chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient reported dizziness S/P Influenza immunization.  Dizziness described as being 'light' and present while sitting upright with eyes open and closed.  Steady gait while ambulating, strong radial pulses, warm and moist skin at trunk, warm and dry at extremities, no loss of consciousness, not orthostatic, although dizziness subsided while supine.  Pt evaluated by a Physicians Assistant and released to follow up with PCP if symptoms persist.  Possible relation to to current prescribed medication, Zoloft.  Patient placed on Zoloft approximately 2-3 weeks ago and denied any side effects.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Apnoea, Bronchitis chronic, Cardio-respiratory arrest, Sleep apnoea syndrome
Clinical narrative: This case was reported by a health care professional to a sales representative and described the occurrence of death in a 2 month old male subject who had received DT toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject was born four weeks premature, "but was apparently healthy when given Pediarix". Concurrent medical conditions included sleep apnea, for which the subject required a sleep apnea monitor. At the time of the vaccination, the subject's weight was over nine pounds. At the time of the vaccination, the subject's weight was over nine pounds. Concurrent medications were not reported. On 4/18/06, the subject received the first dose of Pediarix (Lot number unknown), co-administered vaccinations on that date included haemophilus b conjugate vaccine (non-GSK, mfr unknown) and pneumococcal 7-valent conjugate vaccine (Prevnar, Lederle Laboratories). On 4/18/06, on the same day as vaccination, the infant died. According to the subject's mother, "the monitor went off several times that night and the last time the baby did not respond." An autopsy was planned. At the time of reporting, the autopsy results were not reported.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This case was reported by a health care professional to a sales representative and described the occurrence of death in a 2 month old male subject who had received DT toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject was born four weeks premature, "but was apparently healthy when given Pediarix". Concurrent medical conditions included sleep apnea, for which the subject required a sleep apnea monitor. At the time of the vaccination, the subject's weight was over nine pounds. At the time of the vaccination, the subject's weight was over nine pounds. Concurrent medications were not reported. On 4/18/06, the subject received the first dose of Pediarix (Lot number unknown), co-administered vaccinations on that date included haemophilus b conjugate vaccine (non-GSK, mfr unknown) and pneumococcal 7-valent conjugate vaccine (Prevnar, Lederle Laboratories). On 4/18/06, on the same day as vaccination, the infant died. According to the subject's mother, "the monitor went off several times that night and the last time the baby did not respond." An autopsy was planned. At the time of reporting, the autopsy results were not reported.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a health care professional to a sales representative and described the occurrence of death in a 2 month old male subject who had received DT toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject was born four weeks premature, "but was apparently healthy when given Pediarix". Concurrent medical conditions included sleep apnea, for which the subject required a sleep apnea monitor. At the time of the vaccination, the subject's weight was over nine pounds. At the time of the vaccination, the subject's weight was over nine pounds. Concurrent medications were not reported. On 4/18/06, the subject received the first dose of Pediarix (Lot number unknown), co-administered vaccinations on that date included haemophilus b conjugate vaccine (non-GSK, mfr unknown) and pneumococcal 7-valent conjugate vaccine (Prevnar, Lederle Laboratories). On 4/18/06, on the same day as vaccination, the infant died. According to the subject's mother, "the monitor went off several times that night and the last time the baby did not respond." An autopsy was planned. At the time of reporting, the autopsy results were not reported.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Body temperature decreased, Coma, Cyanosis, Depressed level of consciousness
Clinical narrative: This case was reported by a health care professional to a sales representative and described the occurrence of death in a 2 month old male subject who had received DT toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subject was born four weeks premature, "but was apparently healthy when given Pediarix". Concurrent medical conditions included sleep apnea, for which the subject required a sleep apnea monitor. At the time of the vaccination, the subject's weight was over nine pounds. At the time of the vaccination, the subject's weight was over nine pounds. Concurrent medications were not reported. On 4/18/06, the subject received the first dose of Pediarix (Lot number unknown), co-administered vaccinations on that date included haemophilus b conjugate vaccine (non-GSK, mfr unknown) and pneumococcal 7-valent conjugate vaccine (Prevnar, Lederle Laboratories). On 4/18/06, on the same day as vaccination, the infant died. According to the subject's mother, "the monitor went off several times that night and the last time the baby did not respond." An autopsy was planned. At the time of reporting, the autopsy results were not reported.
Age: 0.03
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Medication error
Clinical narrative: No known adverse event. Immunizations for a 12 month old given to this patient on 4/4/06, at 12 days.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Vaccine administered 4/17/06 at 13:10 presented to EOH on 4/18/06 at 15:00 with hive like rash on forearm. Given Benadryl. Presented to EOH at 7:30 am on 4/19/06 with increased hives, rash on body Prescribed Medrol dose pack.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Diffuse swelling and redness at site.
Sex: F
Vaccine: PPV
Symptoms: Depressed level of consciousness, Hypoaesthesia, Paralysis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced loss of sensation and use of her arm, numb paralysis which lasted for several days and weeks. The physician did not know if this was caused by the vaccine or the administration of the vaccine. At the time of the report, the patient was recovering. Loss of sensation and use of her arm, numb, paralysis were considered to be disabling. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: 19 yr old ADA biracial male who received a smallpox vaccine (primary 3 jabs in left arm), along with an influenza vaccine in his right arm on 11/9/05. Prior to Nov 2005, service member describes his health as being "very good". He denies any unusual local reactions at his influenza vaccine site. His smallpox vaccine site was assessed around day 7 as a take. Around day 7 or 8, he experienced fatigue, headaches, and body aches, as well as redness and swelling around his SPV site and left axillary lymphadenopathy. Around day 9 he began experiencing chest pain located substernally and on the left side of his sternum. The pain was sharp and intermittent. On Friday, 11/18/05, the pain subsided shortly after onset. It returned again on Sunday 11/20, and lasted all day. He went to work on Monday, 11/21, and ended up going to the hospital when the pain intensified. When the pain started, it was rated as a level 5/10, but on 11/21, it had increased to a level 10/10. The pain was brought on with activity. (Pain occurred with walking slowly on a flat surface for 1 or 2 blocks, 3 METS). The pain became worse when he took deep breaths and when he laid down, especially on his left side. The pain was accompanied by shortness of breath, an increased heart rate, and fatigue. At the hospital, his evaluation was consistent with myocarditis and he was admitted to the ICU. He was monitored and treated with anti inflammatories. He was discharged on 11/24/04 and reports he continued to have chest pain, shortness of breath, fatigue and the sensation of his heart racing with minimal exertion. He was evaluated by Cardiology at BAMC on 11/30/06. At that time, he would describe his health as poor. He took Motrin BID and was on limited duty until Jan 16th, when he was re-evaluated by Cardiology and his medication was changed. He currently reports he experiences a racing heart, shortness of breath and chest pain with minimal exertion and with excitement. (Sometimes he wakes up with symptoms following a vivid dream.) He remains on a profile for limited duty. Symptom: Chest pain. Comment: sharp, intermittent CP on day 9 after SPV and flu vaccine; onset with activity and worse with lying on left side and with deep breaths. Fatigue, malaise>60 days. Comment: fatigue started about 1 week after vaccines, but still present 2 months later. Lymphadenopathy, axillary. Comment: around day 7, left axillary (same side as SPV). Symptom: Tachycardia. Comment: heart racing. Symptom: Dyspnea (shortness of breath); Symptom: Headache, general; Symptom: muscle pain. Plan is to initiat a medical board-see enclosed reports.
Age: 19.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Injection site erythema, Injection site oedema, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: 19 yr old ADA biracial male who received a smallpox vaccine (primary 3 jabs in left arm), along with an influenza vaccine in his right arm on 11/9/05. Prior to Nov 2005, service member describes his health as being "very good". He denies any unusual local reactions at his influenza vaccine site. His smallpox vaccine site was assessed around day 7 as a take. Around day 7 or 8, he experienced fatigue, headaches, and body aches, as well as redness and swelling around his SPV site and left axillary lymphadenopathy. Around day 9 he began experiencing chest pain located substernally and on the left side of his sternum. The pain was sharp and intermittent. On Friday, 11/18/05, the pain subsided shortly after onset. It returned again on Sunday 11/20, and lasted all day. He went to work on Monday, 11/21, and ended up going to the hospital when the pain intensified. When the pain started, it was rated as a level 5/10, but on 11/21, it had increased to a level 10/10. The pain was brought on with activity. (Pain occurred with walking slowly on a flat surface for 1 or 2 blocks, 3 METS). The pain became worse when he took deep breaths and when he laid down, especially on his left side. The pain was accompanied by shortness of breath, an increased heart rate, and fatigue. At the hospital, his evaluation was consistent with myocarditis and he was admitted to the ICU. He was monitored and treated with anti inflammatories. He was discharged on 11/24/04 and reports he continued to have chest pain, shortness of breath, fatigue and the sensation of his heart racing with minimal exertion. He was evaluated by Cardiology at BAMC on 11/30/06. At that time, he would describe his health as poor. He took Motrin BID and was on limited duty until Jan 16th, when he was re-evaluated by Cardiology and his medication was changed. He currently reports he experiences a racing heart, shortness of breath and chest pain with minimal exertion and with excitement. (Sometimes he wakes up with symptoms following a vivid dream.) He remains on a profile for limited duty. Symptom: Chest pain. Comment: sharp, intermittent CP on day 9 after SPV and flu vaccine; onset with activity and worse with lying on left side and with deep breaths. Fatigue, malaise>60 days. Comment: fatigue started about 1 week after vaccines, but still present 2 months later. Lymphadenopathy, axillary. Comment: around day 7, left axillary (same side as SPV). Symptom: Tachycardia. Comment: heart racing. Symptom: Dyspnea (shortness of breath); Symptom: Headache, general; Symptom: muscle pain. Plan is to initiat a medical board-see enclosed reports.
Age: 19.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Myocarditis, Tachycardia
Clinical narrative: 19 yr old ADA biracial male who received a smallpox vaccine (primary 3 jabs in left arm), along with an influenza vaccine in his right arm on 11/9/05. Prior to Nov 2005, service member describes his health as being "very good". He denies any unusual local reactions at his influenza vaccine site. His smallpox vaccine site was assessed around day 7 as a take. Around day 7 or 8, he experienced fatigue, headaches, and body aches, as well as redness and swelling around his SPV site and left axillary lymphadenopathy. Around day 9 he began experiencing chest pain located substernally and on the left side of his sternum. The pain was sharp and intermittent. On Friday, 11/18/05, the pain subsided shortly after onset. It returned again on Sunday 11/20, and lasted all day. He went to work on Monday, 11/21, and ended up going to the hospital when the pain intensified. When the pain started, it was rated as a level 5/10, but on 11/21, it had increased to a level 10/10. The pain was brought on with activity. (Pain occurred with walking slowly on a flat surface for 1 or 2 blocks, 3 METS). The pain became worse when he took deep breaths and when he laid down, especially on his left side. The pain was accompanied by shortness of breath, an increased heart rate, and fatigue. At the hospital, his evaluation was consistent with myocarditis and he was admitted to the ICU. He was monitored and treated with anti inflammatories. He was discharged on 11/24/04 and reports he continued to have chest pain, shortness of breath, fatigue and the sensation of his heart racing with minimal exertion. He was evaluated by Cardiology at BAMC on 11/30/06. At that time, he would describe his health as poor. He took Motrin BID and was on limited duty until Jan 16th, when he was re-evaluated by Cardiology and his medication was changed. He currently reports he experiences a racing heart, shortness of breath and chest pain with minimal exertion and with excitement. (Sometimes he wakes up with symptoms following a vivid dream.) He remains on a profile for limited duty. Symptom: Chest pain. Comment: sharp, intermittent CP on day 9 after SPV and flu vaccine; onset with activity and worse with lying on left side and with deep breaths. Fatigue, malaise>60 days. Comment: fatigue started about 1 week after vaccines, but still present 2 months later. Lymphadenopathy, axillary. Comment: around day 7, left axillary (same side as SPV). Symptom: Tachycardia. Comment: heart racing. Symptom: Dyspnea (shortness of breath); Symptom: Headache, general; Symptom: muscle pain. Plan is to initiat a medical board-see enclosed reports.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Arteriovenous malformation, Brain operation, Cerebral haemorrhage, Fatigue, Headache
Clinical narrative: Headaches, tired, rupture vessel in brain. This letter is in regards to the shot my son received on Aug 2,2005 called Menactra. Pt was hospitalized on Nov 11, 2005 due to what the doctors believed to be an AVM. I honestly believe that his injury was caused by the shot Menactra. Pt was in very good health and never complained of headaches before he received this shot. He had surgery on his brain 4 days after he was rushed to emergency and spent 76 days at a hospital. He is now back in school, but goes to therapy 4 times a week to help him with the weakness of his right leg and right arm. 60 day Follow-up Information 12-JUL-2006: At this time patient is going through physical therapy. He has weakness in his right leg and right arm. Follow-up: Still has weakness in right arm, hand and right leg. Pt is now 13 yr old and still wears an ankle brace(R) for proper motion.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Muscular weakness, Orthosis user
Clinical narrative: Headaches, tired, rupture vessel in brain. This letter is in regards to the shot my son received on Aug 2,2005 called Menactra. Pt was hospitalized on Nov 11, 2005 due to what the doctors believed to be an AVM. I honestly believe that his injury was caused by the shot Menactra. Pt was in very good health and never complained of headaches before he received this shot. He had surgery on his brain 4 days after he was rushed to emergency and spent 76 days at a hospital. He is now back in school, but goes to therapy 4 times a week to help him with the weakness of his right leg and right arm. 60 day Follow-up Information 12-JUL-2006: At this time patient is going through physical therapy. He has weakness in his right leg and right arm. Follow-up: Still has weakness in right arm, hand and right leg. Pt is now 13 yr old and still wears an ankle brace(R) for proper motion.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Angiopathy, Asthenia, Haemorrhage, Headache
Clinical narrative: Headaches, tired, rupture vessel in brain. This letter is in regards to the shot my son received on Aug 2,2005 called Menactra. Pt was hospitalized on Nov 11, 2005 due to what the doctors believed to be an AVM. I honestly believe that his injury was caused by the shot Menactra. Pt was in very good health and never complained of headaches before he received this shot. He had surgery on his brain 4 days after he was rushed to emergency and spent 76 days at a hospital. He is now back in school, but goes to therapy 4 times a week to help him with the weakness of his right leg and right arm. 60 day Follow-up Information 12-JUL-2006: At this time patient is going through physical therapy. He has weakness in his right leg and right arm. Follow-up: Still has weakness in right arm, hand and right leg. Pt is now 13 yr old and still wears an ankle brace(R) for proper motion.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bronchiolitis, CSF test abnormal, Dehydration, Hyponatraemia, Laboratory test abnormal
Clinical narrative: 3 days after vaccines developed hyprexia. Went to local ER. Test unk 1 pos meng. 1 - meng. Air vac to hospital. Discharge summary states fever, hyponatremia, bronchiolitis, dehydration.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Respiratory syncytial virus infection, Unevaluable event, Viral infection, White blood cell disorder
Clinical narrative: 3 days after vaccines developed hyprexia. Went to local ER. Test unk 1 pos meng. 1 - meng. Air vac to hospital. Discharge summary states fever, hyponatremia, bronchiolitis, dehydration.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Laboratory test abnormal
Clinical narrative: Localized pain, redness, swelling, involving entire upper arm (right). No fever but marked left shift to WBC S22 B2 L67, S81 L15, CRP 1.05-0.35. Decreased redness, swelling S 56 L 33, CRP 0.35 at d/c hospital. 4/27/06 Review of 10-page  d/c summary done. Final diagnosis was cellulitis. Tx with IV Ancef and Solu-Medrol. Recovering well. Sent home on cephalexin, Benadryl, and prednisone.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: White blood cell disorder
Clinical narrative: Localized pain, redness, swelling, involving entire upper arm (right). No fever but marked left shift to WBC S22 B2 L67, S81 L15, CRP 1.05-0.35. Decreased redness, swelling S 56 L 33, CRP 0.35 at d/c hospital. 4/27/06 Review of 10-page  d/c summary done. Final diagnosis was cellulitis. Tx with IV Ancef and Solu-Medrol. Recovering well. Sent home on cephalexin, Benadryl, and prednisone.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: Vaccine had over heated (to room temperature).
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: She indicates it's been 11 years since she had a tetanus shot so she received Adacel today. The pt is a 39 year old woman here or discussion of a possible allergic reaction to her tetanus shot. She saw another doctor as a new pt on the 11th and received Adacel in the left deltoid. The following day she felt febrile and diffusely achy and then earlier today awoke with the addition of some swelling under her arm. She has never had a reaction like this before. Symptoms are not progressive at this time and involve no respiratory distress or throat congestion. Examination of her left deltoid region reveals no significant erythema. No palpable nodularity, although she is tender to palpation. Mild left axillary fullness as well as left epitrochlear fullness and discomfort with palpation. There is no streaking or cutaneous change noted. Adverse event following single dose Adacel vaccine on 4/11/06. She is currently stable and will improve with time. I did give her a sample of Clarinex 5mg one po daily for the next five days to see of that would help any of her symptoms improve. I review the Adacel package insert with her which did indicate 6 1/2% incident of lymph node selling, 9% incidence of sore and swollen joints and 21.9% incident of body ache or muscle weakness. Her reaction is consistent with these. I am not sure she should never receive another tetanus booster, but I would recommend pre-medicating with Benadryl and consideration should be given to premedicating with low-dose steroid.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Arthralgia, Back pain, Bone disorder, Eye pain
Clinical narrative: Abdominal pain, aches bone, aches joints, aches joints and muscles, cramps legs, cold and flu like symptoms, headaches, hearing problems, visions problem, pain legs, knee and hips, pain lower back pain eye, pain back.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hearing impaired, Influenza like illness, Muscle spasms, Myalgia
Clinical narrative: Abdominal pain, aches bone, aches joints, aches joints and muscles, cramps legs, cold and flu like symptoms, headaches, hearing problems, visions problem, pain legs, knee and hips, pain lower back pain eye, pain back.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pharyngitis, Rhinitis, Visual disturbance
Clinical narrative: Abdominal pain, aches bone, aches joints, aches joints and muscles, cramps legs, cold and flu like symptoms, headaches, hearing problems, visions problem, pain legs, knee and hips, pain lower back pain eye, pain back.
Age: 39.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Arthralgia, Blood urine, Chest X-ray abnormal, Cyst, Diarrhoea
Clinical narrative: Symptom: Joint pain, multiple joints Comment: migratory joint pain; denies muscle pain but describes "bone pain". Pt describes nausea and vomiting and diarrhea as starting around Spring 2003. No triggers identified such as diet changes or stress, but always associated with cycles of joint pain. (Does not know "what end to put on toiler...feels like I'm going to throw up and have diarrhea".) No significant weight loss. His Internist recommended an evaluation by a Gastroenterologist, but service member has not followed through at this time. No abdominal pain, constipation, cramping or bloating. No blood in stools. N history of reflex disease, ulcers, liver disease and gall bladder disease. Reports onset of fatigue in 2002. Describes as feeling drained and having no energy to perform usual activities-"sometimes dragging when I get up" and some days fatigue hits him in the middle of the day. Typically has about 10-15 "good days" per month where he can carry out duties and activities of daily living without problems. On "bay days" rates his energy level as being 20% of his baseline prior to 2002. Longest period over past 12 months where he did not feel fatigued was 3 weeks. No particular pattern of fatigue noted. Denies feeling weak or sleepy. Fatigue does not seem to be affected by alcohol or any medications that he has taken. Fatigue does not seem to be triggered or exacerbated by activity but generally he will no even attempt activities on his "bad days". On a good day, he can carry out activities without noting a prolonged recovery; during a recent period of fatigue he hired his brothers to clean his yard. Denies associated headaches, visual changes, memory changes or difficulty concentrating, but as previously noted , experiences sore throats and migratory arthralgias. 6/2002-Acute earache prior to onset of migratory joint pains. 6/2002-pharyngitis, acute; experiences sore throats prior to onset of migratory joint pains. 2002-malaise and fatigue; chronic fatigue associated with migratory arthralgias. 2002-pain in joints, migratory joint and "bone" pain.
Age: 39.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Ear pain, Fatigue, Hepatic steatosis, Nausea, Pharyngolaryngeal pain
Clinical narrative: Symptom: Joint pain, multiple joints Comment: migratory joint pain; denies muscle pain but describes "bone pain". Pt describes nausea and vomiting and diarrhea as starting around Spring 2003. No triggers identified such as diet changes or stress, but always associated with cycles of joint pain. (Does not know "what end to put on toiler...feels like I'm going to throw up and have diarrhea".) No significant weight loss. His Internist recommended an evaluation by a Gastroenterologist, but service member has not followed through at this time. No abdominal pain, constipation, cramping or bloating. No blood in stools. N history of reflex disease, ulcers, liver disease and gall bladder disease. Reports onset of fatigue in 2002. Describes as feeling drained and having no energy to perform usual activities-"sometimes dragging when I get up" and some days fatigue hits him in the middle of the day. Typically has about 10-15 "good days" per month where he can carry out duties and activities of daily living without problems. On "bay days" rates his energy level as being 20% of his baseline prior to 2002. Longest period over past 12 months where he did not feel fatigued was 3 weeks. No particular pattern of fatigue noted. Denies feeling weak or sleepy. Fatigue does not seem to be affected by alcohol or any medications that he has taken. Fatigue does not seem to be triggered or exacerbated by activity but generally he will no even attempt activities on his "bad days". On a good day, he can carry out activities without noting a prolonged recovery; during a recent period of fatigue he hired his brothers to clean his yard. Denies associated headaches, visual changes, memory changes or difficulty concentrating, but as previously noted , experiences sore throats and migratory arthralgias. 6/2002-Acute earache prior to onset of migratory joint pains. 6/2002-pharyngitis, acute; experiences sore throats prior to onset of migratory joint pains. 2002-malaise and fatigue; chronic fatigue associated with migratory arthralgias. 2002-pain in joints, migratory joint and "bone" pain.
Age: 39.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Red blood cell sedimentation rate increased, Vomiting
Clinical narrative: Symptom: Joint pain, multiple joints Comment: migratory joint pain; denies muscle pain but describes "bone pain". Pt describes nausea and vomiting and diarrhea as starting around Spring 2003. No triggers identified such as diet changes or stress, but always associated with cycles of joint pain. (Does not know "what end to put on toiler...feels like I'm going to throw up and have diarrhea".) No significant weight loss. His Internist recommended an evaluation by a Gastroenterologist, but service member has not followed through at this time. No abdominal pain, constipation, cramping or bloating. No blood in stools. N history of reflex disease, ulcers, liver disease and gall bladder disease. Reports onset of fatigue in 2002. Describes as feeling drained and having no energy to perform usual activities-"sometimes dragging when I get up" and some days fatigue hits him in the middle of the day. Typically has about 10-15 "good days" per month where he can carry out duties and activities of daily living without problems. On "bay days" rates his energy level as being 20% of his baseline prior to 2002. Longest period over past 12 months where he did not feel fatigued was 3 weeks. No particular pattern of fatigue noted. Denies feeling weak or sleepy. Fatigue does not seem to be affected by alcohol or any medications that he has taken. Fatigue does not seem to be triggered or exacerbated by activity but generally he will no even attempt activities on his "bad days". On a good day, he can carry out activities without noting a prolonged recovery; during a recent period of fatigue he hired his brothers to clean his yard. Denies associated headaches, visual changes, memory changes or difficulty concentrating, but as previously noted , experiences sore throats and migratory arthralgias. 6/2002-Acute earache prior to onset of migratory joint pains. 6/2002-pharyngitis, acute; experiences sore throats prior to onset of migratory joint pains. 2002-malaise and fatigue; chronic fatigue associated with migratory arthralgias. 2002-pain in joints, migratory joint and "bone" pain.
Age: 23.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: Tdap in Right arm 4/18/2006 -reported redness around noon an 4/19/2006. 4/20/2006 1 1/2" diameter redness on right arm, tenderness to axillary area with lymph nodes swollen approximately 1/4" diameter per report. Denies fever.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site vesicles
Clinical narrative: At site of smallpox vaccination, blisters formed around site approx. 1/4 in from center.  Blisters formed approx. 5 days after revaccination of smallpox.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Hypotonic urinary bladder, Lethargy, Nausea
Clinical narrative: Nausea, high fever, weakness, body aches, shortness of breath, lethargy.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: Nausea, high fever, weakness, body aches, shortness of breath, lethargy.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: No signs or symptoms of reaction.  Patient died 2-1-06.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Cellulitis, Erythema, Skin striae, Swelling
Clinical narrative: Patient received IPV, MMR, DTaP, PCV on 4-17-06. DTaP and IPV received in left arm; MMR and PCV received in right arm On 4-18-06 at approximately 5:00pm, patient (noted by mom)complained that arm "was on fire".  Mother stated had redness and swelling in left arm with red streaks going down arm. Patient taken to Urgent Care.  Diagnosis of cellulitis made.  Patient placed on antibiotics.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Arthralgia, Influenza like illness, Joint swelling, Pain
Clinical narrative: I began feeling feverish and flu like body symptoms from Tuesday 4/18/06, then knees started getting gradually swollen and painful, swollen fingers and joints, elbows, and pain all over any connecting bone, I then notice a light rash all over body.  Then knees got really swollen to the point I couldn't walk. Right now I can hardly hold anything on my hands because of this weakness and pain on my knuckles.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: I began feeling feverish and flu like body symptoms from Tuesday 4/18/06, then knees started getting gradually swollen and painful, swollen fingers and joints, elbows, and pain all over any connecting bone, I then notice a light rash all over body.  Then knees got really swollen to the point I couldn't walk. Right now I can hardly hold anything on my hands because of this weakness and pain on my knuckles.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Shoulder pain, Sleep disorder, Tenderness
Clinical narrative: Left shoulder sore for 3 days following injection.  Pain went away.  Pain woke pt. from sleep 4/18/06, could not lie on left sied.  4/19/06, pain varies from slight to severe w/radiation to left anterior chest, left shoulder area, posterior left upper arm.  Pain increased w/deep inspiration.  Small nodule w/minimal pain.  No fever.  Mild tenderness to palpation over left acromium.  Mild tenderness w/deep palpation of deltoid & focal tenderness over posterior humerus.  No swelling or erythema.  Left shoulder ROM normal.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Flushing, Injection site induration, Pyrexia
Clinical narrative: PT MOTHER CALLED AND STATED THAT PT HAS HAD LOW GRADE FEVER, FLUSHING OF THE CHEEKS, AND A QUARTER-DOLLAR SIZED INDURATION ON HER RIGHT UPPER ARM WHERE THE VACCINES WERE INJECTED. SYMPTOMS STARTED THE FOLLOWING DAY AFTER ADMINISTRATION.
Sex: M
Vaccine: LYME
Symptoms: Abnormal behaviour, Arthralgia, Autoimmune disorder, Cognitive disorder, Eye disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bells Palsy in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgia, myalgias, Bells Palsy, fatigue, headaches, eye problems, numbness, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reportedly caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manf. (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries.
Sex: M
Vaccine: LYME
Symptoms: Facial palsy, Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bells Palsy in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgia, myalgias, Bells Palsy, fatigue, headaches, eye problems, numbness, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reportedly caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manf. (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries.
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder, Rheumatoid factor
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bells Palsy in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgia, myalgias, Bells Palsy, fatigue, headaches, eye problems, numbness, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reportedly caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manf. (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries.
Sex: M
Vaccine: DTAP
Symptoms: Autism
Clinical narrative: This case was reported by a health care professional and described the occurrence of autism in a male subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject was 3 years old at the time of reporting. On 12/24/02, when the subject was two months old, he received the 1st dose of Infanrix (lot number 578B9). On 2/24/03, when the subject was four months old, he received the 2nd dose of Infanrix (lot number 583B2). On an unspecified date on or before 4/18/06, the subject developed autism. The outcome of the autism was unresolved. The vaccination series was completed with Tripedia. Comment: Autism was assessed as medically serious (OMIC).
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Autism
Clinical narrative: This case was reported by a health care professional and described the occurrence of autism in a 1 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 30Mar01, when the subject was two months old , he received the first dose of Infanrix (lot number 991A2). On 29May01, at four months of age, the subject received the 2nd dose of Infanrix (lot number 982A2). On 26Jul01, when the subject was six months old, he received the third dose of Infanrix (lot number 501A2). On an unspecified date in 2002, at 1 yr of age and six months after the third dose of Infanrix, the subject developed autism. He received a 4th dose of Infanrix (lot number 538A2) on 29April2002. The outcome of the autism was unresolved. Autism was assessed as medically serious by manf (OMIC).
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Listless
Clinical narrative: This case was reported by a consumer and described the occurrence of stopped breathing in a 2 week old female subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. A physician or other health care professional has not verified this report. On 4/6/05, on her date of birth, the subject received 1st dose of Engerix B (0.5ml, unknown). On 4/20/05, 14 days after vaccination with Engerix B, the subject was taken to the emergency room because she stopped breathing. In the emergency room, she was described as having listlessness. On 4/20/05, the subject recovered in the emergency room after approximately 30 minutes, but was admitted to the hospital for observation. The vaccination series with Engerix B was discontinued.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: 2.5 cm x 1.5 cm bruise at injection site, 6cm x 7cm area of erythema, firm, inflamed. Treated with Ibuprofen 150 ng Q 6H x 48H and cool compresses PRN.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 4.5 x 5.5 cm red, swollen, warm to touch and indurated right deltoid increased with ice application to 6.5 x 5.5cm and urticarial. Decreased O/P Zyrtec.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Urticaria
Clinical narrative: 4.5 x 5.5 cm red, swollen, warm to touch and indurated right deltoid increased with ice application to 6.5 x 5.5cm and urticarial. Decreased O/P Zyrtec.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt developed chickenpox (+ clinical varicella) during an outbreak despite vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, MMR, PNC
Symptoms: Pruritus, Pyrexia, Rash, Rash macular
Clinical narrative: Fever 101.5 x 1 day on 4/22/2005, rash started 4/22/05 on entire body, pink macular rash. Atarax as needed for pruritus.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Rash pruritic
Clinical narrative: Within 4-5 days of receiving vaccine I began having small raised itchy bumps along hairline which eventually showed up sporadically over entire body, extremely itchy.
Age: 83.0
Sex: F
Vaccine: TD
Symptoms: Infection, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Client into HO C/T a cat scratch to lip, TD 10 yrs, given 3/21/06 IM Left arm, 4/3/06 client called me ant stated she felt she had had a reaction 1 week after shot with itching, at site, some swelling, soreness continues no rabies in animal.  She went to MD for treatment to lip. 4/18/06 states left breast mastoiditis with antibiotics, a biopsy is planned. Soreness on top her arm remains (mammogram done between 3/21 and 4/3). Sore just below left elbow. Told not to have another TD and for me to file a report.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Eyelid oedema, Flushing, Ocular hyperaemia, Staring
Clinical narrative: Pt was given MMR, IPV and DTaP, 20 mins after vacc, given child lt eye lid became swollen, both eyes red, face flushed deep red. Child had dazed look. Child said throat felt funny, and was clearing throat frequently. Mom states child never had done this. Benadryl 0.45 ml given IM. Child improved color redness. states feels better.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Pt received varicella vaccine 3/17/2006 on 3/23/2006 had red streak marks on right side with severe pain PCP told mother having reaction to vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Asthenia, Nausea, Syncope, Vomiting
Clinical narrative: Pt became nauseated, 5 minutes after receiving vaccine, vomited x 1, became weak, cool cloth to face ammonia under nose. Alert and oriented when leaving clinic 25 mins later.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Feeling hot, Oedema, Tenderness
Clinical narrative: 24 hours after administration pt had erythema, edema and heat. Seen 48 hours after administration and had 10 cm x 12 cm area of erythema and tenderness. No SOB/DOE difficulty breathing.
Age: 1.26
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: 3-4 dozen papules itching.
Age: 35.0
Sex: F
Vaccine: HEP, TD
Symptoms: Chills, Erythema, Hypoaesthesia, Inflammation, Joint range of motion decreased
Clinical narrative: Pt vaccinated on 4/6/06 with Td and HBV. Next day Friday pt developed chills, fever 102, inflammation of LT arm with severe pain redness and numbness. Went to ER. Stated was told whole muscle was. Pt stated was given antibiotics. Did not know name of medication. Stated at one point did not have any range of motion in left arm. States has been going to private MD almost daily. Area continues to be red per history. States has not been back to work since going to ER. States PMD placed pt on different antibiotic Avelox. States has some range of motion now. States has been to see PMD on 4/10/06, 4/11/06, and today 4/13/06. Has return appt next Friday 4/14/06. Pts PMD called in information given about release of information from PT. Pt was notified of National vaccine, injury compensation program and the National Immunization program and national injury compensation program phone numbers. Pt was asked to come to health unit to sign release of information. Package inserts and vis mailed to pt 4/13/06. Pt called to report events on 4/13/06.
Age: 35.0
Sex: F
Vaccine: HEP, TD
Symptoms: Pyrexia
Clinical narrative: Pt vaccinated on 4/6/06 with Td and HBV. Next day Friday pt developed chills, fever 102, inflammation of LT arm with severe pain redness and numbness. Went to ER. Stated was told whole muscle was. Pt stated was given antibiotics. Did not know name of medication. Stated at one point did not have any range of motion in left arm. States has been going to private MD almost daily. Area continues to be red per history. States has not been back to work since going to ER. States PMD placed pt on different antibiotic Avelox. States has some range of motion now. States has been to see PMD on 4/10/06, 4/11/06, and today 4/13/06. Has return appt next Friday 4/14/06. Pts PMD called in information given about release of information from PT. Pt was notified of National vaccine, injury compensation program and the National Immunization program and national injury compensation program phone numbers. Pt was asked to come to health unit to sign release of information. Package inserts and vis mailed to pt 4/13/06. Pt called to report events on 4/13/06.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: DTaP in left arm on 04/17/06. Today is red, swollen, tennis ball size 4/20/06 5/12 x 6cm Per mom am in clinic 4/20/06 2:10 PM, Cellulitis-Cephalexin. RXN to DTaP.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Discomfort, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Swelling, redness, warm to touch approx, 24 hours after injection. Also itching. Redness spread 5 1/2" x 5 1/4". Parents treated with ice denies fever. Benadryl for itching, Tylenol for discomfort.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Pt given DTaP on 4/12/06, On 4/13/2006 pt goes to ER with left thigh swollen and red. Pt F/U with us on 4/17/06.
Age: 5.0
Sex: M
Vaccine: DT
Symptoms: Dysphemia
Clinical narrative: 03/08/2006 parent stated that child started stuttering 3 hours after vaccination and this was never noted before. 3/10/06 child evaluated by Doctor. Doctor didn't think stuttering was related, but continues to evaluate.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Convulsion, Hypotonia, Pyrexia, Staring
Clinical narrative: Fever to at least 102 (as recorded in ER) even after dose of Tylenol given. Patient with seizure episode (Staring episode, limp, unresponsive) for about 6-10 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Adverse reaction to Dtap or IPV vaccine lg red area with swollen deltoid. Unable to determine which immunization caused reaction. Given Benadryl Per DR. Walk in clinic.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Developed chicken pox 10 days after vaccination.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt c/o fingers and toes were tingling and arms felt numb. Approx 1-2 hours after injection pt came back to Dr office walked into room alert. Neuro exam neg. Called pts home 4/31/06 pt doing fine.
Age: 17.0
Sex: M
Vaccine: HEP, MNQ, TD
Symptoms: Face oedema
Clinical narrative: Swelling lips and mouth.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Multiple sclerosis, Tremor
Clinical narrative: Client called today 4/18/06 states left arm and hand tremors developed in March, being tested for MS by DR, now concerned if vaccine associated.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site.