chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pityriasis, Rash, Staphylococcal infection, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 20 year old female daughter with an allergy to "ZECORE" who on 27-OCT-2007 (also reported as 29-OCT-2007) was vaccinated with the first dose of GARDASIL (route, Lot# and expiration date not reported), on 28-DEC-2007 was vaccinated with the second dose of GARDASIL (route, Lot# and expiration date not reported) and on 29-APR-2008 was vaccinated with the third dose of GARDASIL (route, Lot# and expiration date not reported). The consumer stated that her daughter was experiencing hives on her legs on an unspecified date. The get better and then come back again in 2008. Also the consumer daughter developed welts or a rash at the top of her legs and on her buttock after the second dose of GARDASIL (AE onset date also reported as "back in 2008"). She had been examined by three dermatologist, and general physician. She was diagnosed with Staph and treated with BACTRIM. The patient originally improved but then the rash returned. She was then diagnosed with pityriasis on an unspecified date and treated with dapsone. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a pharmacist concerning her 17 year old daughter who on unspecified date was vaccinated with the second dose of GARDASIL (dose, route and lot# not reported). In January 2011 the patient experienced planters warts after her second injection of GARDASIL. The patient sought unspecified medical attention. No treatment was given for the event. At the time of the report, the patient had not recovered. Follow-up information was received from the pharmacist indicating that the 20 year old (also reported as 18 year old) (previously reported as 17 year old) female student who on approximately 06-AUG-2010 was vaccinated with the second dose of GARDASIL and on 20-AUG-2010 the patient got planters warts 2 weeks after the second vaccination (previously reported as January 2011). The patient didn't seek medical attention (previously reported as the patient sought unspecified medical attention). At the time of the report, the patient had recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Agitation, Belligerence, Fatigue, Incorrect dose administered, Injection site haematoma
Clinical narrative: Information has been received from a consumer concerning her daughter who in 2008 (reported as "3 years ago"), was vaccinated with the 3 series of GARDASIL (lot#s not reported). It was reported that "they recently moved" and she took her daughter to a new doctor who gave her daughter another dose of GARDASIL (lot# not reported) shot recently in approximately April 2011 without parental consent. After receiving the shot her daughter became very agitated, belligerent, she was screaming out of her character and she was distraught. The next day she was very tired and at the injection site it was very "nasty" looking and bruised. At the time of reporting, the outcome of the events was not reported. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Screaming
Clinical narrative: Information has been received from a consumer concerning her daughter who in 2008 (reported as "3 years ago"), was vaccinated with the 3 series of GARDASIL (lot#s not reported). It was reported that "they recently moved" and she took her daughter to a new doctor who gave her daughter another dose of GARDASIL (lot# not reported) shot recently in approximately April 2011 without parental consent. After receiving the shot her daughter became very agitated, belligerent, she was screaming out of her character and she was distraught. The next day she was very tired and at the injection site it was very "nasty" looking and bruised. At the time of reporting, the outcome of the events was not reported. The patient did not seek medical attention. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Papilloma viral infection
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female with seasonal allergy who in approximately 2007, about 4 years ago, was vaccinated with the first and the second doses of GARDASIL at 0 and 2 months (dose, route and lot # not reported). Concomitant therapy included CLARITIN. The patient developed HPV "around October 2010". On 25-APR-2011 the patient administered the third dose of GARDASIL. The patient didn't seek medical attention. No treatment was given for the event. "Biopsy" was performed on unspecified location but the result was not reported. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old male who on an unspecified date was vaccinated intramuscularly with the first dose of GARDASIL (lot #: 668229/1569Z) (Expiration unknown). On the same day, concomitant therapy diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, meningococcal conj vaccine (unspecified) and "PPD" vaccine (unspecified). On an unspecified date, the patient promptly fainted and fell sideways. The patient hadn't receive another dose yet. The patient did not seek medical attention. No treatment was given. At the time of the report, the patient had recovered. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: Information has been received from a physician who heard from a nurse that a male patient with rheumatoid arthritis, who on an unspecified date, was vaccinated with the first dose of GARDASIL (lot # not reported). Shortly after receiving the first dose, the patient experienced 9 months of exacerbated rheumatoid arthritis symptoms. The patient's mother had decided to not complete the GARDASIL series. After 9 months, the patient recovered from exacerbated rheumatoid arthritis symptoms. It was unspecified if the patient sought medical attention. Attempts are being made to verify the existence of an identifiable source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Infection
Clinical narrative: Information has been received from a doctor of pharmacy concerning an actually 22 year old female patient with no pertinent medical history and no drug reactions or allergies, who in November 2010 (also reported as December 2010), was vaccinated with the first dose of GARDASIL (lot number not reported). There was no concomitant medication. The doctor of pharmacy reported that within 10 days after receiving  her first dose, the patient developed a yeast infection and had to get a 7 day course of treatment with fluconazole. The first course of treatment began on 03-DEC-2010. During the time she had completed the GARDASIL series, she had 4 courses of treatment with fluconazole 02-DEC-2010, 14-MAR-2011, 28-MAR-2011 and 07-JUN-2011. It appeared that after each dose of GARDASIL the patient developed a yeast infection within 5 to 10 days, as well as additional episodes of infection. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an unspecified amount of female patients who on unspecified dates were vaccinated IM with three doses of GARDASIL. Subsequently the patients had PAP smears which were positive for Human papillomavirus (HPV). No lot number, expiration date, patient demographics, or number of patients provided. At the time of reporting, the patient's outcome were unknown. It was unspecified if the patients sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the physician. The approximately  21 year old patient informed the physician that she received the full series of vaccines from her pediatrician and had Pap smear by HPV positive with Atypical Squamous Cells of Undetermined Significance (ASCUS). This is one of several reports received from the same source. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer and a physician concerning a 5 day old male patient who on 18-OCT-2010 was vaccinated with a dose of GARDASIL (lot # unknown). Father's consumer stated that on 18-OCT-2010 the patient received inadvertently an unspecified dose of GARDASIL (lot # unknown) when he should have received vaccination for hepatitis b. The physician stated that the patient inadvertently received an unspecified dose of GARDASIL by an unspecified route at an unspecified, different pediatrician's office. No adverse effect was reported by the physician. Follow up information has been received from the physician who stated that the now 3 week old patient with not illness at the time of vaccination, no preexisting allergies, birth defects and medical condition was vaccinated on 18-OCT-2010 in the morning (time not specified) intramuscularly with a dose of GARDASIL (Lot # 666597/0768Z). No adverse events were reported. Follow-up information has been received from the physician who stated that the patient was vaccinated with a dose of GARDASIL (lot # 666948/0886Z, reported before as Lot # 666597/0768Z). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a female patient with obesity and sulfonamide allergy who "last week" on approximately 07-FEB-2011 was vaccinated with a first dose of GARDASIL (Lot # not reported). The physician reported that the patient, after receiving her first dose of GARDASIL last weekend, experienced an allergic reaction. Patient had a sulfur allergy and presented with similar symptoms. Patient's primary care physician listened to her chest and reported a breathing difficulty indicative of an allergic reaction. No treatment was given for adverse event. There were no laboratory tests or diagnostic studies performed. It was reported that "the patient will not continue the dose series". At the time of the report, the patient had recovered (date unknown). The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia, Myalgia
Clinical narrative: Information has been received from a physician concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 ml dose of GARDASIL (dose, route and lot# unspecified). Subsequently, it was reported that the patient experienced achiness in her muscles after getting a dose of GARDASIL (date unspecified). It was also reported that the pain was like a fibromyalgia type pain. The patient reported this post vaccination. No treatment was given to the patient. Subsequently, on an unspecified date, the patient recovered. It was unspecified if patient sought for medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL, all three doses, on unspecified dates (dose, route and lot # not reported). At some period after all three doses, the patient had an abnormal Papanicolau (PAP) study which showed a new onset of HPV. Patient's present status was not specified by reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a certified medical assistant concerning an actually 16 year old female patient who on 2009 (dates unknown) was vaccinated with the first and second dose of GARDASIL (Lot numbers not reported). The medical assistant reported that the patient experienced flu like symptoms after the first and second dose of GARDASIL vaccine. Both doses were given on time in 2009. The patient would be getting the third dose late and it would be given today. The patient sought medical attention by speaking with the physician. At the time of the report, patient had recovered from flu like symptoms. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with 3 doses of GARDASIL. At some period after all 3 doses, the patient had an abnormal PAP which showed a new onset of  HPV. The outcome of the patient was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a "16 year old" female patient with no pertinent medical history who on approximately 20-SEP-2010, was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included ZOFRAN. The nurse practitioner reported that on approximately 20-SEP-2010, the patient experienced vomiting after vaccine administration. No lab tests were performed. The patient sought unspecified medical attention. It was noted that the nurse practitioner decided to stop the series of GARDASIL for the patient because of the reaction experienced. It was reported that the patient was treated with ZOFRAN and she was recovering. Follow up information received from the nurse practitioner indicated that the patient was a female student, with no illness at the time of vaccination nor preexisting allergies, birth defects or medical conditions, who in the morning of 27-SEP-2010 was vaccinated with a first dose of GARDASIL (lot # 666931/037Z) intramuscularly in her left deltoid. In the afternoon of 27-SEP-2010 the patient developed abdominal pain and vomiting, these continued for two days. The patient was better on day 3. On 30-SEP-2010 the patient recovered from abdominal pain and vomiting. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 20 year old granddaughter with no pertinent medical history and no allergies who in approximately 2007 ("approximately three years ago") was vaccinated with three doses of GARDASIL (lot#s not reported). There was no concomitant medication. It was reported that the patient had an unremarkable papanicolaou test (PAP test) prior to vaccination. Subsequently the patient had her first PAP test following vaccination came back positive for an unspecified serotype or serotypes of human papilloma virus, and her second PAP test following vaccination come back positive for unspecified abnormal (described as possible cancer) cells. No specific dates were available for either vaccinations or for any of the PAP tests. No specific information was available for any of the results of the PAP tests. Unspecified medical attention was sought via office visit. At the time of this report, the patient's outcome was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with no pertinent medical history and no drug reactions or allergies who on an unspecified date, was vaccinated IM with 0.5 ml first dose of GARDASIL (Lot# not reported). There was no concomitant medication. It was reported that the consumer's daughter on 23-AUG-2010, experienced pain and swelling after being administered GARDASIL. The consumer did not know if it was from a flu vaccination or GARDASIL and she was trying to figure out what caused her daughter's reaction. Lab diagnostics studies were not performed. At the time of the report, the consumer's daughter had not recovered. She did not seek medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Eczema
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 26 year old female patient with eczema, "thyroid issues" and penicillin allergy who on 13-SEP-2010 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL. Concomitant therapy included SYNTHROID. The nurse reported that the patient had eczema prior to beginning the GARDASIL series. On an unspecified date the patient felt that the eczema got worse after beginning the series. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. The patient was currently being treated for the condition at this time with prednisone, ELIDEL cream and hydroxyzine. At the time of the report, the patient was not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old "over 60 years old" female patient who in September 2009 "1 year ago", was vaccinated with one dose GARDASIL injection (Lot# not reported). It was reported that in September 2009 "1 year ago", the patient experienced shortness of breath 35-40 minutes later when the patient contacted her physician. She then felt better and the shortness of breath subsided later the same day. The patient sought unspecified medical attention. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 14 year old female patient who on 29-SEP-2010 was vaccinated a dose of GARDASIL (Lot # and route not reported). The pharmacist reported that on 30-SEP-2010 the patient's mother took her to the emergency room for blurred vision. At the time of the report, the patient outcome was not reported. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ophthalmological examination abnormal, Refraction disorder, Syncope
Clinical narrative: Information has been received from a physician concerning an 13 year old female patient with overweight and no past medical history, who on 26-AUG-2010 was vaccinated with the first dose of GARDASIL (dose not reported, lot # 666121/0597Z), and the second dose of VARIVAX (Merck) (dose not reported, lot # 665038/1044Y). Concomitant therapy included ADACEL (Lot number C3249AA), and MENACTRA (Lot number U3339AA). On 26-AUG-2010, the patient fainted shortly after administered GARDASIL. "The patient came to and the nurse took the patient's blood pressure, then the patient fainted a second time." The patient's blood pressure was 106/71 and eye refraction of 20/40. "The office called 911 and the patient was taken to the emergency room and was given an IV to replenish fluids (not specified)." "The nurse mentioned that the patient is overweight and did not eat before she received her vaccinations." The patient was not hospitalized. The patient did not have a follow-up visit with the physician at the time of reporting. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a physician concerning an 13 year old female patient with overweight and no past medical history, who on 26-AUG-2010 was vaccinated with the first dose of GARDASIL (dose not reported, lot # 666121/0597Z), and the second dose of VARIVAX (Merck) (dose not reported, lot # 665038/1044Y). Concomitant therapy included ADACEL (Lot number C3249AA), and MENACTRA (Lot number U3339AA). On 26-AUG-2010, the patient fainted shortly after administered GARDASIL. "The patient came to and the nurse took the patient's blood pressure, then the patient fainted a second time." The patient's blood pressure was 106/71 and eye refraction of 20/40. "The office called 911 and the patient was taken to the emergency room and was given an IV to replenish fluids (not specified)." "The nurse mentioned that the patient is overweight and did not eat before she received her vaccinations." The patient was not hospitalized. The patient did not have a follow-up visit with the physician at the time of reporting. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 13 year old female patient with overweight and no past medical history, who on 26-AUG-2010 was vaccinated with the first dose of GARDASIL (dose not reported, lot # 666121/0597Z), and the second dose of VARIVAX (Merck) (dose not reported, lot # 665038/1044Y). Concomitant therapy included ADACEL (Lot number C3249AA), and MENACTRA (Lot number U3339AA). On 26-AUG-2010, the patient fainted shortly after administered GARDASIL. "The patient came to and the nurse took the patient's blood pressure, then the patient fainted a second time." The patient's blood pressure was 106/71 and eye refraction of 20/40. "The office called 911 and the patient was taken to the emergency room and was given an IV to replenish fluids (not specified)." "The nurse mentioned that the patient is overweight and did not eat before she received her vaccinations." The patient was not hospitalized. The patient did not have a follow-up visit with the physician at the time of reporting. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ophthalmological examination abnormal, Refraction disorder, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient, with low blood pressure (95/66) and no drug reactions or allergies, who, on an unspecified date, was vaccinated with the first dose of GARDASIL (Lot # 666948/0886Z, expire date not reported), intramuscularly. Concomitant therapy included flu vaccine (manufacturer and appearance were unspecified) "MC-4 vaccine" (manufacturer and appearance were unspecified) and Tdap (manufacturer and appearance were unspecified). Before receiving the GARDASIL, the patient's blood pressure was 95 over 66. "After getting the GARDASIL", the patient's blood pressure reading had dropped to 91 over 53. The patient also experienced dizziness as a result of receiving the GARDASIL. Oxygen was administered to the patient and water was given orally in the office. There were no laboratories diagnostics studies performed. On the same day the patient recovered. Follow-up information was received from a physician regarding a 13 year old obese female (weight reported as 199.8 lbs. and as 215 lbs.) with no known allergies who was seen for a well child adolescent visit on 26-AUG-2010 at which time the physician recommended vaccination with GARDASIL, MENACTRA, a second dose of varicella, and Td (manufacturer unknown). The patient's blood pressure was noted to be 106/71. It was reported that the patient received a dose of GARDASIL (Lot # 66121/0597Z) (Lot # 0597Z, which conflicts with lot number previously reported) intramuscularly in her right arm on 26-AUG-2010 at approximately 3:00 p.m. Shortly after she was given the shots, as the patient got up and stepped out of the examination room, she fainted for about two minutes. She was pale and sweaty. Her blood pressure was measured at 98/68 and the patient was given oxygen with oxygen saturations 99-100%. The patient got up after five to ten minutes saying she was all right. Another blood pressure measurement was to be done as she sat in the lab room and again "she kind of passed out." The patient was pale, sweaty and clammy. Her blood pressure was 90s/60s and oxygen saturations 100% with oxygen via mask. Paramedics were called and the patient was transferred to the emergency room in a gurney. The physician noted that on 26-AUG-2010, the patient recovered. All available medical records will be provided upon request. Follow up information has been received via telephone call from a registered nurse, who clarified that the only lot number that she had for the GARDASIL was 0597Z (lot # 666121/0597Z). No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient, with low blood pressure (95/66) and no drug reactions or allergies, who, on an unspecified date, was vaccinated with the first dose of GARDASIL (Lot # 666948/0886Z, expire date not reported), intramuscularly. Concomitant therapy included flu vaccine (manufacturer and appearance were unspecified) "MC-4 vaccine" (manufacturer and appearance were unspecified) and Tdap (manufacturer and appearance were unspecified). Before receiving the GARDASIL, the patient's blood pressure was 95 over 66. "After getting the GARDASIL", the patient's blood pressure reading had dropped to 91 over 53. The patient also experienced dizziness as a result of receiving the GARDASIL. Oxygen was administered to the patient and water was given orally in the office. There were no laboratories diagnostics studies performed. On the same day the patient recovered. Follow-up information was received from a physician regarding a 13 year old obese female (weight reported as 199.8 lbs. and as 215 lbs.) with no known allergies who was seen for a well child adolescent visit on 26-AUG-2010 at which time the physician recommended vaccination with GARDASIL, MENACTRA, a second dose of varicella, and Td (manufacturer unknown). The patient's blood pressure was noted to be 106/71. It was reported that the patient received a dose of GARDASIL (Lot # 66121/0597Z) (Lot # 0597Z, which conflicts with lot number previously reported) intramuscularly in her right arm on 26-AUG-2010 at approximately 3:00 p.m. Shortly after she was given the shots, as the patient got up and stepped out of the examination room, she fainted for about two minutes. She was pale and sweaty. Her blood pressure was measured at 98/68 and the patient was given oxygen with oxygen saturations 99-100%. The patient got up after five to ten minutes saying she was all right. Another blood pressure measurement was to be done as she sat in the lab room and again "she kind of passed out." The patient was pale, sweaty and clammy. Her blood pressure was 90s/60s and oxygen saturations 100% with oxygen via mask. Paramedics were called and the patient was transferred to the emergency room in a gurney. The physician noted that on 26-AUG-2010, the patient recovered. All available medical records will be provided upon request. Follow up information has been received via telephone call from a registered nurse, who clarified that the only lot number that she had for the GARDASIL was 0597Z (lot # 666121/0597Z). No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient, with low blood pressure (95/66) and no drug reactions or allergies, who, on an unspecified date, was vaccinated with the first dose of GARDASIL (Lot # 666948/0886Z, expire date not reported), intramuscularly. Concomitant therapy included flu vaccine (manufacturer and appearance were unspecified) "MC-4 vaccine" (manufacturer and appearance were unspecified) and Tdap (manufacturer and appearance were unspecified). Before receiving the GARDASIL, the patient's blood pressure was 95 over 66. "After getting the GARDASIL", the patient's blood pressure reading had dropped to 91 over 53. The patient also experienced dizziness as a result of receiving the GARDASIL. Oxygen was administered to the patient and water was given orally in the office. There were no laboratories diagnostics studies performed. On the same day the patient recovered. Follow-up information was received from a physician regarding a 13 year old obese female (weight reported as 199.8 lbs. and as 215 lbs.) with no known allergies who was seen for a well child adolescent visit on 26-AUG-2010 at which time the physician recommended vaccination with GARDASIL, MENACTRA, a second dose of varicella, and Td (manufacturer unknown). The patient's blood pressure was noted to be 106/71. It was reported that the patient received a dose of GARDASIL (Lot # 66121/0597Z) (Lot # 0597Z, which conflicts with lot number previously reported) intramuscularly in her right arm on 26-AUG-2010 at approximately 3:00 p.m. Shortly after she was given the shots, as the patient got up and stepped out of the examination room, she fainted for about two minutes. She was pale and sweaty. Her blood pressure was measured at 98/68 and the patient was given oxygen with oxygen saturations 99-100%. The patient got up after five to ten minutes saying she was all right. Another blood pressure measurement was to be done as she sat in the lab room and again "she kind of passed out." The patient was pale, sweaty and clammy. Her blood pressure was 90s/60s and oxygen saturations 100% with oxygen via mask. Paramedics were called and the patient was transferred to the emergency room in a gurney. The physician noted that on 26-AUG-2010, the patient recovered. All available medical records will be provided upon request. Follow up information has been received via telephone call from a registered nurse, who clarified that the only lot number that she had for the GARDASIL was 0597Z (lot # 666121/0597Z). No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Blood electrolytes, Blood thyroid stimulating hormone
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 20 year old female patient who was recently diagnosed with chronic fatigue syndrome. In July 2010, the patient was vaccinated with a first dose of GARDASIL and she was vaccinated with the second dose of GARDASIL again in August 2010. Concomitant therapy included KLONOPIN. In August 2010, one month after the first dose of vaccine the patient experienced "joint pain, chronic fatigue and weakness, leg pain, and aching muscles". It was reported that the patient sought medical treatment which was "methadone" and MOBIC. She had thyroid level, complete blood count and electrolytes lab was drawn but the results were not reported. The patient's joint pain, chronic fatigue and weakness, leg pain and aching muscles was not subsided at the time of this report. The patient sought unspecified medical attention. Follow up information was received from the Nurse Practitioner (N.P) who reported that the patient had no medical history and experienced low back pain a few weeks after dose one in July 2010. After dose 2, she began experiencing symptoms of arthralgia, myalgia, weakness and fatigue. It was reported that the patient had been evaluated by neurologist, endocrinologist and was also seen at the clinic. She had been diagnosed with chronic fatigue syndrome and fibromyalgia. The office nurse reported that the vaccines were given elsewhere. She checked and could not find reference to the physician or office where GARDASIL was administered. Nurse Practitioner was looking for information pertaining to GARDASIL and similar reports. The health care professional contacted during telephone follow up could not supply the following information; exact dates of vaccination, Lot #, and other healthcare provider name contact information. Follow up information received from the nurse practitioner, stated that the patient received GARDASIL in July 2009 (also reported as July 2010) with complaints of back pain and myalgias within 2-3 weeks of injection. It was also stated that the patient then received her second injection the following month with complaints of worsening myalgias in addition to arthralgias, muscle weakness, persistent fatigue, leg pain and generalized unwell feeling. The nurse indicated that the patient was diagnosed with fibromyalgia in September 2009 and chronic fatigue syndrome in February 2011. It was indicated that the patient was a healthy, vibrant 18 year old prior to the GARDASIL injection with persistent pain and fatigue over the last 1.5 year, post injection. The patient's function overall was reported as poor with chronic pain regimen. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Fibromyalgia, Full blood count, Malaise, Myalgia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 20 year old female patient who was recently diagnosed with chronic fatigue syndrome. In July 2010, the patient was vaccinated with a first dose of GARDASIL and she was vaccinated with the second dose of GARDASIL again in August 2010. Concomitant therapy included KLONOPIN. In August 2010, one month after the first dose of vaccine the patient experienced "joint pain, chronic fatigue and weakness, leg pain, and aching muscles". It was reported that the patient sought medical treatment which was "methadone" and MOBIC. She had thyroid level, complete blood count and electrolytes lab was drawn but the results were not reported. The patient's joint pain, chronic fatigue and weakness, leg pain and aching muscles was not subsided at the time of this report. The patient sought unspecified medical attention. Follow up information was received from the Nurse Practitioner (N.P) who reported that the patient had no medical history and experienced low back pain a few weeks after dose one in July 2010. After dose 2, she began experiencing symptoms of arthralgia, myalgia, weakness and fatigue. It was reported that the patient had been evaluated by neurologist, endocrinologist and was also seen at the clinic. She had been diagnosed with chronic fatigue syndrome and fibromyalgia. The office nurse reported that the vaccines were given elsewhere. She checked and could not find reference to the physician or office where GARDASIL was administered. Nurse Practitioner was looking for information pertaining to GARDASIL and similar reports. The health care professional contacted during telephone follow up could not supply the following information; exact dates of vaccination, Lot #, and other healthcare provider name contact information. Follow up information received from the nurse practitioner, stated that the patient received GARDASIL in July 2009 (also reported as July 2010) with complaints of back pain and myalgias within 2-3 weeks of injection. It was also stated that the patient then received her second injection the following month with complaints of worsening myalgias in addition to arthralgias, muscle weakness, persistent fatigue, leg pain and generalized unwell feeling. The nurse indicated that the patient was diagnosed with fibromyalgia in September 2009 and chronic fatigue syndrome in February 2011. It was indicated that the patient was a healthy, vibrant 18 year old prior to the GARDASIL injection with persistent pain and fatigue over the last 1.5 year, post injection. The patient's function overall was reported as poor with chronic pain regimen. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 20 year old female patient who was recently diagnosed with chronic fatigue syndrome. In July 2010, the patient was vaccinated with a first dose of GARDASIL and she was vaccinated with the second dose of GARDASIL again in August 2010. Concomitant therapy included KLONOPIN. In August 2010, one month after the first dose of vaccine the patient experienced "joint pain, chronic fatigue and weakness, leg pain, and aching muscles". It was reported that the patient sought medical treatment which was "methadone" and MOBIC. She had thyroid level, complete blood count and electrolytes lab was drawn but the results were not reported. The patient's joint pain, chronic fatigue and weakness, leg pain and aching muscles was not subsided at the time of this report. The patient sought unspecified medical attention. Follow up information was received from the Nurse Practitioner (N.P) who reported that the patient had no medical history and experienced low back pain a few weeks after dose one in July 2010. After dose 2, she began experiencing symptoms of arthralgia, myalgia, weakness and fatigue. It was reported that the patient had been evaluated by neurologist, endocrinologist and was also seen at the clinic. She had been diagnosed with chronic fatigue syndrome and fibromyalgia. The office nurse reported that the vaccines were given elsewhere. She checked and could not find reference to the physician or office where GARDASIL was administered. Nurse Practitioner was looking for information pertaining to GARDASIL and similar reports. The health care professional contacted during telephone follow up could not supply the following information; exact dates of vaccination, Lot #, and other healthcare provider name contact information. Follow up information received from the nurse practitioner, stated that the patient received GARDASIL in July 2009 (also reported as July 2010) with complaints of back pain and myalgias within 2-3 weeks of injection. It was also stated that the patient then received her second injection the following month with complaints of worsening myalgias in addition to arthralgias, muscle weakness, persistent fatigue, leg pain and generalized unwell feeling. The nurse indicated that the patient was diagnosed with fibromyalgia in September 2009 and chronic fatigue syndrome in February 2011. It was indicated that the patient was a healthy, vibrant 18 year old prior to the GARDASIL injection with persistent pain and fatigue over the last 1.5 year, post injection. The patient's function overall was reported as poor with chronic pain regimen. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Human chorionic gonadotropin, Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N), for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with latex allergy and lidocaine allergy and with no pertinent medical history who on 12-AUG-2010 was vaccinated IM with her first 0.5ml dose of GARDASIL (lot # 666929/0331Z). Concomitant therapy included Tdap. The patient went to an emergency room because of stomach pain. She had ultrasound, urine beta-human chorionic gonadotropin (HCG) test. She learned of the pregnancy in the emergency room. She was released. At the time  of reporting, the outcome of stomach pain was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Insomnia, Myalgia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who was vaccinated with the first dose of GARDASIL in February 2010, the second dose in April 2010, and the third dose on 23-AUG-2010 (No lot number provided). In July 2010, the patient developed muscle aches, joint pain, daily emesis and insomnia. "The patient did not convey her symptoms to the physician before receiving the third dose of GARDASIL." The patient's muscle aches and joint pain and daily emesis and insomnia persisted. No lab diagnostics studies performed. The patient sought unknown medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 25 year old female who on 14-FEB-2011 was vaccinated with the first dose of GARDASIL (lot# 667866/1437Z) 0.5ml intramuscular. Six days later, on 20-FEB-2011 the patient developed vulvar swelling. The patient was recovering now and did not seek medical attention. Follow up information has been received from a health worker concerning a 25 year old female with no pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination who at 09:45 AM on 14-FEB-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot number: 668229/1569Z) (previously reported as "667866/1437Z) in right deltoid. On 20-FEB-2011 the patient experienced vulvar swelling. No diagnostic test performed. The patient did not seek medical attention. On an unspecified date, the patient recovered. The patient believed that the first injection and swollen vulva were related. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Human papilloma virus test positive, Loop electrosurgical excision procedure, Papilloma viral infection
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 21 year old female patient with asthma and no drug reaction or allergies, who completed the entire GARDASIL series. On 10-JAN-2008, 10-MAR-2008 and 10-JUL-2008, the patient was vaccinated SC with the first, second and third dose of GARDASIL (lot#s not reported), 0.5 ml, respectively. There was no concomitant medication. In approximately March 2011 (reported as "this past March"), the patient had a pap smear which was abnormal. In April 2011, a colposcopy test revealed moderate squamous cell dysplasia with CIN II (cervical intraepithelial neoplasia II). On 17-MAY-2011, a LEEP (loop electrosurgical excision procedure) test was completed that confirmed the diagnosis of HPV with moderate squamous cell dysplasia CIN II. The nurse confirmed the patient was sexually active prior to the start of the GARDASIL series, but had never had an abnormal pap test until this year 2011. At the time of reporting, the patient's outcome was reported as not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 21 year old female patient with asthma and no drug reaction or allergies, who completed the entire GARDASIL series. On 10-JAN-2008, 10-MAR-2008 and 10-JUL-2008, the patient was vaccinated SC with the first, second and third dose of GARDASIL (lot#s not reported), 0.5 ml, respectively. There was no concomitant medication. In approximately March 2011 (reported as "this past March"), the patient had a pap smear which was abnormal. In April 2011, a colposcopy test revealed moderate squamous cell dysplasia with CIN II (cervical intraepithelial neoplasia II). On 17-MAY-2011, a LEEP (loop electrosurgical excision procedure) test was completed that confirmed the diagnosis of HPV with moderate squamous cell dysplasia CIN II. The nurse confirmed the patient was sexually active prior to the start of the GARDASIL series, but had never had an abnormal pap test until this year 2011. At the time of reporting, the patient's outcome was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who (Sometime in 2010) was vaccinated with a first and a second dose of GARDASIL (Doses, and Lot # not reported), IM. The nurse stated that "sometime in 2010" the patient tested positive for human papilloma virus test (HPV) after being administered either the first and the second dose of GARDASIL. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Pyrexia, Restlessness
Clinical narrative: Information has been received from a physician concerning a "19 years old" female with no known drug allergies/reactions who on 14-MAR-2011 was vaccinated with the second dose of GARDASIL (dose not reported) (Lot number: 666595/0992Z). There was no concomitant medication. On 14-MAR-2011, the patient presented to the physicians office with a fever of 101.3, headache, body aches and restlessness. The patient was given unspecified treatment. Upon the time of report, the patient present status was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Concussion, Syncope
Clinical narrative: Information has been received from a nurse concerning a 12 or 13 years old male patient, who on an unknown date, was vaccinated intramuscularly with a dose of GARDASIL (Lot number not reported). The health professional stated that the patient was using GARDASIL and experienced syncope with concussion. The patient went to the emergency room. The patient was given an unspecified treatment for the events. At the time of the report, patient was recovering. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from an office billing supervisor concerning her 22 year old daughter who on 04-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot # 658560/1062U, expire date and route not reported). On 17-DEC-2007, the patient was vaccinated with the second dose of GARDASIL (Lot # 658488/1264U, expire date and route not reported) and on 11-JUN-2008, the patient was vaccinated with the third dose of GARDASIL (Lot # 660393/0067X, expire date and route not reported). Concomitant therapy administered, when the first dose of GARDASIL was given, on 04-OCT-2007, included influenza virus vaccine (unspecified) (manufacturer unknown). The office billing supervisor informed that on 11-MAR-2009 and on 09-APR-2010, her daughter had an abnormal PAP which resulted in multiple colposcopies (results not provided). The patient sought medical attention by an office visit. On an unspecified date, the patient recovered. Follow-up information was received from the office billing supervisor indicating that on 11-APR-2010, her daughter had the second PAP (previously reported as 09-APR-2010 by the office billing supervisor). Follow up information has been received from a nurse practitioner indicating that the 22 year old (currently 25 years old) female patient with no illness at time of vaccination and no preexisting allergies, no birth defects and no medical conditions who on 04-OCT-2007 at 16:03, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly on the left deltoid (Lot # 658560/1062U). On 17-DEC-2007 at 15:16, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly on the left deltoid (Lot # 658488/1264U) and on 11-JUN-2008 at 23:27, the patient was vaccinated with the third dose of GARDASIL 0.5ml, intramuscularly on the right deltoid (Lot # 660393/0067X). On 16-APR-2009, was performed a "necessary" PAP smear reported as abnormal PAP. On 27-APR-2009, was practised a colposcopy that reported epithelial cell abnormality, reading endocervical/transformating zone component present. In December 2011, would schedule next PAP smear. The patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.