chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TD
Symptoms: Arthralgia, Erythema, Fatigue, Joint swelling, Pain in extremity
Clinical narrative: During an annual OBGYN appointment I was strongly urged by the nurse to have a tetanus shot since I couldn't recall the last time I had received one.  She gave me a bunch of horror stories of what could happen.  I then mentioned that my children's pediatrician had said it was a good idea to get Hep A & B vaccines.  They said they could do it all at the same time. The following morning when I woke up I thought that I was getting the flu because I was tired and my joints were bothering me.  As the days went on, I didn't get sick but my joints became more and more painful, even to sleep.  The following Sunday (February 24th) morning, I could barely get out of bed; my boyfriend had to dress me. I phoned my Dr. and was told to go to urgent care right away. At urgent care, the Dr. ran blood work, but said that he thought that I was having a severe reaction to the vaccine.  He told me to take Advil for the pain and the pain should go away soon.  No one ever called me back regarding the results of the blood work. I lived on Advil and Aleve for the next week or so in order to function. I noticed some red spots on my legs.  I thought they were spider bites, but I kept getting more.  The didn't itch, they hurt.  Eventually I had about 15 or 20 on my legs. On Thursday, March 6th I woke up with swollen joints and my hands so painful that I couldn't hold onto anything well.  I made an appointment with my family practitioner.  He looked at the spots and saw my joints.  He ordered more blood work and put me on a 6 day regimen of steroids.  He also prescribed some Vicodine so I could sleep. By the 3rd day of the steroids I felt much better and by the end of the dosing I was back to normal-I thought. Then on the morning of March 13, I woke up in pain again.  Same as before, extreme joint pain.  Have been to rheumatologist and ran several more test.  Pain is only tolerable when taking steroids and anti-inflammatories.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TD
Symptoms: Sleep disorder
Clinical narrative: During an annual OBGYN appointment I was strongly urged by the nurse to have a tetanus shot since I couldn't recall the last time I had received one.  She gave me a bunch of horror stories of what could happen.  I then mentioned that my children's pediatrician had said it was a good idea to get Hep A & B vaccines.  They said they could do it all at the same time. The following morning when I woke up I thought that I was getting the flu because I was tired and my joints were bothering me.  As the days went on, I didn't get sick but my joints became more and more painful, even to sleep.  The following Sunday (February 24th) morning, I could barely get out of bed; my boyfriend had to dress me. I phoned my Dr. and was told to go to urgent care right away. At urgent care, the Dr. ran blood work, but said that he thought that I was having a severe reaction to the vaccine.  He told me to take Advil for the pain and the pain should go away soon.  No one ever called me back regarding the results of the blood work. I lived on Advil and Aleve for the next week or so in order to function. I noticed some red spots on my legs.  I thought they were spider bites, but I kept getting more.  The didn't itch, they hurt.  Eventually I had about 15 or 20 on my legs. On Thursday, March 6th I woke up with swollen joints and my hands so painful that I couldn't hold onto anything well.  I made an appointment with my family practitioner.  He looked at the spots and saw my joints.  He ordered more blood work and put me on a 6 day regimen of steroids.  He also prescribed some Vicodine so I could sleep. By the 3rd day of the steroids I felt much better and by the end of the dosing I was back to normal-I thought. Then on the morning of March 13, I woke up in pain again.  Same as before, extreme joint pain.  Have been to rheumatologist and ran several more test.  Pain is only tolerable when taking steroids and anti-inflammatories.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Back pain, Hallucination, Headache, Hyperaesthesia, Nausea
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal tenderness, Abnormal dreams, Back pain, Blood test normal, Body temperature increased
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dyspnoea, Haematochezia, Hallucination, Headache, Lumbar puncture
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nausea, Neurological examination abnormal, Occult blood positive, Physical examination abnormal, Pyrexia
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Scan, Vasculitis, Visual disturbance
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Activities of daily living impaired, Asthenia, Back pain, C-reactive protein increased, Computerised tomogram normal
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gait disturbance, Headache, Lumbar puncture, Nausea, Neurological examination abnormal
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Physical examination normal, Pyrexia, Red blood cell sedimentation rate normal, Vaccination complication
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vasculitis
Clinical narrative: Information has been received from a physician and a physician's assistant concerning a 17 year old female with attention deficient disorder, and a family history of Crohn's disease, and celiac disease (mother), who on 30-AUG-2007 was vaccinated with a first dose of Gardasil.  On 30-OCT-2007 the patient was vaccinated with a second dose of Gardasil.  The first two doses were well tolerated and without incident.  On 04-MAR-2008 at approximately 16:30 the patient was vaccinated with a third dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently, the patient experienced hallucinations, visual disturbance, and nausea.  On 05-MAR-2008 at approximately 01:30 the patient experienced awoke from a bizarre dream with a fever of 102F, severe low back pain, and some shortness of breath.  The patient has been seen in the emergency room on four occasions in one week, mainly for intractable low back pain.  The patient was treated with OXYCONTIN and PERCOCET.  The shortness of breath resolved, there was no clear accounting of the fever.  The patient also experienced a headache.  The patient had an extensive work-up including blood tests, multiple scans, and a lumbar puncture.  It was reported that the headache predated the lumbar puncture, though it was hard to distinguish from a spinal headache according to the physician.  It was reported that none of the tests have been revealing.  On 12-MAR-2008 the patient's physical exam was notable for some abdominal tenderness, meningeal signs, and heme positive stool.  The physician believed the patient to have vasculitis and initiated a high dose of steroids, (prednisone, 60mg).  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Coma
Clinical narrative: Information has been received from a physician concerning a patient's friend (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient went into a coma.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Upon internal review the coma was considered to be an other important medical event.  Additional information is not available.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Headache, Nausea, Visual disturbance
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with no medical history and no drug allergies, who on 28-JAN-2008 was vaccinated with a first dose of Gardasil along with VARIVAX (MSD), hepatitis A virus vaccine (unspecified) (manufacturer unknown), meningococcal vaccine (unspecified), and DTaP.  Other concomitant therapy included quetiapine funarate (SEROQUEL), oxcarbazepine (TRILEPTAL), and unspecified growth hormone.  On 05-FEB-2008, eight days later, the patient experienced nausea, dizziness, headaches and changes in vision.  The patient was taken to the emergency room because of the dizziness but was not admitted to the hospital.  No laboratory diagnostics were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Upon internal review changes in vision was considered to be an other important medical event.  Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Meningitis aseptic, Nausea, Vomiting
Clinical narrative: Information has been received from an investigator concerning a 67 year old male with diabetes, potassium replacement, gastrooesophageal reflux disease, depression, oedema, hypercholesterolaemia, diverticulitis and osteoarthritis who entered a study.  The patient was vaccinated with blinded therapy on 07-FEB-2008.  Concomitant therapy included GLUCOPHAGE XR, sitagliptin phosphate (MSD), K-DUR, NEXIUM, PROZAC, HCTZ/triamterene and ezetimibe (+) simvastatin (MSD).  On 15-FEB-2008 the patient experienced severe headaches and severe nausea and vomiting and was hospitalized.  The patient was diagnosed with aseptic meningitis.  He was discharged from the hospital on 18-FEB-2008.  The patient's aseptic meningitis persisted, with the patient still experiencing moderate headaches and nausea approx. 3-4 times per week.  The reporting investigator felt that the aseptic meningitis was possibly related to study therapy.  The record for this patient was unblinded on 18-MAR-2008.  The patient was treated with Zostavax (Oka/Merck) 0.65 ml.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a 60 year old female licensed visiting nurse with a history of a cold in January 2008 and chickenpox (otherwise reported to be a normal healthy person with no recent stress or immunosuppression) who on unspecified dates administered Zostavax (Oka/Merck) to many patients. The patient never received Zostavax (Oka/Merck). It was noted that the patient has administered the vaccine to at least 10 patients in the last month. Subsequently the patient developed shingles. Due to her symptoms she has been home from work. The shingles has affected the left side of the patient's face and eye. The patient was seen by a physician. The patient was placed on ZOVIRAX, prednisone and VICODIN. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. The patient considered her events to be disabling.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Ataxia, Ganglioneuroblastoma, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC in the right thigh with a first 0.5 mL dose of Varivax (Oka/Merck) (lot number: 658523/1253U).  Suspect therapy included a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot number: 654687/1025F) (HSA) in the left thigh.  The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia.  The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis.  Lab diagnostic studies performed included an MRI that was negative and a spinal tap that showed a count of 10 white blood cells.  Other unspecified lab studies were performed.  No additional information was available.  Unspecified medical attention was sought.  The outcome was reported as recovering.  There was no product quality complaint.  Follow-up information received indicated that the patient became "shaky" about 4-6 weeks after immunization.  She was noted to have ataxia on 26-JAN-2008.  However, subsequent work-up revealed a ganglioneuroblastoma in her chest.  The patient was hospitalized for 4 days and required medical/surgical intervention.  The ataxia is therefore unrelated to vaccines.  Relevant diagnostic tests and laboratory data included an MRI of the chest that showed a ganglioneuroblastoma which was the cause of her ataxia.  There were no adverse events following prior vaccination.  There was no illness at the time of vaccination.  The outcome is reported as not recovered.  the ganglioneuroblastoma and ataxia were considered an other important medical events.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC in the right thigh with a first 0.5 mL dose of Varivax (Oka/Merck) (lot number: 658523/1253U).  Suspect therapy included a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot number: 654687/1025F) (HSA) in the left thigh.  The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia.  The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis.  Lab diagnostic studies performed included an MRI that was negative and a spinal tap that showed a count of 10 white blood cells.  Other unspecified lab studies were performed.  No additional information was available.  Unspecified medical attention was sought.  The outcome was reported as recovering.  There was no product quality complaint.  Follow-up information received indicated that the patient became "shaky" about 4-6 weeks after immunization.  She was noted to have ataxia on 26-JAN-2008.  However, subsequent work-up revealed a ganglioneuroblastoma in her chest.  The patient was hospitalized for 4 days and required medical/surgical intervention.  The ataxia is therefore unrelated to vaccines.  Relevant diagnostic tests and laboratory data included an MRI of the chest that showed a ganglioneuroblastoma which was the cause of her ataxia.  There were no adverse events following prior vaccination.  There was no illness at the time of vaccination.  The outcome is reported as not recovered.  the ganglioneuroblastoma and ataxia were considered an other important medical events.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Ataxia, CSF white blood cell count, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC in the right thigh with a first 0.5 mL dose of Varivax (Oka/Merck) (lot number: 658523/1253U).  Suspect therapy included a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot number: 654687/1025F) (HSA) in the left thigh.  The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia.  The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis.  Lab diagnostic studies performed included an MRI that was negative and a spinal tap that showed a count of 10 white blood cells.  Other unspecified lab studies were performed.  No additional information was available.  Unspecified medical attention was sought.  The outcome was reported as recovering.  There was no product quality complaint.  Follow-up information received indicated that the patient became "shaky" about 4-6 weeks after immunization.  She was noted to have ataxia on 26-JAN-2008.  However, subsequent work-up revealed a ganglioneuroblastoma in her chest.  The patient was hospitalized for 4 days and required medical/surgical intervention.  The ataxia is therefore unrelated to vaccines.  Relevant diagnostic tests and laboratory data included an MRI of the chest that showed a ganglioneuroblastoma which was the cause of her ataxia.  There were no adverse events following prior vaccination.  There was no illness at the time of vaccination.  The outcome is reported as not recovered.  the ganglioneuroblastoma and ataxia were considered an other important medical events.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Choking, Erythema, Throat irritation, Urticaria
Clinical narrative: Information has been received from a physician concerning an 8 year old male patient who, on an unspecified date, was vaccinated with the second dose of VARIVAX (lot number not provided).  On 11-MAR-2008, the patient immediately developed an itchy feeling in his throat and began choking.  He also broke out in hives and his face and ears became "fiery" red.  This was determined to be an anaphylactic experience.  The patient was treated with an injection of Epi Pen.  Subsequently, on 11-MAR-2008, the patient recovered from his anaphylactic experience.  It was unknown as to whether or not this patient had the same experience with the first dose of the vaccine.  Upon internal review, it was determined that the events were considered serious as other important medical event.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Constipation, Diarrhoea, Hypoxia, Lethargy, Pneumonia
Clinical narrative: Information has been received from a physician for the patient's physician concerning a 2 month old female who on 06-MAR-2008 was vaccinated PO with a dose of Rotateq (not lot# available).  On 07-MAR-2008 the patient was brought to the physician's office where the patient "appeared lethargic, with diarrhea and was vomiting."  "The baby looked like she was dying."  The physician immediately contacted the emergency room and the patient was sent to the ER with a fever and was lethargic on that same day.  The patient appeared to be in "an almost shock state."  The patient was subsequently hospitalized (length of hospitalization unknown).  The vomiting and diarrhea reported to the physician were inaccurate since the ER intake had constipation noted.  The patient was diagnosed with pneumonia, hypoxemia and infectious shock.  The outcome was unknown at the time of this report.  The reporting physician did not think it was related to Rotateq.  There was no product quality complaint.  The events were considered to be immediately life-threatening by the physician.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Pyrexia, Shock, Vomiting
Clinical narrative: Information has been received from a physician for the patient's physician concerning a 2 month old female who on 06-MAR-2008 was vaccinated PO with a dose of Rotateq (not lot# available).  On 07-MAR-2008 the patient was brought to the physician's office where the patient "appeared lethargic, with diarrhea and was vomiting."  "The baby looked like she was dying."  The physician immediately contacted the emergency room and the patient was sent to the ER with a fever and was lethargic on that same day.  The patient appeared to be in "an almost shock state."  The patient was subsequently hospitalized (length of hospitalization unknown).  The vomiting and diarrhea reported to the physician were inaccurate since the ER intake had constipation noted.  The patient was diagnosed with pneumonia, hypoxemia and infectious shock.  The outcome was unknown at the time of this report.  The reporting physician did not think it was related to Rotateq.  There was no product quality complaint.  The events were considered to be immediately life-threatening by the physician.  Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient received DTaP, MMR and VARIVAX flu on 03/07/08 and had a febrile seizure 3/16/08.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Child had received FLUZONE last year so one dose of vaccine was required for this year.  Received .5cc dose instead of correct dose of .25cc.  No adverse reaction reported.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Developed stomach ache approx 1-2 hrs after injection. Symptoms progressively worsened to include headache, nausea, tiredness, pain at injection site. Most severe symptoms was headache.
Age: 6.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Incorrect route of drug administration, No adverse reaction, Wrong drug administered
Clinical narrative: DILUTED VARICELLA WITH BOOSTRIX - ADMINISTERED TO PATIENT SUBCUTANEOUSLY; NO REACTION OR ADVERSE EVENT NOTED; PARENT INFORMED OF ERROR. REVIEWED POSSIBLE REACTIONS TO IMMUNES AGAIN.
Age: 74.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Contusion, Erythema, Feeling hot, Inflammation
Clinical narrative: Client returned to this clinic on 3-18-08.  Client presents with L. mid-upper deltoid with yellowish-purple bruised area approximately 10-15 mm.  Below bruised area, primary area approximately 4.5 inches diameter from medial to lateral aspect was red and inflamed.  (This does not extend to the underside of the arm.)  Secondary reddened area noted, (triceps area) below extending approximately 2.5 inches in diameter.  (See picture and additional documentation attached.)  Lower one third of arm (triceps area) is red and inflamed.  Rt Lower triceps area observed with pinhole needle mark by nurse.  No obvious reaction present at this site.  Client was extremely irritated and uncooperative due to previous discussions with other staff members in another clinical area.  This nurse was not able to converse with or complete an accurate physical assessment of the deltoid area.  The client and interpreter walked out of this clinic.  Nurse did inform both client and interpreter to seek follow up with their primary provider.  Nurse indicated that the deltoid area was firm and warm to touch.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Erythema, Irritability, Pruritus, Pyrexia
Clinical narrative: Fever, severe rash over entire body - red, confluent papules and raised urticarial lesions; pruritis, irritability.  Her twin sister had identical shots and identical reaction.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Fever, severe rash over entire body - red, confluent papules and raised urticarial lesions; pruritis, irritability.  Her twin sister had identical shots and identical reaction.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Irritability, Pruritus, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Fever, severe diffuse full-body rash with red confluent papules and raised urticarial lesions, pruritis, irritability. Her twin sister had same shots and identical reaction.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Fever, severe diffuse full-body rash with red confluent papules and raised urticarial lesions, pruritis, irritability. Her twin sister had same shots and identical reaction.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fungal infection, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Received Tdap vaccine 2/18/08. on 2/22/08 noticed tenderness and swelling in (L) axilla area. PCP saw me the same day 2/22/08. Sx checked to warmth site to see if would resolve on its own. PCP called 2/25/08 due to more swelling in (L) axilla area. PCP started me on antibiotics for 7 days. Tenderness at site better, but swelling persists. After taking antibiotics I had a yeast infection which was treated with Monostat. On 3/19/08 tingling noticed on fingers (R). 3/21/08 noticed swelling, pain and tight feeling in (R) knee. Pain was in the back of knee down into top of calf muscle and Rt lateral area of knee cap down onto shin.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Paraesthesia, Tenderness
Clinical narrative: Received Tdap vaccine 2/18/08. on 2/22/08 noticed tenderness and swelling in (L) axilla area. PCP saw me the same day 2/22/08. Sx checked to warmth site to see if would resolve on its own. PCP called 2/25/08 due to more swelling in (L) axilla area. PCP started me on antibiotics for 7 days. Tenderness at site better, but swelling persists. After taking antibiotics I had a yeast infection which was treated with Monostat. On 3/19/08 tingling noticed on fingers (R). 3/21/08 noticed swelling, pain and tight feeling in (R) knee. Pain was in the back of knee down into top of calf muscle and Rt lateral area of knee cap down onto shin.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Clostridium difficile toxin test, Culture stool negative, Diarrhoea, Rotavirus test negative
Clinical narrative: Began yellow runny stools after dose #3 ROTATEQ 11/29/07 given Amoxicillin, 12/6/07 intussusception bowel reduced in ED.  4/8/08 Reviewed hospital medical records of 12/11/2007. FINAL DX: Intussusception, enema reduced Records reveal patient experienced intermittent screaming, inconsolable crying, restless, vomiting, bloody/mucousy stool, diet refusal, red blotchy rash over face & arms x 1 day.  Had recent watery diarrhea & had been on antibiotics recently for sinus infection.  Formula changed to soy recently.  Peds surgery consult done.  Admitted overnight s/p IS reduction.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, DNA antibody, Full blood count
Clinical narrative: (1) Raynaud Phenomenon left hand on 3-17-08 (2) Pain (L) elbow- 3-15-08 on 3-16-08 (3) Pain (L) shoulder 3-20-08
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Musculoskeletal pain, Raynaud's phenomenon, Red blood cell sedimentation rate, Rheumatoid factor, Urine analysis
Clinical narrative: (1) Raynaud Phenomenon left hand on 3-17-08 (2) Pain (L) elbow- 3-15-08 on 3-16-08 (3) Pain (L) shoulder 3-20-08
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: X-ray limb
Clinical narrative: (1) Raynaud Phenomenon left hand on 3-17-08 (2) Pain (L) elbow- 3-15-08 on 3-16-08 (3) Pain (L) shoulder 3-20-08
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizzy constantly, feverish.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Balance disorder, Dizziness, Pyrexia
Clinical narrative: On evening of immunization developed fever of 104.3, seemed, dizzy and off balance. Resolved by 3-10-08
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Bronchospasm, Chest X-ray, Pain, Wheezing
Clinical narrative: Body aches - Wheezing; Bronchispasm
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Noticed redness and swelling at injection site approximately 18 hours later
Age: 4.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site scab, Injection site warmth
Clinical narrative: (L) arm with 14 x 9 cm erythema and approx 11 x 8 induration around central scab. (+) warmth. (1) Cold compresses and KEFLEX 250/5 1 tsp TID x 10 days (2) Tylenol/Motrin prn pain/fever (3) Benadryl prn for itching (4) if fevers persist > f/up 4 days or worsening rash
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Mother called clinic 031208 reported child developed a rash on 031008, continued 031108, resolving 031208.  She stated "rash on forehead, both face cheeks, chest, stomach.  No elevations or discoloration, complained of itchy feeling.  No other complaints."  Child saw PSP, he did not feel rash was due to vaccines.  Reported above to doctors.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, X-ray limb
Clinical narrative: Approximately 3:00 PM on the date of immunization, pt called SHC to report he was experiencing a local reaction at immunization site. Patient stated area is painful, red and warm with a raised patch approximately 2" inch diameter. "Advised cold compresses, anti-inflammatories if not counter indicated and to consult his PCP. Patient contacted this office about 1 week later stating problem was better but not resolved. On 3/12/08 patient reported problem continues, had X-Ray of left shoulder on this day.
Age: 4.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Nuclear magnetic resonance imaging, Viral infection, Walking disability
Clinical narrative: Mom brought child into clinic today 3/20/08 for PPD reading and stated since 3/18/08 has not been walking. No redness or swelling at injection site (L) thigh. Seen, by provider diag with viral syndrome. Rxd ice to area, a MRI
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Large swelling to left arm, measuring 3"x1 1/2".  24 hour injection.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was inadvertently given DTaP instead of TD. No reaction was reported.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR
Symptoms: Audiogram, Convulsion, Pyrexia, Unresponsive to stimuli, White blood cell count
Clinical narrative: - Fever, prob seizure 8/17/1995 8/17/1995; seen in ER (ambulance) dxom - Lack of understanding or responsiveness to oral language
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Client inadvertently given adult dose Hep A vaccine.  Mother notified - will follow-up in one week.  Corrective action taken: adult vials physically separated from pediatric vials.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram, Hypoaesthesia, Nuclear magnetic resonance imaging, Pain, Paralysis
Clinical narrative: PAIN, WEAKNESS, NUMBNESS & TINGLING FROM WAIST DOWN TO LOWER EXTREMITIES. PROGRESSED TO PARALYSIS FOR 48 HOURS.  GRADUALLY REGAINED NORMAL FEELING.  6/10/08 Received d/c summary from hospital. FINAL DX: lower extremity pain/weakness; inflammation left shoulder injection site. Record reveals patient improved significantly by day after admission & was able to ambulate w/o difficulty & only slight thigh discomfort.  Patient was d/c to home with f/u by neuro./ss  4/11/08 Reviewed hospital medical records of 2/12-2/14/2008. FINAL DX: none stated.  No d/c summary available.  Admit dx: possible GBS. Records reveal patient experienced pain in bilateral thighs, difficulty walking, extreme fatigue, paresthesias of LEs & weakness starting approx 3-4 hours after vaccination.  Seen at Urgent Care facility & referred to hospital.  Then admitted to ICU until able to be transferred to higher level of care.  Neuro exam on admit WNL w/good reflexes & sensation.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Cyanosis, Feeling hot, Nausea, Pain
Clinical narrative: 3 hours after receipt of AVA#1 pt pt had nausea, general body aches and he felt feverish. Temp not taken. Symptoms worsened over next 24 hours. Pt did not eat, drink and take anything for sx. The next day pt also noted cyanotic hands and lips. Within 24 hours all symptoms subsided.
Age: 36.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Received anthrax annual booster in left arm. The next day the pt noticed redness and induration at the site which got worse until 3/17/08 when he presented with 11cm of erythema and 7cm of induration. Tx with topical steroids, warm compresses and Tylenol (pt unable to take NSAIDS). By 3/24/08 only had small amount of redness and induration at the injection site.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling abnormal, Feeling hot, Nausea, Rash macular
Clinical narrative: 3/19/08 received IZ around 10:00  Per mother, within 1/2 hour developed blotchy rash; nauseated; felt bad; hot feverish; no SOB;. This am 3/20/08 went to school; felt better today.
Age: 1.11
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt received immunizations on 03-18-2008. 3-4 hrs later pt developed hives on trunk and limbs.