chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who was vaccinated (date not specified) with the first dose of Gardasil, and following vaccination (time duration not specified), she fainted. The physician confirmed that the patient recovered within a period of 10 minutes. The physician reported that the patient later received both the second and third doses of Gardasil, and was fine after each dose. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Familial risk factor, Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old patient (gender not specified), with a family history of fainting post vaccination, who was vaccinated (date not specified) with the first dose of Gardasil, and fainted following the vaccination. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 25 year old female consumer with no pertinent medical history or drug reactions/allergies who in January 2007, was vaccinated with a first dose of GARDASIL (lot number unknown) and in March 2007 was vaccinated with a second dose of GARDASIL (lot number unknown). Concomitant therapy included hormonal contraceptives (unspecified). The consumer reported that the next day after she received her first and second dose of the vaccinations she had a sharp muscle pain that ran through the left arm all the way up and through her "next" on the left side. The pain lasted for about a month after the injection. The patient recovered about a month after each injection. Medical attention was sought. Additional information has been requested. This is in follow-up to repport (s) previously submitted on 7/16/2007. Follow-up information was received on 9-JUL-2007 via telephone. The patient wanted to know if she should get the third dose of GARDASIL vaccine. No additional adverse event information was provided. Additionla information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Arthropathy
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot number unknown), injection. Concomitant medication not reported. The nurse reported that on an unspecified date the patient developed arthritic symptoms after receiving Gardasil. At the time of reporting it is unknown if the patient had recovered from the arthritic symptoms. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: Information has been received from an office manager concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced syncope. The patient did not pass out but felt like she was going to. At the time of the report, the patient's outcome was unknown. N product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who was vaccinated on 25-MAY-2007 with a 0.5 mL dose of Gardasil. Shortly post-vaccination the patient developed a rash on her arms and legs. The physician reported that the client did not report the rash away, but presented, with the rash to the office. A steroid dose pack was the treatment prescribed. At the time of the report, the patient had not recovered. No product quality complaint was involved.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female who was vaccinated with a dose of Gardasil. Subsequently two of three days after the vaccine the patient experienced "bleeding". Additional information has been requested. This is one of two reports from the same source.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who on an unspecified date, was vaccinated IM with a second dose of Gardasil (Lot # 655205/1426F). Subsequently, the patient was feeling dizzy. Unspecified medical attention was sought. On 11-JUN-2007, the patient recovered. It was reported that the patient experienced no adverse effects after the first dose. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on approximately 04-JUN-2007 "three weeks ago", was vaccinated with a dose of Gardasil. On approximately 25-JUN-2007, the patient came into the office and complained of pain at the injection site. 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.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Injury, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 30-MAY-2007 was vaccinated with her first dose of Gardasil (lot number 654741/1208F) IM. The physician reported that the patient fainted after receiving her first dose of Gardasil IM. Patient also fell down and hit her nose and felt woozy for about 10 minutes. Medical attention was sought. The patient did not eat anything prior to getting a vaccine. At the time of reporting the patient recovered from the adverse events and no further information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 17-MAY-2007 was vaccinated with her first dose of Gardasil IM. The physician reported that the patient felt dizzy right after receiving the first dose of Gardasil IM. At the time of reporting the patient recovered from feeling dizzy and no further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Exfoliative rash, Parapsoriasis, Pityriasis, Pruritus
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and a drug reaction to minocycline who near the end of February 2007, was vaccinated with Gardasil (lot number unknown). On an unspecified date, about two weeks post vaccination the patient developed a scaly purplish rash over her entire body that was mostly on her extremities. Medical attention was sought. The patient was treated with ammonium Lac-Hydrin and at the time of reporting the patient is still recovering. Further information was not available. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Follow-up information was received. In February 2007, the patient developed an extensive pityriasis type rash on arms, legs and trunk. The patient was positive for pruritis. On an unspecified date the patient had a skin biopsy test performed and was consistent with the spectrum of pityriasis lichenoides. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and a drug reaction to minocycline who near the end of February 2007, was vaccinated with Gardasil (lot number unknown). On an unspecified date, about two weeks post vaccination the patient developed a scaly purplish rash over her entire body that was mostly on her extremities. Medical attention was sought. The patient was treated with ammonium Lac-Hydrin and at the time of reporting the patient is still recovering. Further information was not available. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Follow-up information was received. In February 2007, the patient developed an extensive pityriasis type rash on arms, legs and trunk. The patient was positive for pruritis. On an unspecified date the patient had a skin biopsy test performed and was consistent with the spectrum of pityriasis lichenoides. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who on approximately 18-JUN-2007 was vaccinated with a 0.5 ml dose of the Gardasil. After receiving the vaccine, the patient vomited and fainted. The patient sought unspecified medical attention. 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 physician and a healthcare professional concerning a 14 year old female with no pertinent medical history who on 21-JUN-2007 at 2:30 pm was vaccinated intramuscularly in the left arm with a 0.5 ml dose of the GARDASIL (Lot # 657737/0522U) concomitantly with a subcutaneously administered VARIVAX (Oka/Merck) (MSD) (Lot # "0674U") in the left arm. At 2:35 pm on 21-JUN-2007, the patient experienced a "syncope episode-patient passed out, became dizzy then vomited all over". It was also reported that the patient was kept for a while due to decreased blood pressure for observation and to bring vitals back up where they should have been and to make sure the patient was feeling better. The patient recovered on 21-JUN-2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Accidental needle stick, Haemorrhage, Laboratory test
Clinical narrative: Information has been received from a female registered nurse who administered Gardasil to a patient. It was reported that after the vaccine was given to the patient, the needle guard device did not work properly to fully cover and protect the needle. Subsequently, the nurse accidentally stuck her hand with the exposed needle which caused bleeding. She sought unspecified medical attention. A number of blood tests were performed, including a test for human immunodeficiency virus (HIV) (results not provided). The HIV test will be repeated in six months. 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 female registered nurse who administered GARDASIL (Lot # 0210U) to a patient.  It was reported that after the vaccine was given to the patient, the needle guard device did not work properly to fully cover and protect the needle.  Subsequently, the nurse accidentally stuck her hand with the exposed needle which caused bleeding.  She sought unspecified medical attention.  A number of blood tests were performed, including a test for human immunodeficiency virus (HIV) (results not provided).  The HIV test will be repeated in six months.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Feeling hot, Paraesthesia, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with a penicillin allergy who on 06-APR-2007 at 15:00 was vaccinated IM into the right deltoid with the first 0.5 ml dose of the Gardasil. Concomitant therapy included Yaz. Subsequently, the patient fainted. She recovered on an unspecified date. On an unspecified date, the patient was vaccinated with the second 0.5 ml dose of the Gardasil. Subsequently, the patient fainted. She recovered on an unspecified date. Additional information has been requested. Follow-up information indicated that on 06-APR-2007 at 19:00 "three hours after vaccination",  the patient complained of tingling from head to toe, and a "warm feeling" in her head followed by body chills. It was reported that it lasted only seconds. No diagnostic laboratory studies were performed. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information ha been received from a registered nurse concerning a 19 year old female who vaccinated intramuscularly with the third dose of the Gardasil on an unspecified date. Subsequently, the patient almost fainted and became extremely light-headed while at the physician's office. Subsequently, the patient recovered on the same day after receiving in the office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning her 18 year old daughter with no pertinent medical history who on 21-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. There were no concomitant medications. On the evening of 24-JUN-2007, the patient developed a fever of an unknown temperature. Medical attention was sought and the patient was treated with Motrin. The patient's fever persisted. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. Concomitant therapy included 'other vaccines". A couple of minutes after the injection, in the waiting room, the patient fainted. The patient was given "smelling salts and it didn't help, and then she was given epinephrine and the patient didn't react to that either." About about fifteen minutes, the patient "finally came to." Unspecified medical attention was sought. It was reported that the patient recovered on an unknown date. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a healthcare worker concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. The patient subsequently experienced an abnormal PAP smear. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007.  It was reported that in between the first and second dose of GARDASIL vaccine the patient had her annual PAP smeart chich was found to be abnormal. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently the patient developed small bumps all over her body about a week after vaccination. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with no drug allergies and no medical history, who on 08-MAY-2007 was vaccinated intramuscularly in the right deltoid with a second dose of Gardasil. Concomitant therapy included LOESTRIN. Almost immediately after receiving the vaccination the patient fainted in the office in the waiting room. The patient was kept lying down with ice on her head and was observed for 30 minutes. It was reported that the patient was not hospitalized and the patient had recovered before leaving the office on her own. No laboratory diagnostics were performed and there were no illness at the time of vaccination. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previuosly submitted on 7/16/2007. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a certified medical assistant (also reported as a nurse) concerning her 16 year old daughter, who was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a painful, raised, brown square on her arm where the injection was given. The patient did not have any adverse experiences with the first dose. The patient did not seek medical attention. At the time of the report, the patient was recovering. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a certified medical assistant (also reported as a nurse) concerning her 15 year old daughter, who was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a painful, raised, brown square on her arm where the injection was given. The patient did not have any adverse experiences with the first dose. The patient did not seek medical attention. At the time of the report, the patient was recovering. No product quality complain was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with a history of orthostatic hypertension, who on approximately 18-JUN-2007 was vaccinated with Gardasil. Subsequently, after receiving the vaccination the patient fainted, but it took a while to revive her. The patient sought unspecified medical attention. At the time of the report, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a physician's office concerning a 20 year old female, who on 14-MAY-2007 was vaccinated with a dose of Gardasil. Subsequently. on the same day as the vaccination the patient experienced pain in her arm. It was noted that the injection was given to the patient in the wrong position of the arm said to be too interiorly. The patient sought unspecified medical attention. At the time of the report, the patients outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated IM with a first dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). Subsequently the patient fainted and was unconscious for about 15 seconds and then came to. Subsequently, the patient recovered from fainting. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a female patients between 20 - 25 years old who was vaccinated with Gardasil. Subsequently all the patient experienced abdominal cramping "like premenstrual related symptoms". Subsequently, all the patient recovered from abdominal cramping "like premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a female patients between 20 - 25 years old was vaccinated IM with Gardasil. Subsequently all the patient experienced abdominal cramping "like premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several reports from the same source.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 12 year old female patient who on 06-APR-2007, at 03:30 PM was vaccinated with a first dose of Gardasil lot #657621/0387U. On 07-APR-2007 the patient developed fever 102, nausea and abdominal cramping x 4 days. On 09-APR-2007 the patient had vomiting and fatigue. It was not known if patient sought medical advice. The outcome was unknown. Additional information has not been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female assistant director of admissions, who on 19-JUN-2007 was vaccinated with a second dose of Gardasil. On 20-JUN-2007 the patient reported that she woke up with a rash on her back with no itch. At the time of the report, the rash still persisted. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no pertinent medical history who was vaccinated with two doses of the Gardasil (dates not specified). Concomitant therapy included Yasmin. Subsequently, the patient testes positive for human papilloma virus (HPV) with the HPV DNA test. The patient had not experienced any known symptoms. Patient outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from an 18 year old female with no pertinent medical history and a penicillin allergy who on 17-JAN-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection who developed light headedness. On 19-MAR-2007 the patient was vaccinated with a second dose of Gardasil and experienced soreness in her arms. On 25-JUN-2007 the patient received a third dose of Gardasil and experienced soreness in her arms which was given 22 days earlier than scheduled. On 25-JUN-2007 concomitant suspect therapy included hepatitis A vaccine (unspecified) was given. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. No further information was provided. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician, via a company representative , concerning a 15 year old female patient, who on unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). After an unspecified duration of time following the vaccination, the patient developed hives. Treatment included unspecified steroids. At the time of this report, the outcome of the event was unknown.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 21-JUN-2007 was vaccinated with the first dose of the Gardasil. Concomitant therapy included Menactra, DTaP (unspecified) and Varivax (manufacturer unknown), which were also administered on 21-JUN-2007. After receiving the Gardasil, the patient became woozy and slumped in her chair as if she was about to faint. Unspecified medical attention was sought. The reporter noted that the patient had not eaten lunch the day she received the vaccinations. The patient recovered within an hour. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 14 or 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot number unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil 0.5ml injection and passed-out on the elevator. Medical attention was sought. At the time of reporting it is unknown if the patient recovered. No additional information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pain, Pallor, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with no pertinent medical history who on 22-JUN-2007 was vaccinated intramuscularly into the left arm with 0.5 ml of the first dose of the Gardasil (Lot 3 653735/0688F). There was no concomitant medication. Immediately after receiving the vaccination, the patient felt pain and fainted. Unspecified medical attention was sought by the patient. No laboratory or diagnostic tests were performed. The patient was observed for 1/2 hours and then was recovered and sent home. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Follow-up information was received from the physician.  The patient felt sharp pain and passed out for 15 to 20 seconds after receiving GARDASIL.  The patient looked pale.  The blood pressure measurement was 88/60 and pulse rate was 72.  The patient rested for 15-20 minutes.  The patient's repeat blood pressure measurement is 100/60.  The patient recovered on 22-JUN-2007.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received via a company representative, from a health professional (HCP) concerning her daughter (age unspecified), who was vaccinated on an unspecified date, with the second dose, 0.5ml, of Gardasil (Lot # not provided). The HCP reported that her daughter developed pain and swelling at the injection site, that lasted for '3-4 days" and then resolved. No further information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an approximately 13 year old female patient who was vaccinated with a first dose of Gardasil. Right after administration, the patient experienced tingling in her fingers. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Swelling face, Swollen tongue
Clinical narrative: Information has been received from a physician concerning a 22 year old female with a history of an unspecified hypersensitivity and hives who on 02-JAN-2007 was vaccinated with the first dose of Gardasil (Lot # not specified). On 02-MAR-2007 the patient received the second dose of Gardasil (Lot 3656049/0187U). The physician reported that the same day at an unspecified time the patient reported that she felt tired and that her tongue and face had swelled. The patient sought unspecified medical attention. Subsequently, on an unspecified date the patient recovered from the events. Additional information has been requested. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from consumer her 23 year old daughter who on unspecified date was vaccinated with a second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil, the patient developed "bells palsy, which freezes one side of the face" as reported by the patient's mother. The patient sought unspecified medical attention. Subsequently, the patient recovered from bells palsy on an unspecified date. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Diarrhoea, Drug hypersensitivity, Local swelling, Nausea
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 21-JUN-2007 was vaccinated with a second dose of Gardasil (lot # 657737/0522U). On 22-JUN-2007 the patient experienced nausea and diarrhea. Unspecified medical attention was sought. On 25-JUN-2007, the patient recovered from nausea and diarrhea. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 21 year old female student with an allergy to NUVARING (localized swelling) who on an unspecified the patient was vaccinated with a first dose of GARDASIL. The physician reported that the patient had no adverse event in prior vaccinations. On 21-JUN-2007 at 11:11 am, the patient was vaccinated IM in the right deltoid with a second dose of GARDASIL (lot # 657737/0522U). Concomitant therapy included LOESTRIN, and ORTHO-NOVUM. On 23-JUN-2007 the patient experienced nausea, diarrhea and stomach discomfort. On 26-JUN-2007, the patient recovered. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 21-JUN-2007 was vaccinated with a second dose of Gardasil (lot # 657737/0522U). On 22-JUN-2007 the patient experienced nausea and diarrhea. Unspecified medical attention was sought. On 25-JUN-2007, the patient recovered from nausea and diarrhea. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 21 year old female student with an allergy to NUVARING (localized swelling) who on an unspecified the patient was vaccinated with a first dose of GARDASIL. The physician reported that the patient had no adverse event in prior vaccinations. On 21-JUN-2007 at 11:11 am, the patient was vaccinated IM in the right deltoid with a second dose of GARDASIL (lot # 657737/0522U). Concomitant therapy included LOESTRIN, and ORTHO-NOVUM. On 23-JUN-2007 the patient experienced nausea, diarrhea and stomach discomfort. On 26-JUN-2007, the patient recovered. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Body temperature increased, Gait disturbance, Immediate post-injection reaction, Presyncope
Clinical narrative: Information has been received via company representative, from a health professional (HCP) concerning her 16 year old daughter, with restless legs syndrome, who on 20-JUN-2007 was vaccinated IM with the first dose of Gardasil (Lot # invalid). Concomitant therapy included Menactra and tuberculin purified protein derivative (manufacturer unspecified). On 20-JUN-2007, "within 5 minutes of being vaccinated," the patient experienced weakness, elevated temperature, difficulty walking and she felt like she was going to faint. The HCP confirmed that her daughter had recovered (date unspecified), and "is fine now." The HCP stated she had concerns about continuing with the Gardasil series.  The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient with no medical history or drug allergies who on 15-JUN-2007, was vaccinated with a first dose of Gardasil (Lot 3 658094/0524U). There was no concomitant medication. On 20-JUN-2007, the patient experienced arm swelling, joint pain, soreness and achiness. It was reported that after the pain continued for about 5 days, she decided to contact her physician's office. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. "About a week later," the patient recovered from joint pain, soreness and achiness and the outcome of her swelled arm was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a licensed visiting nurse concerning three female patient' who were supposed to be vaccinated with a dose of Gardasil. It was reported that when the nurse removed the vaccine from the refrigerator, she picked up 2 doses of Gardasil and one dose of Pitocin. The nurse stated the error was due to the cap colors of Gardasil and Pitocin being similar. No symptoms were noted in any woman. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. Concomitant therapy included "other vaccines". On 23-JUN-2007, the patient fainted. The patient was "unconscious for about 15 minutes". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. Concomitant therapy include "other vaccines". On 23-JUN-2007, the patient fainted. The patient was "unconscious for about 15 minutes". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Incorrect route of drug administration
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 22-JUN-2007, was vaccinated with a first dose of Gardasil. Immediately, the patient was dizzy and light-headed. Unspecified medical attention was sought. After several minutes 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 07/16/2007. Information has been received from a nurse concerning a 17 year old female patient who on 22-JUN-2007, was vaccinated with a first dose of GARDASIL. Immediately, the patient was dizzy and light-headed. Unspecified medical attention was sought. After several minutes the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Laboratory test normal, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female patient who during the week of 17-JUN-2007 to 22-JUN-2007, was vaccinated with a first dose of Gardasil. On 23-JUN-2007, the patient experienced abdominal pain. 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. Information has been received from a healthcare professional and physician concerning a female patient with no allergies who on 21-JUN-2007, was vaccinated into the left arm with a first dose of GARDASIL. On 21-JUN-2007, the patient went to the emergency room with right sided pain. All exams were negative. The patient was given MOTRIN and released. It was reported that the emergency room physician was unsure if it was a side effect of GARDASIL. The patient has had no previous reactions to other vaccines. At the time of this report, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: Information has been received from a consumer, concerning her female friend (age unspecified), who was vaccinated on unspecified dates, with a first and second dose of Gardasil and subsequently developed ovarian cysts. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who was vaccinated IM, on an unspecified date with the third dose of Gardasil, and subsequently felt dizzy when going to the parking lot. The patient called the nurse, who brought her back to the office, and the patient then fainted. The patient's mother was called to get her, as she was unable to drive. The physician sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse, concerning a 19 year old female patient, who on 21-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #0469U). Concomitant therapy included Yasmin. On 22-JUN-2007, the day following vaccination, she developed a fever of 102F, and had dizziness, nausea and muscle aches. On 25-JUN-2007, the patient's symptoms were improving, though her temperature was then 100 F. The patient sought unspecified medical attention. Additional information has been requested. Additional follow up information was received from the nurse. It was reported that the vaccine series was discontinued for this patient.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site streaking
Clinical narrative: Information has been received from a nurse concerning a 23 year old female who in April 2007, was vaccinated with a first dose of Gardasil. On 22-JUN-2007, the patient received her second dose of Gardasil (Lot# 656371/0181U). On 25-JUN-2007, the patient developed red streaks moving away from the injection site area. 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.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a female (age not reported) who on unspecified dates was vaccinated with first and second doses of Gardasil (lot number unknown). The patient is not having any symptoms from the Gardasil who has been diagnosed with another type of human papilloma virus (HPV) infection (type unspecified) since vaccinated. The patient also reports that as of 27-JUN-2007 the patient is 2 weeks late for her third vaccination. No further information is expected. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Angioedema, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a first dose of Gardasil (lot number unknown) IM. On an unspecified medical dates, the patient developed diffuse rashes and continued to get them. Medical attention was sought. The family physician treated the patient with steroids and was planning to give a work-up of blood test. The physician advised the patient to discontinue therapy with Gardasil. At the time of reporting the patient was recovering. No further information was provided. Follow-up information was received from the physician. the physician reported that the patient had diffuse urticaria and angioedema 12 to 20 minutes after injection. On an unspecified date the patient was given steroids and recovered from urticaria and angioedema. The physician considered urticaria and angioedema to be other medical event (OME) Additional information is not expected. This is one of two reports.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of the Gardasil. Subsequently, the patient experienced "diffused joint pain". Unspecified medical attention was sought. The patient outcome was unknown. The reporting physician was concerned that this could be related to the Gardasil and was worried it could have caused a "problem with the patient's immune response." Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood cholesterol, Haemoglobin urine, Syncope, Thyroid function test
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 15-JUN-2007 was vaccinated with the first dose of the Gardasil (Lot # "03894"). There was no concomitant medication. On 15-JUN-2007, the patient fainted within a half hour of receiving the Gardasil. The patient sought unspecified medical attention, "was given ammonia salts and came to immediately." Laboratory tests performed on 15-JUN-2007 included a thyroid function test, hemoglobin urinalysis, and cholesterol test (results not provided). Subsequently, the patient recovered. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated with the first dose of the Gardasil. Subsequently, the patient developed malaise all over the body, which lasted for about a month. Unspecified medical attention was sought. Subsequently, the patient recovered from malaise all over the body. 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 physician concerning a 19 year old female who on 25-MAY-2007 was vaccinated with the first dose of the GARDASIL. On approximately 25-JUN-2007, the patient developed myalgia, flu-like symptoms, and redness and swelling at the injection site. It was reported that the patient did not alert office to her symptoms until she returned for the second dose of the vaccine. The physician discussed the patient's symptoms with her and decided not to administer the second dose. The patient's symptoms resolved one month after the initial dose of vaccine was administered, on approximately 25-JUN-2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with the first dose of the Gardasil on an unspecified date. The patient started to feel lightheaded immediately after receiving the Gardasil. At the time of the report, the patient was recovering. The patient did not wish to continue the vaccination series. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Ear pain, Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2007 was vaccinated with a 0.5 ml dose of the Gardasil. Concomitant therapy included Menactra. On 25-JUN-2007, the patient developed a rash on her forehead. Unspecified medical attention was sought. The rash was diagnosed with shingles which further progressed into the eyes and the patient developed pain in the ear. The patient's shingles and pain in the ear persisted at the time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Joint swelling, Splenectomy
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil. Subsequently, two weeks after vaccination, the patient developed swollen and painful joints and an enlarged spleen. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Laboratory test, Lymphadenopathy, Pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history who on 21-JUN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. There was no concomitant medication. On 21-JUN-2007 the patient experienced dizziness for about 30 minutes. On 27-JUN-2007, she developed lymphadenopathy on the left side of her groin. It was reported that she had two swollen lymph nodes in her groin closer to her femur. The area is sore and tender. No fever was involved. The patient was seen in the doctor's office. A urinalysis and a blood test were performed, results not reported. The patient was prescribed DURICEF 500 mg. The patient's condition improved but thr nodes were still present in the left groin area. On 21-JUN-2007, the patient recovered from dizziness. At the time of this report, the physician confirmed that the patient was recovering from the lymphadenopathy.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness, Urine analysis
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history who on 21-JUN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. There was no concomitant medication. On 21-JUN-2007 the patient experienced dizziness for about 30 minutes. On 27-JUN-2007, she developed lymphadenopathy on the left side of her groin. It was reported that she had two swollen lymph nodes in her groin closer to her femur. The area is sore and tender. No fever was involved. The patient was seen in the doctor's office. A urinalysis and a blood test were performed, results not reported. The patient was prescribed DURICEF 500 mg. The patient's condition improved but thr nodes were still present in the left groin area. On 21-JUN-2007, the patient recovered from dizziness. At the time of this report, the physician confirmed that the patient was recovering from the lymphadenopathy.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM on 22-SEP-2006 with a first dose of GARDASIL. The physician reported that the patient received her first dose of GARDASIL and "claimed it affected her menstrual cycle". She said her cycle went from being every four weeks to being every six weeks. The patient refused to go on to get the second and third doses. The physician did not believe the adverse experience was related to GARDASIL. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow up information it was indicated that "patient said her periods became irregular after receiving the first dose of GARDASIL vaccine." The patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
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 physician concerning a 12 year old female patient who on 22-JUN-2007, at 11:35 AM was vaccinated IM in left arm deltoid with a second dose of GARDASIL lot #655849/0263U. On 22-JUN-2007 the patient experienced "syncope within one minute of vaccination." Unspecified medical attention was sought by the patient. The patient recovered immediately. Additional information is not expected.