chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with no pertinent medical history and sulfa allergy, CECLOR allergy and seafood allergy who on 18-JUN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (LOT# 660391/0063X). On the same day, the patient was also vaccinated with a dose of ADACEL, MENACTRA and HAVRIX. There was no concomitant medication. On 19-JUN-2008, the patient developed blisters that varied in size from a pin point to an eraser. The blisters first appeared under one arm (which arm was unspecified) and then spread over entire body. Her face was swollen and covered with blisters. The patient was examined by her physician on 21-JUN-2008 and an allergist on 23-JUN-2008. The allergist prescribed prednisone. The patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Blister, Swelling face
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with no pertinent medical history and sulfa allergy, CECLOR allergy and seafood allergy who on 18-JUN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (LOT# 660391/0063X). On the same day, the patient was also vaccinated with a dose of ADACEL, MENACTRA and HAVRIX. There was no concomitant medication. On 19-JUN-2008, the patient developed blisters that varied in size from a pin point to an eraser. The blisters first appeared under one arm (which arm was unspecified) and then spread over entire body. Her face was swollen and covered with blisters. The patient was examined by her physician on 21-JUN-2008 and an allergist on 23-JUN-2008. The allergist prescribed prednisone. The patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Abasia, Arthralgia
Clinical narrative: Information has been received from a consumer concerning her approximately 15 year old daughter, who in December 2007, the end of January 2008 and the end of May 2008 was vaccinated with the first, second and third doses of GARDASIL vaccine. Within two weeks after receiving each shot, the patient experienced severe pain in her hips. The pain was so severe she couldn't walk. She had a magnetic resonance imaging of her hips and it was reported "ok." To this day, the mother reports that her daughter (the patient) experiences hip pain. No further information is available.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Abasia, Arthralgia, Nuclear magnetic resonance imaging normal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her approximately 15 year old daughter, who in December 2007, the end of January 2008 and the end of May 2008 was vaccinated with the first, second and third doses of GARDASIL vaccine. Within two weeks after receiving each shot, the patient experienced severe pain in her hips. The pain was so severe she couldn't walk. She had a magnetic resonance imaging of her hips and it was reported "ok." To this day, the mother reports that her daughter (the patient) experiences hip pain. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Full blood count, Headache, Metabolic function test normal, Migraine
Clinical narrative: Information has been received from a physician concerning her 20 year old with Gilbert's syndrome, CECLOR and BACTRIM allergies and a history of tonsillectomy (June 2008) and wisdom teeth removal (07-JUL-2008), who at the end of May 2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) and on 28-JUL-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml intramuscularly. Concomitant therapy included YAZ. After vaccination with the first dose of GARDASIL vaccine (yeast), the only complaint the patient had was injection site discomfort. The patient developed a severe headache after her second dose of GARDASIL vaccine (yeast). A dull headache began on 29-JUL-2008 around 10:30 pm after she returned home from working at the movie theater. The headache was at the back of her head and radiated to the top. On 30-JUL-2008, she awoke with a severe headache at the back of neck and to the left side of the head. She also had nausea and light sensitivity. The patient stated that "it is the worst headache ever". The patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Phonophobia, Photophobia, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning her 20 year old with Gilbert's syndrome, CECLOR and BACTRIM allergies and a history of tonsillectomy (June 2008) and wisdom teeth removal (07-JUL-2008), who at the end of May 2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) and on 28-JUL-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml intramuscularly. Concomitant therapy included YAZ. After vaccination with the first dose of GARDASIL vaccine (yeast), the only complaint the patient had was injection site discomfort. The patient developed a severe headache after her second dose of GARDASIL vaccine (yeast). A dull headache began on 29-JUL-2008 around 10:30 pm after she returned home from working at the movie theater. The headache was at the back of her head and radiated to the top. On 30-JUL-2008, she awoke with a severe headache at the back of neck and to the left side of the head. She also had nausea and light sensitivity. The patient stated that "it is the worst headache ever". The patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site discomfort, Nausea, Photophobia
Clinical narrative: Information has been received from a physician concerning her 20 year old with Gilbert's syndrome, CECLOR and BACTRIM allergies and a history of tonsillectomy (June 2008) and wisdom teeth removal (07-JUL-2008), who at the end of May 2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) and on 28-JUL-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml intramuscularly. Concomitant therapy included YAZ. After vaccination with the first dose of GARDASIL vaccine (yeast), the only complaint the patient had was injection site discomfort. The patient developed a severe headache after her second dose of GARDASIL vaccine (yeast). A dull headache began on 29-JUL-2008 around 10:30 pm after she returned home from working at the movie theater. The headache was at the back of her head and radiated to the top. On 30-JUL-2008, she awoke with a severe headache at the back of neck and to the left side of the head. She also had nausea and light sensitivity. The patient stated that "it is the worst headache ever". The patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a physician's assistant concerning a female with no drug reactions/allergies, who in August 2007, was vaccinated intramuscularly with a first dose of GARDASIL (lot # not reported) 0.5 mL.  There was no concomitant medication.  In August 2007 after the GARDASIL was administered, the patient experienced immediate severe pain at the injection site of the left arm.  Due to the pain, the patient was unable to participate in sports.  The pain resolved in one week without requiring treatment.  The patient contacted the physician's office via phone.  The patient has not received the second or third dose of GARDASIL.  No further information was available.  Immediate severe pain at the injection site was considered to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female with allergies and attention deficit disorder who on 17-AUG-2007 was vaccinated with the first dose of GARDASIL, the second dose was given on 18-OCT-2007, and the third dose was given on 21-FEB-2008.  Concomitant therapy included montelukast sodium and CONCERTA.  On 27-AUG-2007 the patient developed hives and the hives continued throughout the series and then disappeared in May 2008.  The hives appeared on her face, legs, arms, feet and stomach.  The hives were described as "large welts, like golf ball size".  The patient was seen twice in the emergency room and received EPIPEN administration on each of the visits, she was then discharged home.  The patient had been seen by two allergists.  Skin testing was performed, but it could not determine the cause for the hives.  The physician stated that the allergist believed that the hives were hormone related.  Upon internal review, hives requiring epinephrine was determined to be and other important medical event.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a nurse concerning a 10 year old female who on 26-JUN-2007 was vaccinated with the first dose of GARDASIL (lot no. 655619/1427F). The first dose was administered concomitantly with VARIVAX (Oka/Merck) (MSD). The patient tolerated with the first dose without incident. On 06-MAY-2008 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot no. 657006/0188U) into the deltoid muscle of the left arm. There was no concomitant therapy. On 14-MAY-2008, "eight days after the second dose", the patient experienced pain in hip joint and was hospitalized. The patient was discharged on 16-MAY-2008. On an unspecified date the patient was recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a 12 year old female with asthma and allergy to pertussis and a history of tension headache who on 23-JUN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL 9lot no. 659437/12660) into the right deltoid. Concomitant therapy included tetanus toxoid and albuterol. The physician's office got a call "last night", on approximately 15-JUL-2008, stating that the patient experienced severe migraine and went to the emergency room. The patient was treated with IV fluids, REGLAN and released. The patient was not hospitalized. The outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning her 17 year old daughter who in 2007 received the first and on an unspecified date a second dose of GARDASIL. On 14-AUG-2007 was vaccinated with the third dose of GARDASIL (lot # 655618/0186U) 0.5 ml, IM. On 07-JUL-2008, the patient experienced pain, weakness and numbness in her right thumb and arm. Medical attention was sought, she had blood tests, was seen by a neurologist and will have an Magnetic Resonance Imaging (MRI) the week of 21-JUL-2008. The primary care doctor thought this may be associated with GARDASIL until he saw on the chart that the third dose was given in the opposite arm. At the time of reporting, the patient's pain and weakness and numbness persisted. No additional information at this time. Additional information has been requested.  9/16/2008 MR received from PCP. Seen 7/9/2008 with c/o acute onset of numbness which began in the R thumb and spread up to the level of mid triceps. PE (+) for decreased strength of the fingers, wrist and elbow. Sensory deficit to R mid tricep. Tearful and anxious re: symptoms. Ascending sensory deficit on R hand to upper arm with motor weakness.  Reflexes intact.  Referred to neuro. Neuro consult 7/11/08-improving numbness of unknown etiology. Numbness improving, now only to elbow. Pinprick and touch sensation diminished on R arm. F/U visit 3 weeks later with continued improvement. Still some numbness and decreased sensation of the hand. Will f/u with EMG and/or MRI PRN.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. On an unspecified date was vaccinated with the second dose of GARDASIL 0.5 ml, injection (route). 24-48 hours after receiving her second dose of GARDASIL, the patient experienced rash on her face that went into her ears. The patient sought medical attention. The outcome was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Gastroenteritis, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female with attention deficit disorder who on 14-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659182/1757U). Concomitant therapy included ADDERALL TABLETS and ZOLOFT. On approximately 15-MAY-2008, "within 24 hours", the patient had severe gastroenteritis (vomiting, diarrhea). It was unknown if the patient had fever. On an unspecified date the patient was recovered. The patient's mother called the office to seek unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dysarthria, Headache, Hypersensitivity, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a registered nurse concerning an approximately 25 year old female who on 08-JUL-2008 was vaccinated with the first dose of GARDASIL in an Ob/Gyn office.  On 11-JUL-2008 the patient experienced severe allergic reaction, severe headaches, nausea, heart racing and slurred speech.  Per nurse, the patient also blacked out.  The patient was treated in the reporter's office.  The patient was referred to a neurologist and was brought to the emergency room.  It was unknown if the patient was hospitalized.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a registered nurse concerning an approximately 25 year old female who on 08-JUL-2008 was vaccinated with the first dose of GARDASIL in an Ob/Gyn office.  On 11-JUL-2008 the patient experienced severe allergic reaction, severe headaches, nausea, heart racing and slurred speech.  Per nurse, the patient also blacked out.  The patient was treated in the reporter's office.  The patient was referred to a neurologist and was brought to the emergency room.  It was unknown if the patient was hospitalized.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Nausea, Pharyngeal oedema, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a mother concerning her daughter, a 23 year old female with penicillin allergy and "cold medicines" allergy and a history of bipolar and shaken baby syndrome who on 10-JUL-2008 was vaccinated with the first dose of GARDASIL.  (Dose, route of administration and lot number were not provided).  Concomitant therapy included SEROQUEL, LEXAPRO and TEGRETOL.  The patient felt faint after the vaccination.  Two days later her throat began to swell and was sore.  The mother reported "Her throat was so swollen that she could not eat cereal."  The patient also had a red face, fever and was nauseous.  The patient sought medical attention via telephone.  She started taking BENADRYL on 16-JUL-2008.  Her symptoms were improving since starting the therapy with BENADRYL.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a mother concerning her daughter, a 23 year old female with penicillin allergy and "cold medicines" allergy and a history of bipolar and shaken baby syndrome who on 10-JUL-2008 was vaccinated with the first dose of GARDASIL.  (Dose, route of administration and lot number were not provided).  Concomitant therapy included SEROQUEL, LEXAPRO and TEGRETOL.  The patient felt faint after the vaccination.  Two days later her throat began to swell and was sore.  The mother reported "Her throat was so swollen that she could not eat cereal."  The patient also had a red face, fever and was nauseous.  The patient sought medical attention via telephone.  She started taking BENADRYL on 16-JUL-2008.  Her symptoms were improving since starting the therapy with BENADRYL.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lactose intolerance
Clinical narrative: Information has been received from a nurse practitioner concerning one of three girls in the same family who "a few months ago" in 2008, were vaccinated with GARDASIL. Subsequently, the patient became lactose intolerant after receiving GARDASIL. It was not specified whether the patient sought medical attention. The patient's lactose persisted. Additional information has been requested. This is one of several reports from the same source.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician and a nurse concerning an approximately 17 year old female who on 05-JAN-2008 and 12-MAR-2008 was vaccinated with her first and second doses, respectively, of GARDASIL (Lot # 655327/1287U and 0515X). The patient experienced shortness of breath after her first and second doses of GARDASIL. Subsequently the patient recovered from the events. The reporting physician did not think the reactions were vaccine-related, especially since the patient did not mention the reactions after they happened and came into the office to let the doctor know she would not be getting the third dose. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated intramuscularly with 0.5 ml of first and second doses, respectively, of GARDASIL (lot#s not provided).  It was reported that the patient claims that her period started thirty minutes after each dose of GARDASIL was given.  Unspecified medical attention was sought.  At the time of this report the outcome was unknown.  No additional information available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell count increased, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a female with a family history of rheumatoid arthritis and Lupus who in April 2008, was vaccinated intramuscularly with a first dose of GARDASIL (lot # unspecified).  It was reported that on an unspecified date post vaccination (date reported as "few weeks later") the blood test was performed and the readings showed that there was an increase in patient's sedimentation rate.  Unspecified medical attention was sought.  It was reported that the patient went for more "blood work" where the readings went back to normal.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, Dysarthria, Extensor plantar response, Hyperreflexia, Speech disorder
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of severe scoliosis and histiocytosis x at age 1 who in September 2007, was vaccinated with the first dose of GARDASIL.  In March 2008, the patient was vaccinated with the third 0.5 ml dose of GARDASIL.  The patient experienced ataxia after receiving all three dose of GARDASIL, her speech was slurred and slowed and she was hyper reflexic with present Babinskis bilaterally.  The ataxia started and worsened about the time she started the GARDASIL.  Neurologist had no diagnosis.  At time of reporting patient outcome was not recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of severe scoliosis and histiocytosis x at age 1 who in September 2007, was vaccinated with the first dose of GARDASIL.  In March 2008, the patient was vaccinated with the third 0.5 ml dose of GARDASIL.  The patient experienced ataxia after receiving all three dose of GARDASIL, her speech was slurred and slowed and she was hyper reflexic with present Babinskis bilaterally.  The ataxia started and worsened about the time she started the GARDASIL.  Neurologist had no diagnosis.  At time of reporting patient outcome was not recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Premature labour
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a nurse practitioner concerning a 16 year old female with no drug reactions/allergies, reflux, migraine and a history of cardiac surgery who on 07-MAR-2007 was vaccinated with the first dose of GARDASIL IM (Lot# 654885/1424F).  Concomitant therapy included rizatriptan benzoate (MSD), propranolol HCl and ranitidine.  The patient was pregnant when she was vaccinated with GARDASIL.  The patient had a positive pregnancy test.  As of 01-MAY-2007, she was noted to be 2.5 months gestation.  Follow-up phone call information was received from the nurse practitioner who reported that the patient delivered a healthy, normal, baby that is now 7 months old and not experiencing any problems.  During the pregnancy, the patient did have some symptoms of pre-term labor, but went on to deliver full-term, vaginally.  No additional information is expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow information has been received from a physician concerning a 17 year old white male who on 21-JUL-2007 at 1:00 PM was inadvertently vaccinated IM with a first dose of GARDASIL (Lot # 655205/1426F) instead of MENACTRA. On 31-JUL-2007, the patient was seen in the office and he was healthy, and had to adverse event at all. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Live birth, Nausea, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL from a registered nurse concerning a 16 year old female with depression and anxiety with no prior pregnancies who on 02-JUL-2007 was vaccinated IM with the first dose (0.5 ml) of GARDASIL (Lot# 0212U). Concomitant therapy included ZOLOFT and EFFEXOR. Subsequently, the patient became pregnant. Last menstrual period was 18-JUN-2007 and estimated date of delivery was 24-AR-2008. On 24-OCT-2007 the patient had a routine ultrasound which was within normal limits. On an unspecified, the patient developed nausea and was placed on therapy with PHENEGRAN and ZOFRAN. On 08-MAR-2008 at 37 weeks/4 days the patient had a 7 lb. 2 oz. live born infant with an Apgar score of 8/9. It was reported that the baby was adopted out. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Herpes simplex, Ultrasound scan normal, Vaginal infection
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 27 year old female with a history of three previous pregnancies, 3 full term deliveries with no birth defects or complications, and condyloma, who on 02-MAY-2007 was vaccinated with a first dose of GARDASIL (Lot# 657006/0188U). On 05-JUL-2007, the patient was vaccinated with a second dose of GARDASIL (Lot# 657621/0387U). Subsequently, the patient became pregnant after receiving second dose of the vaccination. On 09-OCT-2007 and 06-DEC-2007 ultrasounds were performed for dating and fetal screening, the results were within normal limits. On 20-NOV-2007 a serum alpha-fetoprotein test was performed for screening, the results were within normal limits. The patient's last menstrual period was 10-JUL-2007 and her estimated delivery date was 15-APR-2008. At the time of the report, the patient's outcomes was unknown. No product quality complaint was involved. On 15-APR-2008, forty weeks from her last menstrual period the patient gave birth to a female infant that weighed 9 pounds 2 ounces. The infant was 20 3/4 inches long, her apgar score was 9/10, and her head circumference was "13 1/2." The infant was normal, with no congenital anomalies, complications, or abnormalities. Other medications used during the pregnancy were REPLIVA 21/7 from 13-MAR-2008 to 18-OCT-2008 once a day as an iron supplement, PRIMACARE ONE from 13-MAR-2008 to 18-OCT-2008 once a day, GYNAZOLE 1 started on 24-SEP-2007 once at bedtime for vaginitis, CLINDESSE started on 24-SEP-2007 once at bedtime for vaginitis, CLINDESSE started on 24-SEP-2007 once at bedtime for vaginitis, and VALTREX 500mg started on 09-OCT-2007 (reported as 09-OCT-2008; two times a day for Herpes simplex outbreak. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a physician and a registered nurse for the Pregnancy Registry for GARDASIL concerning a 20 year old female (demographics not reported) with migraines (also reported as headaches), a sinus disorder, and a history of an abnormal pap (CIN I) who on 28-MAR-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot 656049/0187U; site not reported). On 29-MAY-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot 657622/0388U). Concomitant therapy included montelukast sodium (MSD), AVIANE, and albuterol inhaler (manufacturer unspecified) and ibuprofen (manufacturer unspecified). On 09-SEP-2007, the patient had a positive home pregnancy test, and on 10-SEP-2007, a quantitative HCG blood test confirmed the pregnancy. On 20-Sep-2007, the patient sought unspecified medical attention in the office. On 04-DEC-2007, the patient has an ultrasound for history of prominent fetal stomach (not further specified). On 03-JAN-2008 the patient had a ultrasound which was normal. The patient was treated with an iron supplement for 2 weeks and prenatal vitamins (not further specified). On 26-APR-2008, the patient gave birth to a normal, healthy male infant (8 lb. oz; 22 in). The baby had an Apgar score of 9/9. The infant had no congenital anomalies, complications or abnormalities. There were no complications during pregnancy or during labor and delivery. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive, Seasonal allergy
Clinical narrative: Initial and follow up information has been received from the Merck Pregnancy Registry for GARDASIL via a physician concerning a "healthy" 18 year old white female smoker with a history of some problems with her menses who on 29-JUN-2007 was vaccinated intramuscularly into the left arm with a 0.5 ml first dose of GARDASIL. On 05-NOV-2007, the patient was vaccinated with a second dose of GARDASIL. On 05-NOV-2007, the patient was vaccinated with a second dose of GARDASIL (Lot #655620/0170U). Concomitant therapy included SEASONALE. Subsequently, the patient called the doctor's office and stated her home pregnancy test was positive. On 14-NOV-2007, she was seen in the doctor's office and a urine test confirmed pregnancy. A Quantitative blood test for pregnancy was also performed, but the results were not available yet. The patient's last menstrual period was on 04-OCT-2007, estimated date of conception was 18-OCT-2007 and the estimated date of delivery was 10-Jul-2008. On an unspecified date, the patient developed seasonal allergies and was treated with montelukast (MSD). On 22-FEB-2008 and 19-MAY-2008 the patient had routine ultrasound tests with "good" results. It was reported the patient delivered a normal, 18 1/4 inch, 6 lb. 7 oz. female at 38 weeks, 5 days with a had circumference of 12 3/4 inches (Apgar score not reported). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from the Merck Pregnancy Registry for GARDASIL via a physician concerning a "healthy" 18 year old white female smoker with a history of some problems with her menses who on 29-JUN-2007 was vaccinated intramuscularly into the left arm with a 0.5 ml first dose of GARDASIL. On 05-NOV-2007, the patient was vaccinated with a second dose of GARDASIL. On 05-NOV-2007, the patient was vaccinated with a second dose of GARDASIL (Lot #655620/0170U). Concomitant therapy included SEASONALE. Subsequently, the patient called the doctor's office and stated her home pregnancy test was positive. On 14-NOV-2007, she was seen in the doctor's office and a urine test confirmed pregnancy. A Quantitative blood test for pregnancy was also performed, but the results were not available yet. The patient's last menstrual period was on 04-OCT-2007, estimated date of conception was 18-OCT-2007 and the estimated date of delivery was 10-Jul-2008. On an unspecified date, the patient developed seasonal allergies and was treated with montelukast (MSD). On 22-FEB-2008 and 19-MAY-2008 the patient had routine ultrasound tests with "good" results. It was reported the patient delivered a normal, 18 1/4 inch, 6 lb. 7 oz. female at 38 weeks, 5 days with a had circumference of 12 3/4 inches (Apgar score not reported). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from a physician and a licensed vocational nurse (LVN) concerning a 19 year old female with a history of depression and anxiety.  The patient had a history of an elective termination of 1 previous pregnancy.  On 26-SEP-2007, the patient was vaccinated with her first dose of GARDASIL (Lot # 0530U).  Concomitant therapy included "CLONAZEPAK" (therapy unspecified).  Subsequently, the patient found out she was pregnant.  The patient's last menstrual period (LMP) was 02-OCT-2007, with an estimated delivery date of 09-JUL-2008.  The patient sought medical attention.  On 16-JUN-2008, the patient was treated with VISTARIL 50 mg, 1 every 6 hours PRN for anxiety.  During the pregnancy, the patient had complication of mild pregnancy induced hypertension (PIH).  On 02-JUL-2008, 39 weeks from LMP, the patient delivered a normal female infant with Apgar score of 9/9.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Genital haemorrhage, Live birth, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a registered nurse through the Merck pregnancy registry for GARDASIL concerning a 26 year old female with no previous pregnancies, no pertinent medical history, and no known allergies who on 27-JUL-2007 was vaccinated with her first dose of GARDASIL (Lot #658100/0525U) intramuscularly.  On 28-SEP-2007 the patient received her second dose of GARDASIL (Lot #658100/0525U) intramuscularly.  There was no concomitant medication.  On 28-SEP-2007, before the second dose, a urine pregnancy test was administered.  The result was negative for pregnancy.  The patient called the office stating that she was pregnant and an OB intake appointment was on 14-DEC-2007.  A urine pregnancy test was performed on this day with positive results.  On 27-DEC-2007 an ultrasound was performed, and on 24-JAN-2008 a maternal serum alphafeto protein was done, both tests were within normal limits.  The patients last menstrual period was 02-OCT-2007 and the estimated delivery date was 08-JUL-2008.  During the first trimester, the patient had complication of first trimester spotting.  On 10-JUL-2008, 41 weeks from the LMP, the patient delivered a normal live born female infant weighing 7lbs 14ozs and apgar of 9/9.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a registered nurse through the Merck pregnancy registry for GARDASIL concerning a 26 year old female with no previous pregnancies, no pertinent medical history, and no known allergies who on 27-JUL-2007 was vaccinated with her first dose of GARDASIL (Lot #658100/0525U) intramuscularly.  On 28-SEP-2007 the patient received her second dose of GARDASIL (Lot #658100/0525U) intramuscularly.  There was no concomitant medication.  On 28-SEP-2007, before the second dose, a urine pregnancy test was administered.  The result was negative for pregnancy.  The patient called the office stating that she was pregnant and an OB intake appointment was on 14-DEC-2007.  A urine pregnancy test was performed on this day with positive results.  On 27-DEC-2007 an ultrasound was performed, and on 24-JAN-2008 a maternal serum alphafeto protein was done, both tests were within normal limits.  The patients last menstrual period was 02-OCT-2007 and the estimated delivery date was 08-JUL-2008.  During the first trimester, the patient had complication of first trimester spotting.  On 10-JUL-2008, 41 weeks from the LMP, the patient delivered a normal live born female infant weighing 7lbs 14ozs and apgar of 9/9.  Additional information is not expected.
Age: 48.0
Sex: M
Vaccine: HPV4
Symptoms: Borrelia burgdorferi serology negative, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 48 year old male, with a thyroid nodule, tick bite, allergies to FLEXERIL and SYNTHROID and a history of a positive PPD tuberculin test who on 20-MAY-2008 was vaccinated intramuscularly in the left deltoid with a single dose of GARDASIL (Lot # 658556/1060U).  The nurse reported that the patient was intended to received a tetanus toxoid vaccine (unspecified), but GARDASIL was inadvertently administered.  The nurse confirmed that this was a case of human error and not product confusion.  No problems were reported.  The nurse reports that there were no known adverse events.  The patient was at the office "to evaluate area of tick bite".  The patient had a negative "Lyme's titer" (not further specified).  On 21-May-2008, the office called the patient and the patient reported no ill effects.  The patient has not contacted the office subsequently.  No additional information was provided.  Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Ear pain, Injection site pain, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a now 12 year old male who on 04-JUN-2008 was vaccinated IM in the left arm with a dose GARDASIL (lot# 659962/1740U) 0.5 ml.  Concomitant therapy included BOOSTRIX.  The nurse had indicated that the patient had inadvertently received the GARDASIL vaccine.  No adverse effects were reported at the time.  Follow-up information from the nurse indicated that on 05-JUN-2008, the patient complained of pain at the injection site for 2-3 days and complained of earache of the left ear for a day following the injections.  The patient did not seek medical attention.  The patient recovered on 08-JUN-2008.  Follow-up information from a phone call was received on 01-AUG-2008.  The nurse had clarified that the patient had inadvertently received the GARDASIL due to wrong drug being administered.  The nurse also stated that "the family stated he has had earaches before."  No other information is available.  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse mid-wife concerning a patient who on an unspecified date was vaccinated with a third dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient fainted.  It was unknown whether the patient sought medical attention.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who on an unspecified date, also reported as in August 2008, was vaccinated with GARDASIL in the arm (lot number and injection route not reported). Subsequently the patient developed unspecified arm pain at the injection site. Subsequently, the patient recovered from arm pain at the injection site without treatment. The patient did not sought any medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who was vaccinated with the third dose of GARDASIL.  The patient experienced severe vertigo followed by severe muscle and joint pain after vaccination.  It was noted that the vertigo began three weeks after the patient received the third dose.  The patient was performed magnetic resonance imaging (MRI) test.  The patient's severe vertigo and severe muscle and joint pain persisted.  The patient sought medical attention and seen by practice.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound scan normal, Vaginal haemorrhage
Clinical narrative: Information has been received through the Merck pregnancy registry from a nurse concerning a female with no pertinent medical history and no history of drug reactions or allergies on prior pregnancies who between January and April 2008 received at least 2 doses of GARDASIL at a different facility.  There was no concomitant medication.  The patient was pregnant.  Her last menstrual period was approximately 26-DEC-2007.  The estimated due date is 02-OCT-2008.  The patient was seen in the reporter's office in April 2008 for obstetric care.  On 23-APR-2008, the patient had a normal ultrasound and negative serum alpha-fetoprotein test.  On approximately 26-MAY-2008, the patient developed vaginal bleeding.  On 25-MAY-2008, an ultrasound was performed and was normal.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a medical assistant concerning a 24 year old female with no relevant medical history or allergies who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 659964/1978U) 0.5 ml by intramuscular injection into the left deltoid.  There was no concomitant medication.  On 19-JUN-2008 the patient developed local injection site reaction.  The injection site was red, itchy and swollen.  The patient said it looked like a "Cheetos chip" was inside the arm.  The patient sought unspecified medical attention.  At the time of reporting, the patient's events were recovering.  Follow-up information was received which reported that on 25-JUN-2008, the patient was recovered from all the events.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypoaesthesia facial, Hypoaesthesia oral, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with no known pertinent medical history or drug reactions/allergies who on 11-JUN-2008 was vaccinated with a first dose of GARDASIIL (lot# 660391/0063) 0.5 ml, IM. Concomitant therapy included ZOLOFT. On 12-JUN-2008 the patient experienced face and mouth numbness, pain in her left arm and leg and shortness of breath after receiving GARDASIL. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a female who was inadvertently vaccinated with a dose of GARDASIL, instead of the hepatitis vaccine (manufacturer unknown).  The medical assistant reported that it was staff error only, and that the patient was at the appropriate age for GARDASIL.  The patient sought medical attention at the physician's office.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Rash pruritic, Rash pustular
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning an 18 year old female who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL, on her left deltoid. The patient did not have any illnesses at the time of vaccination. The physician reported that she was vaccinated around 1 PM that day, and took a nap at home, then woke up at 7 PM with a rash on her back and sides of arms that had pustules like pimples, and on her chest had flushing. The bumps were itching and she scratched them. On 01-JUL-2008, the physician saw the patient and gave her BENADRYL. The physician planned to recommend a 2nd dose of GARDASIL. The patient sought medical attention. At the time of the report, the patient had recovered. Additional information has been requested. No further information is available.
Sex: M
Vaccine: HPV4
Symptoms: Accidental exposure, Injection site anaesthesia, Injection site pain, Off label use
Clinical narrative: Information has been received from a nurse concerning a male who on an unspecified date was inadvertently vaccinated with GARDASIL. No concomitant medication was reported. The patient experienced injection site pain and numbness. The patient sought medical attention in the office. On an unspecified date, he recovered. There was no product quality complaint. No further information is available.  This is in follow-up to report (s) previously submitted on 8/14/2008.  Information has been received from a nurse concerning a male who on an unspecified date was inadvertently vaccinated with GARDASIL.  No concomitant medication was reported.  The patient experienced injection site pain and numbness.  The patient experienced injection site pain and numbness.  The patient sought medical attention in the office.  On an unspecifed date, he recovered.  There was no product quality complaint.  No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nervousness, Pregnancy test negative
Clinical narrative: Information has been received from a consumer for the pregnancy registry concerning her 25 year old daughter, who was vaccinated with the first dose of GARDASIL (Lot and batch # not reported).  It was reported that the patient got her GARDASIL vaccine "two weeks ago", was tested and had negative pregnancy test, now has found she is six weeks pregnant, "is a nervous wreck".  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling jittery, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no allergies who on 27-JUN-2008 was vaccinated with a first dose of GARDASIL 0.5ml by intramuscular injection (lot number 657874/0544X) (injection site not reported). Concomitant therapy included hormonal contraceptives (unspecified) and omeprazole (MSD).  On 27-JUN-2008, after the vaccination the patient experienced lightheaded, jittery and sweating. Later on the same day the patient began to experienced nausea which increased in severity over the following two days. The patient also experienced tingling and numbness on the right side of her head which persisted 24 hours. Laboratory tests included head CT, which indicated that probable lipoma in the corpus callosum and brain MRI was normal. Unspecified medical attention was sought. Until the time reporting, the patient was not recovered from the events. Additional information has been requested. Additional information is not expected.  10/14/08 Reviewed OB/GYN medical records of 6/25-8/14/2008. FINAL DX: migraine w/o aura w/right occipital neuralgia Records reveal patient experienced usual state of good health on 6/22 w/breast fibrocystic changes.  RTC for vaccination on 6/25/08 & immediately experienced sweating, dizziness, jitters which recurred appprox every 10-15 min x 1 hour before d/c to home.  RTC 7/2/08 c/o right sided head pain w/tingling & numbness x 24 hours, increasing nausea s/p vaccine on 6/25.  Seen by neuro 8/14/08 for increased HA s/p vaccine.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no allergies who on 27-JUN-2008 was vaccinated with a first dose of GARDASIL 0.5ml by intramuscular injection (lot number 657874/0544X) (injection site not reported). Concomitant therapy included hormonal contraceptives (unspecified) and omeprazole (MSD).  On 27-JUN-2008, after the vaccination the patient experienced lightheaded, jittery and sweating. Later on the same day the patient began to experienced nausea which increased in severity over the following two days. The patient also experienced tingling and numbness on the right side of her head which persisted 24 hours. Laboratory tests included head CT, which indicated that probable lipoma in the corpus callosum and brain MRI was normal. Unspecified medical attention was sought. Until the time reporting, the patient was not recovered from the events. Additional information has been requested. Additional information is not expected.  10/14/08 Reviewed OB/GYN medical records of 6/25-8/14/2008. FINAL DX: migraine w/o aura w/right occipital neuralgia Records reveal patient experienced usual state of good health on 6/22 w/breast fibrocystic changes.  RTC for vaccination on 6/25/08 & immediately experienced sweating, dizziness, jitters which recurred appprox every 10-15 min x 1 hour before d/c to home.  RTC 7/2/08 c/o right sided head pain w/tingling & numbness x 24 hours, increasing nausea s/p vaccine on 6/25.  Seen by neuro 8/14/08 for increased HA s/p vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on 01-JUL-2008, "yesterday", was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  On 02-JUL-2008, in the morning, the patient woke up with a fever of 102 and also had pain at the injection site.  At the time of this report, the patient's symptoms persisted.  The patient sought unspecified medical attention.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 01-JUL-2008 was vaccinated intramuscularly with the third dose of GARDASIL. On the same day, the patient developed a fever of 102.6 and had chills and just felt achy. The patient was taken to the emergency room where she was given medication for the fever. At the time of this report, the patient's symptoms persisted. Additional information has been requested.