chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Headache, Pupils unequal
Clinical narrative: Information has been received from a consumer concerning a 22 year old female who on approximately "03-JUN-2008 or 04-JUN-2008" was vaccinated IM with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 04-JUN-2008, the patient's mother noticed that one of the patient's pupils "was large and the other was small."  The next day "they switched and the small one was large and the other was small."  It was reported that sometimes "both are huge."  Her vision was blurry and she had a steady headache since receiving the vaccine.  "At one point" she "lost her vision for 30 seconds and it came back."  Diagnostic studies performed included: MRI and carotid artery test" (results not reported).  The patient will not be continuing the series.  At the time of the report, the patient had not recovered.  Upon internal review, transient blindness was considered to be an other important medical event.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Convulsion, Fatigue, Headache, Pupils unequal
Clinical narrative: Information has been received from a consumer concerning a 22 year old female who on approximately "03-JUN-2008 or 04-JUN-2008" was vaccinated IM with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 04-JUN-2008, the patient's mother noticed that one of the patient's pupils "was large and the other was small."  The next day "they switched and the small one was large and the other was small."  It was reported that sometimes "both are huge."  Her vision was blurry and she had a steady headache since receiving the vaccine.  "At one point" she "lost her vision for 30 seconds and it came back."  Diagnostic studies performed included: MRI and carotid artery test" (results not reported).  The patient will not be continuing the series.  At the time of the report, the patient had not recovered.  Upon internal review, transient blindness was considered to be an other important medical event.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Tunnel vision
Clinical narrative: Information has been received from a consumer concerning a 22 year old female who on approximately "03-JUN-2008 or 04-JUN-2008" was vaccinated IM with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 04-JUN-2008, the patient's mother noticed that one of the patient's pupils "was large and the other was small."  The next day "they switched and the small one was large and the other was small."  It was reported that sometimes "both are huge."  Her vision was blurry and she had a steady headache since receiving the vaccine.  "At one point" she "lost her vision for 30 seconds and it came back."  Diagnostic studies performed included: MRI and carotid artery test" (results not reported).  The patient will not be continuing the series.  At the time of the report, the patient had not recovered.  Upon internal review, transient blindness was considered to be an other important medical event.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness transient, Headache, Nuclear magnetic resonance imaging, Pupils unequal, Vision blurred
Clinical narrative: Information has been received from a consumer concerning a 22 year old female who on approximately "03-JUN-2008 or 04-JUN-2008" was vaccinated IM with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 04-JUN-2008, the patient's mother noticed that one of the patient's pupils "was large and the other was small."  The next day "they switched and the small one was large and the other was small."  It was reported that sometimes "both are huge."  Her vision was blurry and she had a steady headache since receiving the vaccine.  "At one point" she "lost her vision for 30 seconds and it came back."  Diagnostic studies performed included: MRI and carotid artery test" (results not reported).  The patient will not be continuing the series.  At the time of the report, the patient had not recovered.  Upon internal review, transient blindness was considered to be an other important medical event.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Palpitations
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no known drug reaction/allergies and a history of slow heart rate and an adjustment problems since moving to another country, who on 11-MAR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 659657/1487U).  On the same day the patient was vaccinated with VAQTA and MENACTRA.  After receiving the first dose of GARDASIL, on 11-MAR-2008, the patient experienced intermittent episodes of dizziness.  Two days later, on 13-MAR-2008, the patient experienced dizziness, shortness of breath and increased heart rate which lasted a couple minutes.  The next day, on 14-MAR-2008, the patient experienced fatigue, headache and tightness at the back of the neck.  On 18-MAR-2008 the patient experienced shortness of breath, chills, dizziness.  Later that same day she had 2 short episodes of dizziness and tightness in chest.  Subsequently, "about two weeks ago", on approximately 21-APR-2008, the patient recovered.  The patient was seen in the doctor's office for unspecified medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no known drug reaction/allergies and a history of slow heart rate and an adjustment problems since moving to another country, who on 11-MAR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 659657/1487U).  On the same day the patient was vaccinated with VAQTA and MENACTRA.  After receiving the first dose of GARDASIL, on 11-MAR-2008, the patient experienced intermittent episodes of dizziness.  Two days later, on 13-MAR-2008, the patient experienced dizziness, shortness of breath and increased heart rate which lasted a couple minutes.  The next day, on 14-MAR-2008, the patient experienced fatigue, headache and tightness at the back of the neck.  On 18-MAR-2008 the patient experienced shortness of breath, chills, dizziness.  Later that same day she had 2 short episodes of dizziness and tightness in chest.  Subsequently, "about two weeks ago", on approximately 21-APR-2008, the patient recovered.  The patient was seen in the doctor's office for unspecified medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Headache, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no known drug reaction/allergies and a history of slow heart rate and an adjustment problems since moving to another country, who on 11-MAR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 659657/1487U).  On the same day the patient was vaccinated with VAQTA and MENACTRA.  After receiving the first dose of GARDASIL, on 11-MAR-2008, the patient experienced intermittent episodes of dizziness.  Two days later, on 13-MAR-2008, the patient experienced dizziness, shortness of breath and increased heart rate which lasted a couple minutes.  The next day, on 14-MAR-2008, the patient experienced fatigue, headache and tightness at the back of the neck.  On 18-MAR-2008 the patient experienced shortness of breath, chills, dizziness.  Later that same day she had 2 short episodes of dizziness and tightness in chest.  Subsequently, "about two weeks ago", on approximately 21-APR-2008, the patient recovered.  The patient was seen in the doctor's office for unspecified medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Bacterial infection
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who was vaccinated po with three doses of ROTATEQ at the scheduled intervals (dates unspecified).  The physician reported that within 24 hours of receiving the third vaccine po the patient developed a bacterial infection of the blood and was admitted to the hospital (date unspecified).  No other information was available and outcome was not reported.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy skin abnormal, Endotracheal intubation, Extubation, HIV infection, HIV test positive
Clinical narrative: Information has been received from a physician concerning a 15 month old male with an HIV positive mother who on 05-MAR-2008 was vaccinated in the thigh with a first dose of VARIVAX (lot number not available). "Sometime after vaccination" the patient developed a lesion on the anterior wall of his chest 1/2 cm below his clavicle (the patient had no known exposure to anyone with chickenpox). In May 2008 the patient was diagnosed with HIV and was admitted to the hospital. The patient had the lesion prior to admission and once he was admitted the lesion was not initially addressed. While hospitalized the patient was being treated for possible pneumocystis with high dose steroids. The patient was on the steroids for three weeks prior to any change in the lesion. The lesion then looked fungal and additional lesions spread to the other side of his chest with some lesions on his face. On 30-MAY-2008 a biopsy of the lesion was performed and it grew varicella zoster virus. At the time (after the sample was obtained) the patient was put on high dose acyclovir. While hospitalized the patient was intubated for one month, he was "recently" extubated however the physician indicated that he would probably need to be reintubated. It was noted that the patient might need to have a lung biopsy performed. At the time of the report the patient remained hospitalized. It was noted that the patient's mother was initially HIV negative when screened early in her pregnancy with the patient and "must have been infected late in her pregnancy". It was not until the patient was diagnosed with HIV that she became aware that she was HIV positive, at that time she was tested and the results were positive. The patient's mother never had chickenpox and prior to her diagnosis of HIV was also vaccinated with VARIVAX. The patient's mother did not develop a rash or lesions. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. Two samples were obtained, a cell culture isolate and a swab in viral media. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Immunology test, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 month old male with an HIV positive mother who on 05-MAR-2008 was vaccinated in the thigh with a first dose of VARIVAX (lot number not available). "Sometime after vaccination" the patient developed a lesion on the anterior wall of his chest 1/2 cm below his clavicle (the patient had no known exposure to anyone with chickenpox). In May 2008 the patient was diagnosed with HIV and was admitted to the hospital. The patient had the lesion prior to admission and once he was admitted the lesion was not initially addressed. While hospitalized the patient was being treated for possible pneumocystis with high dose steroids. The patient was on the steroids for three weeks prior to any change in the lesion. The lesion then looked fungal and additional lesions spread to the other side of his chest with some lesions on his face. On 30-MAY-2008 a biopsy of the lesion was performed and it grew varicella zoster virus. At the time (after the sample was obtained) the patient was put on high dose acyclovir. While hospitalized the patient was intubated for one month, he was "recently" extubated however the physician indicated that he would probably need to be reintubated. It was noted that the patient might need to have a lung biopsy performed. At the time of the report the patient remained hospitalized. It was noted that the patient's mother was initially HIV negative when screened early in her pregnancy with the patient and "must have been infected late in her pregnancy". It was not until the patient was diagnosed with HIV that she became aware that she was HIV positive, at that time she was tested and the results were positive. The patient's mother never had chickenpox and prior to her diagnosis of HIV was also vaccinated with VARIVAX. The patient's mother did not develop a rash or lesions. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. Two samples were obtained, a cell culture isolate and a swab in viral media. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Laboratory test normal, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter, who, on an unspecified date, was vaccinated with a first dose of GARDASIL.  The first dose was well tolerated.  On 18-MAR-2008 at 11:00 the patient was vaccinated with a second dose of GARDASIL.  On 19-MAR-2008 the patient experienced a seizure at school.  The patient was taken to the hospital from school.  A computed axial tomography (CAT) scan and blood work were performed and were both "good."  The patient was seen by a neurologist who performed a computed axial tomography (CAT) scan and a magnetic resonance image (MRI) and both "turned out fine."  The mother believed that the patient had the seizure due to the vaccination.  It was reported that the patient was very healthy with no problems before the shot and has had no problems since the shot.  The patient recovered on an unspecified date.  Upon internal review the seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter, who, on an unspecified date, was vaccinated with a first dose of GARDASIL.  The first dose was well tolerated.  On 18-MAR-2008 at 11:00 the patient was vaccinated with a second dose of GARDASIL.  On 19-MAR-2008 the patient experienced a seizure at school.  The patient was taken to the hospital from school.  A computed axial tomography (CAT) scan and blood work were performed and were both "good."  The patient was seen by a neurologist who performed a computed axial tomography (CAT) scan and a magnetic resonance image (MRI) and both "turned out fine."  The mother believed that the patient had the seizure due to the vaccination.  It was reported that the patient was very healthy with no problems before the shot and has had no problems since the shot.  The patient recovered on an unspecified date.  Upon internal review the seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who was vaccinated intramuscularly with the third dose of GARDASIL.  Subsequently, five days post vaccination, the patient experienced seizures.  The patient was taken to the emergency room.  It was reported that the patient cannot drive according to state law for a while.  Computed tomography scan and magnetic resonance imaging were performed with no results reported.  It was reported that the patient is fine now.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  The reporter considered seizures to be disabling.  Additional information has been requested.   2/24/09 Received Neuro medical records of 5/28-10/2/2008. FINAL DX: single gen tonic-clonic seizure secondary to Gardasil injection Initial examination & subsequent office visit both revealed neuro exam WNL.  Referred for EEG & MRI brain which were WNL.  No further records available.  6/19/08-ER records received for DOS 05/20/08-presented with after episode of shaking all over, loss of consciousness, unresponsive. Contusion on back due to sliding out of chair.Seizure probably secondary to Drixoral, coffee and cigarette took second dose only 8 hours after first dose. Impression probable drug reaction.  12/31/08 Reviewed GYN office records. FINAL DX: none provided Records reveal patient experienced good health on vax dates.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who was vaccinated intramuscularly with the third dose of GARDASIL.  Subsequently, five days post vaccination, the patient experienced seizures.  The patient was taken to the emergency room.  It was reported that the patient cannot drive according to state law for a while.  Computed tomography scan and magnetic resonance imaging were performed with no results reported.  It was reported that the patient is fine now.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  The reporter considered seizures to be disabling.  Additional information has been requested.   2/24/09 Received Neuro medical records of 5/28-10/2/2008. FINAL DX: single gen tonic-clonic seizure secondary to Gardasil injection Initial examination & subsequent office visit both revealed neuro exam WNL.  Referred for EEG & MRI brain which were WNL.  No further records available.  6/19/08-ER records received for DOS 05/20/08-presented with after episode of shaking all over, loss of consciousness, unresponsive. Contusion on back due to sliding out of chair.Seizure probably secondary to Drixoral, coffee and cigarette took second dose only 8 hours after first dose. Impression probable drug reaction.  12/31/08 Reviewed GYN office records. FINAL DX: none provided Records reveal patient experienced good health on vax dates.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Eye pain, Laboratory test, Lumbar puncture, Oral contraception
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with pseudotumor cerebri and scoliosis and no drug reactions or allergies, who on 15-APR-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included YAZ and acetazolamide (MSD). The patient's mother stated that her daughter has the condition known as pseudotumor cerebri. As a result of this condition, she sometimes has a build up of intercranial and spinal pressure which causes severe headaches and problems with her eyes, such as pain and sensitivity to light. Prior to receiving the vaccine on 15-APR-2008, her last episode of this increase and build up of intercranial and spinal pressure took place in March 2007. On 11-MAY-2008 the patient had another one of these episodes which caused her to have severe headaches, and problems with her eyes such as pain and sensitivity to light. She was hospitalized for one day so that her physician could do a spinal tap. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.7/21/08-records received for 5/16/08-DC DX: Pseudotumor cerebri. Presented to ED with 5 day history of intermittent headache and 1 day of nausea and vomiting. Headache worse at night and associated with phot and phonophobia. Nauseated and vomiting times two.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with pseudotumor cerebri and scoliosis and no drug reactions or allergies, who on 15-APR-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included YAZ and acetazolamide (MSD). The patient's mother stated that her daughter has the condition known as pseudotumor cerebri. As a result of this condition, she sometimes has a build up of intercranial and spinal pressure which causes severe headaches and problems with her eyes, such as pain and sensitivity to light. Prior to receiving the vaccine on 15-APR-2008, her last episode of this increase and build up of intercranial and spinal pressure took place in March 2007. On 11-MAY-2008 the patient had another one of these episodes which caused her to have severe headaches, and problems with her eyes such as pain and sensitivity to light. She was hospitalized for one day so that her physician could do a spinal tap. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.7/21/08-records received for 5/16/08-DC DX: Pseudotumor cerebri. Presented to ED with 5 day history of intermittent headache and 1 day of nausea and vomiting. Headache worse at night and associated with phot and phonophobia. Nauseated and vomiting times two.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received through the Merck Pregnancy Registry from a registered nurse concerning a 21 year old female who on 05-JUL-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of GARDASIL (lot # 654741/1208F). Concomitant therapy included hormonal contraceptives (unspecified), ibuprofen, cough, cold, and flu therapies (unspecified). On an unspecified date the patient took herself off of these modification due to financial difficulty, albuterol, metformin, and WELLBUTRIN. On an unspecified date the patient went to the emergency room (unspecified reason) and found out she was 3 weeks pregnant. She had an OB/GYN appointment on 05-SEP-2007, results not reported. Her last menstrual period was 14-Aug-2007, with an estimated date of delivery was 20-MAY-2008. In September 2007 the patient experienced a miscarriage. Upon internal review the miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant and an other health professional through a Merck pregnancy registry concerning a 16 year old female with depression and a history of "female problems" (unspecified) and miscarriage (prior to 1st GARDASIL), who on 23-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL.  Concomitant therapy included PAXIL.  Subsequently the patient had a positive home HCG test.  The patient was examined by her obstetrician on 29-JAN-2007 who ordered a serum HCG test.  At the time of this report, results of test were pending.  In early 2007, it was reported that at approximately 5-6 weeks gestation the patient had an "early" spontaneous abortion.  On an unspecified date, the patient received the second dose of GARDASIL and subsequently she had another miscarriage (dates not reported).  Subsequently on an unspecified date, the patient received the third dose of GARDASIL and conceived again (date not reported).  The patient's last menstrual period was approximately November 2007 and her estimated delivery date August 2008.  It was reported that the patient was doing well with no adverse events.  The reporter stated that she did not think any of the events were related to GARDASIL.  After internal review, abortion was considered to be an other important medical event.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received through a pregnancy registry from a 21 year old female with penicillin allergy who on 24-APR-2007 was vaccinated with a third dose 0.5 mL of GARDASIL. There was no concomitant medication. On 24-APR-2007 the patient experienced vaccine exposure during pregnancy. The patient's last menstrual period was 24-MAR-2007 and the estimated due date was 29-DEC-2007. A blood test was positive for pregnancy. Follow up information has been received from the nurse who reported that the patient had a spontaneous abortion during her pregnancy. The nurse could not confirm the estimated gestational age at the time of the "miscarriage". Upon internal review, the patient's spontaneous abortion was considered to be an other important medical event. This patient experienced another adverse event reported in WAES# 806USA002235. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Oligohydramnios, Ultrasound antenatal screen abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received for the Merck Pregnancy Registry from a medical assistant concerning an 18 year old female who on 18-JUL-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of GARDASIL (Lot# 657868/0523U). It was reported that the patient experienced no adverse symptoms. On 28-AUG-2007 the patient's urine beta-human chorionic gonadotropin test reported positive for pregnancy. On 28-AUG-2007 the patient had an ultrasound that showed no evidence that the patient was pregnant. At that time, the patient's HCG level was reported to be only 55. It was reported that it was "too soon to see anything." The patient's last menstrual period was 21-JUL-2007, the estimated conception date was 05-AUG-2007, and the estimated date of delivery was 28-APR-2008. The patient did not have any previous pregnancies. At the time of the report, the patient was 10 weeks pregnant. On an unspecified date the patient underwent an ultrasound which revealed oligohydramnios. On 14-APR-2008, the patient delivered a healthy, normal baby boy via caesearean section due to fetal intolerance to labor and nuchal cord at 38 weeks. The birth weight was 5 pounds 11 ounces, and the infant's apgar score was 9/9. The infant was normal with no congenital anomalies. Other medications that were taken during the pregnancy were unspecified prenatal vitamins and PROMETRIUM, 200 mg for low progesterone from 05-SEP-2007 to 05-OCT-2007. At the time of the report, the outcome of the patient was unknown. Upon internal review caesarean section due to fetal intolerance to labor and nuchal cord was considered to be an other important medical event. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 19 year old female with a penicillin allergy who on 12-SEP-2007 was vaccinated with GARDASIL.  On 08-OCT-2007 the patient was found to be pregnant.  The patient plans to terminate the pregnancy for non medical reasons.  The patient's outcome is unknown.  On 20-OCT-2007 the patient had an elective termination 8 7/8 weeks from her last menstrual period.  Upon internal review the elective termination was considered to be an other important medical event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 19 year old female who on 09-JUL-2007 was vaccinated IM (site not reported) with a first 0.5ml dose of the GARDASIL (lot# 657736/0389U).  The patient was not pregnant at the time of the 1st dose of the GARDASIL.  The patient missed her second dose of the GARDASIL.  The nurse contacted the patient in November 2007, to let her know she needed to come in for her second dose but the she never came.  In December 2007 the patient called the office and said she needed to be seen for pregnancy.  Last menstrual period listed in the office chart was "September or October 2007."  On 12-DEC-2007 the patient called the office with bleeding.  On 13-DEC-2008 the patient had a spontaneous abortion.  The nurse reported that the patient has not resumed the series even though they had attempted many times to contact her.  Upon internal review the spontaneous abortion was determined to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse concerning a female patient who in 1985 was vaccinated with MMR II. It was reported that the patient was vaccinated while pregnant and that she later miscarried. The nurse reported that the patient was seen in the office (date unspecified). The outcome was reported as recovered. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Rash, Serum sickness, Urticaria
Clinical narrative: Hives - developed hives, edema to feet, rash, fever, 36 hrs after immunizations. Felt to be consistent with serum sickness. Hospitalized overnight for observation. 7/18/08-records received for DOS 5/30/08-DC DX:allergic urticaria. Presented with hives and joint swelling admitted for monitoring of non-anaphylactic reaction. Developed diffuse rash, lower lip swelling, extremity edema. Fever to 38.2. Diarrhea.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Oedema peripheral, Pain in extremity, Petechiae
Clinical narrative: Leg swelling bilaterally with petechial rash of lower extremities + pain.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fall, Head injury, Immediate post-injection reaction, Laceration, Syncope
Clinical narrative: Syncope ~2 min after injection, fell, struck head (laceration), brief tonic/clonic movement.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Tonic clonic movements
Clinical narrative: Syncope ~2 min after injection, fell, struck head (laceration), brief tonic/clonic movement.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Otitis media
Clinical narrative: Patient had mild diarrhea and temperature of 98.2 F, received vaccine, developed convulsion and temperature of 103 F.  Taken to ER.  Had negative CSF, urine, blood culture.  Continue to have temperature off and on, on 6-3-09 found to have right otitis media, given Augmentin and fever resolved.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Patient had mild diarrhea and temperature of 98.2 F, received vaccine, developed convulsion and temperature of 103 F.  Taken to ER.  Had negative CSF, urine, blood culture.  Continue to have temperature off and on, on 6-3-09 found to have right otitis media, given Augmentin and fever resolved.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R leg, per mom, swollen on 6/6/08 in evening + increased to size of softball 6/7 with redness + then improved.  No fever at that time.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at tetanus injection site started 24 hrs after shot given.  Pain using L arm, aching in L arm and R arm.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: VARIVAX given 5/23/08.  5/24/08 2" red itchy, swelling around injection site.  5/25/08 well circumscribed blotchy red warm tender swelling 6x8cm.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: VARIVAX given 5/23/08.  5/24/08 2" red itchy, swelling around injection site.  5/25/08 well circumscribed blotchy red warm tender swelling 6x8cm.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Bronchitis, Drooling, Enteritis, Otitis media, Pharyngitis
Clinical narrative: On 6-10-08, mother stated child had fever for a week after immunizations on 4-14-08.  4-24-08 labs done.  4-14-08 follow up for otitis media, bronchitis on 3-31-08.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pharyngitis streptococcal, Pneumonia, Pyrexia, Rotavirus infection, Teething
Clinical narrative: On 6-10-08, mother stated child had fever for a week after immunizations on 4-14-08.  4-24-08 labs done.  4-14-08 follow up for otitis media, bronchitis on 3-31-08.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt. developed hives both lower extremities within less than 5 minutes.
Sex: M
Vaccine: ANTH
Symptoms: Local reaction
Clinical narrative: Moderate local reaction.
Age: 1.51
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Rash erythematous, Skin warm
Clinical narrative: 12cm x 9cm erythematous plaque right lateral thigh warm to touch. Non tender. Diagnosed cellulitis; Omincef 250mg/5ml 5ml po gd x 10 days
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, swollen, warm 13x8cm around tetanus injection site.  treated with antibiotics from er visit
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: redness/swelling/knot/warmth at tetanus injection site.  treated with antibiotics.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Hypersomnia, Impaired work ability, Pyrexia
Clinical narrative: went to work after vaccination post injury.  Left early and developed fever to 101 F.  Slept for 32 hours essentially straight through.  Had generalized fatigue and headache.  Missed about one day of work in total as result. Considered ER visit but ended up not going.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: 7x7cm redness/tenderness/swelling with small nodule at tetanus injection site.  pt was in clinic for a follow up on injury and was put on antibiotics.
Age: 24.0
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Incorrect route of drug administration
Clinical narrative: Menactra vaccine was given subcutaneously versus intramuscularly.
Age: 41.0
Sex: M
Vaccine: DTP
Symptoms: Rash, Rash pruritic
Clinical narrative: Report noticed red ithchy rash in palms of both hands and soles of both feet 48 hours after receiving Tdap vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: patient had 2 varicella vaccines in past and presented today with chicken pox after exposure at school
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Swelling around injection site - redness, itching and pain.  Fever - 101 degrees F. - Worst symptoms so far, about 36-48 hours after the injection was administered.  Only one injection was administered.  The form will not let me make corrections on line 13.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Blister, Lip swelling, Pyrexia
Clinical narrative: The same day of the vaccine administration the child presented with fever (unknown temperature)and swollen lips. Next day (06/07/2008) the child presented with blisters in hands and feet and the swollen lip still persisted.
Age: 0.4
Sex: F
Vaccine: 6VAX-F, HIBV, PPV, RVX
Symptoms: Angioedema, Erythema, Eyelid oedema, Hypersensitivity, Pain of skin
Clinical narrative: My daugther received her 4month shots on 6/7/08 at the Health Department.  On Sunday, she developed what we thought was a heat rash, we treated it with a cool bath, kept it dry.  She spent a few days with my mother (was exposed to no new foods, detergents or environments) I picked her up on Wednesday 6/11/08.  Her face was slightly swollen and the "rash" had spread down her neck and covered 85% of her face.  On Saturday 6/14/08, when she woke up her "rash" had dispeared and in its please was a huge red, raise hive that covered most of her face.  Later in the day after spending a lot of itme trying to figure out what may have caused this it dawned on me that his may be a reaction to her shots.  We went straight to the emergency room where they diagnosed where with an allergic reaction and the red swollen skin were called "hives" They gave her 1 dose of prednizone (and sent us home with a script for 2ml's of predizone for 4 days), within hours the redness/hives had drecreased.  During the time prior to the emergency room trip she would scratch uncontrollably and become upset as it would hurt.  This affected her ability to sleep. Her face and eyelids were swollen and pink. She had a glassy look in her eyes. Her sleep was eradic but was never consistant prior to vaccination.
Age: 0.4
Sex: F
Vaccine: 6VAX-F, HIBV, PPV, RVX
Symptoms: Physical examination, Pruritus, Rash, Sleep disorder, Swelling face
Clinical narrative: My daugther received her 4month shots on 6/7/08 at the Health Department.  On Sunday, she developed what we thought was a heat rash, we treated it with a cool bath, kept it dry.  She spent a few days with my mother (was exposed to no new foods, detergents or environments) I picked her up on Wednesday 6/11/08.  Her face was slightly swollen and the "rash" had spread down her neck and covered 85% of her face.  On Saturday 6/14/08, when she woke up her "rash" had dispeared and in its please was a huge red, raise hive that covered most of her face.  Later in the day after spending a lot of itme trying to figure out what may have caused this it dawned on me that his may be a reaction to her shots.  We went straight to the emergency room where they diagnosed where with an allergic reaction and the red swollen skin were called "hives" They gave her 1 dose of prednizone (and sent us home with a script for 2ml's of predizone for 4 days), within hours the redness/hives had drecreased.  During the time prior to the emergency room trip she would scratch uncontrollably and become upset as it would hurt.  This affected her ability to sleep. Her face and eyelids were swollen and pink. She had a glassy look in her eyes. Her sleep was eradic but was never consistant prior to vaccination.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Rash, Vaccinia
Clinical narrative: Pt complained of tightness in chest, spots/rash on extremities.  Dr at Medical Center reported general vaccinia that will be self limiting.  Dr provided info from CDC.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Fatigue, Flushing, Headache, Hypersomnia
Clinical narrative: 06/11/08 4:00PM home from school. "Flushed", c/o fatigue and went to bed early - reported by Mother.  06/12/08 over slept, c/o headach, fatigue. No fever and appeared lethagic.  Unusual behavior.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, Physical examination normal
Clinical narrative: 06/11/08 4:00PM home from school. "Flushed", c/o fatigue and went to bed early - reported by Mother.  06/12/08 over slept, c/o headach, fatigue. No fever and appeared lethagic.  Unusual behavior.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Asthenia, Febrile convulsion, High-pitched crying, Hypotonia, Pyrexia
Clinical narrative: Within hours of vaccination patient developed a fever of 105 degrees, high pitched screaming, limp and weak body and a febrile seizure.  When we called Dr. she told us it was to be expected and that her illness was not related to the vaccination.  8/19/2008 Neurodevelopmental assessment received dated 8/15/207 with Assessment:  Sensory integration disorder.  Pragmatic language disorder. Speech delay impairment.  Idiosyncratic language.  Feeding dysfunction.  Repetitive behaviors.  Hyperactivity.  Insomnia and sleep disturbance. Discussed causes and tx of Autism. Infant developed high fevers, lethargy and high-pitched crying following immunzations and were stopped at 6-9 months. Met developmental milestones until ~11-13 months. Had several words but stopped talking until 22 months. Currently with  feeding issues, sensory issues, language delay and abnormalities, social interaction problems, repetitive behaviors and sleep problems.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Screaming, Wrong drug administered
Clinical narrative: Within hours of vaccination patient developed a fever of 105 degrees, high pitched screaming, limp and weak body and a febrile seizure.  When we called Dr. she told us it was to be expected and that her illness was not related to the vaccination.  8/19/2008 Neurodevelopmental assessment received dated 8/15/207 with Assessment:  Sensory integration disorder.  Pragmatic language disorder. Speech delay impairment.  Idiosyncratic language.  Feeding dysfunction.  Repetitive behaviors.  Hyperactivity.  Insomnia and sleep disturbance. Discussed causes and tx of Autism. Infant developed high fevers, lethargy and high-pitched crying following immunzations and were stopped at 6-9 months. Met developmental milestones until ~11-13 months. Had several words but stopped talking until 22 months. Currently with  feeding issues, sensory issues, language delay and abnormalities, social interaction problems, repetitive behaviors and sleep problems.
Age: 44.0
Sex: F
Vaccine: DTP
Symptoms: Muscular weakness, Neck pain, Pain in extremity, Physical examination abnormal
Clinical narrative: Pt describes neck pain starting 3 days after injection which radiates to Left arm and has cause weakness. Has done massage therapy and seen nurtritionist for event and has not helped.  Injection was given 10/18/07 in the right deltoid.Did not report fever or any other symptoms.
Age: 47.0
Sex: F
Vaccine: DT, PPV
Symptoms: Chest pain, Cough, Electrocardiogram normal, Hypokinesia, Increased upper airway secretion
Clinical narrative: After receiving shots started experiencing chest pain that was constant all day, malaise, cough with clear phlegm and pain at shot sites with left > right and limiting range of motion, because it persisted and patient was diabetic she was sent to the ER on 6/4/08
Age: 47.0
Sex: F
Vaccine: DT, PPV
Symptoms: Injection site pain, Malaise, Sinus rhythm
Clinical narrative: After receiving shots started experiencing chest pain that was constant all day, malaise, cough with clear phlegm and pain at shot sites with left > right and limiting range of motion, because it persisted and patient was diabetic she was sent to the ER on 6/4/08
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Pruritus generalised, Rash generalised, Wheezing
Clinical narrative: Pt received 1st dose of anthrax vaccine on 6/11/08 and reported to the ER on the morning of 6/15/08. She was complaining of itching and red bumbs all her body. States she had wheezing and shortness of breath the morning after the injection and the rash is getting worse. Treated with benedryl and ordered to follow up with her primary care clinic.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Severe crying for 6 hours on day of immunizations.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Employee given  Hep B vaccine #3 on 3/17/2008.I saw the employee in the hall late in the third week of May. Employee was complaining of continued pain at the injection site in her arm.I examined her arm, there was no redness, no lumps and the site was cool to touch. Employee advised to see her physician for evaluation. Employee unable to remember if she had strained or in any other way may have hurt the arm
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Aortic embolus, Deep vein thrombosis, Dyspnoea, Pulmonary artery dilatation, Pulmonary embolism
Clinical narrative: Bilateral Pulmonary Embolism (Saddle Embolus), Shortness of Breath, Deep Vein Thrombosis - Left Leg.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Pulmonary hypertension
Clinical narrative: Bilateral Pulmonary Embolism (Saddle Embolus), Shortness of Breath, Deep Vein Thrombosis - Left Leg.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: At midnight on the day she received the vaccine, she experienced a seizure and was taken by ambulance to the ED.  She was then stable and was discharged home.  She had a second seizure at 6am and was again taken by ambulance to the ED.  She was then kept for 48 hr. observation. 7/2/08-records received for DOS 6/10-6/11/08-DC DX: Seizures, new onset. Status post Gardasil vaccination. Neurologically intact. Evening of vaccination started seeing bright lights, generalized tonic-clonic seizure, seen in ED without incident. Following morning had second seizure, generalized tonic-clonic seizure with eyes rolled up.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electrocardiogram, Nuclear magnetic resonance imaging
Clinical narrative: At midnight on the day she received the vaccine, she experienced a seizure and was taken by ambulance to the ED.  She was then stable and was discharged home.  She had a second seizure at 6am and was again taken by ambulance to the ED.  She was then kept for 48 hr. observation. 7/2/08-records received for DOS 6/10-6/11/08-DC DX: Seizures, new onset. Status post Gardasil vaccination. Neurologically intact. Evening of vaccination started seeing bright lights, generalized tonic-clonic seizure, seen in ED without incident. Following morning had second seizure, generalized tonic-clonic seizure with eyes rolled up.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Induration and swelling R thigh where received Hib and Prevnar 2 mo immunizations
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Cold sweat, Dizziness, Dyspnoea, Erythema
Clinical narrative: Approximately 5 - 10 minutes after receiving vaccine we were leaving and my son fell into the door frame and then in to me. I lowered him to the floor. He complained of feeling dizzy, nauseated, not being able to see, hard to breathe, and was sweating - although complaining of freezing. His skin was clammy to touch and warm. He never lost consciousness. Clinic staff checked his pulse and put a cool cloth on his head & neck. They told me he "passed out" due to anxiety - although he was NEVER anxious about the vaccine & never passed out completely. After 10 more minutes, I was told to take him home & let him rest. The next day, his left arm from shoulder to elbow was very swollen, dark red, itching, & tender to touch. I gave him benadryl every 6 hours & reported this to his physician. The physician said it sounded like an allergic reaction & continue with benadryl unless he has difficulty breathing & if that occurs, to take him to the ER. The arm remained swollen, red, tender, & itching for 2 more days. Benadryl was given during this time. Time of events were from 06/11/08 until 06/15/08.