chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood iron decreased, Drug exposure during pregnancy, Flank pain, Foetal disorder
Clinical narrative: Information has been received from an emergency medical technician, for GARDASIL a Pregnancy Registry product, concerning an approximately 26 year old female smoker patient with allergy to BENADRYL. The patient had a miscarriage in 2001 (reason unknown). In 2003 the patient delivered a male baby of low birth weight, otherwise healthy. In 2008 the patient delivered a baby boy of low birth weight (6 lbs, 8 oz), the delivery was induced at 38 weeks due to decreased fetal movements. Decreased fetal movement was note throughout the pregnancy in 2008. The patient also had documented poor maternal weight gain during the 2008 pregnancy. Family history included down syndrome and sister had cerebral palsy. On 03-NOV-2008 the patient was vaccinated IM with a 0.5 ml first dose of GARDASIL (660616/0570X). On 02-JAN-2009 the patient was vaccinated with the second dose of GARDASIL (lot number 661531/1311X). Concomitant therapy included LOESTRIN. The reporter stated that the patient returned to the office in May for her third dose and it was discovered that she was pregnant. The third dose was not given. Her LMP was on 17-FEB-2009. Expected date of delivery is approximately 24-NOV-2009. The reported stated "the patient is a seriously unhealthy person. She is a smoker and has been smoking throughout the pregnancy". The patient was seen in June 2009 for complains of left flank pain and first trimester bleeding. In July 2009 she complained of abdominal pain. She was now experiencing third trimester spotting and was having decreased fetal movements that was due to the smoking. Again she had poor maternal weight gain. Laboratory tests included: prenatal blood work completed results: iron was low; ultrasounds: "measuring smaller than dates". At the time of the report the status of the patient was unspecified. The patient sought medical attention by office visit. Follow up information has been received from an emergency medical technician who reported that the patient's LMP was more than one month after she received her second dose of GARDASIL. The reporter stated that the patient's last menstrual period was "not even in February, it was later than that" and that the patient had a history of irregular periods. The patient had not taken all her birth control pills and that the patient had some other prior health related problems and was a heavy smoker. Because of the dates of her LMP the patient was not enrolled in the Pregnancy Registry as she did not meet the dating criteria. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal condition affecting foetus, Ultrasound scan abnormal, Vaginal haemorrhage, Weight gain poor
Clinical narrative: Information has been received from an emergency medical technician, for GARDASIL a Pregnancy Registry product, concerning an approximately 26 year old female smoker patient with allergy to BENADRYL. The patient had a miscarriage in 2001 (reason unknown). In 2003 the patient delivered a male baby of low birth weight, otherwise healthy. In 2008 the patient delivered a baby boy of low birth weight (6 lbs, 8 oz), the delivery was induced at 38 weeks due to decreased fetal movements. Decreased fetal movement was note throughout the pregnancy in 2008. The patient also had documented poor maternal weight gain during the 2008 pregnancy. Family history included down syndrome and sister had cerebral palsy. On 03-NOV-2008 the patient was vaccinated IM with a 0.5 ml first dose of GARDASIL (660616/0570X). On 02-JAN-2009 the patient was vaccinated with the second dose of GARDASIL (lot number 661531/1311X). Concomitant therapy included LOESTRIN. The reporter stated that the patient returned to the office in May for her third dose and it was discovered that she was pregnant. The third dose was not given. Her LMP was on 17-FEB-2009. Expected date of delivery is approximately 24-NOV-2009. The reported stated "the patient is a seriously unhealthy person. She is a smoker and has been smoking throughout the pregnancy". The patient was seen in June 2009 for complains of left flank pain and first trimester bleeding. In July 2009 she complained of abdominal pain. She was now experiencing third trimester spotting and was having decreased fetal movements that was due to the smoking. Again she had poor maternal weight gain. Laboratory tests included: prenatal blood work completed results: iron was low; ultrasounds: "measuring smaller than dates". At the time of the report the status of the patient was unspecified. The patient sought medical attention by office visit. Follow up information has been received from an emergency medical technician who reported that the patient's LMP was more than one month after she received her second dose of GARDASIL. The reporter stated that the patient's last menstrual period was "not even in February, it was later than that" and that the patient had a history of irregular periods. The patient had not taken all her birth control pills and that the patient had some other prior health related problems and was a heavy smoker. Because of the dates of her LMP the patient was not enrolled in the Pregnancy Registry as she did not meet the dating criteria. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female with no medical history and AUGMENTIN, ibuprofen, penicillin and CECLOR allergies who on 07-DEC-2009 was vaccinated with the first dose of GARDASIL (lot# 663452/0671Y). There was no concomitant medication. The patient developed hives covering her whole body except at the injection site after vaccination with her first dose of vaccine. The patient had been prescribed BENADRYL. At the time of report the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Information has been received from a 24 year old female with allergy to penicillin and without a pertinent medical history who 20-APR-2009 was vaccinated with the first dose of GARDASIL (Lot # was not provided). On 20-JUN-2009, the patient was vaccinated with the second dose of GARDASIL. The patient did not experience any AE after first or second dose. On 09-NOV-2009, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml (lot number was not provided). There was no concomitant medication. The reporter mentioned that on 09-NOV-2009 she experienced headache, dizziness, lost of appetite, nausea and she felt very tired after getting the third dose of GARDASIL. No laboratory or test diagnostics were performed. The patient sought a physician for medical attention. At the time of reporting the patient had not recovered. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Information has been received from a 24 year old female with allergy to penicillin and without a pertinent medical history who 20-APR-2009 was vaccinated with the first dose of GARDASIL (Lot # was not provided). On 20-JUN-2009, the patient was vaccinated with the second dose of GARDASIL. The patient did not experience any AE after first or second dose. On 09-NOV-2009, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml (lot number was not provided). There was no concomitant medication. The reporter mentioned that on 09-NOV-2009 she experienced headache, dizziness, lost of appetite, nausea and she felt very tired after getting the third dose of GARDASIL. No laboratory or test diagnostics were performed. The patient sought a physician for medical attention. At the time of reporting the patient had not recovered. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a nurse, fro the Pregnancy Registry for GARDASIL, concerning a 25 year old female with no pertinent medical history who on 24-MAR-2009 was vaccinated with a first IM 0.5 ml dose of GARDASIL (Lot No. 661846/1312X) and a second IM 0.5 ml dose (658271/0058X) on 26-MAY-2009. There was no concomitant medication. It was reported that on 24-JUN-2009 the patient found out she was pregnant. On 25-JUN-2009 the patient had an ultrasound (results not provided). The nurse reported the fetus was underweight. Patient was having another ultrasound scheduled on 01-DEC-2009. The patient sought medical attention by an office visit. At the time of the report, the outcome of the fetus was unknown. The mother's experience has been captured in WAES# 0911USA04741. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL. Subsequently the patient experienced joint and muscle aches. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Wart excision
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 33 year old female patient who on 19-AUG-2009 was vaccinated with the first 0.5 ml doe of GARDASIL (lot # 0670Y). Subsequently, the patient was diagnosed with a single, pinpoint condyloma on the perineum on 20-OCT-2009. The condyloma was excised in the office on that date. Since July 2009 the patient had a new sexual partner. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow up information has been received from the physician concerning the 33 year old female patient with no illness at the time of vaccination and no known allergies, birth defects or medical conditions reported, who on 19-AUG-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (route unknown, lot # 0670Y) at the private doctor's office with private funds. The physician reported that the patient broke out with condyloma shortly after GARDASIL. The physician stated that it was confirmed Condyloma acuminatum on 20-OCT-2009. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Blood thyroid stimulating hormone, Dizziness, Fatigue
Clinical narrative: Information has been received from a nurse who talked to the mother of a 15 year old female patient with no pertinent medical history and no known drug allergies who on 18-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# not provided). There was no concomitant medication. On approximately 18-APR-2009 ("a month after receiving the first dose of GARDASIL") the patient experienced rashes on her legs, headache, swollen glands, joint pain, dizziness, vomiting, nausea, she fainted at school a couple of times, redness and swelling at injection site, muscle aches and abdominal pain. Therapy with human papillomavirus vaccine was discontinued. Patient sought medical attention via a nurse practitioner and lab diagnostics tests were performed. At the time of this report, the patient had not recovered. Follow-up information has been received from a registered nurse who reported that the patient is white, weighs 122 pounds and is 64.25 inches tall. Patient had received the first dose of GARDASIL (lot# 661703/0651X) intramuscularly on the left deltoid. Patient also experienced fatigue and the syncope episode occurred on 23-SEP-2009. On 24-SEP-2009 patient had the following labs performed: CMC, BMP, TSH (results not provided). At the time of this report the patient's outcome was unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site erythema, Injection site swelling, Lymphadenopathy, Metabolic function test
Clinical narrative: Information has been received from a nurse who talked to the mother of a 15 year old female patient with no pertinent medical history and no known drug allergies who on 18-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# not provided). There was no concomitant medication. On approximately 18-APR-2009 ("a month after receiving the first dose of GARDASIL") the patient experienced rashes on her legs, headache, swollen glands, joint pain, dizziness, vomiting, nausea, she fainted at school a couple of times, redness and swelling at injection site, muscle aches and abdominal pain. Therapy with human papillomavirus vaccine was discontinued. Patient sought medical attention via a nurse practitioner and lab diagnostics tests were performed. At the time of this report, the patient had not recovered. Follow-up information has been received from a registered nurse who reported that the patient is white, weighs 122 pounds and is 64.25 inches tall. Patient had received the first dose of GARDASIL (lot# 661703/0651X) intramuscularly on the left deltoid. Patient also experienced fatigue and the syncope episode occurred on 23-SEP-2009. On 24-SEP-2009 patient had the following labs performed: CMC, BMP, TSH (results not provided). At the time of this report the patient's outcome was unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Rash, Syncope, Vomiting
Clinical narrative: Information has been received from a nurse who talked to the mother of a 15 year old female patient with no pertinent medical history and no known drug allergies who on 18-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# not provided). There was no concomitant medication. On approximately 18-APR-2009 ("a month after receiving the first dose of GARDASIL") the patient experienced rashes on her legs, headache, swollen glands, joint pain, dizziness, vomiting, nausea, she fainted at school a couple of times, redness and swelling at injection site, muscle aches and abdominal pain. Therapy with human papillomavirus vaccine was discontinued. Patient sought medical attention via a nurse practitioner and lab diagnostics tests were performed. At the time of this report, the patient had not recovered. Follow-up information has been received from a registered nurse who reported that the patient is white, weighs 122 pounds and is 64.25 inches tall. Patient had received the first dose of GARDASIL (lot# 661703/0651X) intramuscularly on the left deltoid. Patient also experienced fatigue and the syncope episode occurred on 23-SEP-2009. On 24-SEP-2009 patient had the following labs performed: CMC, BMP, TSH (results not provided). At the time of this report the patient's outcome was unknown. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Chest pain, Dyspnoea, Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who was vaccinated on an unspecified date with her second dose of with GARDASIL. The physician stated that her patient had an "acute pain, chest pain and pain in her body" immediately after the vaccine was given. It was reported that the vaccine was given by the patient's pediatrician (name unspecified) but the patient is now seeing her family physician (the reporter). On 23-SEP-2009 the patient was seeing by her family physician that placed the patient on anti-inflammatory medication (name unspecified) and was sent to home). The reporter informed that on 16-OCT-2009 the patient came back to the office with "body aches, headaches and shortness of breath". A blood test was done at this time and the patient continued anti-inflammatory medication. Also was reported that on 19-OCT-2009 the patient had the same complaints including malaise and the blood work was all found to be normal. The reporter mentioned that the patient was placed on prednisone and was sent to home. No adverse events were reported after the first dose of GARDASIL was given. The patient sought medical attention in office visit. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, No reaction on previous exposure to drug, Pain
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who was vaccinated on an unspecified date with her second dose of with GARDASIL. The physician stated that her patient had an "acute pain, chest pain and pain in her body" immediately after the vaccine was given. It was reported that the vaccine was given by the patient's pediatrician (name unspecified) but the patient is now seeing her family physician (the reporter). On 23-SEP-2009 the patient was seeing by her family physician that placed the patient on anti-inflammatory medication (name unspecified) and was sent to home). The reporter informed that on 16-OCT-2009 the patient came back to the office with "body aches, headaches and shortness of breath". A blood test was done at this time and the patient continued anti-inflammatory medication. Also was reported that on 19-OCT-2009 the patient had the same complaints including malaise and the blood work was all found to be normal. The reporter mentioned that the patient was placed on prednisone and was sent to home. No adverse events were reported after the first dose of GARDASIL was given. The patient sought medical attention in office visit. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female patient with no pertinent medical history and no drug reaction/allergies who on 30-NOV-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 663453/0249Y). There was no concomitant medication. On 30-NOV-2009 the patient experienced headache, dizziness. She had taking SINUS EXCEDRIN which temporarily helped the headaches. Medical assistant also mentioned that when the patient initially received GARDASIL she complained of pain with the injection. The patient had called the office this morning to seek medical attention. There were no lab diagnostic tests performed. Patient had recovered from the arm pain but not the headache and dizziness. Additional information had been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient who on 25-NOV-2009 was vaccinated with the first dose of GARDASIL. On 25-NOV-2009 afternoon, the patient called the office and stated that she was having a vaginal discharge. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown) and experienced sweating and fainted at the physician's office. At the time of this report the patient's outcome was unknown. Follow up information has been received concerning the 12 year old female patient with no illness at the time of vaccination and with no known drug allergies, who on 03-AUG-2009 was vaccinated with the first dose of GARDASIL intramuscularly into her right upper extremity (lot # 662518/0087Y) at the private doctor's office/hospital with private funds at 12:30. It was reported that on 03-AUG-2009 the patient received the vaccine in the exam room, then walked to their checkout desk where she stood for approximately 3-4 minutes and then she lost consciousness and felt backwards. The patient was taken back to room and was placed O2 via nasal cannula, she stayed there until she fully recovered on 03-AUG-2009. This is one of several reports from the same source. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced irregular bleeding and decided not to complete the series of injections. At the time of the report the status of the patient was unspecified. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with no drug reactions/allergies and no pertinent medical history who was vaccinated with the first dose of GARDASIL on 15-OCT-2009. There were no concomitant medications. The patient was several days later in her menstrual cycle. The patient's last menstruation period was 28-SEP-2009. The patient had sought medical attention by phone call. There were no lab diagnostic studies performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first and second dose of GARDASIL. After receiving the first and second vaccines, the patient had a swollen neck. the patient would not be finishing the series. The patient had made phone call for medical attention. At the time of reporting, the patient recovered from swollen neck. Additional information has been requested. This is one of several reports from the same source.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient who in October 2008 and December 2008 was vaccinated with the first and second dose of GARDASIL. Both times after receiving the vaccine the patient had vaginal discharge that went away in about a week. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, No reaction on previous exposure to drug, Pain, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the second dose of GARDASIL vaccine on an unspecified date. Subsequently the patient experienced a rash all over the body. "The palms and soles of the feet were really bad and throbbing. Rash and throbbing went away after 48 hours." The patient did not have any problems after the first dose. At the time of the report, the patient had recovered on an unspecified date. Follow up information has been received from a nurse concerning a 23 year old female patient with allergy of clonidine patch allergy and no illness at time of vaccination who on 15-OCT-2009 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 663454/0672Y) in right deltoid. In the morning of 17-OCT-2009 the patient called the office reported the on 16-OCT-2009 she experienced total body rash, palms of hands and feet burning. No medical attention had been sought. No relevant diagnostic test or laboratory test was performed. On 20-OCT-2009 the patient reported that complaint ceased after 48 hours. on 18-OCT-2009 the patient was recovered. No further information is expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Blood bilirubin increased, Blood immunoglobulin M, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who 10 days ago, on 13-OCT-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant vaccine therapy on the same day included a dose of FLUZONE. On 22-OCT-2009 the patient developed an urticarial/vasculitis like rash only on her palms and soles of her feet, she also developed a headache and fever. Medical attention was sought, the patient visited the physician's office. It was unspecified if there were lab studies performed. The patient took ibuprofen for the fever and headache and BENADRYL for the rash with no response. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician's medical records concerning the 14 year old female patient had no illness at the time of vaccination who on 13-OCT-2009 at 15:00 pm was vaccinated IM in the left arm with the third dose of GARDASIL (lot number 660393/0067X). The patient developed cervicalgia/vasculitis rash itchy and throbbing on her palms and soles. The patient had headache too. On 23-OCT-2009 the following labs were collected: ASO screen positive, titer 200 IU/ml (reference negative <200 IU/ml). The patient was treated with 500 mg amoxicillin twice a day for 10 days, Rheumatoid factor negative, ESR-Westergren results of 2 MM/HR (reference 0-20) interpreted as no serologic evidence of infection with B. burgdorferi (Lyme), complement CH50 52 U/mL (reference 30-75), antinuclear AB positive, For CBC, neutrophil count 79% (reference 35-65%) and lymphocyte count 15% (reference 25-45%), lymph absolute 1.09 K/uL (reference 1.3-2.9 K/uL), remaining CBC were within normal limits, total bilirubin 1.4 MG/DL (reference 0.2-1.2), IgM 288 MG/DL (reference 48-226); on 28-OCT-2009 the following lab results were negative: DNA DBL STR AB, SS-A/RO ABS, SS-B/LA ABS, SM antibodies, U1RNP antibody, SCL 70 ABS, JOI antibodies. On an unspecified date, the patient recovered. The physician considered the events non serious. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Headache, Helicobacter test positive, Lymphocyte count decreased, Neck pain, Neutrophil percentage increased
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who 10 days ago, on 13-OCT-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant vaccine therapy on the same day included a dose of FLUZONE. On 22-OCT-2009 the patient developed an urticarial/vasculitis like rash only on her palms and soles of her feet, she also developed a headache and fever. Medical attention was sought, the patient visited the physician's office. It was unspecified if there were lab studies performed. The patient took ibuprofen for the fever and headache and BENADRYL for the rash with no response. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician's medical records concerning the 14 year old female patient had no illness at the time of vaccination who on 13-OCT-2009 at 15:00 pm was vaccinated IM in the left arm with the third dose of GARDASIL (lot number 660393/0067X). The patient developed cervicalgia/vasculitis rash itchy and throbbing on her palms and soles. The patient had headache too. On 23-OCT-2009 the following labs were collected: ASO screen positive, titer 200 IU/ml (reference negative <200 IU/ml). The patient was treated with 500 mg amoxicillin twice a day for 10 days, Rheumatoid factor negative, ESR-Westergren results of 2 MM/HR (reference 0-20) interpreted as no serologic evidence of infection with B. burgdorferi (Lyme), complement CH50 52 U/mL (reference 30-75), antinuclear AB positive, For CBC, neutrophil count 79% (reference 35-65%) and lymphocyte count 15% (reference 25-45%), lymph absolute 1.09 K/uL (reference 1.3-2.9 K/uL), remaining CBC were within normal limits, total bilirubin 1.4 MG/DL (reference 0.2-1.2), IgM 288 MG/DL (reference 48-226); on 28-OCT-2009 the following lab results were negative: DNA DBL STR AB, SS-A/RO ABS, SS-B/LA ABS, SM antibodies, U1RNP antibody, SCL 70 ABS, JOI antibodies. On an unspecified date, the patient recovered. The physician considered the events non serious. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pruritus, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test positive
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who 10 days ago, on 13-OCT-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant vaccine therapy on the same day included a dose of FLUZONE. On 22-OCT-2009 the patient developed an urticarial/vasculitis like rash only on her palms and soles of her feet, she also developed a headache and fever. Medical attention was sought, the patient visited the physician's office. It was unspecified if there were lab studies performed. The patient took ibuprofen for the fever and headache and BENADRYL for the rash with no response. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician's medical records concerning the 14 year old female patient had no illness at the time of vaccination who on 13-OCT-2009 at 15:00 pm was vaccinated IM in the left arm with the third dose of GARDASIL (lot number 660393/0067X). The patient developed cervicalgia/vasculitis rash itchy and throbbing on her palms and soles. The patient had headache too. On 23-OCT-2009 the following labs were collected: ASO screen positive, titer 200 IU/ml (reference negative <200 IU/ml). The patient was treated with 500 mg amoxicillin twice a day for 10 days, Rheumatoid factor negative, ESR-Westergren results of 2 MM/HR (reference 0-20) interpreted as no serologic evidence of infection with B. burgdorferi (Lyme), complement CH50 52 U/mL (reference 30-75), antinuclear AB positive, For CBC, neutrophil count 79% (reference 35-65%) and lymphocyte count 15% (reference 25-45%), lymph absolute 1.09 K/uL (reference 1.3-2.9 K/uL), remaining CBC were within normal limits, total bilirubin 1.4 MG/DL (reference 0.2-1.2), IgM 288 MG/DL (reference 48-226); on 28-OCT-2009 the following lab results were negative: DNA DBL STR AB, SS-A/RO ABS, SS-B/LA ABS, SM antibodies, U1RNP antibody, SCL 70 ABS, JOI antibodies. On an unspecified date, the patient recovered. The physician considered the events non serious. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Urticaria, Vasculitic rash
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who 10 days ago, on 13-OCT-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant vaccine therapy on the same day included a dose of FLUZONE. On 22-OCT-2009 the patient developed an urticarial/vasculitis like rash only on her palms and soles of her feet, she also developed a headache and fever. Medical attention was sought, the patient visited the physician's office. It was unspecified if there were lab studies performed. The patient took ibuprofen for the fever and headache and BENADRYL for the rash with no response. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician's medical records concerning the 14 year old female patient had no illness at the time of vaccination who on 13-OCT-2009 at 15:00 pm was vaccinated IM in the left arm with the third dose of GARDASIL (lot number 660393/0067X). The patient developed cervicalgia/vasculitis rash itchy and throbbing on her palms and soles. The patient had headache too. On 23-OCT-2009 the following labs were collected: ASO screen positive, titer 200 IU/ml (reference negative <200 IU/ml). The patient was treated with 500 mg amoxicillin twice a day for 10 days, Rheumatoid factor negative, ESR-Westergren results of 2 MM/HR (reference 0-20) interpreted as no serologic evidence of infection with B. burgdorferi (Lyme), complement CH50 52 U/mL (reference 30-75), antinuclear AB positive, For CBC, neutrophil count 79% (reference 35-65%) and lymphocyte count 15% (reference 25-45%), lymph absolute 1.09 K/uL (reference 1.3-2.9 K/uL), remaining CBC were within normal limits, total bilirubin 1.4 MG/DL (reference 0.2-1.2), IgM 288 MG/DL (reference 48-226); on 28-OCT-2009 the following lab results were negative: DNA DBL STR AB, SS-A/RO ABS, SS-B/LA ABS, SM antibodies, U1RNP antibody, SCL 70 ABS, JOI antibodies. On an unspecified date, the patient recovered. The physician considered the events non serious. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Depressed mood, Weight increased
Clinical narrative: Information has been received from a consumer concerning her daughter with no drug reactions/allergies who "last year" in 2008 was vaccinated with GARDASIL. There was no concomitant medication. Since then the patient gained a lot of weight and really depressed about it. It was unknown if the patient had sought medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with no pertinent medical history and no drug reactions who on 19-MAY-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# not reported). On 14-OCT-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 660612/0229X). There was no concomitant medication. On 14-OCT-2009 the patient developed a fever of 101F and body aches. Unspecified medical attention was sought via office visit. On 17-OCT-2009, the patient recovered. Follow-up information has been received from the nurse concerning the 16 year old female patient who on 19-MAY-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 662229/1497X), and concomitantly was vaccinated with a dose of HAVRIX (lot# HHHVBZ96AA), a dose of MENACTRA (lot# U2524AA), and a dose of ADACEL (lot# UF460BA). On 14-OCT-2009 the patient was vaccinated with the second dose of GARDASIL (lot# 660612/0229X) and did not received any concomitant vaccinations at that time. The nurse stated that she had spoken to the patient and the patient had recovered. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 11 year old female with pertinent medical history reported as none who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). There was no concomitant medication. On approximately 16-JUL-2007 the patient developed a "rash" at the injection site following her initial GARDASIL dose 2 years ago. The "rash" persisted for several months. It was described as a 1 and 1/2 inch raised area with small dots and itching. Patient self treated with ibuprofen and hydrocortisone. The father of the patient sent a letter to the pediatrician who gave the vaccine with a drawing of the arm and rash. Patient was not seen in the office for the rash only advised to try hydrocortisone by phone nurse at the office. On an unspecified date the patient recovered. There were no laboratories diagnostics studies performed. Follow up information has been received from a physician who reported the patient received the first dose of GARDASIL in a different office in 2007. On the same day patient received a dose of MENACTRA and dose of DTaP (lot # and injection site not reported). The patient developed itchy and rash at the site of GARDASIL. The physician did not believe the rash was examined by the physician. Unspecified laboratories were done. The physician want to know if she should have second and third dose of GARDASIL. This one of two reports from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient with no pertinent medical history and no drug reactions who on 17-JUL-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 659184/0843X). On 13-OCT-2009 the patient was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (Lot # 662404/0312Y). There was no concomitant medication. Within a few hours after her second vaccination, the patient developed a red raised rash at the injection site and hives on her forehead. The patient was seen back in the office that day (13-OCT-2009) and was give BENADRYL and her symptoms were resolved. No laboratory diagnostics studies were performed. The patient mentioned when she came back into the office to be evaluated that the same thing happened after she received the first dose of GARDASIL. At the time of the report, the patient had recovered. Follow up information was received from the registered nurse concerning the 25 year old black female patient who on 15:04 of 13-OCT-2009 was vaccinated intramuscularly into the right upper arm with her second 0.5 ml dose of GARDAIL (Lot # 662404/0312Y). One the same day at 15:50, the patient developed a rash at the injection site, hives on her forehead, wheals and red raised rash on upper arm. The patient was treated with BENADRYL 10 ml by mouth and the treatment was effective. No further information was available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old patient who on 11-NOV-2009 was vaccinated with the first dose of GARDASIL (LOT#0981Y). The registered nurse reported that on 13-NOV-2009, the patient had hives after the vaccination with GARDASIL. The patient sought medical attention by contacting with the office. It was unspecified if lab tests were performed. On an unspecified date, the patient had recovered. Follow up information has been received from the registered nurse regarding the 24 year old female patient with no known drug allergies who on 11-NOV-2009 was intramuscularly vaccinated in the right deltoid with the first dose of GARDASIL (LOT#0981Y) at 10:30 a.m. The registered nurse reported that two day after the vaccination with GARDAIL, on 13-NOV-2009, the patient developed hives. Oral steroid treatment was given to the patient and she was send to her primary care physician. At the time of the report, the patient's outcome was reported as unknown (previously reported as recovered). Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient who on approximately 23-OCT-2009 (also reported as 2 to 3 days ago) was vaccinated with an injection of GARDASIL. On approximately 23-OCT-2009 (also reported as 2 to 3 days ago), after receiving the vaccination the patient experienced tingling on her hands and feet. Unspecified medical attention was sought. At the time of the report, the patient's status was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient who "1 month ago", on approximately 01-NOV-2009 was vaccinated with her first dose of GARDASIL (Lot # not available). According to the physician, the patient passed out 10-15 minutes after receiving GARDASIL. The patient recovered on the same day of vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female patient who on 28-DEC-2009 received her first dose of GARDASIL 0.5mL (lot# 663453/0249Y) into her left deltoid muscle and concomitantly received a dose of MENACTRA (lot# 03058AA). The nurse practitioner reported that after receiving the vaccinations, the patient had a brief loss of consciousness and went into a tonic clonic movement. After the patient recovered from that, and she lost consciousness again an then recovered. In follow-up, it was also reported by the Nurse Practitioner that the patient "passed out" for about 10 to 15 seconds and had a tonic clonic movement for about 10 to 15 seconds. The patient regained consciousness and "passed out" again for about 10 to 15 seconds. The patient regained consciousness and recovered. Follow up information has been received from the nurse practitioner who indicated that the patient was a female student with no allergies and otherwise healthy who on 28-DEC-2009 was vaccinated intramuscularly with the first dose of GARDASIL into her left deltoid at 09:40 AM. On the same day, the patient was administered the first dose of MENACTRA (lot# 03058AA) given intramuscularly into her right deltoid at 09:40. No illness were reported at the time of vaccination. It was reported that on 28-DEC-2009, at 09:40 the patient experienced a syncopal episode with tonic-clonic movements. The patient recovered on 28-DEC-2009. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal disorder, Vaginismus
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). Subsequently, the patient developed vaginal palsey (spasms of the vagina). The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of this report the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiparesis, Hypoaesthesia, Movement disorder, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with no pertinent medical history and no known drug allergies who on 26-AUG-2008 and 09-APR-2009 was vaccinated IM with the first (lot# 660557/0072X) and second (661846/1312X) 0.5 ml doses of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN. On 09-APR-2009 the patient experienced numbness and weakness on her left side, arm and leg (the same side that she received GARDASIL) after receiving her second dose of GARDASIL. The nurse practitioner mentioned the patient did not have any difficulties following the first dose of GARDASIL. After the second the patient reported having "difficulty moving her left leg" on the evening the dose was administered. The dose was administered in the left arm. The difficulty moving her left leg resolved the following morning upon rising for the day. The patient did not seek medical attention at the time of the adverse experience. No diagnostic laboratory test was performed. On unspecified date, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 23 year old female without a pertinent medical history who on 10-NOV-2009 was vaccinated with her initial GARDASIL. There was no concomitant medication. The reporter mentioned that the patient developed tenderness and swelling at the injection site after vaccination with GARDASIL. It was reported that the swelling subsided but the patient continues to experience "tenderness on palpation" at site which looks normal upon inspection. It was also mentioned that this tenderness/pain has limited her range of motion in the arm for these past 3 weeks. No laboratory or test diagnostics were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with conjunctivitis at the time of vaccination, no pertinent medical history and no drug reactions/allergies, who on 28-SEP-2009 at 9:15 am was vaccinated in her left arm with the second dose of series of GARDASIL (lot # 662300/0100Y). The same day, at the same time the patient was vaccinated in the right arm with a dose of influenza virus vaccine (Novartis, lot # 96037). The Physician reported that within two minutes of receiving GARDASIL the patient became syncopatic and had tremors for one minute. The patient then stayed in the office for fifteen minutes to recover, which she had, and then was able to leave.  The patient's symptoms improved on therapy. The patient sought unspecified medical attention in the office. No laboratory diagnostics studies were performed. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Full blood count normal, Metabolic function test, Post inflammatory pigmentation change, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient who was vaccinated with the first and second doses of GARDASIL on 16-MAR-2009 and 26-MAY-2009 respectively. The nurse reported that when the patient was due for the third dose, the patient mentioned that "soon after she received the second dose of GARDASIL", on 26-MAY-2009, she developed rashes on her legs. The nurse also reported that the patient also developed discoloration on the top of her feet, around her ankles and the area behind her knees for both of her legs. The nurse decided not to give the third of GARDASIL dose to the patient until she saw her dermatologist. On 14-OCT-2009, the patient was seen by her dermatologist and a biopsy was performed (results not provided). The dermatologist prescribed LIDEX cream. At the time of the report, the patient's status was unknown. Follow-up information has been received from the licensed practical nurse regarding the 20 year old female patient with asthma and a history of chickenpox who was intramuscularly vaccinated with the first (Lot#660616/0570X) in the left deltoid and second (Lot#658271/0558X) in the right deltoid doses of GARDASIL on 16-MAR-2009 and 26-MAY-2009 respectively. The licensed practical nurse reported that the patient had a rash that developed on back and lower extremities after received the GARDASIL. Then the rash had been gradually worsening. Initially the rash itched but it had lessened. The patient was referred to dermatology. A biopsy was performed - results not available. The patient was diagnosed with postinflammatory hyperpigmentation. A complete blood cell count (CBC) and complete metabolic panel (CMP) were performed on 01-OCT-2009. All results were within normal limits. There was no illness at the time of vaccination. The patient's outcome was unknown. Additional information has been requested.