chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Choking sensation, Culture throat negative, Dyspnoea, Nausea, Pharyngeal oedema
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 29-JAN-2007 at 10:20 am was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot# not provided). On 10-APR-2007 at 14:30 the patient was vaccinated in the right deltoid with the second dose of Gardasil (lot# 03480). On 10-APR-2007 three to four hours post vaccination the patient experienced a swollen throat and had a hard time breathing. The patient was seen in the emergency room due to the severity of the experience. The patient complained of a "feeling of choking," slight nausea with no emesis. The patient reported that no other people in her home were ill with any sickness and she had no known allergies. A quick strep test and throat culture were both negative. The patient was treated with ibuprofen 600 mg, PO every eight hours as needed as well as salt water and loratadine as needed for discomfort. Subsequently, on 12-APR-2007 the patient recovered from the experience.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 29-JAN-2007 at 10:20 am was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot# not provided). On 10-APR-2007 at 14:30 the patient was vaccinated in the right deltoid with the second dose of Gardasil (lot# 03480). On 10-APR-2007 three to four hours post vaccination the patient experienced a swollen throat and had a hard time breathing. The patient was seen in the emergency room due to the severity of the experience. The patient complained of a "feeling of choking," slight nausea with no emesis. The patient reported that no other people in her home were ill with any sickness and she had no known allergies. A quick strep test and throat culture were both negative. The patient was treated with ibuprofen 600 mg, PO every eight hours as needed as well as salt water and loratadine as needed for discomfort. Subsequently, on 12-APR-2007 the patient recovered from the experience.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Hyperaesthesia, Hypersomnia
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter, with a sulfonamide allergy and drug hypersensitivity to codeine, who on 18-APR-2007 was vaccinated IM in the left arm, with the first dose, 0.5 ml, of GARDASIL vaccine (Lot # 655320/0088U). There was no concomitant medication. The patient's mother reported that on 18-APR-2007, immediately after receiving the vaccination, her daughter got pale, said she was going to throw up, and felt faint for about 15 minutes. The mother then added that while going out to the car, her daughter had 3 recurrences of feeling like she was going to faint, and had to sit with an ice pack on her neck for 10 minutes with each occurrence. On the way home in the car, her daughter complained that her hands and feet felt tingly and her vision became blurred for about 10 minutes. Once at home, the mother explained that her daughter experienced severe stomach cramps, and then one hour later had diarrhea "which lasted through the night and into the early afternoon of the next day." On 19-APR-2007 ("the next day"), she became extremely lethargic, fell asleep at 2pm and slept until the next day. On approximately 20-APR-2007 ("the next day"), the mother said her daughter "felt better," however, the arm where the injection was administered was extremely sore, and no pressure could be tolerated on that arm; she confirmed that her daughter had recovered from all of the symptoms, with the exception of her sore arm, which was "still tender but gradually improving." Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Follow up information received from ahealthcare professional, indicated there was no illness at the time of vaccination, and confirmed the events of diarrhea and tingling in the arms and legs occurrred and lasted for 24 hours. however, the date of vaccine adminstration was reported by the healthcare professional as 05-MAR-2007, with a date of recovery on 06-MAR-2007. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lethargy, Nausea, Pain in extremity, Pallor
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter, with a sulfonamide allergy and drug hypersensitivity to codeine, who on 18-APR-2007 was vaccinated IM in the left arm, with the first dose, 0.5 ml, of GARDASIL vaccine (Lot # 655320/0088U). There was no concomitant medication. The patient's mother reported that on 18-APR-2007, immediately after receiving the vaccination, her daughter got pale, said she was going to throw up, and felt faint for about 15 minutes. The mother then added that while going out to the car, her daughter had 3 recurrences of feeling like she was going to faint, and had to sit with an ice pack on her neck for 10 minutes with each occurrence. On the way home in the car, her daughter complained that her hands and feet felt tingly and her vision became blurred for about 10 minutes. Once at home, the mother explained that her daughter experienced severe stomach cramps, and then one hour later had diarrhea "which lasted through the night and into the early afternoon of the next day." On 19-APR-2007 ("the next day"), she became extremely lethargic, fell asleep at 2pm and slept until the next day. On approximately 20-APR-2007 ("the next day"), the mother said her daughter "felt better," however, the arm where the injection was administered was extremely sore, and no pressure could be tolerated on that arm; she confirmed that her daughter had recovered from all of the symptoms, with the exception of her sore arm, which was "still tender but gradually improving." Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Follow up information received from ahealthcare professional, indicated there was no illness at the time of vaccination, and confirmed the events of diarrhea and tingling in the arms and legs occurrred and lasted for 24 hours. however, the date of vaccine adminstration was reported by the healthcare professional as 05-MAR-2007, with a date of recovery on 06-MAR-2007. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Presyncope, Vision blurred
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter, with a sulfonamide allergy and drug hypersensitivity to codeine, who on 18-APR-2007 was vaccinated IM in the left arm, with the first dose, 0.5 ml, of GARDASIL vaccine (Lot # 655320/0088U). There was no concomitant medication. The patient's mother reported that on 18-APR-2007, immediately after receiving the vaccination, her daughter got pale, said she was going to throw up, and felt faint for about 15 minutes. The mother then added that while going out to the car, her daughter had 3 recurrences of feeling like she was going to faint, and had to sit with an ice pack on her neck for 10 minutes with each occurrence. On the way home in the car, her daughter complained that her hands and feet felt tingly and her vision became blurred for about 10 minutes. Once at home, the mother explained that her daughter experienced severe stomach cramps, and then one hour later had diarrhea "which lasted through the night and into the early afternoon of the next day." On 19-APR-2007 ("the next day"), she became extremely lethargic, fell asleep at 2pm and slept until the next day. On approximately 20-APR-2007 ("the next day"), the mother said her daughter "felt better," however, the arm where the injection was administered was extremely sore, and no pressure could be tolerated on that arm; she confirmed that her daughter had recovered from all of the symptoms, with the exception of her sore arm, which was "still tender but gradually improving." Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Follow up information received from ahealthcare professional, indicated there was no illness at the time of vaccination, and confirmed the events of diarrhea and tingling in the arms and legs occurrred and lasted for 24 hours. however, the date of vaccine adminstration was reported by the healthcare professional as 05-MAR-2007, with a date of recovery on 06-MAR-2007. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning an approximately 20 year old female who on approximately 25-FEB-2007 was vaccinated with a first dose of Gardasil. Subsequently the patient developed amenorrhea. Unspecified medical attention was sought. It was reported that the patient planned to discontinue the series of injections. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient who on 25-APR-2007 was vaccinated IM in the left deltoid with her second dose of Gardasil. On the Friday after the injection, 27-APR-2007, swelling and bruising appeared at the injection site. On the Saturday after the injection, the injection site began to bleed. The patient stopped the bleeding with a compress and sought medical attention. She was fully recovered on an unspecified date. Additional information has been requested. Follow up information has been received concerning the medical assistant who at 8:20 a.m. on 15-APR-2007 was vaccinated IM in left deltoid with her second dose of GARDASIL. Two days after the injection the injection site was very sore and started to bleed. It was reorted that the injection site remained sore and bruised looking. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 12 year old female patient with sulfonamide allergy who was vaccinated with her first dose of Gardasil and had a "slight" reaction with a red swelling rash at injection site. In March 2007, she was vaccinated IM with her second dose Gardasil and had "a more extreme" rash. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning 13 year old female patient wit ha sulfonamide allergy who on 12-JAN-2007 was vaccinated IM into the left arm with her first dose of GARDASIL (lot # 653937/0637F).  She had a "slight" reaction with a red swelling rash at the injection site, a red bumpy rash on arms around breast and "mouth burned."  On 14-MAR-2007, she was vaccinated IM into the left arm with her second dose of GARDASIL (lot #655617/1447F).  Two days later on 16-MAR-2007 the patient developed the same reaction, described as a red, bumpy "more extreme" rash on arms, around breast and "mouth burned."  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0705USA00322 is a duplicate of WAES # 0704USA05691.  Therefore WAES # 0705USA00322 is being deleted from our files and the information consolidated into WAES # 0704USA05691.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Oral discomfort, Rash, Skin burning sensation
Clinical narrative: Information has been received from a physician concerning an approximately 12 year old female patient with sulfonamide allergy who was vaccinated with her first dose of Gardasil and had a "slight" reaction with a red swelling rash at injection site. In March 2007, she was vaccinated IM with her second dose Gardasil and had "a more extreme" rash. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning 13 year old female patient wit ha sulfonamide allergy who on 12-JAN-2007 was vaccinated IM into the left arm with her first dose of GARDASIL (lot # 653937/0637F).  She had a "slight" reaction with a red swelling rash at the injection site, a red bumpy rash on arms around breast and "mouth burned."  On 14-MAR-2007, she was vaccinated IM into the left arm with her second dose of GARDASIL (lot #655617/1447F).  Two days later on 16-MAR-2007 the patient developed the same reaction, described as a red, bumpy "more extreme" rash on arms, around breast and "mouth burned."  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0705USA00322 is a duplicate of WAES # 0704USA05691.  Therefore WAES # 0705USA00322 is being deleted from our files and the information consolidated into WAES # 0704USA05691.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from an office manager concerning a female (age not reported) who on 03-APR-2007 was vaccinated with the third dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date after the patient received her third dose of Gardasil, the patient developed a lump and soreness at the injection site. The patient sought unspecified medical attention. The patient's lump and soreness at injection site persisted. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 18-APR-2007 was vaccinated with Gardasil (Lot #653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN. On the evening of 20-APR-2007 the patient experienced hives which were generalized on her trunk. The patient was instructed to take BENADRYL but it did not help. She was examined by a physician in the emergency room on 22-APR-07. She was not admitted. She was given ATARAX and prednisone. After the first dose of Atarax her rash resolved. It was reported that the patient took "CORICIDIN" (therapy unspecified) for the first time the morning of 20-APR-2007. the patient's mother also stated that "her daughter often breaks out in hives". Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Nausea, Somnolence
Clinical narrative: Information has been received from a 26 year old female with a history of asthma who on 24-APR-2007 was vaccinated with Gardasil. Concomitant therapy included Sarafem and Yasmin. On 24-APR-2007 the patient experienced stomach nausea. She also felt very weak and went to bed early. The following day she woke to feel very faint and again had stomach nausea. No further information was provided.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 23-APR-2007 was vaccinated with Gardasil (Lot# 657617/0384U). On 23-APR-2007 the patient fainted before receiving dose two. The patient recovered and received the second dose that same day. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a female nurse in his office who was vaccinated IM with a first dose of Gardasil. The patient experienced "nausea" within 24 hours of receiving the first dose of Gardasil. Unspecified medical attention was sought. The patient was recovering. The physician reported that two other patients experienced nausea after receiving Gardasil. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Burning sensation, Headache, Inappropriate schedule of drug administration, Injection site irritation
Clinical narrative: Information has been received from a 27 year old female with a history of papilloma viral infection and loop electrosurgical excision procedure in January 2007, who was vaccinated with Gardasil. Concomitant therapy included ALLEGRA and YAZ. Subsequently, the patient received two doses of the vaccine. After the first vaccination she experienced pain that the injection site (right arm) which hurt and burn. She did not experience any injection site reactions after the second injection (left arm). She experienced headache approximately one day after her first and second injections. About a week after the second injection, she developed genital warts on her outer lip. She reported that she is not sexually active. At the time of this report, the genital warts persisted. Her last dose is due on 17-MAY-2007. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 27 year old female with a history of papilloma viral infection and loop electrosurgical excision procedure in January 2007, who was vaccinated with Gardasil. Concomitant therapy included ALLEGRA and YAZ. Subsequently, the patient received two doses of the vaccine. After the first vaccination she experienced pain that the injection site (right arm) which hurt and burn. She did not experience any injection site reactions after the second injection (left arm). She experienced headache approximately one day after her first and second injections. About a week after the second injection, she developed genital warts on her outer lip. She reported that she is not sexually active. At the time of this report, the genital warts persisted. Her last dose is due on 17-MAY-2007. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydia serology, Coombs indirect test negative, Culture urine negative, Full blood count normal, HIV antibody negative
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a health professional concerning a 16 year old sexually active female patient who is a smoker of tobacco and marijuana who on 29-NOV-2006 was vaccinated with a first dose of Gardasil. On 29-NOV-2006 the patient was treated with Bactrim DS for 10 days for a urinary tract infection. On 14-DEC-2006 the patient was being treated with Omnicef for days and a single dose of Flagyl for trichomoniasis and a possible urinary tract infection. On 22-JAN-2007 the patient received a second dose of Gardasil, IM into the right deltoid. On 22-JAN-2007 the patient was being treated with Macrodantin, 100 mg twice a day for 10 days for a urinary tract infection. On 05-FEB-2007 the patient was taking Bactrim and clotrimazole. On 09-FEB-2007 the patient was treated with Flagyl for 10 days and Rocephin injection for Zithromax 1 gm for pelvic inflammatory disease. On 09-MAR-2007 the patient was using a Xopenex inhaler and Advair and on 15-MAR-2007 she was taking Flagyl for 14 days. On 29-MAR-2007 she was taking Flagyl 500 mg and doxycycline for 10 days. On 14-APR-2007 serial beta HCG test was 24529 and on 16-APR-2007 it was 54860. (See lab section for additional labs) Her LMP was approximately 28-FEB-2007 (reported as "late February 2007"). It was reported that the baby was born full-term, healthy and normal and both "she" and the mother are fine. There were no complications. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis B antibody negative, Pelvic inflammatory disease, Pregnancy test negative, Rubella antibody negative, Syphilis test
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a health professional concerning a 16 year old sexually active female patient who is a smoker of tobacco and marijuana who on 29-NOV-2006 was vaccinated with a first dose of Gardasil. On 29-NOV-2006 the patient was treated with Bactrim DS for 10 days for a urinary tract infection. On 14-DEC-2006 the patient was being treated with Omnicef for days and a single dose of Flagyl for trichomoniasis and a possible urinary tract infection. On 22-JAN-2007 the patient received a second dose of Gardasil, IM into the right deltoid. On 22-JAN-2007 the patient was being treated with Macrodantin, 100 mg twice a day for 10 days for a urinary tract infection. On 05-FEB-2007 the patient was taking Bactrim and clotrimazole. On 09-FEB-2007 the patient was treated with Flagyl for 10 days and Rocephin injection for Zithromax 1 gm for pelvic inflammatory disease. On 09-MAR-2007 the patient was using a Xopenex inhaler and Advair and on 15-MAR-2007 she was taking Flagyl for 14 days. On 29-MAR-2007 she was taking Flagyl 500 mg and doxycycline for 10 days. On 14-APR-2007 serial beta HCG test was 24529 and on 16-APR-2007 it was 54860. (See lab section for additional labs) Her LMP was approximately 28-FEB-2007 (reported as "late February 2007"). It was reported that the baby was born full-term, healthy and normal and both "she" and the mother are fine. There were no complications. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Trichomoniasis, Urinary tract infection, Urine analysis abnormal, White blood cell count increased
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a health professional concerning a 16 year old sexually active female patient who is a smoker of tobacco and marijuana who on 29-NOV-2006 was vaccinated with a first dose of Gardasil. On 29-NOV-2006 the patient was treated with Bactrim DS for 10 days for a urinary tract infection. On 14-DEC-2006 the patient was being treated with Omnicef for days and a single dose of Flagyl for trichomoniasis and a possible urinary tract infection. On 22-JAN-2007 the patient received a second dose of Gardasil, IM into the right deltoid. On 22-JAN-2007 the patient was being treated with Macrodantin, 100 mg twice a day for 10 days for a urinary tract infection. On 05-FEB-2007 the patient was taking Bactrim and clotrimazole. On 09-FEB-2007 the patient was treated with Flagyl for 10 days and Rocephin injection for Zithromax 1 gm for pelvic inflammatory disease. On 09-MAR-2007 the patient was using a Xopenex inhaler and Advair and on 15-MAR-2007 she was taking Flagyl for 14 days. On 29-MAR-2007 she was taking Flagyl 500 mg and doxycycline for 10 days. On 14-APR-2007 serial beta HCG test was 24529 and on 16-APR-2007 it was 54860. (See lab section for additional labs) Her LMP was approximately 28-FEB-2007 (reported as "late February 2007"). It was reported that the baby was born full-term, healthy and normal and both "she" and the mother are fine. There were no complications. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash maculo-papular, Rash pustular
Clinical narrative: Initial and follow up information has been received from a physician and a health care professional concerning a 19 year old white female student who on 29-MAR-2007 at 1:00 pm was vaccinated IM in the left deltoid with a first dose of Gardasil. The physician reported after receiving the injection the patient developed "small red bumps and pustules behind her ears and along her neck." Follow up report came from a healthcare professional and it was reported that on 19-APR-2007 at 8:00 am the patient had fine, red, non-itchy maculo papular rash behind both ears/thighs. She was treated with prescription medication. The outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Syncope
Clinical narrative: Information has been received from a healthcare worker concerning a female who on 24-APR-2007 was vaccinated with Gardasil. On 25-APR-2007 the patient experienced fainting and other unspecified adverse experiences. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional that a high percentage of patients vaccinated with Gardasil subsequently experienced intense pain at the injection site at the time the vaccine was administered to them. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a health professional that a high percentage of patients vaccinated with GARDASIL subsequently experienced intense pain at the injection site at the time the vaccine was administered to them. It was reported that "at least 90% of patient's receiving the vaccine complained of intense pain at the injection site." The patient's complain that their arms feel heavy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced genital warts. No further information was provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Throat tightness
Clinical narrative: Information has been received from a pharmacist concerning a 26 year old female who on 16-MAR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included ZYRTEC. On 16-MAR-2007 the patient experienced itching and the sensation that her throat was closing up after taking an unspecified antihistamine. Medical attention was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 16 year old female who is not pregnant who was vaccinated with Gardasil. Subsequently, the patient experienced injection site pain about one week after vaccination. The pain diminished for a while and then returned as significant shoulder pain. She had no other vaccinations at the same time. She has had no treatment so far. She had sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from a certified medical assistant concerning a 26 year old female with no pertinent medical history and no prior drug reactions who on 28-FEB-2007 was vaccinated with first dose of Gardasil 0.5 cc intramuscularly in the left deltoid (Lot#656049/0187U). On 02-MAR-2007, two days after receiving the dose, the patient first noticed itching and then saw that she had broke out in red dots on her chest and legs. The symptoms lasted for 2 to 3 days and on approximately 04-MAR-2007 the patient recovered from broke out in red dots on chest and legs and itching. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007; 7/6/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 26 year old female, with no pertinent medical history and no prior drug reactions who on 28-FEB-2007 at 10:00 am was vaccinated with first dose GARDASIL 0.5 cc intramuscularly in the left deltoid (Lot#656049/0187U). Concomitant therapy included ANAPROX DS. On 02-MAR-2007, two days after receiving the dose, the patient first noticed itching and then saw that she had broke out in red dots on her chest and legs. The symptoms lasted for 2 to 3 days and on approximately 05-MAR-2007, the patient recovered. Additional information is not available.
Sex: F
Vaccine: HEPA, HPV4, MMR, VARCEL
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient, who on 24-APR-2007 was vaccinated with a dose of Gardasil (Lot #657617/0384U). Concomitant therapy may have included VARIVAX, MMR II and VAQTA. The nurse reported that "after receiving Gardasil, the patient nearly passed out and was lightheaded." The nurse confirmed that the patient had recovered on the same day, 24-APR-2007. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 19 year old female who on 22-FEB-2007 was vaccinated, in the deltoid, with Gardasil. On 22-FEB-2007 the patient experienced mild rash all over her body. On 23-APR-2007 the patient was vaccinated with her second dose, IM injection in the right deltoid and developed a severe rash all over body. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. It was reported that the physician "did not administer the vaccine and does not have any follow up information to provide". Additional information is not available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 19 year old female who on 22-FEB-2007 was vaccinated, in the deltoid, with Gardasil. On 22-FEB-2007 the patient experienced mild rash all over her body. On 23-APR-2007 the patient was vaccinated with her second dose, IM injection in the right deltoid and developed a severe rash all over body. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. It was reported that the physician "did not administer the vaccine and does not have any follow up information to provide". Additional information is not available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with a penicillin allergy who on 22-FEB-2007 was vaccinated with Gardasil (Lot 655619/1427F). Concomitant therapy included YASMIN. On 22-FEB-2007 the patient experienced rash. On 23-APR-2007 the patient received her second dose of Gardasil (Lot 657006/0188U). Within a few hours she developed a rash on her face, chest, arms and legs described as a red spotty and itchy. The rash was treated with Benadryl. After a couple of days the rash resolved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with a penicillin allergy who on 22-FEB-2007 was vaccinated with Gardasil (Lot 655619/1427F). Concomitant therapy included YASMIN. On 22-FEB-2007 the patient experienced rash. On 23-APR-2007 the patient received her second dose of Gardasil (Lot 657006/0188U). Within a few hours she developed a rash on her face, chest, arms and legs described as a red spotty and itchy. The rash was treated with Benadryl. After a couple of days the rash resolved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 25-APR-2007 was vaccinated with Gardasil. Concomitant therapy included ZOLOFT and YASMIN. On 25-APR-2007 the patient reported feeling lightheaded and saw spots. Subsequently, the patient recovered from feeling lightheaded and saw spots. This is one of two reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested. Information has been received from a physician and a nurse concerning a 21 year old female who on 25-APR-2007 was vaccinated IM into the left deltoid with a first dose of GARDASIL. There was no illness at the time of vaccination. Concomitant therapy included ZOLFT and YASMIN. On 25-APR-2007 the patinet reported feeling lightheaded, like she was going to pass out and sasw spots for 20 to 30 seconds. It was reported that she felt better right away. On 25-APR-207 the patient recovered. The patient had no problems since. This is one of two reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, No reaction on previous exposure to drug, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with Gardasil. After her second dose, the patient experienced nausea, diarrhea, vomiting and fever. The patient did not experience any symptoms after her first dose. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Initial and follow information has been received. Patient had no known allergies and no illness at the time of vaccination, who on 24-Apr-2007 was vaccinated IM in the right deltoid, with the second dose of GARDASIL (Lot # 655619/1427F). The following day, 25-Apr-2007, the patient experienced nausea, diarrhea, vomiting and fever, which lasted ofr 24 hours. The patient did not experience any symptoms after her first dose. The patient sought unspecified medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. the patient came back for her second vaccination and reported that she experienced pain at the injection site after her first vaccination. Subsequently, the patient recovered from pain at the injection site. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site nodule, Myalgia, Ultrasound scan normal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed a mass under her skin at injection site. the patient's mass persisted. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information have been received from a physician concerning a 26 year old female with a Sulfonamide (BACTRIM) allergy to who on 19-FEB-2007 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot #655126/0087U). Subsequently, on 29-MAR-2007 the patient called her physician and reported that she had developed a mass under her skin at injection site. On 02-APR-2007 the patient had an ultrasound of the area which was negative. The patient reported that she also had pain in the area in her triceps when working out. It was reported that after the use of heat/massage the area increased in size from approximately the size of  dime to an area the size of a quarter. On 07-MAY-2007 the patient was seen by the physician who reported that the lump felt like an injection site granuloma <10mm. The physician reported that there were no deformities, color changes or tenderness with deep palpatation. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a health professional concerning an approximately 16 year old female, who on 23-APR-2007 received her second vaccination with Gardasil. On 24-APR-2007 the patient experienced joint pain all over her body. The patient's joint pain persisted and was getting worse. Date of first vaccination not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning an approximately 25 year old female with an allergy to Hydrocodone, who on 15-NOV-2006 was vaccinated with Gardasil. Concomitant therapy included ORTHO-CYCLEN. A short time after her second dose, she had a routine Pap which was positive for abnormal cells and positive for a high risk strain of HPV. No other symptoms were reported. Date of first vaccination not provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Menstruation irregular, Metrorrhagia
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient who on 20-OCT-2006 was vaccinated with her first dose of Gardasil. The patient experienced her menstrual cycle a month late, and changes in flow and also spotting with less blood after receiving her first dose. On 21-DEC-2006 the patient received her second dose of Gardasil and experienced her menstrual cycle 10 days late. On 16-APR-2007 the patient received her third dose of Gardasil. It was reported that the patient developed the same menstrual cycle symptoms after each dose. Medical attention was sought. The patient recovered. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Gingival bleeding
Clinical narrative: Information has been received from a physician's assistant concerning a female who on 18-JAN-2007 was vaccinated with Gardasil. There was no concomitant medication. After vaccination on 18-JAN-2007 and 22-MAR-2007, the patient experienced bleeding gums. The duration and extent of the bleeding gums was unknown. It was unknown if the bleeding got worse with the second vaccination. The patient's father is an oral surgeon and felt that the bleeding of the gums was related to the Gardasil vaccination. The patient's bleeding gums persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Initial and follow-up information has been received from a physician's assistant concerning a female who on 18-JAN-2007 was vaccinated IM with a first dose of GARDASIL vaccine (Lot# 654702/0011U). There was no concomitant medication. Subsequently, the patient experienced bleeding gums. On 22-MAR-2007 the patient was vaccinated IM with a second dose of GARDASIL vaccine. Subsequently, the patient experienced bleeding gums. On 12-JUL-2007 the patient was vaccinated IM with a third dose of GARDASIL. Subsequently, the orthodontist noted "bleeding gums" after the third dose. The orthodontist felt that it was caused by "something new in the bloodstream." The duration and extent of the bleeding gum was unknown. It was unknown if the bleeding got worse with the second vaccination. The patient's father is an oral surgeon and felt that the bleeding of the gums was related to the GARDASIL vaccination. The patient's bleeding gums persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hallucination, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered pharmacist concerning an 11 year old female who, on an unspecified date, was vaccinated with a second dose of Gardasil. On 26-APR-2007, the patient was seen in the emergency room for hallucinations. The patient was discharged from the emergency room with instructions to follow-up with her pediatrician. The reporter stated that the patient was "fine" when she left the hospital. It was also noted by the reporter that the patient had reportedly experienced hallucinations after her first dose of Gardasil and was seen in the emergency room of another hospital. The reporter stated that the patient may have received other vaccinations with one or both of the Gardasil vaccine doses. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a health care worker concerning a 23 year old female with drug reactions to "emytin" and Cipro who on 02-APR-2007 was vaccinated intramuscularly with a third dose of Gardasil (Lot # 657006/0188U). On 02-APR-2007 the patient developed a lump on her right arm after administration of the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient's lump on her right arm persisted. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on approximately 25-FEB-2007 was vaccinated with Gardasil. On approximately 25-FEB-2007 the patient experienced numbness, headache, dizziness and muscle tenderness. After one week, the patient recovered. On 24-APR-2007 the second vaccination with Gardasil was given. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced fever and swollen glands. The patient's outcome was not reported. Medical attention was not sought. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning the daughter of a nurse who was vaccinated with a first dose of Gardasil. Patient experienced "nausea" within 24 hours after she received the first dose of Gardasil. It was not known if the patient sought medical attention. The patient's outcome was unknown. The physician reported that two other patient experienced nausea after receiving Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a daughter of a nurse who was vaccinated with a first dose of Gardasil. Patient experienced "nausea" within 24 hours after she received the first dose of Gardasil. It was not known if patient sought medical attention. The patient's outcome was unknown. The physician reported that two other patient experienced nausea after receiving the first dose of Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, the patient experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Culture, Laboratory test, Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 11 year old female who on 15-MAR-2007 was vaccinated with GARDASIL (lot # 655619/1427F). On 09-APR-2007 the patient experienced a erythematous rash that spread from the injection site down one arm and then to the other arm. Medical attention was sought. The patient had unspecified blood work and had throat culture (results not reported). Subsequently, the patient recovered from rash. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Chest X-ray normal, Full blood count, Lip swelling, Lymphocyte count increased
Clinical narrative: Initial and follow up information has been received from a Physician Assistant concerning an 18 year old female student with a history of tuberculosis test positive with Mantoux test and negative with chest x-ray who on 25-JAN-2007 was vaccinated IM with a first dose of Gardasil, lot # 653650/0702U. Concomitant therapy included Nuvaring. On 29-MAR-2007, at AM the patient was vaccinated with a second dose of Gardasi into the left arml. The night of 29-MAR-2007 she developed pain in the medial aspect of her left foot with swelling. On 30-APR-2007 (next day) she developed swelling of both feet. She also developed swelling along medial aspect of right foot. She tried a pain medication DICLOFENAC which was given to her for another condition without relief. She then had blisters on both hips and swelling of her lower lip. On 04-APR-2007 she was seen in the Urgent Care and was treated with Diclofenac, Claritin D and tapered Prednisone for 6 days. Sedimentation rate, complete Blood Count with differential studies performed. Lymphocytes was slightly elevated which was 48.5 HGB was 13.7. HCT was 39.9 and WBC was 6.3, Sed rate was at 16. The patient was seen on 06-Apr-2007 and 18-Apr-2007. The patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007; 7/6/2007. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a Physician Assistant concerning an 18 year old female student with a history of tuberculosis test positive with Mantoux test and negative with chest x-ray who on 25-JAN-2007 was vaccinated IM with a first dose of Gardasil, lot # 653650/0702U. Concomitant therapy included Nuvaring. On 29-MAR-2007, at AM the patient was vaccinated with a second dose of Gardasi into the left arml. The night of 29-MAR-2007 she developed pain in the medial aspect of her left foot with swelling. On 30-APR-2007 (next day) she developed swelling of both feet. She also developed swelling along medial aspect of right foot. She tried a pain medication DICLOFENAC which was given to her for another condition without relief. She then had blisters on both hips and swelling of her lower lip. On 04-APR-2007 she was seen in the Urgent Care and was treated with Diclofenac, Claritin D and tapered Prednisone for 6 days. Sedimentation rate, complete Blood Count with differential studies performed. Lymphocytes was slightly elevated which was 48.5 HGB was 13.7. HCT was 39.9 and WBC was 6.3, Sed rate was at 16. The patient was seen on 06-Apr-2007 and 18-Apr-2007. The patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007; 7/6/2007. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 year old female student, with asthma and an allergy to cefaclor (Ceclor), per her parents she had hypoglycemia with dizziness and syncope, a recent history of lightheadedness in school, who on 30-OCT-2006 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Zyrtec, Singulair and hormonal contraceptives (unspecified). On 21-DEC-2006, the second vaccination with Gardasil was administered. The patient had no adverse event with the first or second vaccination. On 26-APR-2007, late PM, the patient's vitals were taken (results not reported) and then she was vaccinated IM into the deltoid with a third dose of GARDASIL (lot # 657006/0188U). Concomitant therapy included ZYRTEC, SINGULAIR and hormonal contraceptives (unspecified) Ten minutes later, the patient fainted in the waiting room. Her blood pressure was 90/50. She had not eaten that afternoon before the vaccination. Subsequently, the patient recovered. Additional information has been requested.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient who on 19-FEB-2007 was vaccinated IM a first dose of with Gardasil lot #653736/0689F and on 24-APR-2007 she was vaccinated IM with a second dose of Gardasil lot # 655849/0263U. She became dizzy and flushed with sweating within minutes after her second injection was given. She quickly recovered. Additional information has been requested.  Additional information is not exepcted.