chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female (age was not reported) who was vaccinated with dose 1 and 2 (dates unknown) of Gardasil. Subsequently, after dose 2 was given, the patient developed pain at the injection site and fever. The patient did receive unspecified medical treatment and recovered from the fever and pain at injection site. Additional information has been requested. Information has been received froma physician concerning a female (age not reported) who was vaccinated with dose 1 and 2 (dates unknown) of HPV vaccine. Subsequently, after dose 2 was given, the patient developed pain at the injection site and fever. The patient did receive unspecified medical treatment and recovered fromthe fever and pain at injection site. Additional information has been received fromthe physician's office stating that they do not know which patient this adverse experience is referring to. This office did not report a adverse experience nor do they know who did reported it. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 18-OCT-2007 "this week", was vaccinated with a first 0.5ml dose of Gardasil. Subsequently, the patient fainted. Unspecified medical attention was sought. It was reported that the patient was monitored and recovered. No product quality complaint was involved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Vaginal infection
Clinical narrative: Information has been received from a pharmacy technician concerning a 11 year old daughter of a friend who in January 2007 (exact date unknown), was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). In Jan-2007, the patient developed a red, itching vaginitis after receiving the 1st dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Per the pharmacy technician, the patient's vaginitis persisted throughout the complete HPV rL1 6 11 16 18 VLP vaccine (yeast) series. The patient did receive unspecified medical attention and tropical creams were used to treat the problem. At the time of this report the patient has not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Menstruation delayed, Metrorrhagia
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pre-existing allergies or illness at time of vaccination who has had her period since the 6th grade was vaccinated intramuscularly in the left arm on 01-Aug-2007 with the 1st dose of  GARDASIL (lot# 658488/0930U). The patient was concomitantly vaccinated with HAVRIX. The doctor stated that the patient has not experienced a period since the time of the vaccination. Per the doctor. The patient had 1 day of "spotting" mid September and one day of "spotting" midf October. The patient was vaccinated intramuscularly in the left arm with the 2nd dose of GARDASIL on 05-Oct-2007 (lot# 658558/1061U). The patient cycles had been regular a few years prior to receiving the vaccination. The patient received unspecified medical attention and was referred to a gynecologist. At the time of this report the patient had not experienced a period.  Additional information has been requested.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 10-AUG-2007 was vaccinated with the 1st dose of GARDASIL. The doctor stated that the patient has not experienced a period time the time of that vaccination. The patient was vaccinated with the 2nd dose of GARDASIL on 12-Oct-2007. The patient received unspecified medical attention and at the time of this report, the patient has not experienced a period. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who in September 2007 (exact date unknown), was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast).  The doctor sated that the patient reported extreme pain in her arm since the vaccination 1 month ago.  The patient received unspecified medical attention.  The patient's outcome was not reported.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash macular
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced patient experience redness and blotchy spots on her chest and arms and thighs. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic inflammatory disease
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician reported that patient developed pelvic inflammatory disease after being vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient experienced swelling at the injection site. The patient called the physician's office. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female between the ages of 11 and 18 who on an unspecified date was vaccinated IM with the first dose of Gardasil (Lot# not provided). Subsequently, post vaccination the patient developed hives. The physician referred the patient to an allergist. At the time of this report it was unknown if the patient had recovered from the hives. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Familial risk factor, Menstruation delayed
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who was the daughter of the nurse practitioners patient. It was reported that on 02-SEP-2007 the girl was vaccinated (dose not reported) with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not reported). Subsequently, the girl experienced that her menstrual period was delayed two weeks post vaccination. Subsequently, she recovered from the delayed menstrual period. It was also reported that the patients other daughter had the same experience (WAES# 0710USA6260). Additional informtion has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 05-SEP-2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast)  (Lot# not provided). Subsequently for 24 hours post vaccination the patient experienced flu like symptoms and GI upset. Unspecified medical attention was sought. Subsequently, after 24 hours the patient recovered from the flu like symptoms and GI upset. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Erythema, Haematoma, Injection site discolouration, Injection site erythema
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history reported who in August 2007, was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) with no reaction. On 17-OCT-2007, the patient was vaccinated subcutaneously with a 0.5 mL second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a black and blue mark at the injection site on the same day of vaccination. The area turned red and swollen within 24 hours. The total area was larger than a 50 cents coin. The patient sought medical attention from the nurse. At the time of reporting, the patient had not recovered. Additional information has been requested. Follow-up information was received from the registered nurse. The patient reported that on 17-OCT-2007 the GARDASIL injection was given at the primary care physician's office in the right tricep arm area. On 18-OCT-2007, the hematoma appeared with a red hot area on the edge of the hematoma by the evening. The area was less hard by the morning. The patient also reported a red rash on the chest area which occurred in the morning which resolved. The patient also had local cellulitis from immunization. The patient was given KEFLEX and to do cold compress. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history reported who in August 2007, was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) with no reaction. On 17-OCT-2007, the patient was vaccinated subcutaneously with a 0.5 mL second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a black and blue mark at the injection site on the same day of vaccination. The area turned red and swollen within 24 hours. The total area was larger than a 50 cents coin. The patient sought medical attention from the nurse. At the time of reporting, the patient had not recovered. Additional information has been requested. Follow-up information was received from the registered nurse. The patient reported that on 17-OCT-2007 the GARDASIL injection was given at the primary care physician's office in the right tricep arm area. On 18-OCT-2007, the hematoma appeared with a red hot area on the edge of the hematoma by the evening. The area was less hard by the morning. The patient also reported a red rash on the chest area which occurred in the morning which resolved. The patient also had local cellulitis from immunization. The patient was given KEFLEX and to do cold compress. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), injection (form). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced local reaction at injection site where the area was "lumpy" for two weeks after receiving the HPV rL1 6 11 16 18 VLP vaccine (yeast). Unspecified medical attention was sought. Subsequently on an unspecified date, the patient recovered from local reaction at injection site where the area was "lumpy". No product quality complaint was involved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning an adolescent female ("older teen") who on an unspecified date was vaccinated with HPV rL1 6 11 16 18  VLP vaccine (yeast) (Lot# not reported). The nurse could not remember if this was the first dose of the vaccine the patient had received. Subsequently, post vaccination the patient developed localized redness at the injection site which lasted until the next day. Unspecified medical attention was sought. By the next day the patient was considered to have recovered from localized redness at the injection site. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a nurse practitioner concerning her daughter, a 16 year old female who on 02-SEP-2007 was vaccinated with HPV rL1 6 11 16 18  VLP vaccine (yeast). The patient was vaccinated concomitantly with varicella virus vaccine live (MMD), meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), pertussis vaccine (unspecified), tetanus toxoid and influenza virus vaccine (unspecified). The nurse practitioner reported that the patient started her menstrual period on 29-SEP-2007 and the period never stopped following the vaccination with HPV rL1 6 11 16 18 VLP vaccine (yeast). It was reported that the patient was not a patient of the nurse practitioner, but the daughter of the nurse practitioner. The nurse practitioner did not have further information at the time of the report. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dysmenorrhoea, Injection site pain
Clinical narrative: Information has been received from a grandmother concerning her 18 year old granddaughter with a history of painful menstruation who in approximately August 2007, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). In approximately August 2007, the grandmother had problems after her first vaccination of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient reported the vaccination was very painful. In approximately September 2007 the patient experienced a very painful menstrual period. On 15-OCT-2007 the patient experienced chest pain for which she saw two physicians (no further specified) The patient's very painful menstrual period and vaccination and chest pain persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 22-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast)., 0.5 ml, intramuscularly. On 22-Aug-2007 the patient experienced headaches. Subsequently the headaches resolved after a short duration. On 22-OCT-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 ml, intramuscularly and experienced headaches and nausea within a few hours. As of 22-OCT-2007 the patient's headaches and nausea persisted. The patient sought medical attention via phone. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from the father of a 21 year old female who on 08-OCT-2007 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and, right afterwards, experienced soreness at the injection site which lasted until the time of reporting. There was no concomitant medication. The patient had not recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Heart rate increased, Tremor
Clinical narrative: Information has been received from a physician concerning a 12 year old female who, approximately 3 months ago, on approximately 22-JUL-2007, was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP). On approximately 22-JUL-2007, after the administration of HPV rL1 6 11 16 18 VLP vaccine (yeast) the patient's heart rate speeded up, she got shaky and woozy but did not faint. The patient was laid down in the office, lights turned down and was monitored. Subsequently, the patient fully recovered from heart rate speeded up, got shaky and woozy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Burning sensation, Muscle tightness
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a "staff member" 18 years or older who was vaccinated by injection with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported that "after the patient received the second dose, the patient had experienced burning and muscle tightness. The burning and muscle tightness lasted for about five minutes and then it went away. There was no redness or swelling. The nurse said that they used a different arm from the first injection of HPV rL1 6 11 16 18 VLP vaccine (yeast)". The nurse also reported this same experienced happened to other patients after their second dose. (WAES # 0710USA00703, 0710USA00703). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a "young" female who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). "A while ago," the patient fainted after receiving HPV rL1 6 11 16 18 VLP vaccine. The patient's outcome was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Drug exposure during pregnancy, Fatigue, Laboratory test
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry, for HPV rL1 6 11 16 18 VLP vaccine (yeast), concerning her 13 year old daughter (who is her patient) with no pertinent medical history and with an allergic reaction to nickel who on 24-SEP-20007 was vaccinated with her third dosa of HPV rL1 6 11 16 18 VLP vaccine (yeast), injection (lot # not reported). There was no concomitant medication. The patient's mother said that on 24-SEP-2007, about 10 minutes after getting the third dosa of HPV rL1 6 11 16 18 VLP vaccine (yeast), her daughter had gotten violently ill. She got sick about five times, real weak, dizzy for about an hour, and tired. It was reported that it took about three days for her daughter to recover, and she did not go to school. On an unspecified date a home pregnancy test was performed. On an unspecified date the patient went to the physician's office to get an ultrasound and an unspecified blood test done (values not provided) (method of confirmation not reported). The patient subsequently found out that she was pregnant (date unspecified) (last menstrual period 11 weeks and 3 days, 03-Aug-2007). Estimated delivery date is 09-May-2008. The physician was going to treat the consumer's daughter during her pregnancy. Patient Quality Complaints (PQC) was not involved. Additional information as been requested.This is in follow-up to report (s) previously submittedon 11/14/2007. Follow up information was received on 12-Jun-2008. It was reported by the nurse that the patient had an uncomplicated vaginal birth of a 39 week IGGA male (full term) on 09-May-2008, who was healthy and normal, and weighed 3092 grams. Follow up information was received on 07-Jul-2008 (previously reported as congenital anomaltion and/or complications or abnormalities reported. There were no concurrent medical conditions reported. Follow up information was received on 17-Aug-2008. It was reported by the physician that the female baby's length was 49 cm, the apgar core was 9/9, and the head circumference was 14 cm. The patient developed 39 5/7 weeks from her last menstrual period. The infant was normal. No further information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry, for HPV rL1 6 11 16 18 VLP vaccine (yeast), concerning her 13 year old daughter (who is her patient) with no pertinent medical history and with an allergic reaction to nickel who on 24-SEP-20007 was vaccinated with her third dosa of HPV rL1 6 11 16 18 VLP vaccine (yeast), injection (lot # not reported). There was no concomitant medication. The patient's mother said that on 24-SEP-2007, about 10 minutes after getting the third dosa of HPV rL1 6 11 16 18 VLP vaccine (yeast), her daughter had gotten violently ill. She got sick about five times, real weak, dizzy for about an hour, and tired. It was reported that it took about three days for her daughter to recover, and she did not go to school. On an unspecified date a home pregnancy test was performed. On an unspecified date the patient went to the physician's office to get an ultrasound and an unspecified blood test done (values not provided) (method of confirmation not reported). The patient subsequently found out that she was pregnant (date unspecified) (last menstrual period 11 weeks and 3 days, 03-Aug-2007). Estimated delivery date is 09-May-2008. The physician was going to treat the consumer's daughter during her pregnancy. Patient Quality Complaints (PQC) was not involved. Additional information as been requested.This is in follow-up to report (s) previously submittedon 11/14/2007. Follow up information was received on 12-Jun-2008. It was reported by the nurse that the patient had an uncomplicated vaginal birth of a 39 week IGGA male (full term) on 09-May-2008, who was healthy and normal, and weighed 3092 grams. Follow up information was received on 07-Jul-2008 (previously reported as congenital anomaltion and/or complications or abnormalities reported. There were no concurrent medical conditions reported. Follow up information was received on 17-Aug-2008. It was reported by the physician that the female baby's length was 49 cm, the apgar core was 9/9, and the head circumference was 14 cm. The patient developed 39 5/7 weeks from her last menstrual period. The infant was normal. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no illness reported at the time of vaccination. The mother of the patient said that the patient experienced loss of period (amenorrhea) after receiving the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and the patient sought unspecified medical attention. Subsequently, the patient's period came back (date not reported). The patient experienced amenorrhea after receiving the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and it subsequently had been approximately 4 to 5 months and the patient still did not get period. The patient was not pregnant during these times. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 21 year old female with no known drug allergies, who on 14-AUG-2007 at 11:30 a.m., was vaccinated IM in the left deltoid with the first dose 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658222/0827U). Concomitant therapy included unspecified birth control medication. On 14-AUG_2007 (previously reported as 15-AUG-2007) the patient developed an egg shaped swelling at the injection site that lasted 1 week and dizziness that lasted for 2 days after her first immunization with HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no illness reported at the time of vaccination. The patient mentioned the adverse event at the next office visit. No laboratory/diagnostic tests were performed. Subsequently, the patient recovered from an egg shaped swelling at the injection site and dizziness. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no drug reaction/allergies and no pertinent medical history who on 15-OCT-2007 was vaccinated with 0.5 mL HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 658556/1060U). The patient received a simultaneous injection of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) that same day. On 17-OCT-2007 the patient experienced urticaria (area unspecified) for which the physician prescribed diphenhydramine hydrochloride (BENADRYL). No lab diagnostic studies were performed. Upon examination on 22-OCT-2007 the urticaria was resolved. No other symptoms or treatment were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Bloody discharge, Dyspareunia, Muscle spasms, Smear cervix normal, Ultrasound scan normal
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL vaccine IM (Lot# 657868/0523U). On 06-OCT-2007 the patient was vaccinated with her second dose of GARDASIL IM (Lot# 658558/1061U). Concomitant therapy included SINGULAIR, KARIVA and albuterol VENTILAN (albuterol). After the first dose of GARDASIL vaccine, the patient experienced cramping and bleeding discharge. The patient's outcome is unknown. After the second dose of GARDASIL vaccine, the patient experienced cramping and bleeding discharge only it was worse this time. The patient's cramping and bleeding persisted. The patient was not in her menstrual cycle. Physician performed vaginal screening and results were normal, sexually transmitted disease screen which was negative and a pelvic ultrasound  on 18-OCT-2007 that was within normal limits. It is also reported that the patient is experiencing pain during intercourse. The patient sought medical attention in the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Additional information has been received to indicate the patient has recovered.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 20-OCT-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) IM (Lot# 658560/1062U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 20-OCT-2007 the patient experienced syncope and tonic clonic movements ("slumped to the floor" and "flinching" ("seizure like")). Subsequently, the patient recovered from syncope and tonic clonic movements. The patient was placed into a chair and about 4-5 seconds later, the patient "came out of it." The patient was responsive to the nurse and other staff. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of CIN 1 and Benzoyl Peroxide allergy who on 10-SEP-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) IM (Lot# 658556/1030U). Subsequently the patient developed 2 warts on her fingers. The patient's 2 warts on her fingers persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 23 year old white female who on 09-OCT-2007 was vaccinated intramuscularly, into the left deltoid, with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #657872/0515U). Illness at the time of vaccination included a urinary tract infection. Concomitant therapy included nitrofurantoin (MACROBID) and ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 09-OCT-2007, in th evening, the patient experienced nausea, left arm pain and weakness. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Feeling hot, Malaise, Sleep disorder
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 08-OCT-2007 was vaccinated IM with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658558/1061U). There was no concomitant medication. On 09-OCT-2007 the patient's mother called the office to report that the patient believed that she was having a reaction to the vaccine. The patient was called by the physician. It was reported that the patient woke up through the night with severe abdominal cramps. She had no nausea, diarrhea or vomiting. She possibly had a fever "I felt warm." The patient stated that she didn't feel right. She didn't want to eat because her "stomach kind of hurts." The patient was told that if she experienced any signs of wheezing, trouble breathing or swallowing or if she had a fever she needed to go to the emergency room. The physician reported that this may be influenza type of symptoms but the patient should call her mother to let the office know how she was feeling. The patient recovered. On 01-AUG-2007 the patient was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and there were no concerns. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently "in the last 5 months" (in 2007) the patient passed out within a moment of being vaccinated. Medical attention was sought, in th office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and hepatitis A virus vaccine inactivated (HAVRIX). The other girls were receiving the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Menstrual disorder
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with asthma who on 09-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5mL IM. In August 2007, the patient missed her period for the month of August and developed headaches. The patient saught medical attention. She recovered from the symptoms, date not reported. On 09-OCT-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). She again developed headaches and did not have her period for the month of October. The patient still has headaches. No outcome was reported for missed periods. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning 2 female patients who ere vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently both patients fainted. Medical attention was sought, "they were in the office". Both patients recovered "within a few minutes". Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information will be provided if available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 11 year old female patient with a history of hypersensitivity to illosone who in July 2007, was vaccinated with her third dose of GARDASIL vaccine. Since August 2007, the patient experienced severe hives. The patient did not have any reactions with the first and second doses of GARASIL vaccine. The patient has been seen by a dermatologist and a allergist. In either late August or early September 2007, the patient's hands and feet began to swell requiring a visit to the emergency room. The patient has been on prednisone (manufacturer unknown), doxepin (manufacturer unknown), ranitidine (manufacturer unknown), ALLERGRA, and ZYRTEC. The medications were not helping. The patient did not recover from severe hives nor hands and feet swelling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Dizziness, Feeling hot
Clinical narrative: Information has been received from a healthcare professional concerning a 24 year old female who on 04-APR-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658563/1063U), 0.5mL IM for prophylaxis. Concomitant therapy included desogestrel/ethinyl estradiol (MIRCETTE). On an unspecified date, the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On 22-OCT-2007 the patient received her third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# not reported). On 23-OCT-2007 the patient experienced dizziness and hot and cold sweats. Medical attention was sought. The patient's dizziness and hot and cold sweats persisted. The product quality complaint unit was not involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Dizziness, Feeling of body temperature change, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a healthcare professional concerning a 24 year old female who on 04-APR-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658563/1063U), 0.5mL IM for prophylaxis. Concomitant therapy included desogestrel/ethinyl estradiol (MIRCETTE). On an unspecified date, the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On 22-OCT-2007 the patient received her third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# not reported). On 23-OCT-2007 the patient experienced dizziness and hot and cold sweats. Medical attention was sought. The patient's dizziness and hot and cold sweats persisted. The product quality complaint unit was not involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred, Vision blurred
Clinical narrative: Information has been received from a healthcare professional concerning a 24 year old female who on 04-APR-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658563/1063U), 0.5mL IM for prophylaxis. Concomitant therapy included desogestrel/ethinyl estradiol (MIRCETTE). On an unspecified date, the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On 22-OCT-2007 the patient received her third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# not reported). On 23-OCT-2007 the patient experienced dizziness and hot and cold sweats. Medical attention was sought. The patient's dizziness and hot and cold sweats persisted. The product quality complaint unit was not involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Dizziness, Feeling hot
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 22-OCT-2007 was vaccinated with her third dose of Gardasil vaccine. Concomitant therapy included Mircette. On 23-OCT-2007, the patient felt dizzy with hot and cold sweats, nausea and trouble focusing. The patient did not have any adverse events after receiving the first and second dose. The patient's outcome is unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a Caucasuan 24 year old female who on 22-OCT-2007 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (lot# 658563/1063U). Concomitant therapy included MIRCETTE. On 23-OCT-2007 the patient felt dizzy with hot and cold sweats and trouble focusing. The patient did not have any adverse events after receiving the first and second dose. Lasted at least 24 hours - a flu call was placed. The patient                                                                                              recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Dizziness, Feeling of body temperature change, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 22-OCT-2007 was vaccinated with her third dose of Gardasil vaccine. Concomitant therapy included Mircette. On 23-OCT-2007, the patient felt dizzy with hot and cold sweats, nausea and trouble focusing. The patient did not have any adverse events after receiving the first and second dose. The patient's outcome is unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a Caucasuan 24 year old female who on 22-OCT-2007 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (lot# 658563/1063U). Concomitant therapy included MIRCETTE. On 23-OCT-2007 the patient felt dizzy with hot and cold sweats and trouble focusing. The patient did not have any adverse events after receiving the first and second dose. Lasted at least 24 hours - a flu call was placed. The patient                                                                                              recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 22-OCT-2007 was vaccinated with her third dose of Gardasil vaccine. Concomitant therapy included Mircette. On 23-OCT-2007, the patient felt dizzy with hot and cold sweats, nausea and trouble focusing. The patient did not have any adverse events after receiving the first and second dose. The patient's outcome is unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a Caucasuan 24 year old female who on 22-OCT-2007 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (lot# 658563/1063U). Concomitant therapy included MIRCETTE. On 23-OCT-2007 the patient felt dizzy with hot and cold sweats and trouble focusing. The patient did not have any adverse events after receiving the first and second dose. Lasted at least 24 hours - a flu call was placed. The patient                                                                                              recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with first dose of GARDASIL, 0.5mL intramuscularly (IM). The patient was unable to wait in the office for 15 minutes after receiving GARDASIL. As the patient was walking out, she felt faint, fell and bumped her head. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 23 year old female patient (65 inches, 144 pounds) who on 19-OCT-2007, at 16:15 was vaccinated with first dose of GARDASIL, 0.5mL intramuscularly (IM) to the right deltoid. The patient was unable to wait in the office for 15 minutes after receiving GARDASIL. As the patient was walking out, she felt faint, had a vasovagal reaction, fell and bumped her head. Vital signs were within normal limits after "passing out". Unspecified medical attention was sought. Subsequently, the patient recovered on 18-OCT-2007. The product quality complaint unit was not involved. Further information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced severe muscle pain that last about 15-20 days after vaccination. Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced severe muscle pain that last about 15-20 days after vaccination. Subsequently, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15 who were vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patients fainted, this "happened at all doses not just one particular". Unspecified medical attention was sought. All continued with the therapy. The patient recovered, "all were ok".
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with no past medical history and no prior drug reactions who on 26-APR-2007 received her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot#  0211U), 0.5mL intramuscularly (IM) for prophylaxis. There were no concomitant therapies. On 28-JUN-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot# 0210U) and after a few minutes, fainted. Medical attention was sought in the office. The patient had no other symptoms and has fully recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified medical assistant in a physician's office concerning an 18 year old female who on 23-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). About 24 hours post vaccination the physician treated the patient with ZYRTEC which helped clear up the hives. The patient recently discontinued the use of ZYRTEC and the hives returned. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who in approximately August or September 2007 (exact date not reported) was vaccinated intramuscularly (site not reported) with the 1st dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). Post vaccination the patient fainted. The patient did received unspecified medical attention and recovered. This is one of several reports from the same source. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 11/14/2007. Post vaccination, the patient fainted and recovered after lying down. The patient did not report any other issues. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Injected limb mobility decreased, Injection site warmth, Limb discomfort
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female student (weight 99#, 61.25") who on 15-OCT-2007 at approximately 11:30 am was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #655849/0263U), IM in the left deltoid. Concomitant medication was not reported. On 15-OCT-2007 at 11:30 am, the patient experienced immediate pain, injection site warm to touch, felt clammy like she was going to "pass out", nausea, dizzy and she was unable to lift her arm. The patient was treated with cold compress to the site and acetaminophen (TYLENOL). The physicians office called the patient on an unspecified date, the patient reported that she felt better but her arm was very tender. Subsequently on 16-OCT-2007, the patient recovered from pain, injection site warm to touch, unable to lift arm, nausea, dizzy and felt clammy like she was going to "pass out". Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Tenderness
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female student (weight 99#, 61.25") who on 15-OCT-2007 at approximately 11:30 am was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #655849/0263U), IM in the left deltoid. Concomitant medication was not reported. On 15-OCT-2007 at 11:30 am, the patient experienced immediate pain, injection site warm to touch, felt clammy like she was going to "pass out", nausea, dizzy and she was unable to lift her arm. The patient was treated with cold compress to the site and acetaminophen (TYLENOL). The physicians office called the patient on an unspecified date, the patient reported that she felt better but her arm was very tender. Subsequently on 16-OCT-2007, the patient recovered from pain, injection site warm to touch, unable to lift arm, nausea, dizzy and felt clammy like she was going to "pass out". Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with asthma and allergy to sulfa who on 14-DEC-2006 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 14-DEC-2006 the patient experienced fever. The patient outcome was not reported. On 14-MAR-2007 the patient was vaccinated with a second dose of dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653937/0637F) and experienced local reaction at the injection site and arm swelling. The patient outcome was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Hypoaesthesia facial, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 27-JUL-2007 was vaccinated at her family practitioner with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/mestranol/norethindron (ORTHO-NOVUM). Immediately after being vaccinated with the first dose, she experienced headache and blurred vision and did not seek medical attention. The patient "recovered from that" and was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) on 19-OCT-2007 at her OB/Gyn office (her family doctor ran out of the vaccine) and was "feeling fine". There was no illness reported at the time of vaccinations. Two days later, on 21-OCT-2007, the patient called her OB/Gyn office because she was experiencing headache, blurred vision, numbness in her face and bilateral numbness in her lower extremities. No laboratory/diagnostic tests were performed. The physician reported that they will not administer the third dose. The patient "just didn't feel right" and the patient's headache, blurred vision, numbness in her face and bilateral numbness in her lower extremities persisted. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse midwife concerning a 24 year old female with no pertinent medical history and no drug reactions/allergies who on 12-OCT-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On 14-OCT_2007 the patient experienced nausea, vomiting and fever on the Sunday and Monday after having received a dose of HPV rL1 6 11 16 18 VLP vaccine on Friday. The patient called the office on 16-OCT-2007 to report the symptoms and mentioned that she was feeling better. Additional information has been requested.