chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 09-FEB-2007 was vaccinated with the first dose of GARDASIL (lot # 653736/0014U), the second dose (no lot#) on 10-APR-2007 and the third dose (lot # 0469U) on 08-AUG-2007. The patient had PAP test abnormal on 08-DEC-2009, tested positive for HPV after vaccination. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. This is one several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypothyroidism
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # not reported). Subsequently the patient developed hypothyroidism. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL (lot # not reported). The patient fainted right after receiving the vaccination. No injuries were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered. Follow up information has been received from the nurse practitioner concerning the 24 year old female patient with no other relevant medical history or allergies who on 11-JAN-2010, in the morning, was vaccinated intramuscularly with the first dose of GARDASIL (lot# not reported). On the same day, in the morning, the patient fainted, but she did not fall. She recovered within a few minutes with no damage. There was no illness at time of vaccination. There were no laboratory diagnostics studies performed. Follow up information has been received from the nurse practitioner concerning the female patient who on 11-JAN-2010, in the morning, was vaccinated intramuscularly with the first dose of GARDASIL (lot# 662304/1013Y) into her arm. On the same day, in the morning, the patient fainted, but she did not fall. She recovered quickly within a few minutes with no damage. It was stated that the patient fainted easily. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a currently 18 year old female patient with allergic reaction to antibiotics (AUGMENTIN) and no pertinent medical history who on 19-JAN-2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 654702/0011U), on 23-MAR-2007 was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (Lot # 656051/0244U) and on 13-SEP-2007 was vaccinated intramuscularly with her third 0.5 ml dose of GARDASIL. There was no concomitant medication. It was reported that the patient had an abnormal PAP smear and tested positive for HPV after receiving the three doses of GARDASIL. The patient sought unspecified medical attention. At the time of the report the patient's status was not specified. Follow up information has been received from the registered nurse who indicated that the patient did not have any known drug allergy/reaction and no pertinent medical history. On 05-JAN-2010, the patient had an abnormal pap smear plus a high risk for HPV. The patient required further testing. The nurse also mentioned that the patient's aunt had ovarian cancer. No diagnostic or laboratory tests were performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Skin papilloma, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female consumer concerning herself who in 2008 was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that the patient developed tissue inflammation in the arm that she received GARDASIL. She also experienced the same symptoms and developed warts on her arm and hand within 48 hours of receiving her third dose of HPV. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning an 11 year old female patient with allergic reaction to GENTAMYCIN and no pertinent medical history who on 30-MAR-2009 and 28-AUG-2009 was vaccinated IM with the first dose (lot# 661952/1129X) and second dose (lot# 662724/0313Y) of GARDASIL. On 19-JAN-2010, the patient was vaccinated with the third dose of GARADSIL (lot # 662304/1023Y) IM. The patient had been experiencing headache, nausea and vomiting after receiving each dose of GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin disorder
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in July 2009, was vaccinated with the first dose of GARADSIL (LOT#, route not reported). Four weeks later, in August 2009, the patient experienced "scalp sensitivity". The patient sought unspecified medical attention. The patient's outcome was unknown. No further information is available at this time of the report. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a consumer concerning his 12 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who "about a month ago", on approximately 21-JUL-2009, was vaccinated with a dose of GARDASIL. There was no concomitant medication reported. It was reported that "about a week after first dose", on approximately 28-JUL-2009, the patient had been experiencing headaches and nausea. The patient did not seek medical attention. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of the report. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Biopsy site unspecified abnormal
Clinical narrative: Information has been received from the patient's mother concerning her 20 year old daughter with bronchial problems developed when she was on her teens and amoxicillin allergy who in approximately August 2007 was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included albuterol. It was reported that on 05-AUG-2009 the patient was diagnosed of having "abnormal cells". The patient sought medical attention with the physician. On an unspecified date a biopsy was performed. It was reported that the mother called to check if the patient could still continue with GARDASIL series and if it was safe for the patient to get the second dose. It was reported that the vaccine was not reintroduced. The outcome of the patient was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) concerning a "13 or 14 year old" female patient who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL (Lot # not reported). It was reported that on an unspecified date the patient experienced hair loss after receiving GARDASIL. The patient sought unspecified medical attention. The outcome of the patient was not reported. Follow-up information was received from nurse practitioner who reported a mother and her child who refused vaccine stated she knew of someone who had suffered severe hair loss after her immunization. Attempts to verify the existence of an identifiable patient have been unsuccessful. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Head injury, Lip injury, Nausea, Skin warm
Clinical narrative: Information has been received from a nursing assistant concerning a female who about 2 months ago was vaccinated with a second dose of GARDASIL. After vaccination the patient fainted and hit her head. The patient was fairly warm in the examination room. The patient had a cut on her head and her lip from the fall off of the examination table. Steri - strips were placed on her head. The next day the office contacted the patient and she was fine. The patient sought unspecified medical attention. Follow up information was received from a healthcare professional who indicated that the patient was a 15 year old female with no known drug allergies and no pertinent medical history who on 04-JUN-2009 was vaccinated intramuscularly with her third dose (previously reported as second) of GARDASIL in her right arm at 15:45. No illnesses were reported at the time of vaccination. According to the reporter, the patient was seated on bed receiving the injection; the patient stated that she felt hot and nauseous. It was reported that the nurse turned to open the door while patient was seated on the bed. Subsequently the patient tried to stand up, she fell and hit her head on the floor. Steri - trips were used on her left fore head. The patient recovered on 10-JUN-2009. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nursing assistant concerning a female who about 2 months ago was vaccinated with a second dose of GARDASIL. After vaccination the patient fainted and hit her head. The patient was fairly warm in the examination room. The patient had a cut on her head and her lip from the fall off of the examination table. Steri - strips were placed on her head. The next day the office contacted the patient and she was fine. The patient sought unspecified medical attention. Follow up information was received from a healthcare professional who indicated that the patient was a 15 year old female with no known drug allergies and no pertinent medical history who on 04-JUN-2009 was vaccinated intramuscularly with her third dose (previously reported as second) of GARDASIL in her right arm at 15:45. No illnesses were reported at the time of vaccination. According to the reporter, the patient was seated on bed receiving the injection; the patient stated that she felt hot and nauseous. It was reported that the nurse turned to open the door while patient was seated on the bed. Subsequently the patient tried to stand up, she fell and hit her head on the floor. Steri - trips were used on her left fore head. The patient recovered on 10-JUN-2009. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Fatigue, Loss of consciousness
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with scoliosis and underweight and with no drug allergies who on 08-JUN-2009 and 14-AUG-2009 was intramuscularly vaccinated with her first and second 0.5ml dose of GARDASIL respectively. There was no concomitant medication. 3 days later after the second dose, on 17-AUG-2009 the patient passed out and then started jerking for a few seconds. Afterwards she was very tired. She sat down for about 20 minutes and felt fine. The doctor did not believe that this was related to the vaccination. Unspecified medical attention was sought. No laboratory diagnostics studies were performed. The patient recovered on 17-AUG-2009. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Headache, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with a seasonal allergy and no pertinent medical history who on 12-AUG-2009 was vaccinated with the second dose of 0.5 ml GARDASIL. Concomitant therapy included vitamins (unspecified). Four hours after she received the vaccine, she went for cheerleading practice and experienced trouble breathing and in the evening she had headache and nauseous. The patient sought unspecified medical attention. Next morning, on 13-AUG-2009, the patient was recovered. The nurse mentioned that the patient did not have breakfast or lunch on the day of the vaccination. It was also stated that patient did not have any adverse event on first dose (date not provided). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with no pertinent medical history and no known drug allergies who on 21-AUG-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 659054/0311Y). There was no concomitant medication. The nurse reported that the patient experienced an increase in heart rate and collapsed 1 minute after administration of GARDASIL. The patient regained consciousness and her symptoms were resolved on 21-AUG-2009. No lab diagnostics study was performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who 2 weeks ago (on approximately 11-AUG-2009), was vaccinated with the first dose of GARDASIL. One week after vaccination (on approximately 18-AUG-2009) the patient had an outbreak of plantar warts. The plantar warts were on both knees, fingers on both hands, both elbows and both feet. The patient's outbreak of plantar wart persisted. The patient sought medical attention by visit to an unspecified dermatologist. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Respiratory distress
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated IM with the first dose of GARDASIL. On an unspecified date, the patient experienced respiratory distress after receiving the first dose of GARDASIL. It was reported that the patient received GARDASIL from another doctor. The patient sought unspecified medical attention. On an unknown date, the patient recovered from respiratory distress. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nerve injury, Neuralgia, Neuropathy peripheral
Clinical narrative: Information has been received from a website. It was reported that on an unknown date, a patient was vaccinated with a dose of GARDASIL. The patient's mother stated that she took her daughter to a neurologist and "by that time he said her nerve pain had caused nerve damage. She had peripheral neuropathy and said it was directly related to the GARDASIL". Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an "about 15 year old female patient" who in approximately February 2008, "about a year and a half ago", was vaccinated with a 0.5 mL dose of GARDASIL intramuscularly. It was reported that after having been given GARDASIL, "about a year and a half", "the patient had a quarter sized indentation at the injection that appeared right after the vaccine was administered". The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Oral herpes
Clinical narrative: Information has been received from a 21 year old female consumer who in April 2008 and in June 2008 was vaccinated with a first 0.5 ml dose and a second dose of GARDASIL (routes and lot numbers not reported). The consumer reported that she experienced headaches and cold sores on her lips "a week later after getting the first and second doses of GARDASIL". At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention and it was unspecified if lab studies were performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female who approximately on 25-JUN-2009 was vaccinated with the first dose of GARDASIL. The day after, on approximately 26-JUN-2009, the patient experienced fever, chills and vomiting. The patient sought unspecified medical attention. The patient reported this reactions to the nurse when the patient went into the office for her second dose of GARDASIL. The determination was made not to continue the GARDASIL series. The patient was not going to received the second or third dose of GARDASIL. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning a 19 year old female with no drug allergies who on 28-JUL-2007, 30-SEP-2007 and 31-JAN-2008 was vaccinated in left arm with the first, second and third dose of GARDASIL (LOT# not reported), respectively. The patient reported right arm pain whenever it rained since the GARDASIL. She sought medical attention in the office and was reported as not recovered at the time of this report. Follow-up information has been received and it was reported that on 26-AUG-2009 during a routine physical, the female patient complained that her right arm hurts every time it rained, and "exactly where GARDASIL was given". All three doses of GARDASIL were given IM in her left deltoid, the first dose's lot was 656371/0181U, the second dose's lot was 658490/0802U and the third dose's lot was 658558/1061U. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female patient who on 08-JUN-2009 was vaccinated with the first dose of GARDASIL. On 10-AUG-2009, the patient was vaccinated with the second dose of GARDASIL during the morning and that night the patient had hives from head to toe. The nurse stated that the patient did not have a reaction to the first dose of GARDASIL. On an unspecified date the patient recovered from hives from head to toe. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Weight decreased
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with no known drug allergies who on 09-JAN-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 661531/1311X). On 13-MAR-2009 the patient received her second dose of GARDASIL (Lot # 661952/1129X). On 19-AUG-2009 the patient received the third dose of GARDASIL (Lot # 662404/0312Y). On 18-DEC-2008 the patient's weight was 139 pounds. On 13-AUG-2009, the patient was seen by her primary care physician for 25 pounds weight loss since December 2008, the patient's weight was 115 pounds. The registered nurse used a date of 01-JAN-2009 as the adverse event onset date but cannot confirm when the body weight loss began. Nor can the registered nurse confirm the weight loss was associated with GARDASIL. The patient had "blood work" performed (results not reported). At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Infectious mononucleosis, Mononucleosis heterophile test positive, Syncope
Clinical narrative: Initial information has been received from a healthcare worker concerning a 17 year old female patient with no known pertinent medical history who on 10-AUG-2009 was vaccinated with the first dose of GARDASIL. The healthcare worker reported that on 11-AUG-2009 the patient did not feel well and since then had had falling episodes up to 3 times a day. Follow-up information has been received from a physician's assistant who reported that after received the vaccine the patient was experiencing syncope. The physician's assistant mentioned that the only other medication the patient was on was the birth control OCELLA (manufacturer unspecified). At the time of reporting the patient had not recovered. The patient sought medical attention by seen in the office. Follow up information has been received on 15-SEP-2009 from a physician assistant who reported that "the patient had some laboratory work which showed the patient had mononucleosis". Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 25 year old female with a history of hair loss who in June 2009, was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On approximately 05-AUG-2009, 3 weeks ago the patient experienced "mild" hair loss. The patient had a past history of temporary hair loss after she had received a series of hepatitis B virus vaccine (unspecified) when she was in high school. At the reporting time the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with a penicillin allergy who on 28-OCT-2008 was vaccinated IM with a third dose of GARDASIL (Lot# 661766/0652X) at 11:45 a.m. into the right deltoid. Concomitant therapy included a third dose of DEPO-PROVERA (manufacturer unknown) IM in the right gluteus in the same day at 11:45 a.m. The health professional reported that the patient received the two vaccines and she had put the needles in sharps and the patient fell straight back to the floor, fainted and hit head. Subsequently the "squad" was called. The patient sought medical attention at SQUAD to hospital. At the time of this report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Tooth fracture
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. After receiving the vaccine, the patient passed out and fell and broke two of her front teeth. Dose information was unspecified. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Injection site pain, Nausea
Clinical narrative: Information has been received from a health professional concerning a 21 year old female patient who on 10-AUG-2009 was vaccinated with the second dose of GARDASIL (Lot: 661953/1130X) in the left deltoid at 2:30 pm. On 12-AUG-2009, the patient reported to the physician's office that she has had soreness at the injection site, nausea, dizziness and clamminess every morning since she got GARDASIL. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female with anxiety issues with vaccines who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not reported) and on 21-AUG-2009 was vaccinated with the second dose of GARDASIL (lot # not reported). The physician reported that the patient had anxiety issues about receiving vaccines (names and manufacturer unspecified) and in response to that she usually had vasovagal issues. The physician indicated that on 21-AUG-2009, the patient received her second dose of GARDASIL lying down and about 5 minutes later, she experienced tingling on her skull and the back of her neck like she did after the first dose of GARDASIL. The patient had laid at the office for another half hour and at one point the patient was going to get up and leave when she should up she started to faint, so the patient laid back down. Then later on the patient was alright to leave and had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who approximately two months ago was vaccinated with the first dose of GARDASIL (Lot number was not provided). Concomitant therapy included MENACTRA and ADACEL. The patient following receiving the third injection that day which was GARDASIL fainted or had a syncopal event. The patient immediately snapped back and recovered. The patient did not need any type of medical intervention. The patient was in the nurse's office today and the patient's mother informed the nurse that the patient after that synocopal event and after recovering had soreness in her feet for four days. The patient was eligible for the second dose of GARDASIL today but the nurse deferred the dose of GARDASIL and will be providing the second dose of GARDASIL at the next regular visit when the patient arrives. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a rumor of a local high school aged girl experiencing Guillain-Barre after receiving a dose of GARDASIL. The patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review, Guillain-Barre syndrome was determined to be an other important medical event. Follow-up information was received on 27-AUG-2009 from a medical assistant, who reported that they had heard this report "from a couple of mothers" (name of mother not available). It was not known if the patient was local or if she attended high school or middle school, but she was said to be in a wheelchair. The event could not be confirmed. The Health Care Professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of GARDASIL, intramuscularly. Subsequently the patient experienced numbness in the area where the vaccine was administered. The patient sought unspecified medical attention. The patient's outcome is unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female patient who was vaccinated with the first dose of GARDASIL on an unspecified date. Subsequently the patient experienced pain, headache and fever. The patient went ahead and received the second dose of GARADSIL (IM, 0.5 ml) and experienced fever. The patient declined receiving the third dose. At the reporting time the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with 0.5 ml dose of GARDASIL (route and lot number not reported). The physician reported that on 26-AUG-2009 after the patient received the vaccine she fainted. The patient received an additional vaccine the same day but name and manufacturer of the vaccine was unspecified. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with no pertinent medical history and no drug reactions/allergies who on 21-AUG-2009 was vaccinated with a 0.5 ml dose of GARDASIL (Lot # 660612/0229X) IM. Concomitant therapies were not reported. The registered nurse reported that the patient had not yet started her menses, and on 21-AUG-2009, the patient experienced vaginal bleeding. The patient sought medical attention, phone call. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test negative, Influenza like illness, Pregnancy test negative
Clinical narrative: Information has been received from a physician concerning her daughter a 27 year old female patient with no allergies and no pertinent medical history who in July 2009, was vaccinated with a second 0.5 ml dose of GARDASIL (lot number: 662518/0087Y). There were no concomitant medications. The physician stated that the patient felt like she has the flu after received the second dose of the vaccine (in "July 2009"). Patient's father is the primary care physician and he ran a lot of tests such as pregnancy test and lyme test were performed and the results came out negative. The patient was referred to Neurologist. The physician stated he did not have any information on first dose and he also stated that the patient would not be getting the third dose of the vaccine. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 27-AUG-2009 was vaccinated with her first dose of GARDASIL (route and lot number not reported). There was no concomitant medication. On 27-AUG-2009, after vaccination, she was taken to the waiting room to sit and she felt "woozy". It was reported that it was unsure if the patient fainted or not. The patient was monitored at the office until she felt better. Subsequently, the patient recovered from patient felt "woozy". The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Panic attack
Clinical narrative: Information has been received from a registered nurse concerning a female with torn knee cartilage and no drug reactions/allergies who on an unspecified date was vaccinated with the first dose of GARDASIL. Concomitant therapy included birth control pills. The patient had a panic attack a few hours after receiving the vaccine. The patient did not sought medical attention. The patient has not received any additional dose of GARDASIL yet. The patient said she never had a panic attack prior to receiving GARDASIL. As of 25-AUG-2009, the patient had recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no known drug allergies who in August 2007, was vaccinated with the first dose of GARDASIL (lot# not provided), and on 24-AUG-2009 received her second dose of GARDASIL (lot# not provided). There was no concomitant medication. Patient also started feeling ill since she received the second dose. She experienced fever, headaches and nausea. Patient sought unspecified medical attention. No lab diagnostics studies performed. Patient's outcome was not reported. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with no medical history or drugs allergies, who on 17-AUG-2009 was vaccinated with a first dose of GARDASIL (lot # 662724/0313Y) into the left deltoid. There was no concomitant medication. The patient developed arm pain from her shoulder to her wrist; she also had a restricted range of motion. No laboratories studies performed. The patient sought medical attention through a phone call. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a doctor's employee who reported that her boyfriend who is a paramedic was called to an unspecified clinic when a female patient had an anaphylactic reaction after getting a dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. The patient was taken to the Emergency Room, but the reporter did not know if the patient was admitted. The outcome of the anaphylactic reaction was unknown. The patient was not a patient at the reporting employees office. Attempts are being made to verify the existence of an identifiable patient and reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Presyncope
Clinical narrative: Information has been received from a nurse concerning a 22 year old female with no know drug/reactions allergies and pertinent medical history reported who on 18-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot n. 663454/0672Y). Concomitant therapy included hormonal contraceptives (unspecified). The nurse reported that the patient received the first dose of GARDASIL on 18-AUG-2009 and developed vasovagal response. After administration the patient sat in the office for 15 minutes. She "seemed fine" but then began to feel "terrible". The patient laid down in the office and was given orange juice and peanut butter crackers. The pulse and the blood pressure were taken but no results were provided. The patient recovered in the office in the same date. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. The nurse reported that the patient broke out in a rash all over her body after receiving the second dose of vaccine. The patient declined to receive her third dose. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction, Lumbar puncture
Clinical narrative: Information has been received from a doctor's office staff concerning a 19-26 year old female patient who on an unspecified date was vaccinated with 0.5 ml of a dose of GARDASIL (Lot not reported) intramuscularly. Subsequently, the patient had an adverse reaction to GARDASIL and had to go to the hospital. It was not reported whether the patient was admitted or which hospital she went to. The office staff mentioned a spinal tap, but it was not confirmed if the spinal tap was done on the patient. At the time of reporting the patient's status was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Chills, Vomiting
Clinical narrative: Information has been received from a physician's assistant concerning a 13 year old female patient who on 08-JUL-2009 was vaccinated with the second dose of GARDASIL (lot# 660391/0063X). Concomitant therapy included MENACTRA received on the opposite arm of the GARDASIL. On 09-JUL-2009 the patient experienced vomiting, chills and weakness that lasted 2 days. Patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with two doses of GARDASIL, dates not reported. The nurse reported that after receiving her second dose of GARDASIL in the morning, the patient woke up during the night and had broken out with hives. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 26 year old female nurse who on 02-FEB-2009 was vaccinated with the first dose of GARDASIL (Lot # was not provided). Subsequently, after she received the first dose of GARDASIL she started to experience headaches. On 01-APR-2009 the nurse received the second dose of GARDASIL (Lot # was not provided). The nurse reported she still had a headache and took medicine (name and manufacturer unspecified) almost everyday to help subside the headache. At the time of the report, the patient had not recovered. It was unspecified that the patient sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Headache, Myalgia, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with a history of seasonal allergies and post concussion headaches from an unspecified accident in 2007 (MRI, CAT scan normal) who on 21-JUN-2008 was vaccinated intramuscular with the first and only dose of GARDASIL on left arm (lot # 660553/0070X). Concomitant therapy included CLARITIN, NASONEX and PATANOL. Starting the day after vaccination with GARDASIL on 22-JUL-2008 the patient developed severe muscular ache in the shoulder and neck and lasting no more than a week. Four days after vaccination, the ache became progressively more painful. There were no reports of weakness, numbness of tingling. Nine months after vaccination, on approximately 22-APR-2009 the patient developed headaches. She was recently diagnosed with chronic daily headaches. It was also mentioned that the patient may be seeing a chiropractor and neurologist. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Thrombosis
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a history of blood clots, especially post operative (NOVEMBER 2005) who on 18-DEC-2008 was vaccinated with the third dose of GARDASIL (lot#, route and site of administration not reported). On 09-JUN-2009 the patient developed abdominal blood clots. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Syncope, Urine analysis
Clinical narrative: Information has been received from a consumer concerning a 12 year old female with penicillin allergy, latex allergy and "stomach pain from erythromycin" and a history of seizure (at five years age) who on 23-JUN-2009 was vaccinated intramuscularly with the first 0.5mL dose of GARDASIL (LOT# not reported). Concomitant therapy included erythromycin. On 12-JUL-2009 the patient had fainted. She sought medical attention at an emergency room and was seen by a physician. The patient was recovering as of 12-JUL-2009, she was not admitted to the hospital. Laboratory or diagnostic tests were performed and included: urine test, blood test and CAT scan, but outcome were not provided. The patient's outcome was unknown at the time of this report. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# not reported) "about a year and a half ago". The patient developed a rash and hives after receiving her first dose of GARDASIL. The physician found out about this adverse experience when the patient came back to the office for her second dose of GARDASIL. The second dose of GARDASIL was not given. No diagnostics study was performed. The patient recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dry eye, Eyelid ptosis, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 11-AUG-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not reported) and on 11-AUG-2009 was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # 661046/0381X). It was reported that the patient received her second dose of GARDASIL a year after her first dose and 3 days later she woke up with very dry eyes. The patient went to her eye doctor who informed that this is a common side effect with GARDASIL. The patient was now experiencing droopy eye/eyes. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning his daughter, an approximately 19 year old female patient who on 31-MAY-2007 was vaccinated with the first dose of GARDASIL in deltoid. The patient received the second dose on 20-MAR-2008, the third dose on 23-MAY-2008 and the fourth dose on 14-OCT-2008. The patient experienced pain and redness at injection site post vaccination. The patient sought unspecified medical attention. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: Information has been received from a 21 year old female patient with no known drug allergies and a history of ovarian cyst during pregnancy in October 2008 who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL. On 18-AUG-2009, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 18-AUG-2009, during night the patient experienced muscle aches, pain in her whole left arm where she received the 2nd dose, developed 102 F fever, nausea and her glands were swollen. The patient called the clinic and only spoke to her nurse but was schedule to see her midwife. The patient's muscle aches, pain in her whole left arm, 102 F fever, nausea and glands swollen persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Bronchitis, Drug exposure before pregnancy, Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 30 year old female patient with no pertinent medical history who on 04-NOV-2008 was vaccinated subcutaneously with the first 0.5 ml dose of GARDASIL (lot number 0947X). On 09-JAN-2009 the patient was vaccinated subcutaneously with the second 0.5 ml dose of GARDASIL (lot number 1423X). Concomitant therapy included prenatal vitamins. Subsequently the patient was pregnant. The last menstrual period (LMP) was approximately 14-FEB-2009. The estimated delivery date (EDD) was 21-NOV-2009. Unspecified medical attention was sought. A urine test was performed to confirm the pregnancy. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from the physician concerning the 30 year old female with a history of 1 pregnancy and 1 live birth and no birth defect or infant complications in previous pregnancy who was vaccinated with 2 doses of GARDASIL as previously reported. Concomitant therapy included prenatal vitamins. On an unspecified date, the patient experienced bronchitis and on 03-NOV-2009 was treated with KEFLEX 500mg daily for 10 days. There was no complication during pregnancy, labor. On 17-NOV-2009, the patient delivered a normal, healthy female baby weighing 8 pounds 12 ounces at 39th week. The baby's length was 20, Apgar score was normal. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Arthralgia, Blood test normal, Full blood count, Joint swelling
Clinical narrative: Information has been received from a medical assistant concerning her 18 year old daughter with Von Willebrand's disease and no known drug allergies who on 29-JAN-2007 was vaccinated with the first dose of GARDASIL (lot# 0011Y, valid for ROTATEQ 0.5ml, intramuscularly. On 26-MAR-2007 patient received the second dose of GARDASIL (lot# 0011Y, valid for ROTATEQ) 0.5ml intramuscularly, and on 05-AUG-2009 she received the third dose of GARDASIL (lot# 0073Y, valid for ROTATEQ) 0.5ml intramuscularly. Concomitant therapy included ORTHO-NOVUM. Patient did not receive any concomitant vaccinations when she received GARDASIL. In August 2008 (exact date not reported), the patient experienced hives intermittently in different locations ("she broke out in hives"). On 10-OCT-2008 the patient complained of joint pain in her arms. The joint pain went away and returned another time. The patient also complained of muscle spasm, severe joint pain and swelling, pain in her arms, shoulders, knees and legs with some outbreaks. During some of the outbreaks she is unable to walk without assistance. On 04-NOV-2008 the patient was seen by her physician, and had laboratory blood tests which revealed RA factor negative, SED rate 14, normal, CBC (results not reported). On 14-JAN-2009 the patient was seen one time by a rheumatologist. The patient was evaluated with no diagnosis. Rheumatologist was not able to determine the source of patient's symptoms. On 22-AUG-2009 the patient experienced bilateral hand to elbow pain and swelling. Patient had a scheduled appointment to see the physician (date not reported). At the time of this report the patient had not yet recovered but went back to school. This is one of two cases from the same source. Additional information has been requested.