chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination normal, No reaction on previous exposure to drug, Paraesthesia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history and no drug allergies, who on 11-MAR-2009 was vaccinated with her first dose of GARDASIL (0.5ml, IM, lot # 662404/0312Y) in the left arm. There was no concomitant medications. Two hours after the second vaccination, the patient developed dizziness, vomiting, numbness/tingling to the left arm and both legs. On 16-SEP-2009 the patient experienced numbness in her feet. There were no labs and diagnostic tests performed. No reports of adverse effects after the first vaccination. The patient made a phone call for medical attention. At the time of the report, the patient was not recovered. Follow up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who on 11-MAR-2009 at 9:30 am was vaccinated with the second dose of GARDASIL (lot # 662404/0312Y) IM in the left arm deltoid. The patient's mom called after the patient received injection and stated that her daughter was experienced dizziness, vomiting, headache and tingling of the left arm and both feet on 15-SEP-2009. The patient went to neurologist on 17-SEP-2009 for further evaluation, and her examination was negative. The Lyme's test was negative. The neurologist did consider Guillain-Barre syndrome because of symptoms. The outcome was not reported. Follow up information has been received on 10-MAR-2010 via a phone call from the medical assistant stated that after the patient had received the second dose of GARDASIL, she complained of headache, nausea and left upper extremity tingling. The medical assistant reported that the patient's "numbness improved". The patient was referred to a Neurologist for a Neurology evaluation. It was reported that the patient's father reportedly had a past history of Guillain-Barre syndrome, (GBS) "several years before". The neurologist documented that the patient's symptoms and neurology exam findings were not suggestive of GBS or Transverse Myelitis. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Corrective lens user, Fall, Laceration, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 14-SEP-2009 a 12 year old female patient with asthma was vaccinated with the second dose of GARDASIL (lot # not provided) on the right arm, the first dose of MENACTRA (Lot #U2919AA) on the left arm, and FLUZONE (Lot # U317615A) on the left arm. Concomitant therapy included VENTOLIN and montelukast sodium (MSD). Approximately one minute after administration, adolescent, while sitting down, had syncopal episode, landed face first on the floor, breaking glasses and causing 2 lacerations to the right eye between eyebrow and eyelid. Patient sought medical attention by going to the ER and had an eye exam and stitches. The original reporting source was not provided. The VAERS ID # is 358040. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Face injury, Fall, Ophthalmological examination, Skin laceration, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 14-SEP-2009 a 12 year old female patient with asthma was vaccinated with the second dose of GARDASIL (lot # not provided) on the right arm, the first dose of MENACTRA (Lot #U2919AA) on the left arm, and FLUZONE (Lot # U317615A) on the left arm. Concomitant therapy included VENTOLIN and montelukast sodium (MSD). Approximately one minute after administration, adolescent, while sitting down, had syncopal episode, landed face first on the floor, breaking glasses and causing 2 lacerations to the right eye between eyebrow and eyelid. Patient sought medical attention by going to the ER and had an eye exam and stitches. The original reporting source was not provided. The VAERS ID # is 358040. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Heart rate increased, Hypoaesthesia, Nervousness
Clinical narrative: Information has been received from a Licensed practical nurse concerning a 14 year old female patient with no drug reactions/allergies or pertinent medical history, who on 02-OCT-2009 was vaccinated with her first 0.5 ml dose of GARDASIL, intramuscularly (lot # 663454/0672Y). Concomitant therapy included BUSPAR. The nurse reported that the patient had been complaining of "hyperactivity, increased heart rate, dizziness, stomach aches, jumpy inside, numb and tingling of hands" after receiving her first dose of GARDASIL. At the time of the report the patient had not recovered. The patient called to the office. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Psychomotor hyperactivity
Clinical narrative: Information has been received from a Licensed practical nurse concerning a 14 year old female patient with no drug reactions/allergies or pertinent medical history, who on 02-OCT-2009 was vaccinated with her first 0.5 ml dose of GARDASIL, intramuscularly (lot # 663454/0672Y). Concomitant therapy included BUSPAR. The nurse reported that the patient had been complaining of "hyperactivity, increased heart rate, dizziness, stomach aches, jumpy inside, numb and tingling of hands" after receiving her first dose of GARDASIL. At the time of the report the patient had not recovered. The patient called to the office. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Migraine, Nausea, Photophobia
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 16 year old female with allergy to NAPROSYN who on 25-SEP-2009 was vaccinated with a second dose of GARDASIL. Concomitant therapy included oral contraceptives. On 25-SEP-2009, after 10 to 20 minutes after vaccination, the patient experienced migraine and photophobia. Unspecified medical attention was sought and no laboratory or diagnostic tests were performed. Subsequently, the patient recovered from migraine and photophobia. Follow up information has been received from a physician concerning the 16 year old female student who on 25-SEP-2009, at 11:00, developed instant headache within 10 minutes of getting vaccine. She also developed photophobia and nausea which consistent with migraine. The patient had no illness at time of vaccination. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Rash generalised, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with asthma and attention deficit/hyperactivity disorder and no drug reaction/allergies who on 10-AUG-2009 was vaccinated with the first dose of GARDASIL. On 07-OCT-2009 the patient received the second dose of GARDASIL (IM, 0.5ml). Concomitant therapy included albuterol, PROVENTIL, FLOVENT (MSD), FLUZONE. Information has been received from a nurse concerning a 12 year old female with asthma and attention deficit/hyperactivity disorder and no drug reaction/allergies who on 10-AUG-2009 was vaccinated with the first dose of GARDASIL. On 07-OCT-2009 the patient received the second dose of GARDASIL (IM, 0.5ml). Concomitant therapy included albuterol, PROVENTIL, FLOVENT, montelukast sodium (MSD) and VYVANSE. On 07-OCT-2009 within 15 minutes of the injection the patient developed a generalized rash throughout her body. The patient was given BENADRYL (dose not reported) in the office and was discharged from the office to home with her mother. The office called the patient's mother the following day and the rash had resolved. The mother stated to the nurse that the patient had a similar experience following her first dose of GARDASIL. At the time of the report, the patient had recovered on 08-OCT-2009. Follow-up information has been received from a registered nurse indicating that the 12 year old female with no illness at the time of vaccination had received the second dose of GARDASIL (LOT # 660612/0299X) on 07-OCT-2009 at 4:30PM IM into the right deltoid. Concomitant therapy included the first dose of MENACTRA and the first dose of FLUZONE both administered IM in the left deltoid. On 07-OCT-2009, the patient developed a generalized rash 15 minutes following the vaccination at 4:45PM. The patient denied itching, difficulty breathing or complaint. Fifty mg of BENADRYL was given and after 20 minutes observation, the patient's rash recovered. She was discharged with mother. There were no labs and diagnostic tests performed. The mother stated on 08-OCT-2009 at 13:30 that the rash had cleared, no problems. The patient was doing well. She recovered on 08-OCT-2009. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with doxycycline allergy and no pertinent medical history who on 05-OCT-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 0670Y) into the left deltoid. Concomitant therapy included NUVARING. On 13-OCT-2009 the inside of the patient's left arm felt like it was pulsating. The patient said that she could use her arm but it felt like it was "asleep". She called the office to seek some medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Follow up information has been received concerning the 24 year old female patient who on 13-OCT-2009 experienced pulsating feeling in the inside of her arm after the first vaccination with GARDASIL. There was no illness at time of vaccination. On 15-OCT-2009 the patient recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician assistant concerning a 14 year old female patient with no known drug reactions/allergies or pertinent medical history who on 14-JUL-2009 was vaccinated with her first dose of GARDASIL (lot number unknown). On 22-SEP-2009 the patient was vaccinated with the second dose of GARDASIL (LOT# 663573/0969Y) and at the same visit with influenza virus vaccine (unspecified) (manufacturer unknown). It was reported by the physician assistant that after the first vaccination with GARDASIL, in approximately July 2009, the patient experienced swelling of her lips and a rash on her face, forehead and arms that progressed over a couple of weeks and lasted about a month (until approximately August 2009). After the second dose, given on 22-SEP-2009, the patient on an unspecified date in September 2009, experience swelling of her lips. No lab tests were performed. The patient sought unspecified medical attention. The patient was prescribed BENADRYL. The physician assistant decided to discontinue the series. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Disorientation, Disturbance in attention, Feeling abnormal, Hypoaesthesia facial
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with no pertinent medical history and no known allergies who on 13-AUG-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 661046/0381X). Concomitant therapy included unspecified oral contraceptive. On 15-OCT-2009 the patient was vaccinated IM with the second dose of GARDASIL (lot number 661758/0968Y, the dose amount unspecified). The patient began feeling "funny" within one hour of receiving the second dose of vaccine. Within a few hours of vaccination, the patient became disoriented and experienced numbness to her face. She continued to experience numbness and also experienced lack of concentration and anxiety. On an unspecified date, the patient saw a neurologist. Unspecified blood test performed. A Magnetic Resonance Imaging (MRI) has scheduled for Friday 30-OCT-2009. At the time of the report, the patient had not recovered.  This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Face and mouth X-ray normal, Fall, Loss of consciousness, Muscle twitching, Skin laceration
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies who on 19-OCT-2009 was vaccinated with a first dose of GARDASIL (Lot No. 661046/0381X). Concomitant vaccination on the same day included a "flu shot" (Lot No. U3201AA). It was reported that the GARDASIL was given first, followed by the "flu shot". Subsequently, after the patient received the injections the patient fell and lacerated her chin. She also became unconscious at this time and experienced some twitching of her arms and legs which lasted only a few seconds. The patient was taken to the emergency room where X-Rays of the jaw and nose were taken, which revealed negative results. No electroencephalography (EEG) or computed axial tomography (CT) diagnostic studies were performed. The patient was not admitted for hospitalization. At the time of the report, the patient had recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Malaise
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. The physician reported that after received the second dose of GARDASIL the patient started to feel weak, dizzy and did not feel well. The patient stayed in the office for another 30 minutes and within that time frame the patient started to complain of an upset stomach. The physician reported that the patient went home after 30 minutes and had recovered. The patient did not received any other vaccines that day. Follow-up information was received from the physician who reported that a female patient on 23-SEP-2009 at 11:30 AM was vaccinated with the second dose of GARDASIL (lot # 663451/0216Y), intramuscularly in her right arm. On the same day, the patient received the first dose of influenza virus vaccine (unspecified) (lot # 97838P1), intramuscularly in her left arm. Ten minutes after the vaccines administered the patient experienced weakness, dizziness and abdominal discomfort. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Fatigue, Lymphadenopathy, Ultrasound scan
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient with asthma and allergy to KEFLEX who on 13-OCT-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot No. 662404/0312Y) in her left arm. Concomitant therapy included "birth control" (unspecified), iron, albuterol, ASMANEX and meloxicam. On 14-OCT-2009, the day after vaccination, the patient experienced swollen lymph nodes of the left neck and fatigue. She was treated elsewhere and was given an antibiotic (unspecified). An ultrasound of the left lymph nodes was performed with no results provided. It was reported that the swollen area never resolved. On 14-DEC-2009 the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot No. 665607/1332Y) in her left arm. Subsequently the patient called the physician's office and reported that the lymph node was "now worse". At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypoaesthesia, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 14 year old female student who on 06-NOV-2009 at 07:59 AM was vaccinated intramuscularly with the third dose of GARDASIL (lot# 0702X) in her left deltoid. At 15:00 on 06-NOV-2009 (also reported as 3-4 hours after receiving the injection), the patient complained of numbness in her left arm. The pain radiated to the shoulder. There was a local reaction to the area - red and swollen also complained and numbness and tingling. At the time of the rep ort, the patient had recovered at an unspecified date. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a 14 year old female student who on 06-NOV-2009 at 07:59 AM was vaccinated intramuscularly with the third dose of GARDASIL (lot# 0702X) in her left deltoid. At 15:00 on 06-NOV-2009 (also reported as 3-4 hours after receiving the injection), the patient complained of numbness in her left arm. The pain radiated to the shoulder. There was a local reaction to the area - red and swollen also complained and numbness and tingling. At the time of the rep ort, the patient had recovered at an unspecified date. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Headache, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 26 year old female with hypothyroidism on 18-MAY-2009, was vaccinated with the first dose of GARDASIL (lot # 661953/1130X) IM into her left leg. Concomitant therapy included LEVOXYL and ORTHO EVRA. No pre existing illness was reported. On 18-MAY-2009, the patient experienced headache and pain. The patient reported onset of headache at the same day first dose of GARDASIL was given. Pain lasted for one week and was relieved by taking OTC acetaminophen. The reporter considered the adverse events as non serious. NO further information is available. This was originally reported by a consumer. The VAERS ID # is 367899-1.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from a physician concerning a female patient "in her 20's" who in approximately May 2009, "about 6 months ago", was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. not reported). In 2009 after receiving her first dose the patient developed ankle and knee pain. The patient sought the attention of an acupuncturist. At the time of this report, the patient had not recovered. On 13-NOV-2009, follow up information was received from the physician's office receptionist who indicated that the patient was seen in the physician's office on 22-APR-2009 and offered no complaints. No notation of joint pain or muscle aches was listed in the patient's chart. On 17-JUL-2009 the patient was seen again at the physician's office and her evaluation was listed as "normal" and there was no documentation of complaints of joint or muscle pain. On 14-OCT-2009 the patient was administered her third dose of GARDASIL. There was nothing listed in the patient's chart at that time about joint or muscle pain, the progress note stated that the patient "offered no complaints". On 09-NOV-2009 the patient called the office and reported that she had searched on the internet for "side effects" of GARDASIL and then reported the muscle and joint pain. The receptionist also noted that nowhere in the patient's chart was any documentation that she had been disabled in any way and there was no notation of treatment of any kind for the joint or muscle pain. Follow up information was received from the physician on 16-NOV-2009. The physician indicated that the patient with headaches, anxiety, depression, irritable bowel syndrome and allergy to sulfa on 15-APR-2009 was vaccinated with a first 0.5 ml IM dose of GARDASIL (Lot No. 661952/1129X), a second dose (Lot No. 662300/0100Y) on 15-JUN-2009 and a third dose (663452/0671Y) on 14-OCT-2009. Concomitant therapy included NUVARING and WELLBUTRIN. There was no concomitant vaccination. The patient reported to the physician on 09-NOV-2009, that "ever since first shot" on 15-APR-2009 she experienced joint and muscle aches. The patient saw her primary care physician on 11-NOV-2009 (no further information provided). This is one of two reports received from the same source. Muscle aches and joint pain were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female patient with no pertinent medical history and no known allergies who on 23-NOV-2009 was vaccinated IM in the left upper deltoid with the first 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. Subsequently on an unspecified date the patient experienced numbness, tingling and pain from her toes on her left foot to her left leg after administration of vaccine. The patient stated that her whole left side went numb. Medical attention was sought via telephone. There was no lab studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Erythema, Pruritus, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no known drug allergies who on 03-AUG-2009 was vaccinated with the first dose of GARDASIL. The patient experienced a fever after the first vaccination. On 01-DEC-2009, the patient was vaccinated with the second dose of GARDASIL. No lot number was given. After the second vaccination the patient experienced a fever and itching, red, swollen blisters all over her body. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of the report, the patient recovered on an unspecified date. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Grip strength decreased, Injection site pain, Muscular weakness, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL. Within 1 to 2 days of vaccination the patient developed pain radiating down to her right hand, swelling of her fingers and weakness in her right hand. On an unspecified date, the patient recovered but would not receive further doses. The patient sought unspecified medical attention. Follow up information has been received from the Registered Nurse who reported that the 18 year old female student with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination, was vaccinated intramuscularly in the right deltoid with the second dose of GARDASIL (lot # 663454/0672Y) on 08-DEC-2009 at 10:30. Concomitant therapy included ADDERALL XR. The patient had not experienced any adverse reaction following prior vaccination. It was reported that the same day approximately 7-8 hour after administration (also reported as beginning at 17:00), the patient developed pain radiating down right arm from injection site, with the fingers of the right hand becoming swollen. As of 22-DEC-2009 swelling persisted, with decreased strength of hand. The hand returned to normal on 23-DEC-2009 but the patient still had pain in upper arm at site of injection. No laboratory diagnostic studies were performed. No further information is available.
Age: 18.0
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 intramuscularly with the second 0.5 ml dose of GARDASIL. Within 1 to 2 days of vaccination the patient developed pain radiating down to her right hand, swelling of her fingers and weakness in her right hand. On an unspecified date, the patient recovered but would not receive further doses. The patient sought unspecified medical attention. Follow up information has been received from the Registered Nurse who reported that the 18 year old female student with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination, was vaccinated intramuscularly in the right deltoid with the second dose of GARDASIL (lot # 663454/0672Y) on 08-DEC-2009 at 10:30. Concomitant therapy included ADDERALL XR. The patient had not experienced any adverse reaction following prior vaccination. It was reported that the same day approximately 7-8 hour after administration (also reported as beginning at 17:00), the patient developed pain radiating down right arm from injection site, with the fingers of the right hand becoming swollen. As of 22-DEC-2009 swelling persisted, with decreased strength of hand. The hand returned to normal on 23-DEC-2009 but the patient still had pain in upper arm at site of injection. No laboratory diagnostic studies were performed. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with no known drug reactions/allergies and no pertinent medical history who on 23-OCT-2009 was vaccinated with her second dose of GARDASIL (Lot # 663558/0819Y) in her left arm.  Concomitant therapy included WELLBUTRIN.  It was reported that the night of 23-OCT-2009, the patient went to the emergency room because she was experiencing swelling, numbness, redness, she had to walk with her hand up in the air because her arm and hand were pounding when at her side, and she could not close her hand.  The consumer reported that on 23-OCT-2009 the emergency room sent her home and told her that if it was still bothering her to come back the next night.  Then on 24-OCT-2009 the patient went back to the emergency room and stated that she was experiencing neuropathy and that they were "watching her for the onset of Guillain-Barre".  The consumer also reported that the patient was put on a round of steroids (name and manufacturer unspecified) and it took two weeks for her to recover.  There were no diagnostic tests performed.  It was reported that therapy with GARDASIL was stopped and not reintroduced.  Follow up information has been received from the medical assistant and the physician's office administrator.  The medical assistant, who was able to access the patient's chart and stated that the patient's first dose of GARDASIL was given on 24-AUG-2009 (Lot # 663453/0249Y).  There was no notation in the patient's chart that she had any issues following this injection.  The second dose of GARDASIL (Lot # 663558/0819Y) was given on 23-OCT-2009.  The medical assistant was unable to provide more information.  The office administrator indicated after the second dose of GARDASIL the patient experienced swelling, pain, numbness and redness in her left arm in the evening after her injection.  The patient was evaluated in the ER and was treated with oral steroids and released.  The office administrator stated that there was no notation in the chart that the patient had been admitted to the hospital.  A note in the patient's chart indicated that she was told by the ER staff that her reaction were more likely due to nerve injury rather than an allergic reaction to the GARDASIL injection.  The patient refused to GARDASIL third dose.  The patient was seen in the physician's office on 04-DEC-2009.  There was no mention of Guillain-barre or a neurology consult in the patient's chart.  It was also reported that the patient had not reported anything about Guillain-Barre to them and therefore had no idea how or when it was discussed with the patient or if she had any follow-up as a result of it.  There was nothing in the patient's chart that indicated that her experiences were disabling in anyway.  The administrator further reported that the note in the patient's chart from 04-DEC-2009 suggested a follow up visit with their office in 3 months time.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Hypoaesthesia, Hypokinesia, Nerve injury, Neuropathy peripheral
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with no known drug reactions/allergies and no pertinent medical history who on 23-OCT-2009 was vaccinated with her second dose of GARDASIL (Lot # 663558/0819Y) in her left arm.  Concomitant therapy included WELLBUTRIN.  It was reported that the night of 23-OCT-2009, the patient went to the emergency room because she was experiencing swelling, numbness, redness, she had to walk with her hand up in the air because her arm and hand were pounding when at her side, and she could not close her hand.  The consumer reported that on 23-OCT-2009 the emergency room sent her home and told her that if it was still bothering her to come back the next night.  Then on 24-OCT-2009 the patient went back to the emergency room and stated that she was experiencing neuropathy and that they were "watching her for the onset of Guillain-Barre".  The consumer also reported that the patient was put on a round of steroids (name and manufacturer unspecified) and it took two weeks for her to recover.  There were no diagnostic tests performed.  It was reported that therapy with GARDASIL was stopped and not reintroduced.  Follow up information has been received from the medical assistant and the physician's office administrator.  The medical assistant, who was able to access the patient's chart and stated that the patient's first dose of GARDASIL was given on 24-AUG-2009 (Lot # 663453/0249Y).  There was no notation in the patient's chart that she had any issues following this injection.  The second dose of GARDASIL (Lot # 663558/0819Y) was given on 23-OCT-2009.  The medical assistant was unable to provide more information.  The office administrator indicated after the second dose of GARDASIL the patient experienced swelling, pain, numbness and redness in her left arm in the evening after her injection.  The patient was evaluated in the ER and was treated with oral steroids and released.  The office administrator stated that there was no notation in the chart that the patient had been admitted to the hospital.  A note in the patient's chart indicated that she was told by the ER staff that her reaction were more likely due to nerve injury rather than an allergic reaction to the GARDASIL injection.  The patient refused to GARDASIL third dose.  The patient was seen in the physician's office on 04-DEC-2009.  There was no mention of Guillain-barre or a neurology consult in the patient's chart.  It was also reported that the patient had not reported anything about Guillain-Barre to them and therefore had no idea how or when it was discussed with the patient or if she had any follow-up as a result of it.  There was nothing in the patient's chart that indicated that her experiences were disabling in anyway.  The administrator further reported that the note in the patient's chart from 04-DEC-2009 suggested a follow up visit with their office in 3 months time.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with no known drug reactions/allergies and no pertinent medical history who on 23-OCT-2009 was vaccinated with her second dose of GARDASIL (Lot # 663558/0819Y) in her left arm.  Concomitant therapy included WELLBUTRIN.  It was reported that the night of 23-OCT-2009, the patient went to the emergency room because she was experiencing swelling, numbness, redness, she had to walk with her hand up in the air because her arm and hand were pounding when at her side, and she could not close her hand.  The consumer reported that on 23-OCT-2009 the emergency room sent her home and told her that if it was still bothering her to come back the next night.  Then on 24-OCT-2009 the patient went back to the emergency room and stated that she was experiencing neuropathy and that they were "watching her for the onset of Guillain-Barre".  The consumer also reported that the patient was put on a round of steroids (name and manufacturer unspecified) and it took two weeks for her to recover.  There were no diagnostic tests performed.  It was reported that therapy with GARDASIL was stopped and not reintroduced.  Follow up information has been received from the medical assistant and the physician's office administrator.  The medical assistant, who was able to access the patient's chart and stated that the patient's first dose of GARDASIL was given on 24-AUG-2009 (Lot # 663453/0249Y).  There was no notation in the patient's chart that she had any issues following this injection.  The second dose of GARDASIL (Lot # 663558/0819Y) was given on 23-OCT-2009.  The medical assistant was unable to provide more information.  The office administrator indicated after the second dose of GARDASIL the patient experienced swelling, pain, numbness and redness in her left arm in the evening after her injection.  The patient was evaluated in the ER and was treated with oral steroids and released.  The office administrator stated that there was no notation in the chart that the patient had been admitted to the hospital.  A note in the patient's chart indicated that she was told by the ER staff that her reaction were more likely due to nerve injury rather than an allergic reaction to the GARDASIL injection.  The patient refused to GARDASIL third dose.  The patient was seen in the physician's office on 04-DEC-2009.  There was no mention of Guillain-barre or a neurology consult in the patient's chart.  It was also reported that the patient had not reported anything about Guillain-Barre to them and therefore had no idea how or when it was discussed with the patient or if she had any follow-up as a result of it.  There was nothing in the patient's chart that indicated that her experiences were disabling in anyway.  The administrator further reported that the note in the patient's chart from 04-DEC-2009 suggested a follow up visit with their office in 3 months time.  Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea, Urticaria, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 27 year old female patient with asthma and allergy to peanut and grass who on 17-NOV-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). On 18-NOV-2009 the patient developed vomiting and hives. There was no reaction to the first 2 doses. It was unknown if medical attention was sought. There were no lab studies performed. Subsequently, the patient recovered from vomiting and hives. Follow-up information has been received from the nurse practitioner concerning the 27 year old female with allergy to peanut and grass and no illness at the time of vaccination who on 17-NOV-2009, at 13:30 was vaccinated with the third dose of GARDASIL (lot number 663558/0819Y). The day after vaccination, on 18-NOV-2009, the patient called the nurse practitioner and reported that she woke up nauseated, then vomited and lightheaded. Later in day she developed hives on her arms and thighs. By the time she called the nurse practitioner (15:15), most of the symptoms were resolving. The patient was advised to take BENADRYL. There were no lab studies performed. At the time of the report, the  patient had recovered (date unspecified). Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea, No reaction on previous exposure to drug, Urticaria, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 27 year old female patient with asthma and allergy to peanut and grass who on 17-NOV-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). On 18-NOV-2009 the patient developed vomiting and hives. There was no reaction to the first 2 doses. It was unknown if medical attention was sought. There were no lab studies performed. Subsequently, the patient recovered from vomiting and hives. Follow-up information has been received from the nurse practitioner concerning the 27 year old female with allergy to peanut and grass and no illness at the time of vaccination who on 17-NOV-2009, at 13:30 was vaccinated with the third dose of GARDASIL (lot number 663558/0819Y). The day after vaccination, on 18-NOV-2009, the patient called the nurse practitioner and reported that she woke up nauseated, then vomited and lightheaded. Later in day she developed hives on her arms and thighs. By the time she called the nurse practitioner (15:15), most of the symptoms were resolving. The patient was advised to take BENADRYL. There were no lab studies performed. At the time of the report, the  patient had recovered (date unspecified). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Chills, Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 26-JAN-2010 was vaccinated with the third dose of GARDASIL (lot # 662304/1013Y). The patient received the same lot # 662304/1013Y for her second dose. On 27-JAN-2010 by 1:00 AM, the patient had fever of 101.4, chills and nausea. The physician reported that the patient called the office and came into the office on 27-JAN-2010. On 27-JAN-2010 the patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Chills, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 26-JAN-2010 was vaccinated with the third dose of GARDASIL (lot # 662304/1013Y). The patient received the same lot # 662304/1013Y for her second dose. On 27-JAN-2010 by 1:00 AM, the patient had fever of 101.4, chills and nausea. The physician reported that the patient called the office and came into the office on 27-JAN-2010. On 27-JAN-2010 the patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Loss of consciousness, Nervousness, Tremor
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no known drug reactions/allergies and no pertinent medical history who in July 2009, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL and in September 2009 and December 2009 was vaccinated with her second and third dose of GARDASIL respectively. There was no concomitant medication. It was reported that the patient developed headaches, fatigue, nausea and "feeling winded" after receiving the first dose of GARDASIL. Then, the patient developed left sided tremors after receiving her second dose of GARDASIL. The patient was evaluated by an unspecified physician and had toxicology testing, complete blood count and metabolic panel. The testing was normal. The patient was prescribed an unspecified sedative medication and the tremors had improved. The patient sought medical attention by an office visit. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Fatigue, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no known drug reactions/allergies and no pertinent medical history who in July 2009, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL and in September 2009 and December 2009 was vaccinated with her second and third dose of GARDASIL respectively. There was no concomitant medication. It was reported that the patient developed headaches, fatigue, nausea and "feeling winded" after receiving the first dose of GARDASIL. Then, the patient developed left sided tremors after receiving her second dose of GARDASIL. The patient was evaluated by an unspecified physician and had toxicology testing, complete blood count and metabolic panel. The testing was normal. The patient was prescribed an unspecified sedative medication and the tremors had improved. The patient sought medical attention by an office visit. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Toxicologic test normal, Tremor
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no known drug reactions/allergies and no pertinent medical history who in July 2009, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL and in September 2009 and December 2009 was vaccinated with her second and third dose of GARDASIL respectively. There was no concomitant medication. It was reported that the patient developed headaches, fatigue, nausea and "feeling winded" after receiving the first dose of GARDASIL. Then, the patient developed left sided tremors after receiving her second dose of GARDASIL. The patient was evaluated by an unspecified physician and had toxicology testing, complete blood count and metabolic panel. The testing was normal. The patient was prescribed an unspecified sedative medication and the tremors had improved. The patient sought medical attention by an office visit. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MMR, VARCEL
Symptoms: Fall, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history and no drug reactions/allergies who "last year" was vaccinated with the first 0.5 mL dose of GARDASIL. On 01-MAR-2010, the patient was vaccinated with a fourth 0.5mL dose of GARDASIL. Secondary suspect vaccinations administered on the same day at the same time included a dose of MMR II (MSD) and a dose of VARIVAX (MSD) (duration and dose not reported). No lot numbers were provided. On 01-MAR-2010 the patient fainted after receiving the vaccine. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient was recovering. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history and no drug reactions/allergies who "last year" was vaccinated with the first 0.5 mL dose of GARDASIL. On 01-MAR-2010, the patient was vaccinated with a fourth 0.5mL dose of GARDASIL. Secondary suspect vaccinations administered on the same day at the same time included a dose of MMR II (MSD) and a dose of VARIVAX (MSD) (duration and dose not reported). No lot numbers were provided. On 01-MAR-2010 the patient fainted after receiving the vaccine. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient was recovering. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MMR, VARCEL
Symptoms: Incorrect dose administered, Syncope
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history and no drug reactions/allergies who "last year" was vaccinated with the first 0.5 mL dose of GARDASIL. On 01-MAR-2010, the patient was vaccinated with a fourth 0.5mL dose of GARDASIL. Secondary suspect vaccinations administered on the same day at the same time included a dose of MMR II (MSD) and a dose of VARIVAX (MSD) (duration and dose not reported). No lot numbers were provided. On 01-MAR-2010 the patient fainted after receiving the vaccine. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient was recovering. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Alopecia, Amnesia, Autoimmune disorder, Blood test, Chest pain
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no known drug reactions or allergies or pertinent medical history who in March 2009, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  One or two weeks after received the first dose of GARDASIL, in approximately March 2009, the patient experienced nausea, stomach ache, dizziness, fatigue, headaches and neck pain.  It was noted that these adverse events never improved.  In May 2009, the patient was vaccinated with the second dose of GARDASIL.  One or two weeks after received the second dose of GARDASIL, in approximately May 2009, the patient experienced memory loss, irregular periods, back aches, pain in her muscles and weight loss.  In June 2009, the patient tested positive to H. pylori, Epstein-Barr virus and Scleroderma.  In November 2009, the patient was vaccinated with the third dose of GARDASIL.  One or two weeks after received the third dose of GARDASIL, in approximately November 2009, the patient experienced hair loss and developed allergies to milk, nuts and wheat.  At the time of the report the patient had not recovered for any of the events.  The patient had an endoscopy performed, a blood work and a electroencephalogram (EEG) (results not provided).  The patient sought medical attention at the doctors office.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Electroencephalogram, Endoscopy, Fatigue, Headache
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no known drug reactions or allergies or pertinent medical history who in March 2009, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  One or two weeks after received the first dose of GARDASIL, in approximately March 2009, the patient experienced nausea, stomach ache, dizziness, fatigue, headaches and neck pain.  It was noted that these adverse events never improved.  In May 2009, the patient was vaccinated with the second dose of GARDASIL.  One or two weeks after received the second dose of GARDASIL, in approximately May 2009, the patient experienced memory loss, irregular periods, back aches, pain in her muscles and weight loss.  In June 2009, the patient tested positive to H. pylori, Epstein-Barr virus and Scleroderma.  In November 2009, the patient was vaccinated with the third dose of GARDASIL.  One or two weeks after received the third dose of GARDASIL, in approximately November 2009, the patient experienced hair loss and developed allergies to milk, nuts and wheat.  At the time of the report the patient had not recovered for any of the events.  The patient had an endoscopy performed, a blood work and a electroencephalogram (EEG) (results not provided).  The patient sought medical attention at the doctors office.  No further information is available.