chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Eating disorder, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 02-FEB-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL vaccine (yeast) (lot #655503/012U). Concomitant therapy included DEPO-PROVERA. Illness at the time of vaccination included flu-like symptoms. Immediately after vaccination, the patient had syncope and passed out for approximately one minute. It was also noted that her eating was sporatic. The patient has not passed out with previous injections in the past. The physician did not believe the injection cause the syncope. Unspecified medical attention was sought. On 02-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007 Information has been received from a nurse concerning a 25 year old female  child care provider with no known drug allergies who on 02-FEB-2007 was vaccinated IM with a fiest dose 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 655503/0012U). Concomitant therapy included  DEPO-PROVERA . Illness at the time of vaccination included common cold-type symptoms. Immediately after vaccination , the patient had syncope and passed out for approximately one minute. It was also noted that her eating was sporatic. The patient had not passed out with previous injections u=in the past. The physician did not believe the injection cause the syncope. Unspecified medical attention was sought. On 02-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure fluctuation, Computerised tomogram, Drug administered at inappropriate site, Headache, Hyperventilation
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with no medical history, who on 12-FEB-2007 at 15:30 was vaccinated IM with a second dose of Gardasil (lot# 653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN LO, BENADRYL and TYLENOL EXTRA STRENGTH. Illness at the time of vaccination included bronchitis. It was noted that the patient may have not eaten all day. "At the patient's request she received the vaccination in her glut." After 2 to 3 minutes, the patient felt sick and began to hyperventilate. The patient's blood pressure went up and down and she complained of a left-sided headache. The patient was diagnosed with a migraine. It was noted that the patient was sent to the emergency room. A "CT of her head" was performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Migraine
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with no medical history, who on 12-FEB-2007 at 15:30 was vaccinated IM with a second dose of Gardasil (lot# 653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN LO, BENADRYL and TYLENOL EXTRA STRENGTH. Illness at the time of vaccination included bronchitis. It was noted that the patient may have not eaten all day. "At the patient's request she received the vaccination in her glut." After 2 to 3 minutes, the patient felt sick and began to hyperventilate. The patient's blood pressure went up and down and she complained of a left-sided headache. The patient was diagnosed with a migraine. It was noted that the patient was sent to the emergency room. A "CT of her head" was performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. 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 (age unknown) who on an unspecified date was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, on an unspecified date, the patient passed out. The patient sought unspecified medical attention. subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Gardasil (conflictingly reported oral route). Reportedly. the patient passed out. At the time of the report, it was unknown if the patient recovered.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, Injection site extravasation, No adverse effect, Underdose
Clinical narrative: Information has been received from a physician concerning a patient who on 15-FEB-2007 was vaccinated, intramuscularly, into the deltoid muscle with the first 0.5 ml dose of Gardasil (lot not reported). It was reported that during the administration of the first dose there was some leaking of the vaccine at the injection site. The patient was not able to receive the complete dose. No adverse experience related to this event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician's assistant concerning a female (age not reported) who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported) IM. The patient reported feeling nauseous in between the first and second dose of vaccine. Medical attention was not sought. The outcome of the nausea was not reported. No additional information was provided at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician's assistant concerning an 18 year old female (age not reported) who on 13-DEC-2006 was vaccinated with first dose of GARDASIL (lot # 655618/0186U) IM. The patient reported feeling nauseous in between the first and second dose of vaccine. Medical attention was not sought. The outcome of the nausea was not reported. No additional information was provided at the time of reporting. Additional information was received from the physician's assistant. On 13-FEB-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 655618/0186U). The medication caused nausea on and off, but was not as bad with the second dose. The outcome of the nausea was not reported. No additional information is available.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a family nurse practitioner (FNP), the consumer, a mid thirties year old female who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported). Subsequently, the patient experienced stinging after the vaccination. The patient also reported that her arm was sore and stung more after the second and third vaccination with Gardasil. The patient sought medical attention. At the time of reporting, the patient had recovered. No other information was available at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a family nurse practitioner (FNP), the consumer, a mid thirties year old female who in August 2006 was vaccinated with first dose of GARDASIL (lot # not reported). The second dose of GARDASIL (lot # not reported) was given October 2006 and the third dose of GARDASIL (lot # not reported) was given February 2007. Subsequently, the patient experienced stinging after the vaccination. The patient also reported that her arm was sore and stung more after the second and third vaccination with GARDASIL. She had no reaction with the first injection which was the pre-loaded syringe. The second and third injection was from a vial. The patient sought medical attention. The sore arm lasted about 3 days. At the time of reporting, the patient had recovered.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with pertinent medical history and drug reactions/allergies reported as unspecified on 23-JAN-2007 was vaccinated with Gardasil (lot # not reported) injection. On an unspecified date, the patient went to the hospital with a sore throat and a fever of 100 degrees. After receiving the Gardasil injection, her temperature went to 104.8 degrees on 23-JAN-2007. The physician administered antibiotics for her sore throat. The outcome of the events was unspecified. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female who in January 2007, was vaccinated with Gardasil. In January 2007, the patient developed arthritic symptoms. The patient had developed achy knees and wrists. There was no redness on the knees and the wrists but were sore. It was reported that ibuprofen was little help in relieving the pain. The nurse practitioner reported that she would ask for lab work to be done for rheumatoid arthritis and a sedimentation rate. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007.  Initial and follow up information has been received from a nurse practitioner concerning a 13 year old, female with a sore throat at the time of vaccination, hypothyroidism and growth hormone deficiency, who on either "02-JAN-2007" was vaccinated IM, with a dose of GARDASIL (Lot #655619/1427F).  On 15-FEB-2007, the patient developed arthritic symptoms, including achy knees and wrists.  There was no redness on the knees and the wrists but were sore.  It was reported that IBUPROFEN was little help in relieving the pain.  The nurse practitioner reported that she would ask for lab work for rheumatoid arthritis and a sedimentation rate (results and tests not confirmed).  Follow up information indicated that "according to rheumatology" the patient probably did not have a reaction to (GARDASIL)."  At the time of this report, it was unknown if the patient had recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a female who on approximately 25-JAN-2007 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 25-JAN-2007 the patient experienced "delayed mensis." Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Dizziness, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female who on approximately 15-DEC-2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 15-DEC-2006 the patient developed high fever, dizziness and "several adverse events." Unspecified medical attention was sought. At the time of the report, the patient was recovering and the physician discontinued further series of Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a female patient who was vaccinated with her first Gardasil and developed a rash on her thigh, hip and stomach. After receiving second dose of Gardasil the patient developed hives and a rash. The patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced her first menstrual cycle which was extremely heavy. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information had been received from a physician concerning a female (age unknown) who on an unspecified date was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, on an unspecified date, the patient passed out. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007.  Information has been received from a consumer's mother and physician concerning a 16 year old female with a MOTRIN allergy, and no medical history who on 10-FEB-2007 at 10:00 was vaccinated IM into the left arm with a first 0.5 ml dose of Gardasil (lot# 655617/1447F). There was no concomitant medication.  On 12-FEB-2007, the patient experienced "heart racing, nausea, dizziness, temp of 99.7, abdomen cramps, vomiting, bad headache and diarrhea." The patient's mother reported that the patient "had been out of school all week and was not feeling well." She also stated that "there was a follow up visit with the physician who associated the experience with the vaccine and she was given TIGAN for the nausea and cramps." No labs or testing was needed.  At the time of this report, the patient had not recovered according to the consumer's mother. The physician reported that on 17-FEB-2007 the patient recovered from diarrhea, dizziness, nausea, headache, vomiting, abdomen cramping and low grade fever. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007.  Information has been received from a consumer's mother and physician concerning a 16 year old female with a MOTRIN allergy, and no medical history who on 10-FEB-2007 at 10:00 was vaccinated IM into the left arm with a first 0.5 ml dose of Gardasil (lot# 655617/1447F). There was no concomitant medication.  On 12-FEB-2007, the patient experienced "heart racing, nausea, dizziness, temp of 99.7, abdomen cramps, vomiting, bad headache and diarrhea." The patient's mother reported that the patient "had been out of school all week and was not feeling well." She also stated that "there was a follow up visit with the physician who associated the experience with the vaccine and she was given TIGAN for the nausea and cramps." No labs or testing was needed.  At the time of this report, the patient had not recovered according to the consumer's mother. The physician reported that on 17-FEB-2007 the patient recovered from diarrhea, dizziness, nausea, headache, vomiting, abdomen cramping and low grade fever. No product quality complaint was involved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2006 the patient fainted after the administration of Gardasil. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a 23 year old female with sulfonamide allergy and no pertinent medical history who on 20-OCT-2006 was vaccinated with Gardasil. Concomitant therapy included YASMIN. On 22-OCT-2006, 48 hours after receiving the immunization, the patient developed itching without a visible rash. The patient sought unspecified medical attention. No laboratory tests were performed. The itching persisted for 3 weeks. At the time of reporting, the patient had recovered from the itching on approximately 10-NOV-2006. No other information was available at the time of reporting. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history and no history of drug reactions/allergies who on 09-FEB-2007 was vaccinated with first dose of Gardasil (lot # 655617/1447F) 0.5 ml injection. There was no concomitant medication. On 09-FEB-2007, the patient experienced swelling, tenderness, and redness in the injection site after receiving her first Gardasil dose. The patient sought medical attention. The next morning, the clinic administered 50 mg of BENADRYL and "it went back to normal". The nurse practitioner did not mention if it was because of the diphenhydramine. Subsequently, the patient recovered. They plan to give the second shot. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Dizziness, Feeling cold, Loss of consciousness, Tunnel vision
Clinical narrative: Initial and follow up information has been received from a registered nurse and a health care provider, concerning a 12 year old female patient who on 21-NOV-2006 (previously reported as within the last 3 months) was vaccinated intramuscularly in the right deltoid, with an 0.5 mL dose of GARDASIL vaccine (Lot #653937/0637F), and on 06-FEB-2007, was vaccinated IM in the left deltoid with an additiional 0.5 mL dose of GARDASIl vaccine (Lot # 653937/0637F). After receiving the dose on 06-FEB-2007. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information from the health care provider who administered the vaccine, stated that on 06-FEB-2007 after the vaccination, the patient "was really cold, she got tunnel vision and began to lose her balance." The patient rested for 15 minutes, and was sent home after evaluation by the nurse. The patient was considered to have recovered on the same day. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a nurse via a company representative concerning a 26 year old female with a history of warts from childhood who on 02-FEB-2007 was vaccinated with a first 0.5 mL dose of GARDASIL (lot #655619/1427F), injection in left deltoid. Concomitant therapy included hormonal contraceptives (unspecified). It was reported by the nurse that the patient informed the clinic that she had a breakout of warts in her forearm 4 days after vaccination, on 06-FEB-2007. At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil (yeast). Subsequently the patient experience rash on back. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on 19-FEB-2007 was vaccinated IM with a dose of Gardasil (Lot # 654741/0013U). On 19-FEB-2007, the patient fainted after receiving the Gardasil injection. The patient was known by the provider to be squeamish with injections. After the fainting episode, the patient was observed for a brief period of the time and then was discharged from the physician's office. On 19-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Borrelia test negative, Fatigue
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 18-JAN-2007 was vaccinated IM with a first dose of Gardasil. No other vaccinations were administered. On approximately 18-JAN-2007, the patient experienced soreness at injection site, fatigue, musculo-skeletal pain, and joint pain. The following laboratory tests were performed on the patient: complete blood cell (CBC) count; erythrocyte sedimentation rate (sed rate); rheumatoid factor (RF); antinuclear antibodies test (ANA); creatine kinase (CPK); "strep test"; influenza A and B; Lyme disease enzyme-linked immunosorbent assay. All lat test results were reported as normal. The patient was not prescribed any treatment. By 20-FEB-2007, the patient was fully recovered. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Follow-up from a physician indicated that approximately 10-14 days after the patient was vaccinated, she developed shoulder, hip and ankle pains. On 07-FEB-2007, the patient had a shoulder x-ray, right knee x-ray, and hip x-ray. All were normal. On 07-Feb-2007, the patient's ESR was 41. On 17-FEB-2007 the patient recovered from the shoulder, hip and ankle pain. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Influenza serology negative, Injection site pain, Microbiology test, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 18-JAN-2007 was vaccinated IM with a first dose of Gardasil. No other vaccinations were administered. On approximately 18-JAN-2007, the patient experienced soreness at injection site, fatigue, musculo-skeletal pain, and joint pain. The following laboratory tests were performed on the patient: complete blood cell (CBC) count; erythrocyte sedimentation rate (sed rate); rheumatoid factor (RF); antinuclear antibodies test (ANA); creatine kinase (CPK); "strep test"; influenza A and B; Lyme disease enzyme-linked immunosorbent assay. All lat test results were reported as normal. The patient was not prescribed any treatment. By 20-FEB-2007, the patient was fully recovered. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Follow-up from a physician indicated that approximately 10-14 days after the patient was vaccinated, she developed shoulder, hip and ankle pains. On 07-FEB-2007, the patient had a shoulder x-ray, right knee x-ray, and hip x-ray. All were normal. On 07-Feb-2007, the patient's ESR was 41. On 17-FEB-2007 the patient recovered from the shoulder, hip and ankle pain. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcal serology negative, X-ray limb normal, X-ray of pelvis and hip
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 18-JAN-2007 was vaccinated IM with a first dose of Gardasil. No other vaccinations were administered. On approximately 18-JAN-2007, the patient experienced soreness at injection site, fatigue, musculo-skeletal pain, and joint pain. The following laboratory tests were performed on the patient: complete blood cell (CBC) count; erythrocyte sedimentation rate (sed rate); rheumatoid factor (RF); antinuclear antibodies test (ANA); creatine kinase (CPK); "strep test"; influenza A and B; Lyme disease enzyme-linked immunosorbent assay. All lat test results were reported as normal. The patient was not prescribed any treatment. By 20-FEB-2007, the patient was fully recovered. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Follow-up from a physician indicated that approximately 10-14 days after the patient was vaccinated, she developed shoulder, hip and ankle pains. On 07-FEB-2007, the patient had a shoulder x-ray, right knee x-ray, and hip x-ray. All were normal. On 07-Feb-2007, the patient's ESR was 41. On 17-FEB-2007 the patient recovered from the shoulder, hip and ankle pain. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Formication, Limb discomfort, Pain in extremity, Sensory disturbance
Clinical narrative: Information has been received from a 24 year old female consumer with a history of prednisone reaction unspecified, and a history of papilloma viral infection, knee surgery 6 weeks for unspecified condition who on 12-FEB-2007 was vaccinated with Gardasil (lot # not reported) injection. Concomitant therapy included ORTHO TRI-CYCLEN LO. On 14-FEB-2007, the patient experienced legs (from mid thigh to mid calf) felt creepy-crawling, uncomfortable especially when laying down, they don't feel like my legs after receiving the injection. The patient also reported that her arm was very sore for about 3 days after receiving the injection but that went away. At the time of reporting the creepy-crawling feeling, and limb discomfort persisted. No further information was provided at the time of reporting. Additional information has been requested. This is in follow-up to report (s) previously submittedon 3/14/2007. Additional information was received from a nurse practioner. On 19-Feb-2007, seven days after receiving the vaccination, the patient called the office and complained of pain and numbness in both legs for 5 days. The outcome of the pain and numbness was not reported. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who on an unspecified date was vaccinated IM with Gardasil and experienced a "sore arm" after being vaccinated. Medical attention was sought. The patient was reported as recovered. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a Registered Nurse (R.N.) and a physician concerning a female patient who on an unspecified date was vaccinated IM with a second dose at day 27 of GARDASIL and experienced a "sore arm" after being vaccinated. Medical attention was sought. The patient was reported as recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse via a company representative concerning a female (age not reported) with an allergy to bakers yeast and on a gluten free diet who, on an unspecified date, was vaccinated with a second dose of Gardasil and passed out (dates not reported). It was reported that the patient received the first dose with "no problem". At the time of the report, recovery status of the patient was unspecified. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with a Gardasil. Subsequently the patient developed a cold after the second and third dose. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug administered at inappropriate site, Nausea
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a second dose of Gardasil. The patient was vaccinated in the "glut" per the patient's request. Subsequently the patient felt dizzy and nauseous. It was noted that the patient may have not eaten all day. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second dose of GARDASILl. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Additional information has been requested. Follow up information confirmed thst no known person was identified or involved with the event.  Therefore, VAERS # 0702USA03636 is being deleted from our files.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This is in follow-up to report (s) previously submitted 3/14/2007. Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second dose of GARDASIL. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Additional information has been requested. Follow up information confirmed that no known patient was identified or involved with the event. Therefore, WAES # 0702USA03637 is being deleted from our files. This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received froma physician via a company representative, concerning a female patient who was vaccinated with either a first dose or GARDASIL. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Follow up information confirmed that no known patient was identified or involved with the event. Therefore, WAES # 0702USA03637 is being deleted from our files. This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first or second dose of GARDASIL. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Follow up information confirmed that no known patient was identified or involved with the event. Therefore, WAES # 0702USA03638 is being deleted from our files. The report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who was vaccinated with Gardasil. Subsequently the patient experienced injection site pain and the site was bruised. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning an 18 year  old female who was vaccinated with Gardasil. Subsequently, the patient experienced injection site pain. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gonorrhoea
Clinical narrative: Information has been received from a nurse practitioner through the pregnancy registry concerning a 19 year old female with asthma and genital warts and a history of migraines, miscarriage at 4 months of pregnancy and high blood pressure who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (lot # 654741/0013U). Concomitant therapy included ADVAIR and trichloroacetic acid. On 25-JAN-2007 the patient was noted to be pregnant (last menstrual period was on 03-JAN-2007). On 03-FEB-2007 the patient was treated with 500 mg of CIPRO for gonorrhea. At the time of this report, the outcome of the events was unknown. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a female consumer (age unknown) who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Subsequently, on an unknown date, the patient experienced nausea and dizziness after receiving the second dose of vaccine which was administered with a regular needle. Symptoms subsided after 15-20 minutes. The reporting physician stated that the patient was not affected by the first dose of vaccine which was administered with a safety syringe. The patient sought unspecified medical attention. Subsequently, the patient recovered from nausea and dizziness. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old female patient who was vaccinated "during the last couple of weeks" (February 2007), with the first dose of Gardasil. Concomitant suspect therapy included other vaccines (therapy unspecified) that were administered at the visit. The physician reported that the patient "fainted after getting Gardasil and several other vaccines were administered at the same visit. Subsequently, the patient recovered. The patient sought unspecified medical attentions. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated intramuscularly with a first dose of Gardasil. The next day, the patient developed a high temperature of 103 degrees F. Unspecified medical attention was sought. Subsequently, the patient recovered. The physician plans to continue the series of Gardasil. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 12 year old female with no pertinent medical history who in approximately January 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a lump at the injection site. It was reported that the lump at the injection site "recently" became painful. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the lump and pain at the injection site persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Malaise
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and history of drug reactions/allergies unspecified who on 19-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 IM. There was no concomitant medication. On 20-FEB-2007, the patient developed flu-like symptoms. The patient sought medical attention. The patient reported to the physician that she was experiencing a headache, not feeling well, and all over body pain (but not pain at the injection site). At the time of reporting, the outcome was unspecified. No further information was available at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 15 year old female with no illness at the time of being vaccinated and no pertinent medical history and history of drug reactions/allergies who on 19-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 656372/0243U) 0.5 ml IM in the left hip. There was no concomitant medication. On 20-FEB-2007, the patient developed flu-like symptoms. The patient sought medical attention. The patient reported to the physician that she was experiencing a headache, not feeling well, and all over body pain (but not pain at the injection site). At the time of reporting, the outcome was unspecified. No further information was available at the time of reporting. Additional information was received from the physician. On 19-FEB-2007, in the evening, the patient experienced pain at the injection site, associated hip and leg pain, mild swelling, headache, general malaise, and arthralgias. The events were reported as non-serious. On an unspecified date, the patient recovered. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pain, Pain in extremity, Swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and history of drug reactions/allergies unspecified who on 19-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 IM. There was no concomitant medication. On 20-FEB-2007, the patient developed flu-like symptoms. The patient sought medical attention. The patient reported to the physician that she was experiencing a headache, not feeling well, and all over body pain (but not pain at the injection site). At the time of reporting, the outcome was unspecified. No further information was available at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 15 year old female with no illness at the time of being vaccinated and no pertinent medical history and history of drug reactions/allergies who on 19-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 656372/0243U) 0.5 ml IM in the left hip. There was no concomitant medication. On 20-FEB-2007, the patient developed flu-like symptoms. The patient sought medical attention. The patient reported to the physician that she was experiencing a headache, not feeling well, and all over body pain (but not pain at the injection site). At the time of reporting, the outcome was unspecified. No further information was available at the time of reporting. Additional information was received from the physician. On 19-FEB-2007, in the evening, the patient experienced pain at the injection site, associated hip and leg pain, mild swelling, headache, general malaise, and arthralgias. The events were reported as non-serious. On an unspecified date, the patient recovered. No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007; 4/6/2007. Information has been received from a registered nurse, for the Pregnancy registry for Gardasil, concerning a 19 year old female with no previous pregnancies, no known drug allergies, and a history of anxiety who on 03-NOV-2006 was vaccinated with first dose of Gardasil (lot # 653938/0954F) 0.5 ml in the left deltoid. Concomitant therapy included promethazine hydrochloride. On 05-JAN-2007, the patient was vaccinated with second dose of GARDASIL (lot # 655165/1425) 0.5 ml. There was no concomitant medication. The patient sought medical attention. Her last menstrual period was on 05-DEC-2006. On 29-JAN-2007, the patient's primary physician performed a quantitative beta blood test at the physician's office which was positive for pregnancy. Estimate date of delivery is 11-SEP-2007. On 08-FEB-2007, the patient experienced abdominal discomfort and was sent to the hospital for an ultrasound which was positive for pregnancy. The patient was not hospitalized. At the time of reporting, the patient no longer had abdominal discomfort. Additional information was received from the registered nurse. On 08-FEB-2007, an ultrasound was performed for pain that revealed intrauterine pregnancy of 6 weeks and 5 days and subchorionic hemorrhage. On 16-MAY-2007, an ultrasound was performed that revealed normal anatomy scan. The estimated date of delivery was calculated as 30-SEP-2007. Additional information was received from the registered nurse. The patient's LMP was on 25-DEC-2006. On 09-OCT-2007, 40 weeks from LMP, the patient delivered a female baby weighing 7 pounds 10 ounces. Apgar scale 8/9. The infant was reported as normal and healthy, no congenital anomalies and no complications. Additional information is not expected. 07/08/08 Follow-up information was obtained from a health professional in the physician's office via voice mail. It was reported that they did see the baby one time in the hospital, but it was not their patient. They do not have any medical records for this patient. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. Subsequently the patient experienced a rash and redness around at the injection site. Subsequently, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysmenorrhoea, Fatigue, Somnolence
Clinical narrative: Information has been received from a 21 year old female consumer with pertinent medical history reported as unspecified who on 16-FEB-2007 was vaccinated with the second dose of GARDASIL (lot #655618/0186U), injection (form) left arm. Concomitant therapy included YASMIN and AMITIZA. On 17-FEB-2007, the patient experienced dizziness, menstrual cramping and she felt extremely tired and heavily medicated since she was administered Gardasil on 16-FEB-2007. The patient sought unspecified medical attention. The patient advised that her symptoms were becoming worse and have not improved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. On 17-FEB-2007, the patient experienced dizziness and nausea (previously reported as menstrual cramping, she felt extremely tired and heavily medicated) since she was administered GARDASIL on 16-FEB-2007. The patient sought unspecified medical attention. On 23-FEB-2007, the patient recovered from the nausea and dizziness. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with her first dose of Gardasil and one day later developed hives and itchiness through out her body. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle rigidity, Pallor
Clinical narrative: Information has been received from an RN concerning a 21 year old white female student who on 09 Feb 2007 at 11:00 a.m. was vaccinated with her first dose of Gardasil. After giving the injection, the nurse reported that the patient "passed out less then 2 seconds. Patient got extremely almost like a seizure less than 1 second." The patient never lost breathing and came back pale. She was left lying down for 20 minutes, and was discharged well. It was reported that no medical attention was required. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a health professional concerning a 19 year old white female waitress who on 12 Jan 2007 was vaccinated IM in left deltoid with her second dose of Gardasil and got dizzy, was sweating and nauseated. Her outcome was unknown. There were no concomitant medications; and no adverse events following prior vaccination. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Flushing, Nausea, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 25 year old Hispanic female engineer with no known drug allergies who, on an unspecified date, was vaccinated in the left gluteal muscle with a first dose of Gardasil. There was no concomitant medication. On 26 Oct 2006 the patient became flush, experienced vomiting and nausea. There was no illness at the time of vaccination. It was reported that the patient recovered the same day, 26 Oct 2006. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Pain
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 04-DEC-2006 in the PM was vaccinated with a second dose of Gardasil (lot # 653735/0688F), in the left deltoid. There was no concomitant therapy. On 04-DEC-2006 the patient experienced "pain, hot, sweating, dizzy, nauseated." On 14-SEP-2006 the patient was vaccinated with a first dose of Gardasil (yeast). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Hyperhidrosis, Injection site pain, Nausea, Syncope
Clinical narrative: Information has been received from a health professional concerning a 22 year old female with allergy to CECLOR who on 06-DEC-2006 was vaccinated with a second dose of Gardasil (lot #655619/1427F), in the left deltoid. There was no concomitant medication. on 01-JAN-2007 the patient experienced "faint, sweaty, flushed, nauseated and pain (site). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history and no allergies who on 02-FEB-2007 was vaccinated with a second dose of HPV (lot # 655503/00120), intramuscularly. The first dose of GARDASIL was given on 27-Oct-2006. There was no concomitant medication. On 02-FEB-2007 the patient experienced intermittent headache and soreness at the injection site of the left arm. The patient was examined by the physician on 20-FEB-2007 and was recommended Tylenol. The patient's symptoms lasted for three weeks after which she recovered. No product quality complaint was involved. It was noted that the first dose of HPV was received on 27-OCT-2006. At the time of the report, the patient was considered to be not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 13 year old female patient who on 11-JAN-2007 was vaccinated with the first dose, 0.5ml, IM of HPV. The nurse reported that the patient had developed vaginal bleeding that had "varied from light to heavy and has been continuous since the date of administration." The nurse reported that the patient had been referred to an OBGYN for further evaluation. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 19 year old female with a history of abnormal papanicolaou smear who on 21-DEC-2006 was vaccinated IM in left deltoid with her first dose of HPV, lot # 653736/0689F. Concomitant therapy included Yasmin and Prozac. She experienced severe pain in the arm with the first dose. This reaction was reported at the time of her second vaccination. On 21-FEB-2006 her second dose of HPV, lot # 655617/1447 was administered via gluteus. No symptoms were reported at that time. The patient was reported as recovered on an unspecified date. Additional information has been requested.