chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood pressure, Foaming at mouth, Heart rate normal, Hypotonia, Oxygen saturation normal
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 4 year old female with a history of pyelonephritis who on 18-MAY-2005 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported).  On 22-MAY-2008 the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot number 659331/1462U) in the right arm (injection route not reported) and was also vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot number 0288U) (MSD).  On 22-MAY-2008, 1-2 minutes after vaccination, the patient complained of throat feeling funny.  The patient went limp and pale.  She started vomiting and foaming in the mouth.  The O2 sat was 95-98%, blood pressure was 86/50 and the pulse rate was 96.  The patient was given epinephrine 0.15 mg and was transported via ambulance to emergency room.  The patient was discharged after 4 hours the patient was fully recovered.  According to the HCP, the patient's events were considered to be immediately life-threatening and required medical intervention.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pallor, Throat irritation, Vomiting
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 4 year old female with a history of pyelonephritis who on 18-MAY-2005 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported).  On 22-MAY-2008 the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot number 659331/1462U) in the right arm (injection route not reported) and was also vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot number 0288U) (MSD).  On 22-MAY-2008, 1-2 minutes after vaccination, the patient complained of throat feeling funny.  The patient went limp and pale.  She started vomiting and foaming in the mouth.  The O2 sat was 95-98%, blood pressure was 86/50 and the pulse rate was 96.  The patient was given epinephrine 0.15 mg and was transported via ambulance to emergency room.  The patient was discharged after 4 hours the patient was fully recovered.  According to the HCP, the patient's events were considered to be immediately life-threatening and required medical intervention.  Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: CSF culture negative, CSF glucose normal, CSF protein normal, CSF white blood cell count increased, Enterovirus infection
Clinical narrative: Patient had enterovirus meningitis (was confirmed by culture test) when vaccine was given.  They had been out of the country just days before.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: Gram stain negative, Headache, Meningitis viral, Nausea, Pyrexia
Clinical narrative: Patient had enterovirus meningitis (was confirmed by culture test) when vaccine was given.  They had been out of the country just days before.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: CSF culture negative, Laboratory test abnormal, Meningitis, Pyrexia
Clinical narrative: Patient had enterovirus meningitis (was confirmed by culture test) when vaccine was given.  They had been out of the country just days before.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: Culture positive, Foreign travel, Meningitis enteroviral
Clinical narrative: Patient had enterovirus meningitis (was confirmed by culture test) when vaccine was given.  They had been out of the country just days before.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Accidental needle stick, Haemorrhage
Clinical narrative: Child pulled out the Infanrix (DTaP)# 4 shot with her left hand, while doing this, the needle scratched her thigh causing a small superficial bleeding. I stopped the minor bleeding immediately with a pressure bandage.Mother used her left hand to hold child's arms and right hand to hold child's legs.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Death, Pain
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Coma, Death
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal discomfort, Antinuclear antibody negative, Autopsy, Cardiac enzymes increased, Catheterisation cardiac
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest discomfort, Chest pain, Coxsackie virus serology test negative, Death, Dizziness
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dyspnoea, Echovirus serology test negative, Ejection fraction decreased, Hypoaesthesia, Hypoperfusion
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Influenza serology negative, Influenza serology positive, Myocarditis, Nausea, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pulmonary congestion, Resuscitation, Streptococcal identification test positive, Ventricular tachycardia, Viral test negative
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Virus serology test
Clinical narrative: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included erythromycin, solution, topical.  On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized.  On 05-AUG-2008, the patient experienced myocarditis and died.  Diagnosis was myocarditis but the doctor said it was not related to GARDASIL.  The last time she was seen in this office was 2005.  No additional information at this time.  Additional information has been requested.  10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.  9/22/08 Reviewed PCP medical records.  Reveals patient experienced abdominal pain, chest pain & aching everywhere.  Expired 8/5/08 w/viral infection of the heart.  Concomitant med was erythomycin topical solution for acne.  Patient noted to be in good health on day of vaccination.  4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days.  Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB,  respiratory distress w/hypoxemia, azotemia,  shocklike symptoms.  EKG w/diffuse ST changes & ST elevations.  Dx w/acute anteroseptal MI  Emergent cardiac cath revealed EF 23% & balloon pump placed.  Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Encephalitis
Clinical narrative: Information has been received from a physician concerning a 70 year old male (not his patient) who "2 weeks ago", on approximately 27-AUG-2008 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently the patient experienced encephalitis and was hospitalized. At the time of this report, the patient was still at the hospital. Additional information has been requested.  10/10/08  Reviewed PCP medical records of 5/29-9/22/2008. FINAL DX: encephalitis Records reveal patient experienced usual state of health on 6/12/2008 day of Zostavax vaccination, no lot number provided.  Developed HA, fever, decreased appetite, weakness, axillary & inguinal lymphadenopathy, frequent urination, chills, rash on flank, confusion, weight loss, excessive sleep 8/08.  Seen in ER 8/17 & dx w/muscle tension HA.  Condition worsened & seen by PCP 9/2 w/fatigue x 6 weeks, fever/chills x 4 weeks, right hand weakness/clumsiness, eye floaters, loose stools.  LP & labs done.  Tx w/oral antibiotics & antivirals.  Continued to worsen w/shakiness, gait disturbance, extreme fatigue & tiredness, HA & neck pain.  RTC & sent to hospital for admission 9/4/08 for possible viral meningitis & diagnosed w/encephalitis.   10/1/08 Reviewed hospital medical records of 9/4-9/16/2008. FINAL DX: no d/c summary available.  H&P states meningitis, indolent course; varicella-like rash across right chest wall & abdomen. Records reveal patient experienced feeling ill for approx 6 wks prior to admit.  Had been seen in ER on 8/18/08.  CT scan at that time c/w sinus infection.  Seen by PCP 9/3/08 w/HA, neck pain & intermittent fever & chills, weight loss x 2 weeks. Rash cultured.  LP done in office & when received results sent to ER for admission.  In ER had fever 101.7 w/severe HA, neck pain, fatigue, cough, rash across right chest & abdomen.  Tx w/IV antibiotics & antivirals.  ID consult done.  1/8/09 Reviewed D/C summary for 9/4-9/16. FINAL DX: aseptic meningitis; DM II; HTN; low testosterone. No other new information obtained.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: CSF test abnormal, Hypoaesthesia facial, Multiple sclerosis
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or no drug allergies who on an unspecified date, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  After receiving GARDASIL at an unspecified time, the patient developed left sided facial numbness.  The patient was diagnosed with multiple sclerosis six months after receiving first dose from a magnetic resonance imaging test and from a spinal fluid test.  At the time of reporting, the patient was recovering.  Medical attention was sought via office visit.  No product quality complaint was involved.  Upon internal review, multiple sclerosis was determined to be an other important medical event.  Additional information has been requested.  10/21/08 Reviewed neurology medical records of 8/28-9/9/2008. FINAL DX: multiple sclerosis Records reveal patient experienced left facial & tongue numbness x 6 days on initial evaluation 8/28. RTC 9/9 for spinal tap w/abnormal CSF c/w MS.  Referred for repeat MRI w/gadolinium which had been denied by insurance previously.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Head injury, Headache, Syncope
Clinical narrative: Information has been received from a physician concerning her niece, a 21 year old female patient who about a year ago, in 2007, was vaccinated with the first dose of GARDASIL. The patient received the first dose of GARDASIL and fainted and she hit her head about 10 minutes after receiving the first dose. The patient was transported to the emergency room for the treatment. The patient experienced numerous days of headache and dizziness that went on for at least one month. The patient was unable to compete in sports and missed the rest of her sport season. The patient completed the remaining two doses of GARDASIL without problems. The patient recovered from delayed syncope event, head injury, headache and dizziness. The delayed syncope event, headache and dizziness were considered to be disabling by the physician. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: 9/5/08 - Received Varicella vaccine SQ in right arm. 9/8/08 - Large red area around shot area. Seen at office. Instructed to go t ER if red circle got bigger today. 9/8/08 - To ER. Admitted to R/O cellulitis at varicella inj. site.   12/1/08 MR received for DOS 9/8-10/2008 with D/C DX: Cellulitis. Pt presented with pain, swelling and erythema at the site of varicella vaccine on the R arm. Tx with abx with almost complete resolution by d/c.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Lumbar puncture, Multiple sclerosis, Optic neuritis, Vision blurred
Clinical narrative: Per mother's request - 6/2/08 numbness lower legs.  6/12/08 blurry vision left eye - Optic Neuritis.  6/21/08 numbness shoulder.  09/19/2008 MR received for DOS 6/23-26/08 with Final DX: Suspected Multiple Sclerosis vs ADEM. Left Optic Neuritis.  Pt transfered to current facility with recent dx of Optic Neuritis and brain MRI concerning for MS. Pt developed blurry vision and was seen and dx by ophthamologist. Pt had been experiencing blurry vision. Now experiencing numbness of the L side wrapping around to the back and numness of both 1st toes. PE (+) for decreased strength LUE. Tx with IV solumedrol. D/C for outpt f/u. 1/27/2010 She has been diagnosed with MS.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right deltoid, red, swollen, warm to touch (5" x 5") ice pack for 15 minutes every 2 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm (deltoid) 4x3 1/2" red, swollen, warm to touch.  Ice pack 15 minutes every 2 hours and rubbing area.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: About 30 seconds after administering vaccine, GARDASIL, patient fainted, lot consciousness for approximately 5 seconds. Patient states she felt fine after awakening.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient fainted after needle was withdrawn, lost consciousness for 2 seconds. Mother of patient called our office the next day stating that patient collapsed in coffee shop after having left the clinic. Patient was observed in exam room for 15 minutes, and was released without problem.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Notified by MD office that child was administered Tdap (BOOSTRIX)
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: 9/5/08 - Mom states child had redness and swelling 1 hour after receiving immunizations. Mom states child had a fever and was given Motrin. Area on lateral part of LT. arm was slightly red, swollen - about the size of fifty cents piece and was warm to touch. Instructed mom to take child to family MD or ER. Mom will call us back and let us known what MD found.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dysphonia, Feeling hot, Migraine, Pharyngolaryngeal pain
Clinical narrative: Patient awoke the next day with rash on arm in which GARDASIL given; Rash spread to abd with leg and gradually all over her body. Rash was slightly itchy and she took OTC Benadryl which helped. She states she felt feverish but did not check her temp. She had hoarse voice and complained of slightly sore throat; complained of GI puffiness and loose stools and migraine
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient awoke the next day with rash on arm in which GARDASIL given; Rash spread to abd with leg and gradually all over her body. Rash was slightly itchy and she took OTC Benadryl which helped. She states she felt feverish but did not check her temp. She had hoarse voice and complained of slightly sore throat; complained of GI puffiness and loose stools and migraine
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Diarrhoea, Dysphonia, Feeling hot, Injection site rash
Clinical narrative: Patient awoke the next day with rash on arm in which GARDASIL given; Rash spread to abd with leg and gradually all over her body. Rash was slightly itchy and she took OTC Benadryl which helped. She states she felt feverish but did not check her temp. She had hoarse voice and complained of slightly sore throat; complained of GI puffiness and loose stools and migraine
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine, Oropharyngeal pain, Rash generalised, Rash pruritic
Clinical narrative: Patient awoke the next day with rash on arm in which GARDASIL given; Rash spread to abd with leg and gradually all over her body. Rash was slightly itchy and she took OTC Benadryl which helped. She states she felt feverish but did not check her temp. She had hoarse voice and complained of slightly sore throat; complained of GI puffiness and loose stools and migraine
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling right deltoid, slight redness, knot 4-15mm at site - Restless feeling to arm.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Gave Tdap instead Dtap
Age: 1.01
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: Seizure had one on 8/23/08 Varicella/MMR given 8/26/08. 2nd seizure on 9/1/08
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: Admin 8/11/08 (L) arm. 8/12 itch, warm .50 size red raised. On 8/13/08 appt with Large, local extended Rxn. Red, warm from humeral head to elbow extended entire upper arm. No adenopathy or systemic. sx no fever; 33 yz bicep diam (L) vs 30Y2 Rt phone contact 8/14 and 8!5 sx subsided.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Incorrect route of drug administration
Clinical narrative: Auditing charts and discovered IPV lot # written down by MA on 5-11-07 was an incorrect lot#, upon investigation, discovered that the lot # was for PPD. MA gave PPD 0.5 ml SQ to patient. Patient had not had any adverse effects at this time.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Auditing charts and discovered IPV Lot # written down by MA on 5-11-07 was an incorrect Lot#. Upon investigation, discovered that the lot # was for PPD. MA gave PPD 0.5ml SQ to patient has not had any adverse effects at this time.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema peripheral, Pyrexia, Rash macular
Clinical narrative: Fever up to 102 deg x 2 days post-vaccine. Entire anterior (L) thigh red, swollen on 8/21/08. 8/25/08- raised, red pink spots on both feet and ankles. One week later raised, blotchy rash on (L) thigh.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: warm and red and pain at injection site approx 5 inches diameter
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Large area of redness, warm in, induration involving entire anterior surface of right thigh. Till just above knee.
Age: 42.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Abdominal pain, Activities of daily living impaired, Back pain, Injection site pain, Malaise
Clinical narrative: 9/5 Pt. called today-to inform us of "possible reaction" to 7/28 vaccines. c/o arm pain at site of Hep. A inj.- "shooting pains" up and down arm, continuing for 2 days. Also had cold sx that wk. Saw PCP (7/30 who stated? if ocld or shot rxn since she "felt so ill all over" she had difficulty getting out of bed. "organs hurting when abd. pressure and back pains. Rested 2 days-no other sx.
Age: 42.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pain, Pain in extremity
Clinical narrative: 9/5 Pt. called today-to inform us of "possible reaction" to 7/28 vaccines. c/o arm pain at site of Hep. A inj.- "shooting pains" up and down arm, continuing for 2 days. Also had cold sx that wk. Saw PCP (7/30 who stated? if ocld or shot rxn since she "felt so ill all over" she had difficulty getting out of bed. "organs hurting when abd. pressure and back pains. Rested 2 days-no other sx.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pertussis, Pertussis identification test positive
Clinical narrative: Pentacel vaccine 08/08/08. + Pertussis culture 9/9/08.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Pain in extremity
Clinical narrative: Left shoulder upper arm soreness and swelling with axillary lymph node 1 cm, skin redness/pinkness in 6x4 cm area of axilla.
Age: 31.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Hyperaesthesia, Inappropriate schedule of drug administration, Nausea, Pain
Clinical narrative: Chills, fever, bodyaches, nausea, photosensitvity; Hypersensitivity to touch
Age: 31.0
Sex: M
Vaccine: DTAP
Symptoms: Photosensitivity reaction, Pyrexia, Wrong drug administered
Clinical narrative: Chills, fever, bodyaches, nausea, photosensitvity; Hypersensitivity to touch
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pregnancy test positive
Clinical narrative: No adverse symptoms; (+) urine pregnancy test 9/8/08
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Pt had severe urticaria all over body.
Age: 3.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Aphthous stomatitis, Diarrhoea, Mouth ulceration, Oral intake reduced, Pyrexia
Clinical narrative: -Fever, vomiting x 1, semisolid stools x 2 in first 24 hrs. -Mouth sores on day 2 -> decreased eating, -seen in office day 5 -> aphthous ulcers tongue x 2 posterior pharynx x1, gum x1, well hydrated; No acute distress.
Age: 3.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Tongue ulceration, Vomiting
Clinical narrative: -Fever, vomiting x 1, semisolid stools x 2 in first 24 hrs. -Mouth sores on day 2 -> decreased eating, -seen in office day 5 -> aphthous ulcers tongue x 2 posterior pharynx x1, gum x1, well hydrated; No acute distress.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: No reaction
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Mother of pt noted a rash on her daughters abdomen and neck around 1930 hr. Took her to ER where she was evaluated and sent home with BENADRYL. On 9/4/08 mother took child to Hosp. she was told she had hives, given BENADRYL and TYLENOL.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dysuria, Erectile dysfunction, Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of neuropathy in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID and seasonal allergic rhinitis. There were no concurrent medications. On 19 November 2007 at 12:00 the subject received a dose of FLULAVAL in the left arm. On the evening of 19 November 2007, less than one day after vaccination with FLULAVAL, the subject developed mild inflammation at the injection site. Later, on 20 November 2007, the subject developed an achy feeling, soreness in rib case, numbness from the mid-chest downward, loss of tactile sensation from the waist down, a slight tingling in the extremities (fingers and toes), an inability to urinate for about 8 to 10 hours, impotence and pain in the shoulder and scapula bilaterally (more severe on left injection side). The subject's body temperature was normal. The next day, on 21 November 2007, the subject experienced right leg weakness (leg gave way while walking downstairs). His body temperature was still normal. On 22 November 2007, the subject continued to experience weakness and severe dizziness was noted. The subject was unable to drive a car. Right leg weakness continued (leg gave way while walking downstairs for the second time). On 25 November 2007, impotence resolved, but shoulder, rib and chest soreness continued. The subject's body temperature was normal. The next day, on 26 November 2007, urination was better, but it was still difficult to start urine flow. There was suspected prostate involvement. The subject was started on Bactrim DS twice daily for 21 days. On 05 December 2007, general weakness was improving and mild dizziness continued. On 12 December 2007, acute symptoms resolved, mild dizziness, generalized muscle weakness and tenderness persisted. On 13 December 2007, the subject met with a urologist and he was diagnosed with transient neuropathy, probably related to the flu shot. It was described like Guillain-Barre Syndrome. The pharmacist considered the events were clinically significant (or requiring intervention). As of 15 June 2008, general muscle weakness and tenderness persisted, especially around the upper body. As of 11 September 2008, muscle tenderness persisted throughout the upper body, but the subjects legs were okay. The reporter stated that the following had resolved: muscle tenderness and generalized upper body soreness. The reporter felt that causality of the events to FLULAVAL was probable.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired driving ability, Injection site inflammation, Muscular weakness, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of neuropathy in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID and seasonal allergic rhinitis. There were no concurrent medications. On 19 November 2007 at 12:00 the subject received a dose of FLULAVAL in the left arm. On the evening of 19 November 2007, less than one day after vaccination with FLULAVAL, the subject developed mild inflammation at the injection site. Later, on 20 November 2007, the subject developed an achy feeling, soreness in rib case, numbness from the mid-chest downward, loss of tactile sensation from the waist down, a slight tingling in the extremities (fingers and toes), an inability to urinate for about 8 to 10 hours, impotence and pain in the shoulder and scapula bilaterally (more severe on left injection side). The subject's body temperature was normal. The next day, on 21 November 2007, the subject experienced right leg weakness (leg gave way while walking downstairs). His body temperature was still normal. On 22 November 2007, the subject continued to experience weakness and severe dizziness was noted. The subject was unable to drive a car. Right leg weakness continued (leg gave way while walking downstairs for the second time). On 25 November 2007, impotence resolved, but shoulder, rib and chest soreness continued. The subject's body temperature was normal. The next day, on 26 November 2007, urination was better, but it was still difficult to start urine flow. There was suspected prostate involvement. The subject was started on Bactrim DS twice daily for 21 days. On 05 December 2007, general weakness was improving and mild dizziness continued. On 12 December 2007, acute symptoms resolved, mild dizziness, generalized muscle weakness and tenderness persisted. On 13 December 2007, the subject met with a urologist and he was diagnosed with transient neuropathy, probably related to the flu shot. It was described like Guillain-Barre Syndrome. The pharmacist considered the events were clinically significant (or requiring intervention). As of 15 June 2008, general muscle weakness and tenderness persisted, especially around the upper body. As of 11 September 2008, muscle tenderness persisted throughout the upper body, but the subjects legs were okay. The reporter stated that the following had resolved: muscle tenderness and generalized upper body soreness. The reporter felt that causality of the events to FLULAVAL was probable.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Pain, Paraesthesia, Prostatic specific antigen normal, Rectal examination
Clinical narrative: This case was reported by a pharmacist and described the occurrence of neuropathy in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID and seasonal allergic rhinitis. There were no concurrent medications. On 19 November 2007 at 12:00 the subject received a dose of FLULAVAL in the left arm. On the evening of 19 November 2007, less than one day after vaccination with FLULAVAL, the subject developed mild inflammation at the injection site. Later, on 20 November 2007, the subject developed an achy feeling, soreness in rib case, numbness from the mid-chest downward, loss of tactile sensation from the waist down, a slight tingling in the extremities (fingers and toes), an inability to urinate for about 8 to 10 hours, impotence and pain in the shoulder and scapula bilaterally (more severe on left injection side). The subject's body temperature was normal. The next day, on 21 November 2007, the subject experienced right leg weakness (leg gave way while walking downstairs). His body temperature was still normal. On 22 November 2007, the subject continued to experience weakness and severe dizziness was noted. The subject was unable to drive a car. Right leg weakness continued (leg gave way while walking downstairs for the second time). On 25 November 2007, impotence resolved, but shoulder, rib and chest soreness continued. The subject's body temperature was normal. The next day, on 26 November 2007, urination was better, but it was still difficult to start urine flow. There was suspected prostate involvement. The subject was started on Bactrim DS twice daily for 21 days. On 05 December 2007, general weakness was improving and mild dizziness continued. On 12 December 2007, acute symptoms resolved, mild dizziness, generalized muscle weakness and tenderness persisted. On 13 December 2007, the subject met with a urologist and he was diagnosed with transient neuropathy, probably related to the flu shot. It was described like Guillain-Barre Syndrome. The pharmacist considered the events were clinically significant (or requiring intervention). As of 15 June 2008, general muscle weakness and tenderness persisted, especially around the upper body. As of 11 September 2008, muscle tenderness persisted throughout the upper body, but the subjects legs were okay. The reporter stated that the following had resolved: muscle tenderness and generalized upper body soreness. The reporter felt that causality of the events to FLULAVAL was probable.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss, Tenderness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of neuropathy in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID and seasonal allergic rhinitis. There were no concurrent medications. On 19 November 2007 at 12:00 the subject received a dose of FLULAVAL in the left arm. On the evening of 19 November 2007, less than one day after vaccination with FLULAVAL, the subject developed mild inflammation at the injection site. Later, on 20 November 2007, the subject developed an achy feeling, soreness in rib case, numbness from the mid-chest downward, loss of tactile sensation from the waist down, a slight tingling in the extremities (fingers and toes), an inability to urinate for about 8 to 10 hours, impotence and pain in the shoulder and scapula bilaterally (more severe on left injection side). The subject's body temperature was normal. The next day, on 21 November 2007, the subject experienced right leg weakness (leg gave way while walking downstairs). His body temperature was still normal. On 22 November 2007, the subject continued to experience weakness and severe dizziness was noted. The subject was unable to drive a car. Right leg weakness continued (leg gave way while walking downstairs for the second time). On 25 November 2007, impotence resolved, but shoulder, rib and chest soreness continued. The subject's body temperature was normal. The next day, on 26 November 2007, urination was better, but it was still difficult to start urine flow. There was suspected prostate involvement. The subject was started on Bactrim DS twice daily for 21 days. On 05 December 2007, general weakness was improving and mild dizziness continued. On 12 December 2007, acute symptoms resolved, mild dizziness, generalized muscle weakness and tenderness persisted. On 13 December 2007, the subject met with a urologist and he was diagnosed with transient neuropathy, probably related to the flu shot. It was described like Guillain-Barre Syndrome. The pharmacist considered the events were clinically significant (or requiring intervention). As of 15 June 2008, general muscle weakness and tenderness persisted, especially around the upper body. As of 11 September 2008, muscle tenderness persisted throughout the upper body, but the subjects legs were okay. The reporter stated that the following had resolved: muscle tenderness and generalized upper body soreness. The reporter felt that causality of the events to FLULAVAL was probable.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: 3 days after administration patient developed cellulitis with 12x16 cm erythema, tenderness, warmth. MENACTRA and VARIVAX administered. Same leg.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: sig. swelling, erythema, bruising at injection site and deltoid region.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received inadvertant dose of MCV4 vaccine
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Arm was red "knotty" from shoulder to elbow. Resolved with BENADRYL over 48-72 hr.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Musculoskeletal stiffness, Rash
Clinical narrative: Mom reports (on 8/12/08); Patient experience rash quarter -> palm sized, a little stiffness and itching at injection site for a few days after injection
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pain in extremity
Clinical narrative: 09-12-08 530 PM Dizzy, Diaphoretic, painful in arm all the way down to wrist within minutes after vaccine ->lay down for 10 minutes felt better. 10 minutes later called office to report she had passed out while driving. Advised to go to the ER -
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm soreness all the way down to wrist.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fear of needles, Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episode after receiving GARDASIL, ADACEL and PPD. ADACEL and PPD given 1st. Reaction (fainted) occurred immediately after receiving GARDASIL. Pt does have a fear of needles but has never fainted before.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Patient called complained of itching neck, back 2 small hives in hand with chest tightness. Patient was sent to ER for eval for chest tightness and feeling "closing" up.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Right arm redness, warm to touch, sore ness, itching, swollen x 2 days
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None known
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Induration
Clinical narrative: 15 cm induration treated with prednisone x 3 days
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash on buttocks, trunk, extremities consistent with varicella-active infection
Age: 17.0
Sex: F
Vaccine: DTAPIPVHIB, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt received DTAP and POLIO combo and should have received Tdap as ordered by physician.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain
Clinical narrative: Doctor called wanting to know side effects of Rabies vaccine, c/o body aches and abdominal cramping, started on menstrual cycle, unsure if relates or not. Report is this don't resolve will go to emergency rm. No further contact. Recovery unknown, will call if s/s unresolved.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Abasia, Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Area of erythema and swelling injection site (L) thigh progressively lame 48 hrs. Dx vaccine reaction vs. cellulitis. Rx Orapred, Keflex, Septa.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pruritus, Skin warm
Clinical narrative: 9/13/08 Client to urgent care with mom with acting ok - had .50 size knot with itchy and warmth to touch. Placed on Amoxicillin 1/2 tsp. BID x 10 days - hydrate liquid 7.5 ml q6 PRN. Prednisolone 2 tsp. BID x 5 days.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site. given BENADRYL
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 10 minutes after being given the flu shots, MMR and Varicella #1, PREVNAR, DTaP #4, pt developed hives in the site of the Varicella injection, (R) thigh. Pt. was given BENADRYL.
Age: 5.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Varicella
Clinical narrative: Pt received 2 doses of VARIVAX (1/5/04 and 1/4/08); Pt presented with 5 lesions, Dx with Varicella.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: 6x6.5 cm warm indurated tender area R. Triceps.