chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Information has been received from a consumer concerning of her daughter, a 17 year old female with no pertinent medical history and without concomitant medication.  Who after received the first (MAR-2008) and second dose (date unspecified in 2008) of GARDASIL (site and route unspecified) had injection site reactions (soreness and swelling).  Subsequently on early October, the patient was vaccinated with the third dose of GARDASIL (site and route unspecified).  About a week after vaccination the patient started experiencing tingling and weakness in her arm and legs, dizziness, tiredness, nausea.  The patient has been seen by a neurologist but no cause of the problem could be found.  On an unspecified date in 2008, the laboratories studies perform were a blood work, MRI and Lymes test which were negative.  At the time of reporting, 20-NOV-2008, the outcome of the patient was not recovered.  1/16/09 Reviewed PCP medical records for 3/27-12/22/08. FINAL DX: Records reveal patient experienced usual state of good health on 3/27/08 when received HPV#1, MCV4 & varivax.  On 4/27 seen for erythematous itch rash x 4 days & dx w/probable Fifth's disease.  Tx w/topical meds.  RTC 6/9/08 w/sore throat & fatigue x 3-5 days, HA resolved, occ cough, oral intake reduced.  Rapid strep neg & dx w/viral pharyngitis.  RTC 6/12 w/continued sore throat & tiredness & tender cervical lymph node hyperplasia.  Dx w/pharyngitis & tx w/oral antibiotics as leaving country next day.  RTC 10/13 w/nausea, stomach ache & heavy numb hands & legs.  Dx w/dysmenorrhea.  RTC 10/26 w/continued fatigue, nausea, stomach ache, lightheaded & extra heavy menstruation x 5-6 days.  Dx w/dysmenorrhea, malaise & fatigue & considered BCP.  Referred to neuro prior to starting BCP due to hx of migraine HA.  Neuro consult 10/24/08 for paresthesias/tingling of hands/feet, balance difficulties, gen. weakness all beginning approx 10/12/08.  Neuro exam completely WNL & no dx provided. Returned to neuro 11/11/08 for review of abnormal MRI, no change in physical assessment.  Returned to neuro 12/22/08 for LP with no change in physical assessment. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information on 29-DEC-2008, has been received from a certified medical assistant concerning a 17 year old female patient with no known allergies or pertinent medical history who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (Lot: 659655/1486U) intramuscularly, and on 06-OCT-2008 the patient was vaccinated with the third dose of GARDASIL (Lot: 560620/0571X) intramuscularly. The medical assistant reported there was no adverse event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning of her daughter, a 17 year old female with no pertinent medical history and without concomitant medication.  Who after received the first (MAR-2008) and second dose (date unspecified in 2008) of GARDASIL (site and route unspecified) had injection site reactions (soreness and swelling).  Subsequently on early October, the patient was vaccinated with the third dose of GARDASIL (site and route unspecified).  About a week after vaccination the patient started experiencing tingling and weakness in her arm and legs, dizziness, tiredness, nausea.  The patient has been seen by a neurologist but no cause of the problem could be found.  On an unspecified date in 2008, the laboratories studies perform were a blood work, MRI and Lymes test which were negative.  At the time of reporting, 20-NOV-2008, the outcome of the patient was not recovered.  1/16/09 Reviewed PCP medical records for 3/27-12/22/08. FINAL DX: Records reveal patient experienced usual state of good health on 3/27/08 when received HPV#1, MCV4 & varivax.  On 4/27 seen for erythematous itch rash x 4 days & dx w/probable Fifth's disease.  Tx w/topical meds.  RTC 6/9/08 w/sore throat & fatigue x 3-5 days, HA resolved, occ cough, oral intake reduced.  Rapid strep neg & dx w/viral pharyngitis.  RTC 6/12 w/continued sore throat & tiredness & tender cervical lymph node hyperplasia.  Dx w/pharyngitis & tx w/oral antibiotics as leaving country next day.  RTC 10/13 w/nausea, stomach ache & heavy numb hands & legs.  Dx w/dysmenorrhea.  RTC 10/26 w/continued fatigue, nausea, stomach ache, lightheaded & extra heavy menstruation x 5-6 days.  Dx w/dysmenorrhea, malaise & fatigue & considered BCP.  Referred to neuro prior to starting BCP due to hx of migraine HA.  Neuro consult 10/24/08 for paresthesias/tingling of hands/feet, balance difficulties, gen. weakness all beginning approx 10/12/08.  Neuro exam completely WNL & no dx provided. Returned to neuro 11/11/08 for review of abnormal MRI, no change in physical assessment.  Returned to neuro 12/22/08 for LP with no change in physical assessment. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information on 29-DEC-2008, has been received from a certified medical assistant concerning a 17 year old female patient with no known allergies or pertinent medical history who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (Lot: 659655/1486U) intramuscularly, and on 06-OCT-2008 the patient was vaccinated with the third dose of GARDASIL (Lot: 560620/0571X) intramuscularly. The medical assistant reported there was no adverse event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a certified nurse midwife concerning a 15 year old female patient who on 18-FEB-2008 was vaccinated intramuscularly in the deltoid area with the first dose of GARDASIL (lot # 657621/0387U).  The nurse practitioner mentioned that the patient became faint several minutes after receiving the vaccine.  The patient received her first dose of GARDASIL and waited 15 minutes and was fine.  Then when she got up to leave, her knees buckled and she passed out.  The practitioner nurse reported that the patient had not eaten that day and was anxious about the shot. The nurse reported that the patient was terrified of needles so the fainting was dubious. The patient recovered immediately without incidence.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from an office manager concerning a 23 year old female with no known drug reactions/allergies and no pertinent medical history, who on 09-NOV-2008 was vaccinated with GARDASIL, 0.5ml, intramuscularly.  There was no concomitant medication.  The office manager reported that on 10-NOV-2008, the patient developed pruritic and burning rash all over her body after her first dose of GARDASIL.  The patient was prescribed an antihistamine.  The patient sought medical attention via telephone.  At the time of the report, the patient has not recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site erythema, Injection site induration, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a 20 year old female with anatryptaline allergy and a history of eating disorder, acid reflux and pelvic inflammation (physician found " low recessive cells for cervical"; after treatment and another PAP test the physician suggested getting HVP vaccine) who on 03-SEP-2008 was vaccinated in the upper arm with the first dose of GARDASIL.  On 13-SEP-2008 she found out she was pregnant.  On an unknown date she received a flue shot and prenatal vitamins.  On the day of vaccination the patient experienced "burning pain at the time the shot was given, and after the injection she had a little red dot for a couple of days that eventually turned into a swelled up knot that was very painful to the touch".  The consumer recovered "2 and a half weeks after getting the vaccine".  The consumer sought unspecified medical attention.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pregnancy test positive
Clinical narrative: Information has been received from a 20 year old female with anatryptaline allergy and a history of eating disorder, acid reflux and pelvic inflammation (physician found " low recessive cells for cervical"; after treatment and another PAP test the physician suggested getting HVP vaccine) who on 03-SEP-2008 was vaccinated in the upper arm with the first dose of GARDASIL.  On 13-SEP-2008 she found out she was pregnant.  On an unknown date she received a flue shot and prenatal vitamins.  On the day of vaccination the patient experienced "burning pain at the time the shot was given, and after the injection she had a little red dot for a couple of days that eventually turned into a swelled up knot that was very painful to the touch".  The consumer recovered "2 and a half weeks after getting the vaccine".  The consumer sought unspecified medical attention.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female with asthma who on 10-JUN-2008 was vaccinated with the first dose of GARDASIL and the second dose of GARDASIL on 12-AUG-2008, lot # 660557/0072X, intramuscularly in right deltoid.  It was reported that the patient experienced nausea, abdominal pain, headache, sore throat and fever "several " hours after receiving her second dose of HPV
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site papule, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning an approximately 20 year old female who in approximately September 2008 "a couple months ago"  was vaccinated intramuscularly with the first dose of GARDASIL and experienced "small bump"  at the injection site that lasted for 3-4 days.  On 01-NOV-2008 "17 days ago" the patient was vaccinated with the second dose of GARDASIL and experienced a similar bump for 2 weeks.  After 2 weeks, it got larger and painful and it was "hot".  At the time of reporting, the patient still has "a little bump" that "hurts a little bit when I touch it".  The patient sought unspecified medical attention and had blood work performed.  The result was not reported.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning her 18 year old daughter who was vaccinated with the second and third doses of GARDASIL two years ago (in approximately 2006).  After receiving her second and third doses of GARDASIL the patient experienced fever and pain at the injection site two years (in approximately 2006).  Lot number was not available.  The outcome was unknown.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning a 17 year old female with allergy to Amoxicillin and Codeine and no relevant medical history who on 03-Mar-2008 was vaccinated intramuscularly with a first 0.5ml  dose of GARDASIL (lot number 659441/1446U) (injection site not reported). On 02-Jun-2008 and 08-Sep-2008, the patient was vaccinated intramuscularly with a second and third 0.5ml dose of GARDASIL (lot number 660387/1967U) (injection site not reported). Concomitant therapy included NUVARING. Subsequently the patient was pregnant. Her LMP was 23-Aug-2008. On 22-Sep-2008 the patient had a low grade PAP smear. The patient went to the physician's office. Laboratory tests included ultrasound and blood work (results unspecified). The outcome of the patient's experience was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning an approximately 31 year old female, who on 28-SEP-2006 was vaccinated with the first 0.5ml dose of GARDASIL.  In October 2006, the patient was vaccinated with the second 0.5 ml dose of GARDASIL.  In March 2007, the patient was vaccinated with the third 0.5ml dose of GARDASIL.  On an unspecified date, the papanicolaou test was done and the result revealed abnormal.  At the time of this report, the outcome was unknown.  The patient was see by the physician and sought unspecified medical attention.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Biopsy skin abnormal
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no drug reactions or allergies and a history of seborrhoea who on unspecified dates was vaccinated with GARDASIL series.  Concomitantly, the patient used medicated shampoo.  In May 2008, the patient experienced hair loss.  At the time of this reporting, the patient was recovering from hair loss.  Biopsy was performed and the results showed alopecia with mild fibroplasia.  Unspecified medical attention was sought in the office.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner and a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL.  Shortly after receiving the vaccine the patient experienced syncope.  The patient's outcome was not reported.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a pharmacy student concerning a female who was vaccinated with an unknown number doses of GARDASIL.  The patient experienced hair loss on the top of her head "about 2 weeks ago", on approximately 31-OCT-20088.  The patient's mother called pharmacy.  At the time of reporting, the patient recovered.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Atrophoderma of Pasini and Pierini, Biopsy skin, Injection site atrophy, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with her third dose of GARDASIL (route and site not reported).  In July 2008, the patient developed left arm pain and a depression of her skin at the injection after receiving her third dose of GARDASIL.  A skin biopsy was consistent with atrophoderma.  The patient's left arm pain and a depression of her skin at the injection site persisted.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Full blood count normal, Hyperaesthesia, Laboratory test normal, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL (route and site not reported).  On 20-FEB-2008, 22-APR-2008 and 21-OCT-2008, the patient was given the first, second and third dose of GARDASIL separately.  There were no adverse effects after the first 2 doses.  About 2 days after her last dose of GARDASIL, the patient experienced intermittent episodes of "tingling" in her toes, fingers, and face that last between 30 minutes and 1 hour then resolved.  Complete blood panel- complete blood cell count, comprehensive metabolic panel, Sedimentation rate, thyroid stimulating hormone, and Rapid Plasma Reagin done with all results normal.  The doctor had characterized this as "a skin disturbance".  The patient's tingling in her toes, fingers and face persisted.  Follow-up information was received from the physician.  She stated that this 18 year old female received her 3rd dose of GARDASIL on 21-OCT-2008 and 2 days later experienced tingling intermittently of fingertips and toes.  She stated that the episode last for about 30 minutes and were still occurring intermittently.  The patient reported one episode tingling of the face and also reported that the soles of her feet were more sensitive to touch when the tingling was not present and described the sensation as "ticklish".  The patient was not reporting any associated pain and did not experience these symptoms following dose 1 or 2.  She was concomitantly taking birth control pills since June and was recently treated for Chlamydia.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal, Syphilis test negative
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL (route and site not reported).  On 20-FEB-2008, 22-APR-2008 and 21-OCT-2008, the patient was given the first, second and third dose of GARDASIL separately.  There were no adverse effects after the first 2 doses.  About 2 days after her last dose of GARDASIL, the patient experienced intermittent episodes of "tingling" in her toes, fingers, and face that last between 30 minutes and 1 hour then resolved.  Complete blood panel- complete blood cell count, comprehensive metabolic panel, Sedimentation rate, thyroid stimulating hormone, and Rapid Plasma Reagin done with all results normal.  The doctor had characterized this as "a skin disturbance".  The patient's tingling in her toes, fingers and face persisted.  Follow-up information was received from the physician.  She stated that this 18 year old female received her 3rd dose of GARDASIL on 21-OCT-2008 and 2 days later experienced tingling intermittently of fingertips and toes.  She stated that the episode last for about 30 minutes and were still occurring intermittently.  The patient reported one episode tingling of the face and also reported that the soles of her feet were more sensitive to touch when the tingling was not present and described the sensation as "ticklish".  The patient was not reporting any associated pain and did not experience these symptoms following dose 1 or 2.  She was concomitantly taking birth control pills since June and was recently treated for Chlamydia.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Dizziness, Inappropriate schedule of drug administration, Migraine, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 18 year old female with PENICILLIN, BACTRIM and DUAC gel  allergy and a history of reactive airways who on 03-JAN-2008, 03-APR-2008, 07-AUG-2008, 17-SEP-2008, was vaccinated with the first, second, third and fourth dose of GARDASIL 0.5ml IM separately.  On 17-OCT-2008 the patient experienced the sudden onset of disorientation and dizziness.  The patient subsequently experienced parasthesia of the lower extremities which then extended to include both arms and her face, as well as one episode of emesis.  The patient was seen in the office within 1 hour of the onset of symptoms.  A diagnosis of migraine variant was made and the patient was prescribed PHENERGAN and DARVOCET.  The symptoms resolved within 2 hours of onset.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female with PENICILLIN, BACTRIM and DUAC gel  allergy and a history of reactive airways who on 03-JAN-2008, 03-APR-2008, 07-AUG-2008, 17-SEP-2008, was vaccinated with the first, second, third and fourth dose of GARDASIL 0.5ml IM separately.  On 17-OCT-2008 the patient experienced the sudden onset of disorientation and dizziness.  The patient subsequently experienced parasthesia of the lower extremities which then extended to include both arms and her face, as well as one episode of emesis.  The patient was seen in the office within 1 hour of the onset of symptoms.  A diagnosis of migraine variant was made and the patient was prescribed PHENERGAN and DARVOCET.  The symptoms resolved within 2 hours of onset.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Information has been received from a 56 year old female with allergic to Sulfa and no relevant medical history who on 07-Oct-2008 was vaccinated with a first dose of GARDASIL,(lot number, injection site and route not reported). Concomitant therapy included hormone replacement therapy. In October 2008, also reported as a couple of weeks later, the patient experienced pain in her left arm where she received the vaccine. The patient reported that as the weeks went on she had pain in her arm to the point where she could not lift it up, but for now the pain subsided but had a "dull" ache. The patient called the doctor's office. At the time of this report, the patient's  events was recovering. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Skin discolouration
Clinical narrative: Information has been received from a physician's office manager concerning a 24 year old female, caucacic patient who on 06-Aug-2008 was vaccinated with second dose of GARDASIL single dose vial intramuscularly injection, left deltoid. Concomitant therapy included montelukast sodium (MSD), KLONOPIN and TOPICORT. In Oct-2008 when the patient was accompanying her sibling to an office visit she reported that she experienced a small nickel-sized divet left upper extremity (LUE) after she received her second dose of GARDASIL on 06-Aug-2008. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information has been received on 08-JAN-2009 from a physician who reported that the little impression in the patient's arm has gotten bigger has lost some pigment. Also the physician reported that the patient had a delayed injection site reaction that has progressively gotten worse over the past month. The "divot' in the patient's arm appeared on 20-OCT-2008. Currently the area was 2cm x 1 cm and lost pigmentation to the skin in that area. The depression in the skin was 1/3 - 1/2cm in deep. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a 17 year old female who on 18-JUN-2008 was vaccinated "in her buttocks"  with a first dose of GARDASIL.  In "June 2008", the patient experienced muscle pain and muscle tenderness.  On 18-AUG-2008 was vaccinated in her arm with a second dose of GARDASIL.  She stated the symptoms never resolved and have become worse since receiving her second dose.  At the time of reporting the patient's muscle pain and tenderness persisted.  The patient sought medical attention of the physician.  Additional information has been requested.  2/4/09 Received PCP medical records of 8/12-11/12/2008. FINAL DX: none provided Records reveal patient in good health 8/12.  RTC 11/12 w/pain right gluteal since received HPV #1 in 6/08 at GYN office.  Referred to GYN & neuro if sys persist.  Also had pharyngitis 11/12.  2/17/09 Received GYN vaccine records & medical records of 6/18-2/3/09. FINAL DX: none provided Records reveal patient experienced irregular periods, acne otherwise in good health for vaccinations.  6/18 vax given right gluteal.  11/6/08 note states had problems w/muscle in buttock since vax.  Had stiffness & discomfort in back & hip.  Referred to PCP.  RTC 2/3 for HPV #3 w/o complaints at that time.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 28-OCT-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot number and injection site not reported).  Subsequently the patient experienced fever, chills and nausea.  On 03-NOV-2008, the patient's mother called the physician's office to report the symptoms.  Subsequently, the patient fully recovered from the events without requiring treatment.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cardiovascular disorder
Clinical narrative: Information has been received from a nurse, concerning her niece who approximately on 30-OCT-2008 ("two weeks ago") was vaccinated a dose of GARDASIL (lot number, route and injection site not reported).  The patient believes that she is having  cardiovascular problems since she was given GARDASIL.  It was unknown if she sought any medical attention.  At the time of report, the patient's symptom persisted.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Disorientation, Dizziness, Hypoaesthesia
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 14-year-old female patient with type 2 diabetes, anxiety disorder, Disturbance of skin sensation, insomnia hyperlipidemia and no drug allergies, who on 27-Aug-2008 was vaccinated IM with the first dose of 0.5ml GARDASIL (lot number and injection site not reported). Concomitant therapy included PROZAC, CLARATIN, Mirtazapine, Famotidine (reported as "Samotidine" , manufacturer unknown) and gabapentin for type 2 diabetes, anxiety disorder, disturbance of skin sensation, insomnia, and hyperlipidemia. On 27-Aug-2008 after receiving GARDASIL, the patient experienced numbness all over and passed out; she also experienced immediate dizziness, weakness, and disorientation. Since 28-Aug-2008, the patient has experienced daily episodes of temporary numbness of both feet which lasted an unspecified length of time. The episodes have increased to 2-3 times per day and the numbness, during each episode, now extends from the feet to the mid-chest. The patient was referred for neurologic and orthopedic consultation, providers unspecified and 'all testing was normal" The medical assistant also stated that the patient "has missed a lot of school recently because of the symptoms". In October 2008 the patient did receive the second dose of GARDASIL. At the time of reporting, the patient has not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Loss of consciousness
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 14-year-old female patient with type 2 diabetes, anxiety disorder, Disturbance of skin sensation, insomnia hyperlipidemia and no drug allergies, who on 27-Aug-2008 was vaccinated IM with the first dose of 0.5ml GARDASIL (lot number and injection site not reported). Concomitant therapy included PROZAC, CLARATIN, Mirtazapine, Famotidine (reported as "Samotidine" , manufacturer unknown) and gabapentin for type 2 diabetes, anxiety disorder, disturbance of skin sensation, insomnia, and hyperlipidemia. On 27-Aug-2008 after receiving GARDASIL, the patient experienced numbness all over and passed out; she also experienced immediate dizziness, weakness, and disorientation. Since 28-Aug-2008, the patient has experienced daily episodes of temporary numbness of both feet which lasted an unspecified length of time. The episodes have increased to 2-3 times per day and the numbness, during each episode, now extends from the feet to the mid-chest. The patient was referred for neurologic and orthopedic consultation, providers unspecified and 'all testing was normal" The medical assistant also stated that the patient "has missed a lot of school recently because of the symptoms". In October 2008 the patient did receive the second dose of GARDASIL. At the time of reporting, the patient has not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a nurse practitioner and a registered nurse concerning a female  who on an unspecified date was vaccinated with a dose of GARDASIL.  Shortly after receiving the vaccine the patient experienced syncope and went to the emergency room because she had fallen and hit her head.  The patient "did improve".  Additional information has been requested.  This is one several reports from the same source
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration, Pruritus, Rash generalised, Rash macular
Clinical narrative: Information has been received from a physician concerning a 27 year old female who on 04-NOV-2008 was vaccinated with the first and only dose of GARDASIL 0.5ml/once IM.  One week after the vaccination, the patient developed rash from head to toe.  The patient was given ATARAX and BENADRYL for the treatment.  The patient's rash from head to toe was not recovered.  Additional information has been requested. Follow-up information was received on 17-FEB-2009 from the physician via medical records indicating the patient was a certified nursing assistant (CMA) who worked in a hospital. On 04-NOV-2006, at 09:00, the patient with no pre-existing allergies, birth defects or medical conditions was vaccinated in the right uper arm with a first dose of GARDASIL (lot# 659184/0843X). There was no illness at time of vaccination. On 11-NOV-2008 the patient was seen by the physician complaining of hives spreading in bilaterial arm which lasted "2 days", from 09-NOV-2009, at 09:00, She also complained of pruritus. Physical examination  showed there were "round oval" macules and papules in her neck, trunk and extremities. There was no lesions on her hands. The patient had taken Benadryl, OTC for symptoms. The patient was diagnosed with allergic reaction and was treated with ATARAX, 25mg, three times a day. No diagnostic or laboratory tests were performed. Subsequently, on an unspecified date, the patient recovered. Additional information is not expectede.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 27 year old female who on 04-NOV-2008 was vaccinated with the first and only dose of GARDASIL 0.5ml/once IM.  One week after the vaccination, the patient developed rash from head to toe.  The patient was given ATARAX and BENADRYL for the treatment.  The patient's rash from head to toe was not recovered.  Additional information has been requested. Follow-up information was received on 17-FEB-2009 from the physician via medical records indicating the patient was a certified nursing assistant (CMA) who worked in a hospital. On 04-NOV-2006, at 09:00, the patient with no pre-existing allergies, birth defects or medical conditions was vaccinated in the right uper arm with a first dose of GARDASIL (lot# 659184/0843X). There was no illness at time of vaccination. On 11-NOV-2008 the patient was seen by the physician complaining of hives spreading in bilaterial arm which lasted "2 days", from 09-NOV-2009, at 09:00, She also complained of pruritus. Physical examination  showed there were "round oval" macules and papules in her neck, trunk and extremities. There was no lesions on her hands. The patient had taken Benadryl, OTC for symptoms. The patient was diagnosed with allergic reaction and was treated with ATARAX, 25mg, three times a day. No diagnostic or laboratory tests were performed. Subsequently, on an unspecified date, the patient recovered. Additional information is not expectede.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with penicillin allergy and without illness at time of vaccination, who on 12-NOV-2008 at 11:30 was vaccinated with the third dose of 0.5ml GARDASIL (lot # 661766/0652X)  IM in the right arm and concomitantly at the same time with FLUVIRIN (lot # 89981) IM in the right arm.  On 12-NOV-2008 at 11:55, the patient experienced syncope.  The patient was sitting in exam room after injection for 15 minutes, with no problems, after getting up and walked in the hallway, she fell to the ground.  Right after hitting the ground she opened her eyes.  On the same date, the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning his 12 year old daughter who on the morning of 10-Nov-2008 was vaccinated with GARDASIL , IM. Subsequently the patient got light headed and "woozy" after getting the vaccine. It was noted that the patient didn't have breakfast that morning. The patient was given some juice and recovered a while later. The patient sought medical attention through the reporting physician. No laboratory diagnostic studies were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL.  On an unspecified date, eight hours after the administration of the second dose of GARDASIL, the patient's face and tongue got swollen.  The physician reported that her entire face was swollen the following day.  The patient took BENADRYL and went to bed.  She recovered with therapy.  The physician noted that the patient was around dogs and had her hair dyed on the same day as the administration.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia
Clinical narrative: Information has been received from an emergency room physician concerning a female patient who on an unknown date was vaccinated with GARDASIL.  The emergency room physician stated that she received a call from the patient's primary physician who stated that the patient will be sent to the ER because she experienced weakness symptoms.  At the time of reporting the patient had not recovered.  The patient sought medical attention, contacted the physician.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Fall, Hypotension, Loss of consciousness
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/12/2009. Information has been received from a nurse concerning a 17 year old female patient, with no pertinent medical history and no drug allergies/drug reactions, who on 01-NOV-2008 (previously reported as 07-NOV-2008) was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot # 661764/0650X). Concomitant therapy included Hepatitis A vaccine (inactivated) (manufacturer unknown) and Hepatitis B vaccine (recombinant) (manufacturer unknown).  The nurse reported that the patient felt dizzy and fell 10 minutes after receiving GADASIL vaccine.  It was noted that her blood pressure was low. These events were originally reported with onset dates of 7-NOV-2008. There were no laboratory diagnostics studies performed.  It was reported that she felt normal 20 to 30 minutes after the fall. The patient was recovered on 07-NOV-2008.  The patient was seen by the nurse. Follow up information was received from other health professional: Approximately 10 minutes after injection given on 01-NOV-2008, the child vomited and passed out. The patient's blood pressure dropped to 70/50. The patient was given juice and the blood pressure improved to 90/60. After 10 minutes, patient improved. On an unspecified date, the patient recovered (previously reported as 07-NOV-2008). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/12/2009. Information has been received from a nurse concerning a 17 year old female patient, with no pertinent medical history and no drug allergies/drug reactions, who on 01-NOV-2008 (previously reported as 07-NOV-2008) was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot # 661764/0650X). Concomitant therapy included Hepatitis A vaccine (inactivated) (manufacturer unknown) and Hepatitis B vaccine (recombinant) (manufacturer unknown).  The nurse reported that the patient felt dizzy and fell 10 minutes after receiving GADASIL vaccine.  It was noted that her blood pressure was low. These events were originally reported with onset dates of 7-NOV-2008. There were no laboratory diagnostics studies performed.  It was reported that she felt normal 20 to 30 minutes after the fall. The patient was recovered on 07-NOV-2008.  The patient was seen by the nurse. Follow up information was received from other health professional: Approximately 10 minutes after injection given on 01-NOV-2008, the child vomited and passed out. The patient's blood pressure dropped to 70/50. The patient was given juice and the blood pressure improved to 90/60. After 10 minutes, patient improved. On an unspecified date, the patient recovered (previously reported as 07-NOV-2008). Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 06-NOV-2008 or 07-NOV-2008 was vaccinated with the first dose of GARDASIL.  The physician reported that the patient received another vaccine on the same date on the other arm, but the name and manufacturer of that vaccine was unspecified.  After receiving the vaccination, the patient's arm was swollen about 6 inches and was very red.  The physician reported that the patient has recovered and would not be receiving any more dose of GARDASIL.  The patient sought medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with her first dose of GARDASIL (Lot # not reported).  After she received the first vaccine her arm was tingling and she had a pins and needles feeling in the arm.  The patient sought unspecified medical attention.  Subsequently, the patient recovered and she received the second dose of GARDASIL on 10-NOV-2008.  At the time of the report, on 11-NOV-2008, the office was unaware if this experience happened again.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Autoimmune disorder, Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 12/12/2008. Information has been received from an office manager concerning a 24 year old female with no medical history who in April 2008, was vaccinated IM with a dose of GARDASIL and on 20-OCT-2008 was vaccinated IM with the third dose of GARDASIL (lot # 661530/0575X) in her left arm.  There was no concomitant medication.  On approximately 20-OCT-2008, the patient experienced myalgia and pain from the injection site all the way down to her arm.  The patient said the third dose was given a little bit "higher" in her arm compared to the first and second dose.  The patient had no symptoms with the first and second dose.  The patient was an athlete and could not raise her arm laterally and could not dress herself.  The physician prescribed an anti-inflammatory and an arm sling for one week but the patient had no improvement.  The patient said the first week after the third dose her pain was sharp but the second week the pain was a constant ache.  The patient saw a neurologist (unspecified name) on 11-NOV-2008 and she thought that the patient had an autoimmune reaction to GARDASIL.  The patient was prescribed a steroid (unspecified), LORTAB and physical therapy.  At the time of this report, the patient was not recovered.  Follow-up information received from the healthcare worker concerning the path forward included an ultrasound of the patient's shoulder.  If the patient's ultrasound was clear, the physician would recommend physical therapy.  As of the day of this report, the neurologist's report has not been received by the physician's office.  Additional information has been requested. Follow-up information was received on 28-JAN-2009 from the office manager indicating that she would not send the form back. No adverse experienced follow-up information was provided. Additional information is not expected.  1/23/09 Reviewed GYN & Neuro medical records. Neuro eval 11/11/2008: FINAL DX: left brachial plexopathy. Records reveal patient experienced LUE pain, tenderness & weakness, left hand weakness, inability to raise left arm since vaccination.  Had immediate intense pain which worsened & was from under left clavicle to left shoulder.  Tx w/steroids, pain med & PT.  Referred for EMG/NCS.  GYN records: Reveal patient in good health on day of vaccination.   RTC 10/28 with pain left arm & shoulder which affected ADLs.  Dx w/tendonitis & tx w/NSAIDS & sling.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This is in follow-up to report (s) previously submitted on 12/12/2008. Information has been received from an office manager concerning a 24 year old female with no medical history who in April 2008, was vaccinated IM with a dose of GARDASIL and on 20-OCT-2008 was vaccinated IM with the third dose of GARDASIL (lot # 661530/0575X) in her left arm.  There was no concomitant medication.  On approximately 20-OCT-2008, the patient experienced myalgia and pain from the injection site all the way down to her arm.  The patient said the third dose was given a little bit "higher" in her arm compared to the first and second dose.  The patient had no symptoms with the first and second dose.  The patient was an athlete and could not raise her arm laterally and could not dress herself.  The physician prescribed an anti-inflammatory and an arm sling for one week but the patient had no improvement.  The patient said the first week after the third dose her pain was sharp but the second week the pain was a constant ache.  The patient saw a neurologist (unspecified name) on 11-NOV-2008 and she thought that the patient had an autoimmune reaction to GARDASIL.  The patient was prescribed a steroid (unspecified), LORTAB and physical therapy.  At the time of this report, the patient was not recovered.  Follow-up information received from the healthcare worker concerning the path forward included an ultrasound of the patient's shoulder.  If the patient's ultrasound was clear, the physician would recommend physical therapy.  As of the day of this report, the neurologist's report has not been received by the physician's office.  Additional information has been requested. Follow-up information was received on 28-JAN-2009 from the office manager indicating that she would not send the form back. No adverse experienced follow-up information was provided. Additional information is not expected.  1/23/09 Reviewed GYN & Neuro medical records. Neuro eval 11/11/2008: FINAL DX: left brachial plexopathy. Records reveal patient experienced LUE pain, tenderness & weakness, left hand weakness, inability to raise left arm since vaccination.  Had immediate intense pain which worsened & was from under left clavicle to left shoulder.  Tx w/steroids, pain med & PT.  Referred for EMG/NCS.  GYN records: Reveal patient in good health on day of vaccination.   RTC 10/28 with pain left arm & shoulder which affected ADLs.  Dx w/tendonitis & tx w/NSAIDS & sling.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 23 year old female who on 24-Oct-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot#661764/0650X) in the left deltoid muscle. On 24-Oct-2008 the patient experienced immediate pain at the injection site of the left deltoid muscle after administration of the first dose of GARDASIL. It was noted that the patient initially experienced the pain on the same day that she received the vaccination. The pain "subsided" without treatment in 2 days. The pain at the injection site "returned" on 10-Nov-2008 and was "now" accompanied by firmness" in the area. At the time of this report, the patient's pain and "firmness" at the injection site persisted. The nurse practitioner  added that the patient called the practice for medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Emotional disorder
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on unspecified date was vaccinated with the first dose of GARDASIL in her pediatrician's office.  Concomitant therapy included YAZ.  After vaccination, the patient experienced "a feeling of anxiety and being emotional".  As of 11-NOV-2008, the patient had not recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Information has been received from a health care worker concerning a 20 year old female patient with no pertinent medical history and no drug reactions or allergies reported, who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X).  It was reported that on 07-NOV-2008 the patient received her second dose of GARDASIL (lot # 660557/0072X) 0.5 ml intramuscularly, and on the next day, 07-NOV-2008, she experienced nausea, vomiting and diarrhea.  There were no concomitant medications.  The patient sought medical attention at a doctor's office and no lab diagnostic studies were performed.  At the time of the report the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a female consumer, who was also the patient, who on an unspecified date was vaccinated with a dose of GARDASIL. The patient reported that a huge bump appeared on the injection site after she received the dose. The outcome was unknown. The patient did not seek medical attention. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with GARDASIL. The patient shortly thereafter came down with genital warts. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow-up information from the registered nurse indicated that there were doctors and nurses in her community who have told patient's that there "have been outbreaks of genital warts after receiving GARDASIL". Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. This report no longer meets criteria for submission to the FDA as identifiable patients have not been validated.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Malaise, Vision blurred
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 25 year old female patient who on 04-Sep-2008 was vaccinated with the first dose of GARDASIL in her left deltoid (lot# 659184/0843X). Concomitant therapy included oral hormonal contraceptives (unspecified). Illness at time of vaccination included dizzy lightheaded and blurred vision. On 04-Sep-2008 the patient did not feel well 20 minutes after getting GARDASIL. On 06-Nov-2008 the patient was vaccinated with the second dose of GARDASIL in her left deltoid (lot#661764/0650X). The patient was observed for 20 minutes and had no reaction. Two hours later the patient reported that she experienced the same symptoms as before. The patient recovered from the adverse events. The patient did not seek medical attention. Additional information is not expected.