chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 ml Gardasil. In approximately February 2007, the patient developed a flesh-colored, dry, flakey, itchy rash on her face a couple days after administration of Gardasil. The rash resolved in about 5 days. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Myalgia
Clinical narrative: Information has been received from a pediatrician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced muscle aches and hair loss. On 02-MAR-2007, the patient was going to the pediatrician's office for evaluation. the pediatrician reported that the vaccine was administered by the patient's OB/GYN. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia oral
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with an allergy to gluten or wheat who on 02-JAN-2007 was vaccinated intramuscularly with a 0.5 ml (first dose of Gardasil) (lot 654389/0961F). The CMA reported that the patient's tongue felt numb for several days after her first dose of Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old "healthy individual" female who on approximately 23-FEB-2007, was vaccinated with Gardasil first dose. On approximately 23-FEB-2007 (also reported as about a week after Gardasil was administered, the patient experienced swelling and hives in her extremities area. The reporting physician assistant does not treat this patient and did not want to be contacted. The treating physician works in the same office as the reporter but also did not want to contacted as the physician did not feel the events were related. No lab or diagnostic tests were performed. Unspecified medical attention was sought. As of 02-MAR-2007, the patient's swelling and hives in her extremities persisted. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Diarrhoea, Erythema, Full blood count abnormal, Myalgia
Clinical narrative: Information has been received from a physician concerning a 18 year old female with no relevant medical history of illness at the time of vaccination who on 22-FEB-2007 was vaccinated with a first dose of Gardasil in the left deltoid (lot # 655503/0012U). On 24-FEB-2007, the patient complained of myalgias. On 25-Feb 2007, the patient developed diarrhea. On 26-Feb-2007, the patient developed fever of 101F that lasted for several days. On 28-FEB-2007, the patient developed a red, itchy maculopapular rash on the upper body from the waist up. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. The patient was seen by the physician on 01-Mar-2007. The patient's fever resolved on 02-Mar-2007. The patient's rash resolved on 02-Mar-2007. The pateint's rash resolved on 09-Mar-2007. The patient was considered recovered on 10-Mar-2007. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count normal, Pyrexia, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 18 year old female with no relevant medical history of illness at the time of vaccination who on 22-FEB-2007 was vaccinated with a first dose of Gardasil in the left deltoid (lot # 655503/0012U). On 24-FEB-2007, the patient complained of myalgias. On 25-Feb 2007, the patient developed diarrhea. On 26-Feb-2007, the patient developed fever of 101F that lasted for several days. On 28-FEB-2007, the patient developed a red, itchy maculopapular rash on the upper body from the waist up. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. The patient was seen by the physician on 01-Mar-2007. The patient's fever resolved on 02-Mar-2007. The patient's rash resolved on 02-Mar-2007. The pateint's rash resolved on 09-Mar-2007. The patient was considered recovered on 10-Mar-2007. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 18 year old female with no relevant medical history of illness at the time of vaccination who on 22-FEB-2007 was vaccinated with a first dose of Gardasil in the left deltoid (lot # 655503/0012U). On 24-FEB-2007, the patient complained of myalgias. On 25-Feb 2007, the patient developed diarrhea. On 26-Feb-2007, the patient developed fever of 101F that lasted for several days. On 28-FEB-2007, the patient developed a red, itchy maculopapular rash on the upper body from the waist up. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. The patient was seen by the physician on 01-Mar-2007. The patient's fever resolved on 02-Mar-2007. The patient's rash resolved on 02-Mar-2007. The pateint's rash resolved on 09-Mar-2007. The patient was considered recovered on 10-Mar-2007. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nodule on extremity, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated into the left arm with a 0.5mL first dose of Gardasil. Subsequently, on an unspecified date, the patient developed a swollen arm (reported via company representative). The physician also reported that the patient developed a "nodule on the left arm under the skin, "a pouch, which intermittently becomes itchy." (date not reported). At the time of the report, the patient had not recovered. The patient sough unspecified medical attention. Additional information is not available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: This is in follow-up to reports(s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a registered nurse concerning a 22 year old female with allergies to tetracycline, VICODIN and TRAMADOL who on 12-JAN-2007 at 1:45 PM, was vaccinated IM into the left arm with a 0.5 mL first dose of GARDASIL (Lot# 653650/0697F). There was no illness at the time of vaccination. Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA) and ALLEGRA. On 13-JAN-2007 the patient called complaining of a fever that started on the day of the injection at 8:00PM. The fever was about 102 degrees. Subsequently, the patient recovered and there were no other problems reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 20 year old female with pertinent medical history not reported and drug reactions/allergies reported as none who on an unspecified date was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast), 0.5 ml, IM. Concomitant medication was not reported. Approximately on week after vaccination, the patient reported that she experienced shingles. The outcome and causality of the event was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Crying, Dizziness, Fear, Nervousness
Clinical narrative: This is in follow-up to repor (s) previously submitted on 4/6/2007. Information has been received from a physician via a company representative concerning a "very nervous" 17 year old female who on approximately 26, Feb 2007 ("earlier this week") was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On approximately 26, Feb 2007 ("after injection") the patient fainted. The patient sought unspecified medical attention and was reported as recovered (date not specified). Additional information has been requested. In follow-up it was reported by a registered nurse concerning a "very nervous", 17 year old, female, student, with allergy to codine and no illness at the time of vaccination, whose reported weight was 123 pounds who on 26-FEB-2007 was vaccinated intramuscularly (IM) into the left deltoid muscle with a 0.5 ml dose of GARDASIL (Lot # '02634'). It was reported that the patient had a dizzy feeling and then had a fainting episode. the patient did not fal, she was in a chair and her mother caught her. The nurse stepped out to get the patient water because the patient asked for some. The patient "wet pants" and the patient "came around with ammonia". Her pulse and blood pressure were okay. The patient was crying afterwards and scared. The patient was put on a bed "with head up to elevate her head". The tow physicians saw the patient in the office. The patient recovered and was released to her mother. On 27-FEB-2007, a phone call was placed to the patient's home. The patient's mother reported that the patient slept all afternoon and into the night. She ate dinner and had breakfast and went to school. The nurse told the patient's mother to call a or two before the next appointment to get a prescription for VALIUM, 20 mg and instructed to have the patient take the medication 20-30- minutes before the next appointment.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pulse abnormal, Somnolence, Syncope, Urinary incontinence
Clinical narrative: This is in follow-up to repor (s) previously submitted on 4/6/2007. Information has been received from a physician via a company representative concerning a "very nervous" 17 year old female who on approximately 26, Feb 2007 ("earlier this week") was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On approximately 26, Feb 2007 ("after injection") the patient fainted. The patient sought unspecified medical attention and was reported as recovered (date not specified). Additional information has been requested. In follow-up it was reported by a registered nurse concerning a "very nervous", 17 year old, female, student, with allergy to codine and no illness at the time of vaccination, whose reported weight was 123 pounds who on 26-FEB-2007 was vaccinated intramuscularly (IM) into the left deltoid muscle with a 0.5 ml dose of GARDASIL (Lot # '02634'). It was reported that the patient had a dizzy feeling and then had a fainting episode. the patient did not fal, she was in a chair and her mother caught her. The nurse stepped out to get the patient water because the patient asked for some. The patient "wet pants" and the patient "came around with ammonia". Her pulse and blood pressure were okay. The patient was crying afterwards and scared. The patient was put on a bed "with head up to elevate her head". The tow physicians saw the patient in the office. The patient recovered and was released to her mother. On 27-FEB-2007, a phone call was placed to the patient's home. The patient's mother reported that the patient slept all afternoon and into the night. She ate dinner and had breakfast and went to school. The nurse told the patient's mother to call a or two before the next appointment to get a prescription for VALIUM, 20 mg and instructed to have the patient take the medication 20-30- minutes before the next appointment.
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a physician's assistance concerning a female who on 01-MAR-2007 was vaccinated with Gardasil. On 01-MAR-2007, the patient experienced a little blood at injection site when Gardasil was administered. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil. Subsequently the patient experienced bronchospasm and shortness of breath. The patient was noted to be under a lot of stress "lately". Subsequently, the patient recovered from bronchospasm and shortness of breath. Additional has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash, Medication error
Clinical narrative: Information has been received from a 27 year old female with no allergies who had no problem with her first dose of Gardasil. On 27-FEB-2007 the patient received her second dose of Gardasil via injection. Concomitant therapy included "YAZ" (therapy unspecified). On 01-MAR-2007 the patient experienced bumps and itchiness where she received her Gardasil shot. The patient did not seek medical attention. As of 02-MAR-2007 the patient was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female with fibromyalgia, Ehlers-Danlos syndrome, migraine and insomnia and no know drug allergies who on 16, Dec 2006 was vaccinated intramuscularly with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654885/1424F). Concomitant therapy included amitriptyline hydrochloride (AMITRIPTYLIN), ramelteon (ROZEREM), cephalexin (KEFLEX) and fludrocrtisone acetate (FLORINEF). On 18, Dec 2006 (also reported as "several hours after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast)") the patient developed mild hives on her neck. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19, Dec 2006 ("by the next morning") the hives resolved without treatment. No further problems were reported. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning her 16 year old daughter who in September 2006, was vaccinated with the first IM dose of Gardasil. Concomitant therapy included "RPN" inhaler. The LPN reported her daughter had been "growing out of rheumatoid arthritis". Within 24 hours, at 0400 hours, the patient experienced nausea and vomiting that lasted for several days. The patient was then fine. In November 2006 or December 2006, the patient received her second IM dose of Gardasil. Within 24 hours, at 0400 hours, the patient experienced vomiting and nausea that lasted for several days. Subsequently, the patient was fine. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Culture throat, Dermatitis allergic, Pityriasis rosea, Rash, Rash generalised
Clinical narrative: Information has been received from a health professional concerning a female who on 08-FEB-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot # 653938/0954F). Subsequently the patient developed a rash on her arm and part of her face on approximately 22-FEB-2007. The rash spread to the rest of her body. The patient was referred to a Infectious Disease specialist and was diagnosed with allergic dermatitis and pityriasis rosea. Throat culture was negative. The patient was treated with hydroxyzine hydrochloride (Atarax). Subsequently, the rash resolved. Additional information has been requested. It was reported that another female in her school class experienced allergic dermatitis with pityriasis rosea after vaccination with Gardasil (WAES0703USA04287)
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Dizziness
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on 01-MAR-2007 was vaccinated in right deltoid with a first dose of GARDASIL vaccine, lot #656372/0243U. The patient became dizzy after receiving the injection. She also had stomach cramps when she got home (severe). Weakness and the start of menses shortly after the vaccination. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. The patient recovered from stomach cramps and weakness on 01-MAR-2007. The outcome of dizziness was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Paraesthesia, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 21 year old female patient with asthma who on 15-DEC-2006 was vaccinated IM in her right arm with a dose of Gardasil, lot #654389/0961F. Concomitant therapy included hormonal contraceptives (unspecified) and albuterol inhaler (unspecified). The patient has had difficulty lifting her right arm since she was immunized in that arm on 15-DEC-2006. The patient also experienced tingling in her arm, nausea, and vomiting after the injection. The patient was treated with physical therapy. The patient had not recovered as of the report date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Neuropathy
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an  unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified after being administered the first dose of Gardasil, the patient developed neuropathy and was currently seeing a neurologist. The physician was not sure if the neuropathy was caused by Gardasil or not. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Herpes simplex, Herpes virus infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with her second dose of Gardasil. Approximately a week later, the patient developed herpetic appearing lesions located on the perivulva and/or gynecological area. The patient was diagnosed with type 1 herpes simplex. The patient's outcome was known. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a female patient in her early 20's who on an unspecified date was vaccinated with her first dose of Gardasil. Five minutes after receiving the injection, the painted fainted. She was given fruit juice. Her outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Vomiting
Clinical narrative: Information has been received through the pregnancy registry from a registered nurse concerning a female who on 20-FEB-2007 was vaccinated with a first dose of Gardasil while she was pregnant. Subsequently the patient experienced vomiting. The patient was seen in the emergency room and treated with unspecified fluids. On an unspecified date, the patient's alpha-human chorionic gonadotropin level was 221,000. At the time of the report, the patient was 4 months gestation. Additional information has been requested. 07/08/2008 Follow up information was received. The patient delivered a healthy and normal female by vaginal delivery in August 2007. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with seasonal allergy who on 29-AUG-2006 was vaccinated intramuscularly with a first dose of Gardasil. On 06-NOV-2006, the patient was vaccinated intramuscularly with a second dose of Gardasil. It was reported that the patient received the first and second dose without incident. On 15-FEB-2007, the patient was vaccinated intramuscularly with a third dose of Gardasil. Concomitant therapy included Loratadine. On 16-FEB-2007, at midnight, the patient developed nausea and vomiting that lasted until 14:00 and the patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with no previous drug reactions who on 26, Feb 2007, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) first dose. On 26, Feb 2007, the patient fainted after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast). Unspecified medical attention was sought. The patient recovered from fainting the same day the vaccine was received. Additional information has been requested. This is in follow-up to report (s) previously submittedo n 4/6/2007. Initial follow up information has been received. Follow up information indicated that on 28-Feb-2007, the patient fainted (previously mentioned as on 26-Feb-2007) after receiving the first injection. Unspecified medical attention was sought. On 28-Feb-2007 patient recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a pharmacist concerning a 19 year old female with pertinent medical history and drug reactions/allergies reported as none who on 05, Mar 2007 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), ( lot # 653937/0637F). Concomitant medication was reported as none. On 05, Mar 2007, 5 to 10 minutes after receiving the vaccination, the patient fainted. The patient sought unspecified medical attention. The outcome and causality of the event was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in February 2007, was vaccinated with a first dose of Gardasil. The physician reported that the patient developed muscle pain, headache and dizziness after receiving the first dose. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Nausea, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 04, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). ON approximately 11, Jan 2007 the patient experienced dizziness. The patient described her dizziness as a "head rush" associated with a feeling of 'fuzziness" and a sensation that she was spinning. This feeling may be accompanied by nausea with no vomiting. The dizziness was episodic and lasted for minutes to an hour or so. The dizziness was not positional and did not occur at night. The patient was seen by three physicians and underwent magnetic resonance imaging (MRI). All follow-up examinations and MRI were normal. At the time of this report, the patient had not recovered form the dizziness. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 21 year old female with asthma, migraine headaches, and allergies to penicillin and KEFLEX who on 04-JAN-2007 was vaccinated in the left deltoid with a first dose of GARDASIL (lot 653937/0637F). She had no illness at the time of vaccination. On approximately 14-JAN-2007, 10 days post vaccination, the patient experienced dizziness. The patient described her dizziness as a "head rush" associated with a feeling of "fuzziness" like someone was shaking it, and a sensation that she was spinning in relation to the room. This feeling may be accompanied by nausea with no vomiting. The dizziness was episodic and lasted for minutes to an hour or so. The dizziness was not positional and did not occur at night. The dizziness was followed by generalized nausea and discomfort which lasted for the next 1 to 2 hours. Lying down seemed to help the symptoms. The patient was seen by three physicians and underwent MRI. All follow-up examinations and MRI were normal. The patient subsequently recovered on 21-MAY-2007. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bacterial culture negative, Culture negative, Microbiology test, Virus culture negative, Vulval disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with a history of fever of 102.5 degree a week prior to being vaccinated who on 01-MAR-2007 was vaccinated with Gardasil. In March 2007, soon after vaccination with Gardasil, the patient developed labia lesions. The patient was not sexually active. On 05-MAR-2007, the patient was seen for an office visit. The lesions were cultured and sensitivity of the lesions were negative for bacterial, fungal and viral infections. As of 05-MAR-2007, the patient's labia lesions persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Body temperature decreased, Dizziness, Dizziness postural, Headache
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a physician, via a company representative, concerning a female patient, who with no known drug allergies, fibromyalgia, just recently diagnosed, Attention deficit/hyperactivity disorder, and scoliosis and a history of tonsillectomy who on 05-MAR-2007 was vaccinated with the first dose of GARDASIL. The physician reported that after the vaccination, the patient left the office and lost consciousness momentarily, experienced flu like symptoms including nausea, aches and pains and dizziness. " It was unknown if the patient experienced fever. The patient went to the emergency room (ER) at 9:30 pm on 05-MAR-2007, "but was not admitted into the hospital." In follow-up it was reported by the physician concerning a female, patient who on 05-MAR-2007 was vaccinated into the left arm with the first dose of GARDASIL (Lot # 655619/1427F) and concomitantly was vaccinated into the right arm with ADACEL. Concomitant medication included METADATE and "CLOUIDINE". It was reported that on 05-MAY-2007, in the P.M. the night of the vaccination, the patient developed syncope, brief only (lasted 1 minute), followed by sore throat, nausea and headache. The patient was seen in the ER with no work up done. It was reported that the patient recovered from syncope, sore throat, nausea and headache. Medical Records were received on 09-APR-2007 from the physician, it was reported that the patient with no infectious disease or risk factors, last menstrual period 4 weeks ago, approximately 05-FEB-2007, it was reported that the patient went to the ER, and presented with a sore throat, nausea and headache and an abnormal cramp tonight. She denied dizziness. The patient reported that she had received an injection today. It was reported that the presenting problem started hours ago. The patient reported having a syncope episode lasting for approximately 1 minute. The symptoms developed immediately after the patient stood up. She felt weak and lightheaded just prior to this episode. The patient had never had any previous episode of this type. The patient presented with generalized weakness, complained of dizziness. The patient reported orthostatic dizziness. The onset of the patient's symptoms was about 1 hour ago. Orthostatic vital signs were reported, supine, 98/55 mmHg, standing, 98/66 mmHg, abnormal temperature noted at discharge 96.9 degrees Fahrenheit. It was arranged for the patient to be discharged from the ER to home with the plan for the patient to have a follow-up appointment with her physician. Additional information has been requested. All available medical records will be provided upon request.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Influenza like illness, Loss of consciousness, Muscle spasms, Nausea, Oropharyngeal pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a physician, via a company representative, concerning a female patient, who with no known drug allergies, fibromyalgia, just recently diagnosed, Attention deficit/hyperactivity disorder, and scoliosis and a history of tonsillectomy who on 05-MAR-2007 was vaccinated with the first dose of GARDASIL. The physician reported that after the vaccination, the patient left the office and lost consciousness momentarily, experienced flu like symptoms including nausea, aches and pains and dizziness. " It was unknown if the patient experienced fever. The patient went to the emergency room (ER) at 9:30 pm on 05-MAR-2007, "but was not admitted into the hospital." In follow-up it was reported by the physician concerning a female, patient who on 05-MAR-2007 was vaccinated into the left arm with the first dose of GARDASIL (Lot # 655619/1427F) and concomitantly was vaccinated into the right arm with ADACEL. Concomitant medication included METADATE and "CLOUIDINE". It was reported that on 05-MAY-2007, in the P.M. the night of the vaccination, the patient developed syncope, brief only (lasted 1 minute), followed by sore throat, nausea and headache. The patient was seen in the ER with no work up done. It was reported that the patient recovered from syncope, sore throat, nausea and headache. Medical Records were received on 09-APR-2007 from the physician, it was reported that the patient with no infectious disease or risk factors, last menstrual period 4 weeks ago, approximately 05-FEB-2007, it was reported that the patient went to the ER, and presented with a sore throat, nausea and headache and an abnormal cramp tonight. She denied dizziness. The patient reported that she had received an injection today. It was reported that the presenting problem started hours ago. The patient reported having a syncope episode lasting for approximately 1 minute. The symptoms developed immediately after the patient stood up. She felt weak and lightheaded just prior to this episode. The patient had never had any previous episode of this type. The patient presented with generalized weakness, complained of dizziness. The patient reported orthostatic dizziness. The onset of the patient's symptoms was about 1 hour ago. Orthostatic vital signs were reported, supine, 98/55 mmHg, standing, 98/66 mmHg, abnormal temperature noted at discharge 96.9 degrees Fahrenheit. It was arranged for the patient to be discharged from the ER to home with the plan for the patient to have a follow-up appointment with her physician. Additional information has been requested. All available medical records will be provided upon request.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pain, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a physician, via a company representative, concerning a female patient, who with no known drug allergies, fibromyalgia, just recently diagnosed, Attention deficit/hyperactivity disorder, and scoliosis and a history of tonsillectomy who on 05-MAR-2007 was vaccinated with the first dose of GARDASIL. The physician reported that after the vaccination, the patient left the office and lost consciousness momentarily, experienced flu like symptoms including nausea, aches and pains and dizziness. " It was unknown if the patient experienced fever. The patient went to the emergency room (ER) at 9:30 pm on 05-MAR-2007, "but was not admitted into the hospital." In follow-up it was reported by the physician concerning a female, patient who on 05-MAR-2007 was vaccinated into the left arm with the first dose of GARDASIL (Lot # 655619/1427F) and concomitantly was vaccinated into the right arm with ADACEL. Concomitant medication included METADATE and "CLOUIDINE". It was reported that on 05-MAY-2007, in the P.M. the night of the vaccination, the patient developed syncope, brief only (lasted 1 minute), followed by sore throat, nausea and headache. The patient was seen in the ER with no work up done. It was reported that the patient recovered from syncope, sore throat, nausea and headache. Medical Records were received on 09-APR-2007 from the physician, it was reported that the patient with no infectious disease or risk factors, last menstrual period 4 weeks ago, approximately 05-FEB-2007, it was reported that the patient went to the ER, and presented with a sore throat, nausea and headache and an abnormal cramp tonight. She denied dizziness. The patient reported that she had received an injection today. It was reported that the presenting problem started hours ago. The patient reported having a syncope episode lasting for approximately 1 minute. The symptoms developed immediately after the patient stood up. She felt weak and lightheaded just prior to this episode. The patient had never had any previous episode of this type. The patient presented with generalized weakness, complained of dizziness. The patient reported orthostatic dizziness. The onset of the patient's symptoms was about 1 hour ago. Orthostatic vital signs were reported, supine, 98/55 mmHg, standing, 98/66 mmHg, abnormal temperature noted at discharge 96.9 degrees Fahrenheit. It was arranged for the patient to be discharged from the ER to home with the plan for the patient to have a follow-up appointment with her physician. Additional information has been requested. All available medical records will be provided upon request.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). On 19-FEB-2007 the patient the received vaccine in the bottom. No further information is available.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Menstrual disorder
Clinical narrative: Information has been received from a 36 female with no pertinent medical history who on 02-JAN-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. On 17-JAN-2007 the patient's "period started a week early" and has remained on that schedule. The patient did not seek medical attention. She reported that she would be a few days to a week late receiving her second vaccination of Gardasil because the physician's office was out of stock and had to order more. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female smoker (1/2 pack per day) with genital warts who on 02, Mar 2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654510/0962F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). On 02, Mar 2007, the patient experienced chest pain several hours post vaccination. The character and location of the chest pain was unknown. On 04, Mar 2007, the patient recovered from chest pain without medical attention on treatment. No further problem reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 64 year old male who on 06-MAR-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil instead of Zostavax. It was reported that there was no product confusion and that is was a medication error. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an  unspecified date was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant medication was not reported. Subsequently on an unspecified date, the patient did not come in for her 2nd dose of Gardasil on time and the vaccination was given after 2 months. No adverse experiences were noted. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Eye irritation, Vision blurred
Clinical narrative: Information has been received from a medical assistant concerning a female nurse splashed Gardasil in her eyes. Subsequently, the nurse's eyes were blurry and burning (patient outcome not reported). The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain
Clinical narrative: Information has been received from a physician concerning a female who in December 2006 , was vaccinated with Gardasil 0.5 mL, injection.  In December 2006, the patient experienced muscle aches all over, especially in the legs and arms. The patient's muscle aches all over, especially in the legs and arms persisted for 3 months. The patient sought unspecified medical attention. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Neck mass, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on 30, Jan 2007, was vaccinated with GARDASIL. Subsequently, the patient developed a large lump on her neck and swelling to her thigh at injection site after immunization with GARDASIL. Unspecified medical attention was sought. As of 03, Mar 2007, the patient's large lump on her neck and swelling to her thigh at injection site persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007.  Initial and follow up information has been received from a physician, concerning a 37 year old female patient, who at 1:30pm on 01-FEB-2007 (previously reported as 30-JAN-2007) was vaccinated in the left deltoid (previously reported as the thigh) with the second dose of GARDASIL vaccine (Lot #655617/1447F). On approximately 01-MAR-2007 ("onset at one month"), the patient developed a large lump on her neck and complained of pain in her neck and left arm (previously reported as swelling on the thigh). On 06-MAR-2007, the patient revisited the office, still complaining of pain, and was diagnosed with neck and left arm pain. The physician confirmed that the patient had recovered from the events on 10-MAR-2007. No further information is expected.
Age: 16.0
Sex: F
Vaccine: DTOX, HEPA, HPV4, TTOX
Symptoms: Erythema, Eye swelling, Pruritus
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/6/2007. Information has been received from a registered nurse concerning a 16 year old female with no pertinent medical history and no previous reactions who on 26, Feb 2007, at 3:15 p.m. was vaccinated with HPV rL1 06 11 16 18 VLP vaccine (yeast) first dose. Concomitant therapy included hepatitis A vaccine (inactive) (manufacturer unknown), diphtheria toxoid and tetanus toxoid all administered on the same day (26, Feb 2007). The nurse did not know if the vaccines were administered in the same arm as HPV rL1 6 11 16 18 VLP vaccine. On 26, Feb 2007, the patient developed swelling around both eyes and her face became red and itchy. The patient did not have a fever or any other symptoms. Unspecified medical attention was sought. On 04 Mar 2007, one week later, the patient recovered from swelling around both eyes and red and itchy face. Additional information has been requested. In follow-up it was reported that the patient came into the clinic, one week after the GARDASIL was given. She complained of swelling around both eyes, face itching and red. The patient denied any trouble breathing or trouble swallowing. The swelling and itching starte the day the vaccine was given, on 26-FEB-2007. When the client came into the clinic there was no swelling and no redness on exam. The patient was advised by the physician not to get the second dose of GARDASIL. It was reported that the patient recovered 1 week later. In follow-up the nurse reported that after the patient received her first dose of GARDASIL she developed swelling around both of her eyes and her face became red and itchy. The patient did not have a fever or any other symptoms. That same day, she was vaccinated with VAQTA (inactive) (manufacturer unknown), diphteria toxiod and tetanus toxoid. The nurse did not know if the vaccines were administered in the same arm. No further information is available. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 26-FEB-2007 was vaccinated with the first IM dose of 0.5 ml of Gardasil (lot # 655849/0263). There was no concomitant medication. Later in the day, on 26-FEB-2007 the patient experienced soreness at the injection site. On 27-FEB-2007 the patient developed arm redness and swelling from injection site to fingertips. There was no itching. The patient also experienced dizziness and headache throughout the day (frequency and duration unknown). The patient took ibuprofen on 28-FEB-2007 for the swelling. The swelling and redness subsided the morning of 01-MAR-2007. The patient was still reporting pain at the injection site and no swelling or redness on 05-MAR-2007. The patient was recovering from dizziness and headache. The patient had not been examined at the office since the vaccination. No lab testing was performed. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 26-FEB-2007 was vaccinated with the first IM dose of 0.5 ml of Gardasil (lot # 655849/0263). There was no concomitant medication. Later in the day, on 26-FEB-2007 the patient experienced soreness at the injection site. On 27-FEB-2007 the patient developed arm redness and swelling from injection site to fingertips. There was no itching. The patient also experienced dizziness and headache throughout the day (frequency and duration unknown). The patient took ibuprofen on 28-FEB-2007 for the swelling. The swelling and redness subsided the morning of 01-MAR-2007. The patient was still reporting pain at the injection site and no swelling or redness on 05-MAR-2007. The patient was recovering from dizziness and headache. The patient had not been examined at the office since the vaccination. No lab testing was performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Erythema, Hypoaesthesia, Myalgia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Ten days after HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered, the patient developed numb fingers and hands, fingers turned red and blue, muscle aches, rash and dizziness. Unspecified medical attention was sought. As  of 06, Mar 2007, the patient's numb fingers and hands and fingers turned red and blue, muscle, aches, rash and dizziness persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Ten days after HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered, the patient developed numb fingers and hands, fingers turned red and blue, muscle aches, rash and dizziness. Unspecified medical attention was sought. As  of 06, Mar 2007, the patient's numb fingers and hands and fingers turned red and blue, muscle, aches, rash and dizziness persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Gaze palsy, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who on 15, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 655619/1427F). Concomitant suspect vaccination included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) and a dose of meningoxoccal ACYW conj vaccine (dip toxoid) (MENACTRA). On 15, Jan 2007, within 2 minutes after her vaccinations. the patient became pale and fainted. The nurse also reported that while unconscious, the patient had jerking motions which lasted a couple of seconds. The patient was reported to have rested in the office for 15 minutes and then went home recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/6/2007. On 07-May-2007 follow-up information was received from a registered nurse who indicated that the patient, after immediately receiving the vaccine, became lightheaded and appeared to faint. Her eyes rolled back and she became pale with twitching and jerking motions of the upper extremities which lasted for less than 5 seconds. The patient spontaneously recovered after lying down. No further information was provided.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who on 15, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 655619/1427F). Concomitant suspect vaccination included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) and a dose of meningoxoccal ACYW conj vaccine (dip toxoid) (MENACTRA). On 15, Jan 2007, within 2 minutes after her vaccinations. the patient became pale and fainted. The nurse also reported that while unconscious, the patient had jerking motions which lasted a couple of seconds. The patient was reported to have rested in the office for 15 minutes and then went home recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/6/2007. On 07-May-2007 follow-up information was received from a registered nurse who indicated that the patient, after immediately receiving the vaccine, became lightheaded and appeared to faint. Her eyes rolled back and she became pale with twitching and jerking motions of the upper extremities which lasted for less than 5 seconds. The patient spontaneously recovered after lying down. No further information was provided.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 20 year old female patient, who on 03-JAN-2007 was vaccinated with the first dose, 0.5 ml, IM, of Gardasil (Lot # 654389/0961F). There was no concomitant medication. On approximately 23-FEB-2007, the patient developed "hives that started approximately 1 week before her appointment for the second dose (02-MAR-2007). The nurse added that the patient's "primary physician gave her an analgesic" (name unknown). The nurse stated that the patient"still had the hives when she came to the office" for her appointment and reported "the hives were mostly on both arms." The patient "received the second dose" of Gardasil on 02-MAR-2007. Additional information has been requested.