chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female, who on 15-OCT-2008, was vaccinated with the first dose of GARDASIL, IM, in the deltoid. On 17-OCT-2008, the patient developed hives on the upper body and tingling of the lips. She was seen at the office and given diphenhydramine hydrochloride (BENADRYL). Her symptoms were improving. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received form an advanced registered nurse practitioner concerning a teenage female who was vaccinated with GARDASIL vaccine. Subsequently the patient experienced fever. The fever lasted for 2 days. It was reported the patient sought unspecified medical attention. This was one of 3 reports from the same resource. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Ultrasound scan abnormal
Clinical narrative: Information has been received from a consumer concerning her 19-year-old daughter with no medical history who was vaccinated with a 0.5 mL dose of GARDASIL (lot # not reported). There was no concomitant medication. On an uspecified date, the patient experienced cyst on ovaries after all three doses of GARDASIL. The caller did not have the dates for each dose. Ultrasound was performed. The patient was not recovered by the time of this report. The patient sought medical attention. No further information is available
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with penicillin allergy and sulfa allergy and no previous medical history reported who on 24-APR-2008 was vaccinated with the first dose of GARDISAL, IM, and on 26-JUN-2008 was vaccinated with the second dose of GARDISAL 0.5ml. Concomitant therapy included LOESTRIN. On 26-JUN-2008, after receiving the second vaccination, the patient experienced fever. On an unspecified date, the patient recovered from fever. The patient sought medical attention by spoke to the nurse practitioner. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain in extremity, Wrong technique in drug usage process
Clinical narrative: Information has been received from a nurse concerning her 13 year old female daughter with no pertinent medical history and no known drug reactions or allergies who in February 2008, was vaccinated with the first dose of GARDASIL vaccine, IM. On an unspecified date, the patient received the second dose of GARDASIL vaccine, IM. There were no concomitant medications. The nurse reported that her daughter experienced soreness of the arm after receiving the first  and second dose of GARDASIL vaccine. The daughter recovered about 1-2 days after each vaccination. On 16-OCT-2008, the patient received the third dose of GARDASIL vaccine, IM at the tendon or joint on the arm. She was not able to lift her arm despite using ice and MOTRIM from 16-OCT-2008 for a few days. She is recovering and can move the arm now. But she is still experiencing soreness. the patient sought medical attention and consulted with the nurse's husband who is a physician. There were no lab or diagnostic studies performed. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse concerning her 13 female daughter with no pertinent medical history and no known drug reactions or allergies who in February 2008, was vaccinated with the first dose  of GARDASIL vaccine, IM. On an unspecified date, the patient received the second dose of GARDASIL vaccine, IM. On 16-OCT-2008, the patient received the third dose of GARDASIL vaccine, IM. There was no concomitant medication. The nurse reported that the patient experienced soreness after each dose of GARDASIL vaccine. The patient was treated with ice and MOTRIN. The patient recovered the next day after the first and second doses. The patient recovered two days after the third dose on 18-OCT-2008. The patient sought unspecified medical attention. There were no lab or diagnostic studies performed. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a consumer concerning her 23 year old daughter who in August 2008, was vaccinated with the first dose of GARDASIL. In August 2008, after vaccination, the patient experienced swollen nodes in her armpit since then. It was reported that the swelling started in her left armpit and then went away, and reappeared in her right armpit. At the time of the report, the swelling was in the left armpit. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, White blood cell count
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 06-OCT-2008 was vaccinated with the first dose of GARDASIL vaccine (lot #660620/0571X). On 08-OCT-2008 the patient experienced muscle weakness in arms and legs when they called the office. On 09-OCT-2008 the patient called back still complaining of the issue and patient was advised to go to the ER. The patient sought unspecified medical attention. The white blood count test was performed. Office has not heard form patient since. Additional information has been requested
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with sulfa drugs allergy and no pertinent medical history who on 22-AUG-2008 was vaccinated IM with GARDASIL 0.5 ml. Concomitant therapy included meningococcal vaccine (manufacturer unknown). The registered nurse reported that on 22-AUG-2008 the patient developed generalized itching after receiving her first dose of GARDASIL. On unspecified date the patient recovered. No lab diagnostics were performed. The patient sought medical attention, "AE was mentioned at the next office visit". Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pulmonary vasculitis, Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the third dose of GARDASIL vaccine(dose, route and lot# not reported). The patient might have developed vasculitis after receiving the first dose of GARDASIL vaccine. After the third dose of GARDASIL vaccine, a pulmonologist diagnosed that the patient with vasculitis of the lungs. The patient sought medical attention  for her adverse experience and then the patient recovered from the vasculitis of the lungs. The pulmonologist attributed the vasculitis to GARDASIL vaccine. Additional information has been requested.  1/27/2009  MR received from vascular, pulmonary and sleep clinics. Pt seen 3/3/2008 in Vascular clinic for abnormal chest CT which showed an subclavian vein stenosis with collaterals seen to supply R arm.  CT done to r/o PE due to SOB. No dx noted. Seen in pulmonary clinic 3/31/2008 for eval of hypoxia. In Jan 2008 pt developed cough with blood tinged sputum. DX with Bronchitis with low O2 sats, now improved, however cough remains with occasional choking episodes. Also recently dx with Livido Reticularis due to lacy mottling and coolness of the distal extremities. Reports subQ nodules after HPV shots. PE (+) for lacy reticular rash in arms and legs. Deep coughing spells noted by parent.  No interstitial lung disease and unlikely pulmonary HTN. Referred to sleep clinic. Seen in sleep clinic for choking/coughing episodes at night. On altered school schedule due to sleep disturbances.  Purple discoloration of legs noted on PE.  1/23/09  07-JAN-2009, Dr provided to CDC most of the requested information and the following additional details:  Concomitant medication: prn Zyrtec; no known drug allergies; concurrent condition? / AE?: livedo reticular rash, all over body, on & off from May 2007, around time of vaccines; OTC cortisone cream ineffective; referred to rheumatologist for rash on 29-JAN-2008 - according to consult note, patient had the same rash on her feet "years before"; on 27-FEB-2008, a CT scan of the lung was performed.  2/2/09 MR received from PCP.  Hx as above. Rheum consult with DX Possible Raynauds. Livido reticularis-new onset. 04/07/09 This is in follow-up to report(s) previously submitted on 11/14/2008. Follow up information was received from physician via telephone call. The patient with no drug allergies was intramuscularly vaccinated with three doses of GARDASIL into the right deltoid on 07-MAY-2007, 02-JUL-2007, and 12-NOV-2007 (1st lot #657617/0384U, 2nd lot #657868/0523U, 3rd lot #659439/1267U), respectively. Concomitant therapy included prn ZYRTEC. In approximately May 2007, around time of vaccines, the patient developed livedo reticular rash all over body. OTC cortisone cream was ineffective for her. She referred to rheumatologist for rash on 29-JAN-2008. It was also reported the patient had the same rash on her feet years ago. On 27-FEB-2008, a CT scan of the lung was performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient experienced swollen glands.  The patient sought medical attention at a physician's office.  The outcome of the patient's experience was unknown.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from an office manager concerning a 17 year old female who was vaccinated with the third dose of GARDASIL. The patient then tested positive for HPV. The patient went to her obstetrician and tested positive for HPV. The office was concerned that the vaccine caused the patient to test positive for HPV. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 24 year old female with no pertinent medical history or known allergies, who on approximately 14-OCT-2008, was vaccinated with the second dose of GARDASIL (route and site not reported). Concomitant therapy included ALESSE. On approximately 19-OCT-2008, (five days after vaccination), the patient experienced localized urticaria in the left arm. As of 21-OCT-2008, the urticaria has extended from the injection site to the forearm. No laboratory test was performed. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. Additional information was received from a physician which reported that in August 2008 the patient received her first dose of GARDASIL vaccine (route and site not reported) and two days later the patient noticed a rash at the injection site, the rash was itchy and resolved within a week. The physician reported that in October 2008, two days after second dose of GARDASIL vaccine given in the left deltoid, the patient noticed a purple rash (same as before but more severe) on her left arm (from the injection site down to the wrist). The rash was itchy and resolved in approximately 10 days but left scars on patient's arm. The physician stated that the patient will not received her last and final GARDASIL shot. There was no illness at the time of vaccination. No additional information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Scar, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 24 year old female with no pertinent medical history or known allergies, who on approximately 14-OCT-2008, was vaccinated with the second dose of GARDASIL (route and site not reported). Concomitant therapy included ALESSE. On approximately 19-OCT-2008, (five days after vaccination), the patient experienced localized urticaria in the left arm. As of 21-OCT-2008, the urticaria has extended from the injection site to the forearm. No laboratory test was performed. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. Additional information was received from a physician which reported that in August 2008 the patient received her first dose of GARDASIL vaccine (route and site not reported) and two days later the patient noticed a rash at the injection site, the rash was itchy and resolved within a week. The physician reported that in October 2008, two days after second dose of GARDASIL vaccine given in the left deltoid, the patient noticed a purple rash (same as before but more severe) on her left arm (from the injection site down to the wrist). The rash was itchy and resolved in approximately 10 days but left scars on patient's arm. The physician stated that the patient will not received her last and final GARDASIL shot. There was no illness at the time of vaccination. No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history or known allergies who in approximately April 2007, was vaccinated with the third dose of GARDASIL 0.5 ml, IM.  Concomitant therapy included PAXIL and hormonal contraceptives (unspecified).  It was reported that after the patient received GARDASIL, had a Papanicolaou test positive for HPV.  The patient did not know which strain of the virus it is from.  There were no Papanicolaou test done during the series, so she did not know if she would have tested positive before or after it was reintroduced.  It was reported that a Papanicolaou test done before the vaccination series was "normal".  The reporter did not know where the series begun.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling hot, Influenza like illness, Lymphadenopathy, Pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a physician concerning a 21 year old female patient who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL (lot number 659655/1486) intramuscularly. Concomitant therapy included YASMIN. On 01-JUL-2008 the patient experienced severe flu like symptoms, generalized achiness, fatigue, swollen glands and was feverish but without temperature. Subsequently, on 11-JUL-2008, the patient recovered from severe flu like symptoms, generalized achiness, fatigue, swollen glands and feverish symptoms. No further information was provided. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician assistant concerning a 26 year old female with no medical history or allergies who was vaccinated intramuscularly with all three GARDASIL vaccine (lot# not reported) on time last year, in 2007. This month (OCT 2008) the patient was diagnosed with HPV(strain not known). It was reported that a PAP test was performed, outcome was unknown. Concomitant medication included Drospirenone (+) YAZMIN. The patient sought medical attention at physician's office. At the time of report the patient is recovering. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Neck pain, Pharyngeal oedema, Swelling face
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 16-OCT-2008, was vaccinated, IM, with the first 0.5 ml dose of GARDASIL. Concomitant therapy included influenza virus vaccine administered on 16-OCT-2008. On 20-OCT-2008, the patient experienced left-side facial swelling, left neck pain and "a feeling like her throat is swollen". The patient was examined in the office on 21-OCT-2008, and a cervical x-ray has been ordered. The patient was scheduled for a consultation with an unspecified ENT specialist on the afternoon of 21-OCT-2008. At the time of reporting, the adverse events were ongoing. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history, no known allergies or drug reactions, who on 01-OCT-2008 was vaccinated with the first dose of GARDASIL IM.  Concomitant therapy included VARIVAX (route and site not reported).  On 01-OCT-2008 the patient experienced syncope.  The patient was exiting the office and fainted hitting her head.  On 20-OCT-2008, the patient recovered.  A computed axial tomography was performed (results not reported).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a female who was vaccinated with the first dose of GARDASIL vaccine (site and route not reported). Concomitant therapy included Drospirenone (+) YAZ, prescribed at the same time as vaccination. On an unknown date the patient experienced hives. the physician's assistant believed that hives were caused by the birth control pills. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who in September 2008, was vaccinated with the first dose of GARDASIL (route and site not reported). It was reported that 2 to 3 minutes after recieveing the vaccine, the patient experienced dizziness and blacked out. The patient was unconscious for approximately 1 minute. The patient recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who on 01-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (route and site not reported), on 19-SEP-2008 was vaccinated with the second dose of GARDASIL vaccine (route and site not reported). On an unknown date after receiving second dose of vaccination, the patient developed swollen lymph nodes under both arms. The patient sought unspecified medical attention. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Oropharyngeal pain, Syncope
Clinical narrative: Information has been received from a physician concerning a 8 year old female, who on 14-OCT-2008, was vaccinated with the first dose of GARDASIL, I. M. Concomitant therapy included unspecified flu vaccine manufactured by Sanofi. Subsequently, the patient fainted within two hours. The patient was ill and had a sore throat on the same day that received GARDASIL. Subsequently, the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 13 year old healthy female with no known drug allergies reported who on 04-SEP-2008 was vaccinated with GARDASIL concomitantly with VARIVAX (Oka/Merck), and on 11-SEP-2008, one week later, the patient experienced a rash on her forearm.  The physician characterized the rash as papular and slightly pruritic.  The patient was recovering.  The patient sought physician's medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a physician concerning a number of female patients who were vaccinated with a dose of GARDASIL vaccine and after that felt heat in their arms, at the injection site. The patients sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine inflammation
Clinical narrative: Information has been received from a nurse who stated a family member of the patient reported a 15 year old female who was vaccinated with GARDASIL (dose, route and lot # were not reported).  A family member of the patient told the nurse that after vaccination with GARDASIL the patient had inflammation of the uterus.  No additional AE information reported.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Malaise, Pain
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with the first dose of GARDASIL on an unspecified date.  Subsequently, the patient "felt achy and not well, and her arm hurt" after vaccination.  No problems were reported regarding the second and third doses of GARDASIL.  At the time of the report, no additional AE information reported.  This is one of several reports of siblings.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from an advanced registered nurse practitioner concerning a patient who was vaccinated with GARDASIL. Subsequently, the patient experienced swelling at the injection that lasted for at lest one month after the vaccination with GARDASIL. This was one of 3 reports from the same resource. This is for a multiple patient report. Additional information has been requested. Additional information was received from an advanced registered nurse practioner who stated that all information had been sent. The nurse did not recall which patient had a sore, swelling or fever. Additional information was received from the advanced registered nurse practitioner reported that she operated at a transient clinic where young girls came and went quite often and she just did not remember who the patient was. No furhter information is available.
Sex: U
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from an advanced registered nurse practitioner concerning a patient who was vaccinated with GARDASIL.  Subsequently the patient experienced joint pain that lasted for a week after the vaccination with GARDASIL.  This was one of 3 reports from the same resource.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Vaginal lesion
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with allergy to sulfa who on 06-AUG-2008 or 08-AUG-2008 received the first dose of GARDASIL vaccine injection, (lot# not provided). There was no concomitant medication. About ten days after receiving the vaccine, the patient started to lose her hair above the to right ear. At first the physician thought it was ring worm and had given her medication, name was unspecified. Since the spot did not get better, the patient saw a dermatologist. the dermatologist did a scraping of the spot and the patient was then diagnosed with alopecia. The consumer also reported that her daughter had a sore in her vaginal are. the patient's sore in vaginal area and alopecia persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning his daughter, an 11 year old female with no medical history or allergies who was vaccinated with a first 0.5ml and second dose of GARDASIL (lot # not reported) on an unknown date and a month ago, approximately in Sep 2008, respectively.  There was no concomitant therapy.  Subsequently the patient experienced injection site pain after both doses.  The patient sought medical attention.  She recovered on an unknown date.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 22 year old female with no medical history and no drug allergies who on 16-APR-2008 was vaccinated with the first dose of GARDASIL 0.5 ml by IM.  There was no concomitant medication.  The patient has no reactions with her first dose.  On 20-JUN-2008, the patient was vaccinated with the second dose of GARDASIL 0.5 ml by IM (lot# 658219/0755U).  Subsequently the patient developed injection site reaction, redness, swelling and soreness on her arm.  The patient was seen by the physician.  The reaction lasted about one week.  Then on an unspecified date, the patient recovered from the adverse experience.  The patient did not receive the third dose yet.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling abnormal, Hypoaesthesia, Swelling
Clinical narrative: Information has been received from a physician assistant concerning a 23 year old female, who on 21-OCT-2008, was vaccinated, IM, with the first dose of GARDASIL, 0.5 ml ( Lot # 0152X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). On 21-OCT-2008, a few hours after receiving her first dose of GARDASIL, the patient experienced localized area of redness, swelling, numbness and a raw feeling on her chin. The patient's localized are of redness and swelling and numbness and a raw feeling on her chin persisted. It was reported that the patient sought medical attention: contacted the office by phone and an appointment in the office had been scheduled. Additional information was received from a physician assistant stating that the patient received GARDASIL in the morning and later that afternoon/evening, patient experienced swelling tin the jaw and chin. This was patient's first dose of GARDASIL. AE reported back around 22-OCT-2008. The patient had no significant medical history and no concomitant medication. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Dyskinesia, Electrocardiogram normal, Laboratory test normal, Loss of consciousness
Clinical narrative: Information has been received from the mother of a 13 year old female with a history of mood disorder who on unspecified dates received the first and second doses of GARDASIL.  On 16-SEP-2008 was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  After she received the 3rd dose on 16-SEP-2008, later that day she felt pain in her back and grabbed her spinal column.  The patient lowered herself down to the floor to lie flat on the ground.  She became unconscious and rhythmically moved one of her arms back and forth toward her head.  This movement then stopped and she re-gained consciousness and opened her eyes.  The entire episode lasted only about 1 to 2 minutes.  She seemed fine and normal shortly thereafter.  As a precaution she was taken to the Emergency Department of a local hospital where she had a number of tests.  All of the test results were normal.  She did not have to be admitted as an in-patient to the hospital.  She has seemed normal ever since this incident occurred.  She subsequently went to a cardiologist and a neurologist who specializes in pediatric epilepsy.  The patient's mother said that the neurologist would like to do further testing of her daughter.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from the mother of a 13 year old female with a history of mood disorder who on unspecified dates received the first and second doses of GARDASIL.  On 16-SEP-2008 was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  After she received the 3rd dose on 16-SEP-2008, later that day she felt pain in her back and grabbed her spinal column.  The patient lowered herself down to the floor to lie flat on the ground.  She became unconscious and rhythmically moved one of her arms back and forth toward her head.  This movement then stopped and she re-gained consciousness and opened her eyes.  The entire episode lasted only about 1 to 2 minutes.  She seemed fine and normal shortly thereafter.  As a precaution she was taken to the Emergency Department of a local hospital where she had a number of tests.  All of the test results were normal.  She did not have to be admitted as an in-patient to the hospital.  She has seemed normal ever since this incident occurred.  She subsequently went to a cardiologist and a neurologist who specializes in pediatric epilepsy.  The patient's mother said that the neurologist would like to do further testing of her daughter.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cyst, Influenza like illness
Clinical narrative: Information has been received from a consumer concerning her daughter, a 12 year old female, who in April 2008, was vaccinated with the first dose of GARDASIL, 0.5 ml, IM (therapy site unknown). On 20-OCT-2008, the patient received the third dose of GARDASIL, 0.5 ml, IM (therapy site unknown). Concomitant therapy included a tetanus vaccine (manufacturer not specified) given at the same time in the opposite arm. "Within 24 hours of receiving 3rd dose of GARDASIL", she experienced flu-like symptoms and cyst on her toe. The patient sought medical attention. Physician assistant did a physical exam of the patient and evaluated cyst. At the time of reporting, patient had not recovered. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal, Squamous cell carcinoma
Clinical narrative: Information has been received from a nurse concerning a 28 year old female who is non-sexually active and still has an intact hyman who in January 2008, finished vaccination whith the complete GARDASIL series, 0.5ml, IM.  A recent PAP test for this patient showed her to be positive for high risk HPV and atypical squamous cell of undetermined significance.  The patient sought medical attention.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain
Clinical narrative: Information has been received from a physician assistant concerning an 18 year old female with penicillin allergy who on 06-OCT-2008 was vaccinated with her first dose of GARDASIL into the left deltoid (lot#: 658488/0930U). On 07-OCT-2008 the patient experienced shoulder pain on the same side as the arm where she received GARDASIL. The patient was seen in the office. Her pain was treated with Ibuprofen. The patient's shoulder pain persisted. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Pain in extremity, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male who on 22-OCT-2008 was vaccinated with a dose of GARDASIL vaccine, IM. No problems reported. Follow up information was received from a physician who reported that the patient came into the office for Tdap vaccine (unspecified), MENACTRA and VARIVAX (Oka/Merck) and he mistakenly received GARDASIL. The physician reported that the child experienced some soreness in his arm and weakness, but nothing adverse. The physician stated the the child was fine. Additional information has been requested.   This is in follow-up to report (s) previously submitted on 11/14/2008.  Information has been received from a registered nurse concerning an 11 year old male who on 22-OCT-2008 was vaccinated with a dose of GARDASIL 0.5 mL, IM.  No problems reported.  Follow up information was received from a physician who reported that the patient came into the office for MENACTRA and VARIVAX and he mistakenly received GARDASIL.  The physician reported that the child experiened some soreness in his arm and and weakness, but nothing adverse.  The physician stated that the child was fine.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history, known allergies or drug reactions, who on 18-AUG-2008 was vaccinated with a first dose of GARDASIL (lot no. 660553/0070X) 0.5 ml, IM.  Concomitant therapy included BOOSTRIX.  In August 2008, after vaccination, the patient experienced flu-like symptoms, nausea and vomiting.  Subsequently, the patient recovered the symptoms.  A urinalysis was performed (no results available).  The patient was seen by the physician.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a healthcare worker concerning a 23 year old female who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X) IM into the left deltoid and had a syncopal episode.  The patient felt dizzy while sitting down (the room was spinning) immediately after receiving vaccination.  It was unclear if the patient lost consciousness, but smelling salts were used and the patient was observed for 15 minutes and then was "fine".  There was no concomitant medication.  It was unknown if the patient sought medical attention.  Follow up information was received who reported that the female subject patient with no known pre-existing allergies, and no illness at time of vaccination, was vaccinated with the first dose of GARDASIL (lot # 661044/0548X) at the physician's office at 11:00 am.  On 23-OCT-2008, immediately after receiving vaccination the patient experienced a syncope.  The patient did not fall.  The patient layed down for 15 minutes, and smelling salts and cold compresses were used.  On the same day, the patient recovered 15 minutes later after the vaccination.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient had anxiety about receiving GARDASIL. No specifics known about the patient. At the time of reporting on an unspecified date the patient had recovered and continued in the series. The patient sought medical attention in office. This is one of several patients received from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Lacrimation increased, Pharyngeal oedema, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 35 year old female, who on 20-OCT-2008, was vaccinated with the first dose of GARDASIL. On 21-OCT-2008, the patient's legs were itchy and she also developed tearing, itchy eyes and her throat felt swollen. The patient said it was similar to the reactions she has when she is around cats. The patient was seen in an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL, 0.5 ml, after receiving the vaccine the patient experienced an injection site reaction, a bump the size of a quarter at the injection site which was tender to the touch.  It was also noted that the patient received the vaccine in the buttock.  As of 22-OCT-2008 the patient's adverse events persisted.  The patient called the physician.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 11/14/2008. Follow up information on 29-DEC-2008, has been received from a physician concerning a 17 female patient with penicillin allergy who on 17-JUN-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot#: 66039/0067X) in the left upper buttock. On 08-OCT-2008 was vaccinated with 0.5 ml of the second dose of GARDASIL (Lot#: 663044/0548X) in the right upper outer quadrant buttock. There was no concomitant medication. On approximately 11-OCT-2008, the patient developed a quarter size "lump" under the skin without erythema. Ice was applied. On approximately 01-NOV-2008, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a consumer concerning her daughter who in May 2007, July 2007 and December 2007 was vaccinated with her first, second and third doses of GARDASIL respectively. The consumer reported that starting in August 2008, her daughter had been very nauseous and still was very nauseous and in September 2008,her daughter was put on anti-nauseating medication. The consumer reported that her daughter had been working with a GI,, neurologist and primary care physician, but her daughter stated that the anti nauseating medication (name manufacturer is unspecified) only worked in the morning. At the time of this report, 24-OCT-2008, no outcome reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a physician concerning a 13-year-old female patient about with no history of any drug, food, insect or latex reactions who on 04-SEP-2008 was vaccinated IM in her deltoid with a first dose of GARDASIL (lot #661044/0549X).  Additional suspect vaccination on 04-SEP-2008 included Varivax. Concomitant vaccination on 04-SEP-2008S included DTAP (manufacturer unknown). there was no illness at the time of vaccination (also reported on 05-SEP-2008), the patient experienced rash which was only occasionaly mildly itchy. The patient was given ZYRTEC for the rash without relief, when the patient went to see an allergist, the rash, which was described as pinpoint, slightly erythematous, non vesicular papules over the forearm and wrist, had been improving over the past month. Two months after the vaccine was administered, the patient's mother did call the allergist to report that the patient continued to have  the rash, the allergist did not feel it was related to the GARDISIL and asked the patient to come back for reevaluation. Follow up information was received from the physician who reported that on 06-NOV-2008 the patient recovered from the hives. On 03-NOV-2008 the patient received a second dose of GARDISIL without any event reported. Additional infprmation is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Computerised tomogram normal, Inappropriate schedule of drug administration, Laboratory test normal, Ultrasound scan normal
Clinical narrative: Information has been received from a female consumer, concerning her 13 year old daughter with no medical history or allergies who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL, the second dose on 30-APR-2007 and the third dose on 07-AUG-2007.  There was no concomitant medication.  The consumer reported that, in August 2007, "not too long after receiving the third dose of GARDASIL", the patient started to have severe stomach pain on her upper left side.  The reporter stated that her daughter's pain level on a scale of 1 to 10 was a 7.  The consumer reported that the patient had blood work, ultra sounds and CAT scans done and they all came back normal.  The reporter stated that the next time the patient saw the physician they may have to "put a scope in her to check out her stomach area".  The patient was not recovered at the time of this report.  The patient sought medical attention with a physician.  No further information is available. This is in follow-up to report (s) previously submitted on 11/14/2008.  Information has been received from a female consumer, concerning her 13 year old daughter with no medical history or allergies who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL, the second dose on 30-APR-2007 and the third dose on 07-AUG-2007.  There was no concomitant medication.  The consumer reported that, in August 2007, "not too long after receiving the third dose of GARDASIL", the patient started to have severe stomach pain on her upper left side.  The reporter stated that her daughter's pain level on a scale of 1 to 10 was a 7.  The consumer reported that the patient had blood work, ultra sounds and CAT scans done and they all came back normal.  The reporter stated that the next time the patient saw the physician they may have to "put a scope in her to check out her stomach area".  The patient was not recovered at the time of this report.  The patient sought medical attention with a physician.  This is an amended report.  The vaccination date of the third dose of GARDASIL now reads 07-AUG-2007 instead of 07-AUG-2008.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Syncope
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with no medical history or known drug allergies, who on 21-OCT-2008, was vaccinated, IM, with the first 0.5 ml dose of GARDASIL (lot # 659184/0843X). Concomitant therapy included hormonal contraceptives (unspecified). On 21-OCT-2008, the patient experienced a "fainting episode" after administration of her first dose of GARDASIL. The patient later developed a headache, which lasted 2 days (also reported as the patient had not recovered). At the time of this report, the patient was not recovered from the fainting episode. The patient visited the office for medical attention. Additional information has been requested. Follow up information received from a physician concerning a 23 year old female who on 21-OCT-2008, at 15:22 was vaccinated with the first dose of GARDASIL (lot # 659184/0843X) into the left deltoid. The patient had no illness at the time of vaccination. On 21-OCT-2008, at 15;24, the patient experienced fainting after injection and headache. Follow-up information received from a registered nurse concerning a 23 year old female with no known allergies who on 21-OCT-2008, at 15:23 was vaccinated with the first dose of GARDASIL (lot # 659184/10843X) into the deltoid. The patient had no illness at the time of vaccination. On 23-OCT-2008, at 15:23, the patient fainted after vaccination. The patient also complained of headache and felt ill all evening. The patient was recovered on 24-OCT-2008. No further information is available.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 year old female patient who on 12-SEP-2008 was vaccinated with a first dose of GARDASIL (lot # 659184/0843X). Concomitant therapy also given on 12-SEP-2008 included varricella virus vaccine live (MSD). On 15-SEP-2008, the patient's hands and feet began to peel 2-3 days after she was given the first dose of GARDASIL. The patient contacted the office. On an unspecified date, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2009. Follow up information reported that the Nurse Practioner reported that she "was sorry that the event was a long time ago. She did not have a copy of the event was a long time ago. She did not have a copy of the paperwork". Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a mother of a patient concerning a 11 year old daughter with headache and seasonal allergy who on 02-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and on unspecified date was vaccinated with a second dose of GARDASIL vaccine. After each dose of vaccine the patient's headache became more severe. The patient sought unspecified medical attention. On unspecified date the patient recovered. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a RN concerning a 29 year old female who was intramuscularly vaccinated with the second 0.5 ml dose of GARDASIL on an unspecified date. On 24-OCT-2008 the patient experienced redness, tenderness and warmth at the site of GARDASIL vaccine administration after her second dose. At time of reporting, the outcome of the patient was unknown. The patient called the clinic for medical attention. Additional information has been reported.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Information has been received from a nurse concerning a "teenage" female who was vaccinated with GARDASIL 3 months ago.  The patient developed a lump on the injection site which she had for 3 months later after vaccine.  At the time of the report, the patient was not recovered.  The patient sought medical attention by physician.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a healthcare worker concerning a 17 year old female with asthma who on 27 Aug 2008 was vaccinated with the first dose of GARDASIL intramuscularly. On 23-Oct-2008, the patient was vaccinated with the second dose of GARDASIL intramuscularly concomitant therapy included unspecified oral contraceptives. It was reported that one day after receiving her second dose, on 24-Oct-2008, the patient experienced an asthma attack. Prior to this, it had been 4 years since this patient had experienced an asthma attack. She was treated with an unspecified asthma inhaler. The patient also developed redness, swelling pain and warmth at the injection site after both of her immunization with GARDASIL. All these symptoms were greater after the second dose than the first dose. The onset date of these symptoms was unspecified. At the time of the report, the patient was recovering. The patient sought medical attention, by phone call. Follow up information received on 30-DEC-2009 stated that the patient's mom called and said that the patient has a reaction to the injection, her arm was swollen/warm to touch and she had an asthma attack. Patient has not had an attack for four years wasn't sure if it was related or not. Inhaler made patient feel better. Additional information is not expected.