm and chest area. In November 2010, the patient developed noticeable swelling in her lymph nodes. At the end of January 2011, the patient had outpatient surgery to remove the nodes. The nodes were biopsied. One of the biopsies returned an inconclusive result and two others were negative for cancer. The patient has been examined by her gynecologist, three different lymphoma specialists, the results of which were negative for cancer. The patient had a positron emission tomography (PET) scan in February 2011. The scan showed various lymph nodes, in her neck area and one between her lungs. The patient was still having discomfort in her upper arm, shoulder and neck. The patient received antibiotic (unspecified) for the condition. At the time of reporting, the patient was not recovered and her physicians were still trying to determine the cause of the swollen lymph nodes and a treatment for the condition. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV2, FLU3, HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a certified nurse practitioner concerning a 14 year old male patient who on 17-FEB-2011 was vaccinated with his first dose of GARDASIL (Lot # and expire date not reported), intramuscularly. Certified nurse practitioner stated that on 18-FEB-2011, the patient passed out at school. No treatment was given to the patient. The patient sought medical attention in the office. At the time of the report, patient's outcome was unknown. Follow-up information was received from the certified nurse practitioner concerning a male student with a history of pneumonia who on 17-FEB-2011 was vaccinated with his first dose of GARDASIL (Lot # 666597/0768Z and expire date not reported), intramuscularly into his right arm. Concomitant therapy included FLUZONE (Lot # UH224AC, expire date not reported), intramuscularly into his left arm. The certified nurse practitioner stated that mother's patient called on 22-FEB-2011 and stated that on 18-FEB-2011 at 13:00, her son passed out at school the day after GARDASIL shot. The patient was found under the door next to the school. The nurse called and the patient was picked up, the patient had a "lump red on his head with a headache, they gave him TYLENOL and he was fine". The patient did not seek medical attention. The certified nurse practitioner mentioned that the patient missed his follow-up appointment due to the weather. At the time of this report, patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV2, FLU3, HPV4
Symptoms: Erythema, Headache, Loss of consciousness, Mass
Clinical narrative: Information has been received from a certified nurse practitioner concerning a 14 year old male patient who on 17-FEB-2011 was vaccinated with his first dose of GARDASIL (Lot # and expire date not reported), intramuscularly. Certified nurse practitioner stated that on 18-FEB-2011, the patient passed out at school. No treatment was given to the patient. The patient sought medical attention in the office. At the time of the report, patient's outcome was unknown. Follow-up information was received from the certified nurse practitioner concerning a male student with a history of pneumonia who on 17-FEB-2011 was vaccinated with his first dose of GARDASIL (Lot # 666597/0768Z and expire date not reported), intramuscularly into his right arm. Concomitant therapy included FLUZONE (Lot # UH224AC, expire date not reported), intramuscularly into his left arm. The certified nurse practitioner stated that mother's patient called on 22-FEB-2011 and stated that on 18-FEB-2011 at 13:00, her son passed out at school the day after GARDASIL shot. The patient was found under the door next to the school. The nurse called and the patient was picked up, the patient had a "lump red on his head with a headache, they gave him TYLENOL and he was fine". The patient did not seek medical attention. The certified nurse practitioner mentioned that the patient missed his follow-up appointment due to the weather. At the time of this report, patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Blood pressure decreased, Chills, Dizziness, Hot flush, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old male with "afraid of needles" and a history of "passing out" after receiving a vaccination and no drug reactions or allergies who on 21-APR-2011 was vaccinated IM with the first dose of GARDASIL (lot # 666987/1016Z, expiration date 22-NOV-2012). Concomitant therapy included MENACTRA (lot # U3543AA) administered on the same day. After 3 minutes of receiving the two vaccinations on 21-APR-2011, the patient felt lightheaded. The patient's blood pressure fell and the patient began to sweat profusely. The patient's temperature fell and the patient got cold and clammy. Epinephrine was given IM but the patient continued to not feel well, and thus the patient was transferred to a hospital's emergency room but not admitted to the hospital. The patient's diagnosis was vasovagal syncope. The patient recovered on 21-APR-2011. Upon internal review, vasovagal syncope was determined to be an other important medical event because the patient was treated with epinephrine. This is one of two reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Blood pressure decreased, Body temperature decreased, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old male with "afraid of needles" and a history of "passing out" after receiving a vaccination and no drug reactions or allergies who on 21-APR-2011 was vaccinated IM with the first dose of GARDASIL (lot # 666987/1016Z, expiration date 22-NOV-2012). Concomitant therapy included MENACTRA (lot # U3543AA) administered on the same day. After 3 minutes of receiving the two vaccinations on 21-APR-2011, the patient felt lightheaded. The patient's blood pressure fell and the patient began to sweat profusely. The patient's temperature fell and the patient got cold and clammy. Epinephrine was given IM but the patient continued to not feel well, and thus the patient was transferred to a hospital's emergency room but not admitted to the hospital. The patient's diagnosis was vasovagal syncope. The patient recovered on 21-APR-2011. Upon internal review, vasovagal syncope was determined to be an other important medical event because the patient was treated with epinephrine. This is one of two reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, MNQ
Symptoms: Malaise, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old male with "afraid of needles" and a history of "passing out" after receiving a vaccination and no drug reactions or allergies who on 21-APR-2011 was vaccinated IM with the first dose of GARDASIL (lot # 666987/1016Z, expiration date 22-NOV-2012). Concomitant therapy included MENACTRA (lot # U3543AA) administered on the same day. After 3 minutes of receiving the two vaccinations on 21-APR-2011, the patient felt lightheaded. The patient's blood pressure fell and the patient began to sweat profusely. The patient's temperature fell and the patient got cold and clammy. Epinephrine was given IM but the patient continued to not feel well, and thus the patient was transferred to a hospital's emergency room but not admitted to the hospital. The patient's diagnosis was vasovagal syncope. The patient recovered on 21-APR-2011. Upon internal review, vasovagal syncope was determined to be an other important medical event because the patient was treated with epinephrine. This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse, concerning a 17 year old female patient who, on unspecified dates, was vaccinated with her first and second dose of GARDASIL (Lot #, dose and route not reported). It was reported that second dose was given exactly one month after the first dose. Concomitant therapy included unspecified birth control medication. The registered nurse reported that, the patient experienced joint pain and swelling in her wrist, ankles and knees. Patient sought unspecified medical attention. At the time of the report, the patient's outcome was not recovered. Follow up information has been received from a registered nurse, concerning the 17 year old female patient, with a history of migraines and no known drug allergies, who on 03-FEB-2011, received the first dose of GARDASIL (Lot # 663559/1178Y) (dose and route not reported), and who received concomitantly the second dose of VARIVAX (Merck) (Lot #: 668324/0923Z) (dose and route not reported) and the first dose of HAVRIX (Lot #: AHAVB441) and BOOSTRIX (Lot #: UF500AA). Concomitant therapy also included IMITREX "not being taken at the time of the event". The registered nurse reported that on 02-MAR-2011, the patient received the second dose of GARDASIL (Lot #: 6963559/1178Y) (dose and route not reported). The patient did not receive any concomitant vaccinations at that time. The registered nurse stated that the patient's mother reported that about two weeks after the patient received the second dose of GARDASIL, on approximately 16-MAR-2011, the patient began having joint swelling and pain in her wrists, knees and ankles. She reported that the patient began walking slowly due to joint swelling and pain in her knees and ankles. Nurse stated that on 05-MAY-2011, the patient went to her OBGYN physician and was seen by the nurse practitioner, who felt that the patient's joint swelling and pain was due to the GARDASIL. The patient was then referred back to her Primary Care Provider (PCP). On 09-MAY-2011, the patient was seen by the physician and had blood work drawn which included a Rheumatoid factor "RA panel" (results not received yet), MEDROL dose pack prescribed. The patient was then referred to a Rheumatologist. The registered nurse stated that the patient mostly had swelling and pain in her wrists and knees and that the patient had constant pain "pain persisted" that changed in intensity. She also stated that the patient had intermittent swelling in her wrist "edema comes and goes". At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint swelling, Rheumatoid factor
Clinical narrative: Information has been received from a registered nurse, concerning a 17 year old female patient who, on unspecified dates, was vaccinated with her first and second dose of GARDASIL (Lot #, dose and route not reported). It was reported that second dose was given exactly one month after the first dose. Concomitant therapy included unspecified birth control medication. The registered nurse reported that, the patient experienced joint pain and swelling in her wrist, ankles and knees. Patient sought unspecified medical attention. At the time of the report, the patient's outcome was not recovered. Follow up information has been received from a registered nurse, concerning the 17 year old female patient, with a history of migraines and no known drug allergies, who on 03-FEB-2011, received the first dose of GARDASIL (Lot # 663559/1178Y) (dose and route not reported), and who received concomitantly the second dose of VARIVAX (Merck) (Lot #: 668324/0923Z) (dose and route not reported) and the first dose of HAVRIX (Lot #: AHAVB441) and BOOSTRIX (Lot #: UF500AA). Concomitant therapy also included IMITREX "not being taken at the time of the event". The registered nurse reported that on 02-MAR-2011, the patient received the second dose of GARDASIL (Lot #: 6963559/1178Y) (dose and route not reported). The patient did not receive any concomitant vaccinations at that time. The registered nurse stated that the patient's mother reported that about two weeks after the patient received the second dose of GARDASIL, on approximately 16-MAR-2011, the patient began having joint swelling and pain in her wrists, knees and ankles. She reported that the patient began walking slowly due to joint swelling and pain in her knees and ankles. Nurse stated that on 05-MAY-2011, the patient went to her OBGYN physician and was seen by the nurse practitioner, who felt that the patient's joint swelling and pain was due to the GARDASIL. The patient was then referred back to her Primary Care Provider (PCP). On 09-MAY-2011, the patient was seen by the physician and had blood work drawn which included a Rheumatoid factor "RA panel" (results not received yet), MEDROL dose pack prescribed. The patient was then referred to a Rheumatologist. The registered nurse stated that the patient mostly had swelling and pain in her wrists and knees and that the patient had constant pain "pain persisted" that changed in intensity. She also stated that the patient had intermittent swelling in her wrist "edema comes and goes". At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female patient who on 07-FEB-2011, was vaccinated with the first dose of GARDASIL (route not reported) (lot number 0057AA, Exp: 24-APR-2013), at that time did not report any problem. On 22-APR-2011, the patient was vaccinated with the second dose of GARDASIL (route not reported) (lot number 0057AA, Exp: 24-APR-2013). On 01-MAY-2011, the patient called to the nurse and complained of arm soreness 9 days. The nurse reported that the patient was out of town and to the nurse practitioner's knowledge the patient did not seek medical attention where she was vacationing. The nurse stated that the patient called again on 02-MAY-2011, but was no better. No treatment was prescribed. The patient's arm soreness persisted. Follow-up information has been received from a physician's office concerning a 24 year old female with no illnesses, allergies or chronic problems who on 07-FEB-2011 received first dose of GARDASIL, (lot # 0057AA) (route not reported). On 22-APR-2011 the patient received a second dose of GARDASIL in her left deltoid (lot number 0057AA). Concomitant therapy included YASMIN 28 and FLAGYL (indications not reported). On 02-MAY-2011 the patient called her doctor's office to state she had continuous pain in her shoulder since the injection on 22-APR-2011. It was painful to use the arm or lift it over her head, but she was able to swim while on vacation. Patient was instructed to use ibuprofen (manufacturer not specified) and ice and to seek further care if the pain worsened while on vacation. The patient was instructed to call the physician's office when she returned from vacation. On 17-MAY-2011 the patient was evaluated at her physician's office. The patient complained of inability to lift her arm above her head since the injection 2-3 weeks ago (22-APR-2011). Examination showed there was no change in grip strength, minimal weakness for elevation of arms and lateral movement of arm only on the left injection side. There was a question of a reaction from GARDASIL verses injection site tenderness. It was suggested that the patient be evaluated by a neurologist as the reaction was 3 weeks old and the patient was not improving at all and possibly getting worse. The patient was to try to obtain an appointment with a neurologist in the very near future. Additional information has been requested. All available medical records will be provided upon request.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female patient who on 07-FEB-2011, was vaccinated with the first dose of GARDASIL (route not reported) (lot number 0057AA, Exp: 24-APR-2013), at that time did not report any problem. On 22-APR-2011, the patient was vaccinated with the second dose of GARDASIL (route not reported) (lot number 0057AA, Exp: 24-APR-2013). On 01-MAY-2011, the patient called to the nurse and complained of arm soreness 9 days. The nurse reported that the patient was out of town and to the nurse practitioner's knowledge the patient did not seek medical attention where she was vacationing. The nurse stated that the patient called again on 02-MAY-2011, but was no better. No treatment was prescribed. The patient's arm soreness persisted. Follow-up information has been received from a physician's office concerning a 24 year old female with no illnesses, allergies or chronic problems who on 07-FEB-2011 received first dose of GARDASIL, (lot # 0057AA) (route not reported). On 22-APR-2011 the patient received a second dose of GARDASIL in her left deltoid (lot number 0057AA). Concomitant therapy included YASMIN 28 and FLAGYL (indications not reported). On 02-MAY-2011 the patient called her doctor's office to state she had continuous pain in her shoulder since the injection on 22-APR-2011. It was painful to use the arm or lift it over her head, but she was able to swim while on vacation. Patient was instructed to use ibuprofen (manufacturer not specified) and ice and to seek further care if the pain worsened while on vacation. The patient was instructed to call the physician's office when she returned from vacation. On 17-MAY-2011 the patient was evaluated at her physician's office. The patient complained of inability to lift her arm above her head since the injection 2-3 weeks ago (22-APR-2011). Examination showed there was no change in grip strength, minimal weakness for elevation of arms and lateral movement of arm only on the left injection side. There was a question of a reaction from GARDASIL verses injection site tenderness. It was suggested that the patient be evaluated by a neurologist as the reaction was 3 weeks old and the patient was not improving at all and possibly getting worse. The patient was to try to obtain an appointment with a neurologist in the very near future. Additional information has been requested. All available medical records will be provided upon request.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old male with no drug allergies and myopia and overweight who on 09-SEP-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 666595/0096Z, expired date unspecified) into right deltoid. On 10-MAY-2011 patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # 666598/0786Z, expired date unspecified) into right deltoid. There was no concomitant medication. "The next morning", on 11-MAY-2011 the patient woke up and noticed sandpaper-like rash on his entire face. Patient complained of itching from rash as well. No treatment was given for the adverse event. No lab diagnostics studies were performed. Patient sought medical attention by office visiting. At the time of reporting, patient's outcome was unknown. Follow-up information was received from the physician who reported that on 10-MAY-2011 at around 15:00 the patient with no pre-existing allergies, birth defects, medical conditions and no known illness at the time of vaccination was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # 666598/0786Z, expired date unspecified) into right arm. On 11-MAY-2011 at 07:00 patient experienced facial rash and was treated with antihistamine and steroid cream. Patient was seen on 20-MAY-2011 and his rash had been resolved. There was no lab diagnostic result. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old male with no drug allergies and myopia and overweight who on 09-SEP-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 666595/0096Z, expired date unspecified) into right deltoid. On 10-MAY-2011 patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # 666598/0786Z, expired date unspecified) into right deltoid. There was no concomitant medication. "The next morning", on 11-MAY-2011 the patient woke up and noticed sandpaper-like rash on his entire face. Patient complained of itching from rash as well. No treatment was given for the adverse event. No lab diagnostics studies were performed. Patient sought medical attention by office visiting. At the time of reporting, patient's outcome was unknown. Follow-up information was received from the physician who reported that on 10-MAY-2011 at around 15:00 the patient with no pre-existing allergies, birth defects, medical conditions and no known illness at the time of vaccination was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # 666598/0786Z, expired date unspecified) into right arm. On 11-MAY-2011 at 07:00 patient experienced facial rash and was treated with antihistamine and steroid cream. Patient was seen on 20-MAY-2011 and his rash had been resolved. There was no lab diagnostic result. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a company representative concerning her 11 year old daughter with no pertinent medical history and drug reactions or allergies who on 26-APR-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL. Concomitant therapy included meningococcal vaccine (unspecified) (manufacturer unknown) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 02-MAY-2011 the patient broke out in hives, head to toe. The patient did not seek medical attention, and was given ZYRTEC for treatment. No lab diagnostics studies performed. On 04-MAY-2011, the patient recovered. Follow up information has been received from a registered nurse concerning a female patient with a history of hives who "around 2 weeks ago", on approximately 26-APR-2011 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). 6 days post vaccination, on approximately 02-MAY-2011 the patient experienced a general rash and hives. The patient sought unspecified medical attention and was given BENADRYL for treatment (previously reported as "The patient did not seek medical attention, and was given ZYRTEC for treatment"). Upon the time of the report, the patient's present status was unknown (previously reported as "on 04-MAY-2011, the patient recovered from hives). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a company representative concerning her 11 year old daughter with no pertinent medical history and drug reactions or allergies who on 26-APR-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL. Concomitant therapy included meningococcal vaccine (unspecified) (manufacturer unknown) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 02-MAY-2011 the patient broke out in hives, head to toe. The patient did not seek medical attention, and was given ZYRTEC for treatment. No lab diagnostics studies performed. On 04-MAY-2011, the patient recovered. Follow up information has been received from a registered nurse concerning a female patient with a history of hives who "around 2 weeks ago", on approximately 26-APR-2011 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). 6 days post vaccination, on approximately 02-MAY-2011 the patient experienced a general rash and hives. The patient sought unspecified medical attention and was given BENADRYL for treatment (previously reported as "The patient did not seek medical attention, and was given ZYRTEC for treatment"). Upon the time of the report, the patient's present status was unknown (previously reported as "on 04-MAY-2011, the patient recovered from hives). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no allergies or drug reactions and no pertinent medical history who on 10-MAY-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly in the left arm, (lot number 0298AA, Exp: 21-JUN-2013). There was no concomitant medication. On 11-MAY-2011, the patient developed as first symptoms leg cramps, followed by "limping". On 12-MAY-2011 the patient had experienced nausea. The patient sought medical attention by phone call. The patient did not receive any treatment for the event and no laboratories were performed. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Muscle spasms, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no allergies or drug reactions and no pertinent medical history who on 10-MAY-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly in the left arm, (lot number 0298AA, Exp: 21-JUN-2013). There was no concomitant medication. On 11-MAY-2011, the patient developed as first symptoms leg cramps, followed by "limping". On 12-MAY-2011 the patient had experienced nausea. The patient sought medical attention by phone call. The patient did not receive any treatment for the event and no laboratories were performed. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a Nurse practitioner, concerning a 22 year old female patient with a history of anxiety, who on 21-APR-2011 was vaccinated intramuscularly, with her first dose of 0.5 ml, GARDASIL (Lot #: 667866/1437Z, Exp: 25-FEB-2013). There was no concomitant medication. At the visit, on 21-APR-2011, the patient also received Monsel's solution with colposcopy procedure. The nurse practitioner reported that on 21-APR-2011, after receiving the GARDASIL, the patient developed hives all over her body, anxiety and shortness of breath. The patient sought medical attention by calling the nurse practitioner. ZYRTEC and BENADRYL were given as treatment for the adverse events. On 23-APR-2011, patient recovered from the hives, anxiety and shortness of breath. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Condition aggravated, Dyspnoea, Urticaria
Clinical narrative: Information has been received from a Nurse practitioner, concerning a 22 year old female patient with a history of anxiety, who on 21-APR-2011 was vaccinated intramuscularly, with her first dose of 0.5 ml, GARDASIL (Lot #: 667866/1437Z, Exp: 25-FEB-2013). There was no concomitant medication. At the visit, on 21-APR-2011, the patient also received Monsel's solution with colposcopy procedure. The nurse practitioner reported that on 21-APR-2011, after receiving the GARDASIL, the patient developed hives all over her body, anxiety and shortness of breath. The patient sought medical attention by calling the nurse practitioner. ZYRTEC and BENADRYL were given as treatment for the adverse events. On 23-APR-2011, patient recovered from the hives, anxiety and shortness of breath. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fall, Feeling abnormal, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 13 or 14 year old male patient, who on approximately 09-MAR-2011 was vaccinated intramuscularly with his first 0.5 ml, dose of GARDASIL (lot # not reported). Secondary suspect therapy included VARIVAX (Merck). The physician reported that the patient fainted immediately after the vaccination and that the patient was not told to sit for 15 minutes following the vaccination. The patient was sent to Emergency Room, but was not admitted to the hospital, an X-Ray and a Computed Axial Tomography (CAT) scan were performed (results not provided). It was reported that therapy with GARDASIL was discontinued. Follow-up information has been received from a physician concerning a patient (59 inches, 88.6 pounds) with near syncope approximately 15FEB11 after receiving an unspecified "steroid shot," with no illness at time of vaccination or pre-existing allergies, birth defects, or medical conditions, who on 08MAR11 at 12:00 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z), on the left thigh. The physician reported that on 08MAR11 the patient experienced syncope. It was reported that the patient stood up and walked to front lobby, and passed out - about 3-5 minutes after receiving GARDASIL. Reportedly the patient hit his head on the floor and was hysterical afterward. A neurological examination and a head computed axial tomography (CT-Scan) were performed and both exams were within normal limits. The physician reported that patient vomited twice "and was fine after." At the time of the report, the patient's outcome was recovered. Follow-up information was received from a physician concerning a 14 year old male with a history of near syncope "almost passed out" after receiving a steroid shot (unspecified), who on 08MAR11 at 12:05 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z) intramuscularly. Secondary suspect therapy included a second dose of VARIVAX (Merck) (lot # 668585/1191Z). The physician reported that the patient put his shoes on and then walked to the front office. While his mother checked out he "felt funny" and then passed out. The patient fell and hit his chin on the counter and his head on the floor. The event occurred at least within 5 minutes of vaccination. The patient's neurological exam and CT scan were normal after the event. The physician reported that the patient required an emergency room/doctor visit. EKG, CT scan, CBC, electrolytes were all normal. The patient recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Head injury, Loss of consciousness, Neurological examination normal
Clinical narrative: Information has been received from a physician concerning a 13 or 14 year old male patient, who on approximately 09-MAR-2011 was vaccinated intramuscularly with his first 0.5 ml, dose of GARDASIL (lot # not reported). Secondary suspect therapy included VARIVAX (Merck). The physician reported that the patient fainted immediately after the vaccination and that the patient was not told to sit for 15 minutes following the vaccination. The patient was sent to Emergency Room, but was not admitted to the hospital, an X-Ray and a Computed Axial Tomography (CAT) scan were performed (results not provided). It was reported that therapy with GARDASIL was discontinued. Follow-up information has been received from a physician concerning a patient (59 inches, 88.6 pounds) with near syncope approximately 15FEB11 after receiving an unspecified "steroid shot," with no illness at time of vaccination or pre-existing allergies, birth defects, or medical conditions, who on 08MAR11 at 12:00 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z), on the left thigh. The physician reported that on 08MAR11 the patient experienced syncope. It was reported that the patient stood up and walked to front lobby, and passed out - about 3-5 minutes after receiving GARDASIL. Reportedly the patient hit his head on the floor and was hysterical afterward. A neurological examination and a head computed axial tomography (CT-Scan) were performed and both exams were within normal limits. The physician reported that patient vomited twice "and was fine after." At the time of the report, the patient's outcome was recovered. Follow-up information was received from a physician concerning a 14 year old male with a history of near syncope "almost passed out" after receiving a steroid shot (unspecified), who on 08MAR11 at 12:05 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z) intramuscularly. Secondary suspect therapy included a second dose of VARIVAX (Merck) (lot # 668585/1191Z). The physician reported that the patient put his shoes on and then walked to the front office. While his mother checked out he "felt funny" and then passed out. The patient fell and hit his chin on the counter and his head on the floor. The event occurred at least within 5 minutes of vaccination. The patient's neurological exam and CT scan were normal after the event. The physician reported that the patient required an emergency room/doctor visit. EKG, CT scan, CBC, electrolytes were all normal. The patient recovered. Additional information has been requested.