chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with a history of allergic reaction to antibiotics who on 30-MAY-2008 was vaccinated IM with the first dose of GARDASIL (659439/1267U). Concomitant therapy included hormonal contraceptives (unspecified). On 30-MAY-2008 the patient experienced pain, redness and swelling at the injection site. The patient had increased pain, redness and swelling on 05-JUN-2008. The patient sought unspecified medical attention by calling the physician. Patient outcome was not reported. Follow-up information obtained from the nurse indicated that the patient sought medical attention at the ER. The patient experienced heat, edema and pain at the injection site, was afebrile and tender to touch. The patient denies weakness, numbness or tingling. The patient had a local inflammation secondary to IM injection. The patient recovered on 09-JUN-2008The nurse also reported that "many patients" experience pain related to the administration of GARDASIL. No other information is available at this time. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with a history of allergic reaction to antibiotics who on 30-MAY-2008 was vaccinated IM with the first dose of GARDASIL (659439/1267U). Concomitant therapy included hormonal contraceptives (unspecified). On 30-MAY-2008 the patient experienced pain, redness and swelling at the injection site. The patient had increased pain, redness and swelling on 05-JUN-2008. The patient sought unspecified medical attention by calling the physician. Patient outcome was not reported. Follow-up information obtained from the nurse indicated that the patient sought medical attention at the ER. The patient experienced heat, edema and pain at the injection site, was afebrile and tender to touch. The patient denies weakness, numbness or tingling. The patient had a local inflammation secondary to IM injection. The patient recovered on 09-JUN-2008The nurse also reported that "many patients" experience pain related to the administration of GARDASIL. No other information is available at this time. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 28 year old female, with no relevant medical history and no known drug allergies, who on 30-MAR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 654540/1161F; site not reported). On 01-JUN-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 0210U; site not reported). On 19-OCT-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 0530U; site not reported). There was no concomitant medication. On 04-JUN-2008, the patient called the office and stated that "she had arthritis from GARDASIL". The patient sought unspecified medical treatment by calling the office. The patient outcome was not reported. No additional information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician's office manager concerning a 13 year old female with asthma and a history of hypoglycaemia who on 31-OCT-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # 659437/1266U). On 20-JAN-2008, the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (Lot # 659657/1487U). On 30-MAY-2008, the patient was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot # 660391/0062X). Concomitant therapy included and albuterol inhaler (unspecified). The office manager reported that on 30-MAY-2008 "the patient experienced a syncopal episode after receiving her third dose of GARDASIL". She reported that the patient collapsed as she attempted to leave the office and hit her head on the wall as she fell. The patient did not lose consciousness. The patient was examined in the office and vital signs monitored (not otherwise specified). It was reported that on 30-MAY-2008, the patient recovered from both events within an unspecified amount of time. There were no other symptoms and no treatment reported. No additional information was provided. Additional information has been requested. Follow-up information. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dysgeusia
Clinical narrative: Information has been received from a nurse concerning a female who on 06-JUN-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). Concomitant therapy included VARIVAX, for the treatment of prophylaxis (duration and dose not reported) (lot# not reported). Other concomitant therapy included MENACTRA (lot# not reported). On 06-JUN-2008, after receiving the 3 different vaccines, the patient experienced a metallic in her mouth. She brushed her tongue 20 times, but she could still taste it. The patient's metallic taste in her mouth persisted. The patient sought unspecified medical attention on an unspecified date when her mom called the office. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a physician and healthcare worker concerning a 21 year old female who was vaccinated on 17-JAN-2008 in the left deltoid with her third dose of GARDASIL (lot# 659441/1446U). Concomitant therapy included YAZ. On 17-JAN-2008 the patient felt achy, had a high fever, headache and the chills after receiving her third dose. Subsequently, the patient recovered on 18-JAN-2008 from feeling achy, a high fever, headache and chills. The patient sought unspecified medical attention on an unspecified date. No additional information is expected. This is a consolidation of two reports.
Sex: F
Vaccine: HPV4
Symptoms: Skin warm, Somnolence
Clinical narrative: Information has been received from a Pharmacist (R.Ph.) concerning a "young lady" who on 09-JUN-2008 was vaccinated with a first dose of GARDASIL (lot # not reported). There was no concomitant medication. The Pharmacist reported that the "young lady received her first dose of GARDASIL at the physician's office around 10 am this morning and slept from around 12 noon to about 4:15 PM". She was awakened by her mother as recommended by the pharmacist to check her status. It was reported that "she felt a little warm". The patient sought medical attention by contacting the pharmacist. The patient's present status was reported as "sleepy". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who was vaccinated with a first dose of GARDASIL (lot # not reported). The nurse reported that the patient "developed swollen lips a few days after receiving her first dose of GARDASIL". It was also reported that the patient had also "just started an unspecified birth control medication". The patient sought unspecified medical attention during a phone call to the office. Patient outcome was not reported. Additional has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Chest pain, Headache, Heart rate, Musculoskeletal pain
Clinical narrative: Information has been received from a physician and from Emergency room medical records concerning a 16 year old female with  no pre-existing allergies or medial condition, who on 24-APR-2007 was vaccinated intramuscularly into left deltoid with the first dose of GARDASIL (lot# not reported) and on 10-JUN-2008 was vaccinated with the second dose of GARDASIL (lot # 656051/0244U). On 12-JUN-2008 the patient went to the emergency room and had complaints of headache to the right temporal area, described as constant. The symptoms were aggravated by standing or laying for too long. The patient had right neck pain into her shoulder. Examination was positive for right trapezius, pain at rest, pain with movement. The symptoms began two days ago. Chest pain was also noted (onset not reported). The emergency room report noted that there was no dizziness, fever, nausea, paresthesis, sinus congestion, vision changes, vomiting. The severity of the pain in the emergency department was a "10" out of "10." The patient had not had any similar episode in the past. Physical examination in the emergency room showed that the patient was oriented to person, place, time and her mentation was appropriate for stated age. She had excellent breath sounds in all fields with symmetrical chest wall movement and no wheezing, rales of rhonchi. Her heart sounds were normal with no murmurs, rubs or gallop. Vital signs included: B/P 130/93; pulse 81; respirations 18; temperature 98.7 and pulse oximeter 96& on room air. Impression was tension headache. In the emergency room the patient was given MOTRIN 800 mg orally and FLEXERIL 10 mg orally. Her symptoms improved and she was discharged to home in stable condition with instructions on headache, tension muscle contraction headache. Discharged medications included prescriptions for PHENERGAN (twelve) tablets 25 mg, 1 every 6 hours as needed for nausea; TORADOL 1O mg (twelve) tablets, 2 tablets by mouth to start then 1 tablet every 6 hours as needed. She was to follow up with her physician in 2-3 days. The physician reported that the headache and chest pain were not related to the GARDASIL. On an unspecified date the patient recovered from the headache, chest pain and shoulder pain. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, No reaction on previous exposure to drug, Oxygen saturation, Tension headache
Clinical narrative: Information has been received from a physician and from Emergency room medical records concerning a 16 year old female with  no pre-existing allergies or medial condition, who on 24-APR-2007 was vaccinated intramuscularly into left deltoid with the first dose of GARDASIL (lot# not reported) and on 10-JUN-2008 was vaccinated with the second dose of GARDASIL (lot # 656051/0244U). On 12-JUN-2008 the patient went to the emergency room and had complaints of headache to the right temporal area, described as constant. The symptoms were aggravated by standing or laying for too long. The patient had right neck pain into her shoulder. Examination was positive for right trapezius, pain at rest, pain with movement. The symptoms began two days ago. Chest pain was also noted (onset not reported). The emergency room report noted that there was no dizziness, fever, nausea, paresthesis, sinus congestion, vision changes, vomiting. The severity of the pain in the emergency department was a "10" out of "10." The patient had not had any similar episode in the past. Physical examination in the emergency room showed that the patient was oriented to person, place, time and her mentation was appropriate for stated age. She had excellent breath sounds in all fields with symmetrical chest wall movement and no wheezing, rales of rhonchi. Her heart sounds were normal with no murmurs, rubs or gallop. Vital signs included: B/P 130/93; pulse 81; respirations 18; temperature 98.7 and pulse oximeter 96& on room air. Impression was tension headache. In the emergency room the patient was given MOTRIN 800 mg orally and FLEXERIL 10 mg orally. Her symptoms improved and she was discharged to home in stable condition with instructions on headache, tension muscle contraction headache. Discharged medications included prescriptions for PHENERGAN (twelve) tablets 25 mg, 1 every 6 hours as needed for nausea; TORADOL 1O mg (twelve) tablets, 2 tablets by mouth to start then 1 tablet every 6 hours as needed. She was to follow up with her physician in 2-3 days. The physician reported that the headache and chest pain were not related to the GARDASIL. On an unspecified date the patient recovered from the headache, chest pain and shoulder pain. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with a history of penicillin allergy who on 27-FEB-2008 was vaccinated with IM with the first dose of GARDASIL (658556/1060U). On 23-APR-2008 the patient was vaccinated IM in the right deltoid with the second dose of GARDASIL (659962/1740U). The medical assistant reports that the patient developed a "knot" at the injection site at an unspecified time period after receiving the second dose. The patient phoned the physician's office on 10-JUN-2008 to report the adverse symptom. No other symptoms or treatments were reported and no other information is available. The patient's "knot" at the injection site has persisted. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a history of penicillin allergy who on 09-JUN-2008 was vaccinated IM with the first dose of GARDASIL (658490/0802U). Concomitant therapy included ORTHO TRI-DYCLEN LO. Per the physician the patient developed a "rash" over her entire body 6 hours after administration of her first dose of GARDASIL. The patient sought unspecified medical attention in the physician's office. The patient was prescribed oral prednisone and no additional information was provided. The patient's rash persisted. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of rhinitis allergic who on 05-APR-2008 was vaccinated IM with 0.5 ml of the first dose of GARDASIL. (lot#659655/1486U, site not reported). Concomitant therapy included CLARITIN and RHINOCORT NASAL SPRAY. On 06-APR-2008, one day after receiving the vaccination, the patient experienced rash with red dots on her chest, itching of arms and itching of chest for 1 to 1.5 weeks. No other vaccinations were given, no change in soaps or laundry products. The patient had sought unspecified medical attention in the doctor's office. Subsequently, the patient recovered. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: Initial information and follow up has been received from a physician and 35 year old female who on 08-FEB-2008, was vaccinated intramuscularly in error (the patient was suppose to receive the 2nd dose of hepatitis B) with her second dose of GARDASIL (lot# not reported). Concomitant therapy, in January 2008, included hepatitis B virus vaccine (unspecified manufacturer), for the treatment of prophylaxis (duration and dose not reported). After the first GARDASIL dose, the patient had pain in the opposite arm that lasted 2-3 months (recovered in June 2008). In March or May 2008, the patient went to the doctors office to receive another hepatitis B vaccine and was given another dose of GARDASIL (lot# not reported). The patient does not know if she will complete the GARDASIL or hepatitis B vaccine series. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with a penicillin allergy who on 25-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 0151X). There was no concomitant medication. On an unspecified date, the patient experienced a rash on her back, arms and neck. Subsequently, the patient recovered after 5 days from the rash on her back, arms and neck. The patient sought medical attention on an unspecified date by calling the office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 15 female with acne who on 15-MAR-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot#659182/175U). Concomitant therapy BENZACLIN and RETIN-A. The patient developed widespread muscle aching and a low grade fever within hours of receiving her first dose which resolved in 1-2 days with out requiring treatment. On 10-JUN-2008 the patient was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot#660391/0063X). After the second dose, the patient's mother contacted the office by phone to report her daughter's symptoms of muscle aching, low grade fever, as well as left knee pain that occurred within a few hours of the dose. Rest and ibuprofen were prescribed. At the time of the report, the patient had not recovered. The nurse did not known if the patient was scheduled to receive the third dose. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 21 year old female who on 28-MAY-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL in the left arm. Concomitant therapy included PROZAC, WELLBUTRIN and TRI-SPRINTEC. On 29-MAY-2008, within 18 hours of vaccination the patient developed hives to her arms, legs and trunk. The patient had an office visit with her primary physician. At the time of the report the patient was recovering. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Vitiligo
Clinical narrative: Information has been received from a father concerning his 9 year old daughter who on 23-JAN-2007 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. On 11-APR-2007 she was vaccinated with a second 0.5ml dose GARDASIL. Subsequently, the patient experienced Vitiligo. On 04-FEB-2008 was vaccinated with a third dose of GARDASIL. The patient sought unspecified medical attention. The patient underwent unspecified "labs" (result not reported). At the time of the report the Vitiligo was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female, her nurse, who in May 2008, was vaccinated intramuscularly with her first dose of GARDASIL (lot# not provided). The nurse stated that the experience with the vaccine was horrible, extremely painful and her arm hurt for 3 days. Subsequently, the patient recovered 4 days after the first dose. The patient sought unspecified medical attention on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Localised oedema
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot# not reported) on an unspecified date. "1 week later" the patient experienced bilateral axillary neck edema. "The edema lasted a few days and then resolved." No additional AE information was reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 02-APR-2008 was vaccinated IM with the first dose of GARDASIL vaccine (660387/1967U). the physician reported that the patient experienced nausea and vomiting after administration of the first dose of GARDASIL vaccine. The patient sought unspecified medical attention in the physician's office. Subsequently, the patient recovered from her nausea and vomiting. No additional information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Smear cervix abnormal
Clinical narrative: Information has been received from a Licensed Practical Nurse for the Pregnancy Registry for GARDASIL vaccine, concerning a 20 year old female who on 01-MAR-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (Lot #658556/1060U). On 19-MAY-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL vaccine (lot# 660389/1968U). Concomitant therapy included AZOR. It was unspecified if the patient was "currently on" alprazolam. The patient's LMP was reported as 30-APR-2008 (estimated due date 04-FEB-2009). The patient sought unspecified medical attention during an office visit. Laboratory diagnostics studies performed on an unspecified date included an "abnormal PAP." Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, No reaction on previous exposure to drug, Rash, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 19 year old female for the Pregnancy Registry for GARDASIL vaccine (yeast) with an allergic reaction to antibiotics (cephalexin (KEFLEX)) who in March 2008, was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# not reported). There was no concomitant medication. The patient received the second dose of GARDASIL vaccine (yeast) (lot# not reported) on an unspecified date and was pregnant. The patient's LMP was 01-APR-2008. The day after receiving the second dose of GARDASIL vaccine (yeast), the patient experienced a rash and went to the physician's office. At this time, a urine pregnancy test was conducted and it was positive. The patient's outcome for the rash and pregnancy were not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial information and follow up has been received from a physician's assistant and registered nurse concerning a white 16 year old female who on 13-DEC-2007 was vaccinated intramuscularly in the deltoid with her first dose of GARDASIL vaccine (yeast) (lot# 655154/1210U). There was no concomitant medication. On 03-JUN-2008 the mother informed the physician that the daughter experienced pain and swelling at the injection site on 13-DEC-2007. The patient was not seen as a result of this occurrence and has not decided not to continue the dosing series. Subsequently, the patient recovered from the pain and swelling at the injection site after 2 days. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated on an unspecified date with her first dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently the patient experienced prolonged vomiting. The patient sought medical attention by seeing the physician on an unspecified date. The patient's outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Injection site discomfort, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female with no allergies, who on 09-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot#, and route not reported). There was no concomitant medication. On 17-Jan-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (lot# 655237/1287U) (route not reported). In the evening of 17-JAN-2008, the patient experienced nausea, body aches, vomiting, and weakness. On 18-JAN-2008, the patient had mild discomfort at the injection site and also vomited in the morning. The reporter noted that the patient's symptoms lasted fro a day and on half and them resolved. On 21-MAR-2008, the patient returned to the office for another vaccination, but the vaccination was not administered due to the adverse reaction on 17-JAN-2008. The office was still deciding if they would administer another dose of GARDASIL vaccine. No other information was available. Additional information has been requested.  Follow-up information. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Full blood count normal, Laboratory test normal, Lipase normal, Liver function test normal
Clinical narrative: Information has been received from a physician concerning a female who on 22-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). On 23-APR-2008 the patient experienced nausea, vomiting, dizziness and an unspecified rash. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Additional information has been requested.  This is in follow-up to rpeort (s) previousl submitted on 07/15/2008. Information has been received from a physician concerning a 20 year old female with no illness at the time of being vaccinated who on 22-APR-2008 was vaccinated with a first dose of GARDASIL into the left deltoid. On 23-APR-2008 the patient experienced nausea, vomiting, dizziness and an unspecified rash. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Follow-up information was received. The patient required emergency room treatment. The patient recovered from nausea, vomiting and dizziness. Lab test included: vital signs with normal limits (WNL), hepatic profile (normal), chemical profile (normal), urinalysis test revealed ketones + bacterial). Complete blood cell count (CBC) and Lipase were normal. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Rash, Urine analysis abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who on 22-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). On 23-APR-2008 the patient experienced nausea, vomiting, dizziness and an unspecified rash. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Additional information has been requested.  This is in follow-up to rpeort (s) previousl submitted on 07/15/2008. Information has been received from a physician concerning a 20 year old female with no illness at the time of being vaccinated who on 22-APR-2008 was vaccinated with a first dose of GARDASIL into the left deltoid. On 23-APR-2008 the patient experienced nausea, vomiting, dizziness and an unspecified rash. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Follow-up information was received. The patient required emergency room treatment. The patient recovered from nausea, vomiting and dizziness. Lab test included: vital signs with normal limits (WNL), hepatic profile (normal), chemical profile (normal), urinalysis test revealed ketones + bacterial). Complete blood cell count (CBC) and Lipase were normal. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Metrorrhagia
Clinical narrative: Information has been received from the Merck Pregnancy Registry for GARDASIL vaccine (yeast) via a health professional concerning a 17 year old female with a history of irregular periods (April 2005) and anorexia (March 2006) who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). In January 2008, the patient was seen by the physician for metrorrhagia that was resolved. On 23-JAN-2008 the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL vaccine (yeast) and then discovered she was pregnant. Estimated date of last menstrual period was 22-JAN-2008. Gestation at the time of the report was "5 months along." Estimated date of delivery is 28-OCT-2008. At the time of the report the pregnancy outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a physician concerning a 14 year old female who in November 2007, was vaccinated SC with a first 0.5 ml dose of GARDASIL vaccine (yeast) in the abdomen. There was no concomitant medication. The patient reported having pain in her stomach after the first dose that did resolve. On 12-APR-2007 (previously reported as 04-DEC-2007) the patient was vaccinated IM with a second dose of GARDASIL vaccine (yeast) in the arm. She had no adverse effects after the second dose. The patient sought medical attention in the office. Other business partners numbers included: E2008-05747. No further information is expected. This case is closed.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a second dose of GARDASIL vaccine (yeast) and fainted. At the time of the report the outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 02-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently, the patient fainted after the administration. The patient did not sustain any injuries. The patient sought medical attention in the office. At the time of the report the patient had recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008 Inital and follow up information has been received from a physician and a health professional concerning a 15 year old femaile who on 02-JUN-2008 at 4:50 PM was vaccinated IM with scond dose of GARDASIL (Lot #660553/0070X) in the left deltoid. There was no concomitant medication.After vaccination at 5:10PM, the patient left the office and had a syncopal event at a pharmacy. The patient required medical attention in the office. On 02-JUN-2008, the patient had recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who "one month ago," on approximately 12-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# and route not reported). The reporter noted that the patient broke out in hives, was dizzy and went to the emergency room. No additional information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Information has been received from a nurse concerning a sixteen year old female patient with no medical history or drug allergies reported, who in November 2007, in France, was vaccinated subcutaneously in the abdomen with a first 0.5 mL dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently the patient complained of having pains in her stomach and nausea after the first dose that did resolve. On 04-DEC-2007 (reported as 12/04/2008), in Geneva, Switzerland, the second dose was given intramuscularly in the arm. No reports of adverse effects were indicated after the second dose. The patient sought unspecified medical attention in the office. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site anaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unreported), with concomitant medication, pertinent medical history and drug reactions/allergies reported as none, who was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657737/0522U), IM on an unspecified date. The second dose of GARDASIL vaccine (yeast) (lot # 655322/1211U) was given IM on an unspecified date. Immediately after vaccination the patient experienced numbness of the arm where the injections were given following both her first and second dose of GARDASIL vaccine (yeast). The numbness stretched from where the shot was given and all the way down her arm. The patient sought unspecified medical attention. The patient was treated with acetaminophen (TYLENOL) and subsequently recovered approximately 2 days after vaccination. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland, Lymphadenopathy
Clinical narrative: Information has been received from a health professional concerning herself, who, on an unspecified date, was vaccinated IM with a 0.5mL dose of GARDASIL vaccine (yeast). Subsequently, shortly after the vaccination the patient experienced swollen lymph nodes in her legs. A biopsy was performed of the swollen lymph nodes, and the result was negative. At the time of the report, the patient had not recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, Chemical poisoning, Gait disturbance, Intentional drug misuse, Musculoskeletal stiffness
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female with "high risk human papillomavirus", and a history of genital warts who on 28-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot # 654885/1424F, site and route not reported). Concomitant therapy included "DOXY" (not otherwise specified). On 28-MAY-2008, also reported as "2 weeks before 11-JUN-2008", "the patient had trouble walking because of stiff legs and had trouble opening her jaw". When the patient relaxed on her bed, the symptoms went away, but when she started to walk again, the symptoms came back. The patient went to the emergency room and was released (not further specified). The patient outcome was not reported. No further information was provided. Additional information has been requested. Follow-up information. On an unspecified date, the patient presented to the clinic with ataxis and difficulty speaking. The patient was sent to the emergency room. The nurse practitioner stated the reaction "wasnt related to the vaccine". "The patient had taken her mother's psychiatric medication, ABILIFY and drank some bleach." The patient received activated charcoal, recovered and discharged. When asked if this was a suicide attempt, the nurse practitioner stated "It was just a bunch of kids being kids." The patient took the medication and drank bleach with "a bunch of friends". There was "no adverse reaction to the vaccine". No additional information was provided. Additional information is not available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder, Trismus
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female with "high risk human papillomavirus", and a history of genital warts who on 28-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot # 654885/1424F, site and route not reported). Concomitant therapy included "DOXY" (not otherwise specified). On 28-MAY-2008, also reported as "2 weeks before 11-JUN-2008", "the patient had trouble walking because of stiff legs and had trouble opening her jaw". When the patient relaxed on her bed, the symptoms went away, but when she started to walk again, the symptoms came back. The patient went to the emergency room and was released (not further specified). The patient outcome was not reported. No further information was provided. Additional information has been requested. Follow-up information. On an unspecified date, the patient presented to the clinic with ataxis and difficulty speaking. The patient was sent to the emergency room. The nurse practitioner stated the reaction "wasnt related to the vaccine". "The patient had taken her mother's psychiatric medication, ABILIFY and drank some bleach." The patient received activated charcoal, recovered and discharged. When asked if this was a suicide attempt, the nurse practitioner stated "It was just a bunch of kids being kids." The patient took the medication and drank bleach with "a bunch of friends". There was "no adverse reaction to the vaccine". No additional information was provided. Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug reactions/allergies, who on 06-Nov-2007 was vaccinated with first dose of GARDASIL vaccine (yeast) (lot# unspecified). On 11-Jun-2008, the patient was vaccinated with 0.5ml of second dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that "about 12 hours after vaccination", the patient experienced rash on her arms and face. There was no concomitant medication. It was also reported that the patient had no ill effects after vaccination with her first dose of GARDASIL vaccine (yeast). Unspecified medical attention was sought by calling physician. At the time of this report the patient was still recovering from her experiences. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her daughter who on unspecified date was vaccinated with GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed rash. At the time of this report the outcome was unknown. No other information is available. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amniocentesis, Drug exposure during pregnancy, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a consumer for the Pregnancy Registry for GARDASIL vaccine (yeast) concerning herself, a 21 year old female, who in November 2007, was vaccinated with her third dose of GARDASIL vaccine (yeast) (lot # unspecified) and realized she was pregnant. Dates and lot numbers of the previous 2 doses were not reported. There was no concomitant medication. Unspecified medical attention was sought. Approximately in April 2008 the 7th month sonogram was performed (date not reported), and the physician noticed that the baby had an echogenic bowel. After this was found, on unspecified date the patient had amincentesis performed and the results were reported as "everything was normal". The patient reported that at the time of this report she was 34 weeks pregnant (estimated LMP is 17-Oct-2007). No further information was provided. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a "15 year old" female who on an unspecified date was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL vaccine (yeast) (lot # not reported). Subsequently the patient fainted after receiving the second dose of GARDASIL vaccine (yeast). The patient sought unspecified medical attention. The physician reported that the patient recovered "the same day as the adverse experience". Additional information has been requested. This is in follow-up to freport(s) previously submitted on 7/14/2008. Information has been received from a physician concerning a 15 year old female who on 10-JUN-2008 was vaccinated itramuscularly with a 0.5 ml second dose of GARDASIL (lo #659693/1048U). Subsequently the patient fainted for less than 30 seconds after receiving the second dose of GARDASIL  on 10-JUN-2008. The patient had no seizures and received spontaneously on the same day. The patient felt weak, lighteded and dizzy. She lied doen for 15-10 minutes and felt better so was discharged home, The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Arthritis, C-reactive protein normal, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history and no known drug reactions or allergies who in July 2007 completed three dose series of GARDASIL vaccine (yeast). There was no concomitant medication. It was reported that the patient might have arthritis from GARDASIL vaccine (yeast). Unknown medical attention was sought. Patient outcome was not reported. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning an 18 year old female with arthralgias on hands for one year and no known drug reactions or allergies who received the three doses of GARDASIL on 30-JUL-2007, 02-OCT-2007 and 05-FEB-2008. There was no concomitant medication. The patient might have arthritis from GARDASIL. In July 2007, the patient developed polyarthritis. Since September 2007, the patient developed swelling of hands. Since February 2008 the patient experienced pain. The patient felt better with CELEBREX, prednisone and PLAQUENIL. She is currently recovering from the adverse events. The reporter states a possible relationship with GARDASIL since symptoms before first immunization became worse after second and third doses. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Parvovirus B19 serology negative, Polyarthritis, Red blood cell count normal, Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history and no known drug reactions or allergies who in July 2007 completed three dose series of GARDASIL vaccine (yeast). There was no concomitant medication. It was reported that the patient might have arthritis from GARDASIL vaccine (yeast). Unknown medical attention was sought. Patient outcome was not reported. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning an 18 year old female with arthralgias on hands for one year and no known drug reactions or allergies who received the three doses of GARDASIL on 30-JUL-2007, 02-OCT-2007 and 05-FEB-2008. There was no concomitant medication. The patient might have arthritis from GARDASIL. In July 2007, the patient developed polyarthritis. Since September 2007, the patient developed swelling of hands. Since February 2008 the patient experienced pain. The patient felt better with CELEBREX, prednisone and PLAQUENIL. She is currently recovering from the adverse events. The reporter states a possible relationship with GARDASIL since symptoms before first immunization became worse after second and third doses. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history and no known drug reactions or allergies who in July 2007 completed three dose series of GARDASIL vaccine (yeast). There was no concomitant medication. It was reported that the patient might have arthritis from GARDASIL vaccine (yeast). Unknown medical attention was sought. Patient outcome was not reported. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning an 18 year old female with arthralgias on hands for one year and no known drug reactions or allergies who received the three doses of GARDASIL on 30-JUL-2007, 02-OCT-2007 and 05-FEB-2008. There was no concomitant medication. The patient might have arthritis from GARDASIL. In July 2007, the patient developed polyarthritis. Since September 2007, the patient developed swelling of hands. Since February 2008 the patient experienced pain. The patient felt better with CELEBREX, prednisone and PLAQUENIL. She is currently recovering from the adverse events. The reporter states a possible relationship with GARDASIL since symptoms before first immunization became worse after second and third doses. No additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Gait disturbance, Headache, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history and no known drug reactions or allergies who in April 2008, was vaccinated with the second dose of GARDASIL vaccine (yeast). The day after the second dose of GARDASIL vaccine (yeast) the patient developed bilateral leg pain, headache, nausea, diarrhea, vomiting and felt faint. On an unspecified date the patient recovered from bilateral leg pain, headache, nausea, diarrhea, vomiting and felt faint. Unknown medical attention was sought in the office. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a nurse practitioner concerning a 20 year old female with bipolar disorder, no medical history and no known drug reactions or allergies, who on 28-April 2008, was vaccinated intramuscularly with 0.5 ml of the second dose of GARDASIL (lot# 0210U). Concomitant therapy included DESOGEN (dose unspecified), and 150 mg LAMICTAL (therapy started on 09-Apr-2008) for the treatment of bipolar disorder. It was reported that on 28-Apr-2008, the patient developed bilateral leg "restlessness" and pain, worse with walking, then headache, nausea (dry heaves), diarrhea, vomiting, felt faint and her liquid stools by 3 times. Unspecified medical attention was sought in the office. It was reported that on 29-Apr-2008 (next day) the patient recovered from her experience with no recurrence. It was reported that there was no such a problems with the first dose of GARDASIL. The date and lot# of the first dose of GARDASIL was unspecified. It was also reported that the patient opted against receiving the third dose of GARDASIL. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain in extremity, Retching, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history and no known drug reactions or allergies who in April 2008, was vaccinated with the second dose of GARDASIL vaccine (yeast). The day after the second dose of GARDASIL vaccine (yeast) the patient developed bilateral leg pain, headache, nausea, diarrhea, vomiting and felt faint. On an unspecified date the patient recovered from bilateral leg pain, headache, nausea, diarrhea, vomiting and felt faint. Unknown medical attention was sought in the office. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a nurse practitioner concerning a 20 year old female with bipolar disorder, no medical history and no known drug reactions or allergies, who on 28-April 2008, was vaccinated intramuscularly with 0.5 ml of the second dose of GARDASIL (lot# 0210U). Concomitant therapy included DESOGEN (dose unspecified), and 150 mg LAMICTAL (therapy started on 09-Apr-2008) for the treatment of bipolar disorder. It was reported that on 28-Apr-2008, the patient developed bilateral leg "restlessness" and pain, worse with walking, then headache, nausea (dry heaves), diarrhea, vomiting, felt faint and her liquid stools by 3 times. Unspecified medical attention was sought in the office. It was reported that on 29-Apr-2008 (next day) the patient recovered from her experience with no recurrence. It was reported that there was no such a problems with the first dose of GARDASIL. The date and lot# of the first dose of GARDASIL was unspecified. It was also reported that the patient opted against receiving the third dose of GARDASIL. Additional information is not expected.