chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 12 year old male who in December 2010 (4 months ago, exact date not specified), was vaccinated with a first dose of GARDASIL. In March 2011 "recently", the patient had been complaining of flu-like symptoms and diarrhea. The patient's father believed it was all due to GARDASIL. It was not specified when the patient saw the doctor for the symptoms. The father stated that his son (the patient) will not be getting the second and third doses. The patient's flu-like symptoms and diarrhea persisted. Follow-up information was received from the physician who stated that there was no further information available. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Borrelia test positive, HIV test, HIV test positive, Hepatitis A antibody positive, Myalgia
Clinical narrative: Information has been received from a 23 year old male who in January 2011, was vaccinated with GARDASIL and received his second dose in March 2011, the patient had symptoms of muscle aches starting January 2011 sometime after the first dose of GARDASIL. Prior to receiving his second dose of GARDASIL, blood was drawn and tested for Lymes disease. It came back positive. The patient was being treated with doxycycline (manufacturer unknown) 100mg twice daily for 21 days. There were no other adverse events reported. The patient had discussed with physician. At the time of the report, the patient's status was not recovered. The follow up information has been received from the consumer who had performed Lymes test positive/Elisa test positive; Western IGG antibody positive (Band 41 and Band 34); IGM positive (Band 41 and Band 34) on unspecified day. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma, Injection site induration, Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reaction or allergy who on 01-JUN-2011 was vaccinated with the first dose of GARDASIL (Lot number: 1511Z; expiration date 26-APR-2013). There was no concomitant medication. On 02-JUN-2011 the patient developed a pruritic maculo-papular rash, "2" X 2"", at the injection site, with bruising, some induration, and 2mm papules that were almost vesicular in appearance. On 03-JUN-2011, the itching was "not as bad". No treatment was given. No lab diagnostics study was performed, the patient called the physician. The physician instructed the patient to "keep an eye on it" and to let the physician know if anything changed or worsened. At the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reaction or allergy who on 01-JUN-2011 was vaccinated with the first dose of GARDASIL (Lot number: 1511Z; expiration date 26-APR-2013). There was no concomitant medication. On 02-JUN-2011 the patient developed a pruritic maculo-papular rash, "2" X 2"", at the injection site, with bruising, some induration, and 2mm papules that were almost vesicular in appearance. On 03-JUN-2011, the itching was "not as bad". No treatment was given. No lab diagnostics study was performed, the patient called the physician. The physician instructed the patient to "keep an eye on it" and to let the physician know if anything changed or worsened. At the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who was vaccinated with the first and the second doses of GARDASIL (Lot # of first dose: 666597/0768Z; Lot # of second dose: 667194/1271Z) on 23-NOV-2010 and on 21-MAR-2011 respectively. On approximately 26-APR-2011 the patient was then testing positive for HPV. The patient sought medical attention by phone call. No treatment was given for the event. At the time of the report, the status of the patient was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL injection (dose, route and lot number not provided). The nurse reported that on an unspecified date the patient experienced syncope with no loss of consciousness and slid down the wall after receiving GARDASIL injection. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. This is one of three reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal oedema
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with three doses of GARDASIL respectively. On approximately 29-MAR-2011 ("about 2 weeks ago") the patient experienced vaginal edema after the three doses of GARDASIL. At the time of reporting, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unknown date was intramuscularly vaccinated with 0.5 ml of the three doses (0, 2 and 6 months) of GARDASIL (lot # and expiration not reported) series. Consumer reported that her daughter had the three doses of GARDASIL and had HPV 16. It was unspecified if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Computerised tomogram head, Computerised tomogram normal, Drug screen negative, Electrocardiogram
Clinical narrative: Information has been received from a registered nurse, a physician, and medical records concerning a 18 year old female with no reported allergies who on 08-APR-2011 at 0900 was vaccinated intramuscularly in the right arm with a first dose of GARDASIL, 0.5 ml (Lot # 667930/15612). On 08-APR-2011 at 0854, prior to the patient's vaccination, the nurse reported the patient's blood pressure was 110/70 mmHg. The patient had denied any illnesses at the time of the vaccination. The nurse stated the patient had reported to her mother that within an hour after the first GARDASIL dose, on 08-APR-2011 at 1300-1700, the patient had a "hard time seeing" and had numbness in her teeth, mouth and arm. The patient reported her last menstrual period was 07-MAR-2011. The nurse reported the patient went to the emergency room and was treated with a CT scan of the brain, electrocardiogram and blood work. Her vital signs revealed an increase temperature of 99.2, blood pressure of 134/72 and a pulse rate of 80. According to medical records, on 08-APR-2011, at approximately 15:00 PM, the patient was seen in the emergency room and had the following diagnostic tests performed: CT of the brain without contrast indicated for a headache showed a normal CT brain, complete blood cell count and chemistry blood test both showed normal results and a completed electrocardiogram (results not provided). The patient was also given a screening urine drug test that was negative for amphetamine, tricyclics, tetrahydrocannabinol (THC), cocaine, benzonatate, barbiturate, phencyclidine (PCP) and opiates. On 08-APR-2011, the patient's outpatient medication listed LOESTRIN FE 1 mg-10 MCG/10 MCG, 1 tablet daily. The patient's follow-up instructions were to return to her doctor's office in about two months (around 08-JUN-2011) for her second dose of GARDASIL. On 27-APR-2011 at 1740, the nurse was informed by the patient's physician, that the patient had an allergic reaction to GARDASIL injection, noted as swelling of the mouth and lips. The patient's outcome was not provided at the time of this report. All available medical records will be provided upon request. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Headache, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Information has been received from a registered nurse, a physician, and medical records concerning a 18 year old female with no reported allergies who on 08-APR-2011 at 0900 was vaccinated intramuscularly in the right arm with a first dose of GARDASIL, 0.5 ml (Lot # 667930/15612). On 08-APR-2011 at 0854, prior to the patient's vaccination, the nurse reported the patient's blood pressure was 110/70 mmHg. The patient had denied any illnesses at the time of the vaccination. The nurse stated the patient had reported to her mother that within an hour after the first GARDASIL dose, on 08-APR-2011 at 1300-1700, the patient had a "hard time seeing" and had numbness in her teeth, mouth and arm. The patient reported her last menstrual period was 07-MAR-2011. The nurse reported the patient went to the emergency room and was treated with a CT scan of the brain, electrocardiogram and blood work. Her vital signs revealed an increase temperature of 99.2, blood pressure of 134/72 and a pulse rate of 80. According to medical records, on 08-APR-2011, at approximately 15:00 PM, the patient was seen in the emergency room and had the following diagnostic tests performed: CT of the brain without contrast indicated for a headache showed a normal CT brain, complete blood cell count and chemistry blood test both showed normal results and a completed electrocardiogram (results not provided). The patient was also given a screening urine drug test that was negative for amphetamine, tricyclics, tetrahydrocannabinol (THC), cocaine, benzonatate, barbiturate, phencyclidine (PCP) and opiates. On 08-APR-2011, the patient's outpatient medication listed LOESTRIN FE 1 mg-10 MCG/10 MCG, 1 tablet daily. The patient's follow-up instructions were to return to her doctor's office in about two months (around 08-JUN-2011) for her second dose of GARDASIL. On 27-APR-2011 at 1740, the nurse was informed by the patient's physician, that the patient had an allergic reaction to GARDASIL injection, noted as swelling of the mouth and lips. The patient's outcome was not provided at the time of this report. All available medical records will be provided upon request. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Lip swelling, Oedema mouth, Visual impairment
Clinical narrative: Information has been received from a registered nurse, a physician, and medical records concerning a 18 year old female with no reported allergies who on 08-APR-2011 at 0900 was vaccinated intramuscularly in the right arm with a first dose of GARDASIL, 0.5 ml (Lot # 667930/15612). On 08-APR-2011 at 0854, prior to the patient's vaccination, the nurse reported the patient's blood pressure was 110/70 mmHg. The patient had denied any illnesses at the time of the vaccination. The nurse stated the patient had reported to her mother that within an hour after the first GARDASIL dose, on 08-APR-2011 at 1300-1700, the patient had a "hard time seeing" and had numbness in her teeth, mouth and arm. The patient reported her last menstrual period was 07-MAR-2011. The nurse reported the patient went to the emergency room and was treated with a CT scan of the brain, electrocardiogram and blood work. Her vital signs revealed an increase temperature of 99.2, blood pressure of 134/72 and a pulse rate of 80. According to medical records, on 08-APR-2011, at approximately 15:00 PM, the patient was seen in the emergency room and had the following diagnostic tests performed: CT of the brain without contrast indicated for a headache showed a normal CT brain, complete blood cell count and chemistry blood test both showed normal results and a completed electrocardiogram (results not provided). The patient was also given a screening urine drug test that was negative for amphetamine, tricyclics, tetrahydrocannabinol (THC), cocaine, benzonatate, barbiturate, phencyclidine (PCP) and opiates. On 08-APR-2011, the patient's outpatient medication listed LOESTRIN FE 1 mg-10 MCG/10 MCG, 1 tablet daily. The patient's follow-up instructions were to return to her doctor's office in about two months (around 08-JUN-2011) for her second dose of GARDASIL. On 27-APR-2011 at 1740, the nurse was informed by the patient's physician, that the patient had an allergic reaction to GARDASIL injection, noted as swelling of the mouth and lips. The patient's outcome was not provided at the time of this report. All available medical records will be provided upon request. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician reporting that the mother of the patient contacted the physician's office by phone on 01-JUN-2011 and reported that her 18 year old daughter with no medical history or drug reactions or allergies, on 31-MAY-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication. On 01-JUN-2011 the patient's feet were bloated and swollen. No labs/diagnostics studies were performed. No treatment was given at the time of reporting. At the time of reporting, the patient's outcome was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no pertinent medication and no drug allergies who on 17-NOV-2010 was vaccinated IM in her left arm with her second 0.5ml dose of GARDASIL (lot # 666595/0992Z). There was no concomitant medication. The nurse reported that the mother of the female patient informed the office today that her daughter's arm was sore for 2 months after receiving the vaccination. The mother also told the nurse that her daughter could not move her arm that much. The nurse reported no treatment was given. The patient did not seek medical attention. At the time of the report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Pain in extremity
Clinical narrative: Information has been received from a physician's assistant, concerning a 4 year old female patient, who on 07-JUN-2011 was inadvertently administered intramuscularly a 0.5 ml dose GARDASIL (Lot #: 667165/1167Z, Exp: 08-DEC-2012). Physician's assistant reported that on an unknown date, the patient had a sore arm. It was unknown if patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTP, HPV4, MNQ
Symptoms: Blood test, Hypoaesthesia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 11 year old female with asthma, reflux disease and anxiety disorder and no drug allergy or reaction who on 17-DEC-2010 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MENVEO (also reported as MENZEO) and Tdap (manufacturer unknown) and other unspecified medications. Two days later, on 19-DEC-2010 the patient experienced numbness and pain in both legs. The patient was examined in the emergency room on 19-DEC-2010, but not admitted. On 20-DEC-2010, the patient saw the nurse practitioner at the office. The patient was followed up by neurology for about a month. The patient was not given treatment. Blood tests and an MRI were performed with unspecified results. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter, who on an unspecified date was vaccinated with her first dose of GARDASIL (lot #, dose and route not reported). Consumer reported that on an unknown date, her daughter ended up having a localized reaction at the injection site where there was warmth, redness, swelling and itchiness. The consumer was not sure if her daughter would proceed with the rest of the dosing schedule. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number: 667866/1437Z). On an unspecified date the patient experienced pain in her arm after receiving the GARDASIL. It was unspecified whether the patient sought medical attention. At the time of the report, the patient's present status was unknown. A lot check has been initiated. This is one of several reports received from same source. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a now "30 year old" female who in "two or three years ago" in approximately 2008 (at the age of approximately 28 year old) was vaccinated with a dose of GARDASIL (dose not reported) (Lot number not reported). Two or three years ago, in approximately 2008 the patient experienced a fever and soreness in her arm where she received the injection. The patient saw the nurse practitioner recently and was still complaining of pain in her arm. Unknown as to whether the patient received all three doses of the GARDASIL series. It was unknown whether the patient sought medical attention. The patient was given unspecified treatment. Upon the time of report, the patient was not recovered. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Mydriasis
Clinical narrative: Information has been received from a nurse concerning a male patient who on 29-APR-2011 was vaccinated with the first dose of GARDASIL, intramuscularly (lot number, expiration date and dose not reported). On 29-APR-2011, after receiving an injection of GARDASIL, the patient experienced dilated eyes, he fell backward and hit his head and was unconscious for 5 minutes. No treatment was given for the adverse event. The patient received unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Genital herpes
Clinical narrative: Information has been received from a 20 year old female with no drug allergies and irregular pap smear who on an unspecified date were vaccinated with 3 doses of GARDASIL, respectively. Concomitant therapy included ORTHO TRI-CYCLEN. On approximately 04-MAY-2011 (reported as in the last week) the patient experienced genital warts. The patient was treated with podophyllin for the genital warts. There was no lab diagnostics performed. The current physician had not record of the patient receiving the GARDASIL shots. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician concerning the patient who on 23-NOV-2007, 30-JAN-2008, 04-JUN-2008 were vaccinated with the first, second and third dose of GARDASIL, respectively. On 09-MAY-2011, the patient developed the outbreak of genital herpes and genital warts. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a "17 year old" female with no pertinent medical history who on 15-FEB-2011 was vaccinated with the first dose of GARDASIL (lot # 666931/0337Z). Concomitant therapy included ZITHROMAX (reported as "VITHROMAX"). On 15-FEB-2011 the patient was feeling dizzy. The patient was not given treatment. No lab diagnostics studies performed. The patient did not seek medical attention. On an unspecified date, the patient recovered from dizzy. Follow up information has been received from a registered nurse concerning the 16 year old (previously reported as "17 year old") female student with allergy to ZITHROMAX and no illness at time of vaccination, and no adverse event following prior to vaccination who 14-FEB-2011 (previously reported as "15-FEB-2011") was vaccinated with the first dose of GARDASIL in left deltoid. The patient's mother stated that on the evening of 14-FEB-2011 the patient became very dizzy which continued to the morning of the second day. The mother notified the office 24 hours post dose given. On 15-FEB-2011, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia universalis
Clinical narrative: Information has been received from a physician concerning a friend's daughter who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot number not reported). The physician reported that one month later the patient experienced whole body alopecia. The patient sought unspecified medical attention. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with no pertinent medical history and "tons of allergies to medication" who on an unknown date, was vaccinated with the three doses of GARDASIL (lot number not reported). Concomitant medication included an unspecified medication for migraine and birth control. The consumer reported that, on an unspecified date, her daughter was diagnosed with cervical dysplasia after receiving an abnormal PAP smear. Re-ran PAP and repeated biopsy were performed and they showed that cervical dysplasia still presented. The experience was treated with freezing. The patient sought an unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (dose, route and Lot # not reported) and "6 months ago" on approximately 30-SEP-20110 was vaccinated with a second dose of GARDASIL (dose, route and lot# not reported). The nurse stated that "6 months ago" on approximately 30-SEP-2010, the patient fainted one hour after receiving her second GARDASIL dose. The nurse also stated that the patient did not have a reaction after her first GARDASIL. The nurse reported that there was no treatment necessary, nor provided thus the patient was fine. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician's office concerning a female adolescent patient who on an unspecified date was vaccinated IM with a dose of GARDASIL (lot number unspecified). It was reported that the mother called to say, "her daughter was not feeling well" on an unspecified date. No treatment given for the adverse event. No diagnostic laboratory tests performed. At the time of reporting, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with no known allergies who on 26-DEC-2006 was vaccinated with first dose of GARDASIL (therapy route not provided, lot # 654389/0961F). On 01-MAR-2007 and 20-AUG-2007 the patient was vaccinated with the second and third dose of GARDASIL (therapy route and lot # not provided) respectively. On 22-FEB-2011 the patient had a pap smear performed that resulted positive for human papilloma virus (HPV). A copolscopy exam was scheduled. Patient sought unspecified medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Presyncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old male patient who "in the last couple of weeks", was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unknown date, "within 5 minutes of receiving the injection", the patient developed lightheadedness and almost passed out. The nurse practitioner stated that the patient had a drop in blood pressure and his heart rate lowered. The nurse practitioner stated there was no other adverse event to report. The patient sought medical attention in the medical office. The patient did not receive any treatment for the event. The patient recovered quickly. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with no allergies or drug reaction history, who on 31-JUL-2008, was vaccinated with the first dose of GARDASIL (lot number # 660557/0072X) (route not reported). On 24-MAR-2009, was vaccinated with the second dose of GARDASIL (lot number # 660616/0570X) (route not reported). On 23-MAR-2011, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscular, (lot number # 667194/1081Z exp date unknown). There was not concomitant medication. On 24/MAR/2011 the patient developed headache, fever and dizziness. It was noted no laboratories were performed. At the time of the report the patient was not recovered. The patient contacted the office by phone. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Cold sweat, Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female patient who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (lot number:667165/1167Z) (expiration date, dose and site of administration not reported). On 08-NOV-2010, the patient was vaccinated with the second dose of GARDASIL (lot number: 667165/1167Z) (expiration date, dose and site of administration not reported). On 06-JUN-2011, the patient was vaccinated with the third dose of GARDASIL (lot number: 667165/1167Z) (expiration date, dose and site of administration not reported). On 06-JUN-2011, the patient experienced clamminess, lightheadedness and upset stomach. This was not a problem for the previous two doses. It was unknown if the patient sought medical attention. No treatment was given for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from a doctor's nurse concerning an either 18 or 19 year old female patient who on 09-MAY-2011 was vaccinated with the second dose of GARDASIL (lot #, expire date and route not reported), 0.5 ml. The doctor's nurse stated that the day after the patient got her second GARDASIL shot on 10-MAY-2011, her arm was covered with red bumps and was itchy. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 23-FEB-2011 was vaccinated with the first dose of GARDASIL (Lot # and expiration date not reported) and who after vaccination had "super clavicular lymph node enlargement with tenderness". The patient discontinued the series of GARDASIL. It was unknown if patient sought medical attention and the patient's outcome. Information has been received from licensed practical nurse concerning a 16 year old female patient with no pre-existing allergies, birth defects or medical conditions who on 23-FEB-2011 at 4:30 pm was vaccinated in the left arm with the first dose of GARDASIL (Lot# 666987/1016Z, expiration not reported). On 23-FEB-2011 the patient experienced supraclavicular (LT) lymphadenopathy and tenderness. At the time of reporting the patient had recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Malaise
Clinical narrative: Information has been received from a practitioner nurse concerning a 11 or 12 years old female patient who about a year, in approximately 2010, was vaccinated intramuscularly, 0.5 mL with the first dose of GARDASIL (Lot# and expiration not reported). The nurse reported that about a year, in approximately 2010, the patient became dizzy, hot and felt sick after received her first injection of GARDASIL. The patient sought unspecified medical attention. Therapy with GARDASIL was discontinued about a year ago, in approximately 2010, and not reintroduced. No treatment was given for this adverse event. The patient recovered shortly thereafter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Rash, Rash pruritic, Skin discomfort
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female who on 22-OCT-2010 was vaccinated with the first dose of 0.5 ml GARDASIL (lot # not reported). On 22-DEC-2010 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot # 663558/0819Y, expiration date 10-OCT-2011). Concomitant therapy included montelukast sodium. The patient developed a rash the morning after receiving GARDASIL on 23-DEC-2010. The rash was reported as diffuse-covering face, feet, hands. The rash was described as itchy and when scratched was sensitive. The patient experienced malaise for a period of 48 hours following vaccination. The patient recovered from the events one week following vaccination (on approximately 29-DEC-2010). The patient did not seek medical attention. Unspecified treatment was given to the patient. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old male patient with no medical history, who on 25-FEB-2011 , was vaccinated with a dose of GARDASIL (lot # 666163/0664Z) 0.5 mL, intramuscularly. No concomitant therapy reported. The nurse indicated that on 23-MAR-2011, the patient developed a lump at the injection site. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the lump at the injection site. Follow up information has been received from the nurse practitioner who reported that the 23 year old male student patient with no pre-existing allergies, birth defects or medical conditions who on 25-FEB-2011, was vaccinated IM with the first dose of GARDASIL in the left arm. There was no illness at the time of vaccination. Event reported as none (conflicted information previously reported as a lump at the injection site by the nurse practitioner). The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from the nurse practitioner who clarified that the male patient did indeed had a lump at injection site. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female patient who on unspecified dates was vaccinated with 0.5 ml 3 doses of GARDASIL (lot#'s not reported). It was reported the the patient had an abnormal PAP smear. The patient had the third injection in the series. At the time of the report, the patient had not recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Presyncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old male patient who "in the last couple of weeks", was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unknown date, "within 5 minutes of receiving the injection", the patient developed lightheadedness and almost passed out. The nurse practitioner stated that the patient had a drop in blood pressure and his heart rate lowered. The nurse practitioner stated there was no other adverse event to report. The patient sought medical attention in the medical office. The patient did not receive any treatment for the event. The patient recovered quickly. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Hot flush
Clinical narrative: Information has been received from a nurse concerning a 25 year old female non-smoker who on 28-APR-2011 was vaccinated with the first dose of GARDASIL (Lot # 666597/0768Z exp 17-OCT-2012). Concomitant therapy included LOESTRIN 24 FE. The nurse reported that the patient developed hot flashes and chills simultaneously along with dizzy spells, a "few days" after the first dose of GARDASIL and the patient had "about 2 episodes a week." The patient called office to seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 02-MAY-2011 was vaccinated with the first dose of GARDASIL. On 04-MAY-2011 the patient experienced flu like symptoms and felt like she had been hit by a truck. The patient called the physician. Upon the time of the report, the patient was not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning her daughter who in 2007 was vaccinated with a dose of GARDASIL. On an unspecified date the patient had been diagnosed with HPV type 16. It was unspecified whether the patient sought medical attention. Upon the time of the report, the patient's present status was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal lesion
Clinical narrative: Information has been received by someone in the physician's office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. (Lot number not reported). It was reported stated that the patient was using GARDASIL and experienced vaginal lesions. The patient sought unspecified medical attention. The patient received unspecified treatment for this event. It was reported that the physician was aware of this. 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, Back pain, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 year old female patient with drug allergy to BETADINE, allergy to shell fish and no pertinent medical history who on 28-FEB-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number 666597/0768Z, Exp: October 2012). On 06-MAY-2011, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (lot number 667878/0180AA, Exp: March 2013). Concomitant therapy included LOESTRIN 24 FE and cyanocobalamin. In 2011, after administration of the first and second dose of GARDASIL, the patient experienced pain at injection site. On approximately 06-MAY-2011, after second dose of GARDASIL, the patient had been experiencing headaches, swollen neck glands, joint and back pain after second dose of GARDASIL. The patient did not receive any treatment for the event and no laboratories were performed. The patient sought medical attention via a telephone call. At the time of the report the patient was recovering. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 20 or 21 year old female patient who in approximately April 2011, "about a month ago", was vaccinated with the first dose of GARDASIL, subcutaneously (lot number not reported). In approximately April 2011, "about a month ago", the patient developed syncope. No treatment was given for the adverse event. The patient did not seek medical attention. The patient recovered within a few seconds and was still continuing with treatment. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female patient who during the morning of 25-APR-2011, was vaccinated intramuscularly with the first dose of GARDASIL (lot number not reported) and developed itching at the injection site. Later, on the same day, the patient developed a burning sensation over her whole body. No treatment was given for the experience since the registered nurse was going to recommend BENADRYL for itch but patient did not take it. The patient sought medical attention by phone. At the time of the report, the patient was recovering. Additional information has been request.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Herpes zoster, Injection site discomfort, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a medical assistant reporting that her son's girlfriend, 24 year old female, received her second dose of GARDASIL recently and within 4 hours the patient noticed a "pimple on her neck." When she woke up the next morning, the patient reported that her whole left arm and neck were extremely sore and that there was a circle approximately 4 to 6 inches above the injection site with about 12 bumps that the patient reported were "very sore to touch." The patient took a picture of the circular rash and sent it to the medical assistant. The medical assistant said that they were looking like shingles and that she told the patient to go to her doctor to be examined. Medical assistant said that the patient was convinced that her rash was a reaction to "the shot" of GARDASIL. The patient made an appointment with her Health Care Physician (HCP). The patient had not recovered from the events. Follow up information received from the medical assistant reporting that the GARDASIL injection was part of a dept of health. The patient went to her doctor and was diagnosed with a shingles outbreak. The GARDASIL injection had nothing to do with this while her first lesion appeared only 4 hours after the injection and she did have some discomfort in the site pain to the injection. Follow up information received from the medical assistant reporting that her son's girlfriend got unusual rash that day after her GARDASIL vaccine on 11-MAR-2011. The cluster of lesions on her neck ended up being herpes zoster (shingles). It had nothing to do with the GARDASIL vaccine. The patient was treated with antiviral medications and prednisone and was healed and was fine. The patient was due to have her third dose vaccine this summer. Her physician gave no contraindication to receiving this injection. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Information has been received from a medical assistant reporting that her son's girlfriend, 24 year old female, received her second dose of GARDASIL recently and within 4 hours the patient noticed a "pimple on her neck." When she woke up the next morning, the patient reported that her whole left arm and neck were extremely sore and that there was a circle approximately 4 to 6 inches above the injection site with about 12 bumps that the patient reported were "very sore to touch." The patient took a picture of the circular rash and sent it to the medical assistant. The medical assistant said that they were looking like shingles and that she told the patient to go to her doctor to be examined. Medical assistant said that the patient was convinced that her rash was a reaction to "the shot" of GARDASIL. The patient made an appointment with her Health Care Physician (HCP). The patient had not recovered from the events. Follow up information received from the medical assistant reporting that the GARDASIL injection was part of a dept of health. The patient went to her doctor and was diagnosed with a shingles outbreak. The GARDASIL injection had nothing to do with this while her first lesion appeared only 4 hours after the injection and she did have some discomfort in the site pain to the injection. Follow up information received from the medical assistant reporting that her son's girlfriend got unusual rash that day after her GARDASIL vaccine on 11-MAR-2011. The cluster of lesions on her neck ended up being herpes zoster (shingles). It had nothing to do with the GARDASIL vaccine. The patient was treated with antiviral medications and prednisone and was healed and was fine. The patient was due to have her third dose vaccine this summer. Her physician gave no contraindication to receiving this injection. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL (Lot # and expiration not reported). Physician reported that following the injection of GARDASIL the patient was getting up to sit in another area when the patient fainted. The patient sought medical attention. It was reported that the patient received ice for her face. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with seasonal allergies and sulfa and codeine drug allergies, who on 05-MAY-2011 was vaccinated with the first dose of GARDASIL (lot number not reported). Concomitant vaccination administered on the same day included a dose of hepatitis a virus vaccine (manufacturer unspecified). Concomitant therapy included hydrocodone and LOESTRIN. The consumer reported that on the morning of 06-MAY-2011, her daughter developed a war, raised, itchy rash, the size of baseball surrounding the injection site on her left arm. She also reported that on 05-MAY-2011, her daughter received a dose of hepatitis a virus vaccine, in the right arm, without incident. BENADRYL and ice were given as a treatment for the experience. At the time of the report, the consumer reported that the rash was improving but had not yet resolved; the patient was recovering. The consumer's daughter sought medical attention by called to office twice. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Presyncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old male patient who "in the last couple of weeks", was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unknown date, "within 5 minutes of receiving the injection", the patient developed light headedness and almost passed out. The nurse practitioner stated that the patient had a drop in blood pressure and his heart rate lowered. The nurse practitioner stated there was no other adverse event to report. The patient sought medical attention in the medical office. The patient did not receive any treatment for the event. The patient recovered quickly. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from an office billing supervisor concerning a female patient who on 11-JUN-2008 was vaccinated with the third dose of GARDASIL (lot # expire date and route not reported). The office billing supervisor reported that on an unspecified date the patient ended up having an abnormal PAP and the patient required colposcopy. It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Rash, Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 14 year old female patient with "none" pertinent medical history and "none" drug allergies or reactions, who was vaccinated intramuscularly with the first and second 0.5 ml dose of GARDASIL, on 19-JAN-2011 and 18-MAR-2011 (lot #666948/0886Z expiration date: 21-NOV-2012) respectively. There was no concomitant medication. Nurse reported that after receiving the second dose of GARDASIL, "that evening" (on 18-MAR-2011), the patient developed a swelling in her left hip that was 2 inches long, 1 inch wide and 1/3 inch thick, and a rash on her left hip and her left leg. The nurse reported that the patient's rash was very itchy. Nurse reported that on 19-MAR-2011, the patient also developed swelling in her right hip and an itchy rash on her right hip and her right leg. Patient was treated with BENADRYL and topical hydrocortisone cream. No lab diagnostic studies were performed. It was reported that the patient woke up on 19-MAR-2011, and the swelling had disappeared on the patient's left hip, but the itchiness and rash remained on the patient's left hip and the patient's left leg. The nurse reported that "today" (21-MAR-2011) the patient's mother called the office and reported that the patient still had an itchy rash on both legs and both hips, but the rash was improving. Additional information has been requested.