chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a medical assistant concerning her 18 year old daughter with Von Willebrand's disease and no known drug allergies who on 29-JAN-2007 was vaccinated with the first dose of GARDASIL (lot# 0011Y, valid for ROTATEQ 0.5ml, intramuscularly. On 26-MAR-2007 patient received the second dose of GARDASIL (lot# 0011Y, valid for ROTATEQ) 0.5ml intramuscularly, and on 05-AUG-2009 she received the third dose of GARDASIL (lot# 0073Y, valid for ROTATEQ) 0.5ml intramuscularly. Concomitant therapy included ORTHO-NOVUM. Patient did not receive any concomitant vaccinations when she received GARDASIL. In August 2008 (exact date not reported), the patient experienced hives intermittently in different locations ("she broke out in hives"). On 10-OCT-2008 the patient complained of joint pain in her arms. The joint pain went away and returned another time. The patient also complained of muscle spasm, severe joint pain and swelling, pain in her arms, shoulders, knees and legs with some outbreaks. During some of the outbreaks she is unable to walk without assistance. On 04-NOV-2008 the patient was seen by her physician, and had laboratory blood tests which revealed RA factor negative, SED rate 14, normal, CBC (results not reported). On 14-JAN-2009 the patient was seen one time by a rheumatologist. The patient was evaluated with no diagnosis. Rheumatologist was not able to determine the source of patient's symptoms. On 22-AUG-2009 the patient experienced bilateral hand to elbow pain and swelling. Patient had a scheduled appointment to see the physician (date not reported). At the time of this report the patient had not yet recovered but went back to school. This is one of two cases from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor negative, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning her 18 year old daughter with Von Willebrand's disease and no known drug allergies who on 29-JAN-2007 was vaccinated with the first dose of GARDASIL (lot# 0011Y, valid for ROTATEQ 0.5ml, intramuscularly. On 26-MAR-2007 patient received the second dose of GARDASIL (lot# 0011Y, valid for ROTATEQ) 0.5ml intramuscularly, and on 05-AUG-2009 she received the third dose of GARDASIL (lot# 0073Y, valid for ROTATEQ) 0.5ml intramuscularly. Concomitant therapy included ORTHO-NOVUM. Patient did not receive any concomitant vaccinations when she received GARDASIL. In August 2008 (exact date not reported), the patient experienced hives intermittently in different locations ("she broke out in hives"). On 10-OCT-2008 the patient complained of joint pain in her arms. The joint pain went away and returned another time. The patient also complained of muscle spasm, severe joint pain and swelling, pain in her arms, shoulders, knees and legs with some outbreaks. During some of the outbreaks she is unable to walk without assistance. On 04-NOV-2008 the patient was seen by her physician, and had laboratory blood tests which revealed RA factor negative, SED rate 14, normal, CBC (results not reported). On 14-JAN-2009 the patient was seen one time by a rheumatologist. The patient was evaluated with no diagnosis. Rheumatologist was not able to determine the source of patient's symptoms. On 22-AUG-2009 the patient experienced bilateral hand to elbow pain and swelling. Patient had a scheduled appointment to see the physician (date not reported). At the time of this report the patient had not yet recovered but went back to school. This is one of two cases from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia, Rheumatoid arthritis
Clinical narrative: Information has been received from a nurse indicating that a patient's mother contacted the physician's office concerning her daughter, who completed the series for GARADSIL in July 2007 (unspecified vaccination dates and lot number). Within 4-5 months of completion, the patient developed rheumatoid arthritis and fibromyalgia. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Follow-up information was received from a nurse indicating that a 24 year old female patient with obesity, hypothyroidism, allergic to sulfa and PERCOCET, and a history of multiple surgeries on left ankle and heel (condition and dates not provided), gastric bypass surgery (in December 2008). The patient had no family history of rheumatoid arthritis and fibromyalgia. The patient was vaccinated with the first dose of GARDASIL (Lot #654389/0961F) on 26-JAN-2007, the second dose of GARDASIL (Lot#653736/0014U) and the third dose of GARDASIL (Lot# 0469U). There were no other vaccines given at the time of GARDASIL administration. Concomitant therapies included levothyroxine sodium (manufacturer unknown), VICODIN and cyclobenzaprine hydrochloride (MSD). In April 2009 (previously said "within 4-5 months of completion") the patient developed rheumatoid arthritis and fibramyalgia. The patient had sought medical attention, see a rheumatologist. At the time of the report the patient's status was not recovered. The nurse did not know or any hospitalization information and did not feel that the events were disabling or life threatening. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Oropharyngeal pain
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 07-DEC-2007 was vaccinated with the first dose of GARDASIL. On 29-JUL-2008, the patient was vaccinated with the second dose of GARDASIL and on 06-NOV-2008 the patient was vaccinated with the third dose of GARDASIL. On 18-AUG-2009 the patient received the fourth dose of GARDASIL. No adverse effect was reported. Follow up information received on 25-SEP-2009 from a physician indicated that the patient was a 11 year old female student, with no medical history or allergies and no illness at the time of vaccination. One week after injection the patient presented in the emergency room complained of sore throat. The patient recovered on an unspecified date. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: Information has been received from mother concerning her 17 year old daughter with allergic reaction to CECLOR and no pertinent medical history who in 2007 completed the series of the GARDASIL. Concomitant therapies were not reported. The mother reported that ever since her daughter finished the series, she has been having permanent problems with her menstrual cycle. The mother stated that her daughter has been in excruciating pain every time she gets her monthly period. The patient sought unspecified medical attention. At the time of the reporting, the outcome of the events were unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an 11 year old female patient who on 15-JUL-2009 was vaccinated with GARDASIL (Lot # was not provided). Concomitant therapy included meningococcal vaccine (unspecified) (manufacturer not reported). On 15-JUL-2009 the patient experienced fainting and syncope after getting GARDASIL (Lot # was not provided). Patient was empty stomach before getting GARDASIL. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 20 year old female with environmental allergies who on 04-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot: 659962/1740U). On 15-DEC-2008, the patient received the second dose of GARDASIL (Lot: 660620/0571X) and on 17-AUG-2009, the patient received 0.5 ml of the third dose of GARDASIL (Lot: 661766/0652X) intramuscularly. Concomitant therapy included XYZAL. On 17-AUG-2009 two hours after the patient received the third dose of GARDASIL she developed a red, raised itchy rash on her arm at the injection site, that had extended down to her elbow. At the time of reporting on 20-AUG-2009, the patient's status was unknown. Follow up information has been received from a bachelor of science in nursing concerning a 19 year old (previously reported as 20 year old) with a history of allergies to trees, grass, pollen, cats, dogs from skin testing, who on 17-AUG-2009, was vaccinated with 0.5 ml of the third dose of GARDASIL (Lot: 661766/0652X) at 10:00 am. On 20-AUG-2009, the patient called the office with complain of "itch and rash with bumps" at injection site since 17-AUG-2009. The rash was half way down the arm to elbow with raised rash. The patient was treated with topical steroid cream with relief. On an unknown date the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from an office nurse concerning a female patient who on an unknown date was vaccinated with GARDASIL (lot number, route and site not reported). One or two years later after receiving GARDASIL, the patient developed Papilloma viral infection (HPV). The nurse did not specify how many doses of GARDASIL were given. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a healthcare worker concerning a 25 year old female patient who on 19-AUG-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARADSIL (Lot # 660553/0070X). The healthcare worker reported that on the same day after vaccination the patient became lightheaded and almost passed out about 20 minutes. The patient had just left the office, but came in feeling lightheaded. Subsequently, the patient recovered from feeling lightheaded and passed out. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a mother (WAES# 0907USA03355) who on 13-JAN-2009 was vaccinated with her second dose of GARDASIL (lot # not provided), 0.5 ml. On 21-JUL-2009, the mother was 6 and half months pregnant after getting the 2nd dose of GARDASIL. On 18-OCT-2009 she delivered a normal male infant. Apgar score 1/11, the baby had no congenital abnormalities. On an unspecified date, the infant experienced fetal sepsis. The patient recovered with antibiotic treatment. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Pallor
Clinical narrative: Information has been received from a physician's secretary concerning a 20 year old female with no drug allergies, who on 20-JUL-2009 was vaccinated with her 1st dose of GARADSIL, IM, 0.5 ml. Subsequently, on the same day the patient's "blood pressure dropped to 62/40, she felt faint and became pale". Labs and diagnostic tests included blood pressure measurement. The patient had sought medical attention. At the time of the report the patient's status was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Coagulopathy
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with no pertinent medical history and no known allergies who on unspecified dates in 2008 was vaccinated intramuscularly with all three 0.5 ml doses of GARDASIL. The dates of administration and lot numbers were unknown because the patient received vaccine from another physician. Concomitant therapy included ZOLOFT. The patient was told after donating blood this week (approximately 19-AUG-2009) that she had "blood clotting problems". Medical attention was sought via telephone call. There were no lab studies performed. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Dizziness
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with chronic unspecified abdominal pain who on 16-JUL-2009 was vaccinated with her first dose of GARDASIL (lot# 659655/0940X, IM, 0.5 ml, site: arm). Concomitant therapy included MENACTRA. On 17-JUL-2009 the patient felt nauseated and hot, and then fainted. The patient sought medical attention. On 18-JUL-2009 the patient recovered. Follow-up information has been followed from the registered nurse concerning a 17 year old female student who on 16-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 659655/0940X) in her arm. Concomitant therapy included a first dose of MENACTRA (U2918AA) in her arm. The patient complained of dizziness and weakness 12 hours after the vaccination and lasted to 48 hours after the vaccination. There was no diagnostic laboratory test. The patient recovered on 18-JUL-2009. No further information is available.
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). Concomitant vaccine therapy included a dose of MENACTRA. The patient had a reaction after the vaccination. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient with pertinent medical history reported as none and amoxicillin allergy developed hives who on 03-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # not reported) intramuscularly. On 30-DEC-2008 she received second dose of GARDASIL (lot # 661703/0651X) intramuscularly. There was no concomitant medication. After second dose of vaccine the patient developed rash to her arms and chest. The patient did not seek medical attention for the rash and no treatment was reported. On an unspecified date the patient recovered. On 15-JUL-2009 the patient went to the office for her third dose of GARDASIL but the physician decided not administer any further doses. There were no laboratories diagnostics studies performed. Follow up information has been received from nurse concerning the female patient who received second dose of GARDASIL intramuscularly into left deltoid. On an unknown date after the second dose the patient complained of rash to her arms and chest. On an unknown date, the patient recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Influenza, Malaise, Nausea, Pain
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with seasonal allergy to dust pollen and a history of asthma who on an unknown date complained mild feeling of achiness and flu symptoms after the second dose of GARDASIL (route and site not reported). The third dose of GARDASIL (route and site not reported) was given at 3:00 PM (date not reported). The patient woke up the next morning with severe symptom of flu, vertigo and nausea. The patient "felt like she had influenza without the respiratory symptom". The patient was bedridden for 36 hours. The patient was treated with montelukast sodium (MSD), CLARITIN, COMBIVENT and PATADAY, QHS. Follow up information was received from a Certified Nurse Practitioner concerning the 19 year old female student who on 29-JUN-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL. On 24-SEP-2007 was vaccinated IM with the second dose in the left deltoid and on 18-JAN-2008 was vaccinated IM in the right deltoid with the third dose. Suspect vaccine therapy included the third IM dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown), on 31-AUG-2007 the second IM dose in the left arm of hepatitis B virus vaccine rHBsAg (manufacture unknown) an an IM dose in the right deltoid of MENACTRA and on 18-JAN-2008 a IM 0.5 ml dose of tetanus toxoid booster in the left deltoid. There was no illness reported at the time of vaccination. The patient did OK after the first dose of GARDASIL. On 29-SEP-2007, the patient felt slightly ill after the second dose of GARDASIL which resolved spontaneously. On 29-SEP-2007, the patient felt slightly ill after the second dose of GARDASIL which resolved spontaneously. On 19-JAN-2008, the next morning after the third vaccine dose, the patient experienced vertigo, nausea, felt like influenza without upper respiratory infection. At the time of report the patient had recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Similar reaction on previous exposure to drug, Vertigo
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with seasonal allergy to dust pollen and a history of asthma who on an unknown date complained mild feeling of achiness and flu symptoms after the second dose of GARDASIL (route and site not reported). The third dose of GARDASIL (route and site not reported) was given at 3:00 PM (date not reported). The patient woke up the next morning with severe symptom of flu, vertigo and nausea. The patient "felt like she had influenza without the respiratory symptom". The patient was bedridden for 36 hours. The patient was treated with montelukast sodium (MSD), CLARITIN, COMBIVENT and PATADAY, QHS. Follow up information was received from a Certified Nurse Practitioner concerning the 19 year old female student who on 29-JUN-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL. On 24-SEP-2007 was vaccinated IM with the second dose in the left deltoid and on 18-JAN-2008 was vaccinated IM in the right deltoid with the third dose. Suspect vaccine therapy included the third IM dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown), on 31-AUG-2007 the second IM dose in the left arm of hepatitis B virus vaccine rHBsAg (manufacture unknown) an an IM dose in the right deltoid of MENACTRA and on 18-JAN-2008 a IM 0.5 ml dose of tetanus toxoid booster in the left deltoid. There was no illness reported at the time of vaccination. The patient did OK after the first dose of GARDASIL. On 29-SEP-2007, the patient felt slightly ill after the second dose of GARDASIL which resolved spontaneously. On 29-SEP-2007, the patient felt slightly ill after the second dose of GARDASIL which resolved spontaneously. On 19-JAN-2008, the next morning after the third vaccine dose, the patient experienced vertigo, nausea, felt like influenza without upper respiratory infection. At the time of report the patient had recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Somnolence, Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 12 year old female patient who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # was not provided). Concomitant therapy included MENACTRA. On 11-APR-2008 the patient slept all day and four days later she developed rashes on her left cheek, throat and neck. On 8-MAY-2008 the patient went back to the physician's office and she still had hives that time. The hives were treated with BENADRYL (manufacturer unknown) and MEDROL dose pack (manufacturer unknown). On 15-MAY-2009 the patient went back for another checkup, the hives were already gone. Therapy with GARDASIL was discontinued. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning his daughter, an approximately 14 year old female patient who on 11-MAY-2007 was vaccinated with the first dose of GARDASIL in deltoid. The patient received the second dose on 31-OCT-2008, the third dose on 30-DEC-2008 and the fourth dose on 26-JUN-2009. The patient experienced pain and redness at injection site post vaccination. The patient had sought unspecified medical attention. At the time of report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) concerning an approximately 21 year old female patient with history of eczema who on 10-JUL-2009 was vaccinated with the first 0.5 mL dose of GARDASIL. Concomitant therapy "started around the same time" included NUVARING. It was reported that "a week and a half after getting GARDASIL" the patient started experiencing rash around her waist area that later spread to the whole body. It was reported that the patient did go to the primary physician and was administered a shot for the rash (unspecified what kind). There were no laboratory diagnostic tests performed. It was reported that eventually NUVARING was removed and the patient was recovered three days later. Follow up information has been from a Nurse Practitioner concerning a 22 year old female patient with illness at the time of vaccination reported as none, adverse events following prior vaccination reported as none, no known drug allergies and history of eczema who on 13-MAY-2009 was vaccinated with a first dose of GARDASIL (lot # 661846/1312X) intramuscularly into left upper arm at 10:30 AM. In June 2009 she experienced rash over arms and legs only. Unsure if reaction was due to vaccine because the patient also started NUVARING at the same time. On an unspecified date the patient recovered from rash over arms and legs. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who approximately a year and a half to 2 years ago was vaccinated with a dose of GARDASIL. The patient experienced syncope after receiving the dose of GARDASIL. The patient sought medical attention through her physician. The patient's outcome was unknown. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient, allergic to neomycin, who on 18-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot number 663452/0671Y). Concomitant therapy included DESOGEN. On 20-AUG-2009, the patient complained of swollen glands and difficulty swallowing. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Lethargy, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the three doses of GARDASIL (lot no. not reported) on 21-JAN-2009, 31-MAR-2009 and on 19-AUG-2009. The physician reported that 7 days after second dose of GARDASIL the patient developed fever, headaches and dizziness. The patient fully recovered without treatment in 2 weeks. On 19-AUG-2009, after third dose the patient developed fever of 102F, headaches and dizziness within 4-6 hours. The patient was prescribed MOTRIN and is recovering at the time of the report. Follow up information has been received from the physician which reported that the 11 years old student with no medical history, allergies or drug reaction, on 19-AUG-2009 at 20:00 hours, experienced headache, dizziness, fever of 102F and lethargy after third dose of GARDASIL (lot no. 658271/0558X) into the left arm. The patient had not recovered and was still with intermittent headaches and dizziness. The physician reported that the sibling had dizziness 10 days after a was vaccine given (unspecified). No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 18-AUG-2009 was vaccinated with the first dose of GARDASIL (lot no. 661953/1130X). There was no concomitant medication. The nurse reported that after vaccination the patient started vomiting that evening and her mother called the emergency room that evening and they recommended calling the nurse. The mother called the office next morning to report that the patient had been vomiting on 18-AUG-2009 and 19-AUG-2009. A home pregnancy test was positive. The patient had denied being pregnant on 18-AUG-2009 prior to being vaccinated. It was not known if the patient will be followed at the health professional department or by a physician. The patient's LMP was unknown. Follow-up information has been received from a registered nurse who indicated that on 18-AUG-2009 the student with no illness at the time of vaccination was vaccinated with her first IM dose of GARDASIL (lot # 661953/1130X) in her left arm. Concomitant vaccination administered on 18-AUG-2009 included a first IM dose of BOOSTRIX (lot# AC52B031AB) in her right arm. The registered nurse stated that the patient's mother called the next day after vaccination and mentioned that the patient had vomited the night of 18-AUG-2009, went to the ER (Emergency Room) and had a positive pregnancy test. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chest X-ray normal, Chest discomfort, Fatigue, Influenza like illness
Clinical narrative: Information has been received from the patient's mother who is an office manager, concerning her 18 year old daughter who on 21-NOV-2008 and on 03-MAR-2009 was vaccinated IM with the first and second dose GARDASIL. On 10-JUL-2009 the patient received IM the third dose of GARDASIL (lot # 662404/0312Y). There was no concomitant medication. On 03-MAR-2009 while the second dose of GARDASIL was being administered the "injection burned" but no other symptoms occurred. In the evening of 10-JUL-2009 after the third dose of GARADSIL was administered, the patient experienced sore joints, nausea, fatigue, sore throat and other flu-like symptoms. On 13-JUL-2009 the patient saw her primary care physician who prescribed her ZITHROMAX but her sore throat worsened and she experienced vomiting. On 15-JUL-2009 the patient went to the Emergency Room because she felt pressure in her chest. She had a chest X-ray but results came back inconclusive so she was sent home without being admitted to the hospital. At the time of reporting the patient had recovered from all symptoms. Follow up information has been received from the Medical Assistant who reported the DOB of the patient 14-MAR-2009. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Information has been received from the patient's mother who is an office manager, concerning her 18 year old daughter who on 21-NOV-2008 and on 03-MAR-2009 was vaccinated IM with the first and second dose GARDASIL. On 10-JUL-2009 the patient received IM the third dose of GARDASIL (lot # 662404/0312Y). There was no concomitant medication. On 03-MAR-2009 while the second dose of GARDASIL was being administered the "injection burned" but no other symptoms occurred. In the evening of 10-JUL-2009 after the third dose of GARADSIL was administered, the patient experienced sore joints, nausea, fatigue, sore throat and other flu-like symptoms. On 13-JUL-2009 the patient saw her primary care physician who prescribed her ZITHROMAX but her sore throat worsened and she experienced vomiting. On 15-JUL-2009 the patient went to the Emergency Room because she felt pressure in her chest. She had a chest X-ray but results came back inconclusive so she was sent home without being admitted to the hospital. At the time of reporting the patient had recovered from all symptoms. Follow up information has been received from the Medical Assistant who reported the DOB of the patient 14-MAR-2009. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Nausea
Clinical narrative: Information has been received from a father concerning his daughter who in 2008 was vaccinated with the third dose of GARDASIL (Lot # not provided) on an unspecified date. The patient experienced nausea and gastrointestinal issues since then. The patient had seen several physicians in regard to her continue nausea, but they had not been able to determine the cause. At the reporting time the outcome was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Gait disturbance, Insomnia, Muscle tightness, Musculoskeletal pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who was vaccinated with the first dose of GARDASIL on an unspecified date. In August 2008, the patient experienced tightening in her back. She continued to have upper back pain which caused difficulty in sleeping and walking. The patient sought unknown medical attention. At the time of report the patient's status was not recovered. Follow up information has been received from a medical assistant indicating that the patient was still experiencing back pain. Pain traveled to the shoulder blades into the neck and traveled into the lower back. Mother of the patient told the medical assistant that the patient had not recovered and it was "hard for her to be active, and she was still uncomfortable when sleeping". Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a 28 year old patient with penicillin allergy and no pertinent medical history reported who on 10-JUL-2009 was vaccinated intramuscularly into the right deltoid with first 0.5mL dose of GARDASIL (lot number 661953/1130X). Concomitant therapy included YASMIN. "Four days after injection", on 14-JUL-2009, the patient experienced developed a rash. The fine raised rash started out on her legs or arms and then covered her entire body. No lab tests were performed. The patient sought unspecified medical attention. Follow up information was received from the nurse practitioner. She reported that the patient had decided to not receive any more doses. She reported that the patient has a lot of allergies (to foods, medications). The patient's rash started four days after the first dose of GARDASIL and the rash resolved but it took about a week to resolve. No further information is available.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Activated partial thromboplastin time shortened, Antiphospholipid antibodies negative, Antithrombin III, Cardiolipin antibody negative, Gene mutation identification test negative
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with overweight and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot#657006/0188U) on 01-NOV-2007, the second dose (lot#658488/0930U) on 27-DEC-2007 and the third dose (lot#661531/1311X) on 19-AUG-2009. Concomitant therapy included CLARITIN. On 20-AUG-2009, a blood work was done and showed a protein s deficiency. The patient has been referred to a hematologist. At the time of the report, the patient did not recover. Follow-up information has been received from the physician concerning the patient who on 19-AUG-2009 received the third dose of GARDASIL (lot#661531/1311X) intramuscularly in the left arm and the first dose of DAPTACEL (Sanofi, lot#C2865AA) intramuscularly in the right arm. There was no illness at time of vaccination. It was reported that pre-existing allergies, birth defects and medical conditions had not yet been diagnosed. The patient was diagnosed with protein s deficiency on 20-AUG-2009 and she had a strong family history of this disease. It was reported that the patient had reported no adverse events since receiving GARDASIL and did not require emergency room/doctor visit. On 20-AUG-2009, a protein S free AG test was performed and the result was 13%, the CBC/routine hematology test showed normal. On 14-SEP-2009, the blood studies showed: PROTIME: 13.2sec, INR 1.0, PTT 25.4sec, protein C 115%, ANTITHROMBIN III 113%, lupus anticoagulant negative; lipoprotein a <5mg/dl; anti-cardiolipin IgG 4GPL/ml, anti-cardiolipin IgM 7MPL/ml; the factor V Leiden mutation (G1691A, Arg506Gln) analysis and prothrombin G20210A mutation analysis showed normal. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: International normalised ratio normal, Lipoprotein (a) normal, Protein C, Protein S decreased, Protein S deficiency
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with overweight and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot#657006/0188U) on 01-NOV-2007, the second dose (lot#658488/0930U) on 27-DEC-2007 and the third dose (lot#661531/1311X) on 19-AUG-2009. Concomitant therapy included CLARITIN. On 20-AUG-2009, a blood work was done and showed a protein s deficiency. The patient has been referred to a hematologist. At the time of the report, the patient did not recover. Follow-up information has been received from the physician concerning the patient who on 19-AUG-2009 received the third dose of GARDASIL (lot#661531/1311X) intramuscularly in the left arm and the first dose of DAPTACEL (Sanofi, lot#C2865AA) intramuscularly in the right arm. There was no illness at time of vaccination. It was reported that pre-existing allergies, birth defects and medical conditions had not yet been diagnosed. The patient was diagnosed with protein s deficiency on 20-AUG-2009 and she had a strong family history of this disease. It was reported that the patient had reported no adverse events since receiving GARDASIL and did not require emergency room/doctor visit. On 20-AUG-2009, a protein S free AG test was performed and the result was 13%, the CBC/routine hematology test showed normal. On 14-SEP-2009, the blood studies showed: PROTIME: 13.2sec, INR 1.0, PTT 25.4sec, protein C 115%, ANTITHROMBIN III 113%, lupus anticoagulant negative; lipoprotein a <5mg/dl; anti-cardiolipin IgG 4GPL/ml, anti-cardiolipin IgM 7MPL/ml; the factor V Leiden mutation (G1691A, Arg506Gln) analysis and prothrombin G20210A mutation analysis showed normal. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Prothrombin time prolonged
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with overweight and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot#657006/0188U) on 01-NOV-2007, the second dose (lot#658488/0930U) on 27-DEC-2007 and the third dose (lot#661531/1311X) on 19-AUG-2009. Concomitant therapy included CLARITIN. On 20-AUG-2009, a blood work was done and showed a protein s deficiency. The patient has been referred to a hematologist. At the time of the report, the patient did not recover. Follow-up information has been received from the physician concerning the patient who on 19-AUG-2009 received the third dose of GARDASIL (lot#661531/1311X) intramuscularly in the left arm and the first dose of DAPTACEL (Sanofi, lot#C2865AA) intramuscularly in the right arm. There was no illness at time of vaccination. It was reported that pre-existing allergies, birth defects and medical conditions had not yet been diagnosed. The patient was diagnosed with protein s deficiency on 20-AUG-2009 and she had a strong family history of this disease. It was reported that the patient had reported no adverse events since receiving GARDASIL and did not require emergency room/doctor visit. On 20-AUG-2009, a protein S free AG test was performed and the result was 13%, the CBC/routine hematology test showed normal. On 14-SEP-2009, the blood studies showed: PROTIME: 13.2sec, INR 1.0, PTT 25.4sec, protein C 115%, ANTITHROMBIN III 113%, lupus anticoagulant negative; lipoprotein a <5mg/dl; anti-cardiolipin IgG 4GPL/ml, anti-cardiolipin IgM 7MPL/ml; the factor V Leiden mutation (G1691A, Arg506Gln) analysis and prothrombin G20210A mutation analysis showed normal. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysstasia, Fatigue
Clinical narrative: Information has been received from a consumer concerning his 19 year old daughter with "a problem with penicillin drugs" and no pertinent medical history, who on "late June 2009" was vaccinated intramuscularly with the first dose of GARDASIL, 0.5 ml. Concomitant medication included an unspecified allergy medicine. The consumer reported that on "late June 2009", his daughter felt "woozy" after getting her first GARDASIL dose. The doctor's staff had her lay down after getting vaccinated and when she stood up and she almost fell. She laid down "for a few more minutes" and when she stood up again, the same thing happened. After they had her lay down for a few more minutes, she was able to stand up, but she was really tired for a couple hours. She had not had her second shot yet. The same day, the patient recovered. The patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with GARDASIL. The patient called to the nurse practitioner "2 weeks after receiving the 3rd dose of GARDASIL" because she has been experienced dizziness and numbness. The reporter also mentioned that the therapy with GARDASIL was "discontinued". Lot # was not available and do not further Adverse Experience was provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood test, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Information has been received from a healthcare worker concerning a 23 year old female patient who was vaccinated with a 2nd dose of GARDASIL and experienced lightheadedness. Then on 18-Aug-2009 around 12:30, the patient after received the 3rd dose of GARDASIL (LOT 663451/0216Y), she mentioned that she felt a little funny and then she asked if she could get a glass of water and then she started dripping down and she end up passed out. The medical assistant used ammonia smell and when the patient woke up from passing out she came back, but she looked really haggard and then the nurse and the medical assistant took her blood pressure and it was normal. The patient recovered that day but when she went home, she called the clinic back and told them that she was not feeling right and that she felt anxious. A Blood test was performed but results were not provided. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a healthcare worker concerning a 23 year old female patient who was vaccinated with a 2nd dose of GARDASIL and experienced lightheadedness. Then on 18-Aug-2009 around 12:30, the patient after received the 3rd dose of GARDASIL (LOT 663451/0216Y), she mentioned that she felt a little funny and then she asked if she could get a glass of water and then she started dripping down and she end up passed out. The medical assistant used ammonia smell and when the patient woke up from passing out she came back, but she looked really haggard and then the nurse and the medical assistant took her blood pressure and it was normal. The patient recovered that day but when she went home, she called the clinic back and told them that she was not feeling right and that she felt anxious. A Blood test was performed but results were not provided. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a 20 year old female patient with no pertinent medical history and no drug reactions/allergies who on 13-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # unknown), in her right arm. Concomitant therapy included ORTHO TRI CYCLEN. The patient reported that since she was vaccinated, she had had severe shooting pain the the injection area and the shoulder. She stated that the pain on the injection site was getting worse. She also stated she cannot lift her arm. Lab diagnostic studies were not performed. At the time of the report, the patient had not recovered and she had not contacted her physician yet about her AE. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Migraine
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old female patient with medical history of attention deficit/hyperactivity disorder and reflux disease and with no drug reactions/allergies who in 2007 was vaccinated with the first GARDASIL. Concomitant therapy included VYVANSE and PREVACID. After receiving her first dose of GARDASIL the patient developed migraines. The patient received her second dose of GARDASIL in May 2009. The physician mentioned that he did not believe the migraines were not caused by GARDASIL. The patient had sought medical attention, office visit. There were no lab diagnostic studies performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL on 28-AUG-2009. Concomitant vaccines included a dose of MENACTRA and a dose of VAQTA (manufacturer unknown) at the same office visit. The patient fainted 10 minutes after receiving the vaccine on 28-AUG-2009. The patient was monitored and was able to leave the office fully recovered on 28-AUG-2009. The patient sought unspecified medical attention. Follow up information was received from a physician concerning the 15 year old female (also reported as 16 year old) with no medical history or concurrent condition who on 28-AUG-2009 was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (lot# 661703/0651X). There was no illness at the time of vaccination. On 28-AUG-2009 within 10 minutes of vaccination the patient felt dizziness and fell on the floor in office. The patient was lost of consciousness about 1-2 minutes and regain consciousness. The patient recovered on 28-AUG-2009. No relevant diagnostic tests or laboratory data was collected. There was no adverse event following prior vaccination. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from Bachelor of Science in Nursing concerning a 26 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 02-JUL-2009 was vaccinated with a first dose of GARDASIL (lot # -0455Y) 0.5ml, intramuscularly. Concomitant therapy included DEPO-PROVERA. On 02-JUL-2009 after received the vaccine the patient developed persistent arm pain. Patient found taking ibuprofen provided some minor relief. The patient sought medical attention office visit. At the time on the report on 22-JUL-2009 the patient had not recovered. There were no laboratory diagnostics studies performed. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Diarrhoea, Nausea, Pelvic pain, Ultrasound pelvis
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female patient with no pertinent medical history and drug reactions/allergies who 02-AUG-2009 was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). There was no concomitant medication. On 02-AUG-2009, after receiving GARDASIL, the patient has been experiencing nausea, diarrhea, vomiting and pelvic pain. The consumer reported that the diarrhea, nausea and vomiting were on and off, but the pelvic pain was still on going. The patient had sought unspecified medical attention. Several tests including blood work, urinalysis and pelvic ultrasound have been done, but the results did not come back. At the time of the report, the patient did not recover. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis, Vomiting
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female patient with no pertinent medical history and drug reactions/allergies who 02-AUG-2009 was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). There was no concomitant medication. On 02-AUG-2009, after receiving GARDASIL, the patient has been experiencing nausea, diarrhea, vomiting and pelvic pain. The consumer reported that the diarrhea, nausea and vomiting were on and off, but the pelvic pain was still on going. The patient had sought unspecified medical attention. Several tests including blood work, urinalysis and pelvic ultrasound have been done, but the results did not come back. At the time of the report, the patient did not recover. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Hypoaesthesia oral, Swelling face
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a pertinent medical history of birth control medication who on 21-JUL-2009 was vaccinated with the first 0.5ml dose of GARDASIL. After getting the dose the patient experienced numbness on her right arm through neck until the jaw area. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. All telephone attempts to obtain follow-up information have been unsuccessful on 23-JUL-2009 and 27-JUL-2009. Follow-up information has been received from a physician concerning a 21 year old (previously reported as 23 year old) female patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who was vaccinated IM with the first dose of GARDASIL (Lot# 661764/0650X) in the right deltoid at 6:10pm on 21-JUL-2009. On 21-JUL-2009 after her vaccination she started to feel numbness on the right side of the neck which radiating to the right side of her face. She felt the same sensation on the right side of her mouth. On 22-JUL-2009 in the morning she saw that the right side of her face looked puffy and when she smiled she could see a difference between the right and left side of her face. Her co-workers noticed the puffiness of her right cheek. She had no difficulty swallowing. The physician reported that the right cheek showed a slight puffiness when compared to the left side and there was no difference on the nasolabial folds when she smiled. The physician advised the patient to take 25 mg po of unspecified medication now and repeat later that night. The patient had been advised to call if she felt that the symptoms were worsening. At the time of report the patient's status was recovered. Additional information is not expected.