chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site erythema
Clinical narrative: localized redness in left thigh after DTaP 2 days later redness was decreasing pt had been crying and complaining leg had been bothering him
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Crying, Irritability
Clinical narrative: extreme irritability, fussiness and inconsolable crying for more than 30 minutes, 2-3 times a day for 4 days
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Asthma, Epistaxis, Headache, Influenza
Clinical narrative: Malaise started 12/11/03.  By 12/12/03, temperature: 101.8-102.8; O2 sat 91%, tachypnea (RR60) and in status asthmaticus.  Headache, sore throat, myalgia, treated with hospitalization, tamiflu 75mg 2 times a day, Prednisone, Albuterol hourly, Singulair, Advair.  Discharged 12/14.  On 12/15 still weak with headache and sinusitis with epistaxis; afebrile, and mild end expiratory wheeze on normal respiratory without shortness of breath.  Diagnosis: flu and status asthmaticus then laster sinusitis.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Malaise, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Malaise started 12/11/03.  By 12/12/03, temperature: 101.8-102.8; O2 sat 91%, tachypnea (RR60) and in status asthmaticus.  Headache, sore throat, myalgia, treated with hospitalization, tamiflu 75mg 2 times a day, Prednisone, Albuterol hourly, Singulair, Advair.  Discharged 12/14.  On 12/15 still weak with headache and sinusitis with epistaxis; afebrile, and mild end expiratory wheeze on normal respiratory without shortness of breath.  Diagnosis: flu and status asthmaticus then laster sinusitis.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Sinusitis, Tachypnoea, Wheezing
Clinical narrative: Malaise started 12/11/03.  By 12/12/03, temperature: 101.8-102.8; O2 sat 91%, tachypnea (RR60) and in status asthmaticus.  Headache, sore throat, myalgia, treated with hospitalization, tamiflu 75mg 2 times a day, Prednisone, Albuterol hourly, Singulair, Advair.  Discharged 12/14.  On 12/15 still weak with headache and sinusitis with epistaxis; afebrile, and mild end expiratory wheeze on normal respiratory without shortness of breath.  Diagnosis: flu and status asthmaticus then laster sinusitis.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site oedema
Clinical narrative: COMPLETE EDEMA OF THE LEFT BICEP/TRICEP FROM SHOULDER TO ELBOW. ZERO ERYTHEMA, CIRCUMFRENCIAL EDEMA, ZERO SYSTEMIC SIGNS OR SYMPTOMS
Age: 0.2
Sex: F
Vaccine: DTPHIB, IPV, PPV
Symptoms: Crying, Erythema, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Dr.  stated rarely a high fever occurs that is only side effect. When I arrived for her visit I brought Motrin and asked the nurse the dosage to give, she stated Motrin not recommended, use Tylenol and the nurse would give some in the room.  The nurse stated she didn't have any and she wouldn't need anything. After he gave her the shots, two in each thigh, one bled more and she was screaming. She stopped in the car and when we arrived home she fell right to sleep and slept for hours. She woke up screaming uncontrollably, face beat red, sweating, choking she was crying so hard. Nor myself or my husband could not stop her.  Her legs were in pain. I could not even touch her gently or change her diaper. I paged the doctor and he did not call back. We proceeded to take her to the ER and she fell asleep in the car. Worrying about the flu we chose not to wait there w/the sick because they had no room for her we went home. Paged MD again Covering MD stated not to wake her, not normal to be in that much pain hours later. If she wakes up screaming give .06 Tylenol and wait 20 minutes. If crying does not stop go back to ER. She was sleeping and at 11:00 she still was not breathing right in her sleep.  I tryed to wake her and she was not responding. It took us some time to get her to respond.  She stretched alittle and continued sleeping. She went 13 hours without a bottle and I had to wake her at 7:00AM the next morning.
Age: 0.2
Sex: F
Vaccine: DTPHIB, IPV, PPV
Symptoms: Respiratory disorder, Thrombocytopenia
Clinical narrative: Dr.  stated rarely a high fever occurs that is only side effect. When I arrived for her visit I brought Motrin and asked the nurse the dosage to give, she stated Motrin not recommended, use Tylenol and the nurse would give some in the room.  The nurse stated she didn't have any and she wouldn't need anything. After he gave her the shots, two in each thigh, one bled more and she was screaming. She stopped in the car and when we arrived home she fell right to sleep and slept for hours. She woke up screaming uncontrollably, face beat red, sweating, choking she was crying so hard. Nor myself or my husband could not stop her.  Her legs were in pain. I could not even touch her gently or change her diaper. I paged the doctor and he did not call back. We proceeded to take her to the ER and she fell asleep in the car. Worrying about the flu we chose not to wait there w/the sick because they had no room for her we went home. Paged MD again Covering MD stated not to wake her, not normal to be in that much pain hours later. If she wakes up screaming give .06 Tylenol and wait 20 minutes. If crying does not stop go back to ER. She was sleeping and at 11:00 she still was not breathing right in her sleep.  I tryed to wake her and she was not responding. It took us some time to get her to respond.  She stretched alittle and continued sleeping. She went 13 hours without a bottle and I had to wake her at 7:00AM the next morning.
Age: 57.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Feeling hot, Hot flush
Clinical narrative: Hives, urticaria, fever, throat swelling.
Age: 57.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Hives, urticaria, fever, throat swelling.
Age: 57.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: Hives, urticaria, fever, throat swelling.
Age: 25.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL, TYP
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Probable smallpox-associated myopericarditis. Most of history obtained from inpatient record from hospital (when pt contacted x 2 while in hospital, he requested case manager call him back. Several messages left on answering machine at home phone number, but pt did not return phone calls to case manager. Pt contacted by phone on evening of 11/26, and clinical summary completed). On early morning of 10/18/03, pt began experiencing chest pain and  SOB. He awoke around 0200 with upper back pain, which was attributed to a pulled muscle. The pain persisted, and around 0800, he developed substernal chest pain that radiated to his upper extremities and upper back. Pt took Motrin for pain relief, but the pain persisted. Around 1500 on 10/19/03, the intensity of the chest pain had increased to a level 9 of 10 on a pain scale and was accompanied by SOB, nausea, diaphoresis, dizziness, and palpitations. He denied peripheral edema, cough, or orthopnea. Pt has no positive risk factors for coronary artery disease, except mother has history of heart disease. (Had CABG at age 61). Pt was admitted on 10/19/03. After receiving IV toradol in the ER, he was asymptomatic at the time of admission. On his first hospital day, while on telemetry, he experienced an asymptomatic, 4-beat run of V-tach. During his hospitalization, his maximum temp was 102.9 on hospital day 1. During his 5-day hospital course, echocardiograms, MRI with gadolinium, cardiac catheterization, and cardiac biopsy were completed. Pt was discharged on 10/22/03 on 8 weeks of leave. On 10/16, experienced sore throat, fever and chills. Placed on quarters x 24 hrs. On 10/17, felt fine. Awoke at 0200 on 10/18 with pain in middle of back, by shoulders, nausea, SOB and dizziness. No cough, myalgias or headaches. Smallpox site with typical progression to pustule. Scab fell off on day 21.
Age: 25.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL, TYP
Symptoms: Back pain, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Probable smallpox-associated myopericarditis. Most of history obtained from inpatient record from hospital (when pt contacted x 2 while in hospital, he requested case manager call him back. Several messages left on answering machine at home phone number, but pt did not return phone calls to case manager. Pt contacted by phone on evening of 11/26, and clinical summary completed). On early morning of 10/18/03, pt began experiencing chest pain and  SOB. He awoke around 0200 with upper back pain, which was attributed to a pulled muscle. The pain persisted, and around 0800, he developed substernal chest pain that radiated to his upper extremities and upper back. Pt took Motrin for pain relief, but the pain persisted. Around 1500 on 10/19/03, the intensity of the chest pain had increased to a level 9 of 10 on a pain scale and was accompanied by SOB, nausea, diaphoresis, dizziness, and palpitations. He denied peripheral edema, cough, or orthopnea. Pt has no positive risk factors for coronary artery disease, except mother has history of heart disease. (Had CABG at age 61). Pt was admitted on 10/19/03. After receiving IV toradol in the ER, he was asymptomatic at the time of admission. On his first hospital day, while on telemetry, he experienced an asymptomatic, 4-beat run of V-tach. During his hospitalization, his maximum temp was 102.9 on hospital day 1. During his 5-day hospital course, echocardiograms, MRI with gadolinium, cardiac catheterization, and cardiac biopsy were completed. Pt was discharged on 10/22/03 on 8 weeks of leave. On 10/16, experienced sore throat, fever and chills. Placed on quarters x 24 hrs. On 10/17, felt fine. Awoke at 0200 on 10/18 with pain in middle of back, by shoulders, nausea, SOB and dizziness. No cough, myalgias or headaches. Smallpox site with typical progression to pustule. Scab fell off on day 21.
Age: 25.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL, TYP
Symptoms: Hyperhidrosis, Injection site pustule, Laboratory test abnormal, Nausea, Palpitations
Clinical narrative: Probable smallpox-associated myopericarditis. Most of history obtained from inpatient record from hospital (when pt contacted x 2 while in hospital, he requested case manager call him back. Several messages left on answering machine at home phone number, but pt did not return phone calls to case manager. Pt contacted by phone on evening of 11/26, and clinical summary completed). On early morning of 10/18/03, pt began experiencing chest pain and  SOB. He awoke around 0200 with upper back pain, which was attributed to a pulled muscle. The pain persisted, and around 0800, he developed substernal chest pain that radiated to his upper extremities and upper back. Pt took Motrin for pain relief, but the pain persisted. Around 1500 on 10/19/03, the intensity of the chest pain had increased to a level 9 of 10 on a pain scale and was accompanied by SOB, nausea, diaphoresis, dizziness, and palpitations. He denied peripheral edema, cough, or orthopnea. Pt has no positive risk factors for coronary artery disease, except mother has history of heart disease. (Had CABG at age 61). Pt was admitted on 10/19/03. After receiving IV toradol in the ER, he was asymptomatic at the time of admission. On his first hospital day, while on telemetry, he experienced an asymptomatic, 4-beat run of V-tach. During his hospitalization, his maximum temp was 102.9 on hospital day 1. During his 5-day hospital course, echocardiograms, MRI with gadolinium, cardiac catheterization, and cardiac biopsy were completed. Pt was discharged on 10/22/03 on 8 weeks of leave. On 10/16, experienced sore throat, fever and chills. Placed on quarters x 24 hrs. On 10/17, felt fine. Awoke at 0200 on 10/18 with pain in middle of back, by shoulders, nausea, SOB and dizziness. No cough, myalgias or headaches. Smallpox site with typical progression to pustule. Scab fell off on day 21.
Age: 25.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL, TYP
Symptoms: Pericarditis, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Probable smallpox-associated myopericarditis. Most of history obtained from inpatient record from hospital (when pt contacted x 2 while in hospital, he requested case manager call him back. Several messages left on answering machine at home phone number, but pt did not return phone calls to case manager. Pt contacted by phone on evening of 11/26, and clinical summary completed). On early morning of 10/18/03, pt began experiencing chest pain and  SOB. He awoke around 0200 with upper back pain, which was attributed to a pulled muscle. The pain persisted, and around 0800, he developed substernal chest pain that radiated to his upper extremities and upper back. Pt took Motrin for pain relief, but the pain persisted. Around 1500 on 10/19/03, the intensity of the chest pain had increased to a level 9 of 10 on a pain scale and was accompanied by SOB, nausea, diaphoresis, dizziness, and palpitations. He denied peripheral edema, cough, or orthopnea. Pt has no positive risk factors for coronary artery disease, except mother has history of heart disease. (Had CABG at age 61). Pt was admitted on 10/19/03. After receiving IV toradol in the ER, he was asymptomatic at the time of admission. On his first hospital day, while on telemetry, he experienced an asymptomatic, 4-beat run of V-tach. During his hospitalization, his maximum temp was 102.9 on hospital day 1. During his 5-day hospital course, echocardiograms, MRI with gadolinium, cardiac catheterization, and cardiac biopsy were completed. Pt was discharged on 10/22/03 on 8 weeks of leave. On 10/16, experienced sore throat, fever and chills. Placed on quarters x 24 hrs. On 10/17, felt fine. Awoke at 0200 on 10/18 with pain in middle of back, by shoulders, nausea, SOB and dizziness. No cough, myalgias or headaches. Smallpox site with typical progression to pustule. Scab fell off on day 21.
Age: 18.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Drug ineffective, Meningitis
Clinical narrative: From initial info received on 10/28/2003 from a health care professional regarding an adverse event, it was reported that a 20-year-old [at time of adverse event] female pt received Menomune A/C/Y/W-135, lot #UA298AA, administered subcutaneously in the right arm at 9:30 AM on 02/26/2001. The pt developed meningococcemia secondary to Group C N. meningitis, on 10/20/2003. The pt was hospitalized and still remains in the Intensive Care Unit. She has not recovered from these events. No other info was reported. From additional info obtained on 11/03/2003 from a telephone contact with the reporting physician, it was reported that the physician spoke with the pt's father who reported that the pt was still in the intensive care unit and was intubated and in renal failure. Additionally, the pt may lose her fingertips due to the vasopressive therapy she is undergoing. No other info was reported. From additional info received on 11/06/2003 from the responsible physician, it was reported that the pt also received a Mantoux tuberculin skin test (lot # and manufacturer not reported) on 02/26/2001 at the same doctor's visit. No other info was provided at this time.
Age: 18.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Meningitis, Renal failure
Clinical narrative: From initial info received on 10/28/2003 from a health care professional regarding an adverse event, it was reported that a 20-year-old [at time of adverse event] female pt received Menomune A/C/Y/W-135, lot #UA298AA, administered subcutaneously in the right arm at 9:30 AM on 02/26/2001. The pt developed meningococcemia secondary to Group C N. meningitis, on 10/20/2003. The pt was hospitalized and still remains in the Intensive Care Unit. She has not recovered from these events. No other info was reported. From additional info obtained on 11/03/2003 from a telephone contact with the reporting physician, it was reported that the physician spoke with the pt's father who reported that the pt was still in the intensive care unit and was intubated and in renal failure. Additionally, the pt may lose her fingertips due to the vasopressive therapy she is undergoing. No other info was reported. From additional info received on 11/06/2003 from the responsible physician, it was reported that the pt also received a Mantoux tuberculin skin test (lot # and manufacturer not reported) on 02/26/2001 at the same doctor's visit. No other info was provided at this time.
Age: 43.0
Sex: M
Vaccine: HEPA, MMR, TYP, YF, HEPA, MMR, TYP, YF, HEPA
Symptoms: Eye discharge, Eye irritation, Facial palsy, Hypoaesthesia
Clinical narrative: It was reported that a 43 year old male pt received a dose of Yellow Fever, Hep A vaccine, MMR vaccine and a dose of Typhoid vaccine on 9/23/03. The lot numbers, routes and sites of administration were not reported. Ten days later, on 10/3/03, the pt experienced irritation to his right eye. The following day, he had clear drainage from the right eye and numbness on his lip. The pt was diagnosed with Bell's palsy two days later. The symptoms were treated with prednisone and Valtrex and the pt fully recovered by 11/25/03. From additional info received on 12/15/03 from CDC initially reported by a health care professional, the vaccine administrator's info was provided and the facility address where the pt was vaccinated. Detailed vaccine info was provided. It was reported that the lip numbness was on the right side of the lip. The pt saw a physician on 10/6/03 and was prescribed Prednisone 40mg p.o. b.i.d. for three days, 30mg p.o. b.i.d. for three days, 20mg p.o. b.i.d. for three days, and 10mg p.o. b.i.d. for three days, then discontinue. He was also prescribed Valtrex 500mg p.o. b.i.d. for seven days. fluorescin dye exam of right eye revealed negative corneal abrasion and was to be rechecked one month later. At the time of vaccination, the pt also took Paxil 20mg one daily. His pre-existing medical conditions include PTSD-depression and he is a recovering alcoholic. No other info was provided at this time. Seriousness criteria: other medically significant (OMIC).
Age: 43.0
Sex: M
Vaccine: HEPA, MMR, TYP, YF, HEPA, MMR, TYP, YF, HEPA
Symptoms: Eye discharge, Eye irritation, Facial palsy, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: It was reported that a 43 year old male pt received a dose of Yellow Fever, Hep A vaccine, MMR vaccine and a dose of Typhoid vaccine on 9/23/03. The lot numbers, routes and sites of administration were not reported. Ten days later, on 10/3/03, the pt experienced irritation to his right eye. The following day, he had clear drainage from the right eye and numbness on his lip. The pt was diagnosed with Bell's palsy two days later. The symptoms were treated with prednisone and Valtrex and the pt fully recovered by 11/25/03. From additional info received on 12/15/03 from CDC initially reported by a health care professional, the vaccine administrator's info was provided and the facility address where the pt was vaccinated. Detailed vaccine info was provided. It was reported that the lip numbness was on the right side of the lip. The pt saw a physician on 10/6/03 and was prescribed Prednisone 40mg p.o. b.i.d. for three days, 30mg p.o. b.i.d. for three days, 20mg p.o. b.i.d. for three days, and 10mg p.o. b.i.d. for three days, then discontinue. He was also prescribed Valtrex 500mg p.o. b.i.d. for seven days. fluorescin dye exam of right eye revealed negative corneal abrasion and was to be rechecked one month later. At the time of vaccination, the pt also took Paxil 20mg one daily. His pre-existing medical conditions include PTSD-depression and he is a recovering alcoholic. No other info was provided at this time. Seriousness criteria: other medically significant (OMIC).
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Completed suicide
Clinical narrative: A serviceman hung himself the day after he was given his fourth AVA dose.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Dizziness, Headache, Hypoaesthesia
Clinical narrative: This report describes the occurrence of "serious brain problems" in a female pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt's attorney alleges that the pt was vaccinated with LYMErix and, as a result, is now experiencing "crippling arthritis" and has "serious brain problems." No additional info was reported. On 15Sept04, the pt's attorney alleged that the pt, now 31 years old, experienced joint pain, swelling, tingling, headaches, dizziness, numbness with MRI (magnetic resonance imaging scan) demonstrating bilateral white matter lesions. Time to onset, treatment, and outcome were not reported. Legal case no futher information available.
Sex: F
Vaccine: LYME
Symptoms: Nervous system disorder, Oedema, Paraesthesia, Skin ulcer
Clinical narrative: This report describes the occurrence of "serious brain problems" in a female pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt's attorney alleges that the pt was vaccinated with LYMErix and, as a result, is now experiencing "crippling arthritis" and has "serious brain problems." No additional info was reported. On 15Sept04, the pt's attorney alleged that the pt, now 31 years old, experienced joint pain, swelling, tingling, headaches, dizziness, numbness with MRI (magnetic resonance imaging scan) demonstrating bilateral white matter lesions. Time to onset, treatment, and outcome were not reported. Legal case no futher information available.
Age: 0.2
Sex: F
Vaccine: DTPHIB
Symptoms: Anxiety, Autism, Constipation, Injury, Mental retardation severity unspecified
Clinical narrative: A legal complaint was received from attorney alleging that 11 month old female child received a dose of Tri-Immunol vaccine on 1/24/97, at the age of 11 months, and subsequently "suffered an acute and severe reaction which resulted in log term damage." According to the legal complaint, as a result of her 1/24/97 DPT vaccination, the child is mentally retarded. The legal complaint alleges, "the pertussis component of the DPT vaccine was a producing cause of the damages." An immunization schedule, provided in the medical records indicated that the child received her first doses of DPT and Hemophilus influenzae type B on 5/15/96. The pt was born prematurily; gestational age was reported as 34-36 weeks. At birth, the child's Apgar scores were recorded at 7 after one minute, and 9 after five minutes. During delivery, the child experienced deceleration as a result of the "cord being wrapped around his neck." At age 14 months, the child bit into an electrical cord and experienced a shock which knocked her backwards and resulted in the loser of her bottom teeth. She also experienced a superficial burn and a "hole in her lip." She did not loose consciousness. She was subsequently hospitalized. Her hospital stay was uneventful. The child's mother reported that after the shock the child never again used previously known single vocabulary words. In April 1997, she had pressure equalizing tubes inserted into her ears for chronic otitis media. There are no known allergies, chronic illnesses, or documented toxic exposures. On 5/15/96, she received a dose of DPT. Additional suspected immunization included poliomyelitis vaccine, and DPT/ Hib vaccines, HIB, hep B, and poliomyelitis virus vaccine, live, oral. There were no chronic medications. According to medical records dated 1/28/98, a physician indicated that the pt exhibited characteristics of autism. On 1/7/98, an otolaryngologist confirmed that the pt's speech was performed, diagnoses of attention deficit hyperactivity disorder and speech delay were made. On 4/29/98, an examination by a pediatrician indicated that the child did not fit the criteria for an autistic disorder; however, did fit the criteria for pervasive developmental disorder. On 2/4/99, a psychological evaluation suggested that the pt meets the criteria for "pervasive developmental disorder, NOS." On 1/6/03, at six years of age, a psychiatric evaluation was performed; diagnoses of separation anxiety, elimination disorder, and encopresis with constipation were made. On 2/26/03, a sensory profile was performed; a diagnosis of autism/PDD was made. Medical records are on file.
Age: 0.2
Sex: F
Vaccine: DTPHIB
Symptoms: Neurodevelopmental disorder, Psychomotor hyperactivity, Speech disorder
Clinical narrative: A legal complaint was received from attorney alleging that 11 month old female child received a dose of Tri-Immunol vaccine on 1/24/97, at the age of 11 months, and subsequently "suffered an acute and severe reaction which resulted in log term damage." According to the legal complaint, as a result of her 1/24/97 DPT vaccination, the child is mentally retarded. The legal complaint alleges, "the pertussis component of the DPT vaccine was a producing cause of the damages." An immunization schedule, provided in the medical records indicated that the child received her first doses of DPT and Hemophilus influenzae type B on 5/15/96. The pt was born prematurily; gestational age was reported as 34-36 weeks. At birth, the child's Apgar scores were recorded at 7 after one minute, and 9 after five minutes. During delivery, the child experienced deceleration as a result of the "cord being wrapped around his neck." At age 14 months, the child bit into an electrical cord and experienced a shock which knocked her backwards and resulted in the loser of her bottom teeth. She also experienced a superficial burn and a "hole in her lip." She did not loose consciousness. She was subsequently hospitalized. Her hospital stay was uneventful. The child's mother reported that after the shock the child never again used previously known single vocabulary words. In April 1997, she had pressure equalizing tubes inserted into her ears for chronic otitis media. There are no known allergies, chronic illnesses, or documented toxic exposures. On 5/15/96, she received a dose of DPT. Additional suspected immunization included poliomyelitis vaccine, and DPT/ Hib vaccines, HIB, hep B, and poliomyelitis virus vaccine, live, oral. There were no chronic medications. According to medical records dated 1/28/98, a physician indicated that the pt exhibited characteristics of autism. On 1/7/98, an otolaryngologist confirmed that the pt's speech was performed, diagnoses of attention deficit hyperactivity disorder and speech delay were made. On 4/29/98, an examination by a pediatrician indicated that the child did not fit the criteria for an autistic disorder; however, did fit the criteria for pervasive developmental disorder. On 2/4/99, a psychological evaluation suggested that the pt meets the criteria for "pervasive developmental disorder, NOS." On 1/6/03, at six years of age, a psychiatric evaluation was performed; diagnoses of separation anxiety, elimination disorder, and encopresis with constipation were made. On 2/26/03, a sensory profile was performed; a diagnosis of autism/PDD was made. Medical records are on file.
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Infection, Tonsillitis
Clinical narrative: A physician reported that a male pt received an injection of Prevnar on an unspecified date and experienced drug ineffective, tonsillitis, strep infection, and decreased immune deficiency. The pt's concurrent illness includes developmental delay with a past history of recurrent infections. The reporter indicated that the child has an increased pain threshold. The reporter stated that the child has a history of "multiple problems." The pt received a dose on an unspecified date. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Pt was not taking concomitant therapy. An antibody test was performed on an unspecified date, the results revealed no antigenic reactivity after Prevnar injection. The physician, a geneticist and consultant, reported that the child has not responded to the Prevnar vaccine. The pt has had several "strep infections" including tonsillitis after receiving the vaccine. The pt has had several "strep infections" including tonsillitis after receiving the vaccine. The reporter stated that he is attempting to determine the "problem with the child's immune response." The physician indicated that he considers the events unrelated to the administration of Prevnar. This case was considered medically important (OMIC). No additional info was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: It was reported that an 8 week old male pt received IPOL, and ACTHib both administered on 10/1/02. Routes and sites of administration were not reported. The next day, the pt experienced pyrexia. The pt was hospitalized, but no specific info was provided. The pt reportedly did recover from this event. From additional info received on 12/15/03 through telephone contact with a health care professional, it was reported that the pt was seen in the office the next day in office, where he showed a temp by ear of 99.1 deg F. The mother stated that the infant was running a temp of 100.6 axillary that morning. He was admitted to the hospital on 10/2/02. The pt's physical examination on admission revealed a temp of 100.7 deg F, pulse 168 and respiratory rate of 50. He was alert and smiling. The anterior fontanelle was flat and soft and the tympanic membranes were normal bilaterally. Oropharynx was not red and the nares were clear and supple. The pt's lungs were clear. The heart was a regular rate and rhythm without murmur. Abdomen was soft, no hepatosplenomegaly. There was no evidence of rash. The pt was not on antibiotics and was discharged on 10/3/02. The discharge summary states that the fever is secondary to the immunizations. No other info was reported. 19/Jan/2004: Administrative case closure. No further information is anticipated, this case is considered closed.
Age: 0.9
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Conjunctivitis, Drug ineffective, Hypoxia, Laboratory test abnormal, Lung disorder
Clinical narrative: It was reported that an 11 month old male pt received his third dose of Hib vaccine on an unspecified date. Six days after receiving the third dose, the pt presented to the hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute. The temperature was 39.7 deg C and the oxygen saturation was 73% while breathing room air. Chest auscultation revealed wheezing, and retractions were apparent. Bilateral conjunctival injection was present. A chest radiography demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiraotry syncytial virus antigen by direct fluorescent antibody. The child was admitted and empirically treated with ceftriaxone and axithromycin. The following day, hib, susceptible to ampicillin, was isolated from the blood. CSF obtained on the third hospital day was normal. The pt received a ten day course of ceftriaxone and recovered without sequelae. He had received an Hib conjugate vaccine at approximately three and five months of age. The pt resided in an apartment with his mother and a four year old brother, who was attending a day care center at that time. No other info was provided at this time. The reporter of this case is the same as for case 2003-03330.
Age: 0.9
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Pyrexia, Respiratory distress, Sepsis, Tachycardia, Wheezing
Clinical narrative: It was reported that an 11 month old male pt received his third dose of Hib vaccine on an unspecified date. Six days after receiving the third dose, the pt presented to the hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute. The temperature was 39.7 deg C and the oxygen saturation was 73% while breathing room air. Chest auscultation revealed wheezing, and retractions were apparent. Bilateral conjunctival injection was present. A chest radiography demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiraotry syncytial virus antigen by direct fluorescent antibody. The child was admitted and empirically treated with ceftriaxone and axithromycin. The following day, hib, susceptible to ampicillin, was isolated from the blood. CSF obtained on the third hospital day was normal. The pt received a ten day course of ceftriaxone and recovered without sequelae. He had received an Hib conjugate vaccine at approximately three and five months of age. The pt resided in an apartment with his mother and a four year old brother, who was attending a day care center at that time. No other info was provided at this time. The reporter of this case is the same as for case 2003-03330.
Age: 0.9
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Drug ineffective, Laboratory test abnormal, Lung disorder, Pyrexia, Respiratory distress
Clinical narrative: It was reported that an 11 month old male pt received his third dose of Hib vaccine on an unspecified date. Six days after receiving the third dose, the pt presented to the hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute. The temperature was 39.7 deg C and the oxygen saturation was 73% while breathing room air. Chest auscultation revealed wheezing, and retractions were apparent. Bilateral conjunctival injection was present. A chest radiography demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiraotry syncytial virus antigen by direct fluorescent antibody. The child was admitted and empirically treated with ceftriaxone and axithromycin. The following day, hib, susceptible to ampicillin, was isolated from the blood. CSF obtained on the third hospital day was normal. The pt received a ten day course of ceftriaxone and recovered without sequelae. He had received an Hib conjugate vaccine at approximately three and five months of age. The pt resided in an apartment with his mother and a four year old brother, who was attending a day care center at that time. No other info was provided at this time. The reporter of this case is the same as for case 2003-03330.
Age: 0.9
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Sepsis, Tachycardia, Wheezing
Clinical narrative: It was reported that an 11 month old male pt received his third dose of Hib vaccine on an unspecified date. Six days after receiving the third dose, the pt presented to the hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute. The temperature was 39.7 deg C and the oxygen saturation was 73% while breathing room air. Chest auscultation revealed wheezing, and retractions were apparent. Bilateral conjunctival injection was present. A chest radiography demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiraotry syncytial virus antigen by direct fluorescent antibody. The child was admitted and empirically treated with ceftriaxone and axithromycin. The following day, hib, susceptible to ampicillin, was isolated from the blood. CSF obtained on the third hospital day was normal. The pt received a ten day course of ceftriaxone and recovered without sequelae. He had received an Hib conjugate vaccine at approximately three and five months of age. The pt resided in an apartment with his mother and a four year old brother, who was attending a day care center at that time. No other info was provided at this time. The reporter of this case is the same as for case 2003-03330.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Deep vein thrombosis, Injury, Joint swelling, Rheumatoid arthritis
Clinical narrative: Within weeks of getting the hepatitis b vaccination series, my joints began swelling and hurting. I have subsequently been diagnosed with rheumatoid arthritis. It began suddenly and severely and has been disabling since 1995. Accidental needle stick with contaminated needle. The medical record received on 1/13/04 states deep vein thrombosis. Chronic arthritis pain. Per annual follow up report continued debilitating arthritis pain.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Fatigue, Hypersensitivity, Injection site reaction
Clinical narrative: Pt received Pneumovax on 10/6 and reported to primary care clinic on 10/7 c/o erythema, fatigue, myalgia, and nausea from previous day, and pain on right side of arm to neck. Pt did not report SOB, pruritis, or rash. Unable to differentiate whether actual allergic reaction to Pneumovax vs. local allergic reaction. Pt was given outpt rx for Cephalexin 500mg QID x 10 days and Tylenol QID x 2 days and instructed to go to ER if symptoms persist/worsens. Pt presented to ER with persistent fever and increased RUL swelling and tenderness. Pt admitted to hospital for IV antibiotics x 9 days. Needed for pain. Sunscreen lotion paba-free SPF 15, Bupropion HCL 75mg tab take tow tablets by mouth twice a day take at 8am and 2pm, Trazodone HCL 50mg take one tablet by mouth three times per day and take 2-4 tablets at bedtime, Lisinopril 40mg take one tablet by mouth daily, multivitamin/minerals take 1 tablet by mouth daily, ammonium lactate 12% lotion, Verapamil HCL 240mg SA take one tablet by mouth twice a day, Hydrocortisone/Pramoxine rect foam 1%, hemorrhoidal supp, hydroxyzine pamoate 25mg take one capsule by mouth twice a day as needed, aspirin 81mg EC take one tablet by mouth daily, hydrochlorothiazide 25mg take one-half tablet by mouth daily, Terazosin HCL 2mg take one capsule by mouth at bedtime. Pt ended up with diagnosis of cellulitis in right arm where vaccine given.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nausea, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Pt received Pneumovax on 10/6 and reported to primary care clinic on 10/7 c/o erythema, fatigue, myalgia, and nausea from previous day, and pain on right side of arm to neck. Pt did not report SOB, pruritis, or rash. Unable to differentiate whether actual allergic reaction to Pneumovax vs. local allergic reaction. Pt was given outpt rx for Cephalexin 500mg QID x 10 days and Tylenol QID x 2 days and instructed to go to ER if symptoms persist/worsens. Pt presented to ER with persistent fever and increased RUL swelling and tenderness. Pt admitted to hospital for IV antibiotics x 9 days. Needed for pain. Sunscreen lotion paba-free SPF 15, Bupropion HCL 75mg tab take tow tablets by mouth twice a day take at 8am and 2pm, Trazodone HCL 50mg take one tablet by mouth three times per day and take 2-4 tablets at bedtime, Lisinopril 40mg take one tablet by mouth daily, multivitamin/minerals take 1 tablet by mouth daily, ammonium lactate 12% lotion, Verapamil HCL 240mg SA take one tablet by mouth twice a day, Hydrocortisone/Pramoxine rect foam 1%, hemorrhoidal supp, hydroxyzine pamoate 25mg take one capsule by mouth twice a day as needed, aspirin 81mg EC take one tablet by mouth daily, hydrochlorothiazide 25mg take one-half tablet by mouth daily, Terazosin HCL 2mg take one capsule by mouth at bedtime. Pt ended up with diagnosis of cellulitis in right arm where vaccine given.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Pt received Pneumovax on 10/6 and reported to primary care clinic on 10/7 c/o erythema, fatigue, myalgia, and nausea from previous day, and pain on right side of arm to neck. Pt did not report SOB, pruritis, or rash. Unable to differentiate whether actual allergic reaction to Pneumovax vs. local allergic reaction. Pt was given outpt rx for Cephalexin 500mg QID x 10 days and Tylenol QID x 2 days and instructed to go to ER if symptoms persist/worsens. Pt presented to ER with persistent fever and increased RUL swelling and tenderness. Pt admitted to hospital for IV antibiotics x 9 days. Needed for pain. Sunscreen lotion paba-free SPF 15, Bupropion HCL 75mg tab take tow tablets by mouth twice a day take at 8am and 2pm, Trazodone HCL 50mg take one tablet by mouth three times per day and take 2-4 tablets at bedtime, Lisinopril 40mg take one tablet by mouth daily, multivitamin/minerals take 1 tablet by mouth daily, ammonium lactate 12% lotion, Verapamil HCL 240mg SA take one tablet by mouth twice a day, Hydrocortisone/Pramoxine rect foam 1%, hemorrhoidal supp, hydroxyzine pamoate 25mg take one capsule by mouth twice a day as needed, aspirin 81mg EC take one tablet by mouth daily, hydrochlorothiazide 25mg take one-half tablet by mouth daily, Terazosin HCL 2mg take one capsule by mouth at bedtime. Pt ended up with diagnosis of cellulitis in right arm where vaccine given.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Amnesia, Arthralgia, Cyst, Disturbance in attention, Headache
Clinical narrative: Mass on neck, headaches, joint pain, memory loss (short term), lack of concentration, loss of sleep, numbness R fore arm weakness.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Hypoaesthesia, Muscular weakness, Sleep disorder
Clinical narrative: Mass on neck, headaches, joint pain, memory loss (short term), lack of concentration, loss of sleep, numbness R fore arm weakness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess drainage, Injection site pain, Neck pain, Oedema peripheral
Clinical narrative: 6 hrs after my pneumonia shot my right upper arm and neck became swollen. Sat. morning the fluid and swelling appeared in the lower part of right arm. I had constant pain where I was given the shot. After 2 doctor's visits I was given the proper emds and 2 1/2 wks later was okay.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cyst, Pain
Clinical narrative: Vaccine administered 10/25/03 L deltoid region arm. No symptoms x 1 month, approx. 2 weeks from 12/26/03 noticed a somewhat painful no palpation 3/4cms cystic area at vaccination site. No fever. No redness. No neurologic symptoms. Skin normal appearance. Plan is to observe to ER if it appears or needs incision.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Vertigo
Clinical narrative: 2 Hours after flu vaccine patient became dizzy and lightheaded.  Symptoms progressed (+) vertigo, (+) weakness. Exam was essentially normal; Benadryl prescribed, symptoms resolved in 36 hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site nodule, Pain, Pruritus, Skin ulcer
Clinical narrative: 9x9cm pale erythematous macular with 4x4cm central nodularity, more red, increased sleepiness, lesion pruritic body aches.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: 9x9cm pale erythematous macular with 4x4cm central nodularity, more red, increased sleepiness, lesion pruritic body aches.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema
Clinical narrative: Arm swelling
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Facial palsy, Muscular weakness
Clinical narrative: Bells Palsy right side of face (V1, V2, V3) area noted 23.5 hrs after immunizations. Head CT 12 hrs later=WNL. Prescribed Prelone + ACV orally. Improving but not resolved at the time of report.  Nurse follow up on 08/19/04 states: "Right sided facial weakness."
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Dysphoria
Clinical narrative: Infant ready for discharge.  Noc of 11/18 till 11/19. Became dysphoriec RDS healing intubation, central line placement, multiple tasts, antibiotics, extubated 11/20 14:40. Home on nasal cannula O2 11/28
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Measles rash all over body.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Rash macular
Clinical narrative: 4x6 cm area of redness and swelling left deltoid. Pink fine macular rash-back of neck and upper 1/3 of neck.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Erythema, Feeling hot, Pyrexia
Clinical narrative: 8x10 cm erythema and warmth left deltoid. Temperature max: 101F.
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Ecchymosis
Clinical narrative: At 4 month and 6 month immunizations had purple ecchymoses in his lower legs and feet developed after getting shots.  Not in spots where he was being held.  They last 4-5 days and resolve.
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Fever, increased crying
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Chills, Cough, Dizziness, Headache
Clinical narrative: Received the smallpox vaccine on 28 Nov 2003. Developed dry cough 5-6 days later. Symptoms increased and on day 7 developed a fever of 102.7, body aches, chills, stiff neck, headache, and dizziness. Denied any visual disturbances or altered sensation. Went to emergency later that pm on Dec 5. Had blood work and chest x-ray and was told he had pneumonia.  Denies having lumbar puncture or any imaging of head.   Did not require admission and was sent home with Tylenol, Zithromax and a decongestant. Was told to rest and increase fluids.   Currently reports that he is feeling better, no fevers since Dec 6. Cough is dry. States that his back is sore from coughing and lying around and that appetite is returning. Denies being around anyone with similar symptoms and did have influenza vaccine this year. States that his wife is now starting to experience similar symptoms.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Musculoskeletal stiffness, Pain, Pneumonia, Pyrexia
Clinical narrative: Received the smallpox vaccine on 28 Nov 2003. Developed dry cough 5-6 days later. Symptoms increased and on day 7 developed a fever of 102.7, body aches, chills, stiff neck, headache, and dizziness. Denied any visual disturbances or altered sensation. Went to emergency later that pm on Dec 5. Had blood work and chest x-ray and was told he had pneumonia.  Denies having lumbar puncture or any imaging of head.   Did not require admission and was sent home with Tylenol, Zithromax and a decongestant. Was told to rest and increase fluids.   Currently reports that he is feeling better, no fevers since Dec 6. Cough is dry. States that his back is sore from coughing and lying around and that appetite is returning. Denies being around anyone with similar symptoms and did have influenza vaccine this year. States that his wife is now starting to experience similar symptoms.
Age: 0.5
Sex: F
Vaccine: DTP
Symptoms: Dyskinesia, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Vaccine administered in the morning, baby was fussy all day, that evening at midnight she awoke with a fever of 100F, extremely fussy and irratable.  Unable to comfort.  We gave her infants tylenol.  Shortly after she awoke, she started to jerk (like she was being startled).  This lasted about an hour.  The fever broke about the same time the jerking stopped and she fell into a light sleep.  She slept the night but was very restless, she had some congestion.  She awoke alert and active with a low grade fever but fell back to sleep again after about an hour and slept very sound for 3.5 hours. When she awoke around noon, she was alert and active.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Insomnia, Pruritus, Skin burning sensation
Clinical narrative: Client reported feeling "itchy all over, and burning of her skin".  Client denied hives or other rashes. Client states her lips might have been swollen - she is unsure, also states she had trouble sleeping.
Age: 38.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Dyspnoea, Fatigue, Pain, Tremor, Vomiting
Clinical narrative: Dec 12 received both the influenza and anthrax vaccine 1500 hrs. Returned home at 2300 hrs. Ate a sandwich and prepared for bed. Other than feeling a little achy and tired reported no problems and denied fever. Went to bed at 2400 and feel asleep immediately. Next thing he remembers is awakening at 0030. Has no recall of events for the previous 30 min.  Pt states that his wife reported that he started to shake gradually all over his body and that she was unable to wake him up so she called 911. Stated that shaking lasted 30 60 sec. and that the 911 operator told his wife to place him on his side. Stated that he was gurgling and that breathing was laboured. Reported that he had a small amount of emesis.  Was transported to hospital, blood and urine tests were normal and he was later released at 0500.  Pt denies any incontinence, no trauma to mouth. Never had anything like this before and that he is currently feeling fine.