chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix normal
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 18 year old female patient who in 2009 was vaccinated with two doses of GARDASIL (Lot number not reported) and now had a "negative pap smear result for intraepithelial lesions and malignancy that was HPV high risk positive". She stated that the patient no reported other adverse experienced and that there was no other observable adverse effects. The patient was counseled to use "protection" when having intercourse. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL injection. One or two years ago the patient developed Bell's palsy after being given GARDASIL. It was unknown if it was the patient's first, second or third 0.5 ml dose of GARDASIL. The physician reported that he had reported this adverse event "about a year ago". Outcome of Bell's palsy was unknown at the time of reporting. The patient sought unspecified medical attention. No further information is available.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea, Flushing
Clinical narrative: Information has been received from a physician concerning a 15 year old male patient with allergic rhinitis with no drug reactions or allergies who on unspecified date, within the past month (in February 2011), was vaccinated with the first dose of GARDASIL (route, expiration date and lot number not reported). Concomitant therapy included VERAMYST. The physician reported that the patient experienced trouble breathing and appeared flushed at school, following the vaccination. The physician reported that the patient stated the the trouble breathing resolved with in 5-10 minutes. The patient did not receive treatment for the event. At the time of the report the outcome of the patient was unknown for the flushing. Follow up information has been received from a physician, concerning a 15 year old male student patient who at the time of vaccination was recovering from rhinitis and an infection which occurred "2 weeks ago" (approximately on 12-JAN-2011). On 26-JAN-2011 (previously reported as within the past month (in February 2011)) at 8:30 a.m., the patient was vaccinated in the left deltoid with the first dose of GARDASIL (Lot# 666948/0886Z, expiration date not provided). The physician reported that on 26-JAN-2011, the patient experienced trouble breathing and flushed face, which lasted for 5-10 min. On 26-JAN-2011, the patient recovered. The patient did not seek medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Blood test, Dizziness, Electrocardiogram, Thinking abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who on the afternoon of 13-APR-2011 was vaccinated with a dose of 0.5mL of GARDASIL (route and lot number not reported). On the morning of 14-APR-2011 while at school, the patient experienced changes in behavior and mentation. Nurse reported that the mother stated that teachers noticed the patient "acting goofy, giddy and laughing" and the patient's mother noticed mentation changes. Nurse reported that patient's mother took her daughter to the emergency room and the patient normalized there. An electrocardiogram, unspecified blood work and urinalysis were performed (results not reported) before the patient was discharged. At the time of the report, the patient recovered on 14-APR-2011. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who on the afternoon of 13-APR-2011 was vaccinated with a dose of 0.5mL of GARDASIL (route and lot number not reported). On the morning of 14-APR-2011 while at school, the patient experienced changes in behavior and mentation. Nurse reported that the mother stated that teachers noticed the patient "acting goofy, giddy and laughing" and the patient's mother noticed mentation changes. Nurse reported that patient's mother took her daughter to the emergency room and the patient normalized there. An electrocardiogram, unspecified blood work and urinalysis were performed (results not reported) before the patient was discharged. At the time of the report, the patient recovered on 14-APR-2011. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Eye irrigation, Eye irritation, Eye pain
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female staff who on 19-APR-2011 got splashed in her eyes with GARDASIL (lot # 666987/1016Z, expiration date 22-NOV-2012) during the administration of the vaccine. The patient felt some burning in her eyes but the pain was gone after using eye wash. On 19-APR-2011 the patient recovered from burning in her eyes and pain. The patient sought unspecified medical attention. No lab diagnostics performed. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old male patient who on 27-APR-2011 was vaccinated intramuscularly with the first dose of GARDASIL (lot # and expiration not reported). It was reported that on 27-APR-2011 the patient experienced extreme dizziness. The patient's blood pressure dropped to 100/60 and 10 minutes later it raised to 122/60. Patient did not seek medical attention. Unspecified treatment was given for this adverse events. The patient recovered from the adverse events on 28-APR-2011. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Dizziness, Feeling abnormal, Flushing, Hypoaesthesia
Clinical narrative: Initial and follow up information have been received from a doctor of osteopathic and a medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 05-MAY-2011 was vaccinated IM into right arm with the first dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date 10-MAY-2013). There was no concomitant vaccinations. On 05-MAY-2011 the patient developed muscle pain in both legs which became "tingling and numb" which progressed to both arms. The patient became flushed and dizzy and the physician laid the patient down. The patient was monitored for 40 minutes and stated she felt "like she was floating in air". The physician called for an ambulance and had her transported to the emergency room of a hospital. The hospital did blood work (result unknown), administered IV fluids and the patient recovered within 4 to 5 hours afterwards on the same day. The physician reported that the patient had not eaten and had drunk coffee with 4 espresso shots. The patient was referred to a neurologist for follow-up. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Initial and follow up information have been received from a doctor of osteopathic and a medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 05-MAY-2011 was vaccinated IM into right arm with the first dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date 10-MAY-2013). There was no concomitant vaccinations. On 05-MAY-2011 the patient developed muscle pain in both legs which became "tingling and numb" which progressed to both arms. The patient became flushed and dizzy and the physician laid the patient down. The patient was monitored for 40 minutes and stated she felt "like she was floating in air". The physician called for an ambulance and had her transported to the emergency room of a hospital. The hospital did blood work (result unknown), administered IV fluids and the patient recovered within 4 to 5 hours afterwards on the same day. The physician reported that the patient had not eaten and had drunk coffee with 4 espresso shots. The patient was referred to a neurologist for follow-up. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Borrelia test negative, Burning sensation, HIV test negative, Hypoaesthesia
Clinical narrative: Initial and follow up information have been received from a doctor of osteopathic and a medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 05-MAY-2011 was vaccinated IM into right arm with the first dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date 10-MAY-2013). There was no concomitant vaccinations. On 05-MAY-2011 the patient developed muscle pain in both legs which became "tingling and numb" which progressed to both arms. The patient became flushed and dizzy and the physician laid the patient down. The patient was monitored for 40 minutes and stated she felt "like she was floating in air". The physician called for an ambulance and had her transported to the emergency room of a hospital. The hospital did blood work (result unknown), administered IV fluids and the patient recovered within 4 to 5 hours afterwards on the same day. The physician reported that the patient had not eaten and had drunk coffee with 4 espresso shots. The patient was referred to a neurologist for follow-up. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neuropathy peripheral, Paraesthesia, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Initial and follow up information have been received from a doctor of osteopathic and a medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 05-MAY-2011 was vaccinated IM into right arm with the first dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date 10-MAY-2013). There was no concomitant vaccinations. On 05-MAY-2011 the patient developed muscle pain in both legs which became "tingling and numb" which progressed to both arms. The patient became flushed and dizzy and the physician laid the patient down. The patient was monitored for 40 minutes and stated she felt "like she was floating in air". The physician called for an ambulance and had her transported to the emergency room of a hospital. The hospital did blood work (result unknown), administered IV fluids and the patient recovered within 4 to 5 hours afterwards on the same day. The physician reported that the patient had not eaten and had drunk coffee with 4 espresso shots. The patient was referred to a neurologist for follow-up. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 24 year old female patient with no known drug allergies or reactions who in April 2010, was intramuscularly vaccinated with the first dose of GARDASIL (Lot # and expiration not reported) and in April 2011 was intramuscularly vaccinated with the second dose of GARDASIL (lot # and expiration not reported). The nurse reported that the patient received the first dose of GARDASIL with no complications and 3 days after the second dose of GARDASIL (in April 2011) developed a fever and rash around the injection site which lasted a week. The patient sought unspecified medical attention (called clinic). Unspecified medication was given for the adverse events. At the time of reporting the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient who on 15-APR-2011 was vaccinated intramuscularly with 0.5 ml of the third dose of GARDASIL (lot # and expiration not reported). The physician reported that the patient had a syncopal episode (fainted) on administration of her third dose of GARDASIL last Friday (15-APR-2011). The physician reported that the same patient also fainted on administration of the first and second doses of GARDASIL, dates were unspecified. It was reported that the patient  went to the physician's office. At the time of reporting the patient had recovered on and unspecified date. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a 20 year old female who in approximately 2010 "about a year ago", was vaccinated with series doses of GARDASIL (lot number not reported). In 2011, "recently", the patient had tested positive high risk human papilloma virus (HPV). The patient sought medical attention by office visiting. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood cholesterol, Laboratory test, Thyroid function test
Clinical narrative: Information has been received from a 24 year old female patient with a history of papilloma viral infection (HPV) who was vaccinated with the first dose of GARDASIL (lot number not reported) in December 2010, and the second dose in March 2011. Concomitant therapy included "birth control". In March 2011, since she received her second dose GARDASIL, the patient had experienced hair thinning. The patient stated that she had always had very sick hair, and her hair dresser noticed recently that her hair was substantially thinner than it used to be. She said it was not "coming out in clumps", but she dried her hair in half the time she used to and when she touched it she could tell that it was much thinner than it used to be. The patient reported that she "devastated". She called her gynecologist and cancelled her third dose of GARDASIL. Her primary care physician ordered blood work which she had drawn on 20-APR-2011 and she would await the results before contacting an endocrinologist. Diagnostic laboratory tests "thyroid and cholesterol and other tests" performed, no results provided. The patient reported no other medical conditions and she took only "birth control". The patient's hair thinning persisted. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tremor
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old male patient with PEDIAZOLE allergy. Medical assistant stated no pertinent medical history, no previous history of tremors. On 19-APR-2011 patient was vaccinated intramuscularly on the left arm with 0.5 ml of GARDASIL (lot # and expiration not provided). Medical assistant reported that the child was vaccinated with the first dose of GARDASIL on 19-APR-2011. Immediately post vaccination child became diaphoretic, shaky, dizzy, with LE lower extremity and UE upper extremity tremors. Child was monitored and the reaction lasted about 25 minutes. When child left the office his blood pressure was 100/60 and his pulse was 70. That evening on follow up call child was okay. However child was back on the doctor office on 21-APR-2011 and was lightheaded and dizzy. At time of the report, the patient' outcome for lightheaded and dizzy was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female patient who about a year ago, in approximately 2010, was vaccinated with a dose of GARDASIL (lot # and expiration not reported). Nurse reported that the patient experienced pain with a dose of GARDASIL (unspecified number of injection). Due to complain of pain from the patient, nurse administered the next dose of GARDASIL in buttocks about a year ago. It was unspecified if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. No further information is available.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 28 year old female patient who on 20-MAY-2011 was vaccinated in the right arm with a first dose of GARDASIL (lot # not reported). Concomitant therapy included PAXIL, ethinyl estradiol (+) etonogestrel (MSD), SKELAXIN, lidocaine and cyanocobalamin administered by the patient's rheumatologist. The patient contacted the physician (via telephone) on 24-MAY-2011 and reported that she had pain in her right shoulder joint. The patient was given PERCOCET for pain and was still feeling pain in the right shoulder on 26-MAY-2011. The patient was scheduled to get a sedimentation rate to look for markers of inflammation. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Erythema, Headache, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no relevant medical history who at around 14:00 on 25-MAY-2011 was vaccinated with the third dose of GARDASIL into her deltoid in a local clinic. There was no concomitant medications. At around 16:00 on 25-MAY-2011, the patient developed headache, nausea, vomiting, chest pain, short of breath and erythema of her face, stomach and back, further described as erythema of the trunk of her body. On 25-MAY-2011, the consumer reported to a local hospital and she was being observed there. There was no relevant laboratory data. As of 25-MAY-2011, it was unknown if the consumer will continue on GARDASIL. She no longer experienced shortness of breath, but she continued to have headache, chest pain, nausea and vomiting. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no relevant medical history who at around 14:00 on 25-MAY-2011 was vaccinated with the third dose of GARDASIL into her deltoid in a local clinic. There was no concomitant medications. At around 16:00 on 25-MAY-2011, the patient developed headache, nausea, vomiting, chest pain, short of breath and erythema of her face, stomach and back, further described as erythema of the trunk of her body. On 25-MAY-2011, the consumer reported to a local hospital and she was being observed there. There was no relevant laboratory data. As of 25-MAY-2011, it was unknown if the consumer will continue on GARDASIL. She no longer experienced shortness of breath, but she continued to have headache, chest pain, nausea and vomiting. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a "22 year old" female who on 19-MAY-2011 was vaccinated with the first dose of GARDASIL, 0.5 ml IM in the arm. The patient passed out in the office after receiving first dose of GARDASIL on 19-MAY-2011. Patient regained consciousness soon after and was examined and was sent home with no other episode. Patient also experienced redness and pain around injection site. No additional information provided. The patient sought medical attention at the time of administration. No treatment was given for these adverse events. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old male who on 20-MAY-2011 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot number: 665607/1333Y). Concomitant therapy included meningococcal vaccine (unspecified). On 21-MAY-2011 the patient broke out in a rash on his face, trunk and arms. The patient sought unspecified medical attention and was prescribed BENADRYL for treatment. Therapy was also reported as discontinued on 21-MAY-2011. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, MEN
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Electroencephalogram normal, Pulmonary function test normal
Clinical narrative: Information has been received from an administrator concerning a 15 year old female patient who approximately one month ago in September 2010 was vaccinated with a dose of GARDASIL (lot #, route and dose not reported). Concomitant vaccines given on the same day included a dose of hepatitis B vaccine (manufactured unknown) and meningococcal vaccine (manufactured unknown). The administrator reported that approximately two weeks ago, on 24-SEP-2010 the patient developed shortness of breath and chest pain. The patient underwent a pulmonary function testing, electrocardiography and an EGG, all with result that were within normal limits. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Echocardiogram, Exercise test, Fatigue, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the first dose of GARDASIL IM. The patient got her first dose of GARDASIL vaccine and got "sxs". The patient experienced depression, fainting and fatigue. The father of the patient would like guidance on what to do especially whether the second and third dose should be administered. The patient sought unspecified medical attention. Follow up information concerning a 16 year old female patient with headache at the time of vaccination and no known drug allergies who on 04-SEP-2008 at 12:00 pm was vaccinated with the first dose of GARDASIL (lot # 660555/0279X). On 08-JAN-2009 the patient passed out (first syncope episode). On 27-APR-2009 cardiac echocardiogram was performed (results not provided). On 15-MAY-2009 Exercise Tolerance test (ETT) was performed (result not provided). On 20-MAY-2009 the patient consulted neurology. Outcome of passed out was unknown at the time of reporting. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Presyncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who in approximately August 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # not reported). It was reported that the patient was fine after the first dose. On 02-AUG-2010, 2 years after the first dose, the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot # not reported). On 02-AUG-2010, the patient experienced a vasovagal reaction that lasted  for about 15 minutes. The patient was given cold water and she started shivering. The patient was fine when she left the office. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no known drug allergies who on 16-JUN-2010 at 01:00 PM was vaccinated with the third dose of GARDASIL (Lot #662765/0821Y). Soon after the vaccination, on 17-JUN-2010 the patient experienced flu like symptoms. At this time of reporting, the patient's outcome was unknown. Follow-up information has been received from the licensed practical nurse concerning the 12 year old (also reported as 13 year old) female with birth weight 6 pounds and 11.5 ounces and no sibling who on 30-NOV-2009, 03-MAR-2010 and 16-JUN-2010 was vaccinated intramuscularly with the first (Lot # 663452/0671Y), second (lot # 663452/0671Y) and third (lot # 662765/0821Y) doses of GARDASIL, respectively. No further testing done after flu like symptoms after having third dose of GARDASIL. On an unspecified date, the patient recovered. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Human papilloma virus test positive, Loop electrosurgical excision procedure, Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning herself who in approximately 2005 ("2005 or 2006"), was vaccinated with GARDASIL. The patient completed dosing schedule (lot number not provided). On an unspecified date, the patient was diagnosed as having Human Papilloma Virus (HPV) despite completing the dosing schedule. At the time of reporting, the patient was not recovered. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 29 year old female patient with a history of Crohn's Disease, significant inflammatory bowel disease and anaphylaxis reaction to REMICADE and with no illness at time of vaccination who on 01-NOV-2006, 17-JAN-2007 and 30-MAY-2007 were vaccinated IM with the first, second and third doses of GARDASIL. She was currently receiving immunosuppressant medication. On 19-MAY-2010 the patient underwent PAP smear (LMP 30-APR-2010) with satisfactory for evaluation. Endocervical component was present. HSIL encompassing: moderate and severe dysplasia, carcinoma in situ; CIN 2 and CIN 3. On 15-JUN-2010 ciproscopy and PAP smear revealed the patient had uterine cervix at 4 o'clock and 10 o'clock with CIN 1, at 2 o'clock with no significant histopathologic abnormality. On 21-JUL-2010 genotype testing indicated that she was positive for HPV 16 and negative for HPV 18. On 28-AUG-2010 the patient underwent Loop Electrosurgical Excision Procedure (LEEP). Pathology report indicated that the patient had transformation zone with CIN 1, no evidence of invasion and the dysplasia extended to the ectocervical margin. Post LEEP procedure the patient was instructed to remain on bedrest for 3 weeks and to call with any concerns. On 13-SEP-2010 the patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix normal
Clinical narrative: Information has been received from a consumer concerning herself who in approximately 2005 ("2005 or 2006"), was vaccinated with GARDASIL. The patient completed dosing schedule (lot number not provided). On an unspecified date, the patient was diagnosed as having Human Papilloma Virus (HPV) despite completing the dosing schedule. At the time of reporting, the patient was not recovered. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 29 year old female patient with a history of Crohn's Disease, significant inflammatory bowel disease and anaphylaxis reaction to REMICADE and with no illness at time of vaccination who on 01-NOV-2006, 17-JAN-2007 and 30-MAY-2007 were vaccinated IM with the first, second and third doses of GARDASIL. She was currently receiving immunosuppressant medication. On 19-MAY-2010 the patient underwent PAP smear (LMP 30-APR-2010) with satisfactory for evaluation. Endocervical component was present. HSIL encompassing: moderate and severe dysplasia, carcinoma in situ; CIN 2 and CIN 3. On 15-JUN-2010 ciproscopy and PAP smear revealed the patient had uterine cervix at 4 o'clock and 10 o'clock with CIN 1, at 2 o'clock with no significant histopathologic abnormality. On 21-JUL-2010 genotype testing indicated that she was positive for HPV 16 and negative for HPV 18. On 28-AUG-2010 the patient underwent Loop Electrosurgical Excision Procedure (LEEP). Pathology report indicated that the patient had transformation zone with CIN 1, no evidence of invasion and the dysplasia extended to the ectocervical margin. Post LEEP procedure the patient was instructed to remain on bedrest for 3 weeks and to call with any concerns. On 13-SEP-2010 the patient recovered. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Information has been received from a physician concerning a 9 year and 8 month old female who on 14-JUN-2010 was vaccinated with the first dose of GARDASIL. Concomitant therapy included hepatitis A vaccine (manufacturer unknown) on 14-JUN-2010 in the other arm and had had no symptom in that arm. The physician reported that on 14-JUN-2010, later that night the area of the patient's deltoid was slightly irritated. This resolved. The patient was seen in the office on 07-JUL-2010 for another issue but expressed no complaints from the injection. On 08-JUL-2010 the patient's mother called stating her daughter had an area on her arm that was red, swollen and she was unable to move her arm. She would be seen in the office later on 09-JUL-2010. On 09-JUL-2010, the physician stated that the patient was seen in the office and only had a "knot' at the injection site, and no other problems. The physician stated after speaking to the patient's mother she found out that a knot was usually left behind when a child got an injection. The physician did not know if these symptom were related to GARDASIL. Follow up information has been received from the physician who reported that the patient with no illness at time of vaccination and no pre-existing allergies who was vaccinated with the first dose of GARDASIL, in right deltoid. On 08-JUL-2010 (previously reported as "09-JUL-2010"), the patient developed 0.25 cm area of induration in site of injection. No erythema, no warmth. The patient had visited the physician office. On 09-JUL-2010, the patient had recovered from the event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 24-JUN-2010 was vaccinated with the third dose of GARDASIL intramuscularly (lot number 662304/1013Y). Concomitant therapy included MENACTRA. The physician stated that on 24-JUN-2010 the patient was using GARDASIL and experienced syncope. The patient did not seek medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with her first dose of GARDASIL. Subsequently the patient experienced an abnormally heavy menstrual cycle. At the time of the reporting, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Dyspnoea, Rash generalised, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female who on 27-APR-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 0040Z, expiration date 03-NOV-2011). On approximately 29-APR-2010, 2-3 days post vaccination the patient experienced a body rash and shortness of breath. The outcome of the events was unknown. On 06-JUL-2010 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # 0450Z, expiration date 03-NOV-2011). On approximately 08-JUL-2010, 2-3 days post vaccination the patient again experienced a body rash and shortness of breath. On an unspecified date, the patient took an allergy testing (the result not reported). At the time of reporting, the patient was recovering from a body rash and shortness of breath. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old male patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot# not reported). It was reported that the patient had a syncopal episode in the exam room and was examined. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis acneiform
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 02-AUG-2010 was vaccinated with a first dose of GARDASIL (Lot # 666121/1778Y). There was no concomitant medication. On 04-AUG-2010 the patient experienced an acne-like rash from the middle of her chest, on her forehead and on her back after receiving her first dose of GARDASIL. The patient did visit an unspecified dermatologist and the results of that visit were unknown. When the patient returned for her second dose of GARDASIL the physician declined to administer it due to the previously stated adverse event. At the time of the report, the patient's acne like rash on her chest, forehead and back persisted. Follow up information was received from the registered nurse who stated that the patient with not known drug allergies was vaccinated intramuscularly into the right deltoid with the first dose of GARASIL (lot # 666121/1778Y) The registered nurse reported that a patient reported there that on 21-AUG-2010 she broke out with a rash on her chest, arm and face. The second dose was not given. At the time of the report, the outcome of the patient was unknown. There were not laboratories performed. No further information is available.
Sex: U
Vaccine: HPV4, MEN, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who "a month or so ago" (in approximately October 2010), was vaccinated with a dose of GARDASIL (route and expire date not reported) (route not reported). The patient fainted shortly after receiving GARDASIL (in approximately October 2010). The patient was wheel chaired out of the office. Patient received a dose of meningococcal vaccine, a dose of Tdap and a dose of GARDASIL one right after the next. The patient was in the office when fainted. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history, no drug reactions/allergies who on 08-JUL-2010 received the first 0.5 ml dose of GARDASIL (lot no. 665768/1377Y) IM. Concomitant therapy included MIRCETTE, multivitamins and flax seed. On approximately 10-JUL-2010, "2-3 days after the vaccination", the patient experienced local site reaction. The injection site was red and swollen. On approximately 17-JUL-2010, the patient recovered, the reaction lasted about one week. On 07-SEP-2010 the patient received the second 0.5 ml dose of GARDASIL (lot No. 665768/1377Y) IM. On approximately 09-SEP-2010 the patient experienced local site reaction, the injection site was red and swollen. It lasted about one week and on approximately 16-SEP-2010, the patient recovered. The patient sought unspecified medical attention. Follow-up information has been received from a physician (also reported as a nurse practitioner) concerning a 23 year old female patient who at 8:12 AM on 07-SEP-2010 received the second dose of GARDASIL (lot No. 665768/1377Y) IM in the right deltoid. On 09-SEP-2010, the patient developed erythema, swelling and pruritus 2 to 3 days following injection. The patient also "felt loopy". The patient recovered at time of report. Additional information not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site rash, Injection site urticaria, Rash generalised
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 15 year old female patient who on 23-JUN-2010, was vaccinated with the first dose of GARDASIL (Lot# 663551/1498Y) and on 29-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot# 663551/1498Y) with no concomitant vaccination administered at that time. It was reported that on an unspecified date, the patient experienced anaphylactic reaction and difficulty breathing after her second dose of GARDASIL. The patient's parent called the physician's office and stated that on 30-SEP-2010, the patient had developed a severe rash and hives at the injection site and all over her body. The patient went to the Emergency room. The patient had a topical reaction and was advised not to get another GARDASIL vaccination. The treatment that was given to the patient was unknown. On an unspecified date, the patient went to her primary care physician who stated that the patient had an allergic reaction to GARDASIL. The bachelor of science in nursing stated that the patient's chart was flagged indicating that the patient had an allergic reaction to GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 15 year old female patient who on 23-JUN-2010, was vaccinated with the first dose of GARDASIL (Lot# 663551/1498Y) and on 29-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot# 663551/1498Y) with no concomitant vaccination administered at that time. It was reported that on an unspecified date, the patient experienced anaphylactic reaction and difficulty breathing after her second dose of GARDASIL. The patient's parent called the physician's office and stated that on 30-SEP-2010, the patient had developed a severe rash and hives at the injection site and all over her body. The patient went to the Emergency room. The patient had a topical reaction and was advised not to get another GARDASIL vaccination. The treatment that was given to the patient was unknown. On an unspecified date, the patient went to her primary care physician who stated that the patient had an allergic reaction to GARDASIL. The bachelor of science in nursing stated that the patient's chart was flagged indicating that the patient had an allergic reaction to GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Injection site urticaria, Rash generalised
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 15 year old female patient who on 23-JUN-2010, was vaccinated with the first dose of GARDASIL (Lot# 663551/1498Y) and on 29-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot# 663551/1498Y) with no concomitant vaccination administered at that time. It was reported that on an unspecified date, the patient experienced anaphylactic reaction and difficulty breathing after her second dose of GARDASIL. The patient's parent called the physician's office and stated that on 30-SEP-2010, the patient had developed a severe rash and hives at the injection site and all over her body. The patient went to the Emergency room. The patient had a topical reaction and was advised not to get another GARDASIL vaccination. The treatment that was given to the patient was unknown. On an unspecified date, the patient went to her primary care physician who stated that the patient had an allergic reaction to GARDASIL. The bachelor of science in nursing stated that the patient's chart was flagged indicating that the patient had an allergic reaction to GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site rash, Injection site urticaria, Rash generalised
Clinical narrative: Information has been received from a health professional concerning a 15 year old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, no known adverse events following prior vaccination who on 29-SEP-2010 at 4:15 pm was vaccinated into the left deltoid with the second dose of GARDASIL (lot # 663551/1498Y). The health professional reported that the next morning of vaccination, on 30-SEP-2010, the patient broke out in a severe rash all over and hives on her arm left deltoid where the injection was given. The patient was rushed to the ER and she was told that she had an allergic reaction to GARDASIL. On an unspecified date the patient recovered from the allergic reaction. At the time of the report the patient's parents did not provide information about relevant diagnostics tests performed. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 15 year old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, no known adverse events following prior vaccination who on 29-SEP-2010 at 4:15 pm was vaccinated into the left deltoid with the second dose of GARDASIL (lot # 663551/1498Y). The health professional reported that the next morning of vaccination, on 30-SEP-2010, the patient broke out in a severe rash all over and hives on her arm left deltoid where the injection was given. The patient was rushed to the ER and she was told that she had an allergic reaction to GARDASIL. On an unspecified date the patient recovered from the allergic reaction. At the time of the report the patient's parents did not provide information about relevant diagnostics tests performed. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Injection site urticaria, Rash generalised
Clinical narrative: Information has been received from a health professional concerning a 15 year old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, no known adverse events following prior vaccination who on 29-SEP-2010 at 4:15 pm was vaccinated into the left deltoid with the second dose of GARDASIL (lot # 663551/1498Y). The health professional reported that the next morning of vaccination, on 30-SEP-2010, the patient broke out in a severe rash all over and hives on her arm left deltoid where the injection was given. The patient was rushed to the ER and she was told that she had an allergic reaction to GARDASIL. On an unspecified date the patient recovered from the allergic reaction. At the time of the report the patient's parents did not provide information about relevant diagnostics tests performed. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Musculoskeletal pain, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 14 years old female patient who on 05-OCT-2010 was vaccinated intramuscularly into her left arm with her first 0.5ml dose of GARDASIL (lot number 665265/1378Y). Concomitant therapy included FLUVIRIN into her left arm. The nurse reported that on 06-OCT-2010 " a day after receiving her first dose of GARDASIL", the patient developed hives on the back of her upper arms and chest and she had pain in her left shoulder. On 07-OCT-2010, the patient recovered from hives on the back of her upper arms and chest and from pain in the left shoulder. The patient sought medical attention by a phone call. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who on 07-OCT-2010, was vaccinated with a dose of GARDASIL (lot# not reported). It was reported that the patient fainted after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. No further information is available.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a registered nurse concerning a female patient in her late 30's who on approximately 17-SEP-2010 was vaccinated with the first dose of GARDASIL (Lot # and route not reported). The nurse reported that on approximately 08-OCT-2010, about 3 weeks after receiving the vaccine, the patient gained 4 pounds. At the time of the report, the outcome of the patient was not reported. The patient did not seek medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperventilation, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 27-MAY-2010 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 666121/1778Y). On 21-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # and route not reported). The physician reported that on 27-MAY-2010 20-30 minutes after the patient received the first dose she felt a tingling sensation in both legs greater in the right leg, also, on the same day the patient had hyperventilated because she is afraid of shots. She had recovered within 12-24 hours. On 21-SEP-2010, after the second dose was give 5-10 minutes the patient felt numbness and tingling in the right lower leg and upper posterior thigh. For the second dose that patient had not hyperventilated. She was monitored. The physician reported that on 22-SEP-2010 the symptoms were still present. The patient sought medical attention. Follow up information has been received from the physician who reported that the 17 year old (also reported as 16 year old) healthy student female with no illness at the time of vaccination and no know drug allergies, on 27-MAY-2010 was vaccinated into the left deltoid with the first dose of GARDASIL and on 21-SEP-2010 into the right deltoid with the second dose of GARDASIL (Lot # 666598/0786Z). The physician stated that on 27-MAY-2010 30 minutes after receiving the first dose, the patient experienced bilateral low extremity tingling and without neuro deficit, ED if patient hyperventilated. The event resolved within 12 to 24 hours. On 21-SEP-2010, 5 to 10 minutes after the patient received the second dose, the patient experienced left extremity tingling and without weakness. She did not hyperventilate. The symptoms resolved without sequela within 12 to 24 hours. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated intramuscularly in the deltoid area with a dose of GARDASIL (Lot # and dose not reported). The nurse reported that the patient experienced severe pain n her arm lasting a month. At the time of the report, the outcome of the patient was not reported. Follow up information was received from a Physician Assistant (P.A) via medical records who reported that an 18 year old female student who experienced pain into right deltoid in July 2010. On an unspecified date, an X-ray of right humerus (AP and lateral views) showed no fracture or dislocation (normal radiographic study of the right humerus). The soft tissue appeared normal. There was no radiopaque foreign body. The patient sought unspecified medical attention. It was reported that in August 2010, the patient recovered from the event. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a pharmacy student concerning a 22 year old female patient who on an unspecified date was vaccinated with her first dose of GARDASIL (lot number unknown) and subsequently tested positive for HPV. The patient sought unspecified medical attention. At the time of report, the patient had no recovered. No further information is available.