chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 17 year old old daughter who in January 2007, was vaccinated IM with a 0.5 ml first dose of GARDASIL. In March, 2007 the patient received IM a 0.5 ml second dose of GARDASIL. There was no concomitant medication. The mother reported that the patient had swelling on her arm at the injection site, redness, pain, muscle pain over body, and chills lasting for 3 days a few hours after her second dose in March 2007. Patient was not able to attend school. The first dose, which had same symptoms but to a lesser degree, was in January 2007 and was not sure how long the lasted. Medical attention was not sought. On an unspecified date the patient recovered. Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information from the physician regarding an 18 year old female patient with no previous medical history or no known drug allergies or birth defects, who on 28-Nov-2006 (previously reported by mother as January 2007) was vaccinated IM with the first dose of GARDASIL (lot# not reported) and on 30-Jan-2007 (previously reported as in March 2007) the patient was vaccinated IM with the second dose of GARDASIL (lot# not reported). There was no concomitant medication. On 30-Jan-2007 the patient experienced pain-elbow to middle of back (7 of 10). Then decreased to 3 of 10. After 3rd day, then ached for 2 weeks. Some swelling, fatigued, stiffness all over especially arm. The patient complained of not being able to withstand any pressure on arm. Difficulty sleeping because of pain. Cold (Ice), heat and ibuprofen were all tried but no relief. The patient had difficulty with school work which was very unusual. Patient was unable to participate in high school varsity athletics for a week and missed some school classes. Very painful and caused severe fatigue. Reaction was severe that the physician decided to not go for the third shot. It was also reported the patient had no memory of events of first 3-4 days after receiving shot. On 12-Feb-2007 the patient had recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 17 year old old daughter who in January 2007, was vaccinated IM with a 0.5 ml first dose of GARDASIL. In March, 2007 the patient received IM a 0.5 ml second dose of GARDASIL. There was no concomitant medication. The mother reported that the patient had swelling on her arm at the injection site, redness, pain, muscle pain over body, and chills lasting for 3 days a few hours after her second dose in March 2007. Patient was not able to attend school. The first dose, which had same symptoms but to a lesser degree, was in January 2007 and was not sure how long the lasted. Medical attention was not sought. On an unspecified date the patient recovered. Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information from the physician regarding an 18 year old female patient with no previous medical history or no known drug allergies or birth defects, who on 28-Nov-2006 (previously reported by mother as January 2007) was vaccinated IM with the first dose of GARDASIL (lot# not reported) and on 30-Jan-2007 (previously reported as in March 2007) the patient was vaccinated IM with the second dose of GARDASIL (lot# not reported). There was no concomitant medication. On 30-Jan-2007 the patient experienced pain-elbow to middle of back (7 of 10). Then decreased to 3 of 10. After 3rd day, then ached for 2 weeks. Some swelling, fatigued, stiffness all over especially arm. The patient complained of not being able to withstand any pressure on arm. Difficulty sleeping because of pain. Cold (Ice), heat and ibuprofen were all tried but no relief. The patient had difficulty with school work which was very unusual. Patient was unable to participate in high school varsity athletics for a week and missed some school classes. Very painful and caused severe fatigue. Reaction was severe that the physician decided to not go for the third shot. It was also reported the patient had no memory of events of first 3-4 days after receiving shot. On 12-Feb-2007 the patient had recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Crying, Musculoskeletal pain
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with no medical history and no known allergies who on 23-OCT-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 04-JAN-2008 the patient was vaccinated with IM with the second 0.5 ml dose of GARDASIL (Lot # 658563/1063U) and on an unspecified date was vaccinated IM with the third 0.5 ml dose of GARDASIL (Lot # 65863/1063U). Concomitant therapy included birth control shot. The patient cried with the second dose but did not have severe pain. After the third dose, the patient experienced severe pain radiating to her shoulder and elbow. She was doubled over in pain. She was treated at home with an ice pack and TYLENOL. At the time of reporting, patient was recovering. Unknown medical attention was sought in the office. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of GARDASIL.  Subsequently, the patient developed redness at the injection site in the "shape of a band aid."  It was reported that the patient would put a band aid on the area and the mark was still there.  On an unspecified date the patient returned to the office for her second dose of GARDASIL and the redness at the injection site had not resolved.  The patient sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Syncope
Clinical narrative: Information has been received from a billing manager concerning a 14 year old female who on 25-SEP-2007 was vaccinated with a 1st dose of GARDASIL (lot# 658282/0929U).  On 10-DEC-2007 the patient was vaccinated with a 2nd dose of GARDASIL (lot# 656372/0243U).  On 14-APR-2008 the patient was vaccinated with a 3rd dose of GARDASIL (lot# 659441/1446U).  Concomitant therapy included HAVRIX, lot# AVB223AA).  Subsequently, on 14-APR-2008 the patient fainted 5 minutes after receiving her 3rd dose.  The nurse held the patient.  The patient felt weak so she laid down for 10-15 minutes.  The patient was given water and after 15 minutes, she was fine.  The patient had no symptoms following the previous 2 doses.  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 medical technologist, concerning a female patient (age not specified), who on unknown dates was vaccinated with the first and second and third doses of GARDASIL.  Subsequently, during a routine cervical cancer screen, the patient was found to be positive for both low risk and high risk human papilloma virus.  At the time of this report, the patient had not recovered.  No further information was available.  Additional information has been requested.  This is one of 2 reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml third dose of GARDASIL (lot# not provided). The physician reported patient about 6 months after receiving her third dose of GARDASIL experienced genital warts. Unspecified medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 14 year old female who between October 2006 and May 2007 the patient was vaccinated with her 3 doses of GARDASIL (lot# not reported). It was reported that after May 2007 the patient inadvertently received 2 additional doses of GARDASIL (lot# not provided) from a different physician's office. In April 2008 ("last week"), the patient developed headaches and leg pain. Patient outcome was not reported. The patient sought medical attention at the physician's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Injection site rash, Nausea, Pyrexia, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a nurse practitioner concerning a 16 year old female who on 22-OCT-2007 was vaccinated in the morning IM in the left arm with a 2nd dose of GARDASIL (lot#658563/1063U).  On 22-OCT-2007, in the PM the patient developed a low grade fever, rash surrouding injection site, and also experienced nausea and chills and vomiting (x1 episode) after receiving her vaccination.  Subsequently, the patient recovered from low grade fever, rash surrounding injection site, nausea, chills and vomiting 1 or 2 days later.  The patient sought unspecified medical attention by calling the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first 0.5 ml dose of GARDASIL (no lot number provided). The patient developed hives a few days after the vaccination. The hives did clear up but broke out again after a few weeks. The patient had not received the second dose of GARDASIL yet which was why the physician believed her experienced was not related to the GARDASIL. Unknown medical attention was sought. At time of reporting, patient outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 22-FEB-2008 was vaccinated with GARDASIL (Lot # site and route not reported). Subsequently the patient experienced numbness at injection site. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 23-APR-2008 was vaccinated with GARDASIL (Lot #, dose and site not reported).  On 23-APR-2008 the patient fainted after receiving GARDASIL.  Approximately 10 minutes after fainting, the patient recovered.  No further information was provided.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a white patient (gender not reported) who on 04-APR-2008 was vaccinated IM into the deltoid with a first dose of GARDASIL (lot # 659182/1757U). On 14-APR-2008 the patient complained of rash ("7 days after injection") to both wrists. Subsequently, the patient recovered on it's own on 18-APR-2008. No further information is available.
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a "13-15 year old" female who "last week" (on approximately 18-APR-2008) was vaccinated with a first dose of GARDASIL (Lot # not reported).  Concomitant therapy included MENACTRA and Tdap.  It was reported that the patient received GARDASIL and fainted.  Subsequently, the patient recovered from fainting (date unspecified).  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Colposcopy, Deafness, Dizziness, Flushing
Clinical narrative: Information has been received from a physician concerning a 19 year old Caucasian female student with moderate dysplasia, HPV, and abnormal pap smear (CIN 2 with high risk HPV types) who on 24-APR-2008 was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL (Lot# 659437/1266U).  Concomitant therapy included DEPO-PROVERA.  On 24-APR-2008 the patient became dizzy, clammy, flushed and reported that the injection was painful.  Subsequently, the patient recovered on 24-APR-2008 from dizzy, clammy, flushed and injection pain.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Follow up information was received that indicated that immediately following the injection, the patient became very dizzy, clammy, and her cheeks were flushed.  The patient felt as though she was going to lose consciousness.  She also reported visual and audible "waves".  The symptoms lasted approximately 8 - 10 minutes.  On 24-APR-2008, the patient was recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Smear cervix abnormal, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a 19 year old Caucasian female student with moderate dysplasia, HPV, and abnormal pap smear (CIN 2 with high risk HPV types) who on 24-APR-2008 was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL (Lot# 659437/1266U).  Concomitant therapy included DEPO-PROVERA.  On 24-APR-2008 the patient became dizzy, clammy, flushed and reported that the injection was painful.  Subsequently, the patient recovered on 24-APR-2008 from dizzy, clammy, flushed and injection pain.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Follow up information was received that indicated that immediately following the injection, the patient became very dizzy, clammy, and her cheeks were flushed.  The patient felt as though she was going to lose consciousness.  She also reported visual and audible "waves".  The symptoms lasted approximately 8 - 10 minutes.  On 24-APR-2008, the patient was recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Oral mucosal petechiae, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a female with a history of rhabdomyosarcoma who was vaccinated IM with the second 0.5 ml dose of GARDASIL. After the vaccination, the patient developed bruising on the arm opposite the injection site and on both thighs. She also had petechiae on her pallet. The patient noted that the same symptoms also developed after dose one of the series. Unknown medical attention was sought in the office. At the time of reporting, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). Subsequently, the patient developed a lump at the injection site. The lump lasted 3 to 4 days. No further information was provided. Additional has been requested.
Sex: F
Vaccine: HIBV, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on 24-APR-2008 was vaccinated with a dose of GARDASIL (number of dose and lot number not reported). Concomitant therapy included PEDVAXHIB and MENACTRA (lot numbers not reported). On 24-APR-2008 the patient fainted after receiving GARDASIL. Subsequently, the patient recovered from fainting on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a nurse concerning her 12 year old daughter who on 02-MAR-2007 was vaccinated IM with the first dose of GARDASIL.  On 27-APR-2007, the patient was vaccinated IM with the second dose of GARDASIL and on 17-AUG-2007, the patient was vaccinated IM with the third dose of GARDASIL.  The patient reported pain in the arm at the injection site for 3 days after the vaccination was given.  The pain in the arm included not being able to lift the arm.  The nurse also reported that since multiple patients (3 patients) reported pain in their arms, they started giving the vaccination in the buttocks to an unspecified number of patients.  Unknown medical attention was sought through contact with the nurse.  Patient outcome was unknown.  No product quality complaint was involved.  This is one of the multiple cases from the same source (WAES # 0805USA01521 and 0805USA01522).  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Amenorrhoea, Blood test, Computerised tomogram
Clinical narrative: Information has been received from a consumer concerning her sister who on an unspecified date in October 2007, was vaccinated "by injection" with a 0.5 mL first dose of GARDASIL (lot # not reported). On an unspecified date in November 2007 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). On an unspecified date in April 2008, the patient was vaccinated with a third dose of GARDASIL (lot # not reported). There was no concomitant medication. The consumer reported that "the patient experienced nausea, stomach ache, diarrhea, abdominal pain and rash after getting all three doses". It was also reported that the "patient's LMP was in November 2007 and did a pregnancy test but she is not pregnant". The patient sought unspecified medical attention. The nausea, stomach ache, diarrhea, abdominal pain, rash and amenorrhea persisted. Laboratory tests included a CT scan, blood test and urine test. The results of the CT scan, blood test and urine test were not reported. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Pregnancy test negative, Rash, Urine analysis
Clinical narrative: Information has been received from a consumer concerning her sister who on an unspecified date in October 2007, was vaccinated "by injection" with a 0.5 mL first dose of GARDASIL (lot # not reported). On an unspecified date in November 2007 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). On an unspecified date in April 2008, the patient was vaccinated with a third dose of GARDASIL (lot # not reported). There was no concomitant medication. The consumer reported that "the patient experienced nausea, stomach ache, diarrhea, abdominal pain and rash after getting all three doses". It was also reported that the "patient's LMP was in November 2007 and did a pregnancy test but she is not pregnant". The patient sought unspecified medical attention. The nausea, stomach ache, diarrhea, abdominal pain, rash and amenorrhea persisted. Laboratory tests included a CT scan, blood test and urine test. The results of the CT scan, blood test and urine test were not reported. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her sister who on an unspecified date in October 2007, was vaccinated "by injection" with a 0.5 mL first dose of GARDASIL (lot # not reported). On an unspecified date in November 2007 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). On an unspecified date in April 2008, the patient was vaccinated with a third dose of GARDASIL (lot # not reported). There was no concomitant medication. The consumer reported that "the patient experienced nausea, stomach ache, diarrhea, abdominal pain and rash after getting all three doses". It was also reported that the "patient's LMP was in November 2007 and did a pregnancy test but she is not pregnant". The patient sought unspecified medical attention. The nausea, stomach ache, diarrhea, abdominal pain, rash and amenorrhea persisted. Laboratory tests included a CT scan, blood test and urine test. The results of the CT scan, blood test and urine test were not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning a female (age unknown), who on approximately 25-MAR-2008 was vaccinated with a second dose of GARDASIL. Subsequently, the patient was pregnant and experienced a sore arm. The patient sought unspecified medical attention. At the time of the report the patient was approximately 8 weeks gestation. The patient's last menstrual period was approximately 02-MAR-2008 and her estimated delivery date was 07-DEC-2008. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a female who on 26-APR-2008 was vaccinated intramuscularly with a third dose of GARDASIL (lot # not reported). The nurse reported that the patient received the dose in the morning and in the afternoon, she complained of hives that appeared from her neck up. The patient sought medical attention during a phone call to the physician. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular
Clinical narrative: Information has been received from a health professional concerning a 25 year old female with no medical history and no drug allergies, who on 22-OCT-2007 was vaccinated IM in the right deltoid with a first dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  On 20-DEC-2007 the patient was vaccinated with a second dose of GARDASIL.  The patient received dose one and two without any complaints.  On 26-APR-2008 the patient was vaccinated with a third dose of GARDASIL (Lot# 654272/0073X).  On 26-APR-2008 the patient developed bumps all over her face and on the arms.  The bumps were not itchy or red.  The patient called the office.  No laboratory diagnostics were performed.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no medical history and no drug allergies, who "one month ago" was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient experienced prolonged migraine headaches.  The patient was seen by her physician.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Smear cervix abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician concerning a 19 year old female with Human papilloma virus infection (16,18,31,33,35,39,45,51,52,56,58,59,68) and no allergies, who, on an unspecified date, was vaccinated with a second dose of GARDASIL.  There was no illnesses at the time of vaccination. Subsequently, the patient developed a delayed injection site reaction. It was reported that the vaccine was administered on a Friday and Saturday the patient developed redness at the injection site. On Sunday the patient developed a hard lump on the arm and pain that lasted for 2 to 3 days.  It was noted that the patient had tested positive for human papilloma virus at a prior Pap smear. The patient sought unspecified medical attention. It was reported that the patient was not seen by medical personnel because she was away. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated IM with a 0.5 ml dose of GARDASIL (dose# unknown). Within minutes the patient fainted. Unknown medical attention was sought in the physician's office. The patient was quickly recovered. This is one of two cases from the same source (WAES# 0804USA03629). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported) with an allergy to aluminum, who on an unknown date was vaccinated with the first dose of GARDASIL (lot # not reported). Within 24 hours, she developed hives. The patient called the physician, and was instructed to take BENADRYL. Subsequently, the patient recovered (duration not specified). Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008.  Initial and follow up information has been received from a physician via a company representative and from doctor's office, concerning a 20 year old female nursing student with an allergy to aluminum, who on 13-MAR-2008 at 01:13 PM was vaccinated IM into left deltoid with a second dose of GARDASIL (Lot # 655849/0263U).  The reporter reported that within 24 hours, she developed itching and hives.  The patient called the physician, and was instructed to take BENADRYL.  Subsequently, the patient recovered (duration not specified).  It was reported that patient would not get another dose of GARDASIL.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Menstrual disorder
Clinical narrative: Information has been received through the Merck pregnancy registry, for GARDASIL concerning a female patient who in February 2008, was vaccinated with a dose of GARDASIL. Subsequently, the patient had abnormal periods and became pregnant. The patient sought unspecified medical attention. 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: Human papilloma virus test positive, Viral DNA test positive
Clinical narrative: Information has been received from a nurse concerning her daughter (age unknown) with unknown medical history, who was vaccinated (route unknown) with all three doses of GARDASIL (Lot #'s unknown).  Subsequently, on an unknown date, the patient tested positive for "high grade" HPV infection even after receiving all three doses.  Lab diagnostic studies performed was a "HPV test" (results: + for "high grade" HPV).  Outcome unknown.  The patient was seen by a physician for unspecified medical attention.  No product quality complaint was involved.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information and follow-up information has bee received from a physician concerning a 17 year old Asian female patient who on 02-APR-2008 approximately at 6:00pm, was vaccinated intramuscularly in the arm with a first dose of GARDASIL. The patient fainted right after getting the first dose of GARDASIL walking out from a room. The patient recovered quickly at 6:25 pm. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with all three doses of GARDASIL (lot#'s not reported) at a different office. The physician is treating the patient because she is experiencing headaches that she did not have before the vaccination series. The patient's outcome was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles, Skin reaction
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated intramuscularly with the first dose of GARDASIL. Subsequently, the patient experienced a skin reaction or what was described as half a boiled egg and her skin was bubbling a little at the injection site. No medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Information has been received from a staff member of a physician's office, via a company representative, concerning a 15 year old female patient, who on 26-APR-2008 was vaccinated IM, with the second dose, 0.5 ml, of GARDASIL (lot # 659182/1757U). On 28-APR-2008 the patient developed an itchy rash on her arms and legs. The patient called the physician on the phone, but an office visit was not reported (treatment not specified). Additional information has been requested. 02/18/2010 Follow-up information was received from the physician's office. The patient had no illness or time of vaccination. On 30-APR-2008 the patient developed scattered erythema papules from mid-thigh to the ankle on both legs. The greater amount was on the left ankle. At the time of reporting the patient recovered from the scattered erythema papules. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with GARDASIL (lot # not provided). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced extreme drowsiness within an hour after receiving GARDASIL. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse and a physician concerning a female (age not reported) who, on an unspecified date, was vaccinated with a 0.5 mL dose of GARDASIL into the gluteal.  There was no concomitant medication.  Subsequently, the patient developed notable pain at the injection site.  Outcome was not reported.  The patient sought medical attention in the office.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Mastication disorder, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 22-APR-2008 was vaccinated with a first dose of GARDASIL (lot# 659964/1979U). Concomitant therapy included a dose of MENACTRA. It was reported that the patient fainted after her vaccination. On approximately 22-APR-2008 "one to one and a half weeks ago" the patient experienced an earache and had problems chewing food. The patient's events persisted. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Gastrointestinal disorder, HIV test negative, Inappropriate schedule of drug administration, Laboratory test
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 16-JAN-2007, 11-JUL-2008, and on 18-JAN-2008 was vaccinated IM with a 0.5 ml first, second and third dose of GARDASIL, respectively (first dose lot# 654389/0961F, second dose lot # 658100/05250, and third dose lot# 659653/1448U . There was no concomitant medication. Within the past year, the patient experienced swollen glands, fatigue and digestive problems. The patient had an office visit with the family physician. An HIV test was negative and the patient underwent other unspecified lab diagnostic studies. The patient's swollen glands and fatigue and digestive problems persisted. No product quality complaint was involved. Additional quality has been requested.  06/03/2008 Brief office note dated 4/30/08 received. Pt called to say she had a 1 yr long hx of swollen glands, aches, and fatigue. Testing has been (-) for Lymes, mono, and HIV. Was not treated or seen in that office since vaccines
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 16-JAN-2007, 11-JUL-2008, and on 18-JAN-2008 was vaccinated IM with a 0.5 ml first, second and third dose of GARDASIL, respectively (first dose lot# 654389/0961F, second dose lot # 658100/05250, and third dose lot# 659653/1448U . There was no concomitant medication. Within the past year, the patient experienced swollen glands, fatigue and digestive problems. The patient had an office visit with the family physician. An HIV test was negative and the patient underwent other unspecified lab diagnostic studies. The patient's swollen glands and fatigue and digestive problems persisted. No product quality complaint was involved. Additional quality has been requested.  06/03/2008 Brief office note dated 4/30/08 received. Pt called to say she had a 1 yr long hx of swollen glands, aches, and fatigue. Testing has been (-) for Lymes, mono, and HIV. Was not treated or seen in that office since vaccines
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# 654272/0073X).  Subsequently the patient became violently ill and was throwing up.  The patient was brought back into the office the next day.  Her outcome was not reported and it was unclear whether the patient would continue the GARDASIL series.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Injection site erythema, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with a penicillin allergy and no medical history, who in January 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  In approximately January 2008, the patient developed a reddened injection site and then a delayed onset of fatigue three weeks later.  It was also reported that the patient had an abnormal papanicolaou test (it was negative for human papillomavirus).  It was also reported that the patient was under the care of another provider.  The patient did not seek medical treatment for the symptoms.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme abnormal, Infectious mononucleosis, Mononucleosis heterophile test positive
Clinical narrative: Information has been received from a physician concerning an 18 year old female, with a history of cardiac irregularity detected during an athletic physical, who on 08-APR-2008 was vaccinated with second dose of GARDASIL (lot # not reported). Concomitant therapy included HAVRIX, administered on 08-APR-2008. Blood work taken on 09-APR-2008 showed elevated liver enzymes were positive for mononucleosis. AST (SGOT) level was 129 and her ALT (SGPT) level was 223. Her only symptom was fatigue. The patient sought unspecified medical attention during an office visit. The patient's elevated liver enzymes and mononucleosis persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with no pertinent medical history, who was vaccinated (route unknown) with a first and second dose of GARDASIL (Lot #'s unknown).  The physician indicated that the patient reported after the first dose it was painful.  When the patient received the second dose, "just last week", she reported no pain; however, she fainted.  The patient's outcome is reported as recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 25 year old female with no allergies or medical history, who on 29-MAY-2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  On 29-MAY-2007 a couple hours post vaccination, the patient felt sick, tired and experienced a fever.  On 08-FEB-2008, the patient was vaccinated with a second dose of GARDASIL.  On 08-FEB-2008 the patient felt tired, sick and developed a fever.  Unspecified medical attention was sought.  No diagnostic studies were performed.  The next day after experiencing the events, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 28-APR-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in the arm.  Concomitant therapy also given at the same office visit on 28-APR-2008 included MENACTRA, and "PTD" (unspecified).  GARDASIL and "PTD" was given in the same arm.  On 28-APR-2008, immediately after being vaccinated, the patient experienced syncope, nausea, and passed out.  The patient was kept in the office for 30 minutes until her "high pressure went down".  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician's office concerning a 15 year old female patient who on 28-AUG-2007 at 10:30 AM was vaccinated IM into right upper arm with a first dose of GARDASIL lot # 658556/1060U) and on 14-NOV-2007 she was vaccinated IM into left upper arm with a second dose of GARDASIL (lot #658488/1264U).  It was reported that patient got nausea and vomiting for two days after each vaccination of GARDASIL.  She was reported to be recovered on an unspecified day.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a company representative who overheard a physician in a hospital talking to another physician and he said that a female who was vaccinated with a single dose of GARDASIL (lot# not provided) experienced heavy vaginal bleeding. The patient's outcome was not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter who in April 2008, was vaccinated with a dose of GARDASIL.  The reporter reported that her daughter fainted after receiving the GARDASIL.  Shortly after the vaccination, the patient experienced a debilitating anxiety attack and she was in a fragile state of anxiety.  The outcome was unknown.  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a 17 year old female with pertinent medical history and concomitant medications reported as unspecified, who on approximately 29-FEB-2008 (2 months ago), was vaccinated with her first dose of GARDASIL, IM, (Lot# not reported).  A few hours after her vaccination, she developed injection site swelling and sought unspecified medical attention.  It was reported that the swelling measured 6 inches by 3 inches, and resolved about 5 days later (approximately 05-Mar-2008).  No product quality complaint was involved.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on approximately 22-APR-2008 (a week ago) was vaccinated with a dose of GARDASIL, 0.5 mL. Concomitant medication was not reported. While in the physician's office, the patient experienced syncopal episode after receiving the GARDASIL. The outcome and causality of the event were not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from the agency (#2008023-2478662) from a nurse concerning an 11 year old female, who had reached menarche 8 months prior (approximately Nov-2006), who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL, IM, (Lot # and dose not specified). On 04-OCT-2007 the second dose of GARDASIL, IM, (Lot # and dose not specified) was administered. On 07-FEB-2008 the third dose of GARDASIL (Lot #, dose and route not specified) was administered. The patient's mother reports that the GARDASIL vaccinations caused her daughter to stop menstruating. It was unknown if the daughters periods were regular. The outcome of the event was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from the agency (#2008023-2478662) froma a nurse concerning a 13 year old female (weight 117 1/2,  height 62"), who had reached menarche 8 months prior (approximately Nov-2006), who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (Lot # 658094/0924U), 0.5 mL, IM in the right arm. On 04-Oct-2007, the patient received the second dose of GARDASIL vaccine (Lot #658563/1063U), 0.5 mL, IM in the left arm. On 07-FEB-2008, the patient received the third dose of GARDASIL vaccine (Lot #658488/1264U), 0.5 mL, IM in the left arm. Concomitant medication was not reported. On 17-MAR-2008, the patient's mother visited the physician's office and discussed her concerns regarding GARDASIL vaccine going to cause long term problems according to "research" she had conducted on the internet. On 27-MAR-2008, the patient's mother reported that her daughter has not had her period since January 2008 and this being caused by GARDASIL vaccine. On 21-APR-2008, the patient's mother called again to report the patient still had not had her period. It was unknown if the daughter's periods were regular. The patient was advised to be evaluated by an Ob-Gyn which she had and appointment for on 27-MAY-2008. At the time of the report amenorrhea persisted. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Appendicitis
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with pertinent medical history reported as unspecified, who was vaccinated with a second dose of GARDASIL (Lot#, date, dose, and route unspecified).  Concomitant therapy included other unspecified vaccines normal to that age frame during the same visit.  It was reported that the patient developed appendicitis 2 - 3 months later, sought unspecified medical attention and recovered on an unspecified date.  No other details were provided.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Heart rate increased
Clinical narrative: Information has been received from a physician concerning a female (age unreported) with a history of being overly anxious who was vaccinated with her first dose of GARDASIL (Lot# date, dose and route unspecified).  Concomitant therapy included ADACEL.  A little while after receiving her vaccination with GARDASIL she returned to the physicians office with an increased heart rate that subsided that afternoon.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Eye rolling, Fall, Hyperhidrosis
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no medical history or known drug allergies who on 20-FEB-2008 was vaccinated IM in the left deltoid with a first dose of GARDASIL (lot # 659437/1266U).  On 29-APR-2008 the patient was vaccinated at 4 PM with a second dose of GARDASIL (lot # 660391/0063X).  Later that day she started her period.  She took naproxen.  On 30-APR-2008, at 4 AM the patient was diaphoretic, pale, and experienced cramps.  The patient took 3 tablets of ADVIL.  The mother of the patient, who called the office on 30-APR-2008 at 9:10 AM, also reported that the patient fell on the floor, her eyes rolled back and "came to", the patient continues to be extremely diaphoretic, dizzy, weak, pale with body aches and pains, and her symptoms are similar to the flu.  At the time of reporting, the patient had not recovered.  The mother was advised to take the patient to her primary physician if symptoms did not improve.  No product quality complaint was involved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Muscle spasms, Pain, Pallor
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no medical history or known drug allergies who on 20-FEB-2008 was vaccinated IM in the left deltoid with a first dose of GARDASIL (lot # 659437/1266U).  On 29-APR-2008 the patient was vaccinated at 4 PM with a second dose of GARDASIL (lot # 660391/0063X).  Later that day she started her period.  She took naproxen.  On 30-APR-2008, at 4 AM the patient was diaphoretic, pale, and experienced cramps.  The patient took 3 tablets of ADVIL.  The mother of the patient, who called the office on 30-APR-2008 at 9:10 AM, also reported that the patient fell on the floor, her eyes rolled back and "came to", the patient continues to be extremely diaphoretic, dizzy, weak, pale with body aches and pains, and her symptoms are similar to the flu.  At the time of reporting, the patient had not recovered.  The mother was advised to take the patient to her primary physician if symptoms did not improve.  No product quality complaint was involved.