chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Anaemia, Angiopathy, Arthralgia, Asthenia, Blindness
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Cognitive disorder, Diabetes mellitus, Eye pain, Haematocrit decreased, Headache
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Hypercholesterolaemia, Hypertension, Hypoaesthesia, Hypokinesia, Hypovitaminosis
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test abnormal, Malaise, Memory impairment, Mental retardation severity unspecified, Muscle contractions involuntary
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Neuropathy, Optic atrophy, Optic neuritis, Paraesthesia
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Red blood cell count decreased, Sleep apnoea syndrome, Tremor, Urinary tract disorder, Vaccine positive rechallenge
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Vitreous floaters, Weight increased
Clinical narrative: Optic neuritis after AVA #1 progressed to optic nerve atrophy bilaterally. Also myalgias, arthralgias, and neuropathies later occurred. Pt received his first anthrax vaccination on 07Dec98. He was clinically well at the time of receiving the vaccine and received no other immunizations simultaneously. Within 12 hrs of receiving the vaccine he noticed floaters in the right eye and had right sided headache, right lower field vision loss and pain while moving his right eye. He went to sick call the next morning and was diagnosed with symptoms consistent with optic neuritis. He was given an eye patch and it was determined that steroids were not necessary. He was evaluated by ophthalmology. Meanwhile he continued the anthrax vaccine series, receiving #2 on 22Dec98 and #3 on 5Jan99. The optic symptoms had not resolved when he received these additional vaccinations in the AVA series, however, he does not recall that the symptoms worsened immediately after their receipt.  In the next few weeks his condition worsened, however, and by Mar99 he experienced loss of vision in the upper visual fields and partial loss in the central fields in addition to the lower field loss. He then received a 3 week course of steroids that improved his vision by 50% temporarily. By Jun99 he had developed partial vision loss in the left eye and was now diagnosed with acute ischemic optic neuropathy (AION). He was hospitalized in Jul99 for 4 days and received IV steroids. Around this time he stated he developed general malaise, weakness, headaches, and joint pain. He also had developed an iron deficiency anemia with a hematocrit of 26. He was transfused, given iron supplements and the condition resolved. (It was later thought that bleeding hemorrhoids were the cause of the anemia). He remained on steroids for his optic disorder for 3 months until Sep99. Due to steroid use and the subsequent weight gain he developed hypertension, hypercholesterolemia and obstructive sleep apnea. His optic condition continued to worsen and in the spring of 2000 he was again placed on steroids for 3 wks. Since there was still no lasting improvement in his vision, in Jan01 he was started on interferon (Avonex) for 6 months. This treatment had little effect on his vision but he went on to develop weakness, tremors, fasciculations, and numbness and tingling in the hands and feet. He also developed cognitive difficulties and his processing speed, short term memory and fine motor skills became impaired. Pt was temporarily retired in Jan03. He had developed diabetes, B12/folate deficiency and renal deficiency since retirement and is 100% disabled.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Folliculitis, Injection site hypersensitivity, Pruritus, Rash erythematous, Rash pustular
Clinical narrative: Pt develop flat erythematous rash on chest and back.  Similar to folliculitis or nonviral pustulosis.  Good take.  Local itching at vaccination site.
Age: 1.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Coma, Convulsion, Respiratory syncytial virus infection, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 12 month old daughter with otitis media since December 2004 and no known drug allergies who on 2/25/05 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included influenza virus vaccine and gantrisin. On 3/1/05 the patient experienced a seizure and was unresponsive for 20 minutes. Unspecified medical attention was sought and the patient was admitted to the hospital. An RSV test was done and the patient was also diagnosed with RSV. The patient had a CT scan, x-rays, ECG, EEG, blood work and heart monitor for 24 hours (results not reported). At the time of the report, the patient was recovering. There was no product quality complaint involved. Seizure and RSV were considered to be immediately life threatening by the patient's mother. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: VARCEL
Symptoms: Candidiasis, Condition aggravated, Crying, Dehydration, Pneumonia
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 month old female who on 2/23/05 was vaccinated with a dose of varicella virus vaccine live due to varicella outbreak at day care. It was noted that the child had pneumonia at the time of vaccination. Concomitant therapy included amoxicillin/clavulanate potassium and azithromycin. Post vaccination, on approximately 2/27/05, the child developed a fever of 105 and constant crying. She was taken to the emergency room on 2/27/05 and was admitted with diagnoses of pneumonia, thrush and dehydration. A chest x-ray was normal. She was treated with nystatin and was released on 3/1/05. She is recovering. The reporter felt the patient's experience was an other important medical event (OMIC). Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 month old female who on 2/23/05 was vaccinated with a dose of varicella virus vaccine live due to varicella outbreak at day care. It was noted that the child had pneumonia at the time of vaccination. Concomitant therapy included amoxicillin/clavulanate potassium and azithromycin. Post vaccination, on approximately 2/27/05, the child developed a fever of 105 and constant crying. She was taken to the emergency room on 2/27/05 and was admitted with diagnoses of pneumonia, thrush and dehydration. A chest x-ray was normal. She was treated with nystatin and was released on 3/1/05. She is recovering. The reporter felt the patient's experience was an other important medical event (OMIC). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis, Bacterial infection, Drug ineffective, Epiglottitis, Inflammation
Clinical narrative: It was reported in a published article that a 14 year old white male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient's initial presentation involved inflammation of the ear, costovertebral joint, epiglottis, and ball of foot. A diagnosis of relapsing polychondritis was made through a biopsy of the ear. The patient was eventually controlled on oral steroids and methotrexate. Simultaneously the patient's immune status was evaluated and a noted progressive decrease of the IgG2 occurred. Eventually the subclass reached 45mg/dl and functional responses to polysaccharide antigens failed. The occurrence of a pneumonia with multiple drug resistance pneumococcus inspired the use of monthly IVIG therapy. The patient has been stable from an infectious and autoimmune aspect since the initiation of IVIG. The current drug regime of methotrexate and IVIG has successfully placed the patient into a state of remission. Measurement of the patient's serum IgM and IgA reveal if this patient will progress to common variable immunodeficiency. Relapsing polychondritis was considered to be an other important medical event (OMIC). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test abnormal
Clinical narrative: It was reported in a published article that a 14 year old white male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient's initial presentation involved inflammation of the ear, costovertebral joint, epiglottis, and ball of foot. A diagnosis of relapsing polychondritis was made through a biopsy of the ear. The patient was eventually controlled on oral steroids and methotrexate. Simultaneously the patient's immune status was evaluated and a noted progressive decrease of the IgG2 occurred. Eventually the subclass reached 45mg/dl and functional responses to polysaccharide antigens failed. The occurrence of a pneumonia with multiple drug resistance pneumococcus inspired the use of monthly IVIG therapy. The patient has been stable from an infectious and autoimmune aspect since the initiation of IVIG. The current drug regime of methotrexate and IVIG has successfully placed the patient into a state of remission. Measurement of the patient's serum IgM and IgA reveal if this patient will progress to common variable immunodeficiency. Relapsing polychondritis was considered to be an other important medical event (OMIC). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Thrombocytopenic purpura
Clinical narrative: Developed ITP (Platelets of 6000) on 2/21/05.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Injection site pain, Pain
Clinical narrative: Flu shoot given in left deltoid. complained of pain in rt arm that  evening, then pain spread to both legs and buttocks. She is still havign some pain in back of lower legs, today 02/04/2005"does not wish to see her doctor but does want this reported.
Age: 57.0
Sex: M
Vaccine: FLU3, HEP, IPV, MMR
Symptoms: Blister, Pain
Clinical narrative: Two hours after vaccination- client felt burning-oozing and "deep pain" at site. He (R.A.) removed band aid (non-latex) and discovered 2 small blisters. He cleaned the area and applied ointment. Today 01/26/2005 scab has formed area looks clean and free of infection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash papular
Clinical narrative: Scattered macules and weals with smaller pink papules over trunk on legs and arms. started on 03/15/2005.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema multiforme, Oedema
Clinical narrative: 6cm soft tissue swelling with erythema.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site reaction, Rash maculo-papular
Clinical narrative: Localized erythematous nonblanching papules/macules surrounding area of vaccine site.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective
Clinical narrative: Multiple vesicles in various stages x24 hours.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Pain, Rash erythematous
Clinical narrative: Erythematous tender area 4x2cm  over right deltoid injection area. Painfull to move, chills and temp 97.6 F
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: Mother brought child for 3rd set of vaccines at 7mos. She reported that within 1 hour of receiving  vaccines on 01/03/2005 (2ndset) he developed large red bumps starting from all 3 vaccine sites. Rash covered both thighs up into diaper area. Physician observed at well child visit. No treatment.
Age: 1.06
Sex: M
Vaccine: PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: red bumps, rash
Age: 18.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Diarrhoea, Dysphagia, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Mother reports pt having difficulty swallowing, breathing and diarrhea in evening of injections, the next day c/o feeling hot, tired, and still slight trouble breathing. Not taken to ER/clinic, FHN advised to take to an emergency with trouble breathing or respiratory problems. Advised to have td/hep A only under medical care.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site oedema, Injection site pain
Clinical narrative: Onset c/o pain/swelling the evening of injection. Redness(mild) down to knee, with minor swelling.  decreased c/o pain. Mom states greatly improved, resoloution in progress.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Slightly red and swollen, left deltoid started today.(03/10/2005) 03/11/2005 checked and patient is doing "ok".
Sex: M
Vaccine: HEP
Symptoms: Oral mucosal blistering, Rash
Clinical narrative: t/c from client 03/14/2005 stating "2 days after my 2nd Hep B shot I got blisters in my throat and my face broke out. I called the doctor he said to just watch and see. The blisters were gone by sunday but my face still has places where you can tell I had something"
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Body Rash s/p vaccines listed below
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Left deltoid area swollen on Sat. Sunday a.m. redness to elbow- also noted swelling extended to left elbow, red, and hot to touch-afebrile Monday decreased redness and swelling + ithching no pain, Ice pack and Benadryl.
Age: 1.29
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Urticaria
Clinical narrative: within 5 minutes, developed hives and redness at site where shot was given. Observed in office for about 10 minutes with worsening. At home mother gave 1 dose Benadryl and observed . Hives did not worsen and dissappeared completely by 3:00 P.M.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Pruritus, Skin atrophy
Clinical narrative: Swelling x 4 inch area tight skin, itching, Benadryl given for symptoms.
Age: 3.56
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pediarix given 02/05 mom states slight redness and swollen upper right arm02/06- worse 02/07- " rash" appearance of solid red and swelling  12cm x 9cm- gave topical Benadryl and then 2/6  PO Benadryl x2.
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: Developed maculopapular and vesicular rash 3 weeks after receiving varicella vaccine.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash macular, Skin ulcer
Clinical narrative: Macular lesions about 2 weeks after receiving varicella vaccine.
Age: 1.06
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Parent reported child has a low grade fever with bumps on his face.  ARNP saw child in her office and informed parent that the bumps on his face were mild chickenpox from the vaccine.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial infection, Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: MULTIPLE PAPULAR AND VESICULAR LESION ALL OVER HIS BODY WITH SOME SCABS AND SECONDRY BACTERIAL INFECTION , LESION STARTED TO APPEARE ONE WEEK AFTER ADNINISTRING THE VACCINE.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Bacterial infection, Blood pressure increased, Chills, Dizziness
Clinical narrative: 1 to 2 days post vaccination patient experienced high fever (104 degrees), extreme fatigue, weakness, dizziness, along with chills and sweats. Symptoms lasted for approximately 5 days, and client returned to clinic on 08/21/2003 for following symptoms:  sore throat, earache, HA x 3 days plus elevated HR and BP---tested positive for Strep A.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Ear pain, Fatigue, Heart rate increased, Hyperhidrosis, Pharyngolaryngeal pain
Clinical narrative: 1 to 2 days post vaccination patient experienced high fever (104 degrees), extreme fatigue, weakness, dizziness, along with chills and sweats. Symptoms lasted for approximately 5 days, and client returned to clinic on 08/21/2003 for following symptoms:  sore throat, earache, HA x 3 days plus elevated HR and BP---tested positive for Strep A.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: 1 to 2 days post vaccination patient experienced high fever (104 degrees), extreme fatigue, weakness, dizziness, along with chills and sweats. Symptoms lasted for approximately 5 days, and client returned to clinic on 08/21/2003 for following symptoms:  sore throat, earache, HA x 3 days plus elevated HR and BP---tested positive for Strep A.
Age: 1.66
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant pain, swelling, erythema at site of injection.  Occurred within 12 hours of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: One day post immunizations, mom reported rash on face, neck, torso.  Seen by PMD, records show nonblanchable small brown spots, child not toxic appearing, localized swelling and tenderness at injection site L leg, ?contusion.  On 3/17 mom called with report of increased leg swelling.  Seen by 2nd MD in practice.  On 3/17/05, L leg observed to have increased circumference from R by 1 3/4 ", + adenopathy in L groin, + induration in anterior and posterior spaces.  Area red, warm, painful.  Child could weightbear but was reluctant to do so.  IM Rocephin, Solumedrol given, referred to ER for eval--admitted to hospital x 1 day for IV antibx, r/o cellulitis.  Discharged 3/18/05 to home, improving.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lymphadenopathy, Oedema peripheral, Rash
Clinical narrative: One day post immunizations, mom reported rash on face, neck, torso.  Seen by PMD, records show nonblanchable small brown spots, child not toxic appearing, localized swelling and tenderness at injection site L leg, ?contusion.  On 3/17 mom called with report of increased leg swelling.  Seen by 2nd MD in practice.  On 3/17/05, L leg observed to have increased circumference from R by 1 3/4 ", + adenopathy in L groin, + induration in anterior and posterior spaces.  Area red, warm, painful.  Child could weightbear but was reluctant to do so.  IM Rocephin, Solumedrol given, referred to ER for eval--admitted to hospital x 1 day for IV antibx, r/o cellulitis.  Discharged 3/18/05 to home, improving.
Age: 1.45
Sex: F
Vaccine: MMR
Symptoms: Erythema, Nasal congestion, Pruritus, Rash, Rhinorrhoea
Clinical narrative: Fine, red, pinpoint rash over trunk and diaper area, chest congestion, runny nose, itchy areas on body.  Appeared about 4 days after shot.  No treatment other than moisturizing creams for rash.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: On March 8, 2005, I took my son for his 2 years well visit where he received the Pnewmococcal vaccine.  At approximately 8:00pm, I felt my som was very hot and I took his temperature which was 102.5.  I immediately called the doctor service and spoke with the doctor who gave me instruction to follow to reduce the temperature which I have followed.  My son had a fever range from 100 to 103.4 for 5 days.  On the six day, his temperature reached 104.4, luckily I was at the doctor's office and he gave an antiboitic injection, which reduced the temperature to 101.7.  On the 7th day, the doctor gave my son another antiboitic injection, which reduced the temperature to 100.  At this time his temperature is ranging from a 99.7 to 100.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Oedema peripheral
Clinical narrative: Severe redness swelling in right arm by bed time 12/07/2004 Seen at walk in Keflex given.12/08/2004 Seen at ER given Benadryl (IM), Tetracycline 12/09/2004 Swelling and redness pain from wrist to above shoulder/ 12/13/2004 all redness swelling  has subsided only tenderness at inj./ site now.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, DTAP, HEP, IPV, MMR
Symptoms: Autism, Convulsion, Fall, Oedema peripheral, Rash
Clinical narrative: From initial information received on 3/7/05 from another company, regarding an adverse event occurring in the USA, it was initially reported by the patient's parent that a four year old male received a dose of IPOL, a dose of ENGERIX-B, a dose of INFANRIX, and a dose of MMR on an unspecified date. The INFANRIX was administered in the thigh, but no sites of vaccination were listed for any of the other products. The lot numbers and routes of administration were not reported. Approximately one day post-immunization, on an unspecified date, the patient started falling down. The consumer reported that the next day, he had a rash, the next day, he had a seizure and the next day, he had leg swelling in  the leg that he received the INFANRIX. At an unspecified time following the administration of the vaccines, the patient was diagnosed with autism. Autism was ongoing at the time of initial reporting. The events of falling, rash, seizure, and leg swelling resolved.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Pain
Clinical narrative: From initial information received on 3/11/05 from the patient regarding an adverse event, it was reported that an eighty-one year old female patient received a dose of FLUZONE, lot number not reported, administered in the left arm on 11/17/04. The route of administration was not reported. Two days later, on 11/19/04, the patient developed generalized paralysis. She was seen by several physicians and was treated with 15mg Cortisone that has helped the range of motion in her arms. At the time of the report, the patient feels mainly generalized pain of her entire body and numbness of her fingers during rest. She also has limited range of motion of her arms. Per the patient, she currently is seeing a rheumatologist for a follow up evaluation. She has not recovered from these events. (OMIC)
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Paralysis
Clinical narrative: From initial information received on 3/11/05 from the patient regarding an adverse event, it was reported that an eighty-one year old female patient received a dose of FLUZONE, lot number not reported, administered in the left arm on 11/17/04. The route of administration was not reported. Two days later, on 11/19/04, the patient developed generalized paralysis. She was seen by several physicians and was treated with 15mg Cortisone that has helped the range of motion in her arms. At the time of the report, the patient feels mainly generalized pain of her entire body and numbness of her fingers during rest. She also has limited range of motion of her arms. Per the patient, she currently is seeing a rheumatologist for a follow up evaluation. She has not recovered from these events. (OMIC)
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Laboratory test abnormal, Leukocytosis, Pulmonary embolism, Pyrexia
Clinical narrative: From initial information received on 3/10/05 from another manufacturer, regarding an adverse event occurring in the USA, it was initially reported by a health care facility that a seven month old male patient received a dose of ACTHIB, dose of IPOL, and a dose of TRIPEDIA on 9/28/04. The lot numbers, routes and site of administration were not reported. Six days later, the patient developed pseudomonal sepsis and multiple pulmonary emboli. He expired that same day. It was not reported whether an autopsy was completed.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Sepsis
Clinical narrative: From initial information received on 3/10/05 from another manufacturer, regarding an adverse event occurring in the USA, it was initially reported by a health care facility that a seven month old male patient received a dose of ACTHIB, dose of IPOL, and a dose of TRIPEDIA on 9/28/04. The lot numbers, routes and site of administration were not reported. Six days later, the patient developed pseudomonal sepsis and multiple pulmonary emboli. He expired that same day. It was not reported whether an autopsy was completed.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Pulmonary embolism, Sepsis
Clinical narrative: From initial information received on 3/10/05 from another manufacturer, regarding an adverse event occurring in the USA, it was initially reported by a health care facility that a seven month old male patient received a dose of ACTHIB, dose of IPOL, and a dose of TRIPEDIA on 9/28/04. The lot numbers, routes and site of administration were not reported. Six days later, the patient developed pseudomonal sepsis and multiple pulmonary emboli. He expired that same day. It was not reported whether an autopsy was completed.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Pulmonary embolism, Sepsis
Clinical narrative: From initial information received on 3/10/05 from another manufacturer, regarding an adverse event occurring in the USA, it was initially reported by a health care facility that a seven month old male patient received a dose of ACTHIB, dose of IPOL, and a dose of TRIPEDIA on 9/28/04. The lot numbers, routes and site of administration were not reported. Six days later, the patient developed pseudomonal sepsis and multiple pulmonary emboli. He expired that same day. It was not reported whether an autopsy was completed.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Headache, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: From initial information received on 3/8/05 from another manufacturer (reference number WAES0501USA04558), initially reported by a nurse, regarding an adverse event, it was reported that a 30 year old male patient received his first dose of FLUZONE, lot number U1531AA, administered in the left deltoid (route of administration not reported), and his first dose of PNEUMOVAX 23, lot number 647724/0946N, administered IM in the left deltoid on 1/7/05 at 10:00 AM. Two days later, at 9:00 AM, the patient developed redness, swelling, tenderness, and pain at the site of injection, as well as, nausea, vomiting, and severe headache. The patient was seen in the emergency room that same day. Reportedly, the patient stated that it hurt to raise or move the arm. He was treated with Augmentin and IM Rocephin. On exam, the patient had a fever as well as arm redness, warmth, and swelling. On 1/10/05, per the nurse, the redness, pain, swelling and warmth at the site had increased with decreased range of motion in the arm. The patient was diagnosed with left arm cellulitis and was admitted to the hospital. Medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache, and pain and redness in the left arm. During the hospital course, the patient was treated with IV fluids, Unasyn, Solu-Medrol, Reglan, Entex PSE, and Darvocet-N 100 as well as saline spray and amantadine hydrochloride. Influenza AB screen was presumptive negative for the influenza A or B antigen. The patient was discharged from the hospital and recovered on 1/24/05.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Laboratory test abnormal, Medication error, Nausea
Clinical narrative: From initial information received on 3/8/05 from another manufacturer (reference number WAES0501USA04558), initially reported by a nurse, regarding an adverse event, it was reported that a 30 year old male patient received his first dose of FLUZONE, lot number U1531AA, administered in the left deltoid (route of administration not reported), and his first dose of PNEUMOVAX 23, lot number 647724/0946N, administered IM in the left deltoid on 1/7/05 at 10:00 AM. Two days later, at 9:00 AM, the patient developed redness, swelling, tenderness, and pain at the site of injection, as well as, nausea, vomiting, and severe headache. The patient was seen in the emergency room that same day. Reportedly, the patient stated that it hurt to raise or move the arm. He was treated with Augmentin and IM Rocephin. On exam, the patient had a fever as well as arm redness, warmth, and swelling. On 1/10/05, per the nurse, the redness, pain, swelling and warmth at the site had increased with decreased range of motion in the arm. The patient was diagnosed with left arm cellulitis and was admitted to the hospital. Medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache, and pain and redness in the left arm. During the hospital course, the patient was treated with IV fluids, Unasyn, Solu-Medrol, Reglan, Entex PSE, and Darvocet-N 100 as well as saline spray and amantadine hydrochloride. Influenza AB screen was presumptive negative for the influenza A or B antigen. The patient was discharged from the hospital and recovered on 1/24/05.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: From initial information received on 3/8/05 from another manufacturer (reference number WAES0501USA04558), initially reported by a nurse, regarding an adverse event, it was reported that a 30 year old male patient received his first dose of FLUZONE, lot number U1531AA, administered in the left deltoid (route of administration not reported), and his first dose of PNEUMOVAX 23, lot number 647724/0946N, administered IM in the left deltoid on 1/7/05 at 10:00 AM. Two days later, at 9:00 AM, the patient developed redness, swelling, tenderness, and pain at the site of injection, as well as, nausea, vomiting, and severe headache. The patient was seen in the emergency room that same day. Reportedly, the patient stated that it hurt to raise or move the arm. He was treated with Augmentin and IM Rocephin. On exam, the patient had a fever as well as arm redness, warmth, and swelling. On 1/10/05, per the nurse, the redness, pain, swelling and warmth at the site had increased with decreased range of motion in the arm. The patient was diagnosed with left arm cellulitis and was admitted to the hospital. Medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache, and pain and redness in the left arm. During the hospital course, the patient was treated with IV fluids, Unasyn, Solu-Medrol, Reglan, Entex PSE, and Darvocet-N 100 as well as saline spray and amantadine hydrochloride. Influenza AB screen was presumptive negative for the influenza A or B antigen. The patient was discharged from the hospital and recovered on 1/24/05.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood cholesterol increased, Cellulitis
Clinical narrative: From initial information received on 3/8/05 from another manufacturer (reference number WAES0501USA04558), initially reported by a nurse, regarding an adverse event, it was reported that a 30 year old male patient received his first dose of FLUZONE, lot number U1531AA, administered in the left deltoid (route of administration not reported), and his first dose of PNEUMOVAX 23, lot number 647724/0946N, administered IM in the left deltoid on 1/7/05 at 10:00 AM. Two days later, at 9:00 AM, the patient developed redness, swelling, tenderness, and pain at the site of injection, as well as, nausea, vomiting, and severe headache. The patient was seen in the emergency room that same day. Reportedly, the patient stated that it hurt to raise or move the arm. He was treated with Augmentin and IM Rocephin. On exam, the patient had a fever as well as arm redness, warmth, and swelling. On 1/10/05, per the nurse, the redness, pain, swelling and warmth at the site had increased with decreased range of motion in the arm. The patient was diagnosed with left arm cellulitis and was admitted to the hospital. Medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache, and pain and redness in the left arm. During the hospital course, the patient was treated with IV fluids, Unasyn, Solu-Medrol, Reglan, Entex PSE, and Darvocet-N 100 as well as saline spray and amantadine hydrochloride. Influenza AB screen was presumptive negative for the influenza A or B antigen. The patient was discharged from the hospital and recovered on 1/24/05.