chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who on 21-Feb-2007 was vaccinated with a dose of GARDASIL vaccine. The patient developed a single hive above her upper lip about 20 minutes after the injection. Unspecified medical attention was sought. The patient recovered. The physician did not know if the event was definitely related to the GARDSIL vaccine. 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 and a health care professional concerning a 13 year old female patient with Penicillin allergy who on 14-FEB-2007 was vaccinated IM in right deltoid with a first dose of 0.5 mL of GARDASIL vaccine, lot #655617/1447F. The patient developed a single hive above her upper lip aboout 20 minutes after the injection. No injection site reaction or other reactions noted. The patient was instructed to take BENADRYL by mouth which she took. She recovered the same day. The physician did not know if the event was definitely related to the GARDASIL vaccine. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first and second dose of Gardasil. The patient developed a rash on her face after 1st injection. She developed a more extensive rash on her face after the 2nd injection. In both instances, the rash was isolated to only the patient's face. The physician was not planning to vaccinate the patient with the 3rd dose due to the adverse experience. Unspecified medical attention was sought. The patient was improving as of the report date. Additional information has been requested. Information has been received from a physician concerning a 24 year old female patient with a penicillin allergy who was vaccinated with a first dose of GARDASIL (lot #653978/0955P) intramuscularly in the left deltoid on 31-OCT-2206. About one and a half to two weeks after the first injection, on approximately 14-NOV-2006, the patient developed a rash on her face. On 05-JAN-2007, she was vaccinated with a second dose of GARDASIL (lot #6548851/1424F) intramuscularly in the left deltoid. On 18-JAN-2007, she developed a more extensive rash on her face. In both instances, the rash was isolated to only the patient's face. The physician was not planning to vaccinate the patient with the 3rd dose due to the adverse experience. Unspecified medical attention wsa sought. The patient was instructed to take BENADRYL as needed. The patient had recovered as of the report date. The patient was unable to keep an appointment for evaluation. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who in January 2007 was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a fever of 102.5F for 3 days after her injection. The patient missed one day of school. Unspecified medical attention was sought. The patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 16 year old female with asthma and allergy to "campha" who on 16, Feb 2007 was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), single dose vial. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS). On 27, Feb 2007 the patient was tested for HPV and the pap smear results were positive for high risk HPV. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history who was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced dizziness for three days. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Injection site pain, Injection site reaction, Injection site warmth, Loss of consciousness
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female who was vaccinated with Gardasil (Lot# 653735/0688F). On 12-FEB-2007, the patient lost consciousness and hit her head after receiving her first dose of Gardasil. The patient was taken to the emergency room but was not admitted. The patient also developed local site reaction. On 13-FEB-2007, the patient visited the office and complained of pain at the site and it was warm to the touch. Unspecified medical attention was sought. Subsequently, the patient recovered from lost consciousness, hit head, local site reaction and pain and warmth at injection site. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil first dose. Subsequently, the patient developed a rash over their entire body. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Headache, Loss of consciousness, Neurological examination normal, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a nurse concerning a 17 year old female who on 06-MAR-2007 was vaccinated in the higher anterolateral area of the left thigh with a 0.5 mL second dose of GARDASIL (lot 655617/1447F). At the time of vaccination, the patient was alert and good spirits. The nurse did not notice any bleeding after the injection, but she placed a small bandaid at the injection site. The nurse asked the patient if she was okay, and the patient replied "yes". The patient walked to the check out counter and stated that she had a headache and was rubbing her head. The patient was advised to sit down for 15-20 minutes after the GARDASIL was administered but refused to be seated to passing out. The patient's blood pressure was slightly elevated while she passed out. The nurse was called to the waiting room after the patient fainted. Neurologic check grossly intact. One tooth was bleeding. The patient was taken to the emergency room and checked in. When the patient's father arrived, the patient stated that she did not want to stay. The father asked if patient was okay. The nurse informed him that she was okay, but the physician thought the patient should be evaluated at the emergency room. The patient's father refused treatment. At the time of this report, the outcome was unknown. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tooth injury
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a nurse concerning a 17 year old female who on 06-MAR-2007 was vaccinated in the higher anterolateral area of the left thigh with a 0.5 mL second dose of GARDASIL (lot 655617/1447F). At the time of vaccination, the patient was alert and good spirits. The nurse did not notice any bleeding after the injection, but she placed a small bandaid at the injection site. The nurse asked the patient if she was okay, and the patient replied "yes". The patient walked to the check out counter and stated that she had a headache and was rubbing her head. The patient was advised to sit down for 15-20 minutes after the GARDASIL was administered but refused to be seated to passing out. The patient's blood pressure was slightly elevated while she passed out. The nurse was called to the waiting room after the patient fainted. Neurologic check grossly intact. One tooth was bleeding. The patient was taken to the emergency room and checked in. When the patient's father arrived, the patient stated that she did not want to stay. The father asked if patient was okay. The nurse informed him that she was okay, but the physician thought the patient should be evaluated at the emergency room. The patient's father refused treatment. At the time of this report, the outcome was unknown. No additional information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with asthma who on an unspecified date was vaccinated with the second dose of Gardasil, 0.5 ml, once, IM. Concomitant therapy included Advair and unspecified inhaler (therapy unspecified). Subsequently on an unspecified date, the patient experienced chest tightness and shortness of breath a short time after receiving her second dose of Gardasil. The physician reported that the patient self-medicated with her inhaler and her symptoms resolved. Additional information has been requested. This is in follow-up to reports previoulsy submitted 4/6/2007. Information has been received from a physician concerning a 24 year old female radiology technician with asthma and respiratory symptoms who on 22-NOV-2006 was vaccinated with a second dose of GARDASIL (lot #653937/0637F), 0.5ml, once. IM in the left deltoid. Concomitant therapy included ADVAIR and Albuterol. The first vaccination of GARDASIL (lot #653937/0637F) was received on 20-SEP-2006. IM in the right deltoid. Subsequently on 22-NOV-2006, the patient experienced chest tightness. Shortness of breath and wheezing a short time after her second dose of GARDASIL. The physician reported that the patient self-medicated with her Albuterol inhaler 2 times and her symptoms resolved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a pharmacist concerning her 19 year old daughter with food allergies who in December 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included Yaz. The patient had a routine Papanicolaou (pap) test which revealed a few mild abnormal cells. A colposcopy was scheduled. The patient had not recovered as of the report date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced genital warts. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female who on 02-MAR-2007 was vaccinated with second dose of Gardasil, injection (Lot#655503/0012U). Concomitant therapy included Yaz. On 02-MAR-2007, after administration of Gardasil the patient experienced dizziness and was close to fainting. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from dizziness and close to fainting. The product quality complaint unit was not involved. Additional information has been requested. The same source also provided information concerning other patient's experiences (WAES# 0703USA04318 and WAES# 0703USA04319).
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Neck pain
Clinical narrative: Information has been received from a physician concerning a 27 year old female who on an unspecified date was vaccinated with the first IM dose of Gardasil (lot# 655617/1447F). On 06-FEB-2007, the patient was vaccinated with the second IM dose of 0.5 ml Gardasil. Concomitant therapy included Percocet. On 26-FEB-2007 the patient called the physician's office with complaints of neck pain. No lab testing was performed. The physician reported the patient refused to take the third dose of 0.5 ml Gardasil due to arthralgia after her second dose. Additional information has been requested.
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a female patient, who on 05-MAR-2007 was vaccinated with the first dose, IM, of Gardasil. Concomitant suspect therapy included Tdap. The nurse practitioner reported that "a patient who received the 1 Gardasil in one arm and the Tdap vaccine in the other arm, fainted within a few seconds after being vaccinated." The nurse practitioner states that "the patient was fine after a minute or so." The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HPV4, IPV, PNC
Symptoms: Diarrhoea, Wrong drug administered
Clinical narrative: Information has been received from two consumers, the mother and father of a 4 month old male infant, who on 02-MAR-2007 was vaccinated with a single dose Gardasil by mistake. Concomitant therapy included Dtap (unspecified), IPV (unspecified), OPV (unspecified) and Prevnar. The mother and father of the child reported that their son should have received the "HIB" vaccine (not specified) "but instead (was) given (Gardasil)." On 20-MAR-2007, the mother of the infant reported that the child had been experiencing "diarrhea for over a week," and reported that Pedialyte had been ordered. She added that on 16-MAR-2007, the HIB vaccine was administered. The mother stated that her child did "not appear dehydrated," and continued to have "wet diapers." The patient's twin brother also experienced the events as described above after vaccination with Gardasil (WAES # 0703USA01783). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient who on 10-JAN-2007 was vaccinated with her first dose of Gardasil. On 03-MAR-2007 she was vaccinated IM in her left deltoid with her second dose of Gardasil, lot #654540/0800F. Concomitant therapy included oral contraceptives (unspecified). Shortly after the administration of her second dose,
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Dyskinesia, Fatigue, Injection site pruritus
Clinical narrative: Information has been received from an office receptionist concerning her 19 year old daughter who on an unspecified date was vaccinated with a first dose of Gardasil. The patient's arm was "shaky" after the first injection. On an unspecified date the patient received her 2nd dose of Gardasil. Subsequently, her arm was "jumpy" and she experienced vomiting and diarrhea. Unspecified medical attention was sought. The patient recovered. Additional information has requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/6/2007. Follow up information has been received froma health professional concerning a 19 year old female who on 13-OCT-2006, AM was vaccinated IM in right arm with a first dose of GARDASIL lot #653978/0955F and on 02-JAN-2007, AM she received IM in to right arm the second dose of GARDASIL lot #653978/0955F. After first vaccination in October 2006, the patient experienced itchy and swollen at injection site. In approximately January 2007, at 6:00 PM patient was dizzy, very tired, had nausea and her arm was shaking and had arm weakness. Her hand would jump by itself once in a while. She was fine the next day. The patient recovered. No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Muscular weakness, Nausea, Tremor, Vomiting
Clinical narrative: Information has been received from an office receptionist concerning her 19 year old daughter who on an unspecified date was vaccinated with a first dose of Gardasil. The patient's arm was "shaky" after the first injection. On an unspecified date the patient received her 2nd dose of Gardasil. Subsequently, her arm was "jumpy" and she experienced vomiting and diarrhea. Unspecified medical attention was sought. The patient recovered. Additional information has requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/6/2007. Follow up information has been received froma health professional concerning a 19 year old female who on 13-OCT-2006, AM was vaccinated IM in right arm with a first dose of GARDASIL lot #653978/0955F and on 02-JAN-2007, AM she received IM in to right arm the second dose of GARDASIL lot #653978/0955F. After first vaccination in October 2006, the patient experienced itchy and swollen at injection site. In approximately January 2007, at 6:00 PM patient was dizzy, very tired, had nausea and her arm was shaking and had arm weakness. Her hand would jump by itself once in a while. She was fine the next day. The patient recovered. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site irritation, Injection site pain, Presyncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil first dose. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid administered right before Gardasil. The patient said that while she was being administered the Gartdasil (also reported as immediately after receiving Gardasil, she had stinging and burning sensation (at injection site) and felt as if she was going to faint or pass out. The feeling lasted for approximately fifteen minutes. Thereafter, she felt "okay" Subsequently, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a female patient who was vaccinated with a first dose of Gardasil and fainted after receiving the injection. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. In follow up information it was reported that patient had episode of syncope after the injection and it was reaction to needle, not medication (occurred immediatley after withdraw of needle. Used amnoia capsule. On 03-Nov-2006 the patient recovered. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The patient developed a rash all over the body after the injection. 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.  Initial and follow-up information has been received from a physician concerning a 24 year old female patient with no known food or drug allergies, who was vaccinated with a first dose of GARDASIL.  The patient developed a rash all over the body approximately 10 days after the injection.  The physician characterized the rash as "raised, non-itchy and non-painful".  Unspecified medical attention was sought.  The patient recovered about 10 days later.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 06-MAR-2007 was vaccinated with the first IM dose of Gardasil. On 07-MAR-2007 the patient experienced rash on her neck. The reporter felt that rash on her neck was not related to Gardasil. Patient outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from an employee at a physician's office concerning a female who in December 2006, was vaccinated with Gardasil. In December 2006, the patient experienced nausea. In December 2006, therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered form nausea. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with seasonal allergies who on 28, Feb 2007 was vaccinated IM with a 0.5 mL dose of Gardasil lot # 654389/0961F) and has not begun her period. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (AVLANE), as oral contraception, and fluticasone propionate (FLONASE). The nurse reported that the patient took her 3 weeks of active pills and usually begins her period 2 days after beginning the reminder pills. As of 08, Mar 2007 (4 days after beginning the reminder  pills), the patient had not begun her period. The patient sought unspecified medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Biopsy, HIV antibody negative, Hepatitis B test negative, Herpes simplex serology negative
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 24 year old female with no medical history of drug reactions/allergies who on 25, Jan 2007 was vaccinated with the first IM 0.5 ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 04, Feb 2007 (1 1/2 weeks after the first injection), the patient experienced lesions/"vaginal bumps" on the external vaginal area. The patient contacted the physician on 26, Feb 2007 regarding the "rash" and 'vaginal bumps" . A vulvar biopsy of the left labia and posterior fourchette revealed condyloma. No treatment was provided at the time of reporting.  Cultures were obtained ad HPR, Hep B, Hep C, HSV 1 and 2 HIV tests were performed and were all negative. The patient had not recovered. It was noted in follow-up tht the patient ws vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL on 27-MAR-2007 (Lot # "00844"). As of 05-MAY-2007, there was no report of an adverse experienced with this second dose. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Treponema test negative, Vaginal lesion
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 24 year old female with no medical history of drug reactions/allergies who on 25, Jan 2007 was vaccinated with the first IM 0.5 ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 04, Feb 2007 (1 1/2 weeks after the first injection), the patient experienced lesions/"vaginal bumps" on the external vaginal area. The patient contacted the physician on 26, Feb 2007 regarding the "rash" and 'vaginal bumps" . A vulvar biopsy of the left labia and posterior fourchette revealed condyloma. No treatment was provided at the time of reporting.  Cultures were obtained ad HPR, Hep B, Hep C, HSV 1 and 2 HIV tests were performed and were all negative. The patient had not recovered. It was noted in follow-up tht the patient ws vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL on 27-MAR-2007 (Lot # "00844"). As of 05-MAY-2007, there was no report of an adverse experienced with this second dose. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstruation delayed, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old "nurse" who works in the same physician's office who was vaccinated with first dose of Gardasil. Subsequently, her menstrual cycle did not arrive on time. Her menstruation lasted for 2 weeks and it was a heavier flow. the patient's menstrual cycle ended and then started again. The patient experienced 2 cycles in one month. After her second dose of Gardasil, the patient's menstrual cycle arrived on time but it was a heavier flow. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007.  Follow up information was received from the patients physician which stated that the patient is a 22 year old female who on 14-Nov-2006 received the firse dose of GARDASIL (Lot # not provided). On 19-Feb-2007 at 15:30 the patient received the second vaccination in the left arm of GARDISIL (Lot # 1424F). It was reported that after receiving the second dose of the vaccine the patient experienced heavy menstraul bleeding for two weeks. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HPV4, IPV
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from two consumers, the mother and father of a 4 month old male infant, who on 02-MAR-2007 was vaccinated with single dose by mistake. Concomitant therapy included Dtap (unspecified), IPV, OPV (unspecified). The mother and father of the child reported that their son should have received the HIB vaccine (not specified) "but instead (was) given Gardasil. On 20-MAR-2007, the mother of the infant reported that the child had been experiencing "diarrhea for over a week," and reported that oral electrolyte maintenance (PEDIALYTE) has been ordered. She added that on 16-MAR-2007, the haemophilus influenza type B vaccine was administered. The mother stated that her child did "not appear dehydrated," and continued to have "wet diapers." The patient's twin brother also experienced the events as described above after vaccination with Gardasil (WAES # 0703USA01289). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: Information has been received from an office manager concerning a patient who was vaccinated with a first dose of Gardasil. The patient got dizzy and fell after receiving the injection. The patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Eye haemorrhage, Fatigue, Nausea
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vomiting
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Auricular swelling, Blood albumin normal, Blood creatinine normal, Blood electrolytes normal, Blood urea normal
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Erythema, Full blood count normal, Joint swelling, Pruritus, Red blood cell sedimentation rate normal
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Serum sickness, Swelling, Urticaria
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Erythema, Joint swelling, Lip swelling
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pruritus, Red blood cell sedimentation rate normal, Serum sickness, Skin warm, Tenderness
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urticaria
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 an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a patient who was vaccinated with a first dose of Gardasil. Patient developed hives within 2-3 hours of receiving the injection. The patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 07-MAR-2007, was vaccinated with Gardasil (Lot# 654535/0960F). There was no local site reaction but on 07-MAR-2007, the patient became dizzy and pale. The patient had to wait 20 minutes in the waiting room before she was fine (recovered). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis allergic, Pityriasis rosea, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a female with vaccinated with Gardasil. Subsequently the patient developed a rash on her arm and part of the face. The rash spread to the rest of the body. The patient was diagnosed with allergic dermatitis and pityriasis rosea. Patient outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a patient with contraception who on 07-FEB-2007 was vaccinated with second dose of Gardasil (Lot#655503/0012U). Concomitant therapy included YASMIN, PAXIL and PROTONIX. On 07-FEB-2007, the patient experienced fainted (patient outcome not provided). Additional information has been requested. The same source also provided information regarding other patients' experiences (WAES#0703USA01200 and WAES#0703USA04319).
Sex: U
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning three patients who were vaccinated with Gardasil. Subsequently, the patients were closed to fainting or fainted (patient outcomes not provided). Attempts are being made obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. The same source provided information concerning the experienced of other patients (WAES#0703USA01200 and WAES#0703USA04318).
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.
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 16-FEB-2007 the patient the received vaccine in the bottom. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hot flush, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female student who on 21-DEC-2006, at 2:00PM, was vaccinated IM, into the left deltoid, with a first dose of Gardasil (Lot# 653937/0637F). There was no illness at the time of vaccination. On 21-DEC-2006, after the injection, at 2:00PM, the patient became lightheaded and nauseated, "approximately 15 minutes". The nurse also reported the injection was very painful when vaccine contents injected into muscle and the patient had a hot flash. On 23-FEB-2007, at 3:15PM, the patient was vaccinated IM, into the left deltoid, with a second dose of Gardasil (Lot# 654389/0961F). There was no illness at the time of vaccination. The nurse reported that the patient felt a hot flash immediately post injection . The second injection was also said to be very painful when vaccine contents injected into the muscle (not from needle placement), for "five minutes". No further information is expected.
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: Musculoskeletal stiffness
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 February 2007, the morning after receiving Gardasil the patient experienced a stiff neck which was stiff for about a day. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Medication error, Pain, Pain in extremity
Clinical narrative: Information has been received from a certified family nurse practitioner (CFNP) concerning a 30 year old female clinic employee who in August 2006 was vaccinated with first dose of Gardasil (lot # not reported). In October 2006, the patient was vaccinated with second dose of Gardasil (lot # not reported). In February 2007, the patient was vaccinated with third dose of Gardasil (lot # not reported). In October 2006, the patient experienced stinging and sore arm after the second vaccination. The patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CFNP via telephone. The sore arm lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Medication error, Pain, Pain in extremity
Clinical narrative: Information has been received from a certified family nurse practitioner (CFNP) concerning a 25 year old female clinic employee who in August 2006 was vaccinated with first dose of Gardasil (lot # not reported). In October 2006, the patient was vaccinated with second dose of Gardasil (lot # not reported. In February 2007, the patient was vaccinated with third dose of Gardasil (lot # not reported). In October 2006, the patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CFNP via telephone. The sore arm lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been received.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antinuclear antibody, Bacterial test negative, Demyelination, Hypoaesthesia, Muscular weakness
Clinical narrative: 11/9-Flu shot-yellow mark on arm-slight pain, numb by morning each day numbness spread across left breast then down left side surface pain left breast and under breast. Changing to tightness under left breast numbness spreading to legs and feet over several weeks. Blood Tests, MRI's X-rays. 1/12/07-Numbness starts in left leg 1/12-diagnosis-Transverse Myelitis
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse
Clinical narrative: 11/9-Flu shot-yellow mark on arm-slight pain, numb by morning each day numbness spread across left breast then down left side surface pain left breast and under breast. Changing to tightness under left breast numbness spreading to legs and feet over several weeks. Blood Tests, MRI's X-rays. 1/12/07-Numbness starts in left leg 1/12-diagnosis-Transverse Myelitis
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest discomfort, Discomfort, Hypoaesthesia, Injection site discolouration
Clinical narrative: 11/9-Flu shot-yellow mark on arm-slight pain, numb by morning each day numbness spread across left breast then down left side surface pain left breast and under breast. Changing to tightness under left breast numbness spreading to legs and feet over several weeks. Blood Tests, MRI's X-rays. 1/12/07-Numbness starts in left leg 1/12-diagnosis-Transverse Myelitis
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging, Pain in extremity, Spinal X-ray
Clinical narrative: 11/9-Flu shot-yellow mark on arm-slight pain, numb by morning each day numbness spread across left breast then down left side surface pain left breast and under breast. Changing to tightness under left breast numbness spreading to legs and feet over several weeks. Blood Tests, MRI's X-rays. 1/12/07-Numbness starts in left leg 1/12-diagnosis-Transverse Myelitis
Sex: F
Vaccine: VARCEL, FLU3
Symptoms: Hypertension, Osteoarthritis, Rash
Clinical narrative: 24 hrs after influenza vaccine pt presented to ER and was told that rash on her legs was due to allergic reaction to Influenza vaccine. Was also seen on 2/2/07 at health dept and rash - on abd, arms, legs - Cont Prednisone dose pack by ER and RX hydroxizine ret PRN SX worsen.
Sex: F
Vaccine: VARCEL, FLU3
Symptoms: Hypersensitivity, Rash
Clinical narrative: 24 hrs after influenza vaccine pt presented to ER and was told that rash on her legs was due to allergic reaction to Influenza vaccine. Was also seen on 2/2/07 at health dept and rash - on abd, arms, legs - Cont Prednisone dose pack by ER and RX hydroxizine ret PRN SX worsen.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture, Bowel movement irregularity, Diarrhoea, Moaning, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female with a vibratory heart murmur who on 19-JAN-2007 was vaccinated with a first oral dose of Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a first intramuscular dose of Pediarix (Lot# A021B084BA),  a first intramuscular dose of PedvaxHib (Lot# "1015") and a first intramuscular dose of Prevnar (Lot# B08672E). It was noted that the patient had a cough at the time of vaccination. The patient developed vomiting and diarrhea, diagnosed as gastroenteritis, on 04-FEB-2007, 16 days after the immunizations. The patient was found to have a urinary tract infection and mild hydronephrosis, described as an underlying renal abnormality. The patient was hospitalized twice for the experiences from 05-FEB-2007 to 07-FEB-2007 and from 09-FEB-2007 to 12-FEB-2007. It was noted that during hospitalization the patient received a first dose of Recombivax HB (manufacturer unknown). The patient's stool was negative for Rotateq. Subsequently, the patient recovered. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis, Hydronephrosis, Rotavirus test negative, Urinary tract infection
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female with a vibratory heart murmur who on 19-JAN-2007 was vaccinated with a first oral dose of Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a first intramuscular dose of Pediarix (Lot# A021B084BA),  a first intramuscular dose of PedvaxHib (Lot# "1015") and a first intramuscular dose of Prevnar (Lot# B08672E). It was noted that the patient had a cough at the time of vaccination. The patient developed vomiting and diarrhea, diagnosed as gastroenteritis, on 04-FEB-2007, 16 days after the immunizations. The patient was found to have a urinary tract infection and mild hydronephrosis, described as an underlying renal abnormality. The patient was hospitalized twice for the experiences from 05-FEB-2007 to 07-FEB-2007 and from 09-FEB-2007 to 12-FEB-2007. It was noted that during hospitalization the patient received a first dose of Recombivax HB (manufacturer unknown). The patient's stool was negative for Rotateq. Subsequently, the patient recovered. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female with a vibratory heart murmur who on 19-JAN-2007 was vaccinated with a first oral dose of Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a first intramuscular dose of Pediarix (Lot# A021B084BA),  a first intramuscular dose of PedvaxHib (Lot# "1015") and a first intramuscular dose of Prevnar (Lot# B08672E). It was noted that the patient had a cough at the time of vaccination. The patient developed vomiting and diarrhea, diagnosed as gastroenteritis, on 04-FEB-2007, 16 days after the immunizations. The patient was found to have a urinary tract infection and mild hydronephrosis, described as an underlying renal abnormality. The patient was hospitalized twice for the experiences from 05-FEB-2007 to 07-FEB-2007 and from 09-FEB-2007 to 12-FEB-2007. It was noted that during hospitalization the patient received a first dose of Recombivax HB (manufacturer unknown). The patient's stool was negative for Rotateq. Subsequently, the patient recovered. Additional information has been requested.