chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Retching, Vomiting
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 dry heaves, vomiting, nausea, and flu-like symptoms, which lasted for three weeks.  Subsequently, the patient recovered.  On 05-Feb-2008 the patient was vaccinated with her second dose of Gardasil.  At the time of this report, no symptoms were noted.  Additional information has been requested. Information has been received from a physician concerning a female who on 12-Dec-2007 was vaccinated with the first dose of HPV vaccine (lot # 655154/1210U). Subsequently the patient experienced dry heaves, vomiting, nausea, and flu-like symptoms, which lasted for three weeks. Subsequently, the patient recovered. On 05-Feb-2008 the patient was vaccinated with her second dose of HPV vaccine. At the time of this report, no symptoms were noted. Additional information has been requested. 02/12/2010 Subsequently after second dose of GARDASIL the patient experienced severe stomach pain that induced dry heaves, and nausea. Symptoms continued for approximately 5  days. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Injected limb mobility decreased, Musculoskeletal pain, Radiculitis brachial
Clinical narrative: Information has been received from a physician concerning a 23 year old female who in approximately November 2007, was vaccinated with her first dose of Gardasil.  On 15-JAN-2008 the patient was vaccinated with her second dose of Gardasil.  On 15-Jan-2008, the patient experienced pain in her shoulder and pain in her elbow.  The patient sought treatment in the emergency room and was treated with acetaminophen (+) hydrocodone bitrartrate (VICODIN) and naproxen (unspecified).  The patient had trouble dressing herself and it was difficult to drive.  On 24-Jan-2008, the patient saw her physician and was still complaining of pain.  There was no visible swelling or redness.  As of the date of this report, the pain in the shoulder and elbow persisted.  No further details were provided.  Additional information has been requested. Follow-up received 04/16/2008. On 15-JAN-2008 the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (Lot # 659653/1448U). The patient had several office visits concerning the severe left arm pain and was treated with acetaminophen (+) oxycodone hydrochloride (PERCOCET) and naproxen (unsepcified). The patient was referred to a pain clinic and was diagnosed as having brachial plexus neuritis. As of the date of this report, the brachial plexus neuritis persisted and the patient is still undergoing treatment. No further details were provided. Additional information had been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on approximately 01-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil.  Concomitant therapy included FEMCON FE.  Two - three weeks post vaccination, the patient experienced a rash on her knees, elbows and back of her hands.  The patient visited her dermatologist who said it looked similar to Psoriasis.  The patient recovered from the rash on her knees, elbows and back of her hands.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site atrophy, Lipodystrophy acquired, Muscle atrophy
Clinical narrative: Information has been received from a physician concerning a "16 year old" female with unspecified medical history and allergies reported, who on 11-APR-2007 was vaccinated intramuscularly with a third dose of Gardasil (657621/0387U).  On 11-APR-2007 the patient experienced "lipodystrophy".  She had loss of muscle in her left deltoid where she received the vaccine.  The adverse event started as mildly red and it progressed to be muscle loss of 4.5 by 3.5 cm.  The patient went to see the orthopedic surgeon who confirmed the diagnosis.  The patient is now being referred to a plastic surgeon.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 26 year old female who was vaccinated with a second dose of Gardasil (Lot # not reported).  Subsequently, on an unknown date the patient experienced vomiting and approached fainting.  They were able to lay her down before she actually passed out.  No emergency intervention was needed.  Subsequently, on an unknown date the patient fully recovered from vomiting and approached fainting.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated (date, route and site not reported) with a dose of the Gardasil vaccine (lot # not reported).  Subsequently the patient fainted post vaccination (exact date not reported).  It was unknown at the time of this report if the patient received medical attention or recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated (date, route and site not reported) with a dose of the Gardasil vaccine (lot# not reported).  Subsequently the patient fainted post vaccination (exact date not reported).  It was unknown at the time of this report if the patient received medical attention or recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Antiphospholipid antibodies negative, C-reactive protein normal, Epstein-Barr virus antibody negative, Erythema, Fatigue
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of an allergy to CAT scan contrast dye, who on an unspecified date was vaccinated intramuscularly with her first dose of Gardasil.  On an unspecified date, the patient was vaccinated intramuscularly with her second dose of Gardasil.  In November 2007, the patient was vaccinated intramuscularly with her third dose of Gardasil.  There was no concomitant medication.  Subsequently the patient experienced enlarged lymph nodes in her neck and an intermittent red rash on neck, which seems to be triggered by exertion, and fatigue.  The patient sought unspecified medical attention.  Diagnostic laboratory studies were performed, and all tests were within normal ranges.  At the time of this report, the patient was recovering.  No other information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Liver function test normal, Lymphadenopathy, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of an allergy to CAT scan contrast dye, who on an unspecified date was vaccinated intramuscularly with her first dose of Gardasil.  On an unspecified date, the patient was vaccinated intramuscularly with her second dose of Gardasil.  In November 2007, the patient was vaccinated intramuscularly with her third dose of Gardasil.  There was no concomitant medication.  Subsequently the patient experienced enlarged lymph nodes in her neck and an intermittent red rash on neck, which seems to be triggered by exertion, and fatigue.  The patient sought unspecified medical attention.  Diagnostic laboratory studies were performed, and all tests were within normal ranges.  At the time of this report, the patient was recovering.  No other information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of an allergy to CAT scan contrast dye, who on an unspecified date was vaccinated intramuscularly with her first dose of Gardasil.  On an unspecified date, the patient was vaccinated intramuscularly with her second dose of Gardasil.  In November 2007, the patient was vaccinated intramuscularly with her third dose of Gardasil.  There was no concomitant medication.  Subsequently the patient experienced enlarged lymph nodes in her neck and an intermittent red rash on neck, which seems to be triggered by exertion, and fatigue.  The patient sought unspecified medical attention.  Diagnostic laboratory studies were performed, and all tests were within normal ranges.  At the time of this report, the patient was recovering.  No other information was provided.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Eczema, Eosinophil count decreased, Full blood count abnormal, Inappropriate schedule of drug administration, Neutrophil count decreased
Clinical narrative: Information has been received from a physician concerning a 27 year old female with a family history of eczema and no drug allergies, who on 18-SEP-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  The patient was vaccinated with a second dose of Gardasil (Lot# 659441/1446U).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  Subsequently, "three weeks after the second dose" the patient developed eczema near her eyes and arms.  The patient had no reaction after the first dose.  The patient was seen by the physician.  A complete blood cell count was performed and the patients neutrophil and eosinophil counts were low.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of fainting who on 04-DEC-2007 was vaccinated intramuscularly with her first dose of Gardasil.  The patient fainted while in the waiting room after vaccination.  The patient was instructed to raise her legs, which she did.  She recovered the same day.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Spirometry normal
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old female with allergies who on 03-DEC-2007 was vaccinated with Gardasil.  Concomitant therapy included desloratadine (CLARINEX) and montelukast sodium (MSD).  On 04-DEC-2007 the patient developed a dry, persistent cough.  The patient was examined by her pediatrician and spirometry testing was normal.  The physician recommended the patient increase her montelukast sodium (MSD) dosage from 5 mg to 10 mg at bedtime and to switch from desloratadine (CLARINEX) to fexofenadine hydrochloride (ALLEGRA).  As of 28-JAN-2008, the patient's dry persistent cough persisted.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who in December 2007, was vaccinated with the first dose of Gardasil (lot # not available).  In December 2007, after receiving her first dose of the vaccine, the patient fainted.  Subsequently, the patient recovered the same day.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis contact, Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on 29-OCT-2007 was vaccinated with Gardasil (dose and route of therapy not reported).  Concomitant therapy included birth control pills (unspecified).  On 29-OCT-2007 the patient developed contact dermatitis after being given Gardasil.  The patient was treated with methylprednisolone (MEDROL DOSEPAK).  No other information was reported.  Additional information has been requested. Follow-up received 04/16/2008 reported that the patient had a whole body rash and erythematous pruritic macules after receiving the second dose of GARDASIL on 11-JAN-2008. The patient recovered on 28-JAN-2008.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil 0.5ml injection (second dose).  Subsequently the patient experienced a delayed period.  No other information was reported.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lipoma
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil.  The physician reported that 3 weeks after receiving her 3rd dose of Gardasil, the patient developed a little fatty tumor on her shoulder that the physician described as a benign lipoma.  The patient went to a dermatologist.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a physician concerning a 20 year old female, with a history of allergic reaction to SEPTRA, who on 12-DEC-2007 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (lot # 659437/1266U). The physician reported that 3 weeks after receiving her 3rd dose of GARDASIL (also reported a 15-Dec-2007), the patient developed a little fatty tumor on her shoulder that the physician described as a benign lipoma (also described as a cystic lesion). The patient went to a dermatologist. The benign lipoma spontaneously went away two months later, and the patient has recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning her daughter, a 17 year old female who was vaccinated by injection with the second 0.5 mL dose of Gardasil.  The physician reported that her daughter had experienced a "heavy, heavy period".  The patient sought medical attention as her mother was a physician.  The lot number was not available.  No further information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female who is "15-16 years old" and who was vaccinated with her second dose of Gardasil (lot# unspecified).  The nurse reported that on 28-JAN-2008 the patient "after receiving the second dose of the vaccination had fainted".  Subsequently, the patient recovered.  No further information was available.  Additional information has been requested. Follow-up received 04/16/2008 to report(s) previously submitted on 2/14/2008. Information has been received from a nurse practitioner concerning a female (119 lbs., 64 in.) with no known drug allergies who in "15-16 years old" and who was vaccinated on 28-JAN-2008 with her second dose of GARDASIL (lot# 659401/1446U). Concomitant therapy included varicella virus vaccine live (MSD). The nurse reported that on 28-JAN-2008 the patient "after receiving the second dose of the vaccination had fainted". Subsequently the patient recovered. No further information was avaliable. Follow-up information reported that the patient felt lightheaded about 2-3 minutes after receiving GARDASIL. The patient felt as if she was going to pass out without syncope observed. The patient did fall to the floor without loss  of consciousness.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Breast feeding, Dry mouth, Headache, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 24 year old female who on approximately 21-JAN-2008 was vaccinated intramuscularly with a 0.5 mL third dose of Gardasil.  There was no concomitant medication.  On approximately 26-JAN-2008, "in the last couple of days", the patient had headaches, her mouth was dry, "everything's really stiff", and had a sharp pain in her stomach.  She also developed a rash on her sides, stomach and arms.  The patient reported that she was breast feeding.  The patient did not seek medical attention for her experience.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a 24 year old female who on approximately 21-JAN-2008 was vaccinated intramuscularly with a 0.5 mL third dose of Gardasil.  There was no concomitant medication.  On approximately 26-JAN-2008, "in the last couple of days", the patient had headaches, her mouth was dry, "everything's really stiff", and had a sharp pain in her stomach.  She also developed a rash on her sides, stomach and arms.  The patient reported that she was breast feeding.  The patient did not seek medical attention for her experience.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning her daughter with no allergies or medical history who was vaccinated in another physician's office with her first dose of Gardasil.  Subsequently the patient experienced a rash.  The patient's physician suggested the patient not receive succeeding doses of Gardasil because she was allergic to the preservative.  The representative told the health professional that there was no preservative in Gardasil.  Therapy with human papillomavirus vaccine was discontinued.  The patient's outcome was not provided and she sought unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Nausea
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no known allergies or medical history who in November 2007, was vaccinated with her first dose of Gardasil.  Soon after receiving Gardasil, the patient experienced nausea and did not feel well for about one day following her first dose.  Therapy with human papillomavirus vaccine was discontinued.  Subsequently, the patient recovered from nausea.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash
Clinical narrative: Information has been received from a health professional concerning a 22 year old white female who on 14-NOV-2007 was vaccinated with a dose of Gardasil (lot# 659435/1265U). On 16-NOV-2007 the patient felt dizzy. On 17-NOV-2007 the patient developed rash. On 19-NOV-2007 the patient's rash subsided. The outcome of dizziness and nausea were unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Metrorrhagia, Pregnancy test negative, Ultrasound scan
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with a history of allergies and reactive airway disease (RAD) who on 29-AUG-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (lot# 658556/1060U).  Concomitant therapy included MENACTRA (lot #U2379BA) intramuscularly in the left deltoid.  On 08-JAN-2008 the patient was vaccinated intramuscularly in the left deltoid with her second dose of Gardasil (lot# 659435/1265U).  On 08-JAN-2008 the patient was concerned that she had no menstrual period since last summer prior to the first dose of Gardasil.  She had had a couple times with 1 day of "dark spotting."  Periods were irregular prior to the vaccination, but not this far apart.  On 21-JAN-2008 the patient was again seen in the office and still no period.  She was referred to a GYN and for a pelvic ultrasound.  On 17-JAN-2008 the patient had a pelvic ultrasound.  Also the patient's HCG was negative.  On the day of vaccination, 08-JAN-2008, the patient was having reactive airway exacerbation.  The patient's outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: Information has been received from a physician concerning a female with no known allergies or medical history who was vaccinated with two doses of Gardasil.  On 28-JAN-2008 the patient left a message on the office after-hours answering machine complaining of twitching in her arms and legs.  The patient's twitching of arms and legs persisted.  The physician was unable to provide any further information.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a patient who sometime in January 2008, was vaccinated with a dose of Gardasil which was stored at 33F for 1 to 1 and 1/2 hours.  Medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Lymphadenopathy, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician and a consumer concerning herself who on 02-NOV-2007 was vaccinated with her first dose of Gardasil (lot# 654540/1209U).  On 22-JAN-2008 the patient was vaccinated with her second dose of Gardasil (lot# 655327/1287U).  About a day and a half after receiving the first dose, the patient's lymph node was swollen on her left side near her neck.  The patient indicated it hurt for a couple days.  Also after receiving her second dose of Gardasil, the patient's lymph node had swelled again and it was hurting.  The patient's swollen lymph node in her neck persisted.  The patient indicated she has an appointment in February to have a biopsy done on the swollen lymph node.  It was unclear whether the patient would have the third dose of Gardasil.  Additional information has been requested. This is follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a physician and a consumer concerning herself who on 07-NOV-2007 was vaccinated with her first dose of GARDASIL (lot# 654540/1209U). On 22-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot# 655327/1287U). About a day and a half after receiving the first dose, the patient's lymph node on her left side near her neck. The patient indicated it hurt for a couple of days. Also after receiving her second dose of GARDASIL, the patient's lymph node had swelled again and it was hurting.The patient'sswollen lymph node in her neck persisted. The patient's PCP felt the swollen lymph node was not related to GARDASIL and sent her to an oncologist. She had an ultrasound on 18-JAN-2008. The patient indicated she has an appointment in February to have a biopsy done on the swollen lymph node. The biopsy was benign. It was unclear whether the patient would have the third dose of GARDASIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Injection site scar
Clinical narrative: Information has been received from a physician concerning a 16 year old female who approximately "2 months ago" in November 2007, was intramuscularly vaccinated with her first dose of Gardasil.  The patient had a "3 inch by 2 inch indentation" at the injection site that looked as if "all the tissue beneath it had atrophied."  The patient's mother had stated that this began "almost immediately" after the injection.  There is a scar at the site that looks like "the scar from a small pox vaccine".  The physician gave the patient a saline injection at the site of the injection.  The physician would not provide the demographics of the doctor who administered the vaccine, but stated that he can be contacted with any follow up paper work.  Additional information has been requested. 02/12/2010 Follow up information indicated the patient was diagnoes on 14-Nov-2007 with massive skin atrophy in the subcutaneous tissue in the deltoid area on her left arm. The patient's present status is unknown.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, No reaction on previous exposure to drug, Presyncope, Traumatic brain injury
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of migraines who on 18-JAN-2008 was vaccinated with her third dose of Gardasil. Concomitant therapy included MANTOUX SKIN TEST. Approximately 15 minutes after receiving the vaccination on 18-JAN-2008 the patient fell down and had a loss of consciousness for a few seconds. The patient was taken to the emergency room where her vital signs were checked and everything was normal. She was discharged that day with a "clean bill of health." The patient did not have an adverse reaction to the first or second dose of the vaccine. Subsequently, the patient recovered on 21-JAN-2008 from falling down and loss of consciousness for a few seconds. Additional information has been requested.  Follow-up received 04/16/2008. Concomitant therapy included tuberculin purified protein derivative (MANTOUX SKIN TEST) (LOT # C2670AA) and topical acne medications. Approximately 15 minutes after receiving the vaccination on 18-JAN-2008 the patient fell down and struck her head, completely breaking through the dry wall and had a loss of consciousness for a few seconds. Patient was alert within 10-15 seconds. Her vital signs immediately following the episode were within normal limits. The patient was transferred to the emergency room with a neck collar and back board where she was evaluated and diagnosed with a closed head injury adn vaso-vagal reaction. She was discharged that day with a "clean bill of health." The patient did not have an adverse reaction to the first or second dose of the vaccine. Subsequently, the patient recovered on 21-JAN-2008 from falling down and loss of consciousness for a few seconds. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a health professional concerning a 19 year old female who on 15-NOV-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included OVCON 35. On 15-JAN-2008 the patient was vaccinated with her second dose of Gardasil (lot# 659653/1448U). On 16-JAN-2008 the patient felt dizzy, nauseated, slight abdominal pain and her head hurt. The patient's dizziness, nausea, slight abdominal pain and head hurt persisted. As of 24-JAN-2008 the patient still had a headache and was going to be seen in the office that afternoon. The patient had no adverse reaction after the first dose. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Convulsion, Dizziness, Gaze palsy, Headache, Injection site pain
Clinical narrative: Information has been received from a newspaper article concerning a 17 year old "healthy" female with no reported problems with shots, allergies, or fainting who on 03-JAN-2008 was vaccinated with a first dose of Gardasil. The patient was concomitantly vaccinated with three unspecified vaccines. It was reported that approximately 20 seconds after receiving the vaccinations, the patient felt nauseous and dizzy. She fainted and began to display "seizure-like symptoms" of eyes rolled back in her head and she started shaking. After that, she was unconscious for 3 to 5 minutes. She had a severe headache the entire day and soreness where she received the HPV shot. The patient's outcome was not reported. additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Loss of consciousness, Nausea, Syncope, Tremor
Clinical narrative: Information has been received from a newspaper article concerning a 17 year old "healthy" female with no reported problems with shots, allergies, or fainting who on 03-JAN-2008 was vaccinated with a first dose of Gardasil. The patient was concomitantly vaccinated with three unspecified vaccines. It was reported that approximately 20 seconds after receiving the vaccinations, the patient felt nauseous and dizzy. She fainted and began to display "seizure-like symptoms" of eyes rolled back in her head and she started shaking. After that, she was unconscious for 3 to 5 minutes. She had a severe headache the entire day and soreness where she received the HPV shot. The patient's outcome was not reported. additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in January 2008, was vaccinated intramuscularly with her second dose of Gardasil. In January 2008, the patient experienced vertigo. The patient had gone to a neurologist, but it was not known if the patient went to the neurologist for this reason or another reason. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date was vaccinated with the 3rd dose of Gardasil and passed out. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date was vaccinated with Gardasil and experienced severe pain at the injection site. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil and experienced severe pain at the injection site. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Menstruation delayed
Clinical narrative: Information has been received from a registered nurse concerning a 23 female with no previous history of genital warts, who, on an unspecified date was vaccinated with a 0.5mL first dose of Gardasil. Subsequently, the patient developed genital warts. On another unspecified date the patient was vaccinated with a second dose of Gardasil. Subsequently, after the first and second doses the patient's menstrual cycles were off by about one week. The patient's cycle has returned to normal. On 24-JAN-2008 the patient was vaccinated with a third dose of Gardasil. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested. 02/12/2010 There was no illnes at the time of third vaccination. The patient sought unspecified medical attention. No laboratory product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Nasal congestion
Clinical narrative: Information has been received from a physician concerning an 18 year old female, who on 21-JAN-2008 was vaccinated with a 0.5mL first dose of Gardasil (lot# 659439/1267U). On 22-JAN-2008 the patient developed an injection site rash. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received by a physician concerning an 18 year old female, who on 25-OCT-2007 was vaccinated with a 0.5ml first does of GARISIL (Lot # 659439/1267U). There were no reactions reported after the first dose. On 21-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. On 22-JAN-2008 within 24 hours of the second dose the patient developed an injection site rash, rash on her trunk, and swelling and redness at the injection site. The physician reported that there were no breathing problems or any reactions that would have indicated anaphylaxis. The physician spoke to the patient's mother in regards to the signs and symptoms reported. The patient was unable to come to the office for a visit until 28-JAN-2008. Over the next few days the patient experienced viral like signs and symptoms including a headache, stuffy nose, and intermitten fever. On 28-JAN-2008 the patient was seen at the office for viral like symptoms. It was reported that at the time of the office visit there was no rash. The patient recovered from the rash on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old female, who on 21-JAN-2008 was vaccinated with a 0.5mL first dose of Gardasil (lot# 659439/1267U). On 22-JAN-2008 the patient developed an injection site rash. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received by a physician concerning an 18 year old female, who on 25-OCT-2007 was vaccinated with a 0.5ml first does of GARISIL (Lot # 659439/1267U). There were no reactions reported after the first dose. On 21-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. On 22-JAN-2008 within 24 hours of the second dose the patient developed an injection site rash, rash on her trunk, and swelling and redness at the injection site. The physician reported that there were no breathing problems or any reactions that would have indicated anaphylaxis. The physician spoke to the patient's mother in regards to the signs and symptoms reported. The patient was unable to come to the office for a visit until 28-JAN-2008. Over the next few days the patient experienced viral like signs and symptoms including a headache, stuffy nose, and intermitten fever. On 28-JAN-2008 the patient was seen at the office for viral like symptoms. It was reported that at the time of the office visit there was no rash. The patient recovered from the rash on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Anxiety, Dyspnoea, Hyperventilation, Urticaria
Clinical narrative: Information has been received from a physician assistant concerning a 12 year old female who on 07-JAN-2008 was vaccinated with her third dose of 0.5 ml Gardasil via injection. Concomitant therapy included ROCEPHIN. The physician assistant reports the patient received the third dose of Gardasil and after a couple of hours the patient developed urticaria, anaphylactic reaction, had difficulty breathing, had hives with anxiety and hyperventilating. The physician assistant reported that the mother of the patient wanted to give the patient the third dose of Gardasil and the ROCEPHIN all at the same time before school started, even if the physician assistant wanted to wait to provide the Gardasil. Per the physician assistant, after the patient was given the Gardasil the patient was still fine. The mother of the patient then brought the patient to the dentist on the same day and the patient was given fluoride. The patient went home after the dental appointment and developed the symptoms. The physician assistant noted that the patient was brought back to their office and was given BENADRYL and they called an ambulance to take the patient to the hospital. The patient was brought to the emergency room. The physician assistant was not aware of the present status of the patient and whether the patient was admitted to the hospital. The lot number was not provided and no further information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Myalgia, Pyrexia, Syncope, Viral test negative
Clinical narrative: Information has been received from a physician concerning a 14 year old female who in mid July 2007 was vaccinated with her first dose of Gardasil. The patient did not completely faint because someone caught her before she hit the floor. The physician reported that after receiving her second dose of Gardasil the patient was fine. On approximately 15-JAN-2008 the patient received her third dose of Gardasil via injection and the patient developed severe myalgia and had a temperature of 102 degrees Fahrenheit. The physician reported that the patient was given a bunch of tests for viruses, but all the tests came back negative and the patient recovered the day after receiving the third dose. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 20 year old female daughter with drug hypersensitivity to Vantin who in August 2007 was vaccinated with her first dose of Gardasil and on 26-DEC-2007 was vaccinated with her second dose of 0.5 ml Gardasil intramuscularly. Concomitant therapy included YAZ. The mother stated that after her daughter received her second dose she developed a fever of 103 degrees Fahrenheit and had body aches and felt nauseous. This started when the patient was traveling home after getting the shot. The patient went to the emergency room but was not admitted. Right after the shot was given, while still in the doctor's office, the patient felt dizzy. The office staff gave her crackers and soda and kept her at the office until she felt better. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008.  Initial and follow up information has been received from a physician, and consumer concerning the consumer's 20 year old daughter (a female) with drug hypersensitivity (VANTIN), who in August 2007 was vaccinated with her first dose of GARDASIL vaccine, and on 26-DEC-2007 was vaccinated IM in the left deltoid with her second dose, 0.5 ml. of GARDASIL vaccine (Lot #659439/1267U). Concomitant therapy included YAZ. The mother stated that after her daughter received her second dose, she developed a fever of 103 degrees F. had body aches and felt nauseous. This started when the patient was traveling home after getting the shot. The patient went to the emergency room but was not admitted. Right after the shot was given. While still in the doctor's office, the patient felt dizzy. The office staff gave her crackers and soda and kept her at the office until she felt better. The physician added that the patient reported feeling weak, and when evaluated in the ER, was given TYLENOL. The symptoms then resolved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 12 year old female granddaughter with no known allergies and no reported medical history who was vaccinated with a series of three shots of Gardasil. The reporter stated that her granddaughter told when she got her sot it was really painful and stung alot. No additional information was provided. The onset date was 'after each shot". Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Laboratory test, Myalgia, Oedema peripheral, Rheumatoid factor
Clinical narrative: Information has been received from a mother regarding her 20 year old daughter who in August 2007, was vaccinated with the first dose of Gardasil (lot# unspecified).  The patient was given a second dose of the vaccination sometime in October 2007.  Concomitant therapy included corticosteroids (unspecified).  It was reported that after receiving the second dose, "during the 1st week of November" the patient experienced severe myalgia of her joints and swelling in her hands.  The mother reported that all tests that were done to diagnose arthritis came back negative (Anti CCP, Rheumatoid arthritis testing).  The patient did not have this reaction after the 1st dose in August.  The patient's myalgia of the joints and swelling in hands persisted.  The patient's outcome was reported as not recovered.  Additional information has been requested. Follow-up received 04/16/2008 from the physician who reported that the patient was diagnosed with arthritis. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal discomfort
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated IM with a dose of Gardasil.  Subsequently the patient experienced vulvar pain.  The patient's outcome was not reported.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Gait disturbance, Laboratory test, Nausea
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no known medical history or allergies who on 12-JUL-2007 was vaccinated with her first dose of Gardasil (lot # 657868/0523U).  On 07-SEP-2007 the patient was vaccinated with her second dose of Gardasil (lot # 657868/0523U).  On 04-JAN-2008 the patient was vaccinated with her third dose of Gardasil (lot # 659439/1267U).  The patient experienced nausea, dizziness and difficulty getting up and walking around for about a week after each dose.  The patient also experienced hip and joint pain for about a month after each dose.  The physician did some "autoimmune testing" and it all came back normal.  The patient was still under medical observation for the AE's.  She has not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient with a history of passing out when blood was drawn, who was vaccinated with a dose of Gardasil.  After which, while the office drew this patient's blood she passed out.  Medical attention was sought in the office.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received form a health department nurse concerning a female who on 29-JAN-2008 was vaccinated with Gardasil. The nurse reported that on 29-JAN-2008, the patient fainted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Culture negative, Dyspnoea, Feeling abnormal, Hypoaesthesia, Muscle spasms
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 28-JAN-2008 was vaccinated with a second dose of Gardasil (lot #659964/1740U). Concomitant therapy included hepatitis A vaccine (inactive). The patient came to the physician's office for a sore throat, cough and congestion. On28-JAN-2008 the patient experienced an 8 minute episode of feeling panicky, short of breathe, feeling "out of it" and had numbness and cramps in her hands. Unspecified medical attention was sought. The physician diagnosed her with syncope, upper respiratory infection and panic attack. A strep throat test came back negative. As of 29-JAN-2008 the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Panic attack, Streptococcal identification test negative, Syncope, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 28-JAN-2008 was vaccinated with a second dose of Gardasil (lot #659964/1740U). Concomitant therapy included hepatitis A vaccine (inactive). The patient came to the physician's office for a sore throat, cough and congestion. On28-JAN-2008 the patient experienced an 8 minute episode of feeling panicky, short of breathe, feeling "out of it" and had numbness and cramps in her hands. Unspecified medical attention was sought. The physician diagnosed her with syncope, upper respiratory infection and panic attack. A strep throat test came back negative. As of 29-JAN-2008 the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Injection site nodule
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of humoral bone tumor who on 15-JAN-2008 was vaccinated with Gardasil.  On 16-JAN-2008 the patient experienced influenza-like symptoms.  She also presented with a painless nodule at the injection site measuring a few centimeters.  Subsequently, the patient recovered from influenza-like symptoms.  Neither fever, nor general signs nor adenopathies were observed.  The patient had not yet recovered from injection site reaction.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Cold sweat, Joint warmth, Pain, Varicose vein
Clinical narrative: Information has been received from a newspaper article concerning an 18 year old female who in September 2007, was vaccinated with a first dose of Gardasil.  It was reported that shortly after the shot, the patient felt an overwhelming aching heat in her kneecaps and ankles.  After 24 hours, it spread to the majority of her bones.  Approximately one month after the shot, her body practically went through "withdrawals from missing the vaccinations".  The patient once again had aching bones and "this time cold sweats were involved."  The patient's eyesight had been more blurred since vaccination with HPV vaccine.  The patient developed her first varicose veins all over her thighs and ankles, and her bones hurt from even the softest pressure.  The outcome of the patient's experience was unknown.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a newspaper article concerning an 18 year old female who in September 2007, was vaccinated with a first dose of Gardasil.  It was reported that shortly after the shot, the patient felt an overwhelming aching heat in her kneecaps and ankles.  After 24 hours, it spread to the majority of her bones.  Approximately one month after the shot, her body practically went through "withdrawals from missing the vaccinations".  The patient once again had aching bones and "this time cold sweats were involved."  The patient's eyesight had been more blurred since vaccination with HPV vaccine.  The patient developed her first varicose veins all over her thighs and ankles, and her bones hurt from even the softest pressure.  The outcome of the patient's experience was unknown.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Clonus, Convulsion, Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Information has been received from a newspaper article concerning a 12 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. A few minutes post vaccination, the patient walked about 50 steps then went into what the patient's mother believed to be a seizure. The patient's eyes rolled back in her head, she stiffened up and had clonic jerks. The patient was placed on a stretcher and rushed to the emergency room. The physician's at the emergency room told the patient's mother that the patient experienced vasovagal syncope because "the patient was scared from the shot." Additional information is not expected.