chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: DTAP, HEPA, MNQ
Symptoms: Arthralgia, Chills, Dizziness, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Fever, chills, posterior neck soreness, arm soreness (at injection site), vomiting, sore throat, joint pains, dizziness, possible mild confusion.
Age: 8.0
Sex: M
Vaccine: DTAP, HEPA, MNQ
Symptoms: Neck pain, Pharyngolaryngeal pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, posterior neck soreness, arm soreness (at injection site), vomiting, sore throat, joint pains, dizziness, possible mild confusion.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Head injury, Musculoskeletal stiffness
Clinical narrative: Within 5 minutes after HPV administration, patient was sitting up on bed, put her head in her lap then jerked backward suddenly. Hit head on wall and was stiff all over body for about 5 seconds. Immediately awake, alert. No other problems.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Blood glucose normal, Body temperature increased, Crying, Haemoglobin normal
Clinical narrative: temp 101.1; HR - 78; BP 120/74; feeling weak; fever; personality change - weepy; moody
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Mood altered, Personality change, Platelet count normal, Pyrexia, White blood cell count normal
Clinical narrative: temp 101.1; HR - 78; BP 120/74; feeling weak; fever; personality change - weepy; moody
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity, Hypoaesthesia, Musculoskeletal stiffness, Oedema peripheral, Pain
Clinical narrative: Td was given in her right arm. Patient came back 8/14/08 having allergic reaction, swelling arm, itching, stiffness, pain, tingling and numbness.
Sex: F
Vaccine: TD
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Td was given in her right arm. Patient came back 8/14/08 having allergic reaction, swelling arm, itching, stiffness, pain, tingling and numbness.
Age: 5.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 8.12.08 2pm; VZV, MMR, HepA shots administered; 8.13.00 10am; mom called office to report hives had approved on face last night (8.12.00). Instructed to give Benadryl and call back if ant increased symptoms.
Age: 2.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Pyrexia, Rash maculo-papular, White blood cell count
Clinical narrative: 2 year old female started running fever on 13th (T 103-104)& continued fever thru 7/16/08. Rechecked & WBC 1.6. Rechecked WBC on 7/18-WBC 2.8. Returned 7/25/08 with maculopapular skin lesion that spread over body.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Erythema, Mass
Clinical narrative: Mom called at 12:15 PM and said area is red and had a 1 1/2 inch diameter size knot. Mom will do cool compresses and MOTRIN for pain.
Age: 15.0
Sex: M
Vaccine: DT
Symptoms: Culture positive, Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: Increased pain in right shoulder 8/8/08. Rash in same area 8/09/08. Seen in clinic 8/10/08, rash in C5 distribution. Viral CX done. Got routine booster DT lot # U22940A 08/01/08.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox outbreak 8/13/08
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Gait disturbance, Induration, Pain, Skin warm
Clinical narrative: Red, swollen, warm, hard, painful, limping. Hot pack, augmentin
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Red, swollen, warm, hard, painful, limping. Hot pack, augmentin
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Within 2-3 minutes of receiving vaccine c/o pain at site radiating into upper arm and back of neck. Mod/sev lasted approx. 10 min  and stopped.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: right, posterior thigh erythema/induration
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Tdap administered prior to age 11 yo.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Anxiety, Immediate post-injection reaction, Injection site erythema, Rash macular
Clinical narrative: A 13 year old girl came in for immunization update, accompanied by her mother. The RN administered four vaccines, beginning with Hep A in the right deltoid. By the time the 4th vaccine was administered in the left arm, the patient's chest had developed red blotches, and it appeared to be spreading up her neck. Red blotches were noted over her right shoulder also. There was only minor erythema around the other vaccine sites. Patient denied itching, difficultly breathing, difficulty swallowing. The physician was called in to examine her and he prescribed Benadryl 50mg, po (the patient had expressed and exhibited extreme anxiety over "getting shots"). Benadryl 50 mg po was given at 11:00 am. The red blotches on her chest and neck resolved over the next 20 minutes. Blotchy erythema remained present, though diminished, surrounding the bandaid over the Hep A site. Patient's vital signs were WNL, and she was allowed to leave with her mother at 11:30 am. Her mother was given a prescription for Benadryl 25 mg to be given every 6 hours over the next 2 days, and advised to call 911 for any difficulty breathing or swallowing. Per phone call to the patient's mother three hours later, the redness had completely disappeared, and she reported the child was doing well.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Alopecia on left side noticed early December 2007, probably started November 2007. Increased alopecia several months. Alopecia on right side noticed first part of July, 2008. Alopecia increasing. I've now lost 3/4 of my scalp hair and it continues to shed.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Intense pain at injection site and entire left arm which became stiff and painful to move. Exercise exacerbated symptoms, which last on and off six months. Symptoms would onset suddenly and last a few hours. Patient never sought treatment.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Crying, Inappropriate affect, Pyrexia
Clinical narrative: 8/11/2008-14:00 Given MOTRIN (100/5) 1 1/2 tsp. prior to VARIVAX. Parents report "high" fever 1 1/2 hour after vaccine and whimpers and hysterical laugh. 11 PM parents gave MOTRIN (100/5) one tsp. 12 AM 21/2-3 min febrile seizure and again 03:30.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Blood pressure, Disturbance in attention
Clinical narrative: I have been diagnosed with Hep C in 2002 and for years I had not had any problems conducting normal routines in life and my health, energy, well-being, etc. was never a problem to me. I was put on Prednisone by nurse practicing physician to alleviate pain I had been experiencing in my shoulders (I have had prior in injuries on both of them) and pain in my hips (I have been diagnosed with degenerative disc disorder). I was put on Prednisone to help and the Prednisone caused me to have reactions of stress, high blood pressure, etc. Nurse recommended that she give me a Hepatitis A vaccination. She gave it to me without informing me of the potential dangers and once she did give it to me the other nurse that actually gave me the shot threw the warnings list paper at me and left the room. Later the next day, I started feeling sick and couldn't cognate (think about what and why I was working on at all). I had to leave work. I had felt mildly "strange" or "different" but I went on into work anyway. After I left work, I had to go straight home and to bed and that's where I remained for a little over a month. I was sick and sleeping 18-19 hrs a day. I wanted to get medical attention but I could not afford an emergency room visit. I have lost my TriCare and I am uninsurable. At this time I looked at the paper and saw the potential problems the vaccination would cause and after further study I found that Prednisone should not be given any vaccinations along with it. I have had nerve problems - panic attacks - irregular energy levels, nausea, to the point that I cannot function normally. My Hep C symptom shave become a major problem since I got the vaccination. Prior to the vaccination I would work up to 15 or 16 hrs in a day if needed with no problems but now I never know how I am going to feel. I cannot plan anything. Sometimes it is an hourly thing where sometimes I cannot tell by the hour how I am going to be doing. Sometimes I can do a considerable amount of work and then crash and have to recover from it. I have tried to get help from health departments because that's all I can afford. A doctor has me on Prozac (I am bipolar) and Klonopin (for panic attacks and nerves). This problem has continued since around May 25th, 2006 and I have suffered in all areas of my life because of it. Since I was put on Prednisone and given the Hep A vaccination my life has not been the same. My abilities to function in life were normal as though I had never gotten past the (incubation period) of the disease but after I got that vaccination my immune system suffered and the Hep C "took over" my body. I have not recovered and this is a life threatening disease.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis C, Immune system disorder, Malaise, Musculoskeletal pain, Nausea
Clinical narrative: I have been diagnosed with Hep C in 2002 and for years I had not had any problems conducting normal routines in life and my health, energy, well-being, etc. was never a problem to me. I was put on Prednisone by nurse practicing physician to alleviate pain I had been experiencing in my shoulders (I have had prior in injuries on both of them) and pain in my hips (I have been diagnosed with degenerative disc disorder). I was put on Prednisone to help and the Prednisone caused me to have reactions of stress, high blood pressure, etc. Nurse recommended that she give me a Hepatitis A vaccination. She gave it to me without informing me of the potential dangers and once she did give it to me the other nurse that actually gave me the shot threw the warnings list paper at me and left the room. Later the next day, I started feeling sick and couldn't cognate (think about what and why I was working on at all). I had to leave work. I had felt mildly "strange" or "different" but I went on into work anyway. After I left work, I had to go straight home and to bed and that's where I remained for a little over a month. I was sick and sleeping 18-19 hrs a day. I wanted to get medical attention but I could not afford an emergency room visit. I have lost my TriCare and I am uninsurable. At this time I looked at the paper and saw the potential problems the vaccination would cause and after further study I found that Prednisone should not be given any vaccinations along with it. I have had nerve problems - panic attacks - irregular energy levels, nausea, to the point that I cannot function normally. My Hep C symptom shave become a major problem since I got the vaccination. Prior to the vaccination I would work up to 15 or 16 hrs in a day if needed with no problems but now I never know how I am going to feel. I cannot plan anything. Sometimes it is an hourly thing where sometimes I cannot tell by the hour how I am going to be doing. Sometimes I can do a considerable amount of work and then crash and have to recover from it. I have tried to get help from health departments because that's all I can afford. A doctor has me on Prozac (I am bipolar) and Klonopin (for panic attacks and nerves). This problem has continued since around May 25th, 2006 and I have suffered in all areas of my life because of it. Since I was put on Prednisone and given the Hep A vaccination my life has not been the same. My abilities to function in life were normal as though I had never gotten past the (incubation period) of the disease but after I got that vaccination my immune system suffered and the Hep C "took over" my body. I have not recovered and this is a life threatening disease.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Osteoarthritis, Panic attack, Somnolence, Stress, Viral load increased
Clinical narrative: I have been diagnosed with Hep C in 2002 and for years I had not had any problems conducting normal routines in life and my health, energy, well-being, etc. was never a problem to me. I was put on Prednisone by nurse practicing physician to alleviate pain I had been experiencing in my shoulders (I have had prior in injuries on both of them) and pain in my hips (I have been diagnosed with degenerative disc disorder). I was put on Prednisone to help and the Prednisone caused me to have reactions of stress, high blood pressure, etc. Nurse recommended that she give me a Hepatitis A vaccination. She gave it to me without informing me of the potential dangers and once she did give it to me the other nurse that actually gave me the shot threw the warnings list paper at me and left the room. Later the next day, I started feeling sick and couldn't cognate (think about what and why I was working on at all). I had to leave work. I had felt mildly "strange" or "different" but I went on into work anyway. After I left work, I had to go straight home and to bed and that's where I remained for a little over a month. I was sick and sleeping 18-19 hrs a day. I wanted to get medical attention but I could not afford an emergency room visit. I have lost my TriCare and I am uninsurable. At this time I looked at the paper and saw the potential problems the vaccination would cause and after further study I found that Prednisone should not be given any vaccinations along with it. I have had nerve problems - panic attacks - irregular energy levels, nausea, to the point that I cannot function normally. My Hep C symptom shave become a major problem since I got the vaccination. Prior to the vaccination I would work up to 15 or 16 hrs in a day if needed with no problems but now I never know how I am going to feel. I cannot plan anything. Sometimes it is an hourly thing where sometimes I cannot tell by the hour how I am going to be doing. Sometimes I can do a considerable amount of work and then crash and have to recover from it. I have tried to get help from health departments because that's all I can afford. A doctor has me on Prozac (I am bipolar) and Klonopin (for panic attacks and nerves). This problem has continued since around May 25th, 2006 and I have suffered in all areas of my life because of it. Since I was put on Prednisone and given the Hep A vaccination my life has not been the same. My abilities to function in life were normal as though I had never gotten past the (incubation period) of the disease but after I got that vaccination my immune system suffered and the Hep C "took over" my body. I have not recovered and this is a life threatening disease.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Bronchitis, Pneumonia
Clinical narrative: A non-serious spontaneous report of bronchitis and pneumonia was received from a parent concerning a four-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The child's medical history included cold, seasonal allergy, postnasal drip, atopic, and peanut allergy. No concomitant medication was reported. The patient received FluMist on 03Nov2007. On 07Nov2007, a parent that her son was diagnosed with "bronchitis/early pneumonia" four days following FluMist vaccination. The child had sniffles the day of vaccination. The mother states that it was difficult to tease apart her son's colds from his seasonal allergies and postnasal drips. The child was started on a Z-pack. The patient was recovering. The causality was not reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Blood test, Diplopia, Fatigue, Hypoaesthesia
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Leukoencephalomyelitis, Lumbar puncture, Nerve injury, Nuclear magnetic resonance imaging abnormal, Sensation of heaviness
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Tremor, VIth nerve paralysis
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Diplopia, Leukoencephalomyelitis, Nuclear magnetic resonance imaging
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Diplopia, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoaesthesia, Leukoencephalomyelitis, Lumbar puncture, Multiple sclerosis, Muscular weakness
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Physiotherapy, Sensation of heaviness, Spinal disorder, Tremor
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: VIth nerve paralysis, Vaginal disorder, Visual impairment
Clinical narrative: This report was identified from line listings obtained on request by the Company from the agency under the an Act.  A 14 year old female with a previous illness of dizziness, "sight" and numbness was vaccinated with the second dose (also reported as 0 previous doses) of GARDASIL (lot # 659653/1448U), IM into the left arm, on 05-MAY-2008.  Concomitant therapy included HAVRIX (unspecified) (lot # AHAVB222AA).  On 16-MAY-2008, the patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms and fatigue.  She was seen by the doctor who diagnosed sixth nerve palsy.  The patient was admitted to the hospital.  An MRI was performed on 23-MAY-2008.  A lumbar function was also performed.  The patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM).  The listing indicated that one or more of the events required hospitalization, were considered to be disabling, and were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID# is 316760.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available. Follow-up: Child is being treated for Multiple Sclerosis and is followed by Neurology and Neurosurgery. She is also receiving PT. 1/25/2010 Follow up: Patient now has MS. She has been in the hospital 7 times since the date of vaccination. She has vaginal problems as well as weakness in her limbs. She has new lesions in her spine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 12 days after mmr shot he had high fevers for two days went to ER brought temp down next day high fever again.  Scheduled pediatrician office visit that day and the Doctor told us it was probably a reaction to the shots MMR.  He said we would probably notice a rash also and he now has the rash.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 22 year old female (a relative of another employee) who was vaccinated with a third dose of GARDASIL.  Subsequently the patient died.  The cause of death was unknown.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Premature labour
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning her daughter, a 19 year old female with a history of respiratory syncytial virus infection who in approximately May or June 2007, was vaccinated with the first dose of GARDASIL, she subsequently had the second dose (date unknown); and on 02-JAN-2008, she had the third dose of GARDASIL.  The patient had her LMP on 15-DEC-2007 and they later learned that she was pregnant at the time she had her third dose of GARDASIL.  The patient went into pre-term labor at twenty-eight weeks and gave birth to a baby boy on 28-JUN-2008.  The baby only survived two days.  The death of the baby "was due to the delivery which caused a grade 4 hemorrhaging of the brain".  The patient is presently doing well physically.  The reporter said that her daughter, had consented to our contacting the nurse practitioner.  The patient sought medical attention.  Upon internal review, the baby born at 28 weeks was considered to be an other important medical event.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient who was vaccinated with GARDASIL.  The lot number was not provided.  The physician reported that a neurologist asked her if she had heard about a patient who had a stroke with GARDASIL.  It was unspecified whether or not this patient was of the neurologist.  Upon internal review, stroke was determined to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Contraception, Electroencephalogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no known drug allergies and no pertinent medical history reported, who on an unknown date was vaccinated with the first dose of GARDASIL.  On approximately 18-JAN-2008, she was vaccinated with a second dose of GARDASIL.  On approximately 17-JUN-2008, the patient was vaccinated with a third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  About three weeks after the first dose, the patient had a syncopal episode.  On 08-FEB-2008, about 3 weeks after the second dose, the patient experienced tonic-clonic seizure and was hospitalized overnight.  The patient was hospitalized from 08-FEB-2008 to 09-FEB-2008.  On 08-JUL-2008, about three weeks after the third dose, the patient experienced a second tonic-clonic seizure.  An electroencephalography, a magnetic resonance imaging and blood work were done and showed normal results.  She was started on an anticonvulsant medication.  At the time of reporting, the patient had not recovered.  Upon internal review severe tonic-clonic seizure was determined to be an other important medical event.  Additional information has been requested.  6/9/09 Hospital ER records received DOS 7/6/08. FINAL DIAGNOSIS: Seizure. Post vaccination pt's father witnessed seizure consisting of nonresponsiveness, drooling/twitching of mouth, loss of consciousness.   6/10/09 Neurology consultant records received DOS 8/12/08 to 4/20/09. Assessment: Partial Epilepsy NEC Without Intractable Epilepsy Teacher told parent that pt's right arm twisted up in chair, became unconscious, stiffened up, developed clonic activity, bit tongue. Developed rash and discontinued tegretol. Several months later stiffened up, eyes opened, unconscious. Both times had slurred speech and confusion afterwards. Placed on Keppra, dc'd due to nausea. Now on Topamax. Insomnia.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no known drug allergies and no pertinent medical history reported, who on an unknown date was vaccinated with the first dose of GARDASIL.  On approximately 18-JAN-2008, she was vaccinated with a second dose of GARDASIL.  On approximately 17-JUN-2008, the patient was vaccinated with a third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  About three weeks after the first dose, the patient had a syncopal episode.  On 08-FEB-2008, about 3 weeks after the second dose, the patient experienced tonic-clonic seizure and was hospitalized overnight.  The patient was hospitalized from 08-FEB-2008 to 09-FEB-2008.  On 08-JUL-2008, about three weeks after the third dose, the patient experienced a second tonic-clonic seizure.  An electroencephalography, a magnetic resonance imaging and blood work were done and showed normal results.  She was started on an anticonvulsant medication.  At the time of reporting, the patient had not recovered.  Upon internal review severe tonic-clonic seizure was determined to be an other important medical event.  Additional information has been requested.  6/9/09 Hospital ER records received DOS 7/6/08. FINAL DIAGNOSIS: Seizure. Post vaccination pt's father witnessed seizure consisting of nonresponsiveness, drooling/twitching of mouth, loss of consciousness.   6/10/09 Neurology consultant records received DOS 8/12/08 to 4/20/09. Assessment: Partial Epilepsy NEC Without Intractable Epilepsy Teacher told parent that pt's right arm twisted up in chair, became unconscious, stiffened up, developed clonic activity, bit tongue. Developed rash and discontinued tegretol. Several months later stiffened up, eyes opened, unconscious. Both times had slurred speech and confusion afterwards. Placed on Keppra, dc'd due to nausea. Now on Topamax. Insomnia.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Anaemia, Blood culture negative, Bronchiolitis, Crying, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 12 week old male with gastrooesophageal reflux, a history of bronchiolitis and no reported illness at the time of vaccination who on 27-FEB-2008 at 15:50 was vaccinated IM with the first dose of ROTATEQ (lot # 659682/1733U). On 11-MAR-2008 the patient began with vomiting and watery and profuse diarrhea, general malaise and crying with poor response to treatment (unspecified) the patient was hospitalized. On approximately 11-MAR-2008 the patient had a white blood cell count of 6.9, hemoglobin of 10.4, hematocrit of 30.4, platelets of 425,000, stool was positive for rotavirus, positive culture for Respiratory Syncytial Virus (RSV). It was reported that the patient was alert, active and afebrile while in the hospital. The patient was discharged from the hospital on 23-MAR-2008 with a guarded prognosis, in good condition on a regular diet, no activity restrictions and on albuterol (dose, route unspecified). The discharge diagnosis were bronchiolitis, RSV, acute gastroenteritis, rotavirus positive and anemia. The outcome was reported as recovered resolved. The physician felt that the hospitalization was prolonged (12 days). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis, Haematocrit decreased, Haemoglobin normal, Incorrect route of drug administration, Malaise
Clinical narrative: Information has been received from a physician concerning a 12 week old male with gastrooesophageal reflux, a history of bronchiolitis and no reported illness at the time of vaccination who on 27-FEB-2008 at 15:50 was vaccinated IM with the first dose of ROTATEQ (lot # 659682/1733U). On 11-MAR-2008 the patient began with vomiting and watery and profuse diarrhea, general malaise and crying with poor response to treatment (unspecified) the patient was hospitalized. On approximately 11-MAR-2008 the patient had a white blood cell count of 6.9, hemoglobin of 10.4, hematocrit of 30.4, platelets of 425,000, stool was positive for rotavirus, positive culture for Respiratory Syncytial Virus (RSV). It was reported that the patient was alert, active and afebrile while in the hospital. The patient was discharged from the hospital on 23-MAR-2008 with a guarded prognosis, in good condition on a regular diet, no activity restrictions and on albuterol (dose, route unspecified). The discharge diagnosis were bronchiolitis, RSV, acute gastroenteritis, rotavirus positive and anemia. The outcome was reported as recovered resolved. The physician felt that the hospitalization was prolonged (12 days). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Platelet count normal, Respiratory syncytial virus infection, Rotavirus infection, Rotavirus test positive, Viral test positive
Clinical narrative: Information has been received from a physician concerning a 12 week old male with gastrooesophageal reflux, a history of bronchiolitis and no reported illness at the time of vaccination who on 27-FEB-2008 at 15:50 was vaccinated IM with the first dose of ROTATEQ (lot # 659682/1733U). On 11-MAR-2008 the patient began with vomiting and watery and profuse diarrhea, general malaise and crying with poor response to treatment (unspecified) the patient was hospitalized. On approximately 11-MAR-2008 the patient had a white blood cell count of 6.9, hemoglobin of 10.4, hematocrit of 30.4, platelets of 425,000, stool was positive for rotavirus, positive culture for Respiratory Syncytial Virus (RSV). It was reported that the patient was alert, active and afebrile while in the hospital. The patient was discharged from the hospital on 23-MAR-2008 with a guarded prognosis, in good condition on a regular diet, no activity restrictions and on albuterol (dose, route unspecified). The discharge diagnosis were bronchiolitis, RSV, acute gastroenteritis, rotavirus positive and anemia. The outcome was reported as recovered resolved. The physician felt that the hospitalization was prolonged (12 days). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 12 week old male with gastrooesophageal reflux, a history of bronchiolitis and no reported illness at the time of vaccination who on 27-FEB-2008 at 15:50 was vaccinated IM with the first dose of ROTATEQ (lot # 659682/1733U). On 11-MAR-2008 the patient began with vomiting and watery and profuse diarrhea, general malaise and crying with poor response to treatment (unspecified) the patient was hospitalized. On approximately 11-MAR-2008 the patient had a white blood cell count of 6.9, hemoglobin of 10.4, hematocrit of 30.4, platelets of 425,000, stool was positive for rotavirus, positive culture for Respiratory Syncytial Virus (RSV). It was reported that the patient was alert, active and afebrile while in the hospital. The patient was discharged from the hospital on 23-MAR-2008 with a guarded prognosis, in good condition on a regular diet, no activity restrictions and on albuterol (dose, route unspecified). The discharge diagnosis were bronchiolitis, RSV, acute gastroenteritis, rotavirus positive and anemia. The outcome was reported as recovered resolved. The physician felt that the hospitalization was prolonged (12 days). Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Dehydration, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse concerning a male child who was vaccinated with ROTATEQ (no details about when or how many doses).  The patient was admitted to the hospital for 24 hour observation for rotavirus and to receive IV fluids for rehydration.  The child had a positive stool culture for rotavirus.  The reporter considered the event of rotavirus to be an other important medical event.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a 75 year old male with hypothyroidism, hypertension and penicillin allergy who on 15-JUL-2008 was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included levothyroxine Na and NORVASC.  On approximately 29-JUL-2008 the patient developed rash across the top of his back, that extends down his back.  The rash was also present on his ankles.  The patient was achy, feverish and experiencing chills.  The patient sought medical attention (office visit).  Complete blood cell count was performed which showed low white blood cell count.  At time of reporting, the patient had not recovered.  The reporter considered the events to be disabling.  Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I went to the Dr. with the shingles. They gave me a shot, they told me it was for the shingles. I have never ending pain. They are as bad as they were when I found out I had shingles. I later went to a different Dr. he told me they were not to give this shot unless I did not have the shingles. So every day I have pain. I have suffered with this pain till I tired of it. I have been to Dr. after Dr. no one has helped. I still have the pain. I need to no how I can get rid of this? Giving a shot that is working against me? So please tell me what I can do. Sincerely, pt.  DX: post-herpetic neuralgia per PCP 1/26/2010 Follow-up: Nothing has changed. My pain is as bad as it was 3 years ago. Nothing has helped.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood test, Facial paresis
Clinical narrative: Expressive aphasia facial weakness unilateral  8/29/08  Reviewed hospital medical records of 8/6/2008. FINAL DX: Transient ischemic attack vs hemiplegic migraine Records reveal patient experienced sudden onset of expressive aphasia, left facial drooping, right facial weakness, numbness & tingling, lightheadedness, anxiety.  Seen in outlying ER & had tongue deviation to the left & left facial weakness.  Speech returned in approx 4 hours; left facial weakness/droop persisted.  Symptoms resolved & all tests WNL.  D/C to home same day w/referral to outpatient neuro for continued w/u. Follow-up: This pt has now been determined to have hemiplegic migraines. She has had recurrent migraines and is on treatment.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Chills, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Patient reported to the clinic stating he thinks he has had a reaction to the PNEUMOVAX given yesterday. Left upper arm appears reddened and swollen. Patient states he was awake all night with chills and fever. Temp. today in clinic was 97.1. Doctor here to observe and inspect. Area marked with surgical skin-marking pen. With recheck 6/18 symptoms resolved without antibiotic therapy. Symptoms: Angioedema Treatment Drugs Used: Diphenhydramine Dose: 50 units:MG Freq: PRN Route: PO
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, induration, pain left arm at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Retching, Urticaria
Clinical narrative: Child was given DTaP, IPV, MMR, and varicella, within 10 minutes after immunizations were given child developed hives and was gagging. She was given Epi 1:100 0.15 CC SC. She was given BENADRYL 1 1/4 tsp. She was take to the ER and observed at approximately 5 PM, needed no other meds according to parent.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Broke out in hives 24-36 hr after shots - closer to 36 hr. Still acting ok. Hives still present 4 days later with no fever. Pt never uncomfortable, never received Benadryl. Hives more concentrated on abdomen.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Weight decreased
Clinical narrative: Menstrual cycle stopped, losing weight. (has not skipped since her first period-July 2006)
Age: 67.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned 4 days after yellow fever immunization. Arm is red, swollen and hot to the touch at site of injection.