chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on an unspecified date was vaccinated with the second dose of Gardasil. Subsequently, the patient developed a red, slightly raised area around the injection site. It was reported that the patient improved after two days are was doing fine. Additional information has been requested. This is one of two reports from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Vertigo
Clinical narrative: Information has been received from a physician concerning a 16 year old female student with a penicillin allergy who on 06-APR-2007 at 3:00 pm, was vaccinated IM in the right deltoid with her first dose of Gardasil, lot #654272/0319U. At 7:00 p.m. the patient experienced sudden chills down with vertigo lasting less than 5 seconds. No further information is available.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chest X-ray normal, Dizziness, Electrocardiogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 20 year old female who, on 29-MAY-2007 was vaccinated with a 0.5mL dose of Gardasil (Lot# 657737/0522U). On 08-JUL-2007 the patient experienced dizziness "on and off." An MRI, Chest X ray, EKG, and lab work were performed. 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 has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician and a nurse concerning a 20 year old female who, on 29-MAY-2007 was vaccinated intramuscularly in the left arm with a 0.5mL dose of GARDASIL (Lot# 657737/0522U). Concomitant vaccination on 29-MAY-2007 included VAQTA (657304/0246U) administered intramuscularly into the right arm. On approximately 07-JUN-2007 the patient complained of dizziness (previously reported as 08-JUL-2007 the patient experienced dizziness "on and off"). The signs and symptoms worsened with movement. On 15-JUN-2007 the patient complained of feeling hot. On 19-JUN-2007 an MRI, Chest X ray, EKG, and lab work were performed and were all negative. The patient sought unspecified medical attention. In August 2007 the signs and symptoms resolved on their own and the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Skin warm
Clinical narrative: Information has been received from a physician concerning a 20 year old female who, on 29-MAY-2007 was vaccinated with a 0.5mL dose of Gardasil (Lot# 657737/0522U). On 08-JUL-2007 the patient experienced dizziness "on and off." An MRI, Chest X ray, EKG, and lab work were performed. 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 has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician and a nurse concerning a 20 year old female who, on 29-MAY-2007 was vaccinated intramuscularly in the left arm with a 0.5mL dose of GARDASIL (Lot# 657737/0522U). Concomitant vaccination on 29-MAY-2007 included VAQTA (657304/0246U) administered intramuscularly into the right arm. On approximately 07-JUN-2007 the patient complained of dizziness (previously reported as 08-JUL-2007 the patient experienced dizziness "on and off"). The signs and symptoms worsened with movement. On 15-JUN-2007 the patient complained of feeling hot. On 19-JUN-2007 an MRI, Chest X ray, EKG, and lab work were performed and were all negative. The patient sought unspecified medical attention. In August 2007 the signs and symptoms resolved on their own and the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 year old female who, on 19-JUL-2007 was vaccinated with a first dose of Gardasil. On 20-JUL-2007 the patient broke out with herpes like lesions, the patient sought unspecified medical attention. A culture of the lesions were taken and blood was drawn. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Approximately two weeks after the vaccination the patient developed redness and a large nodule at the injection site. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 18 year old female student who on 19-FEB-2007 was vaccinated in the left deltoid with a first dose of GARDASIL vaccine (Loy# 654702/0011U). Approximately two weeks after the vaccination the patient developed a painful hematoma at the injection site that was 10cm. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered on 26-MAR-2008. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a 0.5ml dose of Gardasil. Subsequently, the patient experienced severe pain in her arm after the vaccination. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning a female patient (age unspecified), who on an unknown date was vaccinated with a dose, 0.5ml, of Gardasil (Lot # "unavailable"). The NP reported that the patient developed a "vaso-vagal condition" following the vaccination. No further details were provided. At the time of the this report, the outcome of the event was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient who on an unspecified date, was vaccinated with a dose of Gardasil (Lot # not provided). Following the vaccination, the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00117, 0708USA00118). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Myalgia, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient in her "early 20's" who was vaccinated with a 0.5ml dose of Gardasil. A few months after being vaccinated, the patient experienced fibromyalgia type symptoms including fatigue, muscle aches, body aches and her thinking process became a little fuzzy. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who was vaccinated with a second dose of Gardasil. Subsequently, the patient became light headed and fainted. This experience lasted for approximately a minute or two. Unspecified medical attention was sought. At the time of this report, the patient recovered. It was reported that just prior to receiving the vaccination, a blood draw was performed and the patient was fine. It was also reported that the patient did not have this experience with the first dose of the vaccine. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil. Subsequently the patient developed a headache. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Erythema multiforme
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient who on 13-JUN-2007, was vaccinated into the left deltoid with a first dose of Gardasil (Lot # 657621/0387U). On 04-JUL-2007 about three weeks after injection, the patient experienced a recurrence of erythema multiforme. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed severe fatigue. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil. Subsequently the patient developed severe fatigue. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 16 year old female who, on approximately 16-JUL-2007 was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced pain in shoulder that lasted for about a week after the vaccination. It was reported that the patient did not experienced pain when she received the first dose of the vaccination. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a licensed visiting nurse (LVN), via a company representative, concerning a female patient (age not specified), who on an unspecified vaccinated with a dose of Gardasil (Lot # not provided). Immediately after the vaccination was administered the patient fainted. The outcome of the event was unknown. The nurse reported that another female patient (age unspecified) also fainted after vaccination with Gardasil (Lot # not provided) (WAES #0707USA04608). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure decreased, Dizziness, Gaze palsy, Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a physician a 14 year old female who on 25-JUL-2007, at 10:00, was vaccinated into the right deltoid with a first dose of Gardasil (656051/0244U). Concomitant therapy included Menactra. On 25-JUL-2007, immediately after receiving the vaccination the patient became lightheaded, had a syncopal episode (approximately 5 second), developed stiffening of arms and eyes rolled back. Blood pressure measurement after syncope was 90/60 (sitting). At 11:30, blood pressure measurement was 100/68 and pulse was 76. There was no seizure activity and the patient was no post-ictal. On 25-JUL-2007, the patient recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 16 year old female student with hypersensitivity to Zithromax and a history of arthralgia due to allergic reaction to unspecified medications, who on 15-JUN-2007 was vaccinated IM with a first dose of Gardasil (lot #0469U). There was no concomitant medication. On 01-JUL-2007 the patient experienced "joint finger arthritis type pain," event to touch in both hands. On 10-JUL-2007, the patient recovered. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a females who was vaccinated in 2007 with a first dose of Gardasil. Subsequently, both patients fainted. Unspecified medical attention was sought, The patient recovered from fainting before leaving the office. No laboratory or diagnostic tests were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning a female between teh ages of 13 to 16 years old with no prior history of drug reactions, who was vaccinated intramuscularly with the second dose of Gardasil (lot # 654741/1208F). On approximately 09-JUL-2007 (also reported as "last 2 days"), immediately after the injection of Gardasil, the patient fainted. Subsequently, the patient recovered from the fainting. 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. The same source provided information on another patient, WAES #0707USA01794 and WAES # 0709USA00163.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient who on an unspecified date, was vaccinated with a dose of Gardasil (Lot # not provided). Following the vaccination, the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with Gardasil (Lot # not provided) (WAES #0707USA04932, 0708usa00118). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (Lot # not provided). Following the vaccination, the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with GARDASIL (Lot # not provided) (WAES #0707USA04932, 0708USA00117). Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician and a healthcare professional, concerning a 13 year old female student who on 04-JUN-2007, was vaccinated with the first dose of GARDASIL (Lot # 655165/1425F). There was no illness at the time of vaccination. Following the vaccination (duration and date not specified), the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with GARDASIL (Lot # not provided) (WAES #0707USA04932, 0708USA00117). Additional information is not expected.
Sex: U
Vaccine: DTAP, HPV4, MNQ
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a patient who was vaccinated with a dose of Gardasil. Concomitant therapy included a dose of DTaP and a dose of Menactra. Subsequently, the patient experienced an instant severe headache and the she was fine. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female (and unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, on an unspecified date, the patient developed redness and pain at the injection site area. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown), who on 29-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Subsequently, a few hours after receiving the vaccination the patient developed widespread hives. The patient self treated with Benadryl and the symptoms resolved within 24 hours. The patient sought unspecified medical attention. On 30-MAY-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain upper, Dyspnoea, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a liscensed practical nurse concerning an 18 year old female with an allergy to Penicillin and no medical history, who on 30-JUL-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot# 655324/0089U). Concomitant vaccination included meningococcal vaccine (unspecified) (manufacturer unknown). On 30-JUL-2007 the patient developed a sore throat. On 31-JUL-2007 the patient experienced 'shortness of breath and stomach tightness." The patient was treated with an albuterol nebulizer treatment and Benadryl 25mg. The shortness of breath resolved with treatment and the stomach tightness improved. No laboratory diagnostics were performed. At the time of the report, the patient was recovering from stomach tightness and sore throat. No product complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Immediate post-injection reaction, Local reaction, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female, patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00508, 0708USA00509, 0708USA00510, 0708USA00511 and 0708USA00512). Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from a physician concerning a 27 year old female who was vaccinated IM into the gluteal area with a first dose of Gardasil. Subsequently, the pateint experienced burning and shooting pains similar to sciatica. Seven days after received the vaccine, the patient went to the emergency room where she was referred to a neurologist. It was reported that the test results were inconclusive and they did not find anything. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Amenorrhoea, Menstrual disorder, Mood altered
Clinical narrative: Information has been received from a physician, via a company representative, regarding a 15 year old female patient, who was vaccinated on an unknown date, with the second or third dose of Gardasil (Lot # not reported), and subsequently stopped getting her menstrual cycle, had a change in behavior, and became very moody. At the time of this report, it was unknown if the patient had recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received a representative at the Health Department concerning a 14 year old female who was vaccinated with a first dose of Gardasil. Subsequently the patient developed swelling in both arms after receiving the first dose of Gardasil. Unspecified medical attention was sought. Subsequently, the patient is fine and the swelling has gone down and the patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Incorrect dose administered, Underdose
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no pertinent medical history who on 23-JUL-2007 was vaccinated intramuscularly with Gardasil and the patient received less than a full dose. There was no concomitant medication. The nurse reported that the needle was not fully attached to the syringe and some of the Gardasil leaked out at the syringe hub. The nurse reported that this was due to misuse not a product quality issue. On 23-JUL-2007 the patient developed a burning sensation after the vaccination that quickly resolved. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to reports previously submitted on 8/14/2007. Initial and follow-up information has been received from a liscensed practical nurse concerning a 12 year old female with no pertinent medical history who on 23-JUL-2007 was vaccinated intramusculary with a dose of GARDASIL (lot# 657622/0388U). There was no concomitant medication. Subsequently the patient received less than a full dose. The nurse reported that the needle was not fully attached to the syringe and some of the GARDASIL leaked out at the syringe hub. The nurse reported that this was due to misuse not a product quality issue. On 23-JUL-2007 the GARDASIL was reported. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient was recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 30-JUL-2007 was vaccinated with a dose of Gardasil (lot # 654510/0962F). On 30-JUL-2007 the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from the fainting. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. On 30-JUL-2007 the patient was checking out after being observed for 20 minutes with no problems and became lightheaded and fainted at 14:20. The patient regained consciousness and felt the experience was caused by "thoughts of the shot." Subsequently, the patient recovered on 30-JUL-2007. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ear discomfort, Immediate post-injection reaction, Paraesthesia, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 31-JUL-2007 was vaccinated with a dose of Gardasil (lot # 658488/0930U). On 31-JUL-2007, the patient fainted for 30 seconds to 1 minute after she was given Gardasil. The patient complained that her ear "felt funny" and left fingers were tingling. On 31-JUL-2007, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with Gardasil (lot # unknown) and developed a rash. At the time of reporting it is unknown if the patient has recovered. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on 20-JUL-2007 was vaccinated with Gardasil (lot # unknown). On 20-JUL-2007 the patient fainted after receiving Gardasil. Medical attention was sought. At the time of reporting the patient recovered. No additional information was provided. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Immediate post-injection reaction, Local reaction, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction reaction involving redness, At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patient also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00509, 0708USA00510, 0708USA00511, and  0708USA00512). Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Immediate post-injection reaction, Local reaction, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of ago") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00510, 0708USA00511, and 0708USA00512). Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Local reaction, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 10 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00509, 0708USA00511, and 0708USA00512). Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Local reaction, Syncope vasovagal
Clinical narrative: Information has been received a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago") was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00509, 0708USA00510, and 0708USA00512). Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Local reaction, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00509, 0708USA00510, and 0708USA00511). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who on an unspecified date, was vaccinated with a dose of Gardasil. On 25-JUL-2007 the patient fainted. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 20-JUL-2007 was vaccinated with a dose of Gardasil. Unspecified medical attention was sought. No adverse event was reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a certified nurse midwife (CNM), concerning an 18 year old female patient, with hypersensitivity to aspirin that involved abdominal distress, who on 17-JUL-2007 was vaccinated IM in the left arm, with a dose of Gardasil (Lot #656372/0243U). Concomitant therapy included hormonal contraceptives (manufacturer unspecified. Within a couple of hours after the vaccination, she experienced pain and soreness of her left arm, though she had no difficulty with movement of the arm. She also stated that she felt feverish, and reported her temperature was 99.2F. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a healthcare professional (HCP), concerning a female patient (age unspecified) with no known drug allergies, who on 30-JUL-2007 was vaccinated IM, with a dose, 0.5ml, of Gardasil (Lot #658490/0802U). There was no concomitant medication. On 30-JUL-2007, following the vaccination, the patient fainted (time duration to onset not specified), but did not have any other symptoms. She recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 24 year old female patient with no known drug allergies, who on 26-JUL-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #658222/0927U). There was no concomitant medication. On 28-JUL-2007, two days after the vaccination, the patient developed itchiness and a rash on the palms of both hands. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. On 30-JUL-2007, the patient was seen by the physician, and treatment included MEDROL dose pack. At the time of this report, the patient had recovered from the rash (duration not specified). The nurse stated that the physician did not feel the rash and itching was related to the immunization. Follow up information received from the nurse indicated that on 24-SEP-2007, the patient was vaccinated with the second dose of GARDASIL (lot #658560/1062U), and she next day, 25-SEP-2007 she again experienced itchy hands. Treatment again included steroids (unspecified), and at the time of this report, the patient had recovered. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropod bite, Carbuncle, Cellulitis, Chlamydial infection, Culture wound positive
Clinical narrative: Information has been received from a registered nurse concerning a her 16 year old daughter who "sometime in mid-June" was vaccinated subcutaneously in the back of the arm with a first dose of Gardasil. On the same day after vaccination, a PAP smear was performed and was positive for chlamydia for which the patient was treated with Zithromax. On approximately 06-JUL-2007, the patient developed a boil/ carbuncle on the right side of her shaved pubic area at the hair growth line, about 3 inches wide. It was described as a "red, hard, angry looking boil." The patient's mother stated that she learned about the boil at a later date and said her daughter was squeezing the boil which had pus underneath. The patient's mother cleaned the boil with hydrogen peroxide and over the counter antibiotic ointment cream. On 23-JUL-2007, the patient was seen by her pediatric physician and the pus-filled boil was drained and had a yellowish discharge. A wound culture of the boil was obtained and was identified as an MRSA infection. The patient was treated with Septra 1 BID for 10 days. The patient's mother stated that it looked like another boil was underneath the original one. Subsequently, the patient's mother noticed a fire ant or spider bite on the patient's left leg, which was swollen like cellulitis. The patient's mother treated her with over the counter antibiotic and 4 x 4 gauze placed on top. The patient's mother did not think that these infections were related to the vaccine. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Furuncle, Incorrect route of drug administration, Smear cervix abnormal, Staphylococcal infection
Clinical narrative: Information has been received from a registered nurse concerning a her 16 year old daughter who "sometime in mid-June" was vaccinated subcutaneously in the back of the arm with a first dose of Gardasil. On the same day after vaccination, a PAP smear was performed and was positive for chlamydia for which the patient was treated with Zithromax. On approximately 06-JUL-2007, the patient developed a boil/ carbuncle on the right side of her shaved pubic area at the hair growth line, about 3 inches wide. It was described as a "red, hard, angry looking boil." The patient's mother stated that she learned about the boil at a later date and said her daughter was squeezing the boil which had pus underneath. The patient's mother cleaned the boil with hydrogen peroxide and over the counter antibiotic ointment cream. On 23-JUL-2007, the patient was seen by her pediatric physician and the pus-filled boil was drained and had a yellowish discharge. A wound culture of the boil was obtained and was identified as an MRSA infection. The patient was treated with Septra 1 BID for 10 days. The patient's mother stated that it looked like another boil was underneath the original one. Subsequently, the patient's mother noticed a fire ant or spider bite on the patient's left leg, which was swollen like cellulitis. The patient's mother treated her with over the counter antibiotic and 4 x 4 gauze placed on top. The patient's mother did not think that these infections were related to the vaccine. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an approximately 18 year old female who was vaccinated in her thigh, with a second dose of Gardasil. Three to four weeks post vaccination the patient developed a "quarter size" raised and tender area in the vicinity of the injection site. Unspecified medical attention as sought. On an unspecified date, the patient recovered. Additional information has been requested. This is one of two reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 15 year old female student, with no pertinent medical history, who on 26-JUL-2007 at 3:15 pm, was vaccinated IM in the right deltoid with a second dose of GARDASIL (lot # 658094/0524U). There was no concomitant medication. Several hours after receiving the vaccination, the patient experienced red, raised and itchy rash. The patient sought unspecified medical attention. The patient was encouraged to use BENADRYL for the itching and watch the area. About a week later the patient recovered. It was reported that it may be possible that the patient developed a rash after the initial vaccination but can not be confirmed. The patient's mother recalled the patient had a very mild rash around the time of the first vaccination but could not be certain of the arm or the time frame. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 18 or 19 year old female with sulfonamide allergy who on an unspecified date recently was vaccinated with a first dose of Gardasil (lot # 657868/0523U) deltoid. On an unspecified date 3 to 4 weeks post first dose the patient developed a quarter-size raised and tender area in the vicinity of the injection site after vaccination. Medical attention was sought. At the time of reporting the patient had not recovered.   Follow-up information was received.  On an unspecified date the patients adverse events have resolved.  On an unspecified date the patient had received the second and third dose of HPV 6 11 16 18 VLP vaccine (yeast) without an incident. Additional information is not expected.  This is in follow-up to report(s) previously submitted on 8/14/2007; 1/7/2008. Follow-up information was received. On an unspecified date the patients adverse events have resolved. On an unspecified date the patient had received the second and third dose of GARDASIL without an incident. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil. On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot # unknown) injection. After receiving the second dose the patient developed a rash at the injection site. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. No further adverse event information was given. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site dryness, Injection site pruritus
Clinical narrative: Information has been received from a 21 year old female licensed practical nurse who on 18-JUL-2007 was vaccinated with Gardasil (lot# unknown). On 18-JUL-2007 she developed dry spots and itching around injection site after receiving the Gardasil. Medical attention was not sought. On 23-JUL-2007 she recovered. No other information was reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 04-JUN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot# 657868/0523U). Concomitant therapy included Ortho-Tri-Cyclen and Zyrtec. On 04-JUN-2007 the patient developed an injection site reaction. The physician reported that the injection site was "a 2 centimeter tall and a 2-3 centimeters wide area that was bruised, swollen, and tender to the touch and looked like the pointy end of an egg". There were no laboratory or diagnostic tests performed. No medical attention was sought. On approximately 11-JUN-2007 the patient recovered from the reaction. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown). On 15-JUN-2007 the patient was vaccinated with a second dose of Gardasil (lot # unknown) injection. On 15-JUN-2007 the patient experienced syncope one hour after the second dose. Subsequently, the patient recovered from syncope. Medical attention was sought. On an unspecified date the patient recovered. No additional information was provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with no pertinent medical history who on 17-APR-2007 was vaccinated intramuscularly in the right arm with a pre-filled syringe of Gardasil (655503/0012U). On 18-JUN-2007  the patient was vaccinated with a second dose of Gardasil (Lot #657737/0522U). On approximately, 20-JUN-2007 the patient developed a "small lump bump" on the right arm at the injection site. The patient reported that it was "achy similar to a bruise". It was described as a small moveable bump under the skin at the injection site. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female lactose intolerant with a history of asthma and no previous history of Guillan-Barre Syndrome who on 16-JUL-2007 at 11:30 am was vaccinated with the first dose of Gardasil (lot #654272/0319U), 0.5ml, IM left deltoid of the non-dominant arm (manufacturer unspecified). She planned on switching to NUVARING) on 22-Jul-2007. Her last menstrual period was on 19-Jun-2007. Concomitant medication was reported as none. On 16-JUL-2007 within five minutes of receiving the dose of Gardasil, as the patient was making her way to her next appointment, she felt lightheadness, and faint and she started to fall. She was lowered to the floor by the medical assistant. She did not hit her head or other body part or loose consciousness. Her blood pressure was 133/88 and pulse was 104. She was a bit diaphoretic. She was talking and able to take some water. An ice pack was placed on her forehead. She rested a bit on the floor and was then wheeled into the non stress test room where she rested on the lounge chair. Her blood pressure was rechecked at 117/79 with a pulse of 62. She reported feeling fine after about 5 minutes and was taking water. The injection site was without redness or swelling. She felt ok to leave and upon standing, did not feel dizzy. Blood pressuer was stable and she left the office. She was to stay well hydrated and follow-up in 2 months for the next injection of GARDASIL. On 30-JUL-2007, the patient called to report that she experienced pain in arm that the vaccine was administered and that she can not raise her arm. Left arm was weak and she was having problems raising it all the way. She could raise it to chest height, but not to her head. If she tried to raise it to her head, there was pain. She felt some tingling in her hand at times, but had full use of her hand. It was suggested that she try ADVIL 400-600 mg 3 - 4 times per day for 1 - 2 days to see if she notes any improvement. No product quality complaint was reported. On 24-Aug-2007 the patient reported the arm was better but was still having some residula discmfort with certain movements. She was advised to see her primary care physician for presistant pain after injection. On 24-Aug-2007 the paitnet was "mostly" recovered. . No product quality complaint was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Body temperature increased, Full blood count, Headache, Pain in extremity, Pyrexia
Clinical narrative: Seen @ Local ER.  Temp 101.4 c/o joint pain; No other changes other than had varicella vaccine 2 days prior
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Arthralgia, Body temperature increased
Clinical narrative: Seen @ Local ER.  Temp 101.4 c/o joint pain; No other changes other than had varicella vaccine 2 days prior
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: Pain at injection site, sore deltoid muscle, malaise, fever (100.4F), nausea, upset stomach, headache
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Stomach discomfort, Wrong drug administered
Clinical narrative: Pain at injection site, sore deltoid muscle, malaise, fever (100.4F), nausea, upset stomach, headache
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Adverse event, Flushing, Hypersensitivity
Clinical narrative: 20 minutes post yellow fever vaccination developed flushing with no other sx to indicate it was an allergic reation but an adverse reaction. Pt treated with Benadryl 25mg.