chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Palpitations, Tachycardia
Clinical narrative: Information has been received from a consumer concerning her daughter a 16 year old female with a history of mild infrequent palpitations who on 16-AUG-2007 was vaccinated IM with the first dose of Gardasil vaccine (Lot # not provided). Concomitant therapy included montelukast sodium (MDS), Yaz and albuterol. On approximately 30-AUG-2007 "two to three weeks" post vaccination the patient experienced an increase in frequency and intensity of her heart palpitations. The patient's mother reported at that time of this report that her daughter's increase in heart palpitations persisted. At the time of this report the patient was under care of her pediatrician. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 11/14/2007.  Initial and follow up information have been received from a consumer and a health care provider concerning her daughter a 16 year old daughter with a history of mild infrequent palpitations who on 16-AUG-2007 was vaccinated IM with the first dose of GARDASIL (Lot # 658554/0928U).  Concomitant therapy included montelukast sodium (MSD), YAZ and albuterol.  On approximately 30-AUG-2007 "two to three weeks" post vaccination the patient experienced an increase in frequency and intensity of her heart palpitations.  The patient's mother reported at that time of this report that her daughter's increase in heart palpitations persisted.  At the time of this report the patient was under the care of her pediatrician.  Follow up information received from a health care provider stated that the patient was diagnosed with tachycardia by her primary care physician.  On 17-OCT-2007 the patient was vaccinated IM with the second dose of GARDASIL (Lot #658563/1063U).  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Breast pain, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with asthma, allergy to animal and grass who on 05-OCT-2007 was vaccinated with a first dose of GARDASIL (lot# 658488/0930U) IM in the right arm. There was no concomitant medication. On 05-OCT-2007 the patient experienced pain in the injection site "right after administration." On 06-OCT-2007 the patient experienced pain in her stomach, had headache, nausea and breasts were hurting. Unspecified medical attention was sought. On an unspecified date the patient has a "pap smear" (results not reported). At the time of report, the patient had not recovered. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. Follow-up information was received from the physician's office. The patient had no illness at the time of vaccination. Concomitant therapy on 05-OCT-2007 also included BOOSTRIX (lot# AC52B0240A) IM in the left arm. The patient recovered from headache and nausea on an unspecified date approximately in a week. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Nausea, Smear cervix
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with asthma, allergy to animal and grass who on 05-OCT-2007 was vaccinated with a first dose of GARDASIL (lot# 658488/0930U) IM in the right arm. There was no concomitant medication. On 05-OCT-2007 the patient experienced pain in the injection site "right after administration." On 06-OCT-2007 the patient experienced pain in her stomach, had headache, nausea and breasts were hurting. Unspecified medical attention was sought. On an unspecified date the patient has a "pap smear" (results not reported). At the time of report, the patient had not recovered. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. Follow-up information was received from the physician's office. The patient had no illness at the time of vaccination. Concomitant therapy on 05-OCT-2007 also included BOOSTRIX (lot# AC52B0240A) IM in the left arm. The patient recovered from headache and nausea on an unspecified date approximately in a week. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who in September 2007, was vaccinated intramuscularly in the left deltoid with a 0.5 dose of GARDASIL vaccine (yeast) and has had pain at the injection site since the vaccination. On 08-Oct-2007 the patient went to doctor's office and complained of injection site pain and weakness at the injection site. At the time of this report, the patient's pain and weakness at injection site persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a nurse concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who on 07-SEP-2007, was vaccinated intramuscularly in the left deltoid with the 1st 0.5 dose of GARDASIL vaccine (lot#658563/1063U) and has had pain at the injection site since the vaccination. On 08-OCT-2007 (approx), the patient went to doctor's office and complained of injection site pain, weakness at the injection site, left shoulder pain, a achy arm at night and reduced range of motion. The patient saw a physical therapist and the pain resolved. The patient received the 2nd GARDASIL vaccine and had no problem. No additional information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient with no medical history who on 26-JUN-2007 was vaccinated into the left deltoid with a first dose of Gardasil vaccine (Lot# 658558/1060U). After the vaccination, the patient fainted. It was reported that it lasted a few seconds and her vital signs wre stable. Unspecified medical attention was sought. No laboratory diagnostic studies wer performed. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted oon 11/14/2007. It was also reported that the patient received a 2nd dose of GARDASIL vaccine with no adverse events. Additional information is not expected
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Lethargy, Pyrexia
Clinical narrative: Information has been received from a office manager in a doctor's office concerning a 15 year old female patient who on 15-AUG-2007 was vaccinated IM into left deltoid with a dose of GARDASIL vaccine (yeast) lot #658222/0927U. The reporter reported that the patient received the injection and developed several hours later on the same day a temperature of 101 F to 102F. The fever took 2 to 3 days to pass. The patient also experienced abdominal pain and was lethargic. The patient saw her primary physician. The 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 (age was not reported) who was vaccinated (date of vaccination not provided) with Gardasil vaccine. It was noted by the doctor that the patient fainted after receiving a dose of Gardasil vaccine. The patient did receive unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 24-JUL-2007 was vaccinated with a first dose of Gardasil vaccine. On 24-JUL-2007, the patient felt dizzy. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a medical assitant concerning a 13 year old female with no pertinent medical history who on 24-JUL-2007 at 9:45 am was vaccinated intramuscularly into the left deltoid with a first dose of GARDASIL (Lot #654272/0319U). On 24-JUL-2007 the patient became lightheaded and faint. The patient did pass out for a brief time. There were no laboratory or diagnostic tests performed. On 24-JUL-2007 the symptoms resolved and the patient was dismissed in stable condition. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy, Pyelonephritis
Clinical narrative: Information has been received from a nurse concerning a female (age was not reported) who in October 2006, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) and subsequently determined to be pregnant. During the patient's pregnancy she developed pyelonephritis. The patient recovered from pyelonephritis prior to delivery and delivered a healthy infant without complication. Patient did receive unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml first dose of GARDASIL vaccine (yeast). Subsequently the patient developed hives that lasted longer than a week. She was treated with diphenhydramine hydrochloride (BENADRYL) but the hives did not go away. Additional information has been requested. This is iin follow-up to report (s) previously submitted on 11/14/2007.  Initial and follow up information has been received from a physician concerning a 26 year old female who was vaccinated on 24-SEP-2007 with a 0.5 ml first dose of GARDASIL.  Concomitant medication included AMBIEN.  Subsequently within a 1- days, on 26-SEP-2007, the patient developed red bumps and was itchy (previous reported as hives).  On 04-OCT-2007 she still had symptoms and was treated with BENADRYL.  She was given a prescription for ALLEGRA 60 mo bid.  The patient believed that she had a reaction to AMBIEN not the GARDASIL.  The  itch stopped after stopping AMBIEN.  As of 10-OCT-2007 she was recovered.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Disturbance in attention, Headache, Lethargy, Nausea
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with coeliac disease and an allergy to wheat, who on 31-JUL-2007 was vaccinated intramuscularly with 0.5ml first dose of GARDASIL vaccine (yeast). On 09-OCT-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 09-OCT-2007 the patient experienced nausea, abdominal pain, headache, lethargy and difficulty concentrating. The symptoms increased overnight. On 10-OCT-2007 the patient contacted the office by phone. The patient was advised to take ibuprofen (MOTRIN) as needed and to report to the emergency room if the symptoms worsened. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling jittery
Clinical narrative: Information has been received from a registered nurse concerning a female, "between the ages of 16 to 17 years of age", who in August 2007, was vaccinated with a first dose of Gardasil vaccine. Subsequently, after the vaccination the patient became "jittery." At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with no medical history and no drug allergies, who on 23-AUG-2007 was vaccinated intramuscularly with a 0.5ml dose of GARDASIL vaccine (yeast). Concomitant therapy included an unspecified thyroid replacement. On approximately 06-SEP-2007 the patient developed scattered, red, hive like, plaques on both legs. The patient went to the office. The patient was treated with cetirizine hydrochloride (ZYRTEC) and hydroxyzine hydrochloride (ATARAX). No laboratory diagnostics were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Induration, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who on 25-SEP-2007 was vaccinated in the right arm with a first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 08-OCT-2007, the patient developed pain in her right hand which turned into shooting pains in the right arm, and a swollen, dark red knot above her right wrist. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer concerning her friend's daughter who was vaccinated with a dose of Gardasil vaccine. The caller wanted to report an adverse event on Gardasil vaccine. No further information was provided. It was unknown if the patient sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pain in extremity, Somnolence
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 08-OCT-2007 was vaccinated with the third dose of Gardasil vaccine (lot # not reported). On 10-OCT-2007, the patient experienced nausea, drowsiness, "achiness" and sore arm after getting the third dose of Gardasil vaccine. It is unknown when the patient received the first or second dose of Gardasil vaccine. There was no adverse event involved during the first or second dose of Gardasil. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. There was no product quality complaint. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female patient with anemia and a history of wrist fracture who on 19-MAR-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL vaccine (yeast) (Lot reported as 656051/0244U, "0367U", 658282/0929U). Concomitant therapy included desloratadine (CLARINEX) and oral hormonal contraceptives (unspecified). About 4 weeks after the vaccination, the patient experienced fatigue and bilateral numbness in her upper arms. Unspecified medical attention was sought. It was reported that the patient has received cyanocobalamin (VITAMIN B-12) injections for pre-existing anemia, that seem to have improved the symptoms. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash generalised, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 26 year old female, with no known allergies, who on 16-JUL-2007 was vaccinated with a first dose of Gardasil vaccine. Concomitant therapy included Yasmin. On approximately 23-JUL-2007, the patient developed a rash over her entire body. The rash became worse and was red and warm to the touch. She was seeing a dermatologist and allergist for treatment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Mouth injury
Clinical narrative: Information has been received from an office representative in billing concerning a female who was vaccinated with a dose of Gardasil vaccine. Subsequently, the patient passed out, hit her head and lost teeth due to the trauma. At the time of the report the patient's outcome was unknown. The reporter was assuming that the patient's passing out, hitting her head and losing teeth was related to the treatment with Gardasil vaccine. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old white female who on 25-JUL-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) into the left arm (lot # 657736/0389U). Within 15 minutes of receiving the vaccine the patient fainted. She quickly recovered after lying down for 15 minutes and was able to return home. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female with no pertinent medical history, who on 09-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 11-AUG-2007, two days after she was vaccinated she developed nausea, chills and a low grade temperature. There were no laboratory or diagnostic tests performed. The patient called the office. Subsequently, the patient fully recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a nurse concerning a 19 year old white female with no known drug allergies and a cold with no temperature at the time of vaccination who on 09-AUG-2007 was vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of GARDASIL (Lot #0469U). Concomitant therapy included hormonal contraceptives (unspecified). On 11-AUG-2007 (reported on 10-OCT-2007) two days after she was vaccinated she developed severe nausea, chills and a low grade temperature. The patient called the office. On 12-AUG-2007, the patient fully recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female who in August 2007, was vaccinated IM with the first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient experienced fever, chills and nausea. No medical attention was sought. Subsequently, the patient recovered from fever, chills and nausea. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Local swelling, Rash generalised
Clinical narrative: Information has been received from a 21 year old female consumer who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced body rash, head swollen and headache. Unknown medical attention was sought. The patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning numerous female patients (ages not reported) who on unspecified dates were vaccinated with a dose of Gardasil vaccine. Concomitant medication was not reported. Subsequently on unspecified dates, the patients complained of pain after receiving the Gardasil vaccination. Unspecified medical attention was sought. The outcome of the events were not reported. No product quality complaint was involved. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Information has been received from the mother of a 23 year old female who on 02-Aug-2007 was vaccinated with the first dose of Gardasil vaccine. Concomitant medication was not reported. On approximately 07-AUG-2007 (5 or 7 days after getting the first vaccine), the patient developed vertigo. Unspecified medical attention was sought. On 06-OCT-2007, the patient was vaccinated with the second dose of Gardasil vaccine. On 09-OCT-2007, ("72 hours after second vaccination"), the patient developed vertigo. Subsequently on an unspecified date, the patient recovered from vertigo. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Nausea
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female who on 12-FEB-2007 was vaccinated with the first dose of Gardasil vaccine (lot #653736/0014U), IM. Concomitant medication was not reported. On 12-Feb-2007, the patient experienced nausea and said she was "feeling out of it." Subsequently, on an unspecified date, the patient recovered from nausea and "feeling out of it." It was reported that the events "cleared on it's own" and that the patient had finished the vaccination series. No product quality complaint was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who on 23-APR-2007 was vaccinated with GARDASIL vaccine (yeast) (lot #657005/0314U). On 23-APR-2007 the patient experienced nausea and feeling out of it. The patient did not seek medical attention. Subsequently, the patient recovered from nausea and feeling out of it. A case was filed for the patient's sister with the same events for WAES #0710USA02783. No further information was provided. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Medical device complication, Skin burning sensation
Clinical narrative: Information has been received from a 32 year old female medical assistant concerning herself who on 11-OCT-2007 was preparing a pre-filled syringe to vaccination a patient with GARDASIL vaccine (yeast) (lot #653650/0640F). On 11-OCT-2007 the pre-filled syringe leaked onto medical assistant's hand. She washed her hands with soap and water but experienced slight burning on her hand with no redness. It was noted that the adverse experience persisted. It was also noted that another employee helping at this time was also splashed in the left eye with the solution (reported in WAES #0710USA03432). No further details were provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Neck mass
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced a lump on her neck after receiving the vaccine. A CT scan was performed to check the lump but no results were available. No further details were provided.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 08-OCT-2007 was vaccinated IM with Gardasil vaccine. Concomitant therapy included Zoloft. On 10-OCT-2007, the patient experienced facial tingling. No additional information at this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. The physician noted that diagnostic tests should be performed to check for infection. The patient did not come into the office for an appointment. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Dizziness, Headache, Muscular weakness, Sensory loss
Clinical narrative: Information has been received from a mother concerning her 25 year old female daughter who in August 2007, was vaccinated IM with Gardasil vaccine. The mother reported that 24 hours after the patient was vaccinated, she fell ill with headaches, muscle weakness, dizziness and she lost feeling in her extremities. Her physician worked her up for allergies, however the mother states that her daughter's symptoms are due to the Gardasil vaccine. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Serum sickness
Clinical narrative: Information has been received regarding a case in litigation from a physician concerning a female patient who in 2007 was vaccinated IM GARDASIL vaccine (yeast). A physician reported that after the patient was vaccinated, she experienced serum sickness. No further information is available at this time.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 09-OCT-2007 was vaccinated with Gardasil vaccine (lot number was not reported). On 09-OCT-2007, the patient experienced fainting while walking out to the waiting area. Subsequently, the patient recovered from fainting while walking out to the waiting area. The physician had used "smelling salt" to wake the patient. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physicians assistant concerning a 25 year old female with a skin disorder who on 04-OCT-2007 was vaccinated with a 0.5 ml first dose of GARDASIL vaccine (yeast) (Lot #658488/1264U). Concomitant therapy included unspecified antibiotics. On 05-OCT-2007 the patient experienced "a generalized rash all over the body". The patient was referred to a dermatologist. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a physicians assistant concerning a 25 year old female with a skin disorder who on 02-OCT-2007 at 09:13 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of GARDASIL (Lot #658488/1264U). Concomitant therapy included unspecified antibiotics. On 04-OCT-2007 the patient experienced "a generalized rash all over the body" (itchy hives). The patient was referred to a dermatologist. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Inappropriate schedule of drug administration, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning her 27 year old daughter who on 10-OCT-2007 was vaccinated intramuscularly with a third dose of Gardasil vaccine. On 10-OCT-2007, the patient fainted immediately. The physician reported that on 10-OCT-2007, her husband came and picked up her daughter at the physician's office and brought her home; the patient was fine then and wanted to go back to work. On 10-OCT-2007, the patient recovered. It was reported by the physician that the patient did not have a reaction to the 1st or 2nd dose of Gardasil vaccine. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning female patients in the age range of 14-17 who were vaccinated with Gardasil vaccine (Lot# 057868/0523U, 657622/0388U, or "0398U"). Subsequently, all of the patients in her office, experienced injection-site pain. At the time of the report the patients outcomes were unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on an unspecified date was vaccinated with Gardasil vaccine (lot # 0530U) injection. The physician reported that the patient experienced severe pain after receiving the third dose of Gardasil vaccine. No further adverse event information was provided. This is one of two reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Headache, Night sweats
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 19 year old female patient, who on 01-OCT-2007 was vaccinated with the second dose of Gardasil vaccine (Lot # not provided). Concomitant therapy included Yasmin. On 01-OCT-2007, the patient experienced heavy pressure in her chest and nights sweats. Treatment was not specified. Subsequently, the patient recovered from the events, and had not sought medical attention. Additional information has been requested. Follow up information from a licensed practical nurse described the pain-like heavy pressure in the patient's chest as "heavy chest discomfort," and added that the patient had also experienced shortness of breath and headache. She indicated that though the patient sought medical attention, no treatment was required. The nurse stated these were the events that had been previously reported: the physician previously indicated that the patient had recovered from all events. The nurse added that the symptoms had resolved within 24 hours. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Eyelid oedema, Urticaria
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a female patient in her late teens with a history of hypersensitivity reactions, who on an unknown date was vaccinated with the first dose , 0.5 mL, of Gardasil vaccine (lot # not specified). Subsequently, the patient "had an anaphylactic reaction," and developed hives all over her body, as well as swollen eyelids. The patient visited the emergency room and was administered Benadryl. She recovered from the events, though the duration of symptoms was not specified. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a patient female (demographics not provided) who on 03-OCT-2007 was vaccinated IM with the first dose of Gardasil vaccine (Lot # not provided). On an unspecified date post vaccination in October 2007, the patient developed a itchy rash on both of her arms and upper chest. The physician reported that the patient attempted to treat herself with Claritin, which was reported to have helped for awhile, but then the itching came back. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 10-AUG-2007 was vaccinated with a first dose of Gardasil vaccine (lot# 658222/0927U) IM in the deltoid. On 10-AUG-2007, the patient experienced immediate tingling in the arm and moved to the whole side of the body which lasted 15 to 20 minutes. The patient recovered from the tingling on 10-AUG-2007. On 05-OCT-2007, the patient was vaccinated with a second dose of Gardasil vaccine (lot# 658558/1061U) IM in the deltoid. On 05-OCT-2007, the patient experienced immediate tingling in the arm and it did not spread past the arm this time. The tingling lasted for 10 minutes. The patient recovered from the tingling on 05-OCT-2007. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning her 20 year old daughter who in May 2007 and August 2007, was vaccinated with first and second doses of Gardasil vaccine, respectively. Subsequently, on an unspecified date, the patient developed swollen lymph nodes. It was noted that the patient had not yet received her third dose of Gardasil vaccine. At the time of this report, the patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning patients (age and gender unknown) who, on unspecified dates, were vaccinated with doses of Gardasil vaccine. Subsequently, the patients complained of painful burning and stinging and swelling at the injection site. At the time of this report, the patients' outcome were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Formication, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with a history of glomerulonephritis, idiopathic thrombocytopenic purpura, Raynaud's syndrome and possible lupus erythematosus, who in April 2007 was vaccinated with Gardasil vaccine. Concomitant therapy included Plaquenil. In June 2007, the patient experienced asthenia, paresthesia. The patient experienced pin-prick sensations along the right thigh and a crawling sensation in the middle of her back. It was reported that the patient sought unspecified medical attention. The patient's paresthesia and crawling like sensation in the middle of her back persisted. The patient's asthenia has improved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a physician concerning a female consumer who on approximately 15-SEP-2007 was vaccinated with Gardasil vaccine. On approximately 15-SEP-2007,  the patient developed a 1.5 cm nodule on her deltoid which was at the injection site. The dates the patient received the first and second doses were unspecified. The patient's nodule on her deltoid persisted. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram ambulatory abnormal, Electrocardiogram normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 10-OCT-2007, was vaccinated with her second dose of Gardasil vaccine (lot #658282/0929U). The patient experienced chest pains and had visited the ER on 11-OCT-2007 and 12-OCT-2007. It was reported that the patient's blood work and EKG were normal. It was also reported that the patient is currently facing some issues at home and the physician believes the events could possibly be anxiety related. No further details were provided. Additional information has been requested. Follow up information has been received from an LPN concerning the 17 year old female student: chest pain during soccer game - unrelenting - transported to hospital - negative chest x-ray, negative EC. DEMEROL and ATIVAN before relief. Second epidode 24 hours later. Per medical records a chest x-ray performed 11-OCT-2006 allowed no pulmonary infiltrates. An ECG performed the same day wsa normal with normal sinus rhythm. D-dimer ws 172 ng/mL. An ECG performed 12-OCT-2007 revealed sinus bradycardia with sinus arhythmia, otherwise normal ECG. D-dimer on that date was 126 ng/mL; troponin T was low. Per a holter monitor report for 15-OCT-2007: Sinus rhythm with frequent brief episodes of sinus tachycardia. No clear correlation between heart rate or rhythm and symptoms described. Variable T-wave morphlogy of uncertain significance. " The patient's outcome remained unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fibrin D dimer normal, Sinus arrhythmia, Sinus bradycardia, Sinus rhythm, Sinus tachycardia
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 10-OCT-2007, was vaccinated with her second dose of Gardasil vaccine (lot #658282/0929U). The patient experienced chest pains and had visited the ER on 11-OCT-2007 and 12-OCT-2007. It was reported that the patient's blood work and EKG were normal. It was also reported that the patient is currently facing some issues at home and the physician believes the events could possibly be anxiety related. No further details were provided. Additional information has been requested. Follow up information has been received from an LPN concerning the 17 year old female student: chest pain during soccer game - unrelenting - transported to hospital - negative chest x-ray, negative EC. DEMEROL and ATIVAN before relief. Second epidode 24 hours later. Per medical records a chest x-ray performed 11-OCT-2006 allowed no pulmonary infiltrates. An ECG performed the same day wsa normal with normal sinus rhythm. D-dimer ws 172 ng/mL. An ECG performed 12-OCT-2007 revealed sinus bradycardia with sinus arhythmia, otherwise normal ECG. D-dimer on that date was 126 ng/mL; troponin T was low. Per a holter monitor report for 15-OCT-2007: Sinus rhythm with frequent brief episodes of sinus tachycardia. No clear correlation between heart rate or rhythm and symptoms described. Variable T-wave morphlogy of uncertain significance. " The patient's outcome remained unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Troponin T
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 10-OCT-2007, was vaccinated with her second dose of Gardasil vaccine (lot #658282/0929U). The patient experienced chest pains and had visited the ER on 11-OCT-2007 and 12-OCT-2007. It was reported that the patient's blood work and EKG were normal. It was also reported that the patient is currently facing some issues at home and the physician believes the events could possibly be anxiety related. No further details were provided. Additional information has been requested. Follow up information has been received from an LPN concerning the 17 year old female student: chest pain during soccer game - unrelenting - transported to hospital - negative chest x-ray, negative EC. DEMEROL and ATIVAN before relief. Second epidode 24 hours later. Per medical records a chest x-ray performed 11-OCT-2006 allowed no pulmonary infiltrates. An ECG performed the same day wsa normal with normal sinus rhythm. D-dimer ws 172 ng/mL. An ECG performed 12-OCT-2007 revealed sinus bradycardia with sinus arhythmia, otherwise normal ECG. D-dimer on that date was 126 ng/mL; troponin T was low. Per a holter monitor report for 15-OCT-2007: Sinus rhythm with frequent brief episodes of sinus tachycardia. No clear correlation between heart rate or rhythm and symptoms described. Variable T-wave morphlogy of uncertain significance. " The patient's outcome remained unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine, 0.5 mL, in the gluteal muscle. Concomitant medication was not reported. On an unspecified date, the patient experienced swelling and redness at the site post vaccination. No other information was provided. The outcome of the events was not reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Supraventricular tachycardia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with her first dose of Gardasil vaccine. After receiving the dose, the patient experienced nausea and dizziness. Subsequently, the patient recovered from nausea and dizziness. The patient sought unspecified medical attention. Additional information has been requested. Follow-up information has been received indicated that the new 15 year old patient who had supraventricular tachycardia (SVT) felt dizzy and nauseous within 1/2 hour of the vaccine that lasted approximately 3-4 hours on 27-Sep-2007. (No fever, registered on the thermometer - head felt warm though). The patient recovered on the same day. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 11-OCT-2007, was vaccinated with her first dose of Gardasil vaccine. On 12-OCT-2007, the patient experienced a rash on legs and abdomen. The patient sought unspecified medical attention and her outcome is unknown. The patient was prescribed, by the physician, Benadryl to treat the rash. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Oedema peripheral, Swelling face
Clinical narrative: Information has been received from a physician concerning a 34 year old female with a history of polycystic ovaries, who on 14-AUG-2007 was vaccinated with her first and only dose of Gardasil vaccine, IM in the left arm. On 15-AUG-2007, the patient experienced swollen arms and face. She sought medical attention by calling the doctors office. The doctor told her to take Benadryl. Subsequently, the patient recovered from swollen arms and face 2 days after the vaccination. The patient mentioned she at shrimp on the same day as the vaccination, but never had a problem with shrimp. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Injection site bruising
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female who in approximately April 2007, "6 months ago", was vaccinated with the first dose of Gardasil vaccine (lot# not reported). There was no concomitant medication. In approximately April 2007, "2 days after vaccination", the patient developed bruised skin and skin atrophy at the injection site. The patient sought unspecified medical attention. No laboratory diagnostic testes were performed. Subsequently, the patient recovered from bruised skin but the indentation from skin atrophy is still noticeable on her arm. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a physicians assistant concerning a 25 year old patient who on 02-OCT-2007 was vaccinated with a first dose of Gardasil vaccine (Lot #658488/1264U). On 05-OCT-2007, the "patient experienced generalized rash all over the body." At the time of the report the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 25 year old female who on 04-OCT-2007, at 15:58, was vaccinated IM, into the left arm, with a first dose of GARDASIL (lot #658488/1264U). On 04-OCT-2007 the patient developed "itchy rash all over body." On 05-OCT-2007, the patient still had the rash. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on approximately 08-OCT-2007, "also reported as sometime last week", was vaccinated with he first dose of Gardasil vaccine. On approximately 08-OCT-2007, "also reported as sometime last week", this patient fainted for about 2 to 3 minutes. The physician reported that "they kept and eye on the patient and waited for her to come back and in time she did." Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of Gardasil vaccine (lot # not reported). There was no concomitant medication. Subsequently, "two to three days after vaccination", the patient developed super clavicle lymph nodes.  The patient's super clavicle lymph nodes persisted. Blood test and chest x-rays were performed (results unknown). There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Information has been received from a health professional concerning her 11 year old daughter, who on approximately 02-OCT-2007 was vaccinated with her first and only Gardasil vaccine. On approximately 02-OCT-2007, the patient experienced injection site pain and joint pain all over her body. Subsequently, three days after the vaccination, the patient recovered from injection site pain and joint pain all over her body. The patient was treated with Tylenol. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a college age female who was vaccinated with her first and second dose of Gardasil vaccine. The patient experienced flu like symptoms after the second dose. Subsequently, the patient eventually recovered several days after the vaccination from the flu like symptoms. The patient had no reaction to the first dose. She received the first dose in the physician's office and the second dose at her college. The patient sought medical attention by calling the physician. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) with no known medical history and/or drug reactions/allergies, who on 26-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil vaccine (lot # 657617/0384U). On 30-AUG-2007, the patient was vaccinated intramuscularly with the second 0.5 mL dose of Gardasil vaccine (lot # 657617/0384U). There was no concomitant medication. In July 2007, "1-2 weeks after receiving the first dose of Gardasil vaccine", the patient developed intermittent fevers to 103.9 Fahrenheit and a full body rash. The symptoms subsided and then reoccurred after the first dose and before the administration of the second dose of Gardasil vaccine. After receiving the second dose, the symptoms continued without change. The patient has seen her primary care physician many times for the symptoms but there is no cause found. No laboratory diagnostic tests were performed. There was no product quality complaint involved. Additional information has been requested. Follow up information obtained on 10-DEC-2007. The registered nurse reported that the white female patient (weighing 174 lbs) received both doses of GARDASIL in the left deltoid. On 16-OCT-2007 the patient called to report that itching, rash and fever occurred after receiving both doses of GARDASIL. The patient sought unspecified medical attention. The patient was treated with unspecified steroids dose pack. The patient recovered. There were no illnesses at time of vaccination or pre-existing allergies, birth defects, or medical conditions. Additional information has been requested.