chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Epstein-Barr virus antibody positive, Fatigue, Gastrointestinal disorder
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Hepatic enzyme increased, Hepatitis, Hepatitis A antibody negative, Malaise, Nausea
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Ocular icterus, Vomiting
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Anorexia, Biopsy liver abnormal, Chromaturia, Diarrhoea, Dizziness
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Foreign travel, Hepatitis
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Hepatomegaly, Hypersomnia, Liver injury, Nausea, Pruritus
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 31.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Pyrexia, Urticaria, Vaginal haemorrhage, Vomiting
Clinical narrative: This case was received on 06 February 2008. A 31- year-old female patient received an injection of YF-Vax (lot number not reported) on 10 January 2008, in preparation for foreign travel. Approximately three days after vaccination, she reported malaise and fatigue; a few days after that, she developed nausea and vomiting. She traveled out of the country on 16 January 2008 despite ongoing symptoms, but returned on 19 January 2008. On 24 January 2008 she presented to the hospital with scleral icterus and ongoing gastrointestinal complaints. She was diagnosed with acute hepatitis with elevated liver enzymes (AST in the 500's, ALT in the 200's, and total bilirubin "around 12"). Testing for Hepatitis A, B, and C was negative, as was testing for CMV. The patient tested IgG positive for EBV (Epstein-Barr Virus). She did not experience any encephalitic symptoms, and her status was reportedly improving. Serum samples were sent to a laboratory for yellow fever PCR (polymerase chain reaction) testing. The case is reported as Possible YF viscerotropic case.  03/31/2008 MR received for 2 admissions 1/24-2/2/2008 with D/CDX:  Traveler's Fever/Diarrhea/Hepatitis and 2/26-29/2008 with DX: Hepatitis. Pt reports sx of fevers, diarrhea and malaise which began after YF and Hep A vax on 1/10/08. Pt traveled to Africa 1/17-21/08 despite ongoing sx.  Presented to ER with above sx on 1/24/08 and with icteric sclera.  LFTs found to be elevated and pt admitted for w/u. Pt had intermittant HRs in the 40s and total body pruritis. Pt re-admitted 2/26/08 with increasing LFTs.  Liver bx c/w autoimmune process and pt started on prednisone. Stable for d/c on 2/29/08 and liver bx to be repeated in 2 mon.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: 2/8/08 >3 watery stools no blood.  2/9/08 10-12 watery stools heme +ve x 1.  2/11/08 ongoing watery stools.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Back pain, Chest pain, Fatigue, Herpes zoster
Clinical narrative: To Whom it May Concern: I am writing to notify you of my experience concerning the Zostavax vaccine.  During a routine physical, I was offered the vaccine because I am over 60.  Because I have been plagued with herpes since childhood, I felt it would be a good idea to receive it, which I did on December 28th.  On January 12th, I had been feeling very tired and began having pain in my ribcage and lower back.  On January 16th I broke out in shingles.  I went in to my doctor and was given a prescription for acyclovir.  I also received the actual information sheet from the pharmaceutical company which stated that a recipient should not be around newborns, pregnant women or immunocompromised persons.  I am an RN in an Intensive Care Nursery and had been working post-vaccine.  This cause quite a bit of distress in the ICN and also the Infectious Disease Department...and, of course, to me.  I also spent my holidays with a person who has leukemia, my grandchildren, one of whom was too young to have received the chickenpox vaccine.  On January 18th one of my grandsons had chickenpox although no other students in his school had them.  I, of course, was not able to return to work until the 6 weeks period ended.  I strongly feel the information regarding avoiding newborns, pregnant women and immunocompromised people should be included on the office handout from CDC.  My doctor is going to give prospective recipients both sheets in the future.  I requested that she also notify you of my situation just to further legitimize these facts.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Headache, Injection site oedema, Local reaction, Malaise
Clinical narrative: 44 y.o. AD SM presents with 30 mm x 300 mm area of local redness, swelling, and warmth upper left arm S/P AVA #2 1/19/08, accompanied by <96 hours of constitutional malaise, HA, body ache, and muscle 'spasms/twitching' left upper arm and thighs.  Symptom: Headache, general.  Start: 01/19/2008.  Comment: No visual disturbances, N or V.  '5-6' on pain scale of 10.  Symptom: Edema at injection site 30-50mm.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area of swelling, redness, warmth left upper arm S/P AVA #2.  Symptom: Erythema.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area erythema, palpable margins left upper arm S/P AVA #2.  Symptom: Fasciculation.  Start: 01/19/2008.  Comment: 'Twitching' left upper arm and and left upper antero-lateral thighs S/P AVA #2.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle contractions involuntary, Muscle spasms, Muscle twitching, Oedema peripheral, Pain
Clinical narrative: 44 y.o. AD SM presents with 30 mm x 300 mm area of local redness, swelling, and warmth upper left arm S/P AVA #2 1/19/08, accompanied by <96 hours of constitutional malaise, HA, body ache, and muscle 'spasms/twitching' left upper arm and thighs.  Symptom: Headache, general.  Start: 01/19/2008.  Comment: No visual disturbances, N or V.  '5-6' on pain scale of 10.  Symptom: Edema at injection site 30-50mm.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area of swelling, redness, warmth left upper arm S/P AVA #2.  Symptom: Erythema.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area erythema, palpable margins left upper arm S/P AVA #2.  Symptom: Fasciculation.  Start: 01/19/2008.  Comment: 'Twitching' left upper arm and and left upper antero-lateral thighs S/P AVA #2.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Skin warm
Clinical narrative: 44 y.o. AD SM presents with 30 mm x 300 mm area of local redness, swelling, and warmth upper left arm S/P AVA #2 1/19/08, accompanied by <96 hours of constitutional malaise, HA, body ache, and muscle 'spasms/twitching' left upper arm and thighs.  Symptom: Headache, general.  Start: 01/19/2008.  Comment: No visual disturbances, N or V.  '5-6' on pain scale of 10.  Symptom: Edema at injection site 30-50mm.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area of swelling, redness, warmth left upper arm S/P AVA #2.  Symptom: Erythema.  Start: 01/19/2008.  Comment: 3 cm x 3 cm area erythema, palpable margins left upper arm S/P AVA #2.  Symptom: Fasciculation.  Start: 01/19/2008.  Comment: 'Twitching' left upper arm and and left upper antero-lateral thighs S/P AVA #2.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: "Patient" was 4yrs, her brother was 10 mos, she Received 1 dose of Varisellas on Dec. 9, 1999 and on 1-2-2000., her brother was in the hospital with a rare case of Varisellas. He was not able to take the vaccination because of his age.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Autoimmune disorder, Headache, Nausea, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Father called hospital this morning about his son regarding frequent episodes of high fever (106 auricular), headache, and nausea usually lasting about 5 days.  Patient received a Varivax immunization on 10-04-07 at doctor's office.  Approximately 2 weeks after receiving the immunization, he developed a high fever and was seen in the doctor's office on 11-16-07, at which time he also had a sore throat.  Patient was again seen in the doctor's office on 12-31-07 with a fever and headache.  At that time he expressed his concern to the doctor that it could be related to his Varivax vaccine.  He called hospital that same day and spoke to an immunization nurse.  She advised him that she would call the doctor's office and ask them to file a Vaccine Adverse Event Report.  On 1/2/2008 she was able to speak to the doctor, who said she would file a VAERS report.  She faxed a VAERS form to their office for them to use.  Father's concern today was that his child continues to have episodes of high fever, headache and nausea and was seen in the doctor's office again on 1-22-08.  I talked to the doctor's office today and no report had been filed.  A rapid strep test was done at his visit on 11-16-07, which was negative.  The doctor's diagnosis at that visit was viral syndrome, as was the diagnosis for the 12-31-07 visit.  Patient was not ill the day of the injection, but in June 2006 he had beer diagnosed with an autoimmune disorder.  His father reports that he had previously had episodes of fever and headache, but they did not last as long and the fevers had been more easily controlled.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Streptococcal identification test
Clinical narrative: Father called hospital this morning about his son regarding frequent episodes of high fever (106 auricular), headache, and nausea usually lasting about 5 days.  Patient received a Varivax immunization on 10-04-07 at doctor's office.  Approximately 2 weeks after receiving the immunization, he developed a high fever and was seen in the doctor's office on 11-16-07, at which time he also had a sore throat.  Patient was again seen in the doctor's office on 12-31-07 with a fever and headache.  At that time he expressed his concern to the doctor that it could be related to his Varivax vaccine.  He called hospital that same day and spoke to an immunization nurse.  She advised him that she would call the doctor's office and ask them to file a Vaccine Adverse Event Report.  On 1/2/2008 she was able to speak to the doctor, who said she would file a VAERS report.  She faxed a VAERS form to their office for them to use.  Father's concern today was that his child continues to have episodes of high fever, headache and nausea and was seen in the doctor's office again on 1-22-08.  I talked to the doctor's office today and no report had been filed.  A rapid strep test was done at his visit on 11-16-07, which was negative.  The doctor's diagnosis at that visit was viral syndrome, as was the diagnosis for the 12-31-07 visit.  Patient was not ill the day of the injection, but in June 2006 he had beer diagnosed with an autoimmune disorder.  His father reports that he had previously had episodes of fever and headache, but they did not last as long and the fevers had been more easily controlled.
Age: 65.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen arm at area of injection, itchy.  Treated with ice compresses.  Lasted about one week.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Mom reports had a giant lump larger than the size of a softball and very bright color of red the night of the injection. Child had no apparent fever.  Mom did not notify physcian of swelling and redness, after injection.  Child came in for 2nd Varivax injection and was questioning nurse whether it was normal to have such a large lump after shot.  Nurse held 2nd Varivax and reported incident to Nurse Practitioner.  Redness and swelling lasted for four days.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Blood creatine phosphokinase increased, Chest X-ray normal, Chest tube insertion, Clostridium difficile toxin test, Congenital musculoskeletal anomaly
Clinical narrative: Parents report that infant lost muscle tone and became less active after receiving his 2 month vaccines.  Pt was subsequently admitted to the hospital with RSV- intubated and had chest tube for pneumothorax- after recovering from this illness was still profoundly hypoptonic- undergoing evaluation by neurology currently.  2/26/08 Reviewed hospital medical records. FINAL DX: respiratory failure, RSV pneumonia; dysphagia; severe hypotonia, etiology uncertain; right pneumothorax w/chest tube placement; small VSD & ASD w/slight right ventricular dilation. HPI: patient experienced 3 day history of nasal congestion, constant nonproductive coughing & difficulty breathing.  D/C from outlying ER on 1/14/08 w/dx viral URI.  No improvement & seen by PCP where RSV tested (+).  Admitted 1/14/-2/06/2008 w/RSV bronchiolitis.  Exam revealed fever, weakness, URI s/s & mild respiratory distress w/exp wheezing & intercostal retractions.  Condition worsened. Transferred to PICU, intubated & chest tube placed for pneumothorax.  Developed pneumonia.  Tx w/IV antibiotics, nebs, chest PT & improved.  Extubated w/o difficulty.  Had continued significant profound hypotonia w/DTRs WNL & very diminished ability to clear his oropharyngeal secretions.  Tx w/diuretic & improved.  Consults by surgery, pulmonogy, cardio, neuro, genetics, speech tx D/C to home on apnea monitor & feeding tube w/neuro, cardio & surgery (for muscle biopsy) outpatient f/u.    2/29/08 Reviewed pcp med records & vax records RO lot # corrected in database.  Records indicate patient well w/normal strength & tone on 11/26/07.  Next office vs 1/14/08 s/p ER for nasal congestion, rhinitis, wheezing, deep wet cough, heavy rapid breathing, lethargic.  Dx w/viral illness, RSV & flu neg.  In office dx w/bronchiolitis & referred to ER for admission.  Returned to office 2/12/08 f/u hospital stay.  On apnea monitor & using lasix as needed to control oral secretions.  Seen by home health nurse 3x/wk.  Scheduled for muscle biopsy same day & followed in feeding clinic & cardiac clinic for dilated RV W/2 holes.  Exam revealed mild nasal congestion.  Doing well overall.  Returned to office 2/19/08.  Had been seen by neuro for EMG.  Muscle biopsy on hold until complete recovery from RSV.  Exam revealed puffy hands/feet & hypotonic throughout w/decreased hand grip strength right hand. Lasix dosing increased.  Returned to office 2/25/08 for difficulty breathing w/grunting & rapid breathing.  Tx w/home nebs & was to have feeding tube replaced next day.  Suspected aspiration & referred to ER if worsened. 1/20/2010 Patient has been diagnosed with Congenital muscular dysncopay.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Electromyogram, Haematocrit decreased, Haemoglobin normal, Hypotonia, Intubation
Clinical narrative: Parents report that infant lost muscle tone and became less active after receiving his 2 month vaccines.  Pt was subsequently admitted to the hospital with RSV- intubated and had chest tube for pneumothorax- after recovering from this illness was still profoundly hypoptonic- undergoing evaluation by neurology currently.  2/26/08 Reviewed hospital medical records. FINAL DX: respiratory failure, RSV pneumonia; dysphagia; severe hypotonia, etiology uncertain; right pneumothorax w/chest tube placement; small VSD & ASD w/slight right ventricular dilation. HPI: patient experienced 3 day history of nasal congestion, constant nonproductive coughing & difficulty breathing.  D/C from outlying ER on 1/14/08 w/dx viral URI.  No improvement & seen by PCP where RSV tested (+).  Admitted 1/14/-2/06/2008 w/RSV bronchiolitis.  Exam revealed fever, weakness, URI s/s & mild respiratory distress w/exp wheezing & intercostal retractions.  Condition worsened. Transferred to PICU, intubated & chest tube placed for pneumothorax.  Developed pneumonia.  Tx w/IV antibiotics, nebs, chest PT & improved.  Extubated w/o difficulty.  Had continued significant profound hypotonia w/DTRs WNL & very diminished ability to clear his oropharyngeal secretions.  Tx w/diuretic & improved.  Consults by surgery, pulmonogy, cardio, neuro, genetics, speech tx D/C to home on apnea monitor & feeding tube w/neuro, cardio & surgery (for muscle biopsy) outpatient f/u.    2/29/08 Reviewed pcp med records & vax records RO lot # corrected in database.  Records indicate patient well w/normal strength & tone on 11/26/07.  Next office vs 1/14/08 s/p ER for nasal congestion, rhinitis, wheezing, deep wet cough, heavy rapid breathing, lethargic.  Dx w/viral illness, RSV & flu neg.  In office dx w/bronchiolitis & referred to ER for admission.  Returned to office 2/12/08 f/u hospital stay.  On apnea monitor & using lasix as needed to control oral secretions.  Seen by home health nurse 3x/wk.  Scheduled for muscle biopsy same day & followed in feeding clinic & cardiac clinic for dilated RV W/2 holes.  Exam revealed mild nasal congestion.  Doing well overall.  Returned to office 2/19/08.  Had been seen by neuro for EMG.  Muscle biopsy on hold until complete recovery from RSV.  Exam revealed puffy hands/feet & hypotonic throughout w/decreased hand grip strength right hand. Lasix dosing increased.  Returned to office 2/25/08 for difficulty breathing w/grunting & rapid breathing.  Tx w/home nebs & was to have feeding tube replaced next day.  Suspected aspiration & referred to ER if worsened. 1/20/2010 Patient has been diagnosed with Congenital muscular dysncopay.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Laboratory test, Lethargy, Nuclear magnetic resonance imaging abnormal, Platelet count increased, Pneumothorax
Clinical narrative: Parents report that infant lost muscle tone and became less active after receiving his 2 month vaccines.  Pt was subsequently admitted to the hospital with RSV- intubated and had chest tube for pneumothorax- after recovering from this illness was still profoundly hypoptonic- undergoing evaluation by neurology currently.  2/26/08 Reviewed hospital medical records. FINAL DX: respiratory failure, RSV pneumonia; dysphagia; severe hypotonia, etiology uncertain; right pneumothorax w/chest tube placement; small VSD & ASD w/slight right ventricular dilation. HPI: patient experienced 3 day history of nasal congestion, constant nonproductive coughing & difficulty breathing.  D/C from outlying ER on 1/14/08 w/dx viral URI.  No improvement & seen by PCP where RSV tested (+).  Admitted 1/14/-2/06/2008 w/RSV bronchiolitis.  Exam revealed fever, weakness, URI s/s & mild respiratory distress w/exp wheezing & intercostal retractions.  Condition worsened. Transferred to PICU, intubated & chest tube placed for pneumothorax.  Developed pneumonia.  Tx w/IV antibiotics, nebs, chest PT & improved.  Extubated w/o difficulty.  Had continued significant profound hypotonia w/DTRs WNL & very diminished ability to clear his oropharyngeal secretions.  Tx w/diuretic & improved.  Consults by surgery, pulmonogy, cardio, neuro, genetics, speech tx D/C to home on apnea monitor & feeding tube w/neuro, cardio & surgery (for muscle biopsy) outpatient f/u.    2/29/08 Reviewed pcp med records & vax records RO lot # corrected in database.  Records indicate patient well w/normal strength & tone on 11/26/07.  Next office vs 1/14/08 s/p ER for nasal congestion, rhinitis, wheezing, deep wet cough, heavy rapid breathing, lethargic.  Dx w/viral illness, RSV & flu neg.  In office dx w/bronchiolitis & referred to ER for admission.  Returned to office 2/12/08 f/u hospital stay.  On apnea monitor & using lasix as needed to control oral secretions.  Seen by home health nurse 3x/wk.  Scheduled for muscle biopsy same day & followed in feeding clinic & cardiac clinic for dilated RV W/2 holes.  Exam revealed mild nasal congestion.  Doing well overall.  Returned to office 2/19/08.  Had been seen by neuro for EMG.  Muscle biopsy on hold until complete recovery from RSV.  Exam revealed puffy hands/feet & hypotonic throughout w/decreased hand grip strength right hand. Lasix dosing increased.  Returned to office 2/25/08 for difficulty breathing w/grunting & rapid breathing.  Tx w/home nebs & was to have feeding tube replaced next day.  Suspected aspiration & referred to ER if worsened. 1/20/2010 Patient has been diagnosed with Congenital muscular dysncopay.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test negative, Scan brain, Urine analysis normal, White blood cell count increased
Clinical narrative: Parents report that infant lost muscle tone and became less active after receiving his 2 month vaccines.  Pt was subsequently admitted to the hospital with RSV- intubated and had chest tube for pneumothorax- after recovering from this illness was still profoundly hypoptonic- undergoing evaluation by neurology currently.  2/26/08 Reviewed hospital medical records. FINAL DX: respiratory failure, RSV pneumonia; dysphagia; severe hypotonia, etiology uncertain; right pneumothorax w/chest tube placement; small VSD & ASD w/slight right ventricular dilation. HPI: patient experienced 3 day history of nasal congestion, constant nonproductive coughing & difficulty breathing.  D/C from outlying ER on 1/14/08 w/dx viral URI.  No improvement & seen by PCP where RSV tested (+).  Admitted 1/14/-2/06/2008 w/RSV bronchiolitis.  Exam revealed fever, weakness, URI s/s & mild respiratory distress w/exp wheezing & intercostal retractions.  Condition worsened. Transferred to PICU, intubated & chest tube placed for pneumothorax.  Developed pneumonia.  Tx w/IV antibiotics, nebs, chest PT & improved.  Extubated w/o difficulty.  Had continued significant profound hypotonia w/DTRs WNL & very diminished ability to clear his oropharyngeal secretions.  Tx w/diuretic & improved.  Consults by surgery, pulmonogy, cardio, neuro, genetics, speech tx D/C to home on apnea monitor & feeding tube w/neuro, cardio & surgery (for muscle biopsy) outpatient f/u.    2/29/08 Reviewed pcp med records & vax records RO lot # corrected in database.  Records indicate patient well w/normal strength & tone on 11/26/07.  Next office vs 1/14/08 s/p ER for nasal congestion, rhinitis, wheezing, deep wet cough, heavy rapid breathing, lethargic.  Dx w/viral illness, RSV & flu neg.  In office dx w/bronchiolitis & referred to ER for admission.  Returned to office 2/12/08 f/u hospital stay.  On apnea monitor & using lasix as needed to control oral secretions.  Seen by home health nurse 3x/wk.  Scheduled for muscle biopsy same day & followed in feeding clinic & cardiac clinic for dilated RV W/2 holes.  Exam revealed mild nasal congestion.  Doing well overall.  Returned to office 2/19/08.  Had been seen by neuro for EMG.  Muscle biopsy on hold until complete recovery from RSV.  Exam revealed puffy hands/feet & hypotonic throughout w/decreased hand grip strength right hand. Lasix dosing increased.  Returned to office 2/25/08 for difficulty breathing w/grunting & rapid breathing.  Tx w/home nebs & was to have feeding tube replaced next day.  Suspected aspiration & referred to ER if worsened. 1/20/2010 Patient has been diagnosed with Congenital muscular dysncopay.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt. noted severe pain at injection site 2/18/08 that radiated into forearm over the next 24 hours. Approx. 24 hours after the inj. her 4th and 5th fingers and ulnar apect of her left hand felt tingling with mild pain at the tips of her fingers. Her sx have continued. No erythema or drainage at inj. site. Normal ROM and sensation in fingers. She had taken ibuprofen 2/19/18 x 1. She is instructed to take ibuprofen 3x daily and apply warm compresses to the inj site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Left arm became red, swollen and tender to the touch and warm 50-54 hours after administration. Tylenol administered, no fever.  Went away after 8-10 hours.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Syncope vasovagal
Clinical narrative: PATIENT TOOK HEP-A LOT# 0494U EXP DATE 03/06/2010 ALSO VARICELLA LOT # 1030U EXP DATE 06/27/2009 AFTER THREE MIN PATIENT FELT DIZZY, PATIENT LAID DOWN AND DRANK A CUP OF WATER AND 1/2 CUP OF GATORADE JUICE. PT RECOVERED IN 2 MIN WENT HOME. PT MOTHER SAID PT DID NOT EAT ANYTHING PRIOR THE DAY BEFORE. DOCTOR THOUGHT IT WAS JUST A MILD VASO VAGAL REACTION.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abasia, Anorexia, Pain, Pyrexia, Upper respiratory tract infection
Clinical narrative: 2/16 at midnight started with fever 103 and body ache. Progressively worsened, was unable to walk by Monday that family took to ER. Has also had vomiting and poor appetite since onset. Mother reported ER stated child had URI or less likely vaccine reaction. Fever ceased Wed 2/20/08.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: 2/16 at midnight started with fever 103 and body ache. Progressively worsened, was unable to walk by Monday that family took to ER. Has also had vomiting and poor appetite since onset. Mother reported ER stated child had URI or less likely vaccine reaction. Fever ceased Wed 2/20/08.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Syncope vasovagal
Clinical narrative: PATIENT FELT SLIGHT DIZZY LESS THAN A MINUTE PATIENT RECOVERED IMMEDIATELY AND WENT HOME. THIS PATIENT ALSO DID NOT HAD ANY FOOD OR LIQUIDS BEFORE VACCINATION. DOCTOR FELT THIS ALSO A VERY MILD VASO VAGAL REACTION.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient was given 2nd Gardasil vaccine 9:00am on 2/14. Patient was fine until after dinner when she fainted.  She came to my clinic on 2/20 and no signs of any additional problems.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 05/16/07 PHONE CALL TO CLINIC FROM ARNP.  CLIENT HAS RAISED RED AREA APROX. 10cm x 8cm AREA ON LEFT ARM.  NO OTHER PROBLEMS PER PROVIDER.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Pt received smallpox vaccination around the 5th of February. She presented to sickcall 15 February with an itchy, maculopapular rash with no drainage on torso and on upper thighs.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Red, warm cellulitis 6X6 inches. Symptoms started by the time patient got home from the office.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient had cellulitic area on the anterior of her left arm not at injection site but in the same arm as injection
Age: 6.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT BEGAN TO COMPLAIN OF LOCALIZED TENDERNESS AT INJECTION SITE WITHIN 6 HOURS OF ADMINISTRATION.  LOCALIZED TENDERNESS, REDNESS, WARMTH, AND EDEMA INCREASED TO AN AREA 3" IN DIAMETER AT SITE OF INJECTION UNTIL COMMENCING TO SUBSIDE ON 3RD DAY AFTER VACCINE ADMINISTRATION.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure decreased, Syncope, Tonic convulsion
Clinical narrative: Patient fainted after Gardasil, and subsequently had seizure-like tonic reactions in both arms. Mom states that child had had similar seizure-like activity at age 7. No known reason for that seizure activity, although MD told her that she probably "needed glasses". No further follow-up was suggested at that time. Patient awoke easily (within 1 minute) after today's seizure like activity with the aid of ammonium salts. She was aware of her surroundings. BP immediately after event was 98/70, and subsequently rose to a normal 104/78. She was observed for 15 minutes after the event, and no adverse events were noted during the observation.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Rash generalised
Clinical narrative: Pt reports had rash all over for 5 days post vaccine (of Td) on 02/13/08.  Pt took Benadryl and did not seek medical care.  Pt reports on 02/20/08 is much improved. Asked that we report the incident to Vaers.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Abasia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Shots were given 0900 Friday Feb 1, 2008. The day after the shots were administered, there was a 2 inch area around the injection site that was raised, red, very warm to the touch, and VERY painful to the point that my daughter could not walk or put pressure on her leg whatsoever. The entire area was very hard, it felt almost as if there was a rock under her skin. This lasted for 3.5 days. Monday February 4th, we took her to see the doctor to be seen and by that point the symptoms and side effects were going away. During the time she was experiencing symptoms, we were giving her Tylenol and Motrin to help with pain and trying our best to keep swelling down by giving her baths and applying cold compresses. 12 days following the shots (Feb 13th) she then had another reaction where she had a fever of 103.2 and ws very cranky. Again, she was given Tylenol and Motrin to help with the fever. These symptoms lasted approx 3 days and she was not seen by the doctor.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Injection site warmth, Irritability, Pyrexia
Clinical narrative: Shots were given 0900 Friday Feb 1, 2008. The day after the shots were administered, there was a 2 inch area around the injection site that was raised, red, very warm to the touch, and VERY painful to the point that my daughter could not walk or put pressure on her leg whatsoever. The entire area was very hard, it felt almost as if there was a rock under her skin. This lasted for 3.5 days. Monday February 4th, we took her to see the doctor to be seen and by that point the symptoms and side effects were going away. During the time she was experiencing symptoms, we were giving her Tylenol and Motrin to help with pain and trying our best to keep swelling down by giving her baths and applying cold compresses. 12 days following the shots (Feb 13th) she then had another reaction where she had a fever of 103.2 and ws very cranky. Again, she was given Tylenol and Motrin to help with the fever. These symptoms lasted approx 3 days and she was not seen by the doctor.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician (allergist) and described the occurrence of anaphylaxis in a 4-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline), MMR II (Merck) and Varivax (Merck) for prophylaxis.  On 25 January 2008 at 12:00 the subject received 2nd dose of Havrix at 0.5 ml in the left arm.  On 25 January 2008 the subject also received unspecified dose of MMR II (the subject had at least one previous dose) and 1st dose of Varivax.  At an unspecified time after vaccination with Havrix, MMR II and Varivax, the subject experienced anaphylaxis, a systemic reaction.  The physician considered the events were life threatening and clinically significant (or requiring intervention).  The subject was treated with Epinephrine, 2 doses), Benadryl, oxygen and prednisone.  Once stabilized, he was sent to the emergency room for observation, but was not admitted.  He required no further treatment.  The child had no reaction to the first dose of Havrix.  In 2008, the events were resolved.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B antigenemia in an adult male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included blood donor and plasma donor.  On an unspecified date the subject received 1st dose of Engerix B (1 ml, unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced hepatitis B antigenemia and vaccination failure.  The physician stated, the male subject was routinely tested for hepatitis B due to blood and plasma donations; that testing showed he was positive for hepatitis B after he was vaccinated.  At the time of this report, no further details were collected.  At the time of reporting the outcome of the events were unspecified.  The physician considered the events were probably related to vaccination with Engerix B.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: This case was reported by a physician and described the occurrence of itching in a 52-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  On 28 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown, right arm).  On 28 November 2007, less than one day after vaccination with Fluarix, the subject experienced itching and generalized rash on multiple body parts.  The subject was treated with Medrol dose pak and Claritin in the physician's office.  At the time of reporting the events were improved.  The physician considered the events were probably related to vaccination with Fluarix.  Follow-up information received on 11 February 2008 indicated that the events resolved by 13 December 2007 and were considered by the reporter to be related to treatment with Fluarix.  The reporter additionally added that the events jeopardized the subject or required intervention (prescription required).  The events did not appear to be an allergic reaction.  At the age of 39, the subject received tetanus toxoid (manufacturer unknown) and became hot, red and swollen at the injection site (necrotic at the center).  The subject was given antibiotic at that time.  Concurrent medications taken at the time of Fluarix vaccination included Toprol, Mobic, Maxide and Aciphex.  Concurrent medical conditions included hypertension, osteoarthritis, peptic ulcer disease and GERD.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Acute lymphocytic leukaemia, Blood uric acid increased, CSF glucose normal, CSF protein normal, CSF test normal
Clinical narrative: Very fatigued since 2.5.2008. Seen by me, pediatrician on 2.8.08 and 2.11.08. Blood work done 2.12.08 showed occasional blasts and patient had blood marrow done. Now DX to have A.L.L. and chemo Rx started.  2/26/08 Reviewed pcp medical records & vax records. FINAL PCP DX: Acute lymphocytic leukemia (pre B-cell). Received HPV #1 0680U on 9/18/07 at GYN office & Menactra U2385BA on 8/7/07 Fluzone U2451AA on 1/4/2008 at pcp office.  Seen 11/07 for cough, sinus pressure, fever, tight chest, ear ache, HA; sibling w/similar symptoms 10 days prior.  Dx w/sinusitis, otalgia & cough.  Tx w/antibiotics.  Returned to office 1/4/08 w/o complaints for flu shot.  Returned to office 2/8/08 c/o of extreme fatigue beginning approx 2/5/08, stomach pain & intermittent hiccups.  Dx w/malaise & fatigue, r/o mono.  Referred for labs.  Returned to office 2/11/08 w/continued fatigue, pallor, feeling miserable, SOB, nausea, decreased appetite, earache.  Temp 100.7 at that time.  2/13/08 notified by lab of abnormal CBC & referred to hospital.  2/18/08 Received call from parent w/dx of ALL (pre-B cell).  Admitted 2/13-2/23/08.  Placed in study & will receive most tx as outpatient.  3/11/08 Reviewed hospital medical records for admission 2/13-2/23/2008. FINAL DX: acute lymphocytic leukemia Patient experienced extreme fatigue, excessive sleepiness, SOB, low grade fever, abdominal distention w/tenderness, petechiae on LEs, pancytopenia & hepatosplenomegaly.  Consults done by heme/onc.  Transfused x 2. Follow-up: Patient is still being treated for high risk A.L.L. at medical center. Report received from hematooncologist (dated 4.14.08) is attached. Please contact them for further information. I have reported this as part of on going surveillance post-licensure for new vaccines.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Fatigue, Full blood count abnormal, Neutrophil count decreased, Platelet count decreased, Red blood cell sedimentation rate increased
Clinical narrative: Very fatigued since 2.5.2008. Seen by me, pediatrician on 2.8.08 and 2.11.08. Blood work done 2.12.08 showed occasional blasts and patient had blood marrow done. Now DX to have A.L.L. and chemo Rx started.  2/26/08 Reviewed pcp medical records & vax records. FINAL PCP DX: Acute lymphocytic leukemia (pre B-cell). Received HPV #1 0680U on 9/18/07 at GYN office & Menactra U2385BA on 8/7/07 Fluzone U2451AA on 1/4/2008 at pcp office.  Seen 11/07 for cough, sinus pressure, fever, tight chest, ear ache, HA; sibling w/similar symptoms 10 days prior.  Dx w/sinusitis, otalgia & cough.  Tx w/antibiotics.  Returned to office 1/4/08 w/o complaints for flu shot.  Returned to office 2/8/08 c/o of extreme fatigue beginning approx 2/5/08, stomach pain & intermittent hiccups.  Dx w/malaise & fatigue, r/o mono.  Referred for labs.  Returned to office 2/11/08 w/continued fatigue, pallor, feeling miserable, SOB, nausea, decreased appetite, earache.  Temp 100.7 at that time.  2/13/08 notified by lab of abnormal CBC & referred to hospital.  2/18/08 Received call from parent w/dx of ALL (pre-B cell).  Admitted 2/13-2/23/08.  Placed in study & will receive most tx as outpatient.  3/11/08 Reviewed hospital medical records for admission 2/13-2/23/2008. FINAL DX: acute lymphocytic leukemia Patient experienced extreme fatigue, excessive sleepiness, SOB, low grade fever, abdominal distention w/tenderness, petechiae on LEs, pancytopenia & hepatosplenomegaly.  Consults done by heme/onc.  Transfused x 2. Follow-up: Patient is still being treated for high risk A.L.L. at medical center. Report received from hematooncologist (dated 4.14.08) is attached. Please contact them for further information. I have reported this as part of on going surveillance post-licensure for new vaccines.