chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007; 4/6/2007. Initial and follow up information has been received from a registered nurse concerning a 25 year old (previously reported as 22 year old), female patient with a history of "problems and reactions" to previous vaccinations who on 26-NOV-2006 was vaccinated IM in the left deltoid with a first dose of GARDASIL (Lot #654540/0800F). Subsequently, the patient developed swelling, describing as her "arm felt tight," around the injection site. The patient was placed on unspecified therapy, and subsequently, recovered. On 09-FEB-2007, the patient was vaccinated, IM in the right deltoid, with a second dose of GARDASIL (Lot #654720/0011U), the patient's arm immediately reddened at the injection site, and she experienced a "tingly" sensation in her arm. The patient was treated with unspecified therapy, and the nurse confirmed she had recovered. The patient informed the nurse that she had "this type of reaction with all IM injections." No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who, on an unspecified date, was vaccinated intramuscularly with a first dose of HPV. Subsequently, on an unspecified date, the patient developed a rash. The patient did not seek medical attention. Subsequently, on an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Sensory disturbance
Clinical narrative: Information has been received from a nursing supervisor concerning a female (age not reported) who on an unspecified date was vaccinated with HPV. Subsequently, the patient reported that her "arm felt dead". At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information confirmed that the patient had recovered on approximately 05-Nov-2007 ("next day") and felt fine. On 07-Feb-2007, the patient was vaccinated with the second dose of GARDASIL, and "was fine." Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness, Sensory disturbance, Syncope
Clinical narrative: Information has been received from a nursing supervisor concerning a female (age not reported) who on an unspecified date was vaccinated with HPV. Subsequently, the patient reported that her "arm felt dead". At the time of this report, the outcome of the event was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a nursing supervisor concerning an 18 year old female who at 11:30am, on 14-DEC-2006 was vaccinated in the left deltoid with the first dose of GARDASIL (Lot # 654389/0961F). Subsequently, the patient reported she felt it go all down her arm during the vaccination, and stated her "arm felt heavy all day long" (previously reported as "felt dead"). In follow up information, the nurse reported that, as the patient was leaving the facility she fainted and "was out for a few seconds". The nurse took the patient's vital signs and gave her juice, and reported "she was fine". The outcome of the events was unknown. It was unknown if the patient recovered from feeling the vaccine go down her arm and the feeling of arm heaviness. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Presyncope
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) concerning a female patient who was vaccinated with a 0.5 mL dose of HPV, (lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. It was reported that the patient almost passed out from the pain. The C.M.A also reported that approximately 19 other patients experienced pain at the injection site lasting for about a week. (WAES# 0702USA00920) 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. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, VARCEL
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 06-NOV-2006 and on 09-JAN-2007 was vaccinated with a first and second dose of HPV. Subsequently the patient experienced irregular menstrual bleeding. Unspecified medical attention was sought. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, VARCEL
Symptoms: Menorrhagia, Menstruation irregular
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 06-NOV-2006 and on 09-JAN-2007 was vaccinated with a first and second dose of HPV. Subsequently the patient experienced irregular menstrual bleeding. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 20-FEB-2007 was vaccinated with a 0.5 mL first dose of HPV. The patient was concomitantly vaccinated with a dose of Boostrix. On 21-FEB-2007 the patient experienced nausea and a headache. The patient sought unspecified medical attention. On 22-FEB-2007, the headache was clearing and the nausea was gone. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dizziness, Fall, Head injury, Impaired work ability
Clinical narrative: Information has been received from a health care professional concerning a 25 year old female with no medical history and no allergies who on 21-FEB-2007 was vaccinated with GARDASIl vaccine (lot # 653736/0014U), intramuscularly. There was no concomitant medication. Later that evening she passed out. She hit her head when she fell to the floor. It was reported to be unknown if treatment was required. She called the doctor this morning and was taking the day off from work. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information was received which stated that the patient had weakness and fatigue at the time of the first intramuscular vaccination in the left deltoid of GARDASIl vaccine (lot # 653736/0014U) on 21-FEB-2007 at 16:45. At 17:30 that same day, post vaccination, the patietn expereinced lightheadedness, dizziness, chest tightening and passed out. No treatment was reported. At the time of the report it was unknown if the patient had recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a health care professional concerning a 25 year old female with no medical history and no allergies who on 21-FEB-2007 was vaccinated with GARDASIl vaccine (lot # 653736/0014U), intramuscularly. There was no concomitant medication. Later that evening she passed out. She hit her head when she fell to the floor. It was reported to be unknown if treatment was required. She called the doctor this morning and was taking the day off from work. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information was received which stated that the patient had weakness and fatigue at the time of the first intramuscular vaccination in the left deltoid of GARDASIl vaccine (lot # 653736/0014U) on 21-FEB-2007 at 16:45. At 17:30 that same day, post vaccination, the patietn expereinced lightheadedness, dizziness, chest tightening and passed out. No treatment was reported. At the time of the report it was unknown if the patient had recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on an unspecified date was vaccinated with a first dose of HPV. The patient was due to her second dose of HPV, and she developed a urinary tract infection. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a physician assistant concerning a 22 year old female with penicillin allergy who on 20-FEB-2007 was vaccinated with a first dose of HPV. On 20-FEB-2007 she developed itching, erythema and swelling at the injection site. On 21-FEB-2007 she developed hives on her abdomen, thighs and chest upon awakening. When she was seen by the physician assistant on 21-FEB-2007 the swelling and redness at the injection site was gone and the patient commented that the hives were less than before. Her prescriber put her on Zyrtec (10 mg) daily for the hives. Unspecified medical attention was sought. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Information has been received from a physician concerning a 25 year old female secretary with on medical history or allergies, who on 20-FEB-2007 was vaccinated IM into the left arm with a 0.5 ml dose of HPV. Concomitant therapy included Depo-Provera. On approximately 20-FEB-2007, the patient experienced soreness at injection site. On 21-FEB-2007 for that day only the patient experienced nausea. On the morning of 22-FEB-2007 the patient noticed what looks similar to lymph nodes that are enlarged, tender, and swollen by the wrist of the arm in which the vaccine was administered. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report the patient recovered from all events but had not recovered from soreness at the injection site. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with penicillin allergy who on 12-FEB-2007 was vaccinated with a dose of HPV (lot #653736/0014U). There was no concomitant medication. On 12-FEB-2007 the patient developed large hives on her arms, trunk and face. Medical attention was sought and the patient was treated with Benadryl 100 mg. There were no laboratory or diagnostic tests performed. On 13-FEB-2007, the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's office concerning a 16 year old female who was vaccinated with a dose of HPV. Subsequently, the patient fainted. The patient did not seek medical attention. The patient's outcome was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: information has been received from a consumer concerning her 19 year old daughter who on 22-FEB-2007 was vaccinated with her second dose of HPV. Concomitant therapy included unspecified birth control. On 22-FEB-2007 the patient experienced "a lot of pain and was in tears" after receiving HPV. Unspecified medical attention was required. It was also reported that the patient experienced "a little pain" after the first dose of HPV was administered. At the time of the report, the patient's pain persisted. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning her daughter who was vaccinated with a dose of HPV during her Christmas holiday break from college. After the vaccination, the patient walked to the reception desk and fainted. The patient awoke by herself. Unspecified medical attention was sought. It was reported that the patient was embarrassed, then walked out to the car with her parents. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Initial and follow-up information has been received from two physicians concerning their daughter, a 22 year old female with ulcerative colitis (in remission) who on 03-JAN-2007, at 3:00 pm, was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 659978/0955F), during her holiday break from college. The physician reported that on 03-JAN-2007, at 3:15 pm, the patient experienced vaso-vagal faint. The patient awoke by herself. Unspecified medical attention was sought. Subsequently, the patient recovered from vaso-vagal faint. It was reported that the patient was embarrassed, then walked out to the care with her parents. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a dose of HPV. Subsequently, on an unspecified date, the patient passed out after receiving the vaccine. The nurse reported that the patient had not eaten. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Information has been received from a registered nurse concerning a female with asthma who on 17-NOV-2006 was vaccinated with the first dose of Gardasil. On 19-NOV-2006, the patient experienced shortness of breath and chest pain. The patient recieved unspecified treatment at the clinic where she was employed. It was reported that the patient attended work the following day, although, had recurrence of shortness of breath. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain in extremity, Paraesthesia, Skin burning sensation, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female nurse practitioner consumer through the pregnancy registry who on unspecified dates was vaccinated with the first and second doses of Gardasil (0.5 ml). Subsequently the patient reported that she had recently became pregnant. The patient also reported that she experiences burning, pain, and nerve tingling in her arm "soon after" receiving the second dose of Gardasil. The patient reported that she had a similar experience to a lesser degree following the first vaccination with Gardasil. It was though that the pregnancy occurred after the above events. Unspecified medical attention was sought. The patient subsequently recovered from the burning, pain, and nerve tingling in her arm "a short time after each injection." Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. In follow-up, the nurse practitioner reported that she was not vaccinated within the timeframe to be in the pregnancy registry. She received her second done at the end of October 2006 and did not get pregnant until the end of Januray 2007. Her baby was 8 months old at the time of this report and was doing "just great". Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Lip swelling, Neck pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with a history of surgery for birth defects and allergic to erythromycin who on 15-JAN-2007 and 16-FEB-2007 was vaccinated with a first and second dose of Gardasil, respectively. There was no concomitant medication. On 22-FEB-2007 'last night", the consumer's daughter experienced headache, sore throat, neck pain and her lips were swollen. No medical attention was sought. No laboratory studies were performed. At the time of this report, the consumer's daughter had not recovered. It was also reported that she tolerated her first of the vaccine with any events. The consumer plans on having her daughter receive the third dose of the vaccine. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Facial palsy, Herpes zoster oticus
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who was vaccinated with a dose of Gardasil. Concomitant therapy administered at the same time at a different anatomical site included a dose of MENACTRA. Illness at the time of vaccination included herpes simplex on the lip. On 09-JAN-2007, the patient was seen in the office and was diagnosed with herpes zoster otitis which progressed to a diagnosis of Bell's palsy and Rasmsay-Hunt Syndrome on 15-JAN-2007. At time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 03/28/07-records received for DOS 1/16/07 DX:Bell's Palsy. Ramsay Hunt Syndrome. PH:1/9/07-Seen by PMD to treat shingles in right ear with acyclovir. TX stopped on 1/16/07 due to bells palsy. Right side facial droop difficulty eating. C/O headache thoughout with shingles. 1/16/07-stomach cramps, diarrhea. Symptoms resolved 2/8/07. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter, an 18 year old female patient who on 09-FEB-2007 was vaccinated with the first dose of Gardasil. The caller reported that on 10-FEB-2007, her daughter "had a TB test administered. "On 22-FEB-2007 the patient experienced fever and flu-like symptoms. The patient sought unspecified medical attention. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007.  Initial and follow up information has been received from two registered nurses concerning a 25 year old previously reported as 24 year old)  female teacher, who at 11:40, on 20-FEB-2007 was vaccinated with the first dose of, 0.5 ml dose, IM, of GARDASIL. There was no concomitant medication. The nurse reported that at 11:50am, ten minutes after the vaccine was administered.  The teacher fainted, experienced a loss of consciousness (previously reported as "did not lose consciousness") and "fell to the ground" but was easily awakened.  The nurse reported that the teacher hit the back of her head when she fell and complained of a headache/pain.  The physician evaluated the teacher and offered to call an ambulance, but the teacher "refused" further care.  The nurse stated that the teacher was walked her to the car at 12:30pm by her mother, and the patient was "awake, alert and oriented"  The  nurse confirmed that the patient recovered on 21-FEB-2007.  No further information is available
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Dizziness, Head injury, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 21  year old female with no pertinent medical history and no drug reactions or allergies who on 29-JAN-2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV (Lot unspecified by reporter). There was no concomitant medication. On 29-JAN-2007 the patient fainted while walking to the waiting room. The patient hit her head on the floor and suffered a concussion. The patient was rushed to an emergency room in an ambulance. She was release later that day. At the time of the report, the patient had recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 21 year old female, whose repported weight was 176 pounds and whose reported height was 65 inches with no pertinent medical history and no illness at the time of vaccination and no drug reactions or allergies who on 29-JAN-2007, at approximately 12:45 P.M., was vaccinated intramuscularly, into the deltoid muscle with the first 0.5 mL dose of GARDASIL vaccine (Lot #654702/0011U). There was no concomitant medication. It was reported that after the vaccination at 12:55 P.M. (also reported as 1:10 P.M.), the patient proceeded to feel dizzy (also reported as "faint") resulting in the patient "passing out" and reported as fainting while walking to the waiting room. The patient hit her head on scale, which was on the floor. The patient was rushed to an emergency roon in an ambulance and was diagnosed with concussion. She was released later that day. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Certified Medical assistant (C.M.A) concerning an 18 year old female patient who was vaccinated with her first dose of HPV. The patient called the office back within 24 hours reporting a large rash on her back. Concomitant therapy included albuterol. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased
Clinical narrative: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated intramuscularly with a first dose of HPV. The next day, the patient developed a high temperature if 103 degrees F. Unspecified medical attention was sought.  Subsequently, the patient recovered. The physician plans to continue the series of HPV. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Food allergy, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient with allergies to cast and scallops who on 21-FEB-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included NYQUIL. 20 hours later, the patient developed hives. Unspecified medical attention was sought. The patient's hives persisted. The reporter indicated the patient had hives from the vaccine. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient with allergies to cast and scallops who on 21-FEB-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included NYQUIL. 20 hours later, the patient developed hives. Unspecified medical attention was sought. The patient's hives persisted. The reporter indicated the patient had hives from the vaccine. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Food allergy, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with a cold at the time of the vaccination and unspecified if history of drug reaction /allergies who on 22-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant therapy included NYQUIL for the cold. On approximately 22-FEB-2007, within 12 to 18 hours of being vaccinated, the patient experienced hives which started on his hips and chest and then spread to her neck and face. Medical attention was sought. The outcome of the hives was not reported. No further information was available at the time of reporting. Additional information has been requested. Information has been received from a nurse practitioner concerning a 17 year old female student with an upper respiratory cold at the time of the vaccination and an allergy to shellfish and cats who on 21-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 655618/0186U) IM in the left deltoid at 2pm. Concomitant therapy included NYQUIL for the cold. On 22-FEB-2007, within 12 to 18 hours of being vaccinated, the patient experienced hives which started on her hips and then spread to her neck and face. Medical attention was sought. The outcome of the hives was not reported. No further information was available at the time of reporting. Additional information was received from the NP who reported that the patient's mother had called on 22-FEB-2007 stating the patient developed hives anout 24 hours (1pm on 22-FEB-2007) after receiving the injection/ The patient took BENADRYL OTC for treatment. Subsequently, the patient recovered.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with a cold at the time of the vaccination and unspecified if history of drug reaction /allergies who on 22-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant therapy included NYQUIL for the cold. On approximately 22-FEB-2007, within 12 to 18 hours of being vaccinated, the patient experienced hives which started on his hips and chest and then spread to her neck and face. Medical attention was sought. The outcome of the hives was not reported. No further information was available at the time of reporting. Additional information has been requested. Information has been received from a nurse practitioner concerning a 17 year old female student with an upper respiratory cold at the time of the vaccination and an allergy to shellfish and cats who on 21-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 655618/0186U) IM in the left deltoid at 2pm. Concomitant therapy included NYQUIL for the cold. On 22-FEB-2007, within 12 to 18 hours of being vaccinated, the patient experienced hives which started on her hips and then spread to her neck and face. Medical attention was sought. The outcome of the hives was not reported. No further information was available at the time of reporting. Additional information was received from the NP who reported that the patient's mother had called on 22-FEB-2007 stating the patient developed hives anout 24 hours (1pm on 22-FEB-2007) after receiving the injection/ The patient took BENADRYL OTC for treatment. Subsequently, the patient recovered.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia, Rash, Sick relative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 12-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 ml IM. Concomitant therapy included YASMIN and ULTRAM. On 12-FEB-2007, the patient developed a rash on her chest, low grade fever and she felt like she had the flu after receiving the first immunization with Gardasil. Unspecified medical attention was sought. On 13-FEB-2007, the patient recovered. No other information was available at the time of reporting. Additional information has been requested. Additional information was received from the LPN who reported that the events occurred on 13-FEB-2007. The patient's children were sick at the time. Her symptoms subsided the next day. No additional information  is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Syncope
Clinical narrative: Information has been received from a mother concerning her 18 year old daughter who on 14-DEC-2006 was vaccinated with Gardasil (lot # not reported) IM. Concomitant therapy included "TENUS therapy unspecified and hepatitis A virus vaccine (unspecified)" date not provided. The mother reported that her daughter fainted and also experienced pain in her arm after receiving Gardasil. The onset date was reported as 24-Dec-2006. At the time of reporting, the patient had recovered. Additional information has been requested. Information has been received from a mother concerning her 18 year old daughter who on 14-DEC-2006 was vaccinated with a first dose of GARDASIL (lot # 654389/0961F) IM in the left arm. Concomitant therapy also given on 14-DEC-2006 included a first dose of HEPATITIS A virus vaccine inactivated (Lot # 656495/1209P) in the left arm and a first dose of ADADEL (lot # 538AA) given in the right arm. The mother reported that her daughter fainted and also experienced pain in her arm after receiving GARDASIL. The onset date was reported as 27-DEC-2006.At the time of reporting, the patient hasd recovered. Additional information was received from the phyhsician. The patient fainted on 14-DEC-2006 and subsequently recovered. On 12-MAR-2007, the patient was vaccinated withthe second dose of GARDASIL (lot # 654389/0961P) in the right arm. No reports of fainting, no problem. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date in January 2007, was vaccinated with Gardasil (lot # not provided). That same day the patient experienced dizziness after the vaccination. At the time of this report the patient had not recovered from the dizziness. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chest pain, Nausea
Clinical narrative: Information has been received from a nurse a the daughter of a female patient (demographics not provided) who on 06-SEP-2006 was vaccinated with the first dose of Gardasil (Lot # not provided). The mother reported to the nurse that on 06-SEP-2006 after receiving the vaccination her daughter developed an elevated temperature (actual measurement not provided), nausea and chest pain. The mother reported to the nurse that she gave her daughter Benadryl (dose not provided). It was reported that the nausea, elevated temperature and chest pain resolved "in about three days". Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Headache, Inappropriate schedule of drug administration, Motion sickness, Nausea
Clinical narrative: Information has been received from a nurse concerning a 27 year old female who on 12-FEB-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # not provided). Subsequently, on 13-FEB-2007 the patient reported that her "face felt hot", she had a fever, nausea and headache. On 23-FEB-2007 the patient reported that she had an additional symptom similar to motion sickness. The patient sought unspecified medical attention. At the time of this report the patient has not recovered from the events. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 27 year old female who on 12-FEB-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # not provided). Subsequently, on 13-FEB-2007 the patient reported that her "face felt hot", she had a fever, nausea and headache. On 23-FEB-2007 the patient reported that she had an additional symptom similar to motion sickness. The patient sought unspecified medical attention. At the time of this report the patient has not recovered from the events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 14 Feb 2007 was vaccinated IM in the left deltoid with a 0.5mL dose of Gardasil vaccine. There was no concomitant medication. On 22 Feb 2007 the patient "developed a painful lump underneath the arm pit of the same injection arm". The nurse reported that the patient was told to follow up with the physician as soon as possible. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site erythema, Oedema peripheral
Clinical narrative: Information has been received from a health professional ("nurse"), via a company representative concerning a 15 year old female who on approximately 14 Feb 2007 ("sometime last week") was vaccinated IM with a second dose of Gardasil vaccine (yeast) (the patient's first vaccination date was not reported). Concomitant suspect vaccinations included a dose of Varicella and hepatitis A vaccine (inactive). On approximately 14 Feb 2006 ("sometime last week"), the instant after getting the vaccinations, the patient developed a "swallowed" red arm 8-9cm long and 6 cm wide. 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. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a health professional ("nurse"), via a company representative and a physician concerning a 15 year old female (weight 124.25%, height 66.5%) with codeine and sulfa allergies who on 16-FEB-2007 was vaccinated IM in the left arm with a second dose of GARDASIL (lot #656049/0187U) (the patient's first vaccination date was not reported). Concomitant suspect vaccinations on 16-FEB-2007 included the second dose of VARIVAX (lot # 654757/1257F), SC in the left arm and the first dose of VAQTA (lot #656017/1280F), IM in the right arm. Other concomitant medication was not reported. On 16-FEB-2006, the instant after getting the vaccinations, the patient developed a "swallowed" red arm 8-9 cm long and 6 cm wide (also reported as redness at the sie of the injection). The patient sought unspecified medical attention and was treated with ZYRTEC. On 16-FEB-2007, the patient recovered from the event. Additional information is not expected. This is in follow-up to report (s) previously submitted on 3/14/2007; 7/6/2007.  Information has been received from a health professional ("nurse"), via a company representative and a physician concerning a 15 year old female with codeine and sulfa allergies who on 16-FEB-2007 was vaccinated IM in the left arm with a second dose of GARDASIL (lot #656049/0187U) (the patient's first vaccination date was not reported).  Concomitant suspect vaccination on 16-FEB-2007 included the second dose of VARIVAX (lot # 654752/1257F), SC in the left arm.  Other concomitant medication included the first dose of VAQTA (lot #656017/1280F), IM in the right arm.  On 16-FEB-2006, the instant after getting the vaccinations, the patient developed a "swallowed" red arm 8-9 cm long and 6 cm wide (also reported as redness at the site of the injection).  The patient sought unspecified medical attention and was treated with ZYRTEC.  On 16-FEB-2007, the patient recovered from the event.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 23 Feb 2007 was vaccinated with the first dose of Gardasil. On 23 Feb 2007, after the vaccination, the patient passed out and experienced a tingling sensation in her extremities. The patient's outcome was unknown.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 21 Feb 2007 was vaccinated with 0.5ml dose of Gardasil. Concomitant therapy included Adacel. Subsequently the patient "felt sick" and passed out. It was reported that the patient was at home when she passed out but it was unknown how long after she received the vaccination. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from an office manager concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a rash over body and legs that caused severe itching after Gardasil was administered. On an unspecified date, the patient sought unspecified medical attention. The patient's rash over body and legs that caused severe itching persisted. Additional information has been requested. Information received 04/03/2009. The patient's rash over body and legs that caused sever itching was gone within 4-5 days. Additional informaiton is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, on an unspecified date, the patient passed out after receiving the vaccine. The nurse reported that the patient had not eaten. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter, a female patient who was vaccinated with the first dose of Gardasil. Subsequently the patient "broke out in hives after initial dose." It is unknown if the patient recovered. The patient sought unspecified medical attention. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Conjunctivitis, Full blood count normal, Keratitis, Photosensitivity reaction
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 17 year old female patient, with a history of a "hive like reaction" after receiving a dose of MMR (vaccine) when she was 1 year old," who on 03-FEB-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. Following the vaccination, on 22-FEB-2007, the nurse reported that her daughter developed uveitis with photosensitivity and an itchy rash to her legs, arms and trunk. The nurse confirmed that the uveitis was treated with prednisolone eye drops, and the condition "improved." The nurse stated that the rash on her daughter's legs, arms and trunk had not resolved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a registered nurse(RN) and a certified physician's assistant (PAC) , concerning the RN's  daughter, 1 17 year old female student, with a history of "hive like reaction" after receiving a dose of MMR vaccine when she as 1 year old, who on 11-JAN-2007 (reported by the mother on 03-FEB-2007) was vaccinated with the first dose of GARDASIL vaccine (yeast) ( Lot # 654885/1424F). There was no concomitant medication. The PAC indicated the patient was seen on the day of vaccination, 11-JAN-2007, for treatment of conjuntivitis and questioned possible adenovirus. The PAC reported the patient developed uveitis with photosensitivity, and an itchy rash to her legs, arms and trunk. She confirmed that the diagnosis of uveitis was made bya an optometrist who had seen her daughter. The nurse stated that the uveitis was treated with PRED-FORTE eye drops for 10 days on a tapering dose. The PAC confirmed that on 26-FEB-2007, the patient had the following diagnostic tests: complete blood count with differential, normal; erythrocyte sedimentation rate 3mm/hour; antinuclear antibodies ELISA screen, negative; and rheeumatoid factor screen, <3 IU/ml. Follow up information from the mother of the patient, indicated that "one week after discontinuing the prednisolone drops, her daughter "got photosensitive again." The mother then took her daughter toa an ophthalmologist, whom she reported was "tending toward  keratitis." Keratitis was also confirmed by the PAC. The patient was again  treated with prednisolone. The PAC confirmed that at the time of this report, the patient had recovered from the events (date  not specified). No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Uveitis
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 17 year old female patient, with a history of a "hive like reaction" after receiving a dose of MMR (vaccine) when she was 1 year old," who on 03-FEB-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. Following the vaccination, on 22-FEB-2007, the nurse reported that her daughter developed uveitis with photosensitivity and an itchy rash to her legs, arms and trunk. The nurse confirmed that the uveitis was treated with prednisolone eye drops, and the condition "improved." The nurse stated that the rash on her daughter's legs, arms and trunk had not resolved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a registered nurse(RN) and a certified physician's assistant (PAC) , concerning the RN's  daughter, 1 17 year old female student, with a history of "hive like reaction" after receiving a dose of MMR vaccine when she as 1 year old, who on 11-JAN-2007 (reported by the mother on 03-FEB-2007) was vaccinated with the first dose of GARDASIL vaccine (yeast) ( Lot # 654885/1424F). There was no concomitant medication. The PAC indicated the patient was seen on the day of vaccination, 11-JAN-2007, for treatment of conjuntivitis and questioned possible adenovirus. The PAC reported the patient developed uveitis with photosensitivity, and an itchy rash to her legs, arms and trunk. She confirmed that the diagnosis of uveitis was made bya an optometrist who had seen her daughter. The nurse stated that the uveitis was treated with PRED-FORTE eye drops for 10 days on a tapering dose. The PAC confirmed that on 26-FEB-2007, the patient had the following diagnostic tests: complete blood count with differential, normal; erythrocyte sedimentation rate 3mm/hour; antinuclear antibodies ELISA screen, negative; and rheeumatoid factor screen, <3 IU/ml. Follow up information from the mother of the patient, indicated that "one week after discontinuing the prednisolone drops, her daughter "got photosensitive again." The mother then took her daughter toa an ophthalmologist, whom she reported was "tending toward  keratitis." Keratitis was also confirmed by the PAC. The patient was again  treated with prednisolone. The PAC confirmed that at the time of this report, the patient had recovered from the events (date  not specified). No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Diarrhoea, Dizziness, Fall, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with autoimmune hepatitis, who on 15 Feb 2005 was vaccinated with a dose, 0.5ml, IM, of Gardasil. Concomitant suspect therapy included Adacel, and other concomitant medication included birth control pills, prednisone, vitamins (unspecified) and calcium (unspecified). The nurse reported that on 15 Feb 2007, "20 hours later," the patient "felt lightheaded and passed out. She came to and when she got up she passed out and fell to the floor." The nurse further stated that "both episodes were very brief." On approximately 16 Feb 2007 ("later") the patient "had one episode of diarrhea." On the morning of 16 Feb 2007, the nurse stated that the patient was seen by the doctor and "blood pressure was normal and injection site looked fine. No treatment required." At the time of this report, the patient had recovered. Additional information has been requested. Information received 04/03/2009. The nurse confirmed that the patient actually experienced "two concurrent bried syncopal episodes." Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician who reported that her daughter was vaccinated with her second dose of HPV and experienced pain during the injection. The patient stated there was no pain when she received the first dose of HPV. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Face injury, Haemorrhage, Syncope, X-ray
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) with a history of "becomes sqeemish after being administered shots" who on approximately 01-JAN-2007 (about 8 weeks ago) was vaccinated with the first dose of HPV. Concomitant medication was not reported. On approximately 01-JAN-2007 (about 8 weeks ago), the patient fainted in the elevator after being administered the HPV and she hit her nose which started to bleed. The patient sought unspecified medical attention and was given an x-ray which showed that her nose was not broken. The patient was recovering from the events. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood test, Erythema, Laboratory test, Rash generalised, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 14-NOV-2007 and 16-JAN-2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV. On 16-JAN-2007, concomitant therapy included a second dose of varicella. Subsequently, on an unspecified date, the patient developed a generalized body rash (20-30 lesions) which were macular papules/erythema and were mainly on the upper extremities and some on the abdomen. There were none on the hands or feet or in the mouth. The patient did not have a temperature or lymph swelling. The papules/erythema were non-painful and not itchy. The physician stated that it did not present like chicken-pox. Routine blood work was performed (results not provided). At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been requested from a registered nurse concerning a female patient between the ages of 11 to 13 who within the last 3 months was vaccinated intramuscularly with a 0.5mL dose of HPV. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a female patient between the ages of 11 to 13 who within the last 3 months was vaccinated intramuscularly with a 0.5 mL dose of HPV. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested.