chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Rash, Tenderness, Urine analysis
Clinical narrative: Information has been received from a secretary concerning a female who was vaccinated with her 3rd dose of Gardasil.  Subsequently the patient experienced severe body aches, rash on face and arms, and numbness.  Unspecified medical attention was sought.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a secretary and a physician concerning a 17 year old female who was vaccinated with third dose of GARDASIL. Two days after the vaccination, the patient experienced severe body aches, rash on face and arms, numbness, low grade fever, general malaise and abdominal pain. Unspecified medical attention was sought. She denied any headaches, burning with urination, no nausea, vomiting nor diarrhea. Vital signs were stable. The patient was non toxic and in no acute distress. Ear, nose, and throat were unremarkable. Abdomen is soft and depressible. Active bowel sounds. There was slight epigastric tenderness. No mass, no guarding, nor rebounding. A urinalysis test reported 5 - 10 white blood count with a few bacteria. The physician explained to the patient and her father that this may be related to something other than GARDASIL. The patient was given PREVACID 30 mg capsule once a day as needed for the epigastric pain. BACTRIM DS twice a day for 3 days and to drink fluids. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count
Clinical narrative: Information has been received from a secretary concerning a female who was vaccinated with her 3rd dose of Gardasil.  Subsequently the patient experienced severe body aches, rash on face and arms, and numbness.  Unspecified medical attention was sought.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a secretary and a physician concerning a 17 year old female who was vaccinated with third dose of GARDASIL. Two days after the vaccination, the patient experienced severe body aches, rash on face and arms, numbness, low grade fever, general malaise and abdominal pain. Unspecified medical attention was sought. She denied any headaches, burning with urination, no nausea, vomiting nor diarrhea. Vital signs were stable. The patient was non toxic and in no acute distress. Ear, nose, and throat were unremarkable. Abdomen is soft and depressible. Active bowel sounds. There was slight epigastric tenderness. No mass, no guarding, nor rebounding. A urinalysis test reported 5 - 10 white blood count with a few bacteria. The physician explained to the patient and her father that this may be related to something other than GARDASIL. The patient was given PREVACID 30 mg capsule once a day as needed for the epigastric pain. BACTRIM DS twice a day for 3 days and to drink fluids. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant and a physician (patient's dermatologist) concerning a 14 year old female student who was vaccinated in April 2007 with her third dose of Gardasil in the left arm and developed an injection site reaction. There was no concomitant medication. In May 20007 the patient developed left arm swelling, redness, tenderness and warm and firm to touch. The patient noted this did not happen with the first and second injections. The patient had recovered three weeks post injection. The patient's OB/GYN office who administered the Gardasil was not concerned. The patient's mother was concerned and took her to a dermatologist. Cool compresses were recommended for the patient. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant and a physician (patient's dermatologist) concerning a 14 year old female student who was vaccinated in April 2007 with her third dose of Gardasil in the left arm and developed an injection site reaction. There was no concomitant medication. In May 20007 the patient developed left arm swelling, redness, tenderness and warm and firm to touch. The patient noted this did not happen with the first and second injections. The patient had recovered three weeks post injection. The patient's OB/GYN office who administered the Gardasil was not concerned. The patient's mother was concerned and took her to a dermatologist. Cool compresses were recommended for the patient. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a Caucasian 24 year old female student with sulfonamide allergy, drug hypersensitivity and surgical tape allergy who on 08-MAY-2007 at PM was vaccinated IM in the right deltoid with her second dose of Gardasil (Lot #657617/0384U).  On 10-MAY-2007 at AM the patient experienced pain and developed swelling at the injection site, patient also had a fever and felt nauseous after receiving Gardasil.  The nurse recommended TYLENOL and BENADRYL and to use an ice pack at the injection site.  In follow up it was reported that on 10-MAY-2007 at AM the patient also developed redness at the injection site and took BENADRYL and TYLENOL and ice to the injection site.  On 11-MAY-2007 it was reported that the patient's condition improved.  Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Injection site pain, Joint range of motion decreased, Pain in extremity, Sensory disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female mall carrier with sulfa, penicillin, amoxicillin, lidocaine and Ceclor allergies who on 02-MAY-2007 was vaccinated IM into the left deltoid a third dose of GARDISIL (lot # 653938/0954P). The patient received her first dose of GARDISIL on 02-NOV-2006 and her second dose on 04-JAN-2007. Concomitant therapy included "Queruatin". On 02-MAY-2007 the patient experienced prolonged injection site pain and decreased range of motion in her arm. The pain began on the day of the of vaccination and had become more severe since that time. The patient called the office on 08-MAY-2007 and complained of very sore arm and "clicking sound in arm" with no redness or swelling. The patient was seen in hte office on 09-MAY-2007. No inflammation or edema was noted at that time. It was noted that the patient had missed 3 days of work. No labs were performed. At the time of this report, the patient had recovered. Additional infortmation is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female with an unspecified drug allergy who on 09-MAY-2007 was vaccinated IM with the first dose of Gardasil. Within an hour, the patient experienced shortness of breath and possibly hives. The physician sent the patient to the ER. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lethargy, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with no drug reactions/allergies and no reported medical history who on 08-MAY-2007 was vaccinated IM with the first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On th evening of 08-MAY-2007 the patient experienced headache, sore throat, swollen glands and felt lethargic.  She had no fever.  The events persisted as of 10-MAY-2007.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Information has been received from a physician and follow up information from a health care professional concerning a 21 year old female patient with no drug reactions/allergies who on 07-MAY-2007 was vaccinated IM in the right deltoid with the third dose of Gardasil (Lot #657617/0384U).  Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING).  On 08-MAY-2007 the patient experienced an injection site reaction of redness, swelling and the area was hot to the touch.  There were three red blotches near the injection site including the injection site.  No labs were performed.  Her outcome was not reported.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 17-APR-2007 was vaccinated with Gardasil.  On 25-APR-2007 the patient experienced pain in her upper right arm.  The physician noted there was no redness or swelling in the injection site area.  Subsequently, on 29-APR-2007, the patient recovered from pain in her upper right arm.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin, Vasculitis
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a BACTRIM allergy and a history of viral myocarditis (approximately 2005) who has had doses of Gardasil. Concomitant therapy included YASMIN. On 15-FEB-2007 the patient experienced subcutaneous vasculitis. A biopsy was performed which confirmed the subcutaneous vasculitis. The physician noted the two dosed of vaccine were administered at another facility so she did not have the dated of administration or the lot numbers. The patient's subcutaneous vasculitis persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal lesion
Clinical narrative: Information has been received from a physician concerning a female who on 05-MAY-2007 was vaccinated with Gardasil.  The physician reported that on 10-MAY-2007, the patient developed a lesion in the vaginal area.  No other information was reported.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 13 year old female who, on an unspecified date, was vaccinated with Gardasil.  Subsequently the patient experienced nausea, a slight fever and dizziness.  The reporting consumer felt that the nausea, slight fever and dizziness were related to therapy with Gardasil.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drooling, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced numbness in her lips and drooling.  This occurred mostly on the side of the body where the injection was given (not further specified).  The numbness lasted 2 hours but a tingling sensation lasted for the rest of the day.  Subsequently, the patient recovered from numbness in her lips and drooling.  The patient sought medical attention.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Medication error, Pain in extremity
Clinical narrative: Information has been received concerning a 26 year old female nursing student who on 09-MAY-2007 vaccinated herself with Gardasil (LOT#654741/1208P) which was exposed to room temperatures for about 4 hours, subcutaneously in her left arm. Concomitant therapy included cough, cold, and flu therapies (unspecified). On 09-MAY-2007 the patient's left arm hurt. The patient's experience persisted. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: Information has been received from a pharmacist concerning his 22 year old daughter with a sulfonamide allergy who on 08-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5ml intramuscularly.  There was no concomitant medication.  "Forty-eight hours post vaccination" on 09-MAY-2007 the patient experienced mild swelling in her throat.  No other symptoms were noted.  Unspecified medical attention was sought.  As of 11-MAY-2007, the patient was recovering.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling of body temperature change, Rash
Clinical narrative: Information has been received from a physician's assistant concerning a 14 year old female with no known drug allergies who on 10-MAY-2007 was vaccinated with a dose of GARDASIL, 0.5ml, intramuscularly (Lot# 654510/0962F). Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours of being vaccinated on 10-MAY-2007, the patient felt feverish and developed a small red rash on her abdomen, back and between her fingers. The patient's mother treated her with over the counter BENADRYL. On 11-MAY-2007, the patient recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Psoriasis, Rash
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no pertinent medical history who, six weeks ago, on approximately 30-MAR-2007, was vaccinated with GARDASIL.  Concomitant therapy included birth control pills (unspecified).  Subsequently, one to two weeks later, the patient developed a rash and was seen by a dermatologist.  The patient told the physician that it was diagnosed as psoriasis and that she received a cortisone injection.  The physician is unsure if this is related to GARDSIL because he has not yet received the report from the dermatologist.  Additional information has been requested. This is in follow-up to report (s) previously submitted on6/14/2007. Initial and follow-up information has been received from a physician concerning a 17 year old (previously reported as 20 year old) female student, who on 21-MAR-2007 was vaccinated IM in the left deltoid with a first dose of GARDASIL (lot # 657737/0522U). Concomitant therapy included birth control pills (unspecified). Subsequently, one to two weeks later, the patient developed a rash and was sen by a dermatologist. The patient told the physician that it was diagnosed as psoriasis and that she received a cortisone injection. The patient developed "OC's". "The physician is unsure of this is related to GARDASIL because he has not yet received the report from the dermatologist. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician's assistant concerning a 25 year old female patient, who was sexually active since October, 2006, and who on 26-JAN-2007 was vaccinated, IM, with the first dose, 0.5ml, of Gardasil, and on 30-MAR-2007, was vaccinated IM, with the second dose, 0.5ml, of Gardasil. Concomitant therapy included SPRINTEC. On 06-APR-2007, following the second vaccination, the patient developed genital warts. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. No additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Nausea, Nausea, Pallor
Clinical narrative: Information has been received from a nurse concerning a "14 or 15" year old female who was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil.  Subsequently the patient experienced nausea, was white in the face, and sick to the stomach.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up report(s) previously submitted on 6/14/2007; 7/6/2007. Information has been received from a nurse concerning a 13 year old female with a history of reactive sympathetic dystrophy, who on 11-DEC-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL second dose of GARDASIL (lot# 653937/0637F). Subsequently the patient experienced sick "queasy" to the stomach, dizzy, and weak immediately following the dose. The patient sought unspecified medical attention. Subsequently, the patient recovered on 11-DEC-2006. The patient's experience did not prevent her from receiving the third vaccination. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Stomach discomfort
Clinical narrative: Information has been received from a nurse concerning a "14 or 15" year old female who was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil.  Subsequently the patient experienced nausea, was white in the face, and sick to the stomach.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up report(s) previously submitted on 6/14/2007; 7/6/2007. Information has been received from a nurse concerning a 13 year old female with a history of reactive sympathetic dystrophy, who on 11-DEC-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL second dose of GARDASIL (lot# 653937/0637F). Subsequently the patient experienced sick "queasy" to the stomach, dizzy, and weak immediately following the dose. The patient sought unspecified medical attention. Subsequently, the patient recovered on 11-DEC-2006. The patient's experience did not prevent her from receiving the third vaccination. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood alkaline phosphatase, Blood chloride decreased, Blood potassium normal, Blood sodium normal, Diarrhoea
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female student who on 27-FEB-2007 was vaccinated in the right deltoid with Gardasil (lot # 655503/0012U) concomitantly with a dose of MENACTRA (lot # U2135AA) in the left deltoid. On 28-FEB-2007 the patient experienced "achey and sore all over", vomiting, dizzy, fever and diarrhea. On 05-MAR-207 the patient was seen in the doctors office and the family nurse practitioner prescribed PHENERGAN TABLETS/SUPPOSITORIES and diagnostic laboratory tests were performed. After 5 doses of PHENERGAN TABLETS/SUPPOSITORIES symptoms resolved. A diagnosis was provided of viral infection versus reaction to Gardasil. The patient's mother does not wish for her to continue the Gardasil series. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Pain, Pyrexia, Red blood cell count normal, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female student who on 27-FEB-2007 was vaccinated in the right deltoid with Gardasil (lot # 655503/0012U) concomitantly with a dose of MENACTRA (lot # U2135AA) in the left deltoid. On 28-FEB-2007 the patient experienced "achey and sore all over", vomiting, dizzy, fever and diarrhea. On 05-MAR-207 the patient was seen in the doctors office and the family nurse practitioner prescribed PHENERGAN TABLETS/SUPPOSITORIES and diagnostic laboratory tests were performed. After 5 doses of PHENERGAN TABLETS/SUPPOSITORIES symptoms resolved. A diagnosis was provided of viral infection versus reaction to Gardasil. The patient's mother does not wish for her to continue the Gardasil series. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: White blood cell count
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female student who on 27-FEB-2007 was vaccinated in the right deltoid with Gardasil (lot # 655503/0012U) concomitantly with a dose of MENACTRA (lot # U2135AA) in the left deltoid. On 28-FEB-2007 the patient experienced "achey and sore all over", vomiting, dizzy, fever and diarrhea. On 05-MAR-207 the patient was seen in the doctors office and the family nurse practitioner prescribed PHENERGAN TABLETS/SUPPOSITORIES and diagnostic laboratory tests were performed. After 5 doses of PHENERGAN TABLETS/SUPPOSITORIES symptoms resolved. A diagnosis was provided of viral infection versus reaction to Gardasil. The patient's mother does not wish for her to continue the Gardasil series. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a company representative concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient experienced severe injection site pain after receiving her first injection of Gardasil.  The patient was unable to lift her arm without pain for 2 days.  The outcome of the event was not reported.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a female who on 08-MAY-2007 was vaccinated IM 0.5mL first dose with GARDASIL vaccine (yeast) (lot# 657006/0188U).  Concomitant therapy included VARIVAX (MSD).  Subsequently the patient experienced swollen arm and arm redness after the Gardasil injection.  Subsequently, the patient recovered from swollen arm and arm redness.  The patient sought unspecified medial attention.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from s health professional concerning a female student who on 08-MAY-2007, in AM was vaccinated IM 0.5ml first dose with GARDASIL vaccine (yeast) (lot# 657006/0188U). Concomitant suspect therapy included one dose  of VARIVAX (lot# 656078/0169U. Other concomitant therapy included MENACTRA vaccine . The patient experienced swollen arm and arm redness after the GARDASIL vaccine (yeast) injection. Subsequently , the patient recovered from swollen arm and arm redness. The patient sought unspecified medical attention. In follow up it was reported that on 08-MAY-2007, "patient said that her arns hurt" and then redness, swelling appaered on 09-MAY-2007 and redness was approximately quarter size. The patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Photosensitivity reaction, Rash erythematous, Rash morbilliform, Seasonal allergy
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 22-MAR-2007 was vaccinated with Gardasil (lot# 657005/0314U). On 23-MAR-2007 the patient experienced diffuse erythematous rash upper and lower extremities. The patient sought medical attention on 26-MAR-2007 and was prescribed ZYRTEC. Subsequently, the patient recovered from diffuse erythematous rash upper and lower extremities. Additional information has been requested. Initial and follow up information has been received from a physician and a physician's assistant, concerning a 12 year old white female student with seasonal allergies, and no illnesses at the time of vaccination, who on 22-MAR-2007, at 9:00am, was vaccinated in the left gluteus maximus, with the first dose of GARDASIL (lot# 657005/0314U). On 23-MAR-2007, at 1:00pm, the patient experienced a morbilliform rash, also described as a diffuse erythematous rash, on the upper and lower extremities. The PA confirmed that the rash worsened when exposed to sunlight, but involved no itching. The patient sought medical attention on 26-MAR-2007 and was prescribed ZYRTEC. No laboratory diagnostic studies were performed. On 28-MAR-2007, the patient recovered from the morbilliform rash. On 21-MAY-2007, at 4:30pm, the patient was vaccinated in the right gluteus maximus, with the second dose of GARDASIL (lot# 657005/0314U). No further information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Diarrhoea, Nausea, Rash
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 09-MAR-2007 was vaccinated, IM 0.5 ml first dose, with Gardasil (lot# 657006/0188U).  On 09-MAR-2007 the patient experienced nausea and diarrhea.  On 12-MAR-2007 the patient experienced a rash on her chest and chest pain.  Subsequently, the patient recovered from nausea, diarrhea, rash and chest pain.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with Gardasil.  Subsequently the patient experienced "brief pain, lasting less than a second" at the injection site.  No additional information was available at the time of this report.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a company representative concerning a female who approximately in February 2007 (3 months ago), was vaccinated with the first dose of Gardasil and she experienced severe genital warts. Unspecified medical attention was sought. No other information was provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 08-May-2007 was vaccinated intramuscularly with 0.5 ml of Gardasil lot #657617/0384U, and felt pain after receiving vaccine.  The pain was initiated at the injection site and radiated down to her 3rd and 4th finger.  There was no visual redness or swelling.  This was her second vaccination.  She did not have any reaction on her first vaccination.  Unspecified medical attention was sought.  As of 14-May-2007, the patient has not recovered from her pain.   No further information is available.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Dysmenorrhoea, Herpes zoster, Local reaction, Pain of skin
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with a history of Hodgkin's disease (at the age of 12, patient was diagnosed with Hodgkin's disease and went thru Chemotherapy), who was vaccinated a few weeks ago with Gardasil. The patient developed localized reaction like shingles after getting vaccine. Unspecified medical attention was sought. No additional information was provided. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 16 year old white female patient with Hodgkin's disease (diagnosed at age 12 and went through Chemotherapy and illness at time of vaccination included dysmenorrhea) who on 15-JAN-2007 at 12:07, was vaccinated IM with a first 0.5 ml dose of GARDASIL. On 22-JAN-2007, one week after receiving the vaccine, the patient developed painful vesicles which lasted for six weeks. The patient described them as a painful cluster of red bumps that enlarged, blisters erupted followed by crusting over. It was reported that the patient was not seen for eight weeks after the injection and the vesicles were not verified by the staff. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Scab
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with a history of Hodgkin's disease (at the age of 12, patient was diagnosed with Hodgkin's disease and went thru Chemotherapy), who was vaccinated a few weeks ago with Gardasil. The patient developed localized reaction like shingles after getting vaccine. Unspecified medical attention was sought. No additional information was provided. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 16 year old white female patient with Hodgkin's disease (diagnosed at age 12 and went through Chemotherapy and illness at time of vaccination included dysmenorrhea) who on 15-JAN-2007 at 12:07, was vaccinated IM with a first 0.5 ml dose of GARDASIL. On 22-JAN-2007, one week after receiving the vaccine, the patient developed painful vesicles which lasted for six weeks. The patient described them as a painful cluster of red bumps that enlarged, blisters erupted followed by crusting over. It was reported that the patient was not seen for eight weeks after the injection and the vesicles were not verified by the staff. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Hot flush, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician and a nurse concerning a 17 year old female who was vaccinated with Gardasil (lot number unknown).  Right after administration of the vaccine, the patient experienced hot flashes, reddening of the face, dizziness and sweating on her head.  The patient's outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed visiting nurse, via a company representative, concerning a female student in twelfth grade, who on 14-MAY-2007 was vaccinated at a high school health fair, with the first dose of Gardasil. Concomitant therapy included MENACTRA. The nurse reported that after receiving the vaccination, the patient fainted, and later recovered on the same day, 14-MAY-2007. The patient sought unspecified medical attention. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning an 18 year old white female student (145 lbs., 64 in.) who on 15-MAR-2007 was vaccinated with Gardasil (Lot #654702/0011U).  On 15-MAR-2007 the patient experienced feeling dizzy after the injection.  The patient had not eaten all day.  The patient's outcome was not reported.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on approximately 14-MAR-2007 ("approximately 2 months ago"), was vaccinated with the first dose of Gardasil (dose not specified).  The day following the vaccination, the patient called the physician to report she had developed a rash on her arm, though not at the injection site, as well as on other parts of her body.  The patient presented to the office 2 or 3 days later, and a cream (unspecified) was prescribed as treatment.  At the time of this report, it wan unknown if the patient had recovered from the rash.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Gardasil.  Subsequently the patient experienced swelling, rash and hives.  The patient's outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL vacine (yeast)l.  Subsequently the patient's arm was sore at the injection site.  The patient recovered after one month.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been eceived from a physician concerning a female who on an unspecified date was vaccinated intramuscularly with GARDASIL vaccine (yeast). The reporting physician was told by a family physician that one of his patients who he vaccinated with GARDASIl vaccine (yeast) subsequently deveolped arm swelling and was sore at the injection site for approximately 10 days post vaccination. The patient recovered after one month.No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician, via a company representative, concerning an approximately 15 year old female patient, who was vaccinated (date and dose not specified) with the second dose of Gardasil.  There was no concomitant medication.  The physician reported that after the vaccine was administered, the patient had a fever that lasted for 24 hours.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Headache, Hypersensitivity, Throat irritation
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 16-APR-2007 was vaccinated with Gardasil (Lot #657005/0314U).  On 16-APR-2007 the patient experienced a cough, headache and itchy throat for two weeks after vaccination.  The patient saw her primary care physician who diagnosed her with allergies and possible bronchitis.  The patient was treated with loratadine (CLARITIN) and amoxicillin.  Medical attention was sought.  The patient's outcome was not reported.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Nausea, Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse and from the emergency room medical record concerning a 23 year old female hair stylist with irregular menstruation, attention deficit/hyperactivity disorder and a history of anaemia, Crohn's disease and infectious mononucleosis who on 08-FEB-2007, at 14:15 PM was vaccinated IM in to right deltoid with a first dose of Gardasil lot #654702/0011U. She received the second dose of Gardasil on an unspecified date. Concomitant therapy included azathioprine (IMURAN (azathioprine)), ethinyl estradiol (+) levonorgestrel (SEASONALE) and balsalazide disodium (COLAZAL). On 08-FEB-2007 later that day patient experienced nausea and vomiting. She was seen in the emergency room (ER) that night. She was treated with an unnamed antinausea medication and intravenous fluids. She was sent home later. She had no adverse symptoms after the second injection. The patient recovered. The reporter felt that getting unnamed antinausea medication and intravenous fluids was to prevent patient from being serious and considered this as a serious other medical event. Additional information has been requested. In the follow up it was indicated that on 08-FEB-2007 patient began experiencing nausea and vomiting approximately 1/2 hour after receiving her first dose of GARDASIL was unable to hold down any food, fluids through the afternoon or evening. She went to the emergency room (ER) for evaluation and Intravenous (IV) fluids. ER record indicated she wen to the ER complained pain in her back, legs and abdomen. She had nausea, vomiting, fever and she was pale and weak. The pain characteristic was cramping, sharp and constant. She also had bodyache and myalgia, she was treated in the ER with TYLENOL gram by mouth, ANTIVERT 12.5 milligram intravenous (IV), TORADOL 30 milligram IV, ROCEPHIN 2 gram IV and 2 litters of normal saline solution (NSS) IV. Initially patient went to the ER her temperature measurement was 102.4 F, pulse was 135, respiration was 20 and blood pressure was 88/52. Patient's blood pressure measurement was 88/55, heart rate was 108 and respiration was 19 at the time of discharge from the ER. Pulse Oximetry was 100% on room air (RA). On 09-FEB-2007 the patient recovered. On an unspecified day she received the second dose of GARDASIL and had no adverse symptoms. The reporter no longer considered the events to be other important medical events. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Enlarged uvula
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 07-MAY-2007 was vaccinated IM with the first dose of Gardasil (Lot #657617/0384U).  On 11-MAY-2007 the patient experienced a swollen uvula.  The patient's outcome was not reported.  Medical attention was sought.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced pain around the injection site for 10 days.  Medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female who on 09-MAY-2007 was vaccinated with a dose of Gardasil (lot# 657622/0388U).  Several hours post vaccination the patient developed a headache and joint pain.  The patient took OTC TYLENOL and the symptoms resolved within 24 hours.  Medical attention was sought.  The patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac flutter
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with 0.5 ml of the first dose of Gardasil. Within 24 hours after receiving the vaccine, the patient experienced rapid fluttering of the heart, which she described as a sort of "heart murmur". Subsequently, the patient recovered from rapid fluttering of the heart. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 25 year old female with no known allergies who on 04-FEB-2007 was vaccinated with the first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 04-FEB-2007 the patient broke out in hives after the first dose of Gardasil.  On 08-MAY-2007, the patient was vaccinated with the second dose of Gardasil.  Within one day, the patient broke out into hives after the second dose.  Medical attention was sought.  The physician treated the patient with Zyrtec and oral steroids.  As of 15-MAY-2007, the patient was recovering.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Culture urine negative, Herpes simplex serology negative, Vaginal lesion
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female who was vaccinated with the third dose of Gardasil. Two weeks after receiving the third dose, the patient experienced a large circular lesion on her vaginal wall. Viral testing including herpes was done and came back negative. No bacterial testing was done. The testing for Trichomonas was negative. The lesion may have resolved. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil and was later found to have HPV. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laryngitis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced laryngitis two days after receiving the vaccine. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Chills, Dysuria, Genital discharge, Hot flush
Clinical narrative: Information has been received from a 23 year old sexually active female who on 08-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (657622/0388U). Concomitant therapy included sitagliptin phosphate (MSD).  On 14-MAY-2007 the patient experienced fever, chills, excessive swelling, swollen uterus and swollen ovaries, hot flashes, perspiration, excessive swelling, yellow discharge, odor, irritation, and itching. She took an unspecified pill for itching that was for yeast infections and it helped. As of 15-MAY-2007 the patient started with not being able to hold urine for long periods of time and burning. A complete urinalysis was performed revealing cloudy urine with the presence of ketones, occult blood, protein, leukocytes esterase, white blood cells, squamos epithelial cells, and bacteria all consistent with vulvovaginitis and a Urinary Tract Infection. Atthe time of the report the patient had not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Occult blood, Ovarian enlargement, Pruritus, Pyrexia
Clinical narrative: Information has been received from a 23 year old sexually active female who on 08-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (657622/0388U). Concomitant therapy included sitagliptin phosphate (MSD).  On 14-MAY-2007 the patient experienced fever, chills, excessive swelling, swollen uterus and swollen ovaries, hot flashes, perspiration, excessive swelling, yellow discharge, odor, irritation, and itching. She took an unspecified pill for itching that was for yeast infections and it helped. As of 15-MAY-2007 the patient started with not being able to hold urine for long periods of time and burning. A complete urinalysis was performed revealing cloudy urine with the presence of ketones, occult blood, protein, leukocytes esterase, white blood cells, squamos epithelial cells, and bacteria all consistent with vulvovaginitis and a Urinary Tract Infection. Atthe time of the report the patient had not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Swelling, Urinary incontinence, Urinary tract infection, Urine leukocyte esterase
Clinical narrative: Information has been received from a 23 year old sexually active female who on 08-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (657622/0388U). Concomitant therapy included sitagliptin phosphate (MSD).  On 14-MAY-2007 the patient experienced fever, chills, excessive swelling, swollen uterus and swollen ovaries, hot flashes, perspiration, excessive swelling, yellow discharge, odor, irritation, and itching. She took an unspecified pill for itching that was for yeast infections and it helped. As of 15-MAY-2007 the patient started with not being able to hold urine for long periods of time and burning. A complete urinalysis was performed revealing cloudy urine with the presence of ketones, occult blood, protein, leukocytes esterase, white blood cells, squamos epithelial cells, and bacteria all consistent with vulvovaginitis and a Urinary Tract Infection. Atthe time of the report the patient had not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urine odour abnormal, Uterine enlargement, Vulvovaginitis
Clinical narrative: Information has been received from a 23 year old sexually active female who on 08-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (657622/0388U). Concomitant therapy included sitagliptin phosphate (MSD).  On 14-MAY-2007 the patient experienced fever, chills, excessive swelling, swollen uterus and swollen ovaries, hot flashes, perspiration, excessive swelling, yellow discharge, odor, irritation, and itching. She took an unspecified pill for itching that was for yeast infections and it helped. As of 15-MAY-2007 the patient started with not being able to hold urine for long periods of time and burning. A complete urinalysis was performed revealing cloudy urine with the presence of ketones, occult blood, protein, leukocytes esterase, white blood cells, squamos epithelial cells, and bacteria all consistent with vulvovaginitis and a Urinary Tract Infection. Atthe time of the report the patient had not recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a female under 18 years old who in approximately April 2007 was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a rash on her complete torso. The patient was prescribed an unknown cream as treatment. The rash did not resolve by 5 days but may have resolved by now. Medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Information has been received from a registered nurse concerning a 15 year old female student with PENICILLIN, AMOXICILLIN and CECLOR allergies who on 19-APR-2007 at 16:23 was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 654702/0011U).  On 22-APR-2007, the patient felt  "cold and achy" which persisted until the p.m. of 23-APR-2007 when itchiness and a rash on her complete torso, knees and back of hands developed.  The patient was prescribed CLARINEX and LOTRISONE cream as treatment.  The rash did not resolve by 5 days.  The patient's mom called on 01-MAY-2007 and reported that the symptoms persisted.  No further information had been received since then.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Pruritus, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced some itching with the first dose, but with the second dose she experienced more severe itching and the her lips began to swell. Subsequently, the patient recovered. The physician indicated that he was planning to vaccinate the patient with the third dose, but planned to have an EPI pen with him just in case the patient had an anaphylactic reaction. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Bacterial test, Blood thyroid stimulating hormone, C-reactive protein, Chest pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female student, with no pertinent medical history, who on 10-APR-2007 at 16:00, was vaccinated IM in the left arm with a first dose of GARDASIL (lot # 657621/0387U). On 22-APR-2007 at 17:00, the patient experienced significant malaise, sore throat, headache, chest pain, weight loss and nausea. The patient sought unspecified medical attention. Lab tests included complete blood cell count, serum antinuclear antibodies test, serum rheumatoid factor test, erythrocyte sedimentation rate, serum C-reactive protein test, total serum thyroxins test, serum thyroid-stimulating hormone test, stool culture test, serum serotonin, stool for ova and parasites, and urine culture (results not reported). At the time of the report, the symptoms were still present despite appropriate therapy- labs. Additional information is not expected.