chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstrual disorder
Clinical narrative: Information has been received from a nurse who reported that a patient said that on an unspecified date her sister was vaccinated with a dose of GARDASIL. Subsequently the patient's sister had her menstrual cycle and it was very heavy and abnormal. The patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstrual disorder
Clinical narrative: Information has been received from a nurse who reported that a patient said that on an unspecified date her friend was vaccinated with a dose of GARDASIL. Subsequently the patient's friend had her menstrual cycle and it was very heavy and abnormal. The patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning her daughter an 18 year old female with no medical history who received 2 doses of GARDASIL last summer in April 2009 and June 2009. In April 2009, after her initial dose of GARDASIL the patient experienced fainted. The patient was treated in office. The same day of vaccination (in April 2009), the patient recovered from faint. The patient was fine with her second dose. The patient's mother was considering not getting the third dose scheduled on 11-JAN-2010. This is one of several reports received from the same source. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Depression
Clinical narrative: Information has been received from a company representative who heard from her friends that a probably 15 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, on an unknown date the patient got very weak and depressed within several weeks of the shot. Lot number was not available. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, recovery status, healthcare provider name and contact information. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Skin discolouration, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL (LOT # was not provided). After receiving GARDASIL the patient experienced syncope. The outcome of the patient was unknown. The patient didn't seek medical attention. Follow-up information has been received from the physician concerning the 11 (also reported as 12) year old patient with a history of fainting in July 2008 (The patient was seen by a cardiologist) who has one sibling. The patient was examined and vaccinated intramuscularly with the first dose of GARDASIL in the physician's office on 24-JUL-2009 at about 2:00 pm. There was no concomitant medication. The patient was alert and intelligent, vital signs were normal. After vaccination, the patient was sitting in the waiting area and began to faint. The patient appeared pale and dusky. The patient was immediately offered oral fluids and saltine crackers. At the time of the report, the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Hyperhidrosis, Hypotension, Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who on 22-JUN-2009 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 662300/0100Y). Subsequently, on 31-AUG-2009 the patient was vaccinated IM with a 0.5 ml second dose of GARDASIL (Lot number 663454/0672Y). Concomitant therapy included MENACTRA on 22-JUN-2009 and influenza virus vaccine (unspecified) on 31-AUG-2009. The physician reported that the patient became diaphoretic, pale, experienced low blood pressure and severe stomach pain immediately after receiving the first and second doses of GARDASIL. The patient recovered about 15 minutes after receiving the first and second dose of GARDASIL respectively. The patient sought  medical attention at the physician's office. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who on 22-JUN-2009 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 662300/0100Y). Subsequently, on 31-AUG-2009 the patient was vaccinated IM with a 0.5 ml second dose of GARDASIL (Lot number 663454/0672Y). Concomitant therapy included MENACTRA on 22-JUN-2009 and influenza virus vaccine (unspecified) on 31-AUG-2009. The physician reported that the patient became diaphoretic, pale, experienced low blood pressure and severe stomach pain immediately after receiving the first and second doses of GARDASIL. The patient recovered about 15 minutes after receiving the first and second dose of GARDASIL respectively. The patient sought  medical attention at the physician's office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site infection, Injection site mass
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse reported that the patient went into the office 3 weeks later with an infected injection site reaction. At the time of the report the patient's outcome was unknown. The patient sought medical attention (was seen in the office). Follow up information has been received from the nurse who reported that on 21-OCT-2009 the Medical Assistant vaccinated the patient with the first dose of GARDASIL (lot # 662304/1013Y), intramuscularly in the right deltoid. It was reported that the patient developed a small lump on the right deltoid with some redness. The patient was seen in the office on 13-NOV-2009 and was treated with BACTRIM DS 160 mg/800 mg, twice a day for seven days. It was stated that the patient went back on 02-DEC-2009 and the right deltoid was completely healed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the fist dose of GARDASIL (route and lot # unknown) and experienced a headache after receiving the vaccine. The patient sought medical attention by contacting the physician. At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Nausea, Pallor
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient with no illness at the time of vaccination, who on 20-NOV-2009 at 11:00 am was vaccinated intramuscularly in the right arm with the first dose of GARDASIL (lot # 662304/1013Y). The nurse stated that the patient felt light headed, nausea and became pale after receiving the GARDASIL. At the time of the report the patient was sleeping in the office. The patient's outcome was unknown. The patient sought medical attention (spoke to the nurse). Follow up information has been received from the nurse who reported that on 20-NOV-2009 at 11:00 am (the same day as GARDASIL) the patient was vaccinated in the left arm with the first dose of DTaP, in the left arm with the first dose of MENACTRA and in the right fore arm with the first dose of tuberculin purified protein derivative. The nurse stated that the patient felt weak and dizzy after GARDASIL. The patient was in prone position for 1 1/2 hour. Then the patient was sent to the emergency room for further evaluation. Blood pressure was 120/70 and 130/70 1/2 hour later. The patient did not pass out. The patient was in the emergency room for 4 hours for follow up. The same day she was cleared and sent home. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain, Rash
Clinical narrative: Information has been received from a health professional concerning a 16 female who was vaccinated with GARDASIL. After the first injection of GARDASIL, in January 2009, the patient developed a swollen injection site and rash, after the second injection of GARDASIL , "in January 2009" it was very painful and she could not move. On an unknown date, events diminished discontinuing of GARDASIL. No further information is available. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Human papilloma virus test positive, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning her approximately 20 year old cousin with no pertinent medical history or drug reactions/allergies who was vaccinated with a first dose (in February 2009), second, and third dose (two months ago, in approximately October 2009) of GARDASIL, IM (Lot # not provided). Concomitant therapy included ALLEGRA, XANAX, and ORTHO EVRA. Patient did not remember when the 2nd dose of GARDASIL was given but remembered to have had swelling and redness at the injection site for 2 weeks. The patient prior to vaccination tested negative for HPV. The nurse mentioned that her cousin received all 3 doses of GARDASIL and tested positive for HPV. Patient mentioned that she found out her HPV test was positive when she called the office trying to get medication for a yeast infection. The patient has sought unspecific medical attention by phone call. At the time of this report, the patient status was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, X-ray limb normal
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who on 12-JAN-2009 was vaccinated with the first dose of GARDASIL. On 13-MAR-2009 the patient was vaccinated with the second dose of GARDASIL. On 17-AUG-2009 the patient was vaccinated with the third dose of GARDASIL into her left deltoid. The patient developed ongoing arm pain after her third vaccination. The arm hurts when moved in specified ways. The patient sought medical attention in an office. At the time of the report, the patient's status was unknown. The health care professional contacted during telephone follow-up could not supply the following information: patient name, lot number, recovery status. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, VARCEL
Symptoms: Inflammation, Rash erythematous, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient who on 23-SEP-2009 was vaccinated with her initial dose of GARDASIL (Lot # not provided). Concomitant therapy included VARIVAX (MSD). Other concomitant therapy included influenza virus vaccine (unspecified). The medical assistant reported that the patient received GARDASIL on 23-SEP-2009 and the next day the patient developed a red spot on her arm about a size of half a dollar coin and that it was raised, round spot and it was warm to the touch. The medical assistant reported that the patient was treated with BENADRYL and ice and within 30 hours, the inflammation was reduced and after 48 hours the spot was gone. The patient sought medical attention by calling the physician's office. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Certified Medical Assistant in a physician's office concerning her 24 year old daughter who on unspecified dates were vaccinated intramuscularly with the first and second 0.5 mL dose of GARDASIL (LOT# not reported). After receiving her second and third dose of GARDASIL the patient developed syncope. The syncope was recovered on unspecified dates. No further information is available at the time of reporting. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered pharmacist concerning her 18 year old daughter, who on an unknown date, was vaccinated with several doses of GARDASIL. The pharmacist reported that the patient experienced symptoms similar to mono after the vaccine. She had swollen lymph nodes after each dose and she felt achy and feverish for several days. The patient's outcome was unknown. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 22 year old female, for GARDASIL, a Pregnancy Registry product, concerning herself with no pertinent medical history and no known drug reactions/allergies who in March 2009, was vaccinated with the first dose of GARDASIL. In November 2009, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On unknown date, the patient was seen in the emergency room with stomach pains. Urine and blood tests were done and revealed pregnancy. The date of last menstrual period was 27-SEP-2009 and the estimated delivery date will be on 04-JUL-2010. Therapy with GARDASIL was discontinued. At the time of reporting, the patient's outcomes were unknown. She had an appointment to see her physician on 14-DEC-2009. Unspecified medical attention was sought. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood test, Urine analysis
Clinical narrative: Information has been received from a consumer concerning his 24 year old wife with no medical history or drug allergies who on approximately 15-SEP-2009 (3 months ago) was vaccinated with the first 0.5ml injection of GARDASIL (lot# not reported). There was no concomitant medication. Subsequently the patient didn't get her menstrual period from two months (approximately on 15-Oct-2009) after getting GARDASIL three months ago. Blood and urine test was performed but the results not provided. The patient sought medical attention via physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia, Rash pruritic, Rash pustular
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history and no known drug allergies, who on 18-NOV-2009 was vaccinated with the first dose of GARDASIL (lot # 661758/0968Y) in the left deltoid. There was no concomitant medication. On 19-NOV-2009 the patient's mother called the office stating her child had total numbness and tingling of upper left side of body, the same side as the site of vaccination. On 20-NOV-2009 another phone call from the mother stated the patient had itchy rash on her abdomen and face. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow up information has been received from a physician concerning an 18 year old female without illness at time of vaccination and no known drug allergies, who on 18-NOV-2009 in the AM was vaccinated with the first dose of GARDASIL (lot # 661758/0968Y) IM in the left deltoid. On 19-NOV-2009 the patient reported she had numbness and tingling of entire left side of body. On 21-NOV-2009, the patient developed rash on trunk initially and spread to face and chin, which was raised, pruritic pustule-like. There were no labs or diagnostic tests performed. The outcome was unknown. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient with latex allergy, drug hypersensitivity to morphine and DEMEROL allergic reaction to CIPRO and BACTRIM and a history of kidney transplant (left) performed twice who on 19-NOV-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 662304/1013Y). Concomitant therapy included prednisone, CELEXA,  trazodone HCL, PROGRAF, vitamins (unspecified). "DAPSRNE" and probiotics (unspecified). According to the nurse, the patient received her first dose of GARDASIL and became ill for 4 days with fever, aches and gastrointestinal upset. The patient was seen by her family physician and a "flu test" was performed and was negative. On an unspecified date the patient recovered. Follow up information has been received and indicated that the patient was a female student with chronic kidney disease, kidney reflux and history of transplant who on 19-NOV-2009 was vaccinated with her first dose of GARDASIL (Lot # 662304/1013Y) intramuscularly at 13:00 into her "left". It was reported that since 25-NOV-2009 at 08:00 AM the patient experienced 4 days of gastrointestinal upset, fever and body aches. The  patient had a negative flu screen. The patient recovered on 29-NOV-2009. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on unspecified dates was vaccinated with the 0.5 ml first, second and third dose of GARDASIL. There was no concomitant medication. On an unspecified date, the patient received her third dose of GARDASIL and developed a quarter sized lump on her arm at injection site. The patient sought unspecified medical attention. As of 23-DEC-2009, the lump had been reduced to the size of a dime. No lot number was provided. Follow up information was received from a licensed practical nurse. It was reported that the 19 year old patient on 17-DEC-2009 was vaccinated with a third dose of GARDASIL at 15:00. The patient stated that the injection site was swollen and sore to the touch or if she would bump her arm. At the time of reporting, the patient had recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient, for the Pregnancy Registry for GARDASIL, who in August 2009 was vaccinated with her third dose of GARDASIL. On approximately 21-NOV-2009, "over the weekend", the patient went to the emergency room with abdominal pain and was confirmed to be pregnant. The patient was also evaluated for ectopic pregnancy. On 23-NOV-2009 the patient was 6 weeks pregnant. The patient's estimated LMP was 12-OCT-2009 and her EDD was estimated to be 08-JUL-2010. At the time of the report, the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on 06-NOV-2006 was vaccinated with GARDASIL. In May 2007 the patient completed the dosing schedule. Concomitant therapies included LAMICTAL and birth control. Subsequently the patient was diagnosed with the following HPV strains despite receiving GARDASIL: 16 18 31 33 35 39 45 51 52 56 58 59 68. The patient had sought unknown medical attention. The lab diagnostic test performed: pap smear. At the time of report the patient' s status was not recovered. Follow-up information has been received from a nurse practitioner concerning the 19 (previously reported as 16) year old female patient. The patient had standard pap smear test in February 2006 and the result was all normal. On 06-NOV-2006 the patient was vaccinated IM with the first dose of GARDASIL (Lot# 653736/0689F). On 06-JAN-2007 the patient was vaccinated IM with the second dose of GARDASIL (lot # 655619/1427F) and on 10-MAY-2007 the patient was vaccinated IM with the third dose of GARDASIL. Pap smear were all normal until June 2009. The patient can back to the office in December 2009 and a pap smear test showed Ascus and that the patient was positive with following HPV strains: 16 18 31 33 35 39 45 51 52 56 59 68. In March 2010 the pap smear test was normal again. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Erythema, Nausea
Clinical narrative: Information has been received from a physician as part of a market research focus group concerning a 16 year old female patient who on an unknown date was vaccinated with a second dose of GARDASIL (lot number, site and route not reported). Subsequently the patient developed redness of skin, shortness of breath, dizziness and nausea after received the second dose of GARDASIL. Therapy with GARDASIL was discontinued. At the time of report, the patient had recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who on approximately 02-DEC-2009, "about two weeks ago" was vaccinated with a dose of GARDASIL (Lot No. not reported). Right after receiving the dose GARDASIL, the patient "got light headed" and fainted. The physician reported that the patient was 98 pounds so they did not know if she fainted because of her weight or because of GARDASIL. The patient sought unspecified medical attention. On an unknown date the patient recovered. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Menstruation delayed
Clinical narrative: Information has been received from a 25 year old female consumer for the Pregnancy Registry for GARDASIL, who in May 2009 was vaccinated with a first dose of GARDASIL and a second dose "around July or August 2009". There was no concomitant medication. It was reported that the consumer was "one week late" with her period. She did not know if she was pregnant. Her last menstrual period ended on 19-OCT-2009 and her estimated date of delivery was 26-Jul-2010. There was no adverse event reported. At the time of the report, the outcome of the consumer was unknown. No laboratory or diagnostic studies were performed. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Infectious mononucleosis
Clinical narrative: Information has been received from an 18 year old female patient with allergic to DURACEF and no pertinent medical history who in "March 2009" and "August 2009" was vaccinated IM with the first and second 0.5 ml doses of GARDASIL (lot # not reported). Concomitant therapy included prednisone. On approximately 26-NOV-2009 the patient developed mononucleosis after getting her second shot of GARDASIL. The patient sought unspecified medical attention. A bloodwork was performed but the outcome was not reported. At the time of the report, the patient was recovering. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 15-DEC-2009 was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). On 16-DEC-2009, in the morning, the patient called the office and reported that she was having abdominal pain. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a Registered Nurse concerning a 15 year old female patient with allergy to AMOXIL and without pertinent medical history or illness at the time of vaccination, who on 28-SEP-2009 at 4:00 PM was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot number 663451/0216Y). Concomitant therapy included influenza virus vaccine (manufacturer unknown). The reporter mentioned that the patient has not had her period since for (approximately 2 months). No laboratory or test diagnostics were performed. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Follow up information has been received from the Registered Nurse who reported that the patient who got the first dose of GARDASIL on 28-SEP-2009 was having regular periods for over 1 year and had no period since GARDASIL (no period in the month of October). The patient did get period on 24-NOV-2009. No further information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site reaction, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on unspecified dates was vaccinated with 3 doses of GARDASIL (no lot number given). The physician reported that the patient experienced injection site reactions after all 3 doses with the third dose being the most painful. The patient sought unspecified medical attention. This is one of two reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac function test, Electroencephalogram, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with three 0.5ml doses of GARDASIL (lot#s not reported) respectively on 17-MAR-2009, 15-MAY-2009 and 30-DEC-2009.  On 22-FEB-2010 the patient experienced syncope and was rushed to the hospital by ambulance.  It was reported that the patient had had other syncope events since then.  Electroencephalography and cardiology test were performed with no results reported.  At the time of this report, the patient's outcome was not reported.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female patient who on 13-JUL-2007 was vaccinated with the first dose of GARDASIL, on 07-JAN-2009 was administered the second dose of GARDASIL and on 15-DEC-2009 received 2 doses of GARDASIL accidentally. According to the nurse the patient was not experiencing any known symptom. At the time of the report the patient's outcome was not specified. Follow up information has been received from the registered nurse who indicated that the patient was a 14 year old (previously reported as 13) student with disorder with speech delay who on 15-DEC-2009 was given her third dose of GARDASIL (Lot # 663454/0672Y) into her left deltoid at 17:25 PM and was given another dose of GARDASIL at the same time. Concomitant therapy included influenza virus A (antigen type unspecified) vaccine (H1N1). There were no illnesses at the time of vaccination. It was reported that the registered nurse and the physician notified immediately. No adverse reaction was noted other than pain at injection site on 16-DEC-2009 at 16:20PM. The patient recovered on 17-DEC-2009. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bone marrow oedema, Lymphadenopathy, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Skeletal injury
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with a history of abnormal pap smear and no drug reactions or allergies reported, who on 27-AUG-2009 was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscular route in the left arm (lot # unknown). There was no concomitant medication. On 27-AUG-2009 the patient experienced left arm pain since receiving her first dose of GARDASIL. On 21-NOV-2009 the patient had an MRI of the left arm at an unspecified facility which revealed bone marrow edema (1x1 cm focus of marrow edema along posterior aspect of the humeral head-neck junction, centered along the posterior lateral physis, compatible with a bone contusion, multiple axillary lymph nodes measuring up to 2 x 1.2 cm of uncertain clinical significance, possible reactive; equivocal undercutting of the posterior inferior glenoid labrum at the seven o'clock position where a minor partial detachment cannot be entirely excluded). The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site warmth, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning the physician's daughter who was vaccinated with the third dose of GARDASIL. Subsequently the patient developed a lump where the injection site was given and it was hot. The patient had sought unknown medical attention and had an MRI done of her arm. At the time of report the patient's status was recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Condition aggravated, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 23 year old daughter with codeine reaction/allergy and an history of acne at 17 year old which was resolved who was vaccinated with the first, second dose and third dose of GARDASIL on 06-MAY-2009, 26-AUG-2009 and 15-DEC-2009 respectively. Concomitant therapy included KARIVA. The consumer reported that two weeks after the first vaccination, on approximately 20-MAY-2009, the patient developed acne. The patient was seen by a dermatologist but they never attributed the acne to the vaccine till now. The consumer states that on approximately 16-DEC-2009, after the third vaccination in the arm the patient experienced tingling of the leg, on the same side of the arm that was vaccinated with GARDASIL, but the consumer could not remember if it was right or left. At the time of the report the acne outcome was unspecified and the patient's tingling of the leg persisted. It was noted that at the time of the report, the patient was talking with her physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 15 year old female who was vaccinated with a dose of GARDASIL. The reporter mentioned that the patient had a syncopal episode. It was unknown if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. This is one of two reports received from the same source. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female patient who on an unspecified date was vaccinated with the three doses of GARDASIL (Lot number unspecified). After her first sexual exposure which occurred after she completed the GARDASIL series the patient tested positive for HPV on a PAP smear. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. The physician reported that on an unspecified date the patient came late for the second dose of GARDASIL, she was pregnant (LMP and EDD was unspecified) and had an abnormal pap smear. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient with no illness at the time of vaccination and no pre-existing allergies who on 31-OCT-2008 and 31-DEC-2008 was vaccinated with the first and second dose of GARDASIL (lot # 661766/0652X) in her buttock. On 29-APR-2009, the patient was vaccinated with the third dose of GARDASIL (lot# 0294Y) in her buttock. There was no concomitant medication. On 31-OCT-2008, after the first dose of vaccination, the patient experienced vaginal watery discharge. On 06-NOV-2008, the patient recovered. On 31-DEC-2008, after the second dose of vaccination, the patient experienced vaginal watery discharge. Medical attention was not sought. There were no laboratory diagnostic studies performed. On 06-JAN-2009, the patient recovered. Follow-up information has been received from a physician who reported that all three doses of GARDASIL administered to the patient were 0.5mL. There was no adverse event following prior vaccination. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Laboratory test, Myalgia
Clinical narrative: Information has been received from a pharmacist concerning a female patient "in her early 20s" who "in early 2008" was vaccinated with 3 doses of GARDASIL (lot number not reported). The patient received her doses from another facility. About one year after dose 3 was administered, in 2009, the patient began to experience myalgia and tiredness. Unspecified medical contact was sought. The patient did have lab work done but the pharmacist doesn't know which ones. At the time of the report, the patient had not recovered. The Pharmacist contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event and recovery status. The Pharmacist was waiting to speak with the doctor regarding these patients and would provide more information later. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, No reaction on previous exposure to drug, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female patient with sulfa allergy and no pertinent medical history who on 12-JUN-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 662300/0100Y), on 12-AUG-2009 was vaccinated with her second dose of GARDASIL (Lot # 661046/0381X), the nurse mentioned that the patient had not reactions after the first and second doses of GARDASIL. On 14-DEC-2009 the patient was vaccinated with her third dose of GARDASIL (Lot # 662304/1013Y). Concomitant therapy included hormonal contraceptives (unspecified). According to the nurse, on 15-DEC-2009 the patient experienced a reddened itchy area that was a couple inches below the injection site. The treatment for the patient was an antihistamine and cold compress. At the time of the report the patient was recovering. The patient sought medical attention by a phone call and a visit to the office. No diagnostic tests were performed. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage urinary tract, Thrombosis
Clinical narrative: Information has been received from a 17 year old female consumer with no medical history or allergies who on 29-DEC-2009 was vaccinated with the second dose of GARDASIL injection. There was no concomitant medication. On 30-DEC-2009 the patient experienced a light blood clot the day of administration and one last night. The consumer also mentioned after urination she noticed she was bleeding. There as no laboratory studies performed. The consumer did not seek medical attention. At the time of report, the patient's outcome was unknown. The consumer mentioned she went to a county health clinic and she did not know the doctor's name. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a 26 year old female patient who on 09-DEC-2009 was vaccinated with her first dose of GARDASIL (lot # not reported). There was no concomitant medication. At the time of this report, the patient should have started her menstrual cycle between December 11th and 15th, however she still had not gotten it. No diagnostic laboratory test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cyst removal, Ovarian cyst
Clinical narrative: Information has been received from a physician concerning a 18 year old female with no allergies reported and a history of high pelvic pressure especially with menses who on 02-AUG-2007 was vaccinated with a first dose of GARDASIL (lot number: 658222/0927U) in the left deltoid. On 11-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (lot number: 658554/0928U) in the left deltoid and on 12-FEB-2008 the patient received the third dose of GARDASIL (lot number not reported) in the left deltoid. Suspect vaccine included a dose of MENACTRA in the right deltoid on 02-AUG-2007 (lot number: U2340CA). There was no concomitant medication reported. There was no illness at the time of vaccination. On 07-OCT-2008 the patient experienced ovarian cyst and required emergency room visit. The physician reported that the patient removal ovarian cyst 12X12X9cm after history of pelvic pressure especially with menses and the cyst was benign. At the time of the report the outcome of the patient was unknown. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with a history of seizure disorder and no known allergies who in August 2009, was vaccinated with the second dose of GARDASIL (lot number not reported). Concomitant therapy included TOPAMAX, PROZAC, magnesium (unspecified) and unspecified oral contraceptives. Approximately in August 2009, the patient developed headaches and aching in her legs and "generally not feeling well" a few days after vaccination. Medical attention was sought via phone call. There were no lab studies performed. On an unknown date, the patient recovered. Follow-up information has been received from the consumer and a health care professional concerning the 16 year old female patient with asthma, a history of migraines and no known drug allergies who on 24-AUG-2009 was vaccinated in the left deltoid with the first dose (previously reported as the second dose) of GARDASIL (lot number 662404/0312Y). On an unspecified date the patient developed achy, leg pain and there was no treatment for the achy at the office. The health care professional thought the patient may had seen her primary care physician. Follow-up information was received which reported that on 24-AUG-2009, the 16 year old female was vaccinated with a dose of GARDASIL (lot #662404/0312Y) into the left deltoid. Subsequently, the patient experienced leg ache and body ache per phone call. The patient cancelled GARDASIL vaccination on 23-DEC-2009. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient with no pertinent medical history who on 25-NOV-2009 was vaccinated with a second dose of GARDASIL in her "butt". There was no concomitant medication. On 25-NOV-2009 the patient developed vaginal watery discharge. Subsequently, the patient recovered. No laboratory or diagnostic studies were performed. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse concerning a 24 year old female who on 10-NOV-2009 was vaccinated IM with a first dose of GARDASIL (lot number: 663552/1350Y). The nurse told that the patient called at the office and stated that she experienced a high fever of 101 with chills and aches on 12-NOV-2009. The patient reported that the symptoms resolved within 24 hours of onset (on 13-NOV-2009). The patient sought medical attention at the physician's office. Follow up information has been received from Registered Nurse who reported that 24 year old female patient who on 10-NOV-2009 was vaccinated with a first dose of GARDASIL (lot number: 663552/1350Y) in the left deltoid. On 13-NOV-2009 " (also reported by Registered Nurse as on 12-NOV-2009)", the patient complained of temperature of 101 with chills. As of 13-NOV-2009, she was feeling better. It was reported that she felt it may be due to GARDASIL but today. On 16-NOV-2009, a telephone follow up to the patient who reported that she was feeling better and the symptoms were developed into a cold. Additional information is no expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 17 year old female who was vaccinated with a dose of GARDASIL. The reporter mentioned that the patient had a syncopal episode. It was unknown if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. This is one of two reports received from the same source. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Influenza, Placenta praevia, Ultrasound scan, Underweight
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female patient with no pertinent medical history who on 24-MAR-2009 was vaccinated with a first IM 0.5 ml dose of GARDASIL (Lot No. 661846/1312X) and a second IM 0.5 ml dose (658271/0558X) on 26-MAY-2009. There was no concomitant medication. It was reported that on 24-JUN-2009 the patient found out she was pregnant. On 25-JUN-2009 the patient had an ultrasound (results not provided). Nurse stated that patient had a placenta previa and contractions at 24 weeks and again at 26 weeks of pregnancy. There was not hospitalization for these early contractions and they were stopped by unspecified medications. The nurse reported that patient and fetus were underweight. On approximately 13-NOV-2009, at week 27, the patient had the common flu. Patient's LMP was on 08-MAY-2009 and her EDD was estimated to be 12-FEB-2010. Patient was having another ultrasound scheduled on 01-DEC-2009. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. This is one of four reports received from the same source. This is a consolidation of two reports concerning the same patient. The fetus's experience has been captures in WAES# 0911USA04741B1. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine contractions during pregnancy
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female patient with no pertinent medical history who on 24-MAR-2009 was vaccinated with a first IM 0.5 ml dose of GARDASIL (Lot No. 661846/1312X) and a second IM 0.5 ml dose (658271/0558X) on 26-MAY-2009. There was no concomitant medication. It was reported that on 24-JUN-2009 the patient found out she was pregnant. On 25-JUN-2009 the patient had an ultrasound (results not provided). Nurse stated that patient had a placenta previa and contractions at 24 weeks and again at 26 weeks of pregnancy. There was not hospitalization for these early contractions and they were stopped by unspecified medications. The nurse reported that patient and fetus were underweight. On approximately 13-NOV-2009, at week 27, the patient had the common flu. Patient's LMP was on 08-MAY-2009 and her EDD was estimated to be 12-FEB-2010. Patient was having another ultrasound scheduled on 01-DEC-2009. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. This is one of four reports received from the same source. This is a consolidation of two reports concerning the same patient. The fetus's experience has been captures in WAES# 0911USA04741B1. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Immediate post-injection reaction, Oropharyngeal pain, Pharyngeal oedema, Throat tightness
Clinical narrative: Information has been received from a nurse concerning a 22 year old female patient who on 09-NOV-2009 was vaccinated with the first dose of GARDASIL. Lot number was not available. Subsequently, on an unspecified date the patient's throat started closing after vaccination. The patient sought medical attention by a nurse practitioner. On an unspecified date, the patient had recovered. Follow-up information has been received from a nurse practitioner concerning a female patient with no pertinent medical history who on 09-NOV-2009 was vaccinated intramuscularly left GM with the first dose of GARDASIL (lot # 662518/0087Y). On 09-NOV-2009, the patient experienced throat swelling, sore throat and cough just after vaccination. It was also reported that the patient did not require emergency room or doctor visit. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Visual impairment
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient with no pertinent medical history and no known allergies who on 21-MAY-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 661952/1129X). On 27-JUL-2009 the patient was vaccinated with the second dose of GARDASIL (lot number 659054/0315Y). There was no concomitant medication. Subsequently the patient saw white spots and felt dizzy during her softball practice after received the second dose of GARDASIL. The patient called the office. There were no lab studies performed. The patient recovered on 27-JUL-2009. Additional information has been requested.