chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Orthostatic hypotension
Clinical narrative: Information has been received from a physician concerning four female patient's who were vaccinated with dose of GARDASIL. Subsequently the patients experienced postural hypotension. Unspecified medical attention was sought. At the time of this report, the outcomes were unknown. Follow up information was received from a physician concerning a female patient. The physician stated that after further discussions, it was decided that there was no relation to these events and the GARDASIL vaccination. The physician was confident that the patient was fine. This is one of several reports from the same source. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cystitis, Drug exposure during pregnancy, Influenza, Malaise
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 21 year old white female with no significant past medical history or concurrent medical conditions and no previous pregnancies who on 20-FEB-2009 was vaccinated with the third dose of GARDASIL (Lot # 661954/1496X) by her obstetrician in another office. The patient's LMP was reported as 12-JAN-2009, EDD 19-OCT-2009. It was not reported whether the patients sought medical attention. Follow-up information was received from a registered nurse via phone call on 16-APR-2009 which reported that the patient told her that she had gotten GARDASIL during this pregnancy at a different office in another country. The patient was recently 13 weeks estimated gestational and had an EDD of 19-OCT-2009. According to the patient, the patient was told by her general practitioner that she should not breast feed this baby after birth, since she was exposed to the vaccine during pregnancy. The reporting registered nurse referred the patient to her obstetrician for further discussion. No further information was provided at this time. Follow-up information has been received from a pregnancy questionnaire. On an unspecified date in 2009, "during pregnancy", the patient experienced sickness, flu and bladder infections. The outcome was unknown. No other information was provided at this time. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 11-MAR-2009 was vaccinated with GARDASIL (lot number, route and site not reported). Concomitant therapy included DAPTACEL and LUPRON. The patient was to receive DAPTACEL and MENACTRA. It was not product confusion. It was a human error on the part of the nurse. Based on child's age the nurse thought GARDASIL was to be given. The patient's mother did not want the child to get GARDASIL. No adverse effects noted. The patient sought medical attention. Follow up information was received from consumer concerning her daughter. The mother stated her daughter would not continue with the 2nd  or 3rd dose of GARDASIL. Follow-up information has been received from a health professional concerning the 11 year old female who on 11-MAR-2009 was vaccinated with the first dose of GARDASIL (lot number 661846/1312X, route not reported) into her right deltoids. Concomitant therapy included her first dose of DAPTACEL, (lot number AC52B030AA, route not reported) into her left deltoid. The patient has two siblings. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who on 24-MAR-2009 was vaccinated with the first dose of GARDASIL subcutaneously instead of intramuscularly. No AE involved. The patient sought medical attention with physician. Follow up information was received from the registered nurse. It was reported the 10 year old (previously reported as 11 year old) patient with no known allergies or medical conditions who at approximately 12:45 pm on 23-MAR-2009 (previously reported as 24-MAR-2009) was vaccinated with the first dose of GARDASIL (lot # 661952/1129X) subcutaneously into the right arm instead of intramuscularly in error. At the same time, the patient complained of soreness at site. No labs or diagnostic tests were performed. At the time of reporting, the outcome was not reported. No further information was available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemoglobin normal, Streptococcal identification test negative
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 16 year old female, who on 26-FEB-2008 was vaccinated with the first dose of GARDASIL, on 19-MAY-2008, was vaccinated with the second dose of GARDASIL and on 08-OCT-2008, was vaccinated with the third dose of GARDASIL.  The registered nurse reported that the patient received the GARDASIL vaccine while pregnant.  The patient sought medical attention at the nurse's office.  The estimated date of last menstrual period was 14-MAY-2008.  The delivery date was 18-FEB-2009.  The reporter stated that the pregnancy was normal and the baby was doing fine.  Follow-up information was received from questionnaire completed by the registered nurse indicating that she was a patient with a history of 0 previous pregnancies, polycystic ovaries syndrome (so minimal ovulation's) and no concurrent medical conditions.  The patient did not have infections or illnesses during pregnancy .  Routine tests performed included:  an ultrasound done at 28 weeks of gestation to track gestation age (first prenatal appointment); group B streptococcus test done 3 to 4 weeks before delivery resulting negative and a gestational diabetes test done at 30 to 32 weeks of gestation which resulted negative.  Medication taken during pregnancy included children chewable vitamins taken daily since 28 weeks of gestation.  The patient was not progressing past 8 centimeters.  The patient gave birth to a normal female child, who weighted 8 pounds 3 oz.  The baby did not have any congenital anomaly.  Follow up information has been received from a physician via medical record which reported that the on 25-FEB-2009 the patient, the patient's mother and the baby went to the doctor's office.  The baby's height was 20.5 inches.  The baby was feeding with baby feeding formula (SIMILAC ADVANCED IRON) and baby drink 2-3 oz every 2-3 hours.  The patient was still taking vitamins (physician suggested to take them until 6 weeks postpartum).  Physician stated that the baby had some yellowing jaundice onset (25-FEB-2009 date approximate) to the skin but was otherwise pink.  The mother was slightly pale but had hemoglobin of 11.8.  A postpartum appointment was scheduled on May for follow up.  On 23-MAR-2009 the patient and the baby went to the doctor's office for follow up.  The baby was almost 5 weeks old and was drinking at the time 4 oz formula every 3-4 hours.  The baby is pooping and peeing okay according to the mother.  The patient had hemoglobin of 14.1 the physician stated that everything was doing fine with the mother and the baby.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for the GARDASIL a Pregnancy Registry product concerning a 14 year old female patient who on 29-MAR-2007 was vaccinated with the first 0.5 mL IM dose of GARDASIL (lot # 654535/0960F) and on 20-MAR-2009 with the second 0.5 mL IM dose of GARDASIL (lot # 661703/0651X).  Concomitant therapy included unspecified birth control pills, and on 20-MAR-2009 received MENACTRA), HAVRIX, and unspecified therapy for urinary tract infection.  It was reported that on 20-MAR-2009 the patient received her second dose of GARDASIL and was pregnant.  Her LMP was 23-FEB-2009 and her EDD was 09-DEC-2009.  Laboratory test performed included urine pregnancy test with positive results.  Follow-up information received on 01-MAY-2009 from an initial pregnancy questionnaire completed by the physician stated that the patient was a 14 year old Hispanic female, with no previous pregnancies, who on 20-MAR-2009, was vaccinated with the second dose of GARDASIL (lot # 661703/0651X).  Concomitant therapy given on 20-MAR-2009 included MENACTRA, 0.5ml, BOOSTRIX, 0.5ml, HAVRIX, 0.5ml and BACTRIM, DS BID for urinary tract infection.  Her last menstrual period was on 23-FEB-2009 and the estimated delivery date is 09-DEC-2009.  The estimated conception date was 09-MAR-2009.  It was reported that none prenatal testing had been performed at the time of the report.  Follow up information received on 06-MAY-2009 from an initial and an outcome pregnancy questionnaire completed by the physician and the registered nurse stated that on 20-MAR-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 661703/0651X).  Concomitant therapy included MENACTRA, BOOSTRIX (lot # AC52B03AA), HAVRIX (lot # AHAVB260AA) and BACTRIM, DS BID for an uncomplicated urinary tract infection on 20-MAR-2009.  Follow up information was received from a Registered Nurse (R.N.) who stated that the patient has not delivered as of 21-MAY-2009, her LMP was reiterated as 23-FEB-2009.  Follow up information was received from a registered nurse who indicated that the patient had no significant past medical history.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Diarrhoea, Fatigue, Malaise, Pyrexia
Clinical narrative: 5/28/09: Client received MMR and Varicella vaccines. Mom was instructed to observe carefully for fever 5-12 days after vaccine administration and to consider giving TYLENOL prophylactically during this time; due to client's history of febrile seizure disorder. 6/4/09: Mom reports that client developed a low fever of <101 degrees Fahrenheit on 6/3/09. He experienced "3 small seizures" on this date that mom related to the fever. He also vomited a couple of times. She did not administer any DIASTAT to manage his seizures. Mom states that he is better today (6/4/09)--eating and drinking normally, and playing. She is giving him TYLENOL and/or ibuprofen every 4-6 hours around the clock to manage his fever. PMD and client's pediatric neurologist notified. 6/5/09: Mom reports that client still appears ill and vomited this morning. He is eating and drinking normally. His energy level is variable. Mom took client in to see MD this afternoon. No change in plan of care was created during MD visit on 6-5-09. Mom continued to give TYLENOL every four hours to manage client's fever. 6/11/09: Mom reports that the episodes of vomiting continued, and that on the evening of 6-5-09, client also developed diarrhea, which continued for the next two days. During this time, mom reports that client was very fatigued and was either sleeping or "staring off into space...he just seemed ill." She denies any observable seizure activity during this time period. She states that he was "back to normal" by 6-8-09 and is not currently experiencing fever or the gastrointestinal symptoms. He has not seen his MD since the 6-5-09 visit. 6/12/09: MD and client's pediatric neurologist notified by public health nurse of subsequent symptoms during this time period after vaccine administration.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Somnolence, Staring, Vomiting
Clinical narrative: 5/28/09: Client received MMR and Varicella vaccines. Mom was instructed to observe carefully for fever 5-12 days after vaccine administration and to consider giving TYLENOL prophylactically during this time; due to client's history of febrile seizure disorder. 6/4/09: Mom reports that client developed a low fever of <101 degrees Fahrenheit on 6/3/09. He experienced "3 small seizures" on this date that mom related to the fever. He also vomited a couple of times. She did not administer any DIASTAT to manage his seizures. Mom states that he is better today (6/4/09)--eating and drinking normally, and playing. She is giving him TYLENOL and/or ibuprofen every 4-6 hours around the clock to manage his fever. PMD and client's pediatric neurologist notified. 6/5/09: Mom reports that client still appears ill and vomited this morning. He is eating and drinking normally. His energy level is variable. Mom took client in to see MD this afternoon. No change in plan of care was created during MD visit on 6-5-09. Mom continued to give TYLENOL every four hours to manage client's fever. 6/11/09: Mom reports that the episodes of vomiting continued, and that on the evening of 6-5-09, client also developed diarrhea, which continued for the next two days. During this time, mom reports that client was very fatigued and was either sleeping or "staring off into space...he just seemed ill." She denies any observable seizure activity during this time period. She states that he was "back to normal" by 6-8-09 and is not currently experiencing fever or the gastrointestinal symptoms. He has not seen his MD since the 6-5-09 visit. 6/12/09: MD and client's pediatric neurologist notified by public health nurse of subsequent symptoms during this time period after vaccine administration.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: False positive laboratory result, Parasite blood test
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinate with on unspecified dates (doses and LOT# were not reported). When donating blood after vaccinated with GARDASIL the patient's parasite blood test showed positive for Chagas. Further testing showed the original test was false positive and she did not have Chagas disease. The patient was told that Chagas test showed positive was frequently see in patients that have vaccinated with GARDASIL. Follow-up information has been received via a phone call from the physician concerning a 17 year old female who was vaccinated with GARDASIL on unspecified dates (dose and LOT# were not reported). The patient attempted to donate blood and was told that she had a false positive confirmatory test for Chagas disease. It reported that  the false positive test was related to the GARDASIL vaccination. Follow-up information has been received via a phone call from a medical assistant (M.A.) concerning the 17 year old female who on 06-AUG-2007, 15-NOV-2007 and 03-MAR-2008 was vaccinated with a dose of GARDASIL (LOT# not reported, 659435/1265U, 659182/1757U respectively). No other concomitant vaccines were given at the time of the GARDASIL doses. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a caller concerning her daughter a 17 year old who became very ill after receiving injection the first dose of GARDASIL on 01-MAY-2008. There was no concomitant medication. She had a fever, nausea, dizziness, and pain on the entire length of the arm where the injection was given. The patient sought medical attention and the outcome was unknown. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Vomiting
Clinical narrative: Information has been received from a 20 year old female patient with parakeratotic cells evidenced in previous PAP test, who on 20-APR-2009 was vaccinated with the first dose of GARDASIL. On 29-APR-2009 the patient vomited after receiving the vaccine. The patient further stated that she was still feeling weak, tired and dizzy. The patient did not seek medical attention. It was reported that GARDASIL was discontinued. At the time of reporting the patient had not recovered. No further information is available.  7/13/09 Medical notes received DOS 4/28/09 to 6/30/09. Patient presented on day of immunization for follow-up of abnormal PAP. Abdomen tender on palpation. Subsequent visits:pelvic pain, irregular 'bleeds' with thick white discharge, burning urine. Vaginal infection, UTI.
Sex: F
Vaccine: HPV4, MMR
Symptoms: Abdominal pain, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a consumer concerning herself with no previous pregnancies and no reported past drug history who on 01-MAY-2009 was vaccinated with a dose of GARDASIL. Secondary suspect vaccine given on the same day included MMR II (manufacturer unknown). There was no concomitant medication reported. It was reported that on 01-MAY-2009, in the evening after getting the vaccines the patient got really sharp belly pain. On 02-MAY-2009 a home pregnancy test was done and the result was positive. The last menstrual period of the patient was on 25-APR-2009 and the estimated delivery date was 30-Jan-2010. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/12/2009.  Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning herself with no previous pregnancies and no reported past drug history who on 01-MAY-2009 was vaccinated with a dose of GARDASIL.  Secondary suspect vaccine given on the same day included MMR II (manufacturer unknown).  There was no concomitant medication reported.  It was reported that on 01-MAY-2009, in the evening after getting the vaccines the patient got really sharp belly pain.  On 02-MAY-2009 a home pregnancy test was done and the result was positive.  The last menstrual period of the patient was on 25-APR-2009 and the estimated delivery date was 30-Jan-2010.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0905USA00271 is a duplicate of WAES # 0905USA00270.  Therefore, WAES # 0905USA00271 is being deleted from our files and the reports consolidated into WAES # 0905USA00270.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no pertinent medical history reported and no known drug allergies who on 15-Apr-2009 at 11:30 am was vaccinated intramuscularly in the left arm with third dose of GARDASIL (lot number 661044/0548X). There was no concomitant  medication. The following day, on 16-Apr-2009 at 11:30, the patient experienced hives. The patient recovered from the event on an unspecified date. No lab tests were performed. The patient did not seek medical attention. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dyspnoea, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 27-Feb-2009 was vaccinated intramuscularly. 0.5ml, with the first dose of GARDASIL (lot# 661046/0546X). Concomitant therapy included montelukast sodium (MSD) and Ortho Evra. The patient experienced a cough after receiving GARDASIL on 27-Feb-2009. The patient was brought to the emergency room due to her difficulty in breathing. The patient sought medical attention by speaking to the nurse practitioner and recovered. Follow up information has been received from the office manager who reported that no other vaccines were given at the time of GARDASIL vaccines dose. It was confirmed that the patient was not admitted. Emergency room treat included Acetaminophen and Ibuprofen (dose and duration not reported) for fever and pain. The patient was discharged home in stable condition. The emergency room records stated, "Impression: Drug Reaction. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with a history of epstein-barr virus infection and lymphadenectomy on 8-JAN-2009 who was vaccinated with the first dose of GARDASIL on 01-MAY-2009 (lot#: 662300/0100Y). When the patient woke up on 02-MAY-2009 she experienced tremors. The nurse practitioner reported that the patient was still experiencing tremors periodically and is coming into the office on 4-MAY-2009. No further AE information provided. Unspecified medical attention had been sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Information has been received from a physician concerning a teenager female who was vaccinated with the first dose of GARDASIL in April 2007 and second dose in August 2007. There was no concomitant medication and medical history. In November 2007, the patient started experiencing vertigo. Unspecified lab diagnostic studies had been performed. The patient had sought unspecified medical attention. It was reported that therapy with GARDASIL was discontinued. At time of reporting, the patient was not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Drug screen negative, Erythema, Haemoglobin normal, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female with PENICILLIN allergy and no pertinent medical history who was vaccinated with three doses of GARDASIL (lot # 659435/1265U, exp: 16-JUL-2010) 0.5 ml, intramuscular administration.  She received the first dose on 19-MAY-2008, the second dose on 09-JUL-2008, and the third dose on 05-NOV-2008.  Concomitant therapy on 19-MAY-2008 included doses of ADACEL (lot # not reported), and MENACTRA (lot # not reported), other concomitant therapy included FLONASE.  Two or three months after the third dose of GARDASIL (lot # 659435/1265U), exp: 16-JUL-2010, in January or February 2009, the patient experienced redness and tingling to the distal aspect of the feet when standing upright and redness in the left calf after walking, "such as in a mall".  The patient was seen in the office on 24-APR-2009 and blood work was obtained.  Results of labs were as follows: antinuclear antibody (ANA) and rheumatoid factor (RF) were negative.  Urine drug screen (at the mom's request because she thought her daughter was doing drug) was negative.  Sedimentation rate (sed rate) was 4, hemoglobin was 12.9, white blood cell count was 6.5, and platelet count was normal.  The patient was seen again on 04-MAY-2009, and there was significant erythema, pinkness, and warmth distally when the left leg was in a dependent position.  The patient was referred to a vascular surgeon for further evaluation.  At the time of reporting the patient's symptoms persisted.  Additional information has been requested.  7/13/09 Medical records received DOS 4/24/09 to 5/4/09. Assessment: Pain in limb/Bilateral, unchanged. Patient presents with feet that turn red and skin stings when she stands for over 10 minutes. Pain in calf when she walks in the mall. Pins and needles sensation in feet. Feet are erythematous, blanches, great toes are warmer than rest of foot.  Surgical referral suggested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Skin warm, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with PENICILLIN allergy and no pertinent medical history who was vaccinated with three doses of GARDASIL (lot # 659435/1265U, exp: 16-JUL-2010) 0.5 ml, intramuscular administration.  She received the first dose on 19-MAY-2008, the second dose on 09-JUL-2008, and the third dose on 05-NOV-2008.  Concomitant therapy on 19-MAY-2008 included doses of ADACEL (lot # not reported), and MENACTRA (lot # not reported), other concomitant therapy included FLONASE.  Two or three months after the third dose of GARDASIL (lot # 659435/1265U), exp: 16-JUL-2010, in January or February 2009, the patient experienced redness and tingling to the distal aspect of the feet when standing upright and redness in the left calf after walking, "such as in a mall".  The patient was seen in the office on 24-APR-2009 and blood work was obtained.  Results of labs were as follows: antinuclear antibody (ANA) and rheumatoid factor (RF) were negative.  Urine drug screen (at the mom's request because she thought her daughter was doing drug) was negative.  Sedimentation rate (sed rate) was 4, hemoglobin was 12.9, white blood cell count was 6.5, and platelet count was normal.  The patient was seen again on 04-MAY-2009, and there was significant erythema, pinkness, and warmth distally when the left leg was in a dependent position.  The patient was referred to a vascular surgeon for further evaluation.  At the time of reporting the patient's symptoms persisted.  Additional information has been requested.  7/13/09 Medical records received DOS 4/24/09 to 5/4/09. Assessment: Pain in limb/Bilateral, unchanged. Patient presents with feet that turn red and skin stings when she stands for over 10 minutes. Pain in calf when she walks in the mall. Pins and needles sensation in feet. Feet are erythematous, blanches, great toes are warmer than rest of foot.  Surgical referral suggested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Dizziness, Fatigue, Hot flush, Influenza like illness
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 17 year old female who on 24-JUL-2008 was vaccinated with the first dose (lot number: 660553/0070X) and on 16-DEC-2008 with the second dose (lot number:661703/0651X) of GARDASIL (route not reported). On 16-DEC-2008, the patient appeared at the doctor's office and complained of flu-like symptoms (dizziness, nausea and hot flashes) which started approximately 09-DEC-2008 (one week prior to the office visit). The patient received the second dose despite the symptoms. The physician performed a physical diagnosed fatigue and dizziness and sent the patient for blood work (not specified) the same day. The blood work results were all normal. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 17 year old female who on 24-JUL-2008 was vaccinated with the first dose (lot number: 660553/0070X) and on 16-DEC-2008 with the second dose (lot number:661703/0651X) of GARDASIL (route not reported). On 16-DEC-2008, the patient appeared at the doctor's office and complained of flu-like symptoms (dizziness, nausea and hot flashes) which started approximately 09-DEC-2008 (one week prior to the office visit). The patient received the second dose despite the symptoms. The physician performed a physical diagnosed fatigue and dizziness and sent the patient for blood work (not specified) the same day. The blood work results were all normal. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a mother concerning a her daughter who on 3-JUN-2008 was vaccinated with her first dose of GARDASIL (dose, route and lot number not reported).  The mother stated that after getting first dose, her daughter experienced headache.  Therapy with GARDASIL was discontinued on 3-JUN-2008.  It was not specified if the patient sought medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on 04-MAY-2009 was vaccinated with the first dose of GARDASIL (lot #:  661766/0652X).  The patient did not receive any concomitant vaccines at that time.  About 5 minutes after the vaccination the patient experienced fainted for about a "second" and regained consciousness.  The patient rested for a few minutes and then had fully recovered.  Unspecified medical attention had been sought.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL and experienced syncope, the patient fainted within 15 minutes of receiving GARDASIL.  Subsequently, the patient recovered from syncope on the same day.  No further information provided at the time of reporting.  The patient sought medical attention with a physician.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on an unspecified date was vaccinated with her first dose of GARDASIL (LOT# was not reported). Approximately one week after vaccination, the patient started bleeding. It was reported that the patient had not started or gotten her menstrual cycle quite yet but the reporter thought that bleeding could be her actual cycle since her daughter is 12 year old. No other adverse event was reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Urticaria
Clinical narrative: Information has been received from a doctor of osteopathic medicine (D.O.) concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL (LOT # was not reported). On an unspecified date, after vaccination the patient experienced injection site pain and a hive reaction. The patient also was reported as recovered on an unspecified date. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who "soon" before developing diarrhea on 01-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # 661846/1312X) 0.5ml intramuscular administration.  Concomitant therapy included SEASONIQUE, ascorbic acid, calcium, (unspecified), cyanocobalamin and minerals (unspecified) (+) vitamins (unspecified) (store brand WOMENS DAILY MULTIVITAMIN).  On 01-MAY-2009 the patient experienced diarrhea.  The first three days after onset were pretty bad.  She called the office.  The patient has diarrhea 3-4 times a day now.  At the time of reporting, the patient was not recovered.  Follow up information was received from a registered nurse concerning the 21 year old female student who on 01-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # 661846/1312X) into the left deltoid.  The patient had no illness at time of vaccination.  On 01-MAY-2009, the patient complained with episodes of diarrhea 3-4 times a day from 01-MAY-2009 to 05-MAY-2009.  She was advised to use IMODIUM, clear liquid diet and slowly advance to a bland diet.  The patient was advised to call if symptoms unresolved.  At time of reporting, the reporter had no further contact from the patient.  It was unknown whether the patient recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Crying, Drug exposure during pregnancy, Muscle spasms, Ovarian cyst
Clinical narrative: Information has been received from a medical assistant and the patient's mother, for GARDASIL, a Pregnancy Registry product, concerning an 17 year old female with depression (diagnosed 3 years ago) and history of a cyst on her ovary (diagnosed 2 years ago) who on 21-APR-2009 was vaccinated with a first dose of GARDASIL (lot number 661846/1312X) (injection site and route not reported). There was no concomitant medication. Prior to receiving the vaccination, the patient had a negative urine pregnancy test (approximately 21-APR-2009), the patient's mother reported that on 04-MAY-2009 the patient started complaining about bad cramps that were so bad that she started to cry. The patient's mother called the physician who advised the patient be taken to the hospital for evaluation. The patient was brought to the emergency room but she was not admitted to the hospital and she was diagnosed with an ovarian cyst. The patient's mother said a blood pregnancy test, a urine pregnancy test and an ultrasound determined the patient was pregnant. As of 05-MAY-2009, the patient was five weeks, 4 days pregnant (LMP 26-MAR-2009, EDDD 31-DEC-2009). The patient had an appointment with an OBGYN. The patient's bad cramps (ovarian cyst) persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from a medical assistant and the patient's mother, for GARDASIL, a Pregnancy Registry product, concerning an 17 year old female with depression (diagnosed 3 years ago) and history of a cyst on her ovary (diagnosed 2 years ago) who on 21-APR-2009 was vaccinated with a first dose of GARDASIL (lot number 661846/1312X) (injection site and route not reported). There was no concomitant medication. Prior to receiving the vaccination, the patient had a negative urine pregnancy test (approximately 21-APR-2009), the patient's mother reported that on 04-MAY-2009 the patient started complaining about bad cramps that were so bad that she started to cry. The patient's mother called the physician who advised the patient be taken to the hospital for evaluation. The patient was brought to the emergency room but she was not admitted to the hospital and she was diagnosed with an ovarian cyst. The patient's mother said a blood pregnancy test, a urine pregnancy test and an ultrasound determined the patient was pregnant. As of 05-MAY-2009, the patient was five weeks, 4 days pregnant (LMP 26-MAR-2009, EDDD 31-DEC-2009). The patient had an appointment with an OBGYN. The patient's bad cramps (ovarian cyst) persisted. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL (Lot # 659184/0843X), concerning a 25 year old female who on 21-AUG-2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  The patient's last menstrual period was 22-JUL-2008.  35 weeks from her LMP she gave a birth to a healthy baby on 24-MAR-2009.  Currently she is breast feeding the baby.  The patient had sought medical attention.  Follow up information has been received from this practical nurse.  She reported that she did not have any more information than what she had provided.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Information has been received from a 25 year old female certified medical assistant concerning herself that she was vaccinated IM with the third 0.5 ml dose of GARDASIL.  Subsequently she experienced extreme arm pain, including shooting pain in her arm, and difficulty lifting her arm for 2 days and she recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Pain, Rash pruritic, Scab
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 14 year old female with no pertinent medical history who on 07-APR-2009 was vaccinated with the first dose of GARDASIL (lot#: 661952/1129X) 0.5ml IM left deltoid. On approximately 2.5 weeks after the first injection, it's approximately on 24-APR-2009 the patient experienced a rash on her back that was itchy and painful. There was no concomitant medication. The patient was seen by the primary care physician and was diagnosed with shingles. Patient did not express any concern or idea that the shingles was a result of the GARDASIL vaccination. The patient had no fever. The patient was placed on Valacyclovir hydrochloride, 500 mg, 3 times a day for 7 days (It was also reported that the patient was placed on Valacyclovir Hydrochloride, 500 mg, 2 three times a day for 7 days), experienced scabbing on her back. At the time of reporting the patient was recovering and no further information was available. Additional Information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning her 18 year old daughter who was vaccinated with the third dose of GARDASIL and later experienced intermittent pain or achiness in the arm where she received GARDASIL. Follow up information has been received from the healthcare worker and a nurse. It was reported that the 16 year old patient on 20-APR-2007 was vaccinated with the first dose of GARDASIL (Lot# 657617/0384U), on 8-AUG-2007 was vaccinated with the second dose of GARDASIL (Lot# 655620/0171U) and on 9-NOV-2007 was vaccinated with her third dose of GARDASIL (Lot# 658560/1062U). After vaccinated the third dose of GARDASIL, the patient had pain in the arm where she received the GARDASIL and the pain was "on and off". The patient went on to receive the following vaccinations: MENACTRA, Lot# 02343AA, ADACEL, Lot# AC52B015AA and the first dose of HAVRIX, Lot# 1280F, all administered on 22-JAN-2008. The patient received the second dose of HAVRIX on 21-AUG-2008. Lot# 1280F. The nurse stated that the patient had an appoint to see the physician on 08-MAY-2009. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a 23 year old female who on 04-MAR-2009 was vaccinated with with second dose of GARDASIL.  The patient had no medical history.  It was reported that the patient had her period was right after getting the second dose of GARDASIL. On 07-MAY-2009, the patient reported that her period was 3 days late.  The patient didn't know if she was pregnant and didn't do any pregnancy test yet.  The patient did not seek medical attention.  At the time of reporting, the patient had not recovered.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy site unspecified normal, Culture negative, Laboratory test normal, Rash, Skin test negative
Clinical narrative: Information has been received from a consumer concerning her daughter a 23 year old female with a history of eczema and Dairy allergies (cause of the eczema) who completed vaccination series of GARDASIL "just about a year ago". Concomitant therapy included omega-3 marine triglycerides, proboitics, and pure essential brand (Dr. Ashes Brand). The patient didn't experience any symptoms after the first or second dose of GARDASIL. Two days after the third dose the patient developed a vaginal rash during her menstruation the rash became worse. The patient also had "abscesses" that had developed on the outside of the vagina. She stated that the abscesses were caused from an e-coli bacteria. The patient had been test for sexually transmitted diseases, skin cultures, abscess cultures, and biopsies all of which had been negative. The mother also stated her daughter has not engaged in any sexual activity and could not identify a source for rashes. The patient had been placed on antibiotics that do not provide relief and was last prescribed a cortisone cream that states "has settled things a little bit this week during her period." The mother and her daughter believed in "doing everything natural and only received GARDASIL after it was highly recommended by a physician who is a friend of the family." The office manager at the gynecologist explained the patient didn't receive her vaccinations at their office and speculated that the vaccines were given either at school or by the patient's father, who is a physician. The patient was now visiting her physician about two times a week due to "flare ups" and was going to be seeing an infectious disease physician. The patient was not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal abscess
Clinical narrative: Information has been received from a consumer concerning her daughter a 23 year old female with a history of eczema and Dairy allergies (cause of the eczema) who completed vaccination series of GARDASIL "just about a year ago". Concomitant therapy included omega-3 marine triglycerides, proboitics, and pure essential brand (Dr. Ashes Brand). The patient didn't experience any symptoms after the first or second dose of GARDASIL. Two days after the third dose the patient developed a vaginal rash during her menstruation the rash became worse. The patient also had "abscesses" that had developed on the outside of the vagina. She stated that the abscesses were caused from an e-coli bacteria. The patient had been test for sexually transmitted diseases, skin cultures, abscess cultures, and biopsies all of which had been negative. The mother also stated her daughter has not engaged in any sexual activity and could not identify a source for rashes. The patient had been placed on antibiotics that do not provide relief and was last prescribed a cortisone cream that states "has settled things a little bit this week during her period." The mother and her daughter believed in "doing everything natural and only received GARDASIL after it was highly recommended by a physician who is a friend of the family." The office manager at the gynecologist explained the patient didn't receive her vaccinations at their office and speculated that the vaccines were given either at school or by the patient's father, who is a physician. The patient was now visiting her physician about two times a week due to "flare ups" and was going to be seeing an infectious disease physician. The patient was not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DPP, HEPA, HPV4, MNQ
Symptoms: Fall, Migraine, Panic attack, Respiratory rate increased, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 06-MAY-2009 was intramuscular vaccinated with her 05ml dose of GARDASIL. Suspect therapy given on the same day included VAQTA (manufacturer unknown). Concomitant therapy included DTAP and MENACTRA. Subsequently the patient fainted and fell on the ground, when the patient came to, she had a migraine. She had a panic attack which included shaking and breathing fast. The patient had sought medical attention. The patient had recovered by the report time. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DPP, HEPA, HPV4, MNQ
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 06-MAY-2009 was intramuscular vaccinated with her 05ml dose of GARDASIL. Suspect therapy given on the same day included VAQTA (manufacturer unknown). Concomitant therapy included DTAP and MENACTRA. Subsequently the patient fainted and fell on the ground, when the patient came to, she had a migraine. She had a panic attack which included shaking and breathing fast. The patient had sought medical attention. The patient had recovered by the report time. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a pharmacist who heard from a nurse (mother of the patient) concerning the female patient who on unspecified dates was vaccinated with all three doses of GARDASIL (lot# were not reported). On an unspecified date, the patient experienced dermatological warts (not genital, only dermatological). It was reported that the patient did not seek medical attention and also was reported that the outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a 23 year old female with no medical history or drug allergy who on 01-May-2009 was vaccinated with the first dose of GARDASIL and found out later she was pregnant. Concomitant therapy included Flagyl. The patient stated that her original visit to the practice was because she thought she was pregnant, however after a urine test the office stated she wasn't and administered the vaccine. The patient reported after getting the vaccine she started experiencing some abdominal pain and went for testing again and found out she was pregnant. The patient had "blood work" performed. At the time of the report the patient was recovered. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 27 year old female with penicillin allergy and no pertinent medical history or concurrent conditions who on 09-Mar-2009 was vaccinated with the first dose of GARDASIL (lot# 661703/0651). 0.5ml, intramuscular administration. There was no concomitant medication and no other vaccines given with the GARDASIL that day. On 10-Mar-2009 the patient experienced facial cheek twitch. ("one of her cheeks had a little twitching for a week"). The patient did not report the adverse event until she came to the office for her second dose of GARDASIL. The doctor determined that the second dose of GARDASIL was discontinued. It was reported that the patient was recovered a week after it started. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Genital swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female who in October 2007, was vaccinated with the first dose of GARDASIL. Subsequently the patient developed swollen labia on both sides. The patient still had swollen labia but only on one side by the report time. The patient had sought medical attention. Follow up information has been received from this nurse practitioner concerning this 21 year old female who in October 2008 (not 2007 as previously reported) was vaccinated with the first dose of GARDASIL. Subsequently the patient had labia swelling on the left side and had no pain. The patient was treated with medication and had a follow-up visit scheduled with the nurse practitioner in two weeks. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nasal congestion, Urticaria
Clinical narrative: Information has been received from a nurse manager concerning a 25 year old female who on 08-MAR-2009 was vaccinated with GARDASIL. There was no concomitant medication. Subsequently the patient developed hives and felt the sensation of the right nostril closing up throughout the night of vaccination onto the next day. She was seen on 09-MAR-2009 at her primary care and was prescribed a (MEDROL DOSEPAK). Patient is inquiring about continuing the GARDASIL series. At this report time the patient had recovered. Follow up information has been received from this nurse manager: Their office did not perform any lab/diagnostic tests. The events did not require hospitalization, and were not disabling or life threatening. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was intramuscular vaccinated with GARDASIL. Subsequently the patient immediately after fainted. The office called an ambulance. The patient had sought medical attention. Follow up information has been received from an office administrator. He reported that a couple of months ago a girl who got "several vaccines" (not specifically GARDASIL) got dizzy after the shots. An office employee called the ambulance by mistake. The girl was not transported any where, and she didn't faint. Additional information is not expected.