chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 15-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot# not reported). Concomitant therapy included tetanus toxoid (manufacturer unknown). On 16-MAR-2007 the patient called her physician office and reported that at an unspecified time on 15-MAR-2007 post vaccination she developed dizziness, vomiting and a fever (actual temperature not reported). Unspecified medical attention was sought. The patient has not contacted the physician again.
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, C-reactive protein normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Information has been received from a physician concerning his daughter, a female patient, with a penicillin allergy, who on 15-DEC-2006 was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. On approximately 15-JAN-2007 (" one month later") the physician's daughter experienced "numbness and pain in her right foot and leg." The physician reported that his daughter was examined by both a neurologist and a rheumatologist, and was not certain if she was "experiencing significant disability," but was waiting to see if the numbness and pain resolved. The physician reported there was "some improvement." Additional information has been requested. 01-Jan-2007 magnetic resonance imaging, Negative, 01-Jan-2007 serum C-reactive protein test, Negative, 01-Jan-2007 serum antinuclear antibodies test, Positive
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning his daughter, a female patient, with a penicillin allergy, who on 15-DEC-2006 was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. On approximately 15-JAN-2007 (" one month later") the physician's daughter experienced "numbness and pain in her right foot and leg." The physician reported that his daughter was examined by both a neurologist and a rheumatologist, and was not certain if she was "experiencing significant disability," but was waiting to see if the numbness and pain resolved. The physician reported there was "some improvement." Additional information has been requested. 01-Jan-2007 magnetic resonance imaging, Negative, 01-Jan-2007 serum C-reactive protein test, Negative, 01-Jan-2007 serum antinuclear antibodies test, Positive
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated with a dose of Gardasil. The nurse reported that the patient left to go to the hospital lab, and approximately 10 minutes after the vaccine was administered, she "because very clammy and faint and felt that she was going to pass out." The patient was referred to the emergency services department.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient who was vaccinated with a dose of Gardasil (date not specified). On 25-OCT-2006 the patient developed "a temperature elevation of 102 degrees." Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician, concerning an 11 year old female patient, who on 25-OCT-2006, was vaccinated in teh afternoon (exact time not specified), in the left arm with the firs dose of GARDASIL (Lot #651650/0702F). The physician confirmed that the patient's physical exam at the visit "revealed no sign of illness." By 9:00 pm that evening, the patient had developed a temperature or 102.5F, and a swollen left arm. On 26-OCT-2006, the next day, the patient's temperature further elevated to 103 degrees, and she experienced chills. the physician reported that the patient recovered from the swollen arm, fever and chills on 28-OCT-2006, within 72 hours of the vaccination. No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray, Chest discomfort, Computerised tomogram, Electrocardiogram
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a sulfonamide allergy and drug hypersensitivity to benzyl peroxide, who was vaccinated with the first dose of Gardasil (date not specified), and on 12-MAR-2007 was vaccinated with the second dose of Gardasil. Concomitant therapy included birth control (unspecified). The consumer reported that after the first vaccination, her daughter's "arm was sore." On 14-MAR-2007, two days after the second vaccination, the patient developed a fever (unspecified), chest pressure, elevated heart rate (unspecified) and lethargy. The consumer reported her daughter had the following diagnostics performed: "blood test, electrocardiogram (EKG), computed tomography scan (CT), and a chest x-ray, however the results were not reported. It was unknown if the patient's arm soreness resolved. The patient's fever, chest pressure, elevated heart rate and lethargy persisted. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a sulfonamide allergy and drug hypersensitivity to benzyl peroxide, who was vaccinated with the first dose of Gardasil (date not specified), and on 12-MAR-2007 was vaccinated with the second dose of Gardasil. Concomitant therapy included birth control (unspecified). The consumer reported that after the first vaccination, her daughter's "arm was sore." On 14-MAR-2007, two days after the second vaccination, the patient developed a fever (unspecified), chest pressure, elevated heart rate (unspecified) and lethargy. The consumer reported her daughter had the following diagnostics performed: "blood test, electrocardiogram (EKG), computed tomography scan (CT), and a chest x-ray, however the results were not reported. It was unknown if the patient's arm soreness resolved. The patient's fever, chest pressure, elevated heart rate and lethargy persisted. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Menorrhagia, Tuberculin test
Clinical narrative: Initial and follow up information has been received from a physician and a health care professional concerning a 13 year old female patient who on 15-MAR-2007 at 04:30 PM was vaccinated IM with a first dose of GARDASIL vaccine, lot #654510/0962F. Concomitant therapy included ADACEL, MENACTRA and tuberculin purified protein derivative. On 19-MAR-2007 the patient developed an off cycle additional menstrual cycle with a heavy flow. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Headache, Malaise
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient with chronic seasonal allergies, allergic rhinitis, obesity and possible attention deficit disorder who on 14-MAR-2007, at 5:00 PM  was vaccinated IM with a dose of Gardasil. lot # 655849/0263U. Later that day she developed a headache between her eyes and malaise. In folllow up it was reported that on 14-MAR-2007 patient developed headaches, eye pain and mild malaise at 6:00 PM. On 15-MAR-2007 patient had a physical examination which was normal. Her symptoms completely resolved within a few days. On 16-MAR-2007 patient recoverd. Addititional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Muscle spasms, Nausea, Pain
Clinical narrative: Information has been received from a health care professional concerning a 15 year old female patient who on 08-JAN-2007 was vaccinated in her right arm with a first dose of Gardasil, lot #654389/0961F. Subsequently the patient developed nausea, headache, dizziness, cramping and soreness. The patient's outcome was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a Registered Nurse Practitioner (R.N.P.) concerning a 14 year old female student who on 12-JAN-2007 was vaccinated IM in her left deltoid with a first dose of Gardasil, lot# 655619/1427F. Concomitant therapy included ADDERALL TABLETS, STRATTERA, PROZAC, montelukast sodium, bupropion, "exofendadine", ranitidine and minocycline. Of note, the patient was switching from CONCERTA to ADDERALL. On 20-FEB-2007 the patient developed arthralgias in hips, ankles, and hands. Patient saw pediatrician. It was reported that the events persisted as of 09-MAR-2007. On 16-MAR-2007 the patient's mother reported, the events resolved. The outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia, Vaccine positive rechallenge, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 23-JAN-2007 was vaccinated IM with a first dose of Gardasil, lot#654702/0011u. On an unspecified date, the patient received the second dose of Gardasil, lot #656372/0243U. 10 days after the first injection (on 02-FEB-2007) the patient developed fever of 103F. She developed fever of 103F 6 days after her second dose of Gardasil. The patient recovered completely after the first dose and the status was unknown after the second dose. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female patient who on 19-MAR-2007 was vaccinated with a dose of Gardasil. After receiving the injection the patient developed a rash that extended from head  to toe. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test, Human papilloma virus test positive
Clinical narrative: Information has been received from a Physician Assistant (P.A.) concerning a 24 year old female patient who in January 2007, was vaccinated IM with a dose of Gardasil. In MAR-2007 the patient tested positive for 3 types of Human Papilloma Virus (HPV) that are in the vaccine (types unspecified). The reporter did not think that the patient was tested prior to vaccination so it was unknown whether or not the patient was originally positive or negative for the HPV types. The Polymerase Chain Reaction (PCR) test was taken in March 2007. The outcome of the patient was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Physician Assistant Certified (P.AC.) concerning a 24 year old female patient who in January 2007, was vaccinated IM with a dose of GARDASIL. In MAR-2007 the patient tested positive for 3 types of HPV that are in the vaccine (types unspecified). The reporter did not think that the patient was tested prior to vaccination so it was unknown whether or not the patient was originally positive or negative for the HPV types. The PCR test was taken in March 2007. In follow up the PA indicated that patient was tested positive for HPV serum human papillomavirus 6 neutralization test, HPV serum human papillomavirus 11 neutralization test and serum human papillomavirus 18 neutralization test and his concern was that whether the vaccine could cause a false positive PCR test. The outcome of the patient was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling cold, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 14 year old female patient, who on 19-MAR-2007 was vaccinated in the right arm, with the first dose of Gardasil (yeast). There was no concomitant medication. On 19-MAR-2007, "within one hour of the vaccination," the patient developed swelling and coldness in the right arm and hand. The patient was reported to be recovering at the time of this report. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 18 year old female patient who on 08-JAN-2007 was vaccinated with the first dose, 0.5 of Gardasil, and on approximately 08-MAR-2007 ("two months later") was vaccinated with the second dose, 0.5 ml, of Gardasil. The physician reported that on 08-JAN-2007, soon after receiving the first vaccination, the patient passed out, "she recovered after a short while in the physician office." Following the second vaccination, the physician reported the patient "had no ill effects". Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 01-DEC-2006 was vaccinated with the first dose of Gardasil. IM. Concomitant medication was not reported. In February 2007, the patient went to the physician's office for the second dose of Gardasil but the patient had a fever and was sick, so the second dose was not given. On 20-MAR-2007, the patient received the second dose of Gardasil. Subsequently on an unspecified date, the patient recovered from the events. The causality of the events was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from the mother of a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced pain. The mother reported that her daughter will receive the third vaccination "late". Additional information has been requested. It was also reported that another daughter was vaccinated with Gardasil and experienced pain (WAES 0703USA02877).
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) who in March 2007 "within the last several weeks," was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently in March "within the last several weeks", the patient experienced shortness of breath after receiving Gardasil. The patient was sent to the emergency room, however it was unknown if the patient was admitted to the hospital. The outcome and causality of the event was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pustular
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female with penicillin allergy who on 11-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included lot# 655619/1427F. Concomitant therapy included Ortho-Tri-Cyclen. The patient developed pustular lesions on her face, chest, umbilical area and bilateral upper extremities one and a half days after receiving the first injection. The patient self-treated with Proactiv solution. On 20-MAR-2007, it was noted on examination that the lesions remained "about the same." Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Nurse Practitioner (N.P.) concerning a 24 year old (previously reported as 23 year old) female patient with penicillin allergy who on 11-JAN-2007 was vaccinated IM into left deltoid with a first dose of GARDASIL lot# 655619/1427F. In follow up it was reported that patient was given second dose on 27-MAR-2007 and on 17-JUL-2007 received the third dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient developed pustular lesions on her face, chest, umbilical area and bilateral upper extremities one and a half days after receiving the first injection. The patient self-treated with PROACTIV solution. On 20-MAR-2007, it was noted on examination that the lesions on her arms had resolved but the remaining lesions remained "about the same". In follow up it was reported that patient had no shortness of breath, "nonpurited". The pustular type acne started about 3 days after the first immunization. She was seen at the doctor's office on 20-MAR-2007 and was treated for acne and they changed her birth control pill (unspecified). There were no adverse events after the second and third dose. On 27-MAR-2007 patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: Information has been received from a certified medical assistant assistant and a physician concerning a female with acne and a history of urticaria (2004 unknown cause) who in February 2007 ("about 3 weeks ago"), was vaccinated IM with Gardasil. Concomitant therapy included unspecified antibiotic. Within a week the patient experienced urticaria, itchiness, low grade fever (100 F) and soreness. Subsequently, the patient recovered from urticaria, itchiness, low grade fever 100f and soreness. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female who on 12-FEB-2007 was vaccinated with the first dose of Gardasil, (lot#654510/0962F), IM. Concomitant therapy included desogestrel/ethinyl estradiol (APRI). On approximately 12-MAR-2007 ("a month after first dose"), the patient experienced stomach aches and nausea. The patient sought unspecified medical attention. The patient experienced the symptoms off and on and if the problem persists the physician may decide to discontinue further series of Gardasil. The patient's stomach aches and nausea persisted. The causality of the events was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Sensory disturbance
Clinical narrative: Information has been received from a physician at a Grand Rounds meeting at a hospital concerning another physician's female teenager patient who was vaccinated with GARDASIL and "recently" experienced unknown hand and arm sensations. The reporting physician did not have any patient information because it was someone else's patient. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a history of cervical intraepithelial neoplasia who on 03-JAN-2007 was vaccinated intramuscularly into the left arm with a first dose of GARDASIL vaccine (lot#655165/1425F)). There was no concomitant medication. On 03-JAN-2007 the patient experienced hives all over her body after vaccination with GARDASIL vaccine. The hives appeared all over her body on the day of vaccination. BENADRYL was prescribed to the patient and she fully recovered 48 hours after the vaccination. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. No laboratory diagnositic studies were performed. The patient fully recovered 48 hours after the vaccination (also reported as 04-JAN-2007). No further information is available.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Rash
Clinical narrative: Information has been received from a physician concerning a 31 year old female who was vaccinated with Gardasil. Subsequently the patient developed a severe rash. The patient was vaccinated in the biceps and possibly subcutaneouusly. The patient was not given a second dose to the previous rash. As of 20-MAR-2007, the patient was recovering from the severe rash. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash papular, Rash pruritic, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician and a health care professional concerning a 15 year old female who on 15-MAR-2007 at 11:00 AM was vaccinated in the left arm with a second dose of GARDASIL lot #65605/0244U. On 15-MAR-2007, the patient received her second dose and experienced generalized hives which the physician described as a migratory rash. The patient sought unspecified medical attention. The patient tolerated her first dose well. In follow-up it was indicated that on 17-MAR-2007 patient had painful, itchy rash raised, on right arm, face, left fore arm. She was advised to give 25 milligram BENADRYL every 6 hours until no hives for 24 hours. Subsequently, on 04-APR-2007 the patient recovered from generalized hives and migratory rash. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 17-FEB-2007 was vaccinated with Gardasil (invalid lot# "00140"). On 20-FEB-2007, 3 days after she was administered Gardasil the patient developed swelling and pruritus below the injection site. Subsequently, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with skin allergies and a rash to other medications in the past who on 05-FEB-2007 was vaccinated IM in the right deltoid with a third dose of Gardasil vaccine (yeast) (lot # 654702/0011U). There was no concomitant medication. The patient tolerated the vaccination well. 3 to 4 weeks post vaccination on 06-MAR-2007 the patient noticed a lump at the injection site deep in the muscle. The lump was a pea in size and was oblong in shape in the right deltoid approximately 1 cm, which was the injection site deep in the muscle. No redness, pain or fever noted. The patient took therapy with ADVIL as needed. The patient was seen last week, on approximately 13-MAR-2007, and the lump had gotten smaller from the last week. As of 20-MAR-2007 the patient had not fully recovered. The patient took therapy with ADVIL as needed. The patient was seen last week, on approximately 13-Mar-2007, and the lump had gotton smaller from the last week. As of 20-Mar-2007 the patient had not fully recovered.Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. The patient had no illness at the time of vaccination. Concomitant therapy included ZOLOFT and LOESTRIN. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Urine human chorionic gonadotropin
Clinical narrative: Information has been received from a physician concerning a 17 or 18 year old female who was vaccinated with Gardasil. Subsequently, the patient experienced delayed menstrual cycle after receiving Gardasil. She underwent a pregnancy test which was negative. The physician advised the patient to contact her after one month if she still did not have a menstrual cycle. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported the bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (yeast) (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported the bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported the bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a consumer, via a company representative, concerning the consumer's 19 year old daughter, with diabetes, who was vaccinated with a dose, 0.5ml, of Gardasil (date unspecified). Concomitant therapy included hepatitis A virus vaccine (unspecified). The mother reported that her daughter experienced "tingling in her fingertips after receiving Gardasil. The patient sought unspecified medical attention. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchial disorder, Chest X-ray, Dizziness, Dyspnoea, Headache
Clinical narrative: Information has been received from a consumer (an office manager), via a company representative, concerning the consumer's 17 year old daughter, who in December 2006, was vaccinated with the first dose, 0.5ml, of Gardasil vaccine (yeast), and vaccinated with the second dose of Gardasil vaccine (yeast) (date not specified). In December 2006, three days after the first vaccination, the consumer reported her daughter experienced "dizziness, lightheadedness, vertigo, difficulty breathing, respiratory distress and bronchial inflammation." The consumer reported her daughter was taken to the ER, but she was not admitted. She added that a chest x-ray and "bloodwork" were performed (results not provided). In addition, she added that after her daughter experienced nausea, headache, and dizziness after the second vaccination was administered (dates not specified). At the time of the report, it was unknown if the patient had recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Laboratory test, Nausea, Respiratory distress, Vertigo
Clinical narrative: Information has been received from a consumer (an office manager), via a company representative, concerning the consumer's 17 year old daughter, who in December 2006, was vaccinated with the first dose, 0.5ml, of Gardasil vaccine (yeast), and vaccinated with the second dose of Gardasil vaccine (yeast) (date not specified). In December 2006, three days after the first vaccination, the consumer reported her daughter experienced "dizziness, lightheadedness, vertigo, difficulty breathing, respiratory distress and bronchial inflammation." The consumer reported her daughter was taken to the ER, but she was not admitted. She added that a chest x-ray and "bloodwork" were performed (results not provided). In addition, she added that after her daughter experienced nausea, headache, and dizziness after the second vaccination was administered (dates not specified). At the time of the report, it was unknown if the patient had recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Swelling, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not reported) who was vaccinated in the right arm with a first dose of Gardasil (date unspecified), followed by a second dose of Gardasil (date unspecified). Subsequently, after the first vaccination the patient developed swelling of two fingers on her left hand. Following the second vaccination, the patient had a recurrence of the swelling in her fingers on her left hand. The nurse indicated that the swelling had improved. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) prevously submitted on 4/13/2007. The MA reported that 12 hours after the first vaccination was administered, the patient developed swelling with redness and pain in two fingers, the middle and fith digit, on her right hand (previously identified as left hand), confirmed as the opposite arm of the vaccination. The swelling lasted approximately 2-3 days. Following the second dose, again 12 hours after the vaccination was administered, the patient had a recurrence of the swelling with pain and redness, in the same fingers of the same hand. The MA stated the recurrent symptoms lasted 1 to 1 1/2 days, and indicated the patient had full recovered. The patient sought unspecified medical attention. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse, concerning a 20 year old female student, who on 06-MAR-2007 at 11:00 am, was vaccinated with the first dose, 0.5ml, IM in the left deltoid, of Gardasil (Lot # 654702/0011U). The nurse reported that "approximately 5 minutes after" the vaccination (time reported as 11:15am), the patient "felt lightheaded and fainted, lost consciousness for approximately less than a minute." The nurse stated that the patient complained of feeling "strange in her head" and experienced abdominal cramps" that lasted for approximately 20 minutes. The nurse indicated that the patient had not had breakfast that morning and felt better after drinking some orange juice. The patient recovered from the events on 07-MAR-2007. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin decreased, Drug exposure during pregnancy, Metrorrhagia, Progesterone, Progesterone decreased
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/23/2007. Information has been received through the pregnancy registry, from a registered nurse, concerning a 25 year old female patient, who on 17-JAN-2007 was vaccinated with the first dose, 0.5ML, IM, of Gardasil (Lot # 655617/1447F). There was no concomitant medication. The nurse reported that the patient is pregnant. The date of the last LMP was 22-JAN-2007, with an estimated date of delivery on 29-OCT-2007. Pregnancy was confirmed by a positive serum pregnancy test and a "fetal ultrasound" was performed (results not provided). The nurse stated that on 23-FEB-2007, the patient experienced vaginal spotting; she added the patient also had a "low" serum progesterone level (date and result not provided). Subsequently, the patient recovered from the vaginal spotting (date unspecified). It was unknown if the low serum progesterone recovered. The patient sought unspecified medical attention. Additional information has been requested. Follow-up phone call information was received from a registered nurse who reported that the patient delivered a normal, healthy full term baby on 13-OCT-2007. There were no reported complications with the birth whatsoever. The VAERS number is 276862. No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/23/2007. Information has been received through the pregnancy registry, from a registered nurse, concerning a 25 year old female patient, who on 17-JAN-2007 was vaccinated with the first dose, 0.5ML, IM, of Gardasil (Lot # 655617/1447F). There was no concomitant medication. The nurse reported that the patient is pregnant. The date of the last LMP was 22-JAN-2007, with an estimated date of delivery on 29-OCT-2007. Pregnancy was confirmed by a positive serum pregnancy test and a "fetal ultrasound" was performed (results not provided). The nurse stated that on 23-FEB-2007, the patient experienced vaginal spotting; she added the patient also had a "low" serum progesterone level (date and result not provided). Subsequently, the patient recovered from the vaginal spotting (date unspecified). It was unknown if the low serum progesterone recovered. The patient sought unspecified medical attention. Additional information has been requested. Follow-up phone call information was received from a registered nurse who reported that the patient delivered a normal, healthy full term baby on 13-OCT-2007. There were no reported complications with the birth whatsoever. The VAERS number is 276862. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Epstein-Barr virus antibody negative, Influenza serology negative, Laboratory test normal, Laboratory test normal
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age with allergies to sulfonamide and penicillin, who on 15-MAR-2007 was vaccinated with a dose, 0.5 ml, IM, of Gardasil. There was no concomitant medication. On approximately 18-MAR-2007 ("three days" later) the patient developed a fever of 104F, and visited the emergency room. Diagnostic labs were as follows: complete metabolic panel (CMP), urinalysis, "mono, strep and influenza" screenings, all with negative results. Subsequently, the patient recovered from the fever. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Mononucleosis heterophile test negative, Pyrexia, Streptococcal identification test negative, Urine analysis
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age with allergies to sulfonamide and penicillin, who on 15-MAR-2007 was vaccinated with a dose, 0.5 ml, IM, of Gardasil. There was no concomitant medication. On approximately 18-MAR-2007 ("three days" later) the patient developed a fever of 104F, and visited the emergency room. Diagnostic labs were as follows: complete metabolic panel (CMP), urinalysis, "mono, strep and influenza" screenings, all with negative results. Subsequently, the patient recovered from the fever. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 20 year old female patient who on 16-FEB-2007 was vaccinated IM in the deltoid muscle with a dose of Gardasil vaccine (yeast), lot # 655617/1447F. The patient recently noted a small lump in her deltoid muscle at the injection site, also described as a bump in her arm at injection site. Unspecified medical attention was sought. The patient was recovering as of the report day. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: Information has been received from a health care worker concerning a female patient who was vaccinated with a dose of Gardasil vaccine (yeast). The patient developed arthritis while taking the Gardasil vaccine (yeast). Unspecified medical attention was sought. The patient was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 12-MAR-2007 was vaccinated with Gardasil (yeast) (lot # 657006/0188U). Concomitant therapy included FLONASE and PONSTEL. On 13-MAR-2007 the patient experienced a fever of 104F. Unspecified medical attention was sought. The patient missed school and was treated with acetaminophen (TYLENOL). Subsequently, the patient recovered from the fever. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning his 18 year old daughter who was vaccinated with first dose of Gardasil. Subsequently the patient experienced injection site pain. The patient's outcome was not reported. No product quality complaint was involved.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 20 Mar-2007 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast) (lot # 656051/0244U). Concomitant medication included ethinyl estradiol (+) norethindrone acetate "1/20 BCP's." On 20-MAR-2007 the patient fainted after receiving a shot of the vaccine. The patient laid down, smelling salt used and was given juice and a granola bar. The patient had not eaten since the night before. Subsequently, the patient recovered in less than 5 minutes. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with seasonal allergies, glucose intolerance and penicillin allergy who on 06-DEC-2006 was vaccinated IM 0.5 mL, first dose , with Gardasil (lot#653978/0955F). The patient received her second vaccination IM 0.5mL of Gardasil (lot#653978/0955F) on 26-FEB-2007. There was no concomitant medication. On 27-FEB-2007 the patient experienced fatigue and widespread joint pain. No adverse event was reported on the first vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently, the patient developed blood clots in her legs. It was reported that the patient was treated by her primary care physician. The patient's outcomes was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner a 19 year old white female with a history of "CIN1" (cervical neoplasm) and "HR HPV" who on 15-DEC-2006 was vaccinated IM in the left deltoid with 0.5mL of Gardasil vaccine (yeast) (lot # 654741/1208F) at 16:00. On 15-DEC-2006 the patient experienced mild nausea 1 hour after receiving vaccination and the nausea lasted 2-3 days. On 16-FEB-2007 the patient was vaccinated, second dose, IM in the left deltoid with 0.5 mL of Gardasil vaccine (yeast) (lot # 656049/0187U) at 16:00. The patient experienced nausea and vomiting 1 hour after vaccination and it lasted approximately 1 week. The nausea and vomiting would occur after eating or attempting to eat. The patient sought unspecified medical attention. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pruritus, Rash, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female who on 19-MAR-2007 was vaccinated IM 0.5mL with her first dose of Gardasil vaccine (yeast) (lot# 656049/0187U). There was no concomitant medication. On 19-MAR-2007 the patient experienced a rash on her wrist (wrist not specified) about 4 hours after receiving the vaccination. The rash was described as itchy, bright red bumps and slightly raised. On 21-MAR-2007 the patient reported a similar rash on one leg (leg not specified) from knee to thigh. Subsequently, the patient recovered from itchy, bright red bumps and, slightly raised wrist rash. At the time of the report, the patient's rash on one leg from knee to thigh persisted. The patient sought unspecified medical attention. No further information is available. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. The patient also reported a bright red raised rash on her thigh in the evening after vaccination. Subsequently, the patient recovered from itchy, bright red bumps and slightly raised wrist rash and the bright red raised rash on her thigh. The patient reported no rash or itching at the injection site. The nurse reported that it could have been a possible allergic reaction. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Immediately afterward, the patient experienced numbness on one side of body. Additional information has been requested. It was reported that another female experienced numbness on one side of the body immediately after receiving Gardasil (WAES 0703USA02125)
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female with diabetes who in November 2006, was vaccinated with the first dose of Gardasil vaccine (yeast). The physician's office called the patient to remind her to come in for second dose as she was late for the dose and the patient reported that the pain from the injection was so severe that she refused to come in for the other doses. The patient reported that is was the worst pain she ever had with an injection. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician and a registered nurse concerning a 14 year old female with diabetes (patient gives herself injections daily) and cystic fibrosis who on 06-NOV-2006, was vaccinated with the first dose of GARDASIL (lot number 653735/0688F). The physician's office called the patient to remind her to come in for second dose as she was late for the dose and the patient reported that the pain from the injection was so severe that she refused to come in for the other doses. The nurse reported that the patient does not want another injection because it was extremely painful. The patient reported that it was the worst pain she ever had with an injection and the needle was "absurdly long". Subsequently, the patient recovered from the injection site pain. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood potassium normal, Body temperature normal, Chills, Dizziness
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter, who was vaccinated with the first dose of GARDASIL vaccine (date unspecified), and on 13-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. The consumer reported her daughter experienced "pain at the injection site" after the first vaccination. The patient's mother reported that on 21-MAR-2007, eight days after the second vaccination was administered, her daughter experienced a headache, neck pain, nausea and throat pain, and on approximately 22-MAR-2007, she felt "like her throat is closing up." On 22-MAR-2007 ("this morning"), her daughter felt worse when she woke up and was rushed to the emergency room. At the time of the report, the patient had not recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up received from a physician included medical records received from the ER, and indicated that the patient was a college student, with no illness at the time of vaccination. The medical records confirmed concomitant vaccination with inlfuenza virus vaccine (unspecified) and meningococcal vaccine (unspecified), dates not specified (not confirmed by the physician). The ER medical records also indicated that on 22-MAR-2007, the patient presented with symptoms of headache (documented as at the base of the skull), and neck pain, with an original onset date of 21-MAR-2007 (also reported by the physician in follow up, an onset date of 22-MAR-2007). Other symptoms included "body aches," fever, chills, dizziness, weakness, and nausea (without vomiting). Vital signs in the ER included: blood pressure 110/70, pulse 100, respirations 20, and temperature 100.2F. The records documented that "airway/breathing" was within normal limits. Treatment included normal saline (intravenous), phenergan 12.5mg (intravenous), and TYLENOL. A complete blood count revealed the following: neutrophils 86.6%, lymphocytes 9.2%, and neutrophil count 9.3 (units not provided). The clinical impressionof the ER physician was noted as "acute febrile illness." The medical records documented that the patient "felt better" after treatment, and was discharged to home in "stable" condition on 22-MAR-2007. Vital signs at discharge were: BP 115/75, pulse 95, respirations 30, and temperature 99F, discharge instructions included acetaminophen or ibuprofen every 8 hours, and remain off of work/school for the next 2 days. At the time of this report, the physician confirmed that the patient had recovered from the events (date not specified). The follow up information (medical records) received on 09-APR-2007 also contained the following adverse expereinces: potassium low, 3.3 mmol/L (22-MAR-2007); sodium low, 132 mmol/L (22-MAR-2007); osmolality low, 272 mOsmol/kg (22-MAR-2007). No further informationis expected.