chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 4/26/2006 from the patient. A 74 year old female patient, who had concurrent sinusitis, and was taking Ceftin, received an administration of a Diphtheria and tetanus toxoids, on 1/26/2006. The manufacturer, route, and site of administration were not reported. Two days post immunization, the patient had redness, and her arm was stiff and painful. She had mild fever of 100 deg F. Upon examination by a physician, the patient was treated with Epipen and prednisone. The next day, the redness was spreading and she went to the emergency room, where her temp was found to be 102 degree F, Benadryl was administered. The next day, the redness had spread to her elbow, and the injection site was hot and swollen. She returned to the ER where she was given Bactrim. A day later, the redness had spread under the arm, and the patient was sent to an infectious disease physician, who treated her with IV Solumedrol. She received two more doses of Iv Solumedrol over the next two days. After the last dose of IV Solumedrol on 2/2/2006 her symptoms resolved.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 4/26/2006 from the patient. A 74 year old female patient, who had concurrent sinusitis, and was taking Ceftin, received an administration of a Diphtheria and tetanus toxoids, on 1/26/2006. The manufacturer, route, and site of administration were not reported. Two days post immunization, the patient had redness, and her arm was stiff and painful. She had mild fever of 100 deg F. Upon examination by a physician, the patient was treated with Epipen and prednisone. The next day, the redness was spreading and she went to the emergency room, where her temp was found to be 102 degree F, Benadryl was administered. The next day, the redness had spread to her elbow, and the injection site was hot and swollen. She returned to the ER where she was given Bactrim. A day later, the redness had spread under the arm, and the patient was sent to an infectious disease physician, who treated her with IV Solumedrol. She received two more doses of Iv Solumedrol over the next two days. After the last dose of IV Solumedrol on 2/2/2006 her symptoms resolved.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Arthritis bacterial, Lymphopenia, Malaise, Movement disorder
Clinical narrative: Information has been received concerning a 68 year old female with rheumatoid arthritis, osteoporosis and pain who on 11/25/2005 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown) and a jab of influenza virus vaccine unspecified. Concomitant therapy included diclofenac, leflunomide, tramadol HC1 (Tramadolor), cholecaloiferol, risedronate sodium (Actonel) and etanercept Enbrel. It was reported that a patient was a participant in a study. In the evening of 11/25/2005 the patient also had a dose of etanercept Enbrel. Approximately three months post initiation of etanercept Enbrel therapy and one day after Saturday 11/26/2005 receiving the Pneumococcal 23v polysaccharide vaccine, the patient started feeling ill (malaise), pain in joints (knees, elbows, all over body, arthralgia), and wasn't able to move (movement disorder). On 11/27/2005, the patient called the ambulance and was accepted as an inpatient on 11/28/2005 (2 days later) for an unknown period of time. Therapy with etanercept Enbrel was discontinued. The patient was diagnosed with polyarticular septic arthritis. Treatment included intravenous antibiotics unspecified. It was reported that the patient was re admitted to the hospital approximately one month later, additional details were not provided. It was reported that the septic arthritis was considered severe and it persisted. The reporter suspected the event was related to therapy with etanercept Enbrel and Pneumococcal 23v polysaccharide vaccine was identified as co suspect. The temporal relationship between the onset of the event and the administration of therapy suggests that a causal relationship is possible, however, causality is confounded by the concurrent use of diclofenac, leflunomide, tramadol HCL Tramadolor, and Pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neutropenia, White blood cell count increased
Clinical narrative: Information has been received concerning a 68 year old female with rheumatoid arthritis, osteoporosis and pain who on 11/25/2005 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown) and a jab of influenza virus vaccine unspecified. Concomitant therapy included diclofenac, leflunomide, tramadol HC1 (Tramadolor), cholecaloiferol, risedronate sodium (Actonel) and etanercept Enbrel. It was reported that a patient was a participant in a study. In the evening of 11/25/2005 the patient also had a dose of etanercept Enbrel. Approximately three months post initiation of etanercept Enbrel therapy and one day after Saturday 11/26/2005 receiving the Pneumococcal 23v polysaccharide vaccine, the patient started feeling ill (malaise), pain in joints (knees, elbows, all over body, arthralgia), and wasn't able to move (movement disorder). On 11/27/2005, the patient called the ambulance and was accepted as an inpatient on 11/28/2005 (2 days later) for an unknown period of time. Therapy with etanercept Enbrel was discontinued. The patient was diagnosed with polyarticular septic arthritis. Treatment included intravenous antibiotics unspecified. It was reported that the patient was re admitted to the hospital approximately one month later, additional details were not provided. It was reported that the septic arthritis was considered severe and it persisted. The reporter suspected the event was related to therapy with etanercept Enbrel and Pneumococcal 23v polysaccharide vaccine was identified as co suspect. The temporal relationship between the onset of the event and the administration of therapy suggests that a causal relationship is possible, however, causality is confounded by the concurrent use of diclofenac, leflunomide, tramadol HCL Tramadolor, and Pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Age: 36.0
Sex: U
Vaccine: HEP
Symptoms: Myelopathy
Clinical narrative: Information has been received from a lawyer concerning a literature article where a 36 year old patient was vaccinated with a booster dose of RECOMBIVAX HB manufacturer unknown. Subsequently, the patient developed a progressive and ultimately fatal, inflammatory myelopathy polyradiculopathy nine days after the booster dose. It was reported that the patient had no fever or systemic illness and did not respond to extensive immunotherapy. No further information was available at the time of this report. Additional information has been requested. A copy of the published article will be provided, when available, as further documentation of the patients experience.
Sex: M
Vaccine: HEP
Symptoms: Guillain-Barre syndrome, Hypertension
Clinical narrative: Information has been received from a lawyer concerning a male who was vaccinated with RECOMBIVAX HB (manufacturer unknown). The patient suffered a vaccine injury Guillain Barre syndrome as a result of RECOMBIVAX HB. In 2005 the patient died from hypertension. No further information was available at the time of this report. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Candidiasis, Cerebral haemorrhage, Chromosome abnormality, Coagulopathy, Dehydration
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo.  Had also used 2 IND drugs on this patient (ribavirin & VeriZIG)  PMH: preexisting pulmonary fibrosis & intermittent thrush since birth.  Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks.  Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration.  PMH: protracted history of colds & ear infections.  Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg.  Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06.  Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage.  8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Hypoxia, Immune system disorder, Laboratory test abnormal, Liver function test abnormal, Lung disorder
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo.  Had also used 2 IND drugs on this patient (ribavirin & VeriZIG)  PMH: preexisting pulmonary fibrosis & intermittent thrush since birth.  Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks.  Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration.  PMH: protracted history of colds & ear infections.  Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg.  Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06.  Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage.  8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pneumonia, Pulmonary fibrosis, Rash vesicular, Respiratory distress, Sepsis
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo.  Had also used 2 IND drugs on this patient (ribavirin & VeriZIG)  PMH: preexisting pulmonary fibrosis & intermittent thrush since birth.  Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks.  Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration.  PMH: protracted history of colds & ear infections.  Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg.  Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06.  Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage.  8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo.  Had also used 2 IND drugs on this patient (ribavirin & VeriZIG)  PMH: preexisting pulmonary fibrosis & intermittent thrush since birth.  Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks.  Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration.  PMH: protracted history of colds & ear infections.  Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg.  Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06.  Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage.  8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Coagulopathy, Hepatitis, Lymphopenia, Pneumonitis, Respiratory distress
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo.  Had also used 2 IND drugs on this patient (ribavirin & VeriZIG)  PMH: preexisting pulmonary fibrosis & intermittent thrush since birth.  Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks.  Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration.  PMH: protracted history of colds & ear infections.  Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg.  Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06.  Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage.  8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.
Age: 1.01
Sex: M
Vaccine: PNC
Symptoms: Autism, Constipation, Sleep disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding her son who experienced autism. The child, who is currently 5 years of age, received the fourth dose of Prevnar on 7/30/2001, at 12 months of age. The patients concurrent illness includes trisomy 21 with a past history of ear tube insertion, surgery for cryptorchism and atrial septal defect PFO hole in heart, early 2001) which closed on its own. Indication for Prevnar was immunisation. Product was administered on 7/30/2001. Dose regimen was 1 dose 1 time per day intramuscular. there other vaccines unspecified are suspect and were administered on 10/5/2000, along with the first dose of Prevnar. Concomitant medications were not reported. According to the child's mother, her son was diagnosed with autism after receiving the series of Prevnar injections. The reporter noted that the diagnosis of autism occurred on 11/23/2003. The fourth and last dose of Prevnar was administered on 7/30/2001. The child is currently 5 years of age and is entering kindergarten. Since 2003, the child takes oral therapies, glycolax powder for constipation, melatonin for sleep disorder, calcium/magnesium/zinc as a dietary supplement. No additional information was available at the time of this report.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Lymphopenia, Meningitis, Myalgia, Pyrexia
Clinical narrative: Cephalgia, fever, myalgias, T 38.4C. Presented to ED to r/o meningitis on 4/7/06. Diagnosis: viral syndrome. I do not know if Adacel played any role in this event. Reporting for the purpose of adverse SE surveillance (OMIC)
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Viral infection, White blood cell disorder
Clinical narrative: Cephalgia, fever, myalgias, T 38.4C. Presented to ED to r/o meningitis on 4/7/06. Diagnosis: viral syndrome. I do not know if Adacel played any role in this event. Reporting for the purpose of adverse SE surveillance (OMIC)
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Bone disorder, Injection site erythema, Injection site swelling, Joint stiffness
Clinical narrative: Symptoms: Joint pain, multiple joints, muscle pain, paresthesia, tingling in lower extremities. Service member would like to report a vaccine related side effect-reports polyarthralgia, polymyalgia, and neuropathy in lower extremities following receipt of her 3rd anthrax vaccine. Received anthrax (3) in left arm over triceps on 3/7/03. Had a moderate local reaction with swelling and redness from near shoulder to just above elbow with myalgias described as dull, aching type pain affecting all joints and major muscle groups. Describes muscle pain as "tightness fatigued, like after major muscle use", but with minimal muscle exertion (example: after climbing 1 flight of stairs, leg muscles feel like she has pushed herself running several miles). Also reports muscles sometimes "tremble" which is self limited and last <1 minute. Usually wakes up with morning joint stiffness that last 2-3 hours; stiffness becomes more severe after sitting during a 45 minute drive, especially pain in sacral area. At end of day, "everything hurts". Stretching and heat help with pain. Also, if on her feet for extended periods, finds standing with a wide-based stance helps. Takes Motrin 800mg bid on daily basis, which helps make pain tolerable. Has taken Percocet for more severe pain, especially at the end of the day. Denies swelling, redness or increased warmth over joints. She thought the pain was related to 40 pound weight gain. Some improvement with weight loss accomplished through increased exercise (walking); when she stopped walking, her left SI joint became extremely painful and there was evidence of inflammation of SI joint around that time per CT. Has been evaluated by Rheumatology, with no definitive diagnosis. She denies history of trauma or injuries. No decreased strength. Positive family history of RA. Noted onset of bilateral lower leg, ankle and feet tingling. Paresthesias have gradually worsened. Neurology exam diagnosed as peripheral neuropathy, but not able to attribute to DM or other etiology. No stumbling or altered gait.
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Symptoms: Joint pain, multiple joints, muscle pain, paresthesia, tingling in lower extremities. Service member would like to report a vaccine related side effect-reports polyarthralgia, polymyalgia, and neuropathy in lower extremities following receipt of her 3rd anthrax vaccine. Received anthrax (3) in left arm over triceps on 3/7/03. Had a moderate local reaction with swelling and redness from near shoulder to just above elbow with myalgias described as dull, aching type pain affecting all joints and major muscle groups. Describes muscle pain as "tightness fatigued, like after major muscle use", but with minimal muscle exertion (example: after climbing 1 flight of stairs, leg muscles feel like she has pushed herself running several miles). Also reports muscles sometimes "tremble" which is self limited and last <1 minute. Usually wakes up with morning joint stiffness that last 2-3 hours; stiffness becomes more severe after sitting during a 45 minute drive, especially pain in sacral area. At end of day, "everything hurts". Stretching and heat help with pain. Also, if on her feet for extended periods, finds standing with a wide-based stance helps. Takes Motrin 800mg bid on daily basis, which helps make pain tolerable. Has taken Percocet for more severe pain, especially at the end of the day. Denies swelling, redness or increased warmth over joints. She thought the pain was related to 40 pound weight gain. Some improvement with weight loss accomplished through increased exercise (walking); when she stopped walking, her left SI joint became extremely painful and there was evidence of inflammation of SI joint around that time per CT. Has been evaluated by Rheumatology, with no definitive diagnosis. She denies history of trauma or injuries. No decreased strength. Positive family history of RA. Noted onset of bilateral lower leg, ankle and feet tingling. Paresthesias have gradually worsened. Neurology exam diagnosed as peripheral neuropathy, but not able to attribute to DM or other etiology. No stumbling or altered gait.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: Hives, redness, itching at site. Benadryl given.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MER
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Nickel-sized wheal around IPV site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child received immunizations PM of 4/26. Arm was slightly red on 4/27, when woke up. Child told mother bumped on bed. 4/28, child c/o very sore arm, red, swollen, hard and warm. Came to HD and was referred to PMD. Seen in PM of 4/28. Instructed to apply warm compress and massage area (3x3) to help hardness decrease. Given Benadryl 1 tsp q 6 hrs until 4/30. Better on 4/29 and cleared by 4/30. 5/2/06, Talked in person to RN that saw child at clinic on 4/28. Area on arm that reacted was deltoid where DTAP was given, not posterior where MMR was given. Reaction to DTAP entered.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Parent reported Now-stop, high-pitched crying approximately 2 1/2 hours after vaccine administration. Patient evaluated in office. Afebrile 97/9 (R). Tylenol 80mg q 4h. Parent reported crying had stopped approximately 8 hours after vaccine administration.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody positive, Arthralgia, Fatigue, Joint swelling, Rash maculo-papular
Clinical narrative: 3.12 to 3/18/06: Fatigue, intense. 3/20/06-macular rash/macular papular abdomen. 3/22/06-Pain in ankles, knees, hands with swelling.
Age: 1.61
Sex: F
Vaccine: MMR
Symptoms: Crying, Pyrexia, Rash, Screaming
Clinical narrative: Fever up to 102 and persistent crying 10 hours after administration of vaccine, fever for 36 hours. Rash 15-17 days starting on neck, moved to face, spread to torso.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: The evening after vaccine complained of nausea, sore arm at injection site. The next day about 22 hours after vaccine came home from school with 102 F fever. Fever persisted for 48 hours then resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pruritus, Rash papular, Rash vesicular, Viral infection
Clinical narrative: Presented in office 3/30/06 with itchy papules x 4-6 days. Scabbed over papules GU, abdomen, and neck. Dx with Varicella. Hx Varivax 5/9/00.
Age: 45.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injury, Muscle disorder, Shoulder pain
Clinical narrative: States after last injection had severe pain in left shoulder starting about 3 days after injection on 11/17/05. Pain lasted about 3 weeks went to health science center and was seen by MD there. States was told that she had muscle trauma from the injection. States MD prescribed Tylenol 3 for pain. Denies any pain or problems currently with shoulder.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: When dad came for PPD reading on 4/14/06, he mention that the left arm is slightly swollen and slightly warm. Seen by Dr on 4/14/06 and ordered ice pack to be applied and to take Benadryl 12.5 mg PO x06 hours.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Swelling and redness of left thigh around site of vaccine injection with 24 hours from injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Red raised rash with itching left leg started out red than turned to raised and itchy. Benadryl. Still present 10 days after vaccine, 6x8cm redness, erythema.
Age: 0.76
Sex: F
Vaccine: HIBV, IPV
Symptoms: Condition aggravated, Dysphonia, Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: At injection site on left thigh, next morning following injection, patient had a hard, knot like bump with redness, swelling. Size was described as half dollar by parent. Irritable on day following immunizations, Hoarseness in voice (may have been present at time of immunizations) got much more severe. Hoarseness recovered left thigh gradually resolving area of swelling.
Age: 0.76
Sex: F
Vaccine: HIBV, IPV
Symptoms: Irritability
Clinical narrative: At injection site on left thigh, next morning following injection, patient had a hard, knot like bump with redness, swelling. Size was described as half dollar by parent. Irritable on day following immunizations, Hoarseness in voice (may have been present at time of immunizations) got much more severe. Hoarseness recovered left thigh gradually resolving area of swelling.
Age: 13.0
Sex: F
Vaccine: TTOX, VARCEL
Symptoms: Injection site pain
Clinical narrative: Soreness at the site of shot.
Age: 27.0
Sex: F
Vaccine: HEPAB, IPV, TTOX, YF
Symptoms: Headache, Vomiting
Clinical narrative: Pt. experienced vomiting and headache approx. 3 hours after each dose of Vivotif.  Pt. states no pills in vomit.  Pt. completed course of vaccine.  None of these episodes were reported at the time.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Hepatitis, Jaundice, Viral infection
Clinical narrative: This case was reported by a physician and described the occurrence of jaundice in a 2 month old subject of unspecified gender who was vaccinated with hep B vaccine recombinant (Engerix) for prophylaxis. At the time of the subject's birth, the mother was negative for hep B. On an unspecified date before 10May06, the subject received 2nd dose of Engerix B. On an unspecified date on or before 10May06, 2 days after vaccination with Engerix B, the subject experienced jaundice. The subject was seen at a physician's office. The physician reported that a hep B test was performed and results were positive for hep B. At the time of initial reporting, 10May06, the events were ongoing. Jaundice was assessed as medically serious by manf (OMIC).
Age: 33.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Blood glucose increased, Dizziness, Nausea
Clinical narrative: Felt lightheaded approximately 1 1/2 - 2 hours post taking the oral typhoid. Also has slight nausea. VSS 100/82 (NL Low BP for PT0 86 -R16, Blood sugar 112, Rest, fluids oral, ate cracker.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Contusion, Erythema, Oedema, Pruritus
Clinical narrative: Swelling x 1 day, itching, redness, bruising.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Chest pain, Injection site hypersensitivity, Pain, Pyrexia, Urticaria
Clinical narrative: Donor had 4th shot on 5/9/06. Donor called on 5/10/06 and reported that she had red whelps where her shots were given and that she is running a fever 101, having chest pains and feeling achy all over. Advised donor to go to the ER immediately.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Cellulitis, Joint swelling, Laboratory test abnormal, Polyarthritis, Rash
Clinical narrative: Swelling of joints, migratory polyarthritis, diagnosed 5/5/06, RX prednisone, Lasix started 5/2/06, cellulitis diagnosed 10/21/06 welt, rash on face, RX Prednisone, Cipro.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Swelling of joints, migratory polyarthritis, diagnosed 5/5/06, RX prednisone, Lasix started 5/2/06, cellulitis diagnosed 10/21/06 welt, rash on face, RX Prednisone, Cipro.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Face oedema, Oedema peripheral
Clinical narrative: 5/8/06 pt here for redness and swelling around face and right leg, had vaccines 1 hr prior to this reaction. Gave Epinephrine 1:1000 solution 0.2mg (.2ml) SQ, SIG clearing after 5 mins, after 10 mins only had mild edema of lip. HR 88
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Redness and swelling of left thigh 21 x 12 cm.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling, Injection site urticaria, Skin nodule, Tenderness, Urticaria
Clinical narrative: 1 day after vaccine leg tender, 5 days after vaccine raised urticaria at site 3x4cm, 6 days after vaccine 8 small raised wheels around original hive. Pt has mastocytosis.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Received Varivax 1996, today break thru Varicella, not severe reporting for informational purposes only.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 7 days post vaccination, development of total localized area of 10cm diameter of erythema, warmth, and mild induration.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: 7cm area of erythema with tenderness at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Patient with swelling, warmth and itching erythema and pain right thigh at site of DTaP and IPV given on 4/19/06. Care sought on 4/21/06 patient with low grade temp Benadryl 12.5 mg given. 4/24 v'd with mom and son much improved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Patient with swelling, warmth and itching erythema and pain right thigh at site of DTaP and IPV given on 4/19/06. Care sought on 4/21/06 patient with low grade temp Benadryl 12.5 mg given. 4/24 v'd with mom and son much improved.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 04/20/2006 received injection 4/21/06 site had soft tissue swelling, warm and hard to touch. Site was erythematous as well.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Apnoea, Dizziness, Hypoxia, Injury, Loss of consciousness
Clinical narrative: 1 min. after receiving smallpox vaccine pt. complained of lightheadedness.  Immediately loss consciousness & fell to the floor hitting head on a shelf.  Became apneic, pale, & demonstrated tonic-clonic activity in the upper & lower extremities.  Epi X 1 given.  Ventilated with bag-valve mask, IV started, O2 applied per non-rebrather mask after about 2 minutes.  Regained consciousness in 4-5 minutes.  Transported to local ER per EMS.  Observed for 3 1/2 hours.  Given Peocid 40mg IVP, Solu-Medrol 125mg IVP, & Benadryl 25mg IVP.  Vital signs remained WNL.  Returned to medical Clinic that afternoon and the next morning for follow-up evaluation.  Review of systems all WNL.  Scheduled for a evaluation by Neurology in 1 week.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Muscle twitching, Pallor
Clinical narrative: 1 min. after receiving smallpox vaccine pt. complained of lightheadedness.  Immediately loss consciousness & fell to the floor hitting head on a shelf.  Became apneic, pale, & demonstrated tonic-clonic activity in the upper & lower extremities.  Epi X 1 given.  Ventilated with bag-valve mask, IV started, O2 applied per non-rebrather mask after about 2 minutes.  Regained consciousness in 4-5 minutes.  Transported to local ER per EMS.  Observed for 3 1/2 hours.  Given Peocid 40mg IVP, Solu-Medrol 125mg IVP, & Benadryl 25mg IVP.  Vital signs remained WNL.  Returned to medical Clinic that afternoon and the next morning for follow-up evaluation.  Review of systems all WNL.  Scheduled for a evaluation by Neurology in 1 week.
Age: 0.0
Sex: U
Vaccine: DTAP, HBHEPB, IPV, MNQ
Symptoms: Medication error
Clinical narrative: None noted - MCV4 incorrectly given instead of PCV4
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, MNQ
Symptoms: Medication error
Clinical narrative: N.A. - MCV4 incorrectly given instead of PCV4
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: C/o itching in left upper arm last night according to father. Upper arm red, warm and slightly swollen. No treatment per father enc to apply ice and give an antihistamine for age.
Age: 1.38
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Bacterial infection, Dermatitis bullous
Clinical narrative: Two weeks after receiving his Varicella vaccine he developed a rash, which was seen by the doctor and confirmed as varicella
Age: 1.19
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Muscle twitching
Clinical narrative: Jerking head to shoulder (twitching) for the past 3-4 days. No fever or seizure activity. Instructed to follow up with a medical care provider.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Hives 24 hours after Td injection. Self medicated with Benadryl, hives resolved.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Hypokinesia, Oedema
Clinical narrative: Left upper arm became very swollen, hot to touch.  Arm was difficult to move due to pain. (Tdap incorrectly given instead of Td)
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt recieved dt right deltoid 4/24/06 subsequently c/o muscle aches to RUE to neck, reports fevers. Pt is unaware if she recieved dt in the past. Physical exam is negative and pt is afibrile.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: At site of DTaP, patient developed redness, swelling and induration (5 x 5.5 cm.)  Mom scheduled office visit.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: Pt has 10.5 cm x 8 cm area of erythema with 8 cm x 6.5 cm area induration with 3 cm diameter centrally of minor excoriation.  Pt complaints pf pruritus. Pt has no complaints of pain or has a fever.
Age: 35.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Patient presented to this Immunization Clinic on 8 May 2006 at 1300 hours stating PA-C had advised her to receive a Pneumonia Vaccine.  Therefore, patient was vaccinated with Pneumovax(adult formulation)0.5ml given SQ over the right deltoid without any reaction noted at time of vaccination.  Patient contacted this Immunization Clinic on 10 May 2006 stating she had localized redness, swelling, and heat at the injection site on her right arm and was advised to see a provider for further evaluation.  Patient presented to PA-C for this evaluation at 1430 hours on 10 May 2006.  PA-C documented patchy, mild redness, and edema of the right upper upper arm from the inner aspect of the mid-humerous to the lateral aspect of the upper deltoid area with no significant redness or edema at the injection site.  Patient was positive for tenderness at injection site with no systemic symptoms.  Patient stated the site was improved from the previous day.
Age: 15.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Convulsion
Clinical narrative: Administered Hep B and Td in separate deltoid without incident.  After asking pt if ok and taling with him approx 1 minute, pt walked approx 12 feet down hall; stood in place aprox one min then collasped and hit his head on teh floor; pt started to seizure for approx 2 minutes, then stopped and pt became alert.   EMS ambulance staff transported pt out of the building at 5:00 p.m.  TETANUS AND DIPTHERIA TOXIOD ADMIN WAS DECAVAC
Age: 1.26
Sex: F
Vaccine: HBHEPB, HEPA
Symptoms: Erythema, Rash vesicular, Skin ulcer
Clinical narrative: 10 days post vaccination multiple red based lesions, 2 with small vesicles
Age: 12.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Vomiting
Clinical narrative: FEVER 101.6, VOMITING, REDNESS AND PAIN INJECTION SITE
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Erythema, Musculoskeletal stiffness, Myalgia
Clinical narrative: On awakening at 4:30 am on 4/19 left arm was sore and muscles in upper body and back were sore like when recently exercised - worsened all day.  Started to have fever about 2:30 with chills. Took temp. at 6pm was 100.6 degrees.  Felt so cold and muscles in legs, feet, hands were sore and stiff.  Hips hurt so she could not lie down.  Unable to sleep at night. Started to take Advil every 4 hours, at 6pm on 4/19/06.  Highest temp was 100.8 degrees on 4/20/06.  Advil 4 tabs every 4 hours during the day took edge off body discomfort.  Took advil before sleep with ambian and slept thru the night 4/20/06. Returned to work 4/21/06 with less soreness but 2.5cm x 3cm red swollen area on left deltoid.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema, Pain, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: On awakening at 4:30 am on 4/19 left arm was sore and muscles in upper body and back were sore like when recently exercised - worsened all day.  Started to have fever about 2:30 with chills. Took temp. at 6pm was 100.6 degrees.  Felt so cold and muscles in legs, feet, hands were sore and stiff.  Hips hurt so she could not lie down.  Unable to sleep at night. Started to take Advil every 4 hours, at 6pm on 4/19/06.  Highest temp was 100.8 degrees on 4/20/06.  Advil 4 tabs every 4 hours during the day took edge off body discomfort.  Took advil before sleep with ambian and slept thru the night 4/20/06. Returned to work 4/21/06 with less soreness but 2.5cm x 3cm red swollen area on left deltoid.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site rash
Clinical narrative: 8cm rash with induration on left thigh at site of dtap #4
Age: 48.0
Sex: F
Vaccine: HEPA, IPV, MEN, PPV, TYP, YF, HEPA, IPV, MNQ, PPV, TYP, HEPA, IPV, TYP, YF
Symptoms: Chills, Musculoskeletal stiffness, Pyrexia, Shoulder pain, Tremor
Clinical narrative: 4 yellow fever, Typhoid, hep A, Polio Monday 5/10/06, L Pneumonia and Meningitis R.  Wed 5/3/06, 3pm Wednesday fever, chills, neck pain, leg pain, stomach ache, hyperventilation, shaking, left upper arm red rash, very painful to touch, fever 101.5F,  ER, admit to hosp.
Age: 48.0
Sex: F
Vaccine: HEPA, IPV, MEN, PPV, TYP, YF, HEPA, IPV, MNQ, PPV, TYP, HEPA, IPV, TYP, YF
Symptoms: Abdominal pain upper, Chills, Hyperventilation, Injection site hypersensitivity, Injection site pain
Clinical narrative: 4 yellow fever, Typhoid, hep A, Polio Monday 5/10/06, L Pneumonia and Meningitis R.  Wed 5/3/06, 3pm Wednesday fever, chills, neck pain, leg pain, stomach ache, hyperventilation, shaking, left upper arm red rash, very painful to touch, fever 101.5F,  ER, admit to hosp.
Age: 48.0
Sex: F
Vaccine: HEPA, IPV, MEN, PPV, TYP, YF, HEPA, IPV, MNQ, PPV, TYP, HEPA, IPV, TYP, YF
Symptoms: Neck pain, Pain, Pyrexia, Rash, Tremor
Clinical narrative: 4 yellow fever, Typhoid, hep A, Polio Monday 5/10/06, L Pneumonia and Meningitis R.  Wed 5/3/06, 3pm Wednesday fever, chills, neck pain, leg pain, stomach ache, hyperventilation, shaking, left upper arm red rash, very painful to touch, fever 101.5F,  ER, admit to hosp.
Age: 48.0
Sex: F
Vaccine: HEPA, IPV, MEN, PPV, TYP, YF, HEPA, IPV, MNQ, PPV, TYP, HEPA, IPV, TYP, YF
Symptoms: Blood sodium decreased, Chills, Myalgia, Neck pain, Pyrexia
Clinical narrative: 4 yellow fever, Typhoid, hep A, Polio Monday 5/10/06, L Pneumonia and Meningitis R.  Wed 5/3/06, 3pm Wednesday fever, chills, neck pain, leg pain, stomach ache, hyperventilation, shaking, left upper arm red rash, very painful to touch, fever 101.5F,  ER, admit to hosp.
Age: 48.0
Sex: F
Vaccine: HEPA, IPV, MEN, PPV, TYP, YF, HEPA, IPV, MNQ, PPV, TYP, HEPA, IPV, TYP, YF
Symptoms: Tremor, White blood cell count increased
Clinical narrative: 4 yellow fever, Typhoid, hep A, Polio Monday 5/10/06, L Pneumonia and Meningitis R.  Wed 5/3/06, 3pm Wednesday fever, chills, neck pain, leg pain, stomach ache, hyperventilation, shaking, left upper arm red rash, very painful to touch, fever 101.5F,  ER, admit to hosp.
Age: 19.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Encephalitis, Facial palsy, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: HA, vomiting, Bell's Palsy, Encephalitis. Hospitalized. Serum sent to CDC for yellow fever testing. Follow-up: 06-Aug-2007 year the investigation BELL's Palsy has been resolved. Symptoms of shoulder/neck pain continues. Reminder: This case originates from FM025 which is a post marketing observation study.