chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Lymphocyte count normal, Myalgia, Nausea
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter, who was vaccinated with the first dose of GARDASIL vaccine (date unspecified), and on 13-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. The consumer reported her daughter experienced "pain at the injection site" after the first vaccination. The patient's mother reported that on 21-MAR-2007, eight days after the second vaccination was administered, her daughter experienced a headache, neck pain, nausea and throat pain, and on approximately 22-MAR-2007, she felt "like her throat is closing up." On 22-MAR-2007 ("this morning"), her daughter felt worse when she woke up and was rushed to the emergency room. At the time of the report, the patient had not recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up received from a physician included medical records received from the ER, and indicated that the patient was a college student, with no illness at the time of vaccination. The medical records confirmed concomitant vaccination with inlfuenza virus vaccine (unspecified) and meningococcal vaccine (unspecified), dates not specified (not confirmed by the physician). The ER medical records also indicated that on 22-MAR-2007, the patient presented with symptoms of headache (documented as at the base of the skull), and neck pain, with an original onset date of 21-MAR-2007 (also reported by the physician in follow up, an onset date of 22-MAR-2007). Other symptoms included "body aches," fever, chills, dizziness, weakness, and nausea (without vomiting). Vital signs in the ER included: blood pressure 110/70, pulse 100, respirations 20, and temperature 100.2F. The records documented that "airway/breathing" was within normal limits. Treatment included normal saline (intravenous), phenergan 12.5mg (intravenous), and TYLENOL. A complete blood count revealed the following: neutrophils 86.6%, lymphocytes 9.2%, and neutrophil count 9.3 (units not provided). The clinical impressionof the ER physician was noted as "acute febrile illness." The medical records documented that the patient "felt better" after treatment, and was discharged to home in "stable" condition on 22-MAR-2007. Vital signs at discharge were: BP 115/75, pulse 95, respirations 30, and temperature 99F, discharge instructions included acetaminophen or ibuprofen every 8 hours, and remain off of work/school for the next 2 days. At the time of this report, the physician confirmed that the patient had recovered from the events (date not specified). The follow up information (medical records) received on 09-APR-2007 also contained the following adverse expereinces: potassium low, 3.3 mmol/L (22-MAR-2007); sodium low, 132 mmol/L (22-MAR-2007); osmolality low, 272 mOsmol/kg (22-MAR-2007). No further informationis expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Neutrophil count normal, Pharyngolaryngeal pain, Pyrexia, Throat tightness
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter, who was vaccinated with the first dose of GARDASIL vaccine (date unspecified), and on 13-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. The consumer reported her daughter experienced "pain at the injection site" after the first vaccination. The patient's mother reported that on 21-MAR-2007, eight days after the second vaccination was administered, her daughter experienced a headache, neck pain, nausea and throat pain, and on approximately 22-MAR-2007, she felt "like her throat is closing up." On 22-MAR-2007 ("this morning"), her daughter felt worse when she woke up and was rushed to the emergency room. At the time of the report, the patient had not recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up received from a physician included medical records received from the ER, and indicated that the patient was a college student, with no illness at the time of vaccination. The medical records confirmed concomitant vaccination with inlfuenza virus vaccine (unspecified) and meningococcal vaccine (unspecified), dates not specified (not confirmed by the physician). The ER medical records also indicated that on 22-MAR-2007, the patient presented with symptoms of headache (documented as at the base of the skull), and neck pain, with an original onset date of 21-MAR-2007 (also reported by the physician in follow up, an onset date of 22-MAR-2007). Other symptoms included "body aches," fever, chills, dizziness, weakness, and nausea (without vomiting). Vital signs in the ER included: blood pressure 110/70, pulse 100, respirations 20, and temperature 100.2F. The records documented that "airway/breathing" was within normal limits. Treatment included normal saline (intravenous), phenergan 12.5mg (intravenous), and TYLENOL. A complete blood count revealed the following: neutrophils 86.6%, lymphocytes 9.2%, and neutrophil count 9.3 (units not provided). The clinical impressionof the ER physician was noted as "acute febrile illness." The medical records documented that the patient "felt better" after treatment, and was discharged to home in "stable" condition on 22-MAR-2007. Vital signs at discharge were: BP 115/75, pulse 95, respirations 30, and temperature 99F, discharge instructions included acetaminophen or ibuprofen every 8 hours, and remain off of work/school for the next 2 days. At the time of this report, the physician confirmed that the patient had recovered from the events (date not specified). The follow up information (medical records) received on 09-APR-2007 also contained the following adverse expereinces: potassium low, 3.3 mmol/L (22-MAR-2007); sodium low, 132 mmol/L (22-MAR-2007); osmolality low, 272 mOsmol/kg (22-MAR-2007). No further informationis expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site mass, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who was vaccinated in the right arm with a second dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient developed a "knot the size of a baseball at the injection site" with numbness and tingling down the whole arm below her elbow, and felt like blood was rushing to her fingers. The physician stated the patient would be seen at the office on 22-MAR-2007. At the time of the report, the patient had not recovered.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner (N. P.) concerning a 23 year old female patient who on 19-MAR-2007 was vaccinated with a first dose of Gardasil (yeast). About two hours later the patient developed itchiness. On the morning of 20-MAR-2007 the patient broke out in hives about the size of a half dollar and they were  painful. The NP reported that they treated the patient with a methylprednisolone (MEDROL DOS-PACK) and sterile triamcinolone acetonide (KENOLOG-40) high dose steroid. The patient was improving , but they will not continue the Gardasil vaccination series for the patient. Patient to be followed up. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a Nurse Practitioner and Medical Assistant concerning a 23 year old female with allergies to penicillin and OMNICEF for which she carried an epinephrine pen; who on 19-MAR-2007 at 12:30 pmwas vaccinated with a first dose of GARDASIL IM in right deltoid (lot# 656049/0187U). She had no illness at the time of the vaccination. On 19-MAR-2007, about 2 hours post-vaccination, the patient experienced itchiness. On 20-MAR-2007 at 03:00 (AM or PM not specified) the patient broke out in painful, itchy hives about the size of a half dollar. The hives were all over her body, and were worse around the hairline and joints. The reporter stated that they treated the patient with small dose of methylprednisolone at first then high dose taper, IM sterile KENOLOG-40 high dose steroid and for itching ATARAX. The NP reported that they will not continue with the GARDASIL vaccination series for the patient. Follow up report indicated that on 27-MAR-2007 the patient completely recovered. No additional information is expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hot flush, Immediate post-injection reaction, Injected limb mobility decreased, Lacrimation increased
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female student who on 02-MAR-2007 at 11:50AM, was vaccinated IM into the left deltoid with a first dose of Gardasil (Lot# 654389/0961F). There was no illness at the time of vaccination. On 02-MAR-2007, immediately post injection, the patient experienced acute pain bringing her to tears. The patient complained of hot flash surrounding her face, lightheadedness and stiff arm with difficulty raising her arm due to pain. The nurse indicated that the symptoms subsided in five minutes except the pain continued. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female student who on 02-MAR-2007 at 11:50AM, was vaccinated IM into the left deltoid with a first dose of Gardasil (Lot# 654389/0961F). There was no illness at the time of vaccination. On 02-MAR-2007, immediately post injection, the patient experienced acute pain bringing her to tears. The patient complained of hot flash surrounding her face, lightheadedness and stiff arm with difficulty raising her arm due to pain. The nurse indicated that the symptoms subsided in five minutes except the pain continued. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on 22-MAR-2007 was vaccinated with a dose, 0.5ml, of Gardasil. The physician reported that on 22-MAR-2007, after the vaccination was administered, the patient "experienced dizziness and almost passed out." At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Peripheral coldness
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently one hour after the patient received Gardasil, the patient's hand and arms were cold. Subsequently on an unspecified date, the patient recovered from hands and arms were cold. The causality of the event was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a 17 or 18 year old female who was vaccinated with Gardasil. Subsequently, the patient experienced delayed menstrual cycle after receiving Gardasil. The physician advised the patient to contact her after one month if she still did not have a menstrual cycle. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a dose of Gardasil at another practice. The patient developed an outbreak of genital warts after receiving the Gardasil. The time frame was unknown between the vaccination and the outbreaks. Unspecified medical attention was sought. The patient's outcome was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Petechiae
Clinical narrative: Information has been received from a physician concerning a female who was under 18 years old who on 20-MAR-2007 was vaccinated IM with her second dose of Gardasil. On 20-MAR-2007, within 12 hours after vaccination the patient experienced joint achiness. On 22-MAR-2007, the patient sought medical attention and the Nurse practitioner reported that the patient experienced "petikia" on her face and a red bump on the white of her one eye. Nurse Practitioner reported that the patient had no reaction to her 1st dose of Gardasil, but they are not planning to vaccinate the patient with the 3rd dose at this time. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Information has been received from a registered nurse (school nurse), via a company representative, concerning a 7th grade female student, who was vaccinated, IM (date not specified), with the first dose of Gardasil. The next day ("within 24 hours"), the student developed a fever, headache and dizziness, and had to stay home from school. The school nurse reported that the following day, the "symptoms went away" and the the student returned to school. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose, Drug administered at inappropriate site, Pallor, Syncope
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 20 year old female with a history of an abnormal papanicolaou smear, who on 19-MAR-2007 was vaccinated, iM in the buttocks, with the second dose of Gardasil. There was no concomitant medication. The nurse reported that on 19-MAR-2007, a few minutes after the vaccination, the patient "turned pale and fainted for a few seconds." The nurse reported the patient's blood sugar was 110 (units not specified). Subsequently, the patient recovered on the same day. additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with a first dose of Gardasil. The patient developed sting at injection site. Unspecified medical attention was sought. The patient was recovering as of the report date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 15 year old female patient who was vaccinated IM in the gluteus with a first dose of Gardasil in another practice. On 12-FEB-2007, she was vaccinated IM in the gluteus with a second dose of Gardasil, lot #653978/0955F. Concomitant therapy included Ortho-Tri-Cyclen Lo. Within minutes of the vaccination, the patient developed dizziness, blurred vision and severe headache. The patient visited the emergency room and was diagnosed with migraines. The patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient who on approximately 21-MAR-2007 ("two days ago") was vaccinated with a dose , 0.5ml, of Gardasil vaccine (yeast). Concomitant vaccine administered included tuberculin purified protein derivative. On approximately 21-MAR-2007 the patient "had a reaction after receiving Gardasil (yeast), "described as "a tiny rash on both of her arms." Treatment included diphenhydramine HCl (BENADRYL). The nurse practitioner indicated that the patient was recovering from the rash. At the time of this report, the outcome was uinknown. The NP indicated feeling unsure if the rash was related to GARDASIL. Additional information has been requested.  No further information is expected.
Age: 15.0
Sex: F
Vaccine: DTAP, HPV4, UNK
Symptoms: Dizziness, Wrong drug administered
Clinical narrative: Information has been received from a physician, concerning a 15 year old female patient, who on 22-MAR-2007 was vaccinated with the first dose of Gardasil. Concomitant vaccine administration included DTaP (manufacturer unspecified) and a third vaccine [therapy unspecified]. On approximately 22-MAR-2007 the patient experienced dizziness. At the time of this report, the patient's dizziness persisted. 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 medical assistant concerning a female who was vaccinated with the first dose of Gardasil. Subsequently, the patient fainted on the exam table after vaccination. The patient will discontinue further series of the vaccine. Patient outcome was unknown. Additional information has been requested. It was reported that another female fainted after Gardasil vaccination (WAES0703USA03189).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated IM, first dose, with Gardasil vaccine (yeast). Subsequently the patient experienced itching both arms after receiving the vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Induration
Clinical narrative: Information has been received from a nurse practitioner and two registered nurses, concerning a female patient in her late teens, who was vaccinated (date not specified) with the second dose of Gardasil. Subsequently the patient experienced induration and erythema, associated with the second dose. The reporters indicated they believed the induration and erythema lasted "a couple of days." Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Hypoaesthesia, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female with reactive airways disease and penicillin allergy who on 21-MAR-2007 was vaccinated IM with a 0.5mL first dose of Gardasil vaccine (yeast) (lot#654540/0800F). Concomitant therapy included "multiple psychiatric medications." On 26-MAR-2007 the patient experienced numbness in fingertips that gradually spread up both arms and to her legs, pruritus and "funny feeling" in extremities. The patient sought medical attention at the emergency room and no laboratory tests were performed. The patient's numbness in fingertips, both arms and legs and pruritus and "funny feeling" in extremities persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. The patient sought medical attention at the emergency room and no laboratory tests were performed. It was confirmed the patient does not have a rash or any other symptoms. It was reported that the patient had adjustment of her psychiatric medications just prior to getting GARDASIL. The patient was seen by psychiatry and her symptoms resolved when dosage were readjusted. The patient's symptoms were felt to be secondary to medications. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Eczema
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a nurse concerning her daughter (age not reported) who on an unspecified date was vaccinated IM with a 0.5 mL first dose of Gardasil. Subsequently the patient experienced eczema on both arms. The patient sought unspecified medical attention. The patient's physician believed that the eczema may have been due to the high aluminum content in the vaccine. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with a history of adhesive tape allergy and elastoplast allergy who on 03-JAN-2007 was vaccinated IM with her first dose of Gardasil (Lot#654450/1162F). There was no concomitant medication. On 04-JAN-2007 the patient experienced peeling skin on the pale side of her fingers on both hands. The patient did seek unspecified medical attention. There were no laboratory diagnostics performed. Subsequently, the patient recovered in about 1 week from peeling skin on the palm side of her fingers on both hands. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Mydriasis
Clinical narrative: Information has been received from a 21 year old female with a history of penicillin allergy who on 26-MAR-2007 was vaccinated IM with her second dose of Gardasil vaccine (yeast). Concomitant therapy included NUVARING. On 26-MAR-2007 the patient experienced "a dilated right pupil" after receiving her second dosage. The patient used Visine to treat her eye. The patient's dilated right pupil persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old female patient who was vaccinated (date not specified) with a dose of Gardasil. Right after the shot was administered, the patient experienced "more than moderate itching" at the injection site. At the time of this report, the physician reported that the patient was recovering. The patient sought unspecified medical attention. The patient's two sisters also experienced the event as described above after vaccination with Gardasil (WAES 0703USA05417, 0703USA05418). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Vulval disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who on 05-FEB-2007 was vaccinated with a first dose of Gardasil (lot# 655618/1427F). On 26-FEB-2007 the patient experienced three separate "vulvar-type blisters" which were "slightly raised" with a white, plaque-like surface. The patient was re-examined on 12-Mar-2007, and the above lesions had completely resolved. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a registered nurse concerning several young girls with allergies or medical history who "several months ago" were vaccinated IM with a 0.5 ml dose of GARDASIL. There were no illnesses at the time of vaccination. Subsequently, "several young girls passed out or were nauseated and lightheaded" after receiving vaccine. It was also reported that some patients' passed out and laid down to receive the second and third doses from this experience. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On an unspecified date, the patients' recovered. No product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a Certified Medical Assistant for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus who on 11-JAN-2007 was vaccinated IM with her first dose of Gardasil, lot#655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of Gardasil. The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Additional information has been requested. Follow-up information received 4/16/08 from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 10/23/07. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Medications used during the pregnancy were prental vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 05/31/07 and 10/21/07 which were normal. A maternal serum alpha-fetoprotein screening (MSAFP) was performed on 05/31/2007 which was within normal limits. 07/08/2008 Initial and follow up information has been received from a Certified nurse manager for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus and a heart murmur and a history of gallbladder removal and 0 pregnancies who on 11-JAN-2007 was vaccinated IM with her first dose of GARDASIL, lot #655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of GARDASIL. Her LMP was 17-JAN-2007 (estimated date of delivery 24-OCT-2007). The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Follow-up information received from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 23-Oct-2007. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Her apgar score was 8/9. Medications used during pregnancy were prenatal vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 31-May-2007 and 21-Oct-2007 which were normal. A maternal serum alpha-fetoprotein screening was performed on 31-May-2007 which was within normal limits.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a Certified Medical Assistant for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus who on 11-JAN-2007 was vaccinated IM with her first dose of Gardasil, lot#655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of Gardasil. The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Additional information has been requested. Follow-up information received 4/16/08 from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 10/23/07. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Medications used during the pregnancy were prental vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 05/31/07 and 10/21/07 which were normal. A maternal serum alpha-fetoprotein screening (MSAFP) was performed on 05/31/2007 which was within normal limits. 07/08/2008 Initial and follow up information has been received from a Certified nurse manager for the pregnancy registry for GARDASIL concerning a 16 year old female patient with human papilloma virus and a heart murmur and a history of gallbladder removal and 0 pregnancies who on 11-JAN-2007 was vaccinated IM with her first dose of GARDASIL, lot #655619/1427F. On 16-MAR-2007 the patient, who was 9 weeks pregnant (positive pregnancy test) received her 2nd dose of GARDASIL. Her LMP was 17-JAN-2007 (estimated date of delivery 24-OCT-2007). The patient reported vaginal spotting during this pregnancy. Her outcome was unknown. Follow-up information received from the Certified nurse manager indicated that the now 17 year old patient delivered the baby on 23-Oct-2007. The baby was a female weighing 7 lbs and 14 oz and length was 20 1/2 inches. Her apgar score was 8/9. Medications used during pregnancy were prenatal vitamins once daily and iron (unspecified) 325 mg twice daily for anemia. Laboratory diagnostic tests included ultrasounds on 31-May-2007 and 21-Oct-2007 which were normal. A maternal serum alpha-fetoprotein screening was performed on 31-May-2007 which was within normal limits.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Viral infection
Clinical narrative: Information has been received from a nurse practitioner, concerning a female patient, who on 17-FEB-2007 was vaccinated with the first dose of Gardasil and on 27-MAR-2007 was vaccinated with the second dose of Gardasil. The nurse practitioner stated that the patient was not able to get her second dose on 17-MAR-2007 because she developed Bell's palsy (date not specified). The reporter stated that Bell's palsy was not related to therapy with Gardasil. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to reports previously submitted on 4/13/2007. Initial and follow up information has been received from a nurse practitioner, concerning a 21 year old female stundent, who on 17-JAN-2007 previously reported as 17-FEB2-2007 was vaccinated IM in the left deltoid, with the first dose of GARDASIL (Lot #655619/1427F). Following the vaccination, the patient had a "recent viral infection" (date unspecified), that was followed on 17-MAR-2007, with the development of bells palsy. The primary care physician was consulted, and approved for the patient to receive her second dose of the vaccine although she had bell's palsy. The NP clarified that on 21-MAR-2007 at 1:00pm (previously reported as 27-MAR-2007, the patient was vaccinated IM in the left deltoid, with the second dose of GARDASIL (Lot #656050/0245U). The reporter stated that Bell's palsy. was not related to therapy with GARDASIL. At the time of this report, it was unknown if the patient had recovered from the viral infection or the Bell's palsy. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning a female patient, who was vaccinated in her deltoid muscle with the second dose, 0.5ml, of Gardasil (date unspecified). The NP stated that "immediately after the administration of the vaccine," the patient developed swelling in an "adjacent part of the injection site." The NP confirmed that the patient did not have a reaction following her first dose of Gardasil (date unspecified). At the time of the report, the NP stated the patient was recovering from the event. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up reports previously submitted on 4/13/2007. Information has been received from a nurse practioner, concerning a female patient, who was vaccinated with a dose 0.5ml of PNEUMOVAX 23 (previously reported by the company representive as swelling at the injection site from GARDASIL. The NP reported that the patient had a severe reaction to the PNEUMOVAX 23 (details not specified). It was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant, concerning a 24 year old white female receptionist, who on 16-MAR-2007 was vaccinated at 4:30pm, IM in the right arm, with the first dose of Gardasil. On 19-MAR-2007, at 9:00am, the patient developed swelling under the injection site. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a certified medical assistant, concerning a 24 year old female, who on 16-MAR-2007 was vaccinated at 4:30pm, IM in the right arm, with the first dose of GARDASIL. On 19-MAR-2007, at 9:00am, the patient developed swelling under the injection site. The CMA confirmed that the patient was recovered on 23-MAR-2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose with Gardasil. Subsequently the patient experienced joint pain and ache. Additional information has been requested.  This is in follow-up to report (s) preveiously submittedon 4/13/2007. Initial and follow-up information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL vaccine. Subsequently the patient experienced joint pain and ache. It was undecided whether the patient would receive the second vaccination. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a consumer concerning her 14 year old female with penicillin allergy who on 27-MAR-2007 was vaccinated with 0.5 mL of Gardasil. On 27-MAR-2007 the patient experienced severe stomach pain. The patient's severe stomach pain persisted. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat positive, Dysphagia, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Initial and follow up information has been received from a 25 year old female patient with hypothyroidism and penicillin allergy who at the end of February 2007, was vaccinated with her first dose of GARDASIL vaccine. Concomitant therapy included thyroid medication. At the end of February 2007, the patient experienced severe injection site pain immediately. Within a few days the patient had a severe headache, difficulty swallowing, general body aches, very weak muscles and slight fever. The patient sough medical attention. Laboratory diagnostics performed was a throat culture which was positive for strep. She took TYLENOL, ADVIL and antimicrobial (unspecified). The patient's severe injection site pain and severe headache and difficulty swallowing and general body aches and very weak muscles and slight fever persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Immediately after the injection, the patient experienced severe injection site pain. later that night, the pain kept her awake. She took TYLENOL and ADVIL for the pain and fever. She saw her physician and a throat swab was performed which was positive for strep. She was treated fo r strep throat with an unspecified antibiotic. The patient's menstrual cycle was 4 days delayer with no possibility of pregnancy. She reports that in the past when taking unspecified antibiotics her cycle was delayer by a few days. The patient was improving. The patient subsequently called back inquiring whether or not she should receive the second dose of GARDASIL vaccine. Her first dose had been administered at the end of February and as of 29-MAY2007 she had not yet received the second dose. Additional information has been reuested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Pain, Poor quality sleep, Pyrexia, Streptococcal infection
Clinical narrative: Initial and follow up information has been received from a 25 year old female patient with hypothyroidism and penicillin allergy who at the end of February 2007, was vaccinated with her first dose of GARDASIL vaccine. Concomitant therapy included thyroid medication. At the end of February 2007, the patient experienced severe injection site pain immediately. Within a few days the patient had a severe headache, difficulty swallowing, general body aches, very weak muscles and slight fever. The patient sough medical attention. Laboratory diagnostics performed was a throat culture which was positive for strep. She took TYLENOL, ADVIL and antimicrobial (unspecified). The patient's severe injection site pain and severe headache and difficulty swallowing and general body aches and very weak muscles and slight fever persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Immediately after the injection, the patient experienced severe injection site pain. later that night, the pain kept her awake. She took TYLENOL and ADVIL for the pain and fever. She saw her physician and a throat swab was performed which was positive for strep. She was treated fo r strep throat with an unspecified antibiotic. The patient's menstrual cycle was 4 days delayer with no possibility of pregnancy. She reports that in the past when taking unspecified antibiotics her cycle was delayer by a few days. The patient was improving. The patient subsequently called back inquiring whether or not she should receive the second dose of GARDASIL vaccine. Her first dose had been administered at the end of February and as of 29-MAY2007 she had not yet received the second dose. Additional information has been reuested.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with Gardasil. Subsequently the patient experienced chest pain and shortness of breath. The patient sought medical attention at the emergency room. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 22-JAN-2007 was vaccinated with 0.5mL IM, first dose, Gardasil (lot# 655165/1425F). Concomitant therapy included Seasonale. On 23-JAN-2007 the patient experienced fever of 103F and nausea. The patient sought unspecified medical attention and did not require lab diagnostic studies to be performed. Subsequently, the patient recovered from fever of 103F and nausea after the injection x 2 days. The patient also experienced nausea (was nauseated). The patient sought unspecified medical attention and did not require lab diagnositc studies to be performed. Subsquently, the patient recovered completely. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Additional attempts to contact the patient had been unsuccessful sin 27-Mar-2007 when she reported the reaction. At the time of this report, the patient had not returned for ther second GARDASIL. No product quality comlaint was involved. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated with an IM, third dose with Gardasil. Subsequently the patient experienced numbness in legs. Subsequently, the patient recovered from numbness in legs. It was reported the patient had no problems following the first 2 doses. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician concerning a 19 year old female with asthma, morbid obesity and peanut allergy and a history of orthopedic injuries from previous falls who on 26-FEB-2007 was vaccinated in her left arm with a third dose of GARDASIL (lot# 655849/0263U) at 11:00. On 27-FEB-2007 at 10:00 the patient experienced light vaginal bleeding that was between her menstrual cycles and numbness in both legs. Subsequently, the patient in one week recovered from light vaginal bleeding and numbness in both legs after 7 days. The patient did not seek medical attention until several weeks after these symptoms. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 18 year old female who was vaccinated with a second dose of Gardasil. Subsequently the patient fainted. The patient's outcome was unknown. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 19-Jan-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). On 26-JAN-2007 it was reported to the office, that on an unspecified date, post vaccination, the patient developed nausea and vomiting. Unspecified medical attention was sought. On an unspecified date, the patient recovered from the nausea and vomiting. The physician does not know if the patient will receive their second dose of the vaccine. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning her daughter who was vaccinated with the first  doses of Gardasil. Subsequently the patient experienced joint pain the following day on both occasions. Unspecified medical attention was sought. The physician indicated that each time the pain went away after one day. No product quality complaint was involved.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a dose of Gardasil at another practice. The patient developed an outbreak of genital warts after receiving the Gardasil. The time frame was unknown between the vaccination and the outbreaks. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated with the first dose, IM, of Gardasil (date not specified). Subsequently the patient broke out into a rash on her neck and abdomen. The nurse stated that the patient was advised to take Benadryl as treatment. At the time of the report, it was unknown if the patient had recovered from the rash though the patient was scheduled to be seen in the office on 29-MAR-2007. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient who was vaccinated (date not specified) with the first dose of Gardasil. Subsequently the patient experienced prolonged pain at the injection site. The patient was scheduled for an evaluation visit at the physician's office. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache, Pruritus, Skin irritation, Urticaria
Clinical narrative: Information has been received from a receptionist in the physician's office and a Certified Nurse Midwife (CNM) concerning a 20 year old female patient with a history of prior contact dermatitis, hive reaction who on 26-FEB-2007, at 11:00 AM was vaccinated with a first dose of Gardasil. On 26-FEB-2007 at 11:15 AM she broke out in hives after the injection. The patient came back to office within about 15 minutes after getting the injection with some itchiness, some small red hive areas, with rubbing, the hives then extended. They were on both of patient's wrists, on her neck, and her right chest wall, patient had no papules and she appeared coherent. She was given immediately 50mg of liquid BENADRYL. The patient came back to the office in one hour and she had no hives. She had a residual headache from the experience that was persisting at the time of this report. The patien planned to go  home early and stated her boy friend would be home in the afternoon to check on her periodically to monitor for any signs of reaction. The reporter plan to contact the vaccine adverse event reporting system, to get some recommendation on whether or not they should continue the second and third injection. The reporter thought that hives and itchiness were other important medical event. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a registered nurse, concerning a 21 year old female patient, with a penicillin allergy and drug hypersensitivity including a history of rash from penicillin and acetaminophen/propoxyphene (DARVOCET), irritation from miconazole (MONISTAT) and urticaria from neosporin, who on 28-MAR-2007, was vaccinated with the third dose of Gardasil (Lot #655324/0088U). There were no problems reported with administration of the first and second dose of Gardasil (dates not specified). There was no concomitant medication. On 28-MAR-2007, at the time of the IM vaccination in the left arm, the patient experienced burning at the injection site, and the needle was withdrawn after only 0.3ml had been administered. The nurse stated that after "a short wait," the remaining 0.2ml of the dose was administered into the right arm, and the patient again complained of the burning sensation. Shortly after the vaccination was completed in the right arm, the nurse confirmed the "burning sensation went away and the client recovered." Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Genital herpes, Therapeutic response decreased
Clinical narrative: Information has been received from a physician concerning female with a history of herpes genitalis and varios sexually transmitted diseases who on 23-Jan-2007 was vaccinated with her first dose of Gardasil (lot# 653978/0955F) and on 27-Mar-2007 received her second dose of HPV (lot# 657006/0188U). Concomitant therapy included valacyclovir HCl (VALTREX) and famciclovir (FAMVIR). Subsequently the patient indicated that since receiving the vaccination she can not clear her outbreaks of genital herpes. The medication that usually clears a herpes outbreak is not working effectively. Unspecified medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician concerning a female, with a history of herpes genitalis and various sexually transmitted diseases, who on 21-Jan-2007 was vaccinated in the left deltoid with her first dose, 0.5ml, of GARDASIL (lot# 653978/0955F), and on 27-MAR-2007 received her second dose of GARDASIL (lot# 657006/0188U). Concomitant therapy included VALTREX and FAMVIR. Subsequently the patient indicated that since she received the first dose of GARDASIL, she could not clear her outbreaks of genital herpes. The medication that usually clears a herpes outbreak is not working effectively. Unspecified medical attention was sought. No product quality complaint was involved. At the time of this report, it was unknown if the patient had recovered from the herpes outbreak. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female who on 24-Jan-2007 was vaccinated with her first dose of Gardasil (yeast) (lot # 655617/1447F). There was no concomitant medication. The patient has not had a menstrual cycle since being vaccinated. The last menstrual cycle started on 03-Jan-2007 and the patient is not sexually active. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a licensed practical nurse concerning a 15 year old female who on 24-Jan-2007 was vaccinated with her first dose of GARDASIL (lot # 655617/1447F). Concomitant medication included VAQTA (lot# 1209F) and MENACTRA (lot# 41967AA) intramuscular. The patient has not had a menstrual cycle since being vaccinated. The last menstrual cycle started on 03-Jan-2007. Unspecified medical attention was sought. Since patient is not sexually active and is not pregnant, the family elected to wait until the return of her menses before giving the 2nd dose of GARDASIL. The patient's outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.