chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: HEPA, IPV, MMR, TD, TYP
Symptoms: Necrosis, Viral infection
Clinical narrative: From initial information received on 04May05 from a literature report regarding an adverse event, it was reported that a 35 year old male pt received multiple immunization as part of preparation for deployment. The vaccinations consisted of Diphtheria and tetanus, tuberculin PPD, Typhoid vaccine, oral polio, hep A, MMR. The trade names, manf, lot numbers, routes and sites of admin were not reported. The vaccines were all administered on a single occasion on an unspecified date. Several days post immunization, the pt started to feel ill with fatigue, malaise, and general flu-like symptoms that progressed over several days. One week later, he presented to his primary care physician. The pt had no significant surgical history or prior transfusions. The pt was currently taking a beta blocker and diuretic for hypertension. He denied any recent ingestion of over the counter supplements. The pt denied any family history of liver disorders or autoimmune diseases. He denied a smoking history and his alcohol intake was infrequent small quantities. The pt denied any allergies to medications or food. Physical exam was unremarkable. At presentation, the pt's lab tests were significant for elevated liver associated enzymes with an aspartate aminotransferase (AST) level of 1361U/L, alanine aminotransferase (ALT) of 2656U/L, and alkaline phosphatase of 152u/L. Total bilirubin was 4.8mg/dL, with a direct bilirubin component of 3.1mg/dl. Additional lab tests included total protein of 7.8mg/dl, albumin of 4.2mg/dl, and y-glutamyl transpeptidase biopsy performed one month after initial presentation showed severe chronic hepatitis with widespread parenchymal injury, chronic portal inflammation, numerous plasma cells, and piecemeal necrosis. These findings were suggestive of AIH. Steroid therapy was initiated, and after two months of therapy, the liver enzymes responded well, with AST decreasing to 46u/L and ALT to 73u/L. Azathioprine was added to the medical regimen at two months post steroid therapy and the liver enzymes increased, AST to 895u/L and ALT to 1922u/L, after seven weeks of therapy. Repeat autoimmune markers showed ASMA of 1;80 and negative ANA, with IgG elevated, at 1590mg/dl. Endoscopic retrograde cholangiopancreatography was normal. Azathioprine was discontinued, steroids were increased, and tacrolimus was initiated. The medical regimen over the next five years consisted of prednisone, 10-20mg daily, and tacrolimus, 1mg twice a day. Attempts to taper the prednisone lower than 10 mg caused significant elevations in AST and ALT. A repeat biopsy performed five years following presentation showed moderate inflammatory activity consisting of plasma cells with mild periportal fibrosis. It was not reported whether this pt recovered from these events.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, HEPAB
Symptoms: Blindness, Cyst, Demyelination, Encephalopathy, Eye pain
Clinical narrative: Developed headaches, vision loss and eye pain. 5Dec03: Received anthrax #1, Twinrix and Influenza vaccines. 13Dec03: noticed fluid filled lesion on forefoot and a similar swelling under tongue that sometimes impaired speech. 20Dec03: Developed photophobia and throbbing headaches everywhere in head. He took Tylenol, continued full duty and did not seek medical care. He had sinus congestion at the time and these symptoms were related. 22Dec03: Awakened with headache and vision loss in right eye. Experienced aching in the eyeball itself and had acute pain in right eye when moving it. Pt was went to med center on 23Dec03 and was admitted to the inpatient service for an expedited malignancy workup. Diagnosis: right subretinal growth, likely idiopathic granuloma. Work up proved negative except for evidence of old granulomatous growth found on CT of the chest. He was also evaluated in ENT and the sulingual lesion was diagnosed as a mucocele and the lesion on the foot as a ganglionic cyst. He was started on prednisone 20mg and sent on CVL. Ophthalmology expected that his eye improve enough (if not fully) such that he will be a deployable soldier in the next 6-12 months. He continued on the prednisone for 3 weeks and his right vision improved so that he could see shapes but not details or colors. He followed up regularly with providers near his home. An MRI of the brain in Jun2004 showed Patchy white matter lesions possibly demyelinating or related to Leukoencephalopathy. Daily headaches have continued until the present. There is no pattern to them and some episodes are more severe than others. In Feb05 he returned to med center for further medical evaluation. This evaluation continues to the present.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, HEPAB
Symptoms: Fluid retention, Granuloma, Headache, Laboratory test abnormal, Mucous membrane disorder
Clinical narrative: Developed headaches, vision loss and eye pain. 5Dec03: Received anthrax #1, Twinrix and Influenza vaccines. 13Dec03: noticed fluid filled lesion on forefoot and a similar swelling under tongue that sometimes impaired speech. 20Dec03: Developed photophobia and throbbing headaches everywhere in head. He took Tylenol, continued full duty and did not seek medical care. He had sinus congestion at the time and these symptoms were related. 22Dec03: Awakened with headache and vision loss in right eye. Experienced aching in the eyeball itself and had acute pain in right eye when moving it. Pt was went to med center on 23Dec03 and was admitted to the inpatient service for an expedited malignancy workup. Diagnosis: right subretinal growth, likely idiopathic granuloma. Work up proved negative except for evidence of old granulomatous growth found on CT of the chest. He was also evaluated in ENT and the sulingual lesion was diagnosed as a mucocele and the lesion on the foot as a ganglionic cyst. He was started on prednisone 20mg and sent on CVL. Ophthalmology expected that his eye improve enough (if not fully) such that he will be a deployable soldier in the next 6-12 months. He continued on the prednisone for 3 weeks and his right vision improved so that he could see shapes but not details or colors. He followed up regularly with providers near his home. An MRI of the brain in Jun2004 showed Patchy white matter lesions possibly demyelinating or related to Leukoencephalopathy. Daily headaches have continued until the present. There is no pattern to them and some episodes are more severe than others. In Feb05 he returned to med center for further medical evaluation. This evaluation continues to the present.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, HEPAB
Symptoms: Photophobia, Sinus congestion, Sinusitis, Skin ulcer, Speech disorder
Clinical narrative: Developed headaches, vision loss and eye pain. 5Dec03: Received anthrax #1, Twinrix and Influenza vaccines. 13Dec03: noticed fluid filled lesion on forefoot and a similar swelling under tongue that sometimes impaired speech. 20Dec03: Developed photophobia and throbbing headaches everywhere in head. He took Tylenol, continued full duty and did not seek medical care. He had sinus congestion at the time and these symptoms were related. 22Dec03: Awakened with headache and vision loss in right eye. Experienced aching in the eyeball itself and had acute pain in right eye when moving it. Pt was went to med center on 23Dec03 and was admitted to the inpatient service for an expedited malignancy workup. Diagnosis: right subretinal growth, likely idiopathic granuloma. Work up proved negative except for evidence of old granulomatous growth found on CT of the chest. He was also evaluated in ENT and the sulingual lesion was diagnosed as a mucocele and the lesion on the foot as a ganglionic cyst. He was started on prednisone 20mg and sent on CVL. Ophthalmology expected that his eye improve enough (if not fully) such that he will be a deployable soldier in the next 6-12 months. He continued on the prednisone for 3 weeks and his right vision improved so that he could see shapes but not details or colors. He followed up regularly with providers near his home. An MRI of the brain in Jun2004 showed Patchy white matter lesions possibly demyelinating or related to Leukoencephalopathy. Daily headaches have continued until the present. There is no pattern to them and some episodes are more severe than others. In Feb05 he returned to med center for further medical evaluation. This evaluation continues to the present.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, HEPAB
Symptoms: Tongue oedema
Clinical narrative: Developed headaches, vision loss and eye pain. 5Dec03: Received anthrax #1, Twinrix and Influenza vaccines. 13Dec03: noticed fluid filled lesion on forefoot and a similar swelling under tongue that sometimes impaired speech. 20Dec03: Developed photophobia and throbbing headaches everywhere in head. He took Tylenol, continued full duty and did not seek medical care. He had sinus congestion at the time and these symptoms were related. 22Dec03: Awakened with headache and vision loss in right eye. Experienced aching in the eyeball itself and had acute pain in right eye when moving it. Pt was went to med center on 23Dec03 and was admitted to the inpatient service for an expedited malignancy workup. Diagnosis: right subretinal growth, likely idiopathic granuloma. Work up proved negative except for evidence of old granulomatous growth found on CT of the chest. He was also evaluated in ENT and the sulingual lesion was diagnosed as a mucocele and the lesion on the foot as a ganglionic cyst. He was started on prednisone 20mg and sent on CVL. Ophthalmology expected that his eye improve enough (if not fully) such that he will be a deployable soldier in the next 6-12 months. He continued on the prednisone for 3 weeks and his right vision improved so that he could see shapes but not details or colors. He followed up regularly with providers near his home. An MRI of the brain in Jun2004 showed Patchy white matter lesions possibly demyelinating or related to Leukoencephalopathy. Daily headaches have continued until the present. There is no pattern to them and some episodes are more severe than others. In Feb05 he returned to med center for further medical evaluation. This evaluation continues to the present.
Sex: M
Vaccine: HEP
Symptoms: Agitation, Autism, Constipation, Crying, Irritability
Clinical narrative: Crying, irritability, constipation, vomiting. Follow up 7/18/05:My son has PPD NOS (high-functioning autism) and ADHD. There is no cure. When will the drug makers be held accountable for what they have done to a whole generation of children? Subject has autism.  To my knowledge, there is no cure.  I hope one is found soon.  Subject was born with a birth defect.  His stomach was turned the wrong way causing him to vomit his feedings.  This was not known on 5-16-1996 when he was vaccinated.  He should Never have been vaccinated before being examined.  His weakened condition from the birth defect and then the vaccination caused his autism.
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Crying, irritability, constipation, vomiting. Follow up 7/18/05:My son has PPD NOS (high-functioning autism) and ADHD. There is no cure. When will the drug makers be held accountable for what they have done to a whole generation of children? Subject has autism.  To my knowledge, there is no cure.  I hope one is found soon.  Subject was born with a birth defect.  His stomach was turned the wrong way causing him to vomit his feedings.  This was not known on 5-16-1996 when he was vaccinated.  He should Never have been vaccinated before being examined.  His weakened condition from the birth defect and then the vaccination caused his autism.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Bacterial infection, Bence Jones protein urine present, CSF test abnormal, Central nervous system neoplasm, Cerebrovascular disorder
Clinical narrative: 10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI's, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis).  D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia.  PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000.  MRI done 11/1 showed multiple lesions on the brainstem.  LP w/high WBC & protein.  By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally.  Tx with high dose steroids & antibiotics.  Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions.  Developed low platelet counts which prevented PEG & tracheostomy.  Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban.  Stopped that when developed pancytopenia.  Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Coordination abnormal, Ear pain, Encephalitis toxic, Facial neuralgia
Clinical narrative: 10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI's, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis).  D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia.  PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000.  MRI done 11/1 showed multiple lesions on the brainstem.  LP w/high WBC & protein.  By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally.  Tx with high dose steroids & antibiotics.  Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions.  Developed low platelet counts which prevented PEG & tracheostomy.  Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban.  Stopped that when developed pancytopenia.  Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Headache, Hypoaesthesia oral, Nausea, Nervous system disorder
Clinical narrative: 10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI's, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis).  D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia.  PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000.  MRI done 11/1 showed multiple lesions on the brainstem.  LP w/high WBC & protein.  By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally.  Tx with high dose steroids & antibiotics.  Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions.  Developed low platelet counts which prevented PEG & tracheostomy.  Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban.  Stopped that when developed pancytopenia.  Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Neuralgia, Neurological symptom, Nuclear magnetic resonance imaging brain abnormal, Ophthalmoplegia, Optic neuritis
Clinical narrative: 10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI's, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis).  D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia.  PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000.  MRI done 11/1 showed multiple lesions on the brainstem.  LP w/high WBC & protein.  By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally.  Tx with high dose steroids & antibiotics.  Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions.  Developed low platelet counts which prevented PEG & tracheostomy.  Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban.  Stopped that when developed pancytopenia.  Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Protein bound iodine increased, Skin ulcer, Viral infection, Vomiting, White blood cell count increased
Clinical narrative: 10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI's, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis).  D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia.  PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000.  MRI done 11/1 showed multiple lesions on the brainstem.  LP w/high WBC & protein.  By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally.  Tx with high dose steroids & antibiotics.  Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions.  Developed low platelet counts which prevented PEG & tracheostomy.  Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban.  Stopped that when developed pancytopenia.  Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.
Age: 21.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Diabetes mellitus, Erythema, Erythema multiforme, Injection site erythema, Injection site induration
Clinical narrative: Reaction started with redness and swelling x 2-3 days. developed into a golf ball sized boil with red swelling and a white center x 1-2 weeks,. Very hard to the touch, took almost a year to go away. Skin at site is still indented. Stated pt recovered until the age of 12 when the onset of TypeI diabetes happened.
Age: 21.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Injection site mass, Injection site oedema, Skin disorder
Clinical narrative: Reaction started with redness and swelling x 2-3 days. developed into a golf ball sized boil with red swelling and a white center x 1-2 weeks,. Very hard to the touch, took almost a year to go away. Skin at site is still indented. Stated pt recovered until the age of 12 when the onset of TypeI diabetes happened.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Autoinoculation ULA and possibly left leg.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash vesicular, Tenderness
Clinical narrative: Seven days after vaccination, pt reports small vesicles appearing on the left arm and forearm and left lateral hip. They are itchy and tender. Pt hospitalized to remove him from areas.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Large erythematous patch from site of vaccine extending to lateral chest wall/axilla, treated with abx for cellulitis.
Age: 23.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Urticaria
Clinical narrative: States 5 days after vaccines noticed a couple of hives on face and on Wednesday one more. By Thursday no new hives, no treatment needed. No other symptoms.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus, Rash maculo-papular
Clinical narrative: Injection of Td administered left deltoid, once at home noticed arm very red, itchy, swollen (approx 1cm) and painful 4/10. Red bumpy rash and itch lasted for approx one month, area covering 3"x3" approx. Did not impair use of/mobility of left arm.
Age: 86.0
Sex: M
Vaccine: FLUX
Symptoms: Fluid retention, Rash erythematous, Rash pruritic
Clinical narrative: Pt received influenza vaccine on Fri (Jan 8) and developed fluid build up in left arm, hand, and left ankle. Also had N/V and rash on arm. Reported to ER on 01/11/05. Red rash that itched. Kenalog 40mg IM given. Instructed not to ever take the flu vaccine again. No new meds started in relation to occurrence of event.
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: Reaction to Pneumovax injection, swelling, itchy at site up to axilla left arm.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt c/o left arm pain and small lump to injection site since 4/20/05.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See attachment
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Pain
Clinical narrative: Edema, Pain/Swelling
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Medication variance: Delay and/or omission of administration of pneumococcal vaccine on day of discharge as per pre printed orders. Action: Considering placing vaccine in the refrigerator to be accessed through automated cabinet to decrease delay when order is processed by the pharmacist early in the hospitalization as per preprinted order, give on day of discharge.
Age: 1.03
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Developed erythema, tenderness and swelling at the injection site, approx 5cm in diameter. Parents returned to our clinic with concern.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Pt presented to office today with varicella lesions on back, arm, trunk.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Right arm, red, hard, swollen, warm to touch.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Screaming, Somnolence
Clinical narrative: Excessive sleep, excessive crying.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site reaction, Rash papular
Clinical narrative: Mother states pt developed small area of redness and warmth at site of varicella immunization at left thigh noted evening of 5/3/05. Area was dime sized. Pt was afebrile with cough, cold symptoms, no distress. On evening of 5/4/05 pt noted to have large area of redness, induration at site. Pt seen 5/5/05 in clinic with area of redness, some warmth and some erythema at Left leg injection site measuring 5cm x 6cm. Skin  within this region had five papular rash (faint). Pt was in no respiratory distress, remained febrile. And had not other lesions or rashes. At the time of the visit he continued on Omnicef for his otitis media.  Impression: local delayed hypersensitivity reaction at site of varicella vaccination site, suspect Gelatin or Neomycin as sensitizing agent. Mother to observe for worsening sxs. F/U by phone done 5/6/05. Clinic F/U of reassessment of exam in 2 wks to conicide with ear check.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Somnolence
Clinical narrative: Low grade fever. Slept constantly for 2 days. Awakens briefly to eat then back to sleep.
Age: 1.53
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left leg got swollen and red where vaccine was given. Applied ice pack.
Sex: M
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, warmth and swelling at site of vaccine (Hep B). Patient went to ER and had ultrasound.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms started 5/10/05 at 3:30 PM. Symptoms were red, swollen, and hot to touch left arm. The deltoid area.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: 5/14/05 Child woke up with a few chicken pox lesions; more broke out 5/15/06. Seen by this office 5/16/05 for confirmation. Child looks well. No other symptoms. Has 20-30 varicella lesions.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient received DTaP booster in left deltoid on 5/13/05. Was taken to ER on 5/14/05 with fever of 103 oral, redness and swelling from shot site down to elbow. Complained of pain and tenderness at shot site.
Sex: M
Vaccine: IPV, MMR, PNC
Symptoms: Viral infection
Clinical narrative: Varicella outbreak.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Hypoventilation, Pallor
Clinical narrative: Turned gray and shallow breathing a couple hours.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Contusion, Erythema, Injection site warmth
Clinical narrative: 4/14/05 Phone call from mom. Right thigh small bruise and red area down from injection site. 4/15/05 Mom in clinic with patient. Left arm has red area down from HAV/IPV injection site 4-5" of small bruise. Warm to touch.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Headache
Clinical narrative: Father called health center 5/4/05 saying son experienced a headache and dizziness 48 hours after vaccination. Patient did not want to be seen for follow up at this facility.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced localized reaction within 24 hours. Seen in MD office 48 hours after injection. Upper arm rash, red, swollen, hot; size approximately 6"x10". Cold compresses, Benadryl PRN and follow up 24 hours.
Age: 41.0
Sex: F
Vaccine: HEP, TD
Symptoms: Guillain-Barre syndrome, Hyporeflexia, Mydriasis, Paralysis
Clinical narrative: Guillain Barre. Belame partially paralyzed. Was in ICU x 1 week. Received IVIG and currently in PT. Up to 6 months for a full recovery. Follow up 7/16/05: Still have dialated pupil and reflexes are not fully recovered. Weakness. Doing much better than before.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Viral infection
Clinical narrative: Chicken pox.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Marked redness/swelling onto top of shoulder and all the way to elbow at 48 hours post vaccine. No fever. Some pain. Tylenol/cool compresses.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Numbness and tingling both hands, arms, tingling to face below eyes to chin. Recurred 5/7 in arms; again on 5/9 to arms and face. To physician on 5/10, while experiencing no symptoms. On 5/11, tingling (crawling) to face and scalp. Temp today 99.8 orally.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Right deltoid red, swollen, heat present, raised 2mm circle deltoid about 10mm. Complained of itching last night.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: 7cmx7cm. Positive erythematous, positive tenderness, and positive warmth.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Thermal burn
Clinical narrative: 5/7/05 Received Td vaccine. Experienced tenderness and burning at injection site. 5/8/05 Redness and swelling of upper right arm. 5/9/05 Same symptoms but worse. Right arm induration 10cm.
Age: 1.11
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Around 3 PM on 4/22/05, she had diarrhea. After that time she had diarrhea 6 more times (from 3 PM to 10 PM).I called the ER and they said they couldn't do nothing for a baby with diarrhea, but for me to keep her hydrated with Pedialyte. So I did that.  On 4/23/05, she had diarrhea 8 times. On 4/24/05, she had diarrhea 6 times. She had diarrhea 4 times by 4/26/05. She did not have anymore diarrhea.
Age: 1.43
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Erythema, Hypokinesia, Pain, Subcutaneous nodule, Tenderness
Clinical narrative: On 4/13/05 parents notified child not using right arm, or not using wrist level. Notified 3cm SQ nodule, tender, and red (1cm of redness surrounding).
Sex: F
Vaccine: HEP, TD
Symptoms: Arthralgia, Cyanosis, Hypoaesthesia, Injection site swelling, Myalgia
Clinical narrative: Soreness of arm, shoulder, joint, shoulder blade, numbness in arm (upper and lower). Poor circulation down to fingertips. Blueness in hand. Slight swelling at site of shot. Patient reports taking prednisone for about 4-5 days.
Age: 1.16
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Multiple vesicular lesions on trunk with scabbed over lesions. - Varicella break out after vaccine.
Age: 1.24
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash erythematous, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: 4-5 lesions on trunk, erythematous vesicular rash. DX; modified varicella break out.
Age: 1.61
Sex: M
Vaccine: DTAP, PNC
Symptoms: Rash papular
Clinical narrative: Child developed papular rash on abdomen, extremities, and head on 5/2/05, 2 weeks post vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pruritic, erythematous swelling involving anterior left thigh. Treated with cool compresses, Ibuprofen and diphenhydramine.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Irritability, Sleep disorder
Clinical narrative: 6 month well child received DTaP, HIB, Prevnar at check up. Very fussy that night; had irritability, poor sleep. 2 minute generalized seizure 6 AM next day. Temp 101. ER by ambulance. Evaluated at ER.
Age: 0.98
Sex: F
Vaccine: HIBV, PNC
Symptoms: Viral infection
Clinical narrative: Chicken pox.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Swelling
Clinical narrative: Swollen upper arm; soreness down arm.
Age: 10.0
Sex: F
Vaccine: 6VAX-F, PNC
Symptoms: Torticollis
Clinical narrative: At 4 month WCC visit, parents reported that about 72 hours after vaccines, patient developed torticollis. Symptoms resolved slowly over next 2 months; minimally present at 4 month WCC. Parents are concerned this related to vaccines. Born full term/healthy.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg red, swollen, warm to touch 24 hours after vaccination.
Age: 1.53
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema, Injection site warmth, Pyrexia, Swelling
Clinical narrative: Large local reaction with fever; leg red and swollen, hot to touch.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HEP, PNC
Symptoms: Crying
Clinical narrative: Crying for two days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HEP, PNC
Symptoms: Crying, Irritability
Clinical narrative: Crying for two days.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Coma, Convulsion, Dyskinesia, Eye movement disorder
Clinical narrative: Tonic seizure about noon. Eyes rolled back and jerked in sockets with unresponsiveness for about 3 minutes.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Rash papular
Clinical narrative: 2 days after administration, lumps becoming pink and tender about injection site. Now has gradually developed new papules which become hard and tender on arms. 2 areas of purpura on hand and right arm weakness.
Age: 4.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Blister, Erythema, Oedema
Clinical narrative: Red, edematous left upper arm with several blisters.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4cmx5cm area of erythema and induration right arm.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Oral intake reduced, Pyrexia
Clinical narrative: Irritable, fussy, decreased PO, decreased sleep since vaccines given 5/17/05. Fever 100 axillary on exam 5/18/05. Patient with similar symptoms after 2 month immunization (3/17) but at time symptoms not clearly related to immunizations.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Site became red afternoon of shot date, gradually became bigger.  Intially raised about 1 1/2 x 1 1/2 now 3 3/4 x 3 inches.  Red, blistery.  Grandmother applying cool compresses.  Scratches - apply Hydro-cortisone cream to site.  5/10/05 talked to caretaker reports called doctor - gave Benadryl.  Site bigger, but fading light pink now and she says it feels better.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Mom reports that after receiving Hep A vaccine #2, patient had swelling at injection site, site was warm to touch, red and itchy. It resolved in about 1 week.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Immediately following immunizations child c/o intense itching all over body.  Skin became reddened.  He was taken to MD for assessment.  Within five minutes of receiving vaccines, hives erupted all over child.  MD administered 0.3cc epinephrine R upper arm. EMS was called and child transported to ER at approx. 11:15am.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Lacrimation increased, Pyrexia, Rhinorrhoea
Clinical narrative: 5/16/05 Mother reported that 5/13/05 in the afternoon pt had "runny nose and eyes", 5/13/05 in the evening he had some trouble with breathing and by 5/14/05 in the evening he had a temperature of 102.4 and more difficulty with breathing when he was taken to the ER.  Neck and chest x-rays negative.  ER informed her symptoms were an allergic reaction to vaccine and child given epinephrine and steroid with improvement in symptomes and sent home. 5/16/05 symptoms are only a "runny nose" and lower than normal energy.  Family MD saw pt today and suggested cold unrelated.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Chills, Fatigue, Feeling hot, Somnolence
Clinical narrative: Patient awoke around 4AM with hard chills and felt hot to touch(no thermoneter).  Chills lasted 20-30 minutes. She denied headache,nausea.  Complained of lassitude until around 11AM.  She then slept most of the day.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Local Erythema, Induration, Tenderness, Warmth
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abdominal pain, Convulsion, Crying
Clinical narrative: On 8/25/04 parents noticed at approximately 9am after awakening that  baby was shuttering  and crying extremely hard.  These symptoms periodically occurred for 1 week and resolved spontaneously. Mom said, baby did not have a fever. Mom said baby was very colicy at that time and they  thought this  was part of the  colic symptoms. They did not seek medical care for symptoms.  No treatment was given. When parents came back into clinic at 6 mos. of age for more immunizations, mom discussed the above symptoms with nurse. Nurse referred them to MD for consult regarding future vaccinations.  MD told mom that baby probably had mild seizures from DTAP vaccine.  He said that baby should not get any more Pertussis vaccine product.  Mom returned to the health department on 11/23/04 for more immunizations and baby received IPV, HEP.B, Prevnar.  No DTAP product was given and baby did not have any adverse reactions.  No VAERS was completed at this time.  When baby came back in on 05/18/05 for his MMR and Varivax vaccine, a VAERS was completed for the problem the baby experienced on 08/25/04.  Nurse advised parent to follow up with MD in regards to receiving DT vaccine at MD's office, because we do not have DT product here at the health department.  Mom agreed to this plan.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: Extensive swelling of left arm at injection site and diffuse erythema and swelling and rash from deltoid to just above the elbow. Hard and warm to touch. No joint involvement. Moderate pain. 3 days duration. Examined by medical doctor=no infection.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia, Restless legs syndrome, Tremor, Type III immune complex mediated reaction, Urticaria
Clinical narrative: Developed arthus reaction from triceps to wrist then tremors and paresthesias of the hands and restless legs syndrome. Had allergic urticaria event but likely was unrelated to vaccines.
Age: 4.0
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Medication error, Viral infection
Clinical narrative: Information has been received from a RN concerning a 4 year old female pt in daycare who on 18-APR-2000 was vaccinated with a dose of varicella virus vaccine live that was improperly stored. The reporter indicated that this occurred at a child provider doctor's office. Concomitant therapy included a first dose of hepatitis b vaccine, a first dose of Hib vaccine, a first dose of MMR, a third dose of DTP and a third dose of poliovirus vaccine. There were no other vaccinations within 4 weeks prior to 18-APR-2003. In late December 2003 the pt developed chickenpox. The outcome was reported as recovered. There were no relevant diagnostic test or laboratory data. Unspecified medical attention was sought. There was no product quality complaint. The reporter also mentioned other patients who may have been vaccinated with improperly stored varicella virus vaccine live (WAES0403USA02035, WAES0403USA02036, WAES0403USA02038, WAES0403USA02039 and WAES0403USA02040). These patients included three other children in the same daycare who also reported having chickenpox within the same time period (WAES0403USA02036, WAES0403USA02038 and WAES0403USA02039). Another child in the same daycare also reported having chickenpox within the same time period, but has not previously received varicella virus vaccine live. No further information is expected.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female patient in her forties with a medical history of varicella, al low titer and a concurrent condition of Crohn's disease who was vaccinated on approximately 12-Mar-2004, "about 1 week ago" with a dose of varicella virus vaccine live (Oka/Merck). concomitant therapy included immunosuppressive medication for Crohn's disease. On approximately 12-Mar-2004, "within 24 hours," the patient developed a vesicular rash. No treatment was required.  Unspecified medical attention was sought. There was no product quality complaint involved.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Apnoea, Coma, Cyanosis, Dermatitis bullous, Dyskinesia
Clinical narrative: Information has been received from a RN concerning a 12 month old white male pt with an upper respiratory infection and no past medical history who on 19Mar04 was vaccinated with a first dose of varicella virus vaccine live (lot 647263/1136N), SC in the right lower thigh. Concomitant therapy included budesonide (Pulmicort) respules and albuterol via nebulizer. On 29Mar04, 10 days post vaccination, the pt developed a fever of 101 degrees F and then had a seizure. The pt was then taken to the ER at the hospital. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 22Mar04 the pt developed a severe local reaction. The mother gave the child acetaminophen (Tylenol) and applied ice to the site. On 29Mar04 the child was noted to have multiple pox on his abdomen, back, neck and extremities as well as a temp of 99 degrees by ear thermometer. On 28Mar04 in the PM (previously reported as at approx 7:00PM, on 29Mar04), nine days after  varicella virus vaccine live administration the child was drinking a bottle, became stiff, his eyes rolled back in his head and he was cyanotic, jerking motions, not breathing and unresponsive. The mother called 911 and the child was assessed in the ER. It was reported that the child had a temp of 101.4 rectally and that he had a febrile seizure. It was reported that the prescription drug treatment was not required. The pt was also diagnosed with bilateral otitis media and was put on antibiotics. There was a large welt noted on the right thigh. The pt recovered. It was also noted that the pt and the pt's sibling did not experience any adverse events following prior vaccinations. Upon internal review, fever of 101.4 degrees F and then a seizure was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Injection site reaction, Musculoskeletal stiffness, Otitis media
Clinical narrative: Information has been received from a RN concerning a 12 month old white male pt with an upper respiratory infection and no past medical history who on 19Mar04 was vaccinated with a first dose of varicella virus vaccine live (lot 647263/1136N), SC in the right lower thigh. Concomitant therapy included budesonide (Pulmicort) respules and albuterol via nebulizer. On 29Mar04, 10 days post vaccination, the pt developed a fever of 101 degrees F and then had a seizure. The pt was then taken to the ER at the hospital. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 22Mar04 the pt developed a severe local reaction. The mother gave the child acetaminophen (Tylenol) and applied ice to the site. On 29Mar04 the child was noted to have multiple pox on his abdomen, back, neck and extremities as well as a temp of 99 degrees by ear thermometer. On 28Mar04 in the PM (previously reported as at approx 7:00PM, on 29Mar04), nine days after  varicella virus vaccine live administration the child was drinking a bottle, became stiff, his eyes rolled back in his head and he was cyanotic, jerking motions, not breathing and unresponsive. The mother called 911 and the child was assessed in the ER. It was reported that the child had a temp of 101.4 rectally and that he had a febrile seizure. It was reported that the prescription drug treatment was not required. The pt was also diagnosed with bilateral otitis media and was put on antibiotics. There was a large welt noted on the right thigh. The pt recovered. It was also noted that the pt and the pt's sibling did not experience any adverse events following prior vaccinations. Upon internal review, fever of 101.4 degrees F and then a seizure was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a RN concerning a 12 month old white male pt with an upper respiratory infection and no past medical history who on 19Mar04 was vaccinated with a first dose of varicella virus vaccine live (lot 647263/1136N), SC in the right lower thigh. Concomitant therapy included budesonide (Pulmicort) respules and albuterol via nebulizer. On 29Mar04, 10 days post vaccination, the pt developed a fever of 101 degrees F and then had a seizure. The pt was then taken to the ER at the hospital. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 22Mar04 the pt developed a severe local reaction. The mother gave the child acetaminophen (Tylenol) and applied ice to the site. On 29Mar04 the child was noted to have multiple pox on his abdomen, back, neck and extremities as well as a temp of 99 degrees by ear thermometer. On 28Mar04 in the PM (previously reported as at approx 7:00PM, on 29Mar04), nine days after  varicella virus vaccine live administration the child was drinking a bottle, became stiff, his eyes rolled back in his head and he was cyanotic, jerking motions, not breathing and unresponsive. The mother called 911 and the child was assessed in the ER. It was reported that the child had a temp of 101.4 rectally and that he had a febrile seizure. It was reported that the prescription drug treatment was not required. The pt was also diagnosed with bilateral otitis media and was put on antibiotics. There was a large welt noted on the right thigh. The pt recovered. It was also noted that the pt and the pt's sibling did not experience any adverse events following prior vaccinations. Upon internal review, fever of 101.4 degrees F and then a seizure was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Information has been received from licensed practical nurse concerning a 9 year old white male who on 26-JUN-1998 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot #624777/1564E). On 18-MAR-2004 the pt developed varicella breakthrough that was noted on his left arm. It was also noted that there was a varicella outbreak. Subsequently, the pt recovered. Additional information is not expected.