chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site abscess sterile
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a licensed practical nurse concerning a 26 year old female (weight 148#, height 66") who on 22-NOV-2006 was vaccinated with the first dose of GARDASIL. The patient was vaccinated with the second dose of GARDASIL (Lot #653937/0637F) on 22-JAN-2007 and the third dose (Lot #657622/0388U) on 21-MAY-2007 at 2:00 pm in the right deltoid. Concomitant therapy included LEXAPRO. No illness was reported at the time of vaccination. On 21-MAY-2007, the patient was vaccinated and developed a quarter-sized knot around the injection site. On 13-JUN-2007, the patient was seen by her physician and was diagnosed with a sterile abscess at the injection site which was not being treated (previously reported as being treated with antibiotics). As of 14-JUN-2007, the patient had not recovered. On an unspecified date, the area resolved and the patient recovered from the injection site abscess. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient was at the front desk to make another appointment when she fainted. Medical attention was sought. Additional information has been requested. Information has been received from a physician concerning a 14 year old female student who was vaccinated with a first dose of GARDASIL. On 11-APR-2007, the patient fainted a few minutes after receiving the vaccine. The physician had her lie down and took her blood pressure which was 98/60. The patient was watched for 10 to 15 minutes and then she went home. It was reported that there was no nausea or vomiting. On 11-APR-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: HPV4, TTOX
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil in one arm and then fainted while receiving a tetanus vaccine (manufacturer unknown) in the other arm. Medical attention was sought. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a nurse concerning a female who on 09-APR-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot #655165/1425F). On approximately 23-APR-2007 the patient experienced bruising at the injection site. Medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. At the time of this report, the  patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female with sulfonamide allergy who on 04-APR-2007 was vaccinated IM with the first dose of Gardasil. Concomitant therapy included allergy medicines. On 04-APR-2007 the patient was vaccinated and two hours later broke out in a rash. The rash looked like the type of rash from a sulfa allergy rather than hives. The physician gave the patient Benadryl and the patient recovered on 08-APR-2007. Medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning an 4 approximately 18 year old females who in approximately May 2007, were vaccinated with Gardasil. There was no concomitant medication. The all fainted after receiving the vaccine. After a while they all came to. Medical attention was sought. Additional information has been requested. Initial and follow-up information has been received from a registered nurse concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 23-MAY-2007 "about a month ago" was vaccinated with the first dose of GARDASIL (lot# 657617/03840), IM in the left deltoid. Concomitant suspect therapy included VAQTA  (lot# 656017/1280P), IM in the right deltoid. Concomitant therapy included MENACTRA (lot #U2228AA), IM in the right deltoid. On 23-MAY-2007, the patient was given the first dose of GARDASIL vaccine and then immediately given the first dose of VAQTA. The patient fainted immediately after given the first dose of VAQTA  while sitting up. The nurse laid the patient down and she came to almost immediately. The patient was weak and very pale. The nurse laid the patient down for approximately 15 minutes while being monitored by the nurse and the patient's mother. The patient was treated with ice that was applied to her forehead and neck. Approximately 30 minutes after the event the patient was fine and walked out of the physician's office. The reporter felt that the event was related to therapy with GARDASIL. On 08-AUG2002, the patient was vaccinated with the second dose of GARDASIL (lot #655205/1426P). IM in the left deltoid. The patient did not experience any events with the second dose of GARDASIL. Additional information is not expected. Information has been received from a registered nurse concerning an approximately  18 year old female with no pertinent medical history or drug reaction/allergies who in approximately May 2007 "about a month ago" was vaccinated with the first dose of GARDASIL,  IM. The patient fainted after receiving the vaccine. After a while the patient came to and she was instructed to lay down. Medical attention was sought. The patient recovered from the event that same day. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema mouth
Clinical narrative: Information has been received from a nurse concerning a 22 year old female with no medical history or allergies, who on 28-MAR-2007 was vaccinated intramuscularly with a first 0.5mL dose of Gardasil (lot#656049/0187U). There was no concomitant medication. The patient reported that on 28-MAR-2007 the roof of her mouth felt swollen for about 24 hours after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Culture stool negative, Diarrhoea, Fatigue, Gastrointestinal disorder
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of Gardasil. After being vaccinated the patient had "GI problems and fatigue." The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL. On 01-APR-2007 the patient experienced "GI problems" of diarrhea and abdominal cramps and fatigue. It was reported that the "c-pl" test was normal and the stool giardia antigen test was negative for giardia. The patient was last seen on 02-JUN-2007 and the patient's "GI problems" of diarrhea and abdominal cramps and fatigue persisted. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of Gardasil. After being vaccinated the patient had "GI problems and fatigue." The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL. On 01-APR-2007 the patient experienced "GI problems" of diarrhea and abdominal cramps and fatigue. It was reported that the "c-pl" test was normal and the stool giardia antigen test was negative for giardia. The patient was last seen on 02-JUN-2007 and the patient's "GI problems" of diarrhea and abdominal cramps and fatigue persisted. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the dose the patient received was unspecified. On an unspecified date, the patient developed genital warts after receiving the vaccine. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Choking, Inappropriate schedule of drug administration, Pharyngeal oedema
Clinical narrative: Information has been received from a health professional concerning a 32 year old female patient with no medical history or allergies who on 24-APR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 654535/0136U). There was no concomitant medication. On 24-APR-2007, the patient developed swelling in her throat and it caused her to choke. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a health professional concerning a 32 year old female patient with no medical history or allergies who on 24-APR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 654535/0136U). There was no concomitant medication. On 24-APR-2007, the patient developed swelling in her throat and it caused her to choke.  On an unspecified date, the patient experienced shortness of breath.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered from swelling in her throat and choking.  At the time of this report, the patient's outcome of her shortness of breath was unknown.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who on 06-JUN-2007 intramuscularly with a 0.5 ml dose of Gardasil. On 06-JUN-2007, the patient experienced significant pain and swelling at the injection site. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a local rash around the injection site. The rash was about 3 inches in diameter. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Face injury, Fall, Laboratory test, Malaise, Tooth injury
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who on 12-JUN-2007 received the first dose of Gardasil. Immediately upon injection, the patient complained of not feeling well and collapsed as the nurse was removing the needle from her arm. The patient fell on the side of her face and was rushed to the emergency room of a local hospital where she received 20 stitches in her face and mouth. Also, two of her front teeth were knocked loose. An unspecified blood test was performed (results not provided). It was also reported that the patient did not have anything to eat all day and the dose was given at 2:00 pm. The patient recovered on 12-JUN-2007. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Rash
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 11-JAN-2007 received the first dose of Gardasil. Subsequently, the patient developed a rash on her arm and "had a temperature". On 15-MAR-2007, the patient received the second dose of the Gardasil. On 15-MAR-2007, the patient developed a rash on her arm and legs and "had a temperature". The patient sought unspecified medical attention. The patient recovered. It was also reported that the patient will not receive her "3rd dose" of the vaccine. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a registered nurse concerning an 18 year old female who on 11-JAN-2007 was vaccinated intramuscularly into the right deltoid with the first dose of the GARDASIL (Lot # 653735/0688F). On 12-JAN-2007, the patient developed "some rash on her arm" and an elevated temperature. On 15-MAR-2007, the patient was vaccinated intramuscularly into the "left upper quadrant" with the second dose of the GARDASIL. On 16-MAR-2007, the patient developed a rash on her arms and legs and an elevated temperature. Treatment included TYLENOL and BENADRYL. The patient recovered. It was also reported that the patient will not receive her "3rd dose" of the vaccine. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Epstein-Barr virus antibody negative, Tonsillitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning her 21 year old daughter with no pertinent medical history who, on approximately 22-NOV-2006, received the first dose of Gardasil. There was no concomitant medication. On approximately 29-NOV-2006, the patient developed tonsillitis. The patient was treated with penicillin. Subsequently, the patient recovered. On 22-Jan-2007, the patient received the second dose of Gardasil. On approximately 01-FEB-2007, "ten to fourteen days later", the patient developed tonsillitis. She was treated with ZITHROMAX and recovered "a couple of days after starting ZITHROMAX". On 22-MAY-2007, the patient received the third dose of Gardasil. On approximately 01-JUN-2007, the patient developed tonsillitis. She was treated with AMOXIL. Diagnostic studies performed after the third occurrence of the tonsillitis in June 2007 included a "strep screen" and a "mononucleosis spot", both of which were negative. The patient recovered on 11-JUN-2007. The reporter indicated that for all three occurrences, the patient's tonsils were coated with "white stuff". Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Streptococcus test negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who was vaccinated with a second dose of Gardasil. Subsequently "about a day or two" after receiving the vaccination the patient developed rash all over her body. The patient returned to the office and they confirmed the rash was everywhere. A Streptococcus oralis culture came back negative. The patient was advised to take diphenhydramine 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 17 year old female (previously reported as 14 years), with no pertinent medical history, who on 14-MAY-2007 was vaccinated IM in the left deltoid with a second dose of GARDASIL (lot # 655205/1426F). On 18-MAY-2007 at 10:00 am, the patient developed a rash covering her torso (previously reported as all over her body). The patient returned to the office and they confirmed the rash "it was everywhere". A Strepococcus oralis culture came back negative. The patient was advised to take BENADRYL. Subsequently, the patient recovered from the rash on her torso. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 16 year old female patient who on 13-MAY-2007 was vaccinated with a dose of Gardasil. On 13-MAY-2007 the patient fainted. The reporter mentioned that 2 weeks later the patient fainted again while sitting down. Subsequently, the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse concerning her 11 year old daughter with a history of fibromyalgia who on 10-APR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection. On 10-APR-2007 the nurse reported that "2 and a half weeks" after her daughter was administered with Gardasil, her daughter experienced pain all over her body. Medical attention was sought. The patient was prescribed VICODIN for the pain. At the time of the reporting, patient has not recovered. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Initial and follow-up information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 13-JUN-2007 was vaccinated with Gardasil (Lot number unknown) 0.5 mL injection. There was no concomitant medication used. On 13-JUN-2007 the patient experienced dizziness. Medical attention was  sought. The patient recovered on 13-JUN-2007. Additional information was not provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. It was reported as tranlent and lasted less than twenty minutes. The patietn was treated with cool cloths, sitting, and juice. The patient recovered on 13-Jun-2007. It was also reported that the patient stated that she did not eat breakfase that morning. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a Medical Assistant concerning a 16 year old female patient who in approximately April 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included ALLEGRA. The reporter indicated that the patient "has not had regular menstrual cycles since receiving her first dose of GARDASIL". The patient was not pregnant. Medical attention was sought. At the time of reporting the event was ongoing. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, with a sulfonamide allergy, who on 13-JUN-2007, was vaccinated with the second dose of Gardasil (Lot #0212U). Concomitant therapy included YASMIN and AMBIEN. Forty five minutes after the vaccine had been administered, the mother of the patient called the office to report her daughter was "violently vomiting." At the time of this report, the patient was recovering from the event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Body temperature increased, Dyspnoea, Influenza like illness, Injection site pain
Clinical narrative: Information has been received from a physician concerning her 18 year old daughter who on approximately 24-MAY-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included appetite depressant (unspecified) and Meningococcal (unspecified). On approximately 25-MAY-2007 the patient experienced tenderness at injection site 6 to 12 hours after vaccination. Twent-four hours after vaccination the patient experienced flu like symptoms of joint aches, high fever of 102 degrees F, sore throat and shortness of breath. Unspecified medical attention was sought. The patient was monitored for the shortness of breath with a pulse oximetry reported normal. The mother reported that two days after the onset of the symptoms the symptoms resolved spontaneously. The physician examined the patient on 12-JUN-2007 and the patient had no symptoms. Subsequently, the patient recovered from the flu like symptoms. Additional information has been requested.  Additional infromation is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oxygen saturation, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning her 18 year old daughter who on approximately 24-MAY-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included appetite depressant (unspecified) and Meningococcal (unspecified). On approximately 25-MAY-2007 the patient experienced tenderness at injection site 6 to 12 hours after vaccination. Twent-four hours after vaccination the patient experienced flu like symptoms of joint aches, high fever of 102 degrees F, sore throat and shortness of breath. Unspecified medical attention was sought. The patient was monitored for the shortness of breath with a pulse oximetry reported normal. The mother reported that two days after the onset of the symptoms the symptoms resolved spontaneously. The physician examined the patient on 12-JUN-2007 and the patient had no symptoms. Subsequently, the patient recovered from the flu like symptoms. Additional information has been requested.  Additional infromation is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning her 18 year old daughter who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. The patient had arm pain five days after receiving the vaccination. The patient did not seek medical attention. At the time of the report, the patient outcome was unspecified. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female, who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. The patient fainted after receiving the vaccination. The patient regained consciousness and was sent home. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abscess
Clinical narrative: Information has been received from a physician concerning a 16 year old female on an unspecified date who was vaccinated with her first dose of Gardasil (lot number unknown). The physician reported that on an unspecified date the patient developed an abscess on her left breast two weeks after her first dose of Gardasil. Medical attention was sought. Additional information was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Vaccination complication
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female who on approximately 07-JUN-2007 received her first dose of GARDASIL, 0.5 ml. The patient experienced an "acute immediate reaction" after receiving the vaccination. She was rushed to the hospital. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Follow-up information has been received from a physician who states that, "It was not my patient who had the adverse event with GARDASIL vaccine. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Skin warm, Urticaria
Clinical narrative: Information has been received from an office worker concerning a female (age not reported) who was vaccinated on unspecified dates with her first and second dose of Gardasil (lot number unknown) 0.5 mL injection. The office worker reported that on an unspecified date the patient developed a large, hot welt, size of a baseball on her right deltoid 24 hours after receiving her third dose of Gardasil (lot number unknown) 0.5 mL injection. Medical attention was sought. On 24-APR-2007 the patient recovered from the adverse which lasted about four days. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (Lot number unknown). The registered nurse reported that the patient received her second dose of Gardasil (Lot number unknown) approximately in MARCH of 2007 at the college health clinic and experienced a temperature of 103 degrees. Medical attention was sought. At the time of reporting the patient recovered from the temperature of 103 degrees. The nurse reported that they are unsure about giving the patient her third dose of Gardasil due to the patient's experience with the second dose. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 25 year old female, who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, on an unspecified date the patient developed a low grade fever after being vaccinated. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Breast swelling, Breast tenderness
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning an 11 year old white female with no pertinent medical history who on 12-JUN-2007 at 3:15 pm, received her first dose of Gardasil (lot # 656049/0187U), 0.5 ml, intramuscularly into the left arm. There was no concomitant medication. Subsequently, the patient experienced swelling of her left breast. At the time of the report, the patient had not recovered. She was seen at the doctor's office on 14-JUN-2007. It was reported that the patient will receive her second dose of Gardasil on schedule. The medical assistant reported that the patient had no reaction to the vaccine. Her breast tenderness was linked to another issue. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse, concerning a 20 year old female patient, with a penicillin allergy involving a rash, who on 12-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # 657737/0522U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (LOESTRIN FE). On 14-JUN-2007 when the patient woke up in the morning, she had hives all over her body. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Malaise, Pyrexia
Clinical narrative: Information has been received from the office manager in a doctor's office concerning an 18 year old female patient with penicillin allergy who was vaccinated with a first dose of Gardasil and a second dose of Gardasil. The patient developed fever of 103 F after 8 hours of getting the second injection. She also did not feel well and had "problem breathing". She had no reaction after the first injection with Gardasil. Unspecified medical attention was sought by the patient. The patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Ultrasound abdomen abnormal
Clinical narrative: Initial and follow up information has been received from Pregnancy Registry and a Nurse Practitioner (N.P.) concerning an 18 year old female client who on an unspecified day was vaccinated with a first dose of GARDASIL and at the end of February 2007, was vaccinated with a second dose of GARDASIL. The reporter was unsure of the last menstrual period (LMP) provided by the patient. On 07-JUN-2007 Ultrasound was performed and the estimated date of conception (EDC) was mentioned as 19-DEC-2006. On 14-JUN-2007 patient went to clinic and was prescribed ZITHROMAX for Chlamydia. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 26-MAR-2007 was vaccinated IM in left deltoid with her first dose of Gardasil. On 27-MAR-2007 she developed a rash on the left side of her body. Unspecified medical attention was sought. The patient recovered two weeks after the event occurred. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history or pre-existing allergies,  birthdefects, or medical conditions who on     04-JAN-2007 was vaccinated with a first dose of Gardasil. On 22-May-2007, the patient was vaccinated Intramuscularly with a 0.5 mL second dose of Gardasil. Concomitant therapy included YASMIN, RITALIN and BENTYL. The nurse reported that the patient's mother called the office stating that the patient gained weight after receiving dose 2 of Gardasil. The patient did not have weight gain with dose one. The patient received dose two of Gardasil on 22-MAY-2007 and was a size two. The patient did not exhibit any illneses at the time of the vaccination. The patient then went to college and returned as a size 6. The only weight measurements that the office had were that the patient weighed 115 lbs in August 2005 and weighed 122 lbs when she received dose one on 04-JAN-2007. The present weight of the patient was unknown The patient sought unspecified medical attention. At the time of this report, the patient's weight gain persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 13-JUN-2007 was vaccinated with a dose of Gardasil in the left upper arm. Concomitant medication was not reported. On 13-JUN-2007, later in the evening, the patient's left hand became swollen, itchy, red and painful." The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.  This is in follow-up to report (s) previously concerning a 12 year old female student (weight 102L - hight 60") who on 14-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine in the left upper arm (also reported as deltoid). Concomitant medication was not reported. No illness was reported at the time of vaccination. On 14-JUN-2007, later in the evening, the patient's left hand ("ipsilateral side") became swollen, itchy, red and painful." The patient sought unspecified medical attention. On 15-JUN-2007 less than 24 hours, the patient recovered from the events. At the time of reporting, there were no further complaints. Additional information is not expected.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a female (age unknown) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. An unknown vaccination was administered at the same appointment. Subsequently the patient fainted. At the time of this report, the outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. No further information is available.
Age: 11.0
Sex: F
Vaccine: DTOX, HEPA, HPV4
Symptoms: Injection site cellulitis, Lymphadenopathy, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 11 yr old female who on 04-MAY-2007 was vaccinated with a first dose of Gardasil. On the same day, the patient also received Vaqta and hepatitis A virus vaccine (unspecified) ("HEP A") in the other arm. On 04-MAY-2007 the patient developed a large ulcer on her arm. The ulcer was on the arm where the patient received Gardasil. The patient also developed swollen lymph nodes under her jaw. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up informatoin has been received from a physician concerning an 11 year old female student with no medical history, allergies or illness at the time of vaccination who on 02-MAY-2007 was vaccinated in the left arm with a second dose of GARDASIL (lot # 654510/0962P). Concomitant vaccination included a second dose of VAQTA (MSD) (Lot # 652294/0249U) in the left arm (also reported as the other arm). Other concomitant vaccination included a first dose of DIP TOXIOD (lot # 41909M) in the left arm (also reorted as the other arm). On 02-MAY-2007, the patient developed a large ulcer on her arm. The ulcer was in the arm where the patient received GARDASIL vaccine. The patient also developed swollen lymph nodes undr her jaw. The patient was prescribed and treated with CEPHALEXIN 500 mg PO once a day for 10 days. On 04-MAY-2007, the patient had recovered from the cellulitis at the injection site. At the time of this report, the outcome of the ulcer on the arm and the swollen lymph nodes under her jaw was unknown. No product quality complaint was involved. Cellulitis at injection site was considered to be an other important medical event according to the reporting physician. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a registered school nurse concerning an approximately 11 year old female who, on an unspecified date during her sixth grade physical, was vaccinated with Gardasil. Subsequently the patient developed a "red, hot to touch area about the size of a baseball". The patient was taken out of school and taken to her physician. The patient's mother reported that the area was "bigger than it had been the night before". At the time of this report, the outcome of the event was unknown. NO further information is expected. This is one of two reports from the same source.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 22-NOV-2006 was vaccinated with the first dose of Gardasil (Lot # not reported). On approximately 22-NOV-2006 the patient experienced feeling light headed. on 24-JAN-2007 the patient received the second dose of Gardasil (lot # not reported). on approximately 24-JAN-2007 the patient experienced feeling light headed. on 06-JUN-2007 the patient received the third dose of Gardasil (Lot# not reported). On approximately 06-JUN-2007 the patient experienced feeling light headed and vomited. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Dizziness, Inappropriate schedule of drug administration, Irritability, Presyncope
Clinical narrative: This is in follow-up to report (s) previously submitted on 7/16/2007. Information has been received from a 30 year old female with no medical history or allergies, who on 14-JUN-2007 was vaccinated with 0.5 mL first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient became very dizzy and stated that she almost fainted. The consumer also stated that the "nurse did not shake the liquid in the syringe before administering the vaccine." In addition to the dizziness felt after teh injection, and which carried on for a few days, the patient had a general felling of irritability and anxiety, as well as recurrent tachycardia. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia
Clinical narrative: This is in follow-up to report (s) previously submitted on 7/16/2007. Information has been received from a 30 year old female with no medical history or allergies, who on 14-JUN-2007 was vaccinated with 0.5 mL first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient became very dizzy and stated that she almost fainted. The consumer also stated that the "nurse did not shake the liquid in the syringe before administering the vaccine." In addition to the dizziness felt after teh injection, and which carried on for a few days, the patient had a general felling of irritability and anxiety, as well as recurrent tachycardia. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Respiratory rate increased, Throat tightness, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on unspecified dates was vaccinated with a first and second dose of Gardasil (lot number unknown). In June 2007, the patient received her third dose of Gardasil (Lot # 653650/0702F) IM. The patient was observed for about 15 minutes and she seemed fine, but soon after the patient started complaining of her throat tightening and the patient started trembling. The nurse checked her blood pressure (148/85) and heart rate (97) both of which were elevated. The office did not believe it was an anaphylactic reaction since there was no respiratory distress. The patient was given diphenhydramine hydrochloride 25mg (BENADRYL) and ibuprofen (MOTRIN). The patient recovered from throat tightening, elevated blood pressure and elevated heart rate within 20 minutes and was sent home. Medical attention was sought. The patient called the next day and said she was feeling fine. She felt fine after the first two doses. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a nurse concerning her 19 year old daughter who is a student with no medical history allergies, or illness at the time of vaccination, who in January 2007, was vaccinated with a first dose of GARDASIL. She was vaccinated in the left deltoid with a second dose in approximately March 2007 or early April 2007. Concomitant therapy included YASMIN. The patient experienced a stiff neck on the left side and neck pain after vaccination with the second dose of GARDASIL. The symptoms began at least 24 hours after the vaccination and resolved after 72 hours. The pain radiated from the shoulder of the arm (arm unspecified) up to her neck. The patient sought unspecified medical attention. Ibuprofen (MOTRIN) was taken for the symptoms. No laboratory diagnostic studies were performed. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on an unspecified date was vaccinated with the first dose of Gardasil (lot number unknown). On an unspecified date, the patient was vaccinated with her second dose of Gardasil and developed genital warts. Medical attention was sought. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Nausea, Vomiting
Clinical narrative: Information has been received from an office manager concerning a 28 year old female with no medical history or allergies, who on 12-JUN-2007 was vaccinated intramuscular with a third 0.5mL dose of Gardasil (lot #657005/0314U). There was no concomitant medication. Subsequently several hours after being vaccinated the patient experienced nausea and vomiting. No laboratory diagnostic studies were performed. The symptoms improved within 24 hours. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information ahs been received from a physician concerning a 16 year old female patient who on 15-JUN-2007 was vaccinated with a first dose of Gardasil. On 15-JUN-2007, the patient experienced a vasovagal reaction. Unspecified medical attention was sought. On 15-JUN-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The next morning, the patient experienced extreme nausea. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No laboratory diagnostic studies were performed.No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, on an unspecified date the patient developed a low grade fever after being vaccinated. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who received 0.5 ml of the first dose of Gardasil on an unspecified date. Concomitant therapy included DEPO-PROVERA. It was reported that the patient experienced dehydration and flu-like symptoms one week after receiving the vaccination. She went to the emergency room (ER). On an unspecified date, the patient was vaccinated with a second dose of Gardasil. Two weeks after receiving her second dose of Gardasil, she ad the same symptoms, but they were not as severe. The patient's outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chemotherapy, Dyspnoea, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with acute lymphocytic leukaemia treated with chemotherapy (1989) and a drug allergy to BENADRYL (hives, trouble breathing) who on 22-FEB-2007 at 10:00, was vaccinated IM into the left arm with a first dose of Gardasil (Lot# 654741/0013U). Concomitant therapy included DEPO-PROVERA. "Within a day or two later," the patient's left forearm swelled from the injection site to the upper arm after lifting weights of 20 to 40 pounds. It was reported that the patient denied any erythema or itching. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. After 2 to 3 days, the swelling resolved. It was also reported the patient has not yet received the second dose of the vaccine. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 7/16/2007; 10/8/2007. The day following immunization, the patient's left upper arm and forearm swelled. The patient described that her forearm "swelled to the size of her upper arm". She noticed this after lifting weights (20-40 pounds). It was reported that the patient denied any itching, erythema, SOB, wheeezes or pain. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On 26-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Fungal infection, Inappropriate schedule of drug administration, No reaction on previous exposure to drug, Pruritus
Clinical narrative: Information has been received from a 27 year old female consumer with a history of yeast infection (after taking antibiotics) and allergic reaction to antibiotics telithromycin KETEK and levofloxacin LEVAQUIN, who on 12-MAR-2007 was vaccinated with a third dose of Gardasil. There was no concomitant medication. On 26-MAR-2007, the consumer developed a yeast infection two weeks later. It was reported that the consumer was initially treated with antibiotics (name not known) for treatment of what they thought was a urinary tract infection. She was then given fluconazole (DIFLUCAN) which did not resolve the yeast infection, and metronidazole (FLAGYL) which still has not resolved the yeast infection. It was reported that the consumer continues to experienced burning, itching and discomfort. Her symptoms have not changed in intensity. On 07-JUN-2007, a culture was taken that showed a yeast infection. It was reported that the consumer did not experience any difficulties after the last two vaccinations. At the time of this report, the consumer was reported to be recovering. It was reported that on 26-AUG-2006, the patient was vaccinated IM with a 0.5ml dose of Gardasil (Lot # 654540/0800F). No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7-16/2007. Information has been received from a 27 year old female consumer with a history of yeast infection (after taking antibiotics), endometriosis and allergic reaction to antibiotics KETEK and LEVAQUIN, who on 12-MAR-2007 was vaccinated into the left hip with a third dose of GARDASIL (Lot # 654540/0800F). There was no concomitant medication. About one week after the vaccination, the patient experienced severe itching, burning and pain. On 26-MAR-2007 two weeks later, the consumer developed a yeast infection. It was reported that the consumer was initially treated with antibiotics SEPTRA DS, MACRODANTIN for treatment of what they thought was a urinary tract infection. She was then given DIFLUCAN which did not resolve the yeast infection, and FLAGYL which still has not resolved the yeast infection. On 07-JUN-2007, a culture was taken that showed a yeast infection. It was reported that the consumer did not experience any difficulties after the last two vaccinations. It was reported that the symptoms lasted for two and a half months. Subsequently, the patient was recovering from yeast infection. It was reported that on 26-AUG-2006, the patient was vaccinated IM with a 0.5ml dose of GARDASIL (Lot # 654540/0800F). No product quality complaint was involved. Additional information is not expected.