chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hair growth abnormal, Smear cervix abnormal, Vaginal disorder
Clinical narrative: Information has been received from a 29 year old female consumer who was vaccinated on an unspecified date with the second dose of GARDASIL 0.5 ml intramuscularly. The patient reported that the vaccine "really tore [her] whole body up" as it "ruptured in her vagina", she had an abnormal pap smear and it stopped her hair from growing. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Arthralgia, Borrelia burgdorferi serology, Hypothyroidism
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with sulfa allergy and with no previous medical history reported who on 15-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot number 658490/0802U) and on 16-JUN-2008 with the second dose of GARDASIL (Lot number 659180/1758U).  Concomitant  therapy included LEVOTHYROXINE Na.  Four months ago, approximately in September 2008, the patient experienced joint pain in her ankles and wrists after receiving GARDASIL.  The reporter also noted that the patient had experienced hypothyroidism after she received GARDASIL.  The patient's joint pain in her ankles and wrists and hypothyroidism persisted.  Bone scan and blood work were performed to test for lymes disease (results were not provided).  The patient sought medical attention with the physician.   The consumer wanted to know if there have been any reports of these symptoms associated with the specific lot numbers that her daughter had received.  A lot check has been initiated.  Additional information has been requested. A standard lot check investigation was performed. All in-process qualit checks for the lot number in question were satisfactory. The lot met the requirments and was released. Additional information has been requested.   8/3/09 Records received from PCP for dates 10/2007 to 6/2008. In for WCC 10/15/07 with assessment: Healthy. Acne. 3 vax given. Pt returned 11/29/07 with c/o worsening H/As, most recent x 4 days, not resolving. Now more frequent.  Painful mass on head. Assess:  H/A- some migrainous characteristics. Lump/mass on head. Sent for head CT which was abnormal.  Visual exam 12/7/07 doubt ocular origin of H/A.  Referred to neurology. Thyroid studies noted to be abnormal.  Now with c/o fatigue.  Missing multiple days of school.  7/7/09 PCP MR received. OV for HPV vax on 6/16/08 (1758U). OV 8/14/08 for itchy, painful rash.  Erythematous papular lesions with excoriation of center noted.  Culture (-). OV 12/4/08 with c/o 1-2 month hx of bilateral wrist pain and stiffness and more acute heel pain. Having difficulty walking. PE (+) for diffuse tenderness over dorsal wrists and with dorsiflexion, ball of foot. Sent for labs. Assess:  Joint pain. Return 1/5/09, 4/22/09 with same c/o.  Ortho consult 4/20/09. Dx:  Tendonitis.  Joint Pain.   7/23/09 Medical records received DOS 6/20/08 to 6/26/09. Assessment: Autoimmune Hypothyroidism. Patient continues to be on thyroid replacement, has chronic migraine headaches, and had a recent repair of a left meningeal cyst. Surgical scar left fronto-parietal junction. Insect bites on both legs that are blistering. Joint stiffness and achiness involving ankles, wrists, fingers. Right heel pain. Redness over wrists. Bilateral ankle pain. Ligamentous laxity. Trouble sleeping. Elevated systolic blood pressure.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood prolactin normal, Headache, Laboratory test normal, Thyroid function test normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female with asthma and no known drug allergies who on 06-AUG-2007, 15-OCT-2007 and 28-APR-2008 was vaccinated respectively with the first, second and third dose of GARDASIL, 0.5 mL, intramuscularly (dose 1 lot # 0927U, dose 2 lot # 658558/1061U, and dose 3 lot # 660387/1967U).  Concomitant therapy included LOESTRIN (1.5/30).  The medical assistant stated that the patient's mother called the office on 27-JAN-2009 because her daughter had had a headache for 7 weeks.  It was reported that the patient was evaluated by an unspecified neurologist who could not find anything wrong.  Laboratory tests including "hormones", prolactin, and thyroid were normal.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Lacrimation increased, Photophobia
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with allergy to VICODIN who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL (lot # 660616/0570X), 0.5 mL, intramuscularly.  Concomitant therapy included NECON.  The nurse reported that on 21-JAN-2009 the patient developed itchy, watery eyes with sensitivity to light, a few hours after receiving GARDASIL vaccine.  The patient contacted the office by phone and was prescribed BENADRYL.  The practitioner suggested that the patient not complete the vaccine series.  At the tome of reporting, the patient had recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Crying, Skin exfoliation, Swelling
Clinical narrative: Information has been received from a consumer concerning someone she saw on the television news, a female who was vaccinated with GARDASIL of unknown dose and frequency on an unknown date for an unknown indication.  The patient's relevant medical history, concomitant medications and relevant past drug history were unknown.  Subsequently the patient was crying and her skin was peeling and swollen really bad.  It was unknown if any laboratory testing had been performed.  As of 07-FEB-2009, it was unknown if the patient continued to take GARDASIL and the outcome of the crying, skin that was peeling and swollen were unknown.  The mother of the patient said that "she wished she had known, because her daughter would have never gotten GARDASIL".  Additional information is not expected.  Attempts made to verify the existence of an identifiable patient and reporter have been unsuccessful.  This is one of several reports received from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL.  The patient's relevant medical history, concomitant medication, and past drug history were unknown.  On unknown date, after being administered GARDASIL, the patient complained of getting "sick" more often.  It was unknown if there was any laboratory data.  As of 09-FEB-2009, it was unknown if she continued to receive GARDASIL and it was unknown if she continued to get "sick" more often.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure, Heart rate, Syncope
Clinical narrative: Information has been received from a physician concerning a 11 years old female patient who on 02-FEB-2009 at afternoon was vaccinated with the third dose of GARDASIL intramuscularly into her arm.  Concomitant therapy included a second dose of HAVRIX,which administered on the same day intramuscularly into her arm.  It was reported that on 02-FEB-2009 the patient had syncopal episode more than 5 minutes later in room.  It was reported that the patient recovered in less 1 minute but had to lay on table for 1/2 hour.  The reporting physician considered the syncopal episode to be other important medical event.  Follow up information was received on 12-FEB-2009 from a physician who stated that the patient experienced syncope.  It was reported that a blood pressure measurement and pulse rate count were performed (results not provided).  It was reported that the physician allowed her to rest for 45 minutes.  It was reported that intervention to prevent serious criteria was not actually required.  The patient had recovered at the time of this report.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia, Vaginal haemorrhage
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a first dose of GARDASIL in arm.  On unknown date the patient experienced breakthrough bleeding and spotting.  On unspecified date, the patient recovered from breakthrough bleeding and spotting.  The patient sought unspecified medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain
Clinical narrative: Information has been received from a physician concerning a 23 years old female with allergy to CIPRO and a history of mitral valve prolapse who on 02-FEB-2009 was intramuscularly vaccinated with the first dose of GARDASIL.  Concomitant therapy included birth control bills (manufacturer unspecified).  The patient experienced headache and body ache.  The patient had taken over the counter analgesics to treat her symptoms.  At the time of reporting, the patient recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a history of papanicolaou smear abnormal in January 2006 but was not tested for HPV at that time. On 13-NOV-2006, the patient was vaccinated with the first dose of GARDASIL. On 15-JAN-2007, the patient was vaccinated with the second dose of GARDASIL (lot number was reported as 1426S, which is a available lot number of dexamethasone acetate). On 12-JUL-2007, the patient was vaccinated with the third dose of GARDASIL (lot # 658100/0525U). Concomitant therapy included ORTHO TRI-CYCLEN. On 16-JAN-2009 the patient experienced abnormal PAP smear that was positive for high risk HPV. The specific type of HPV she had was unknown. The patient was scheduled to have a colposcopy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 ml dose of GARDASIL (lot # was not provided, dose of series was unknown.  Before getting vaccine the patient took a HPV test with negative results.  After getting vaccine, the patient got a HPV test with positive result.  At the time of this report, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female who was vaccinated with her first dose of GARDASIL (lot number not reported) 0.5ml IM into her left deltoid.  There was no concomitant medication.  Two days after administration, "a few week ago" the patient experienced soreness at the injection site.  The patient then developed induration at the injection site.  The patient was examined in the office but no treatment was prescribed.  The current status of the patient was unknown. Follow-up information was received from the registered nurse concerning the patient with penicillin allergy (rash) who on 20-JAN-2009 was vaccinated with her first dose of GARDISIL (lot number 661766/0052X). On 20-JAN-2009 the patient had a hard, sore and circular area around injection site that developed a couple days after injection. The outcome was un known. There was no illness at the time of the vaccination.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 19 year old female who was vaccinated intramuscularly with her first, second and third dose of GARDASIL on 16-JAN-2007, 15-MAY-2007 and 23-NOV-2007 respectively. The patient experienced severe hair loss after receiving her second dose of GARDASIL (MAY 2007). She was sent to an endocrinologist for medical attention after the adverse experience occurred. Lot numbers were not available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her daughter who developed soreness on her arm and neck after receiving a dose of GARDASIL. Lot # is not available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Information has been received from an immunization coordinator concerning a 24 year old female patient.  "Sometime last week" the patient was vaccinated with her first dose of GARDASIL 0.5 ml (lot number and site not reported).  Subsequently the patient experienced shortness of breath and dizziness.  Blood pressure was performed with no result reported.  The patient also was checked her lungs, but no result was reported.  "Soon after reaction" the patient recovered from shortness of breath and dizziness.  No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Cervical dysplasia, Colposcopy, Colposcopy abnormal, Dysplasia
Clinical narrative: Information has been received from a physician concerning a female (approximately 24 year old) with history of an abnormal Atypical squamous cells of undetermined significance (ASCUS) PAP smear in 2006 and 2007 who was vaccinated with her first (lot#656048/0187U), second (657621/0387U) and third (658558/1061U) dose of GARDASIL on 06-MAR-2007, 07-MAY-2007 and 05-SEP-2007 respectively. Concomitant medications included unspecified birth control. They did not test for HPV at the PAP smear in 2007. She had another PAP smear in November 2007 which showed high grade dysplasia. The patient had a colposcopy which showed that she had high grade squamous epithelial lesions. She also had a cold cone biopsy on 21-DEC-2007 which came back positive for squamous metaplasia. The first PAP smear she received in 2008 was normal but the second came back as positive for HPV. She had another PAP smear in January 2009 that came back as normal. The outcome is unknown. The patient's sister also experienced an adverse event following vaccination (WAES# 0902USA01061). The patient sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal, Uterine cervical squamous metaplasia
Clinical narrative: Information has been received from a physician concerning a female (approximately 24 year old) with history of an abnormal Atypical squamous cells of undetermined significance (ASCUS) PAP smear in 2006 and 2007 who was vaccinated with her first (lot#656048/0187U), second (657621/0387U) and third (658558/1061U) dose of GARDASIL on 06-MAR-2007, 07-MAY-2007 and 05-SEP-2007 respectively. Concomitant medications included unspecified birth control. They did not test for HPV at the PAP smear in 2007. She had another PAP smear in November 2007 which showed high grade dysplasia. The patient had a colposcopy which showed that she had high grade squamous epithelial lesions. She also had a cold cone biopsy on 21-DEC-2007 which came back positive for squamous metaplasia. The first PAP smear she received in 2008 was normal but the second came back as positive for HPV. She had another PAP smear in January 2009 that came back as normal. The outcome is unknown. The patient's sister also experienced an adverse event following vaccination (WAES# 0902USA01061). The patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 14 year old female with a history of contact dermatitis who on 22-JAN-2008 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL.  On 22-JAN-2009 the patient developed pain and soreness at the injection site after receiving the third dose of vaccine.  As of 05-FEB-2009, the patient was not recovered.  The patient received the first and second dose of GARDASIL on 12-JUL-2008 and 19-SEP-2008 respectively.  She had not experienced any problems with the first two doses.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a consumer concerning her daughter (a 21 year old female) with diabetes as well as allergies to heat and penicillin who at 3:15 pm on 04-FEB-2009 was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL. Concomitant therapy included ATARAX, ADDERALL, NEXIUM and insulin. The patient had an anaphylactic reaction on 05-FEB-2009 (after 12:00 am). She was recovered on 05-FEB-2009. The patient received the first dose of vaccine on 03-FEB-2008. There was no reaction after the first dose. The patient did not seek medical attention. Additional information has been requested.  3/31/09 Office note received dated 2/5/09. Pt reported to MD that ~12 hrs s/p Gardasil pt developed ? tight throat and ? difficulty breathing. HPV series D/c.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 01-MAY-2008 was vaccinated with the first dose of GARDASIL.  On 02-AUG-2008 was vaccinated with second dose of GARDASIL (lot no. 660389/1968U) (site and route not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  Physician reported that the patient experienced arthritic pain in her hand and back after second dose of GARDASIL.  Physician reported that the patient saw another physician on 26-JAN-2009 for the pain.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female patient who in December 2008, was vaccinated with her first dose of GARDASIL.  It was reported that after receiving GARDASIL the patient experienced amenorrhea.  Eventually patient did get her period again.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Peroneal nerve palsy
Clinical narrative: Information has been received from a medical assistant concerning a female patient who in approximately February 2009 finished the series of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient experienced "foot drop". It is unknown if the patient sought medical attention. As of 06-FEB-2009 the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Skin test, Urticaria
Clinical narrative: Information has been received from a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 15-JAN-2009 was vaccinated with the third 0.5 ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that the patient had itchy rash/hives after receiving GARDASIL. A skin test was performed (results not reported). It was reported that the patient had not recovered at the time of the report. The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no drug reactions or allergies who began the GARDASIL series around July of 2007 and finished the series in 2008 (lot # were not reported).  Concomitant therapy included MINOCYCLINE.  In approximately November 2008 the patient experiencing aching leg pain that began behind the back of her knees and then radiated to the front of her knees and thighs.  The patient also has been experiencing pain in her shoulders.  In January, the patient was seen by her physician for the pain.  The patient had not recovered.  Additional information has been requested.  4/2/09 MR received from PCP including vax recs.  15 yr WCC 7/24/08 with normal exam with exception of PMH rash/hyperpigmented skin. Returned 1/7/09 with c/o several  month hx of thigh/hamstring pain. PE (+) for decreased flexion.  Assess: Probable muscle strain.   F/u 2/12/09 with continued pain which has now spread to knees, elbows, wrists and fingers with low grade temp of 99'F.  Referred to rheum. 6/8/09 Rheumatology records received DOS 2/7/09 to 3/30/09. FINAL DIAGNOSIS: Juvenile Rheumatoid Arthritis, Poly. Presents with knee pain, hurts more when going up/down. At night/waking up. Arm pain, shoulder blade. Fever, energy level fair, chest pain, armpit rash. TMJ tenderness. Joint tenderness, limited ROM. Acne.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a 37 year old female with no allergy and medical history who on 18-AUG-2008 was vaccinated with a first dose of GARDASIL.  On 22-OCT-2008, the patient was vaccinated with a second dose of GARDASIL.  Concomitant therapy included oral OCELLA.  On 08-NOV-2008 the patient experienced severe itching all over her body, mainly on her chest, back, stomach and all pressure points.  On 13-NOV-2008 the patient was put on oral steroids.  On 25-NOv-2008, the patient recovered from the events.  The steroids did not work completely and received a second oral steroid which did help the itching.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood aluminium increased, Gastrointestinal pain, Pelvic pain, Weight decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with a history of appendectomy conducted in December 2007 and a gall bladder removed in April 2008 who was vaccinated with the first dose of GARDASIL.  Four weeks later the patient experienced gastrointestinal and pelvic pain.  The patient was diagnosed as having high aluminum content and lost approximately 10 pounds.  At the time of this report, the patient recovered and was still undergoing nutrition therapy.  It is unknown if the patient sought medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pruritus, Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter who in December 2008, was vaccinated with a first 0.5 ml dose of GARDASIL.  "Four weeks later", the patient developed hives and experienced itchiness and joint pain.  Unspecified medical attention was sought.  At the time of the report, 05-FEB-2009, the patient had not recovered.  No additional information was provided.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Injection site hypersensitivity, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a female with a history of injection site reaction (vaccine unknown) who was vaccinated with the first dose of GARDASIL 0.5ml (Lot number not provided).  Subsequently the patient experienced "allergic reaction" at the injection site.  The outcome of the adverse event was unknown.  The physician was not going to give the patient the rest of the series.  It was reported that the patient sought unspecified medical attention.  Additional information has been received from a physician concerning the 22 year old female with allergies to CECLOR, AUGMENTIN and PENICILLIN who on 20-JAN-2009 was vaccinated IM with the second dose of GARDASIL 0.5ml in the arm (Lot number 661766/0652X).  "2 days after the vaccine administration" (on 22-Jan-2009), the patient developed lower extremity pruritis.  "On third day" (on 23-Jan-2009) the patient experienced swelling of hands, pruritis of the feet and scattered "hives" by description.  The symptoms resolved at time of exam.  The patient reported similar prior reaction to CECLOR.  Further information is not available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Menorrhagia, Menstruation irregular
Clinical narrative: Information has been received from a healthcare worker concerning her daughter, a 15 year old female with no pertinent medical history and no known drug allergies who on 26-NOV-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 05-JAN-2009 the patient began a 15 days menstrual cycle. She experienced irregular menstrual and cramping after vaccination. On 26-JAN-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL. On 02-FEB-2009 the patient experienced pain with her menstrual cycle. The patient took MIDOL tablets but the cramping did not subside. The patient never had cramping and irregular cycles prior to the first dose of GARDASIL. The patient's symptoms persisted. The patient sought medical attention by consultation with nurse practitioner. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Information has been received from a physician concerning a nurse's daughter who was vaccinated with GARDASIL a year ago. Coincidentally, the patient started losing her hair about the same time. The patient has subsequently been diagnosed with alopecia areata. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: Information has been received from an office manager concerning a female patient who in 2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The reporter stated that she over heard another office staff member stating that the patient received the first dose of GARDASIL and she felt like she "was dying". The patient never called about the experience at the time it happened. The patient didn't sought medical attention. Her outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Drug exposure during pregnancy, Pregnancy test urine positive, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female patient who on 26-Feb-2008 was vaccinated intramuscularly with a 0.5ml dose of GARDASIL (lot# 658100 / 0525U) , on 22-Apr-2008 with the second dose (lot # 657617 / 0384U) and on 02-Dec-2008 with the third dose (lot# 661530 / 0575X). On 02-Feb-2009 the patient developed lower back pain and went to the emergency room. She had an urine test and an ultrasound that showed that she was 31 weeks pregnant. She was given a due date of 07- Apr-2009 (LMP 01-Jul-2008). The patient had no signs or symptoms of pregnancy prior the ER visit. She had no complications thus far and will be having a baby girl. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a Nurse concerning a female patient who was vaccinated with the first dose of GARDASIL (Lot # not reported). Patient broke out in hives all over her body after receiving the first dose of vaccine. The patient sought medical attention with the physician. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, VARCEL
Symptoms: Lip swelling, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 26-NOV-2007 was vaccinated with a 0.5 ml dose of GARDASIL. Secondary suspect therapy included Varicella virus vaccine live (manufacturer unknown). Concomitant therapy included influenza virus vaccine (unspecified). The patient sought unspecified medical attention. It was reported that "24 to 36 hours after receiving the vaccine" the patient experienced hives and lip swelling. The patient recovered " a couple of days later". Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no drug reactions or allergy who on 14-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported). There were no concomitants medications. On 15-JAN-2009 the patient experienced high fever, weakness and nauseated. The patient sough unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known allergies/drug reactions who on 25-Jan-2008 was vaccinated with the first dose of GARDASIL (lot#659962/17400) 0.5ml intramuscularly. The patient received the second dose of GARDASIL (lot# 660389 / 1968U) 0.5ml intramuscularly on 29-Apr-200. Concomitant therapy included ~~~~ 4/8/09 GYN records received. OV 1/28/08 with HPV#1 given-1740U. HPV#2 given-1968U. Report states no prior rxn to vaccine.  4/21/09 Office notes received from PCP for 2 OVs 3/4/09 with dx:  Anxiety and 3/24/09 with DX: Herpes simplex oral-resolving.  First seen for c/o 1-2 month hx of anxiety, tenseness, tremoulousness, palpitations, dyspnea, irritability, insomnia and difficulty relaxing r/t heavy school load. PE WNL.  Returned 3/24/09 with R sided oral cold sore and swollen gland under the neck, now resolving.  Pt reports no other c/o.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Local reaction
Clinical narrative: Information has been received from a nurse concerning a 11 year old female patient who on 04-DEC-2008 was vaccinated with GARDASIL (lot# 661530/0575X). Concomitant therapy included MENACTRA and ADACEL. She received the vaccines in the other arm the same day. On 06-DEC-2008 the patient had a slight local reaction as her arm was inflamed. The patient was given KEFLEX. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Biotin deficiency, Contusion, Laboratory test, PCO2 normal
Clinical narrative: Information has been received from a consumer concerning her daughter, a 21 year old female with no medical history or drug allergy who was vaccinated with all 3 doses (first dose on 16-JAN-2007) of GARDASIL.  There was no concomitant medication.  Subsequently the patient started loosing her hair in fall 2007, before getting the third dose, she always had very thick hair and she lost about 35-40% of it already.  The caller also mentioned that she started experiencing excessive bruising on her legs around the same time the hair loss started.  The bruising was all gone, and the hair was not coming out as bad as it use to.  She had multiple tests (including tested vitamin levels (a little low on Biotin), thyroid test, Cushing's disease test, PCOS and urine test) done to see what was wrong.  She had thyroid test done and it did spike but when the second test was done it came back normal.  All other tests came back normal as well.  At the time of the report the patient was not recovered.  The patient sought medical attention.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test abnormal, Urine analysis normal
Clinical narrative: Information has been received from a consumer concerning her daughter, a 21 year old female with no medical history or drug allergy who was vaccinated with all 3 doses (first dose on 16-JAN-2007) of GARDASIL.  There was no concomitant medication.  Subsequently the patient started loosing her hair in fall 2007, before getting the third dose, she always had very thick hair and she lost about 35-40% of it already.  The caller also mentioned that she started experiencing excessive bruising on her legs around the same time the hair loss started.  The bruising was all gone, and the hair was not coming out as bad as it use to.  She had multiple tests (including tested vitamin levels (a little low on Biotin), thyroid test, Cushing's disease test, PCOS and urine test) done to see what was wrong.  She had thyroid test done and it did spike but when the second test was done it came back normal.  All other tests came back normal as well.  At the time of the report the patient was not recovered.  The patient sought medical attention.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Injection site pruritus, Injection site urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who in October 2008 was vaccinated with the third dose of GARDASIL (lot number not reported). In December 2008, the patient developed low-grade SIL. At time of reporting the outcome was unknown. The patient sought unspecified medical attention. Follow up information was received from the physician's assistant who reported the patient was intramuscularly vaccinated with the second dose of GARDASIL (lot # 0152X) into the left deltoid at 10:00 on 12-JUN-2008. At 08:00 on 13-JUN-2008 the patient developed hive like lesion on left deltoid to left arm and mild itching. It lasted half of a day and went away by itself. The patient did not call medical office for reporting the above symptoms. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL and may have an unspecified reaction to GARDASIL.  At the time of reporting the outcome was unknown.  Follow up information was received from the nurse concerning the 20 years old female patient who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL.  On 10-SEP-2008 the patient was vaccinated with the second dose of GARDASIL.  The patient experienced hair loss in October, 2008, after receiving the second dose of HPV.  On 03-JAN-2009 the patient was vaccinated with the third dose of GARDASIL.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on unspecified dates was vaccinated with the first and second doses of GARDASIL by IM. After receiving the vaccines, the patient experienced headache, fatigue and tiredness. The patient's symptoms resolved after sleeping for about 4 hours. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache
Clinical narrative: Information has been received from a consumer, concerning her daughter who in October 2008 and December 2008, was vaccinated with her first and second dose of GARDASIL IM (lot number and site not reported) respectively.  Since the patient got her second dose vaccine, she experienced light headedness, headaches and stomach pain.  The patient's adverse events were recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with three dose of GARDASIL. Subsequently the patient "contracted HPV" after getting all three dose of GARDASIL. The patient underwent a Pap test. The patient's contracted HPV" persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Prostatic acid phosphatase abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no drug reaction/allergies history who on 16-JAN-2009 was vaccinated with her first dose of GARDASIL (lot # 661046/0546X) IM.  Concomitant medication included oral contraceptive.  The patient had an abnormal pap result from a specimen taken on 16-JAN-2009.  The PAP result was low Grade Squamous Intraepithelial Lesion with both high risk and low risk HPV.  The patient had visited office for medical attention.  The outcome of the patient's adverse effect was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a nurse concerning a female with no medical history or allergy who on 26-DEC-2008 was vaccinated with the first dose of GARDASIL IM, 0.5 ml (lot# 660616/0570X). There was no concomitant medication. Subsequently the patient experienced an irregular menstrual cycle. The patient's irregular menstrual cycle persisted. The patient was seen at the practice. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 22 year old female who was vaccinated with three dose of GARDASIL between February 2007 and August 2007 (lot number not provided, 1st dose 0.5ml). In 2009 the patient had PAP test on unspecified sate and results came in as HPV positive. The patient sought unspecified medical attention and did not recover at time of reporting. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache, Migraine
Clinical narrative: Information has been received from a consumer concerning herself (a 24 year old female) with migraine who received the first two doses of GARDASIL already and noticed increased incidents of headaches and migraines after getting the first dose. She was diagnosed with migraines before starting the GARDASIL, however she experienced more often since starting the therapy. At the time of reporting the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a 21 year old female with no pertinent medical history or drug allergy who on 20-NOV-2008 was vaccinated with a first dose of GARDASIL.  On 15-JAN-2008 was vaccinated with a second dose of GARDASIL.  Concomitant therapy included vitamins (unspecified) and birth control pills.  On 15-JAN-2009 the patient was performed a papanicolaou (PAP) smear which came back positive.  At the time of reporting, the patient's PAP smear positive persisted.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with 3 doses of GARDASIL on unspecified dates. Subsequently she had an abnormal pap. The patient did not have an abnormal PAP prior to receiving GARDASIL. The outcome was unknown at time of reporting. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning her daughter who on an unknown date was vaccinated with a dose of GARDASIL. The patient was experiencing severe headaches. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a registered nurse reporting that she received an e-mail from a woman who stated that she received the complete GARDASIL series and has now tested positive for HPV. It was reported that the woman is not the nurse's patient. Attempts are being made to verify the existence of an identifiable patient and reporter. Follow-up information was received from the RN, who is a senior member of an HPV Health Board, and stated that she receives and responds to many anonymous emails. She indicated that on the patient's email, the woman mentioned that she was diagnosed with HPV but could not confirm the strain. The nurse stated that she is waiting for the woman to provide this information and will call back when/if she receives it. The nurse stated that there was no way for her to determine the name of the patient since the emails are anonymous. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with asthma, bipolar disorder, LEXAPRO and PAXIL allergy and a history of obesity, varicella and bulimia who on 14-MAR-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # : 659655/1486U) and on 11-JUN-2008 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # : 658100/0525U).  Concomitant therapy included PROZAC, LAMICTAL, LITHIUM, TOPAMAX, ADDERALL, SEROQUEL and RESTORIL.  On 11-JUN-2008, after administration of her second dose of GARDASIL, the patient experienced nausea and syncope.  Subsequently, the patient recovered from nausea and syncope.  The patient sought medical attention by office visit.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Culture urine negative, Dysuria, Pollakiuria, Pyrexia, Urinary tract infection
Clinical narrative: Information has been received from a Registered Nurse concerning a 22 year old female with psychiatric disorders and a history of pyelonephritis who was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (lot#660616/0570X) on 29-JAN-2009. There was no concomitant medication. Subsequently, the patient developed urinary tract infection. After receiving the dose, she complained of high fever of 102 degrees F along with burning sensations when she urinates. She also had increased frequency of urination. Urine analysis showed presence of leukocyte, protein, but no blood. The patient was treated with CIPRO for 1 week. Urine culture was negative. At the time of reporting the patient was recovered. The patient had received her first dose of GARDASIL on 16-OCT-2008. The patient sought medical attention and was seen by the nurse. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis abnormal
Clinical narrative: Information has been received from a Registered Nurse concerning a 22 year old female with psychiatric disorders and a history of pyelonephritis who was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (lot#660616/0570X) on 29-JAN-2009. There was no concomitant medication. Subsequently, the patient developed urinary tract infection. After receiving the dose, she complained of high fever of 102 degrees F along with burning sensations when she urinates. She also had increased frequency of urination. Urine analysis showed presence of leukocyte, protein, but no blood. The patient was treated with CIPRO for 1 week. Urine culture was negative. At the time of reporting the patient was recovered. The patient had received her first dose of GARDASIL on 16-OCT-2008. The patient sought medical attention and was seen by the nurse. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) concerning a 19 year old female with no medical history and no known allergies who on 08-Jan-2009 was vaccinated with the first dose of GARDASIL (lot#0947X) and as the patient was about to pay at the front desk her eyes rolled back and the person at the front desk went around and caught the patient before she hit the ground. It was reported that when the patient was caught she started to come to and eat in the office for about 19 minutes and then was fine to leave the office. The patient was recovered on 08-Jan-2009. Follow up information was received from a certified medical assistant concerning the 19 year old female patient with no pre-existing allergies, birth defects, or medical conditions who on 08-Jan-2009 was vaccinated intramuscularly in the right arm with the first dose of GARDASIL (lot# 0947X). There was no illness at the time of vaccination. On 08-Jan-2009 at 12:00 pm the patient passed out in office approximately 10 minutes after being vaccinated with the vaccine. The patient was recovered on 08-Jan-2009. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Drug exposure during pregnancy, Weight increased
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her daughter an 18 year old female with an unspecified sexually transmitted disease who received unspecified pills for the infection who on 22-JAN-2009 (2 weeks ago on a Thursday) was vaccinated with the first dose of GARDASIL. The physician said the patient was not pregnant, but the mother believed she was, because "her stomach is really swollen and she used to be thin". At the time of the report the outcome of the patient was unknown. The patient was seen by the physician in office. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with no previous medical history and no known allergies who on 05-DEC-2007 was vaccinated with her first dose of GARDASIL (Lot# not reported). On 14-MAY-2008, the patient was vaccinated with her second dose of GARDASIL (Lot# not reported) and tested as pregnant with an office pregnancy test. The patient stated that her LMP was last week (estimated LMP = 07-May-2008). LMP or gestation was uncertain. There was no concomitant medication. There were no problems reported. Unknown medical attention was sought in the office. The patient's outcome is unknown. Follow up information was received from registered nurse and phone call. It was reported the patient's last menstrual period (LMP) was 20-MAR-2008 (previously reported as "estimated LMP = 07-May-2008") and estimated delivery date (EDD) was 02-JAN-2009. On 20-AUG-2008 the patient had serum alpha-fetoprotein test (MSAFP) done and the result was negative. The mother declined amnio testing. On 20-AUG-2008 (at 14 weeks gestation) ultrasound did show sonographic markers for trisomy however the repeat ultrasound in 18-DEC-2008 was normal. On 24-DEC-2008 the patient delivered a 7 pounds 7 ounces male baby without complication during pregnancy or labor/delivery and without infection or illnesses during pregnancy. It had been a vaginal delivery and there were no congenital anomalies. The baby had spent one week in the hospital with fever of unknown origin and received unspecified antibiotics but was otherwise healthy and normal. The patient had returned for postpartum visit since. Her baby was "fine". No further information was available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes
Clinical narrative: Information has been received from the Merck Pregnancy Registry from a 22 year old female with no pertinent medical history who on 17-DEC-2007 was vaccinated IM with a first dose of GARDASIL vaccine (lot #659437/1266U). Concomitant therapy included ZOLOFT. It was reported that the patient was vaccinated while she was pregnant. Last menstrual period was 19-NOV-2007 and estimated date of delivery was 25-AUG-2008. It was reported that there was no adverse event involved. There were no laboratory or diagnostic tests performed. Follow-up information received from the patient who reported that she had developed gestational diabetes during the pregnancy. She delivered the baby at term. The baby was healthy and normal "and has had a few colds".