chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from an office receptionist concerning a 20 year old female patient with family history of heart disease, allergic reaction to antibiotics, who on 02-FEB-2007 was vaccinated IM with a first dose of Gardasil lot #654741/0013U. Concomitant therapy included Ortho Tri-Cyclean Lo. On 02-FEB-2007 the patient developed arm soreness but otherwise felt fine. On 16-APR-2007, the patient was vaccinated IM with the second dose of Gardasil lot #657621/0387U. Within one to one and half hours after the second injection patient developed muscle spasm in chest area which radiated from left chest to center. She described pain as sharp intermittent and took her breath away. On 18-APR-2007 she took Advil for something else (not specified) and it helped pain a little but was not relieved. The physician instructed patient to go the emergency room (ER). Patient was planning to go to the ER on 19-APR-2007. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Drug exposure during pregnancy, Nausea, Smear cervix, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a Certified Medical Assistant through Merck Pregnancy concerning a 23 year old female patient with moderate dysplasia of the cervix and a history of loop electrosurgical excision procedure (LEEP) who on 02-JAN-2007 was vaccinated IM in right deltoid with a first dose of Gardasil and had menstruation cycle on that day. On 27-FEB-2007 the patient was vaccinated IM in right deltoid with a second dose of Gardasil. Concomitant therapy included Mirena IUD birth control. On 05-MAR-2007 the patient presented to office experiencing nausea. Urine pregnancy test was performed and it was positive for pregnancy. The reporter stated that client had unusual history; her birth control was a Mirena IUD but on manual examination it was not found. The MA stated that it must have expulsed. She had a cervical smear (PAP) test done which showed moderate dysplasia. On 04-NOV-2006 patient had Leep procedure performed. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainted. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on 19-APR-2007 was vaccinated with a dose of Gardasil. Patient developed dizziness and weakness after the vaccine was administered. Unspecified medical attention was sought was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated "a few months ago" with a dose of Gardasil. The patient experienced pain in the arm from the injection site to the fingers after receiving the dose of Gardasil. Unspecified medical attention was sought. Patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 02-FEB-2007 was vaccinated with a first dose of Gardasil. On 18-APR-2007 she was vaccinated with a second dose of Gardasil (lot #654702/0011U) 0.5 ml. On 18-APR-2007, the patient  developed a rash (site unknown) and hives. She was sent to Urgent care center. Patient would not receive the third dose of Gardasil based on her experience with the second injection. The outcome of the event was unknown. Additional information was received from the office manager who reported that the patient was not seen in thier office. The rash was reported by way of the patient's father. He was told that his daughter should go to an urgent care facility to be seen. The office did not receive a call back nor a report. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil IM. Subsequently the patient experienced menstrual irregularity. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure to communicable disease, Urticaria, Varicella
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning an 11 year old female who on 12-APR-2007 was vaccinated with the second dose Gardasil. Concomitant therapy included Boostrix. On 16-APR-2007 the patient experienced intermittent hives that look like tiny pimples that are not itchy. The event persisted as of 20-APR-2007. Follow up information from the NP, via the company representative, confirmed that the patient's hives/rash was "diagnosed as a case of chicken pox." The NP stated that there was an outbreak in the patient's school district. At the time of this report, the patient had not recovered from the chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Anogenital warts
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a patient who was vaccinated with a dose of Gardasil. Subsequently the patient developed genital warts. The outcome of the patient was unknown. The NP reported that two other patients developed genital warts after receiving the Gardasil. She verbalized concern that she seen three episodes of genital warts developing soon after Gardasil. She believed the patient's immune systems can not handle the viral load. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. In follow up it was indicated that on 09-FEB-2007 patient was seen at planned parenthood clinic and advised she had visible Candyloma (as previous history). She was treated x2 with TCA 80% on 10-MAR-2007 and on 24-MAY-2007. The outcome was unknown for the events at the time of this report. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Eye swelling, Eyelid oedema, Fatigue, Pyrexia
Clinical narrative: Information has been received via The Poison Control Center and from a consumer concerning her daughter, a 15 year old female, who on 12-APR-2007 was vaccinated with Gardasil. It was reported that on Friday, 13-APR-2007 and over the weekend, the patient experienced being very tired and developed puffy eyes. On May, approximately, 16-APR-2007, the patient's eyelids started getting puffier. On Tuesday, approximately 17-APR-2007, it was reported that the patient had increased puffiness of eyelids. On Wednesday, 18-APR-2007 the patient developed face swollen and was seen by ("ENT"). On Friday, 20-APR-2007 the patient was seen by the primary care physician (PCP) and had developed rash and hives. At the time of the report, the patient had a fever of 102 and increased rash and hives. It was recommended that the patient go to the Emergency Room (ER) for an evaluation. At the time of the report, it was unknown, if the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Information has been received via The Poison Control Center and from a consumer concerning her daughter, a 15 year old female, who on 12-APR-2007 was vaccinated with Gardasil. It was reported that on Friday, 13-APR-2007 and over the weekend, the patient experienced being very tired and developed puffy eyes. On May, approximately, 16-APR-2007, the patient's eyelids started getting puffier. On Tuesday, approximately 17-APR-2007, it was reported that the patient had increased puffiness of eyelids. On Wednesday, 18-APR-2007 the patient developed face swollen and was seen by ("ENT"). On Friday, 20-APR-2007 the patient was seen by the primary care physician (PCP) and had developed rash and hives. At the time of the report, the patient had a fever of 102 and increased rash and hives. It was recommended that the patient go to the Emergency Room (ER) for an evaluation. At the time of the report, it was unknown, if the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a female patient who was vaccinated with a first dose of Gardasil. The patient developed her arm being sore, red and hot one day after the injection was given (a Friday). The patient was seen on Monday and the arm was not as red, swollen and hot. She was told to take Tylenol for discomfort. The MA believed that the patient had the second dose of Gardasil and she was okay. The outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female patient who on 08-FEB-2007 was vaccinated IM with a first dose of Gardasil and on 17-APR-2007 was vaccinated IM in the left deltoid a second dose of Gardasil lot #655849/0263U. Concomitant therapy included Adderall Tablets and thyroid medication (therapy unspecified). A few days after receiving the second injection, the patient developed tenderness, soreness, erythema, swelling. warmth, burning and pruritus in the injection site area of her left arm. She also developed a red bruise on her chest, medical attention was sought. Patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female patient who on 08-FEB-2007 was vaccinated IM with a first dose of Gardasil and on 17-APR-2007 was vaccinated IM in the left deltoid a second dose of Gardasil lot #655849/0263U. Concomitant therapy included Adderall Tablets and thyroid medication (therapy unspecified). A few days after receiving the second injection, the patient developed tenderness, soreness, erythema, swelling. warmth, burning and pruritus in the injection site area of her left arm. She also developed a red bruise on her chest, medical attention was sought. Patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma
Clinical narrative: Initial and follow up information has been received from a Certified Registered Nurse Practitioner (CRNP) concerning a 16 year old female student with asthma who on 21-APR-2007 at 9:30 AM was vaccinated IM with a first dose of Gardasil (lot #0210U not valid). Concomitant therapy included montelukast sodium and albuterol over the counter (OTC)-10. On 21-APR-2007 at 5:00PM the patient developed exacerbation of asthma with activity during two basketball games one at 5:00PM and one at 8:00PM. She used albuterol 7 times during the basketball game. Normally she didn't need to use the albuterol that many times. On 22-APR-2007 the patient recovered in the AM. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis
Clinical narrative: Information has been received from an office worker in a physician's office concerning her 13 year old daughter, who on 18-APR-2007 was vaccinated with a first dose of Gardasil and developed cellulitis. She went to the Emergency Room (E.R.) and received an anti-biotic. The patient was recovering. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Medication error, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 34 year old female patient, who on 09-SEP-2006 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot #653937/0637F). Concomitant therapy included Loestrin and Detrol LA. The nurse reported that after the vaccine was administered (date unspecified), the patient "experienced tingling and numbness in most areas of her body." On an unspecified date, the patient received her second dose, 0.5 ml, IM, of Gardasil (Lot #653938/0954F), and had a recurrence of the numbness and tingling in her body. On 20-MAR-2007, the patient received her third dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U), and once again had a recurrence of the numbness and tingling in her body (date unspecified). A magnetic resonance imaging test was performed (date unspecified), and was negative. At the time of this report, the nurse confirmed that the patient had not recovered. Additional information has been requested. 6/27/07-records received for DOS 3/27/07-6/15/07-On 3/27/07-presented with bilateral leg pain, numbness and tingling. No strength issues.  Seeing neurologist. Note on 4/26/07-suspect restless leg syndrome for her migratory sensory discomfort in all 4 limbs and torso. Neuro exam did not show peripheral neuropathy. Note on 6/20/07-Sensory 85%  better.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 34 year old female patient, who on 09-SEP-2006 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot #653937/0637F). Concomitant therapy included Loestrin and Detrol LA. The nurse reported that after the vaccine was administered (date unspecified), the patient "experienced tingling and numbness in most areas of her body." On an unspecified date, the patient received her second dose, 0.5 ml, IM, of Gardasil (Lot #653938/0954F), and had a recurrence of the numbness and tingling in her body. On 20-MAR-2007, the patient received her third dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U), and once again had a recurrence of the numbness and tingling in her body (date unspecified). A magnetic resonance imaging test was performed (date unspecified), and was negative. At the time of this report, the nurse confirmed that the patient had not recovered. Additional information has been requested. 6/27/07-records received for DOS 3/27/07-6/15/07-On 3/27/07-presented with bilateral leg pain, numbness and tingling. No strength issues.  Seeing neurologist. Note on 4/26/07-suspect restless leg syndrome for her migratory sensory discomfort in all 4 limbs and torso. Neuro exam did not show peripheral neuropathy. Note on 6/20/07-Sensory 85%  better.
Sex: F
Vaccine: HPV4
Symptoms: Molluscum contagiosum
Clinical narrative: Information has been received from a Registered Nurse (R.N.) manager concerning a female patient who was vaccinated with a first dose of Gardasil. The patient developed "a rash known as "Molloscum Contagiousum" on her stomach after the injection. The Nurse Manager did not believe that the rash was related to Gardasil because it was a virus. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 20-OCT-2006 was vaccinated with the first dose of Gardasil, injection, 0.5 ml. Concomitant therapy included Ortho Tri-Cyclen. On approximately 27-OCT-2006 one week after receiving the first dose of Gardasil, the patient developed vomiting. On 19-DEC-2006, the patient received the second dose of Gardasil. On approximately 26-DEC-2006 one week after received the second dose of Gardasil, the patient developed vomiting. The patient sought unspecified medical attention. Subsequently on unspecified dates, the patient recovered from the events of vomiting. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site rash, Pyrexia, Rash, Urticaria
Clinical narrative: Initial and follow up information has been received from a nurse practitioner (NP)/ certified nurse midwife, and a nurse, concerning a 17 year old caucasionr female patient, who on 17-APR-2007, at 3:30pm was vaccinated IM in the left deltoid with the first dose of Gardasil (Lot #657617/0384U). Concomitant therapy included Yasmin. There was no known illness at the time of vaccination. The nurse practitioner reported that 18-APR-2007, (previously reported by the nurse as on the same day, 17-APR-2007), the patient developed a rash on the left arm (the arm of injection), which later spread to both arms; the rash was described as "redness with urticarial raised patches." The nurse added that the patient also developed a fever. At the time of this report, the NP confirmed that the patient had recovered from the rash and fever (date unspecified). The patient sought unspecified medical attention. No further information is expected. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, No reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning his 18 year old female step daughter who in 2007 was vaccinated with the third dose of Gardasil. Concomitant medication was not reported. Nurse practitioner reported that the patient completed the series and did not experience a reaction with dose one or two. In 2007 within 24 hours of receiving the third vaccination of Gardasil, the patient experienced nausea and vomiting. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered from nausea and vomiting. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise, Nausea
Clinical narrative: initial and follow up information has been received from a physician,  concerning his 16 year old daughter, with a history of patient ductus arteriosis (PDA) ligation who on 11-JUL-2006 was vaccinated with the first dose of Gardasil, on 23-Oct-2006, with the second dose of Gardasil and on 06-APR-2007 was vaccinated, IM, with the third dose of Gardasil. The physician reported that on 07-APR-2007, the day following the vaccination, his daughter experienced flu-like symptoms, was extremely nauseated, and had severe malaise that lasted for three to four days after the vaccine had been administered and then recovered (approximately 12-MAR-2007).  The patient's sister also experienced flu-like symptoms and nausea and malaise after vaccination with Gardasil (WAES #0704USA05005).   Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise, Nausea
Clinical narrative: Information has been received from a physician concerning a 15 year old, (previously reported as a 16 year old), white female student,  who on 09-AUG-2006 in the pm. was vaccinated with the first dose of Gardasil in the right arm.  On 03-NOV-2006 in the pm. was vaccinated with the second dose of Gardasil in the left arm.  On 23-FEB-2007 in the pm. was vaccinated with the third dose of Gardasil in the right arm (previously reported left arm) it was reported at the time of the vaccine the patient had nausea and severe malaise.  Unspecified medical attention was sought.  On approximately 27-APR-2007, the patient recovered from flu like symptoms extreme nausea, and severe malaise.    Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Scar, Skin discolouration
Clinical narrative: Information has been received from a nurse concerning a 20 year old white female student who in August 2006, was vaccinated with a first dose of Gardasil. In August 2006, the patient developed discoloration and circular scarring. In November 2006, the patient was vaccinated with a second dose of Gardasil. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Feeling cold, Hypoaesthesia, Hypotension
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of Gardasil (lot # "0014V"). Almost immediately after the vaccination, the patient experienced pain at the injection site, cold and numbness is her left arm and was unable to make a fist with her left hand. Seven minutes later the patient experienced dizziness. The physician reported that the patient's blood pressure lower then normal at that time. Fourteen minutes later the patient developed a fever of 101 degrees. The patient was treated with ibuprofen 600 mg. Twenty-five minutes later patient's fever 99.1 degrees and her other vital signs were stable. Subsequently, the patient recovered and was sent home. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of Gardasil (lot # "0014V"). Almost immediately after the vaccination, the patient experienced pain at the injection site, cold and numbness is her left arm and was unable to make a fist with her left hand. Seven minutes later the patient experienced dizziness. The physician reported that the patient's blood pressure lower then normal at that time. Fourteen minutes later the patient developed a fever of 101 degrees. The patient was treated with ibuprofen 600 mg. Twenty-five minutes later patient's fever 99.1 degrees and her other vital signs were stable. Subsequently, the patient recovered and was sent home. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Immediately after the vaccination, the patient experienced dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. Initial and follow-up information has been received from a physician and a health professional concerning a 16 year old female with no pertinent medical history who on 31-MAY-2007, at 13:30, was vaccinated, into the left arm, with a first dose of GARDASIL (lot # 657736/0389U). On 31-MAY-2007, at 13:15,  the patient experienced dizziness, sweaty, pale and was nauseous. Blood pressure measurement was 90/60, total heartbeat was 64 and pulse oximetry oxygen saturation measurement was 99 percent. The patient was laid down on the exam table and given water. Her color improved and she felt better. On 31-MAY-2007, the patient recovered from dizzines, sweaty, pale and nauseaus. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a registered nurse concerning a female who on 03-FEB-2007 was vaccinated with Gardasil. In 2007 the patient experienced mononucleosis. The patient's mononucleosis persisted. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site swelling, Lethargy, Malaise, Nodule
Clinical narrative: Information has been received from a physician's assistant concerning a 28 year old female  (67inches, 227lbs.) with hypothyroidism, drug hypersensitivity to morphine sulfate, DEMEROL and ZITHROMAX who on 11-APR-2007 was vaccinated with the first dose of Gardasil (Lot#657617/0384U) intramuscularly in the left deltoid. Concomitant therapy included paroxetine, LEVOXYL and MIRCETE. Within 24 hours, on 12-APR-2007, the patient experienced significant swelling at injection site, swelling/swollen nodular area over left clavicle, significant malaise/lethargy and low grade fever. As of 20-APR-2007 the patient was significantly improved and considered recovered. The patient declined an appointment. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Swelling
Clinical narrative: Information has been received from a physician's assistant concerning a 28 year old female  (67inches, 227lbs.) with hypothyroidism, drug hypersensitivity to morphine sulfate, DEMEROL and ZITHROMAX who on 11-APR-2007 was vaccinated with the first dose of Gardasil (Lot#657617/0384U) intramuscularly in the left deltoid. Concomitant therapy included paroxetine, LEVOXYL and MIRCETE. Within 24 hours, on 12-APR-2007, the patient experienced significant swelling at injection site, swelling/swollen nodular area over left clavicle, significant malaise/lethargy and low grade fever. As of 20-APR-2007 the patient was significantly improved and considered recovered. The patient declined an appointment. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 03-FEB-2007 was vaccinated with the first dose of Gardasil. The patient had not yet received the second dose. The second dose was delayed since the patient developed mononucleosis in 2007. The outcome was not reported. Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. the patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on and unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 15 year old female student with no drug allergies and no medical history who, on 26-MAR-2007 at approximately 14:30 was vaccinated intramuscularly in the left deltoid with a 0.5 mL first dose of GARDASIL (Lot# 655165/1425F). Subsequently, the patient felt very dirry (it was previously reported that the patient had fainted) which was not noted by staff but witnessed by the patient's mom. The patient noted that she sat on the exam table for a while and felt better. It was noted that the patient received at least one other vaccine on the same date was when GARDASIL was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed and there were no illnesses at the time of vaccination. The patient recovered on 26-MAR-2007. On 11-JUL-2007 the patient was vaccinated with a second dose of GARDASIL. The patient layed on the exam table for five minutes and no adverse effects were reported after the second dose. No product quality complaint was involved. This is on of several reports received from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 years old female student with no drug allergies, recurrent cold sores and Attention deficit/hyperactivity disorder who, on 19-MAR-2007 at 10:00   was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Gardasil (Lot# 656741/12084). Concomitant vaccination included meninigococcal vaccine (unspecified) and concomitant therapy included ADDERALL. Subsequently, at approximately 10:05 the patient felt "funny" and briefly passed out (previosulsy reported as felt dizzy) and fainted. The patient fell to the floor. After falling the patient woke and was able to walk to the exam table and laid down for a while where she felt better. The physician reported that fainting was due to a vasovagal reaction. The patient then seemed ok and walked out of the office. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on 19-MAR-2007 recovered on the same day as when the injection was given. No product quality complaint was involved.   This is one of several reports from the same source.   Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Dizziness, Dizziness, Pallor, Smear cervix
Clinical narrative: Initial and follow up information has been received from a physician concerning a female 19 years old with no drug allergies, debilitating dysmenorrhea, acne, weight loss, and irregular break-through bleeding, and with a history of yeast infection, bacterial vaginois, varicella (1/90), cellulitis (5/06), urinary tract infectin, cramping, and abscess of legs  who, on 27-Jun-2007 at 12:30 (Lot # 657868/0523U) was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Concomitant therapy included TRI-CYCLEN LO. It was also noted that the patient received at least one other vaccine on the same date as when GARDASIL was administered. The patient sought unspecified medical attention. Subsequently, at approximately 12:31 the patient felt dizzy (previously reported that she fainted), complained of lightheadness, and was very pale. The patient was given water and animal crackers while she laid on the exam table. Within a few minutes the patient felt better and was able to sit up with return of good color. The patient sought unpecified medical attention.No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submited on 5/14/2007. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, UNK
Symptoms: Dizziness, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 13 years old premenarchal female student with no drug allergies, "constitutional growth delay", bumpy/itchy rash on anterior chest wall after showering (that resolved after drying self), and warts on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow information has been received from a registered nurse and a healthcare professional, concerning a 20 year old female patient, who also initiated therapy with YASMIN on the morning of 23-APR-2007, and on 23-APR-2007, at 9:30am, was vaccinated with a dose, 0.5ml, IM, of GARDASIL (Lot #654272/0319U). There was no illness at the time of vaccination. The nurse reported that the patient "vomited 3 times within the first hour of vaccination," and the healthcare worker clarified that the vomiting started at 10:30am, 1 hour after vaccination, and continued with 3-4 more episodes before she recovered at 2:30pm. The healthcare worker confirmed that a visit to the physician or ER was not required. At the time of this report, the patient had recovered. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise, Nausea, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a physician, via a company representative, concerning the physician's daughter, age 15 or 16 years, who on approximately 09-MAR-2007 ("about six weeks ago") was vaccinated, IM, with the third dose Gardasil. The physician reported that following the vaccination, his daughter experienced flu-like symptoms and nausea, that lasted for three days after the vaccine had been administered, approximately 12-MAR-2007. The physician confirmed that following the three days, his daughter was "fine." The patient's sister also experienced flu-like symptoms and nausea after vaccination with Gardasil (WAES#0704USA04661). Additional information has been requested. Initial and follow up information has been received from a physician, concerning his 14 year old daughter, who on 31-JUL-2006, was vaccinated with the first dose of GARDASIL, on 23-OCT-2006, with the second dose of GARDASIL, and on 06-APR-2007, was vaccinated, IM, with the third dose of GARDASIL. The physician reported that on 07-APR-2007, the day following the vaccination, his daughter experienced flu-like symptoms, was extremely nauseated, and had severe malaise that lasted for three to four days after the vaccine had been administered, and then recovered (approximately 11-MAR-2007). The patient's sister also experienced flu-like symptoms, nausea and malaise after vaccination with GARDASIL (WAES #0704USA04661). Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy induced hypertension, Prenatal care
Clinical narrative: Information has been received from a physician through a Merck Pregnancy Registry concerning a female with asthma, back pain and depression who on 05-FEB-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (Lot # 654535/0960F). The date of the patient's last menstrual period (LMP) was 14-MAR-2007. On 18-APR-2007, the patient was vaccinated, intramuscularly with the second 0.5 mL dose of Gardasil, (Lot # 654510/0962F). Concomitant therapy included PERCOCET, prednisone, MOTRIN and albuterol. It was reported that the patient was pregnant and had gestational hypertension. The patient sought unspecified medical attention. It was reported that the patient had laboratory evaluation of "prenatal ops". The estimated date of delivery was 19-DEC-2007. Additional information has been requested. Follow up information was received from the physician on 10-APR-2008 via telephone call. The physician reported that the patient had initiated her prenatal care with them, but then switched to another hospital for care. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Condition aggravated, Oedema peripheral
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female with no known drug allergies, plantar warts on hand/fingers at the time of vaccination and a history of gastrooesophageal reflux who on 18-APR-2007 at 16:15 was vaccinated with intramuscularly into the right deltoid with a first 0.5 mL dose of GARDASIL (lot #654535/0960F). Concomitant therapy included VARIVAX given at the same visit using a different site. On 23-APR-2007 at 07:00 (also reported as "a short time after the vaccination"), the patient developed swelling and pain in the fingers of the hand near the pre-existing plantar warts on the hand of the arm in which she received the GARDASIL (also reported as swelling in both of her hands but mostly in the right). The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. The symptoms resolved over 5 days and "are now gone." No further information was provided. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Immune system disorder, Malaise
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced that she was not feeling well. The patient's mother felt that the vaccine may have weakened her daughter's immune system. it was reported that the patient sought unspecified medical attention. the patient had not yet recovered at the time of this report. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 23 year old female who was vaccinated with Gardasil. Subsequently the patient experienced pain in her arm pit and shoulder one week after receiving the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient's pain in arm pit and pain in shoulder persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female who in February 2007, was vaccinated with Gardasil. Following vaccination, the patient experienced pain and lump at the injection site and fever. The patient's pain and a lump at the injection site and fever persisted. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician her 23 year old daughter who in December 2006, was vaccinated with a first dose of Gardasil. On 18-DEC-2006, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 25-DEC-2006 the patient recovered. In February 2007, the patient was vaccinated with a second dose of Gardasil. On 14-FEB-2007, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 21-FEB-2007, the patient recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: Information has been received from a 16 year old female, who on 24-APR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included sleeping pills [therapy unspecified]. The patient reported that she experienced a headache and vomiting, which she felt were like "symptoms of pregnancy." At the time of this report, the patient stated that her symptoms had not improved, but that otherwise she was "fine." The patient confirmed that she had not sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female who on 23-APR-2007 was vaccinated with the first dose of Gardasil in the left deltoid (lot# 654702/0010U). On 23-APR-2007 the patient experienced a rash and swelling from injection site to her elbow. At the time of the report the patient was recovering "on therapy" (not specified). Additional information has been requested. This is in follow-up to reports previously submitted on 5/14/2007. Initial and follow up information has been received from a licensed practial nurse concerning a 15 year old female stundent who on 23-APR-2007 was vaccinated IM with the first dose of GARDASIL (lot# 654702/0011U). Subsequently, immediately after the patient expeiienced rash, "jet red" swelling from injection site to her elbow. The patient was given BENADRYL 25mg tablet with good results. The swelling began to subside before the patient left the office. On 24-APR-2007, the patient recovered from the rash and "jet red" swelling from injection site to her elbow. The licensed practical nurse spoke to the mother and the patient the following day and there was no lasting effects. Additional information not expected.
Sex: F
Vaccine: HEPA, HPV4, MMR, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient, who on 24-APR-2007 was vaccinated with a dose of Gardasil (Lot #657617/0384U). Concomitant therapy may have included Varivax, MMR II and Vaqta. the nurse reported that "after receiving Gardasil, the patient passed out." The nurse confirmed that the patient had recovered on the same day, 24-APR-2007. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a nurse, concerning a female patient, who on 24-APR-2007 was vaccinated with a dose of GARDASIL (Lot #657617/0384U). Concomitant therapy may have included VARIVAX (MSD), MMR II (MSD) and VAQTA (MSD). The nurse reported that "after receiving (GARDASIL), the patient passed out". The nurse confirmed that the patient had recovered on the same day, 24-APR-2007, and added that the patient had no additional complaints. The patient sought unspecified medical attention. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Clonus, Feeling cold, Loss of consciousness, Syncope, Tremor
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who was vaccinated with Gardasil (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, felt cold and was shaking. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from an other health professional and a physician concerning a 16 year old female who was vaccinated IM into the deltoid with an entire second 0.5ml dose of GARDASIL (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, was cold and shaking. The physician reported that the patient experienced a syncopal episode with approximately 30 seconds of clonic activity and urinary incontinence. The physician mentioned there was no post ictal confusion. The patient did well with Trendelenburg and rest. The physician reported that the patient was ok for discharge after approximately 10 minutes of monitoring. Subsequently, the patient recovered from syncopal episode, urinary incontinence and clonic activity. No product quality complaint was involved. Upon internal review, clonic activity was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary incontinence
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who was vaccinated with Gardasil (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, felt cold and was shaking. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from an other health professional and a physician concerning a 16 year old female who was vaccinated IM into the deltoid with an entire second 0.5ml dose of GARDASIL (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, was cold and shaking. The physician reported that the patient experienced a syncopal episode with approximately 30 seconds of clonic activity and urinary incontinence. The physician mentioned there was no post ictal confusion. The patient did well with Trendelenburg and rest. The physician reported that the patient was ok for discharge after approximately 10 minutes of monitoring. Subsequently, the patient recovered from syncopal episode, urinary incontinence and clonic activity. No product quality complaint was involved. Upon internal review, clonic activity was considered to be an other important medical event. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who was vaccinated with a second dose of Gardasil (date unspecified). Subsequently, one week following the injection, the patient developed a bump at the injection site. It was reported that the patient had no adverse events following the first dose of Gardasil (date unspecified). Additional information has been requested.