chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Induration, Lymphadenopathy, Mass, Pain, Pain in extremity
Clinical narrative: Pt had TDAP vaccine on 10/29/08, exhibited expected s/sx after injection "knot at side, pain, fever, headache". Two weeks later had lymph node on clavicle. Having periodic pain (burning) to arm, top of shoulder and clavicle area - having ODS to remove lymph node.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate, Ultrasound scan, X-ray
Clinical narrative: Pt had TDAP vaccine on 10/29/08, exhibited expected s/sx after injection "knot at side, pain, fever, headache". Two weeks later had lymph node on clavicle. Having periodic pain (burning) to arm, top of shoulder and clavicle area - having ODS to remove lymph node.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary mass, Headache, Injection site mass, Nodule, Pain
Clinical narrative: Pt had TDAP vaccine on 10/29/08, exhibited expected s/sx after injection "knot at side, pain, fever, headache". Two weeks later had lymph node on clavicle. Having periodic pain (burning) to arm, top of shoulder and clavicle area - having ODS to remove lymph node.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Ultrasound scan abnormal
Clinical narrative: Pt had TDAP vaccine on 10/29/08, exhibited expected s/sx after injection "knot at side, pain, fever, headache". Two weeks later had lymph node on clavicle. Having periodic pain (burning) to arm, top of shoulder and clavicle area - having ODS to remove lymph node.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash, Respiratory tract congestion
Clinical narrative: Arm Pain- Contests Rash
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Child broke out in lesions mostly on trunk.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Bilateral leg weakness / had to use crutches for weeks / had weakness, numbness / tingling in legs. Still with some symptoms.  1/23/09 Received PCP medical records of 1/6/09 FINAL DX: none provided Records reveal patient experienced back & leg pain, muscle cramps, weakness & tingling since 9/08.  Had traveled out of country 8/08 to remain x 4 mo.  Progressed to legs giving out & needed to use crutches.  Saw neurologist out of country where exam WNL.  MRI of back at that time revealed inflammation SI joint & received PT.  Improved then s/s recurred which did not improve w/additional PT.  Returned home to continue w/u.  No further records available.
Sex: U
Vaccine: TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: 24 After immunization unable to maintain LUE advection above 90
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Felt faint 30 sec post injection, laid down that-ammonic inhalant.  15 min later again syncope episode ammonia, inhalants & crackers & juice given
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Fatigue, Syncope
Clinical narrative: Felt faint 30 sec post injection, laid down that-ammonic inhalant.  15 min later again syncope episode ammonia, inhalants & crackers & juice given
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash papular
Clinical narrative: Rash is diffuse in location, reddish and fine papular, no skin thickening, induration or subcutaneous nodules , noted after the vaccines were given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Phone call from patient stating a possible reaction to shingles vaccine. Three days after arm had swelling, huge welt, itchy, painful, no fever, lasted for a few days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient received 1st Tdap in L upper A, then MENACTRA in R upper Arm. I turned around for no more than 6 seconds to throw needles away in sharps (ont. and mom jumped up to help him as he fell from exam table to floor. Patient passed out and came to it almost immediately. Woke up in fright, had never passed out r/fainted prior.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: 2 months old girl with one day history of emesis, starting on the morning following her first series of vaccines.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Syncope vasovagal, Unresponsive to stimuli
Clinical narrative: Hypotensive, unresponsive for NSR.  Took 1 hr before could vagal episode - No LOC.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: 24 hrs after ZOSTAVAX - developed herpes zoster L ant chest, near arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anorexia, Erythema, Induration, Pain, Skin warm
Clinical narrative: Redness, induration, just below deltoid area L arm began 24 hrs after injections of influenza & pneumonia vaccine.  Achey &  aneretis at onset, + 48 hrs area of redness warm & mildly tender at onset.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Redness, induration, just below deltoid area L arm began 24 hrs after injections of influenza & pneumonia vaccine.  Achey &  aneretis at onset, + 48 hrs area of redness warm & mildly tender at onset.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac monitoring normal, Neurological examination normal, Syncope
Clinical narrative: 25 days after GARDASIL #3 developed syncopal episodes- recurrent, over course of 6 mos. Neuro and cardio work- ups WNL.  1/22/09 MR received from PCP including multiple neurology and cardiology consults from 8/07-1/13/09. OV 2/4/08 for recurrent sinusitis since 9/2007. HPV#3 given.  Returned 3/3/08 with c/o H/As and dizziness as well as 1 fainting episode over past few days. Tx with abx for sinusitis and vasovagal syncope discussed. Pt fainted after blood draw in office with continued fuzzy vision and inability to get up. Unresponsive x 45 minutes.To ER. Received IVF which caused swelling. Still feeling unwell with photophobia, H/A, lightheadedness and neck soreness. No memory of ambulance ride. Still c/o H/A 3/6/08.  Somewhat better 3/14/08 with exception of exhaustion.  Several more episodes of H/A, fainting, chest ache with racing heart, stomachaches. Episode 9/17/08 face red, extremities grey with tonic-clonic movements of extremities and eyes rolling back. Unresponsive x 45 minutes. Referred to Neuro and Cardiology.  Neuro consult 4/14/08 and 9/25/08 with normal exams. DX: Syncope. Panic attacks. Vasovagal syncope. Cardiolgy consult 10/2/08 for eval of syncope with shock-like, stabbing chest pain which self resolved. Subsequent episode with heart racing and difficulty breathing. No dx mde. Improved by 1/13/09.
Age: 15.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse symptoms known-3rd MMR given.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Induration - 2x2, Erythema - 5x3 left arm warm compressor.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: 1/12/09 received call from mother she states that about 34 hours post vaccination hives appeared on arms, BENADRYL given with relief. On 1/12/09 hives appeared on face BENADRYL given. Upon returning home from school child had hives on torso, back and face. BENADRYL given. 1/13/09 child awoke with hives on face and arms BENADRYL given with no further outbreaks.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Lacrimation increased, Ocular hyperaemia, Throat tightness
Clinical narrative: 7pm 12/14/08 received flu shot 10pm 12/14/08 throat started feeling tight and full. Also had red, watery eyes and swelling of the eye lids. Treatment, OTC BENADRYL 50mg.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient had fainted about 2-4 min post vaccination with GARDASIL and VARIVAX. As family signed out in waiting room. Regained consciousness, 5 min post.
Age: 1.3
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Rash maculo-papular, Viral skin infection
Clinical narrative: Patient developed fever, irritability and rash on 12-31-08. Parent took child to ER. ER MD noted fever and maculopapular rash diagnosed viral exanthem or possible chicken pox.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting x 2 approx 6-8 hours after receiving vaccines. Running 101 degree fever although parent states has given fever reducer. Next morning no nausea or vomiting still have low grade temp but feeling much better.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein increased, Fatigue, Full blood count normal
Clinical narrative: Week of 1/23/2007 pain at site of GARDASIL injection #2 5 week past GARDASIL. Myalgias, hip pain, elbow, wrist, hand, finger, knee, foot pain, fatigue, petechiae legs, decreased ROM, lab NL. Seen by rheumatology, resolved completely 4/3/08. Followed by rheumatology no reoccurrence as of 1/09.  1/29/09 Received PCP medical records which included Rheum & Ortho consults. FINAL DX: Polyarticular reactive arthritis Records reveal patient experienced usual state of good health on 5/18/07, day of HPV#1 & Varicella vaccinations.  RTC 8/23/07 with symptoms x 3 days of pain & swelling of multiple joints; gen aching; fatigue; decreased appetite; difficulty standing, walking & making fist or extending fingers; low grade fever; oral ulcers; scattered petechiae of LEs; searing pain where HPV#2 given 7/18/07.  6/20-23 had illness w/cough, sore throat, fatigue, HA, fever, pain in hips/ankles, stiff joints.  Rheum consult of 9/5/07, 4/3/08, 7/10/08 & 1/5/09.  Ortho consult of 7/30/08.  Referred to pulm & ID on 1/5/09.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity, Petechiae, Red blood cell sedimentation rate normal
Clinical narrative: Week of 1/23/2007 pain at site of GARDASIL injection #2 5 week past GARDASIL. Myalgias, hip pain, elbow, wrist, hand, finger, knee, foot pain, fatigue, petechiae legs, decreased ROM, lab NL. Seen by rheumatology, resolved completely 4/3/08. Followed by rheumatology no reoccurrence as of 1/09.  1/29/09 Received PCP medical records which included Rheum & Ortho consults. FINAL DX: Polyarticular reactive arthritis Records reveal patient experienced usual state of good health on 5/18/07, day of HPV#1 & Varicella vaccinations.  RTC 8/23/07 with symptoms x 3 days of pain & swelling of multiple joints; gen aching; fatigue; decreased appetite; difficulty standing, walking & making fist or extending fingers; low grade fever; oral ulcers; scattered petechiae of LEs; searing pain where HPV#2 given 7/18/07.  6/20-23 had illness w/cough, sore throat, fatigue, HA, fever, pain in hips/ankles, stiff joints.  Rheum consult of 9/5/07, 4/3/08, 7/10/08 & 1/5/09.  Ortho consult of 7/30/08.  Referred to pulm & ID on 1/5/09.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor negative, Streptococcal identification test, Streptococcal identification test negative, Urine analysis normal
Clinical narrative: Week of 1/23/2007 pain at site of GARDASIL injection #2 5 week past GARDASIL. Myalgias, hip pain, elbow, wrist, hand, finger, knee, foot pain, fatigue, petechiae legs, decreased ROM, lab NL. Seen by rheumatology, resolved completely 4/3/08. Followed by rheumatology no reoccurrence as of 1/09.  1/29/09 Received PCP medical records which included Rheum & Ortho consults. FINAL DX: Polyarticular reactive arthritis Records reveal patient experienced usual state of good health on 5/18/07, day of HPV#1 & Varicella vaccinations.  RTC 8/23/07 with symptoms x 3 days of pain & swelling of multiple joints; gen aching; fatigue; decreased appetite; difficulty standing, walking & making fist or extending fingers; low grade fever; oral ulcers; scattered petechiae of LEs; searing pain where HPV#2 given 7/18/07.  6/20-23 had illness w/cough, sore throat, fatigue, HA, fever, pain in hips/ankles, stiff joints.  Rheum consult of 9/5/07, 4/3/08, 7/10/08 & 1/5/09.  Ortho consult of 7/30/08.  Referred to pulm & ID on 1/5/09.
Age: 0.4
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse reactions. Child was given influenza vaccine at 4 mo of age- though to be 7 mo when it was given. Infant had no ill effects.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Computerised tomogram, Convulsion, Full blood count, Pyrexia, X-ray
Clinical narrative: Patient seen in office today for seizure yesterday after vaccines; took child to ER for fever of 104.3 and developed seizure.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Lyme disease
Clinical narrative: + mono + lyme
Age: 59.0
Sex: M
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Patient was given Td vaccine and in about 4 to 5 minutes later he was given PNEUMOVAX. After PNEUMOVAX, patient stated that he felt very hot, broke out in rash and turns red. Patient was given 50mg BENADRYL injection, oxygen and IV fluids and is now in stable condition.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: No adverse event
Clinical narrative: None Stated
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Ocular hyperaemia, Pain in extremity, Rash
Clinical narrative: 1-9 Had immunization at 11 am temp. started 4 or 5 pm. Cheeks red, eyes blood shot. 1-10 rash on face and arms, 7 am left arm painful. Rash spread to legs. Better after BENADRYL. HA comes back in 24 hrs. 1-14 still having rash on and off.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Abdominal pain, Chills, Diarrhoea, Pyrexia
Clinical narrative: June 1 Sun- fever, chills, abdominal pain, diarrhea lasting 3 days. Symptoms subsided-she then felt well. No reaction at site of injection. She was in contact, prior to 5-29 with person who had similar symptoms.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician assistant concerning an 18 year old female who on unspecified dates was vaccinated with a first, second and third dose of GARDASIL, lot # unknown. It was reported that the patient had been short of breath since receiving her third dose of GARDASIL. At the time of reporting, the outcome of the event was unknown.  2/3/09 MR received from Pulmonary Med consults dated 9/9/08, 10/27/08 and 1212/10/08 with DX: Shortness of breath/chest tightness.  Allergic rhinitis improved.  Referred by PCP for eval of increasing SOB and chronic cough. Sleeping more lately and waking at night and unable to catch breath. PE WNL. O2 sat 96-98%.  Referred for heart cath later in the yr to r/o pulmonary HTN.
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 female patient who was vaccinated with the complete series of GARDASIL (lot not reported) when the vaccine was fairly new on the market and recently was found to had an abnormal PAP. The patient had HPV. At the time of reporting, 10-DEC-2008, the outcome of the patient was unknown. Additional information was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Skin discolouration
Clinical narrative: Information has been received from a sonographer concerning her daughter, who an on unspecified date was vaccinated with the first dose of GARDASIL. On the same day, the patient was nauseous and turned green and within a few minutes after vaccination had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy
Clinical narrative: Information has been received from a nurse and later a physician concerning a 15 or 16 years immunocopetent female patient with asthma and allergies to codeine, and shellfish who on unspecified date  was vaccinated intramuscularly with the first a 0.5 ml first dose of GARDASIL (lot# 660620/0571X). On approximately 12-NOV-2008 the patient developed an indent on her arm after receiving the first dose of GARDASIL. The patient sought physician's medical attention. Concomitant therapy included ADVAIR, MSD and ZYRTEC. The physician stated that the patient received the vaccination with out incident but gradually noticed a "quarter-sized" indentation in the area of the deltoid that is obvious to visual inspection. No pain, erythema, limited movement, rash or other complaints were reported. The patient is schedule to be seen in follow-up next week. At the time of this report it is unknown if the patient recovered. Additional information has been requested.  Follow up information was receivied from a physician who reported a 13 year old female (previously reported as 15 or 16 year old) with no medical history, illness at the time of vaccination and allergy history was intramuscularly vaccinated with the first dose of GARDASIL (lot# 660620/0571X) at 16:30 am on 03-NOV-2008 on the left arm. At 14:53 on 14-NOV-2008 (previously reported approximately 12-NOV-2008) the patient developed indentation to the left deltoid area at injection site with no pain. She performed shoulder soft tissue ultrasound but results were pending. The outcome was not reported.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, Dizziness, Full blood count, Metabolic function test
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of asthma and recurrent otitis media; penicillin, KEFLEX, and sulfa drug allergies, who on 13-OCT-2008 was vaccinated with a first dose of GARDASIL (lot # 655205/1426P), intramuscularly.  Concomitant therapy included medroxyprogesterone acetate DEPO-PROVERA.  On October 2008 the patient experienced dizziness.  She experienced the dizziness mainly in the in the morning but the dizziness is progressively getting worse and occurs during the day also.  Laboratory diagnostics studies performed included a CBC, a complete metabolic panel and a TSH on 03-Dec-2008.  The patient sought medial attention through an office visit.  The patient had not recovered.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL, lot number 661703/0651X.  Within a week of receiving her first dose the patient experienced blurriness in the left eye, pain and tingling in her hands and feet, and joint pain and headache.  The patient sought medical attention at the physician's office.  Patient recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow up information was received from her physician. The patient was a female attorney (height 64 inches, weight 106 pounds) with no known pre-existing allergies, birth defects or medical conditions who was vaccinated in the morning of 20-OCT-2008 with first dose of GARDASIL, 0.5 mL, in the deltoid. In approximately October 2008, the patient experienced blurry vision in one eye, pain and tingling in hands and feet, joint pain and headaches. The patient's outcome was unknown. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test normal, Nausea, Ultrasound scan normal
Clinical narrative: Information has been received a consumer through a Merck pregnancy registry concerning herself, a 41 year old female with allergies to Sulfa and iron supplements", who on 29-Apr-2008 was vaccinated IM with the third dose of 0.5 ml GARDASIL while she was pregnant. Her LMP was 27-Jan-2008. Expected date of delivery was 02-Nov-2008. The patient visited physician's office for medical attention. Prenatal testing included ultrasound for her has been normal. The patient had received the first dose of GARDASIL on 01-Oct-2007. Follow-up information has been received from a completed questionnaire. The patient was a Caucasian  with no previous pregnancies. She also had Crohn's disease and multiple bowel excisions. Medications during her pregnancy included prenatal vitamins for routine use and REPLIVA 21/7 for anemia. She also had ZOFRAN for nausea on 13-March-2008. Ultrasound on 05-Jun-2008 was normal. On 13-Nov-2008, 41 weeks from her LMP, the patient delivered a live normal male infant weighing 6 pounds 3 ounces. The infant's Apgar score was 8/9 without congenital anomalies, complications or abnormalities. There were no complications, infections or illnesses during the patient's pregnancy and delivery. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Fungal infection, Herpes simplex, Herpes simplex serology positive
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 26 year old female patient with no pertinent medical history or concurrent conditions and no drug reactions/allergies, who on 29-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # 655327/1287U) 0.5 mL, IM. On 03-MAR-2008, the patient received the second dose of GARDASIL (lot # 655604/0052X) 0.5 mL, IM. There was no concomitant medication. The patient was subsequently determined to be pregnant in April 2008. In April 2008, the patient's urine pregnancy test was positive for pregnancy. The patient sought medical attention with an office visit. The last menstrual period was on 09-FEB-2008. Therapy with GARDASIL was discontinued. The patient's estimate date of conception was 23-FEB-2008 and estimated date of delivery was 15-NOV-2008. No problems reported. Prenatal testing included. On 23-Apr-2008 ultrasound: Routine test - Within normal limits. On 16-Jun-2008 serum alpha-fetoprotein test: Negative. Time 4. Routine test. On 07-Jul-2008 ultrasound: Routine test. Within normal limits. The patient had five previous pregnancies and five (previously report that on 21-NOV-2008, the patient delivered a normal and healthy female baby weighing 8 lb and 14 oz and apgar score 9/10. No complications during the pregnancy and labor/delivery, no congenital anomalies, and no complications or abnormalities. During the pregnancy, prenatal laboratories were performed. There was infections or illness during the pregnancy, a laboratory test was positive for HSV I and II. The patient received prophylactic Valtrex, 500 mg, BID, started on 06-OCT-2008 to delivery day 21-NOV-2008. Other medications used during this pregnancy included Metronidazole 500 mg for 7 days on 20-OCT-2008 for bacterial vaginosis and Diflucan 150 mg one time oral dose that same day for a vaginal yeast infection. Additional information is not available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 26 year old female patient with no pertinent medical history or concurrent conditions and no drug reactions/allergies, who on 29-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # 655327/1287U) 0.5 mL, IM. On 03-MAR-2008, the patient received the second dose of GARDASIL (lot # 655604/0052X) 0.5 mL, IM. There was no concomitant medication. The patient was subsequently determined to be pregnant in April 2008. In April 2008, the patient's urine pregnancy test was positive for pregnancy. The patient sought medical attention with an office visit. The last menstrual period was on 09-FEB-2008. Therapy with GARDASIL was discontinued. The patient's estimate date of conception was 23-FEB-2008 and estimated date of delivery was 15-NOV-2008. No problems reported. Prenatal testing included. On 23-Apr-2008 ultrasound: Routine test - Within normal limits. On 16-Jun-2008 serum alpha-fetoprotein test: Negative. Time 4. Routine test. On 07-Jul-2008 ultrasound: Routine test. Within normal limits. The patient had five previous pregnancies and five (previously report that on 21-NOV-2008, the patient delivered a normal and healthy female baby weighing 8 lb and 14 oz and apgar score 9/10. No complications during the pregnancy and labor/delivery, no congenital anomalies, and no complications or abnormalities. During the pregnancy, prenatal laboratories were performed. There was infections or illness during the pregnancy, a laboratory test was positive for HSV I and II. The patient received prophylactic Valtrex, 500 mg, BID, started on 06-OCT-2008 to delivery day 21-NOV-2008. Other medications used during this pregnancy included Metronidazole 500 mg for 7 days on 20-OCT-2008 for bacterial vaginosis and Diflucan 150 mg one time oral dose that same day for a vaginal yeast infection. Additional information is not available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan, Urinary tract infection
Clinical narrative: Information has been received from a health care professional for GARDASIL regarding a 15 year old female who on 29-FEB-2008 was vaccinated with an unknown dose of GARDASIL (lot number unspecified). On 29-FEB-2008 the patient received vaccine when she was pregnant. The patient's LMP=11/21/07. The patient is not experiencing any known symptoms. Unspecified labs were performed on 02-MAY-2008. The patient sought unspecified medical treatment in the office. Follow up information was received from a health care professional who reported on 24-AUG-2008 the patient delivered a normal, healthy female baby weighing 6 pounds, 11 ounces at her 39 weeks and 4 days from LMP. The baby's apgar score was 9/9. It was also reported other medications used during pregnancy included MACROBID due to urinary tract infection from 09-MAY-2008 to 15-MAY-2008, biotin (+) carbonyl iron (+) ducosate sodium (+) folic acid (+) minerals (unspecified) (+) vitamins (unspecified) PRENATE ELITE and EXPEXTA LIPIL for prenatal vitamins from 02-MAY-2008. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Arrested labour, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Ultrasound scan normal
Clinical narrative: Initial Information and follow up has been received from a pharmacist and nurse for the Pregnancy Registry of GARDASIL concerning a 24 year old female with a history of 0 pregnancies and 0 live births who on 01-NOV-2007 was vaccinated with her first dose of GARDASIL (lot # not reported).  On 27-DEC-2007 the patient was vaccinated with her second dose of GARDASIL (lot # not reported).  Concomitant therapy included methyldopa, 500 mg BID for hypertension.  The patient is now pregnant with an LMP date of 11-MAR-2008 and a delivery due date of 16-DEC-2008.  No problems were reported.  The patient is also taking 40mg daily of PROTONIX for gastrooesophageal reflux disease (GERD).  The patient sought medical attention by contacting her physician on an unspecified date.  Follow-up information was received from an RN for the Pregnancy Registry for GARDASIL.  On 28-JUL-2008 and 12-SEP-2008, ultrasounds were performed for the evaluation of growth and date, and the results were within the normal limit.  On 09-DEC-2008, the patient with chronic hypertension (CHTN) and gastrooesophageal reflux disease (GERD) gave birth to a 7 pounds 0 ounce male infant.  The labor was forced for arrested descent.  Apgar score was 8/9.  The infant was normal without congenital anomalies.  There was no infections or illnesses during pregnancy.  No further information is available. Follow up informatin was received from a registered nurse for GARDASIL vaccine. On 28-JUL-2008 and 12-SEP-2008, ultrasounds were performed for the evaluation of growth and date, and the results were within the normal limit. On 09-DEC-2008, the patient had chronic hypertension and gastrooesophageal reflux disease. Forceps vaginal delivery was performed for arrested descent. On 09-DEC-2008, she delivered a 7 pound 0 ounces normal male infant. APGAR score of 8/9. The infant was normal without congenital anomalies. There was no infections or illnesses during pregnancy. Follow up information was received from an RN for the Pregnancy registry for GARDASIL. The delivery date was 18 weeks and 6 days from LMP. The infants length was reported as 20.5 inches. Complication during labor/pregnancy was forcep vaginal delivery. No further information is available.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, HPV4, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 1 year old female who was inadvertently vaccinated with a first dose of GARDASIL (658554/0928U).  Subsequently the patient experienced inappropriate age and inappropriate schedule of vaccine administered.  No other information as available.  Follow-up information was received on 26-DEC-2008 from the N.P. indicating that the patient is a 2 (previously reported as 1) year old female child with no pre-existing allergies, birth defects or medical conditions.  On an unspecified date the patient was vaccinated with a dose of GARDASIL instead of a dose of POLIOVIRUS vaccine inactivated (unspecified).  On the same day she also received a dose of VARIVAX virus vaccine live (Oka/Merck) (MSD), DTaP/Hib (manufacturer unknown), MMR II and VAQTA (manufacturer unknown).  There was no illness at time of vaccination.  It was reported that there was no adverse event.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Oedema, Pregnancy induced hypertension, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a health department nurse and from a registered nurse concerning a 15 year old female, with sulfonamide allergy, asthma, seasonal allergies and a history of smoking, who on 09-Aug-2006 was vaccinated with the first dose of GARDASIL, on 30-May-2007 was vaccinated with the second dose of GARDASIL and on 05-Dec-2008 was vaccinated with the third dose of GARDASIL (lot# 660616/0570X). Concomitant therapy included asthma medication, Meclizine, vitamins and ALLEGRA-D. The health department nurse reported that the patient was pregnant after receiving two doses of the HPV vaccine. The patient was seen at the Department on 06-Mar-2008 and a urine test was positive for pregnancy. The patient's date of last menstrual period was 30-Jan-2008. The estimated date of delivery was 05-Nov-2008, Ultrasounds were performed on 06-June-2008, 06-Aug-2008, 17-Sep-2008 and 14-Oct-2008 and results were within normal limits, small for dates, PIH and edema. A sonogram and a biophysical profile was also performed and resulted within normal limits. On 15-Oct-2008, the patient delivered a normal, healthy male baby weighing 5 pounds 3.7 ounces. There was no congenital anomalies. The baby's length was 18.5 inches and his Apgar score was 8/9 . the baby presented short foreskin. Complications during pregnancy included UTI, edema, increased blood pressure and hyperemesis. Complications during delivery included PIH and vacuum delivery. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive, Vomiting
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a health department nurse and from a registered nurse concerning a 15 year old female, with sulfonamide allergy, asthma, seasonal allergies and a history of smoking, who on 09-Aug-2006 was vaccinated with the first dose of GARDASIL, on 30-May-2007 was vaccinated with the second dose of GARDASIL and on 05-Dec-2008 was vaccinated with the third dose of GARDASIL (lot# 660616/0570X). Concomitant therapy included asthma medication, Meclizine, vitamins and ALLEGRA-D. The health department nurse reported that the patient was pregnant after receiving two doses of the HPV vaccine. The patient was seen at the Department on 06-Mar-2008 and a urine test was positive for pregnancy. The patient's date of last menstrual period was 30-Jan-2008. The estimated date of delivery was 05-Nov-2008, Ultrasounds were performed on 06-June-2008, 06-Aug-2008, 17-Sep-2008 and 14-Oct-2008 and results were within normal limits, small for dates, PIH and edema. A sonogram and a biophysical profile was also performed and resulted within normal limits. On 15-Oct-2008, the patient delivered a normal, healthy male baby weighing 5 pounds 3.7 ounces. There was no congenital anomalies. The baby's length was 18.5 inches and his Apgar score was 8/9 . the baby presented short foreskin. Complications during pregnancy included UTI, edema, increased blood pressure and hyperemesis. Complications during delivery included PIH and vacuum delivery. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Amniocentesis, Drug exposure during pregnancy, Foetal disorder, Fungal infection
Clinical narrative: Information has been received from a medical assistant and a nurse practitioner, for the pregnancy registry for GARDASIL, concerning a 23 year old female patient with Glioblastoma multiforme in 2007, cholecystectomy in 2001, history of smoking and asthma, and with a history of 4 pregnancies and a 4 full term deliveries, who on 08-NOV-2007 was vaccinated the first 0.5 ml dose of with GARDASIL (Lot #654540/1209U).  The patient became pregnant after receiving the vaccination.  Her LMP was 18-DEC-2007. Estimated conception date was 15-DEC-2007 and EDD was 26-SEP-2008.  Other medications used during pregnancy included MONISTAT on 11-apr-2008 for yeast and prenatal vitamins 7 tablets once a day on 11-APR-2008.  Prenatal care panel were performed.  On 07-FEB-2008 ultrasound was performed for SGA with the result of pregnancy 5 week 6/7 day; on 25-APR-2008 amniocentesis was performed for SGA with the result of pregnancy 5 week 6/7 day;  on 25-APR-2008 amniocentesis was performed for SGA with the result of pregnancy 17 week 2/7 day, and MSAFP was performed for screening with the result of Neg x4.  On 24-SEP-2008 the patient had a normal female infant (6 pounds, 10 ounces) with no congenital anomalies.  Other complication was choroid plexus cyst.  There was not complication during pregnancy and labor/delivery, and not infections or illness during pregnancy for the patient.  BS monitoring per 6 AM was performed during pregnancy.  Follow up information was received from a nurse practitioner.  She reported that the fetal choroid plexus cyst was noted only prenatally on a mid-trimester ultrasound.  On 10-JUN-2008, at 25 weeks EGA, the patient had a  follow up sonogram with a perinatologist who said the cyst had resolved.  No further testing was done or needed.  The reporter also noted that the baby was fine with no problems and no anomalies.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Ultrasound scan abnormal
Clinical narrative: Information has been received from a medical assistant and a nurse practitioner, for the pregnancy registry for GARDASIL, concerning a 23 year old female patient with Glioblastoma multiforme in 2007, cholecystectomy in 2001, history of smoking and asthma, and with a history of 4 pregnancies and a 4 full term deliveries, who on 08-NOV-2007 was vaccinated the first 0.5 ml dose of with GARDASIL (Lot #654540/1209U).  The patient became pregnant after receiving the vaccination.  Her LMP was 18-DEC-2007. Estimated conception date was 15-DEC-2007 and EDD was 26-SEP-2008.  Other medications used during pregnancy included MONISTAT on 11-apr-2008 for yeast and prenatal vitamins 7 tablets once a day on 11-APR-2008.  Prenatal care panel were performed.  On 07-FEB-2008 ultrasound was performed for SGA with the result of pregnancy 5 week 6/7 day; on 25-APR-2008 amniocentesis was performed for SGA with the result of pregnancy 5 week 6/7 day;  on 25-APR-2008 amniocentesis was performed for SGA with the result of pregnancy 17 week 2/7 day, and MSAFP was performed for screening with the result of Neg x4.  On 24-SEP-2008 the patient had a normal female infant (6 pounds, 10 ounces) with no congenital anomalies.  Other complication was choroid plexus cyst.  There was not complication during pregnancy and labor/delivery, and not infections or illness during pregnancy for the patient.  BS monitoring per 6 AM was performed during pregnancy.  Follow up information was received from a nurse practitioner.  She reported that the fetal choroid plexus cyst was noted only prenatally on a mid-trimester ultrasound.  On 10-JUN-2008, at 25 weeks EGA, the patient had a  follow up sonogram with a perinatologist who said the cyst had resolved.  No further testing was done or needed.  The reporter also noted that the baby was fine with no problems and no anomalies.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Chest pain, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with asthma and no known allergies who on 11-DEC-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml intramuscularly.  Concomitant therapy included ADACEL and HAVRIX.  On 11-DEC-2008 the patient experienced left arm pain, arm pit pain, left sided chest pain and swelling of her left arm.  The patient sought medical attention at the office.  At the time of report the patient was recovering.  Additional information has been requested. Fllow up information received from the registered nurse indicated that the 19 year old female patient weighted 135 pounds and was 69 inches height. The nurse reported that the patient developed right arm hurting and swollen at the injection site (previously reported as left arm swelling), then the pain went to under arm and the right side of the chest (previously reported as left side). Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Facial pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female patient who 1.5 year ago, approximately in July 2007, was vaccinated with the first dose of GARDASIL vaccine 0.5 mL IM.  Approximately thirty days after received GARDASIL vaccine, in approximately August 2007, the patient experienced bilateral facial pain, numbness of her feet and hands, pain in her hands and gastrointestinal upset.  It was noted
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination normal, Pain in extremity
Clinical narrative: This is in follow-up to report (s) previously submitted on 1/16/2009. Information has been received from a pharmacist, concerning a female patient with hyperlipidaemia and no known drug reactions or allergies, who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscularly and on 21-NOV-2008 was vaccinated with the second dose of the HPV vaccine (Lot # 655165/0137U), 0.5ml, intramuscularly.  Concomitant therapy included LIPITOR and clobetasol propionate cream. The pharmacist reported the patient developed arm apin 3 weeks after the second dose of vaccination date. At the time of ther report, the pain has not resolved. Follow-up information received from pharmacist indicated that the patient had no known drug reaction/allergies or any medical condition, who on 21-NOV-2000 at 15:30 pm, the patient was vaccinated with the second dose of GARDASIL in the left deltoid. On 15-DEC-2008, the patient developed arm pain, most on deltoid area and traveled down her arm. A neurology exam was performed resulting negative per patient. At the time of the report, the patient had recovered. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with drug hypersensitivity who a month ago was vaccinated with GARDASIL intramuscularly, lot # 661764/0650X.  The patient reported to the nurse that she developed a lump at the injection site where the HPV vaccine was given.  At the time of reporting, the patient had not recovered.  Additional information has been requested.  This is one of several reports received from the same source.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with no medical history and allergy to KEFLEX, who on 02-OCT-2008 was vaccinated with a 0.5ml first dose of GARDASIL (lot# 660612/0229X), intramuscularly. On 4-OCT-2008 the patient developed a raised, "gum ball sized", itchy, burning area at the injection site. The reaction resolved without treatment. On 11-Dec-2008 the patient received the deltoid muscle of the right arm and later that night developed itchiness and swelling of both hands. The patient contacted the office by phone on 12-Dec-2008 and was prescribed BENADRYL. There were no laboratory diagnostics performed. The patient had not recovered for the itchiness and swelling of both hands. The patient sought medical attention through a phone call to the doctor's office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTAP, FLUN3, HPV4, MNQ
Symptoms: Drug exposure during pregnancy, Pyrexia, Vomiting
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a Registered Nurse concerning a 14 year old female patient who on 05-DEC-2008 was vaccinated with first dose of GARDASIL (Lot # not provided).  Concomitant therapy included Diphtheria Toxoid (+) PERTUSSIS ACELLULAR vaccine (unspecified) (+) TETANUS TOXOID (manufacturer unspecified), FLUMIST and MENACTRA .  After the patient received the vaccines she went to the Emergency Room with a fever of 102.6F and vomiting.  It was at this time she discovered she was about 8 to 12 weeks pregnant.  Additional information has been requested. Thisi s in follow-up to report (s) previously submitted on 1/16/2009. Additional information has been received from a prengnancy registry for GARDASIL from a registered nurse who reported that a patient on 10-Dec-2008; the patient was vaccianted with the first dose of GARDASIL (lot # 661046/0381X). Concomitent medication included an unspecified psychiatric medication and DEPO PROVEN. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female who in November 2008, was vaccinated with a dose of GARDASIL vaccine, lot# not reported. It was reported that the patient received the GARDASIL vaccine and waited for 20 minutes and was fine, however she left to the pharmacy and felt light headed and she had to sit down. The physician stated that the patient was fine and was released home after 20 minutes of observation. Patient recovered the same day. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, DNA antibody negative, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 24 year old female who "more than a year ago" was vaccinated with GARDASIL, 0.5 mL, intramuscularly.  Concomitant therapy included NUVARING.  It was reported that the patient was tested for HPV prior to HPV vaccination: DNA negative for HPV and had a normal PAP smear.  The patient completed her series about a year ago.  The physician stated that at the end of NOVEMBER 2008 the patient had a HPV test, and was positive for the HPV in the high risk panel.  At the time of the report the patient was not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information received from her physician indicated that she was a female patient with no known allergies who on 04-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 656049/0187U), the second dose of GARDASIL (lot number 658558/1061U) on 27-AUG-2007, and the third dose of GARDASIL (lot number 659055/1522U) on 11-DEC-2007. The physician noticed that the patient had a pap smear on 22-DEC-2008, the following abnormalities were found: low grade squamous intraepithelial lesion (LGSIL), positive high risk panel for GARDASIL, Colposcopy confirmed LGSIL. Patient not recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix normal
Clinical narrative: Information has been received from a physician concerning a 24 year old female who "more than a year ago" was vaccinated with GARDASIL, 0.5 mL, intramuscularly.  Concomitant therapy included NUVARING.  It was reported that the patient was tested for HPV prior to HPV vaccination: DNA negative for HPV and had a normal PAP smear.  The patient completed her series about a year ago.  The physician stated that at the end of NOVEMBER 2008 the patient had a HPV test, and was positive for the HPV in the high risk panel.  At the time of the report the patient was not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information received from her physician indicated that she was a female patient with no known allergies who on 04-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 656049/0187U), the second dose of GARDASIL (lot number 658558/1061U) on 27-AUG-2007, and the third dose of GARDASIL (lot number 659055/1522U) on 11-DEC-2007. The physician noticed that the patient had a pap smear on 22-DEC-2008, the following abnormalities were found: low grade squamous intraepithelial lesion (LGSIL), positive high risk panel for GARDASIL, Colposcopy confirmed LGSIL. Patient not recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Head injury, Paraesthesia, Syncope
Clinical narrative: Initial and follow up information has been received from a medical assistant a physician concerning a 15 year old female patient, 131 pounds, 63.5 inches height, with no known drug reaction/allergies and no pertinent medical history, who on 11-NOV-2008, at 15:00 was vaccinated with the first dose of GARDASIL, 0.5ml (Lot # 661046/0546X), intramuscularly, in the right gluteus. There was not concomitant medication. The physician reported that after receiving the HPV vaccine, the patient fainted.  Since then, the patient had been consistently feeling a tingling sensation throughout her body.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  Additional information has been requested. Follow up information indicated that the patient experienced fainted after vaccination, fall, hit back of head. The patient had been feeling a dizziness when puts head down and as patient described "tingly" feeling all over body. Patient is unable to give specifics on symptoms. A brain MRI was performed and resulted normal. It is unknown if the patient recovered. There were no illnesses at timeof vaccination. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Smear cervix, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL concerning a 23 year old female patient who on 06-APR-2007 was vaccination with the first dose of GARDASIL 0.5 ml intramuscularly.  On 06-JUN-2007 the patient received the second dose of GARDASIL 0.5 ml intramuscularly and the third dose of GARDASIL 0.5 ml intramuscularly was administered on 06-OCT-2007.  The patient had an abnormal Pap smear result on 01-OCT-2008.  Also the patient was currently pregnant.  Second Pap smear results are pending.  The patient sought medical attention. Follow up information was received concerning the patient's due date: 01-MAY-2009, last menstrual period: 25-JUL-2008. Additional information has been requested.