chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Chest pain, Diverticulitis, Dyspnoea, Fatigue, Hypotension
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Malaise
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Asthenia, Cardiac failure congestive, Chest discomfort, Dyspnoea, Influenza like illness
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on Oct 22, 2002 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on Feb 20, 2003. Discharged on Feb 25, 2003. Outcome: recovered. The investigator assessed the event as possible related to the study product. This pt experienced congestive heart failure with shortness of breath and chest discomfort 174 days post vaccination and was admitted to hospital on April 14, 2003 and discharged on Apr 18, 2003. Outcome recovered. Cross reference with manf report 200300440. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Admission date: 4/15/03. Indication for admission: severe weakness, shortness of breath. History of present illness: An 80 year old white female admitted primarily because of swelling in lower extremity, flu like symptoms and generalized weakness. Pt is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the pt just feels poorly and it was felt that the pt should be admitted for further evaluation. Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Social history: the pt does not smoke or drink. Medication allergies: codeine, Tylenol, Lidocaine. Physical examination: vital signs: temp 99.4, pulse 116, respirations 20, blood pressure 149/95. General: this is an 80 year old white female who appears somewhat worn out and tired. HEENT: benign. Neck: supple with minimal jugular venous distention. Heart: regular rhythm and rate, no murmurs or gallops. Chest: lungs are clear. Abdomen: soft, nontender, normoactive bowel sounds. No rebound or guarding. Extremities: No clubbing, cyanosis. Pt has 2+ edema in the lower extremity and old scars in the midline abdomen as well as lower back from previous laminectomy. Impression: congestive heart failure; generalized debilitation; hypertension; coronary artery disease; history of cerebrovascular accident; diverticular disease; chronic obstructive pulmonary disease. Plan: pt admitted at this time for diuresis and monitoring of her cardiac status. The subject received Non adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Malaise, Oedema
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on Oct 22, 2002 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on Feb 20, 2003. Discharged on Feb 25, 2003. Outcome: recovered. The investigator assessed the event as possible related to the study product. This pt experienced congestive heart failure with shortness of breath and chest discomfort 174 days post vaccination and was admitted to hospital on April 14, 2003 and discharged on Apr 18, 2003. Outcome recovered. Cross reference with manf report 200300440. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Admission date: 4/15/03. Indication for admission: severe weakness, shortness of breath. History of present illness: An 80 year old white female admitted primarily because of swelling in lower extremity, flu like symptoms and generalized weakness. Pt is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the pt just feels poorly and it was felt that the pt should be admitted for further evaluation. Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Social history: the pt does not smoke or drink. Medication allergies: codeine, Tylenol, Lidocaine. Physical examination: vital signs: temp 99.4, pulse 116, respirations 20, blood pressure 149/95. General: this is an 80 year old white female who appears somewhat worn out and tired. HEENT: benign. Neck: supple with minimal jugular venous distention. Heart: regular rhythm and rate, no murmurs or gallops. Chest: lungs are clear. Abdomen: soft, nontender, normoactive bowel sounds. No rebound or guarding. Extremities: No clubbing, cyanosis. Pt has 2+ edema in the lower extremity and old scars in the midline abdomen as well as lower back from previous laminectomy. Impression: congestive heart failure; generalized debilitation; hypertension; coronary artery disease; history of cerebrovascular accident; diverticular disease; chronic obstructive pulmonary disease. Plan: pt admitted at this time for diuresis and monitoring of her cardiac status. The subject received Non adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Arrhythmia, Asthenia, Asthma, Cardiac failure congestive, Cerebrovascular accident
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on Oct 22, 2002 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on Feb 20, 2003. Discharged on Feb 25, 2003. Outcome: recovered. The investigator assessed the event as possible related to the study product. This pt experienced congestive heart failure with shortness of breath and chest discomfort 174 days post vaccination and was admitted to hospital on April 14, 2003 and discharged on Apr 18, 2003. Outcome recovered. Cross reference with manf report 200300440. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Admission date: 4/15/03. Indication for admission: severe weakness, shortness of breath. History of present illness: An 80 year old white female admitted primarily because of swelling in lower extremity, flu like symptoms and generalized weakness. Pt is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the pt just feels poorly and it was felt that the pt should be admitted for further evaluation. Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Social history: the pt does not smoke or drink. Medication allergies: codeine, Tylenol, Lidocaine. Physical examination: vital signs: temp 99.4, pulse 116, respirations 20, blood pressure 149/95. General: this is an 80 year old white female who appears somewhat worn out and tired. HEENT: benign. Neck: supple with minimal jugular venous distention. Heart: regular rhythm and rate, no murmurs or gallops. Chest: lungs are clear. Abdomen: soft, nontender, normoactive bowel sounds. No rebound or guarding. Extremities: No clubbing, cyanosis. Pt has 2+ edema in the lower extremity and old scars in the midline abdomen as well as lower back from previous laminectomy. Impression: congestive heart failure; generalized debilitation; hypertension; coronary artery disease; history of cerebrovascular accident; diverticular disease; chronic obstructive pulmonary disease. Plan: pt admitted at this time for diuresis and monitoring of her cardiac status. The subject received Non adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Chest pain, Diverticulitis, Dyspnoea, Fatigue, Hypotension
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on Oct 22, 2002 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on Feb 20, 2003. Discharged on Feb 25, 2003. Outcome: recovered. The investigator assessed the event as possible related to the study product. This pt experienced congestive heart failure with shortness of breath and chest discomfort 174 days post vaccination and was admitted to hospital on April 14, 2003 and discharged on Apr 18, 2003. Outcome recovered. Cross reference with manf report 200300440. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Admission date: 4/15/03. Indication for admission: severe weakness, shortness of breath. History of present illness: An 80 year old white female admitted primarily because of swelling in lower extremity, flu like symptoms and generalized weakness. Pt is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the pt just feels poorly and it was felt that the pt should be admitted for further evaluation. Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Social history: the pt does not smoke or drink. Medication allergies: codeine, Tylenol, Lidocaine. Physical examination: vital signs: temp 99.4, pulse 116, respirations 20, blood pressure 149/95. General: this is an 80 year old white female who appears somewhat worn out and tired. HEENT: benign. Neck: supple with minimal jugular venous distention. Heart: regular rhythm and rate, no murmurs or gallops. Chest: lungs are clear. Abdomen: soft, nontender, normoactive bowel sounds. No rebound or guarding. Extremities: No clubbing, cyanosis. Pt has 2+ edema in the lower extremity and old scars in the midline abdomen as well as lower back from previous laminectomy. Impression: congestive heart failure; generalized debilitation; hypertension; coronary artery disease; history of cerebrovascular accident; diverticular disease; chronic obstructive pulmonary disease. Plan: pt admitted at this time for diuresis and monitoring of her cardiac status. The subject received Non adjuvanted RSV vaccine.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3, UNK
Symptoms: Malaise
Clinical narrative: An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on Oct 22, 2002 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on Feb 20, 2003. Discharged on Feb 25, 2003. Outcome: recovered. The investigator assessed the event as possible related to the study product. This pt experienced congestive heart failure with shortness of breath and chest discomfort 174 days post vaccination and was admitted to hospital on April 14, 2003 and discharged on Apr 18, 2003. Outcome recovered. Cross reference with manf report 200300440. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Admission date: 4/15/03. Indication for admission: severe weakness, shortness of breath. History of present illness: An 80 year old white female admitted primarily because of swelling in lower extremity, flu like symptoms and generalized weakness. Pt is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the pt just feels poorly and it was felt that the pt should be admitted for further evaluation. Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Social history: the pt does not smoke or drink. Medication allergies: codeine, Tylenol, Lidocaine. Physical examination: vital signs: temp 99.4, pulse 116, respirations 20, blood pressure 149/95. General: this is an 80 year old white female who appears somewhat worn out and tired. HEENT: benign. Neck: supple with minimal jugular venous distention. Heart: regular rhythm and rate, no murmurs or gallops. Chest: lungs are clear. Abdomen: soft, nontender, normoactive bowel sounds. No rebound or guarding. Extremities: No clubbing, cyanosis. Pt has 2+ edema in the lower extremity and old scars in the midline abdomen as well as lower back from previous laminectomy. Impression: congestive heart failure; generalized debilitation; hypertension; coronary artery disease; history of cerebrovascular accident; diverticular disease; chronic obstructive pulmonary disease. Plan: pt admitted at this time for diuresis and monitoring of her cardiac status. The subject received Non adjuvanted RSV vaccine.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a consumer and described the occurrence of death in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date before 5/27/05, the subject received a dose of Pediarix (dose number not provided). The reporter stated that  her, "child died one day after receiving Pediarix." It is unknown whether an autopsy was performed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Diabetes mellitus, Influenza like illness, Injection site pain
Clinical narrative: Extremely sore vaccination site for days (arm). Followed by flu-like symptoms and then diagnosis of Type I (Juvenile) Diabetes.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ, MNQ
Symptoms: Asthma, Bronchitis, Convulsion, Cough, Diarrhoea
Clinical narrative: 5/6/05 HBV and Menactra were administered. 5/11/05 bronchitis, treated with Biaxin/Albuterol and Prednisone; 5/14/05 Diarrhea, vomiting; 5/15/05 generalized seizure, ER, Dx: viral meningitis. Pt 15 yo child was seen in our office on 5/6/05 for well visit. He was given HBV and Menactra. No calls received from parents regarding any side effects. On 5/11/05 child was seen for cough, wheezing. He was diagnosed bronchitis/RAD, started on Biaxin XC, Albuterol Inhaler and Prednisone for 5 days. As per mom, he developed vomiting and diarrhea on 5/14/05. On 5/15/05 he developed generalized seizure. No h/o high fever or stiff neck or rash. Child was taken to nearest hospital by ambulance. CBC, Lumbar puncture, blood and urine culture, drug screen, Ct scan brain were done. Child was started on Ceftriaxone, Dexamethasone, Vancomycin and transferred to another hospital. He was admitted because of change in mental status. He was also started on Acyclovir. EEG NL, Neuro was consulted, child was discharged on no medication. All antibiotics were discontinued because cultures and PCR (CSF) negative in deciding for herpes simplex. the final diagnosis was viral meningitis and seizure. Please see enclosed lab results.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ, MNQ
Symptoms: Meningitis, Thinking abnormal, Viral infection, Vomiting, Wheezing
Clinical narrative: 5/6/05 HBV and Menactra were administered. 5/11/05 bronchitis, treated with Biaxin/Albuterol and Prednisone; 5/14/05 Diarrhea, vomiting; 5/15/05 generalized seizure, ER, Dx: viral meningitis. Pt 15 yo child was seen in our office on 5/6/05 for well visit. He was given HBV and Menactra. No calls received from parents regarding any side effects. On 5/11/05 child was seen for cough, wheezing. He was diagnosed bronchitis/RAD, started on Biaxin XC, Albuterol Inhaler and Prednisone for 5 days. As per mom, he developed vomiting and diarrhea on 5/14/05. On 5/15/05 he developed generalized seizure. No h/o high fever or stiff neck or rash. Child was taken to nearest hospital by ambulance. CBC, Lumbar puncture, blood and urine culture, drug screen, Ct scan brain were done. Child was started on Ceftriaxone, Dexamethasone, Vancomycin and transferred to another hospital. He was admitted because of change in mental status. He was also started on Acyclovir. EEG NL, Neuro was consulted, child was discharged on no medication. All antibiotics were discontinued because cultures and PCR (CSF) negative in deciding for herpes simplex. the final diagnosis was viral meningitis and seizure. Please see enclosed lab results.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ, MNQ
Symptoms: Diarrhoea, Grand mal convulsion, Meningitis, Nausea, Pyrexia
Clinical narrative: 5/6/05 HBV and Menactra were administered. 5/11/05 bronchitis, treated with Biaxin/Albuterol and Prednisone; 5/14/05 Diarrhea, vomiting; 5/15/05 generalized seizure, ER, Dx: viral meningitis. Pt 15 yo child was seen in our office on 5/6/05 for well visit. He was given HBV and Menactra. No calls received from parents regarding any side effects. On 5/11/05 child was seen for cough, wheezing. He was diagnosed bronchitis/RAD, started on Biaxin XC, Albuterol Inhaler and Prednisone for 5 days. As per mom, he developed vomiting and diarrhea on 5/14/05. On 5/15/05 he developed generalized seizure. No h/o high fever or stiff neck or rash. Child was taken to nearest hospital by ambulance. CBC, Lumbar puncture, blood and urine culture, drug screen, Ct scan brain were done. Child was started on Ceftriaxone, Dexamethasone, Vancomycin and transferred to another hospital. He was admitted because of change in mental status. He was also started on Acyclovir. EEG NL, Neuro was consulted, child was discharged on no medication. All antibiotics were discontinued because cultures and PCR (CSF) negative in deciding for herpes simplex. the final diagnosis was viral meningitis and seizure. Please see enclosed lab results.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ, MNQ
Symptoms: Viral infection, Vomiting, White blood cell disorder
Clinical narrative: 5/6/05 HBV and Menactra were administered. 5/11/05 bronchitis, treated with Biaxin/Albuterol and Prednisone; 5/14/05 Diarrhea, vomiting; 5/15/05 generalized seizure, ER, Dx: viral meningitis. Pt 15 yo child was seen in our office on 5/6/05 for well visit. He was given HBV and Menactra. No calls received from parents regarding any side effects. On 5/11/05 child was seen for cough, wheezing. He was diagnosed bronchitis/RAD, started on Biaxin XC, Albuterol Inhaler and Prednisone for 5 days. As per mom, he developed vomiting and diarrhea on 5/14/05. On 5/15/05 he developed generalized seizure. No h/o high fever or stiff neck or rash. Child was taken to nearest hospital by ambulance. CBC, Lumbar puncture, blood and urine culture, drug screen, Ct scan brain were done. Child was started on Ceftriaxone, Dexamethasone, Vancomycin and transferred to another hospital. He was admitted because of change in mental status. He was also started on Acyclovir. EEG NL, Neuro was consulted, child was discharged on no medication. All antibiotics were discontinued because cultures and PCR (CSF) negative in deciding for herpes simplex. the final diagnosis was viral meningitis and seizure. Please see enclosed lab results.
Age: 31.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Amnesia, Arthralgia, Asthenia, Back pain, Balance disorder
Clinical narrative: Multiple neurological symptoms after multiple vaccines and exacerbation after Hep B #3. Head bobbing, gait abnormality (loss of balance at times), memory loss short term, tremors, paresthesia, sensation decrease (in feet), cognitive deficiency, weakness, joint pain isolated (back pain), fatigue/malaise >60 days, burred vision, diplopia, depression, hoarseness. Follow up on 8/01/05: Member has probable diagnosis of dopamine dependent dystonia and cervical dystonia and has responded to sinemet. Has to take sinemet regularly to function normally. Will be medically separated from military. Total reaction was a conversion disorder, no adverse event at all!
Age: 31.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Cognitive disorder, Depressed level of consciousness, Depression, Diplopia, Dysphonia
Clinical narrative: Multiple neurological symptoms after multiple vaccines and exacerbation after Hep B #3. Head bobbing, gait abnormality (loss of balance at times), memory loss short term, tremors, paresthesia, sensation decrease (in feet), cognitive deficiency, weakness, joint pain isolated (back pain), fatigue/malaise >60 days, burred vision, diplopia, depression, hoarseness. Follow up on 8/01/05: Member has probable diagnosis of dopamine dependent dystonia and cervical dystonia and has responded to sinemet. Has to take sinemet regularly to function normally. Will be medically separated from military. Total reaction was a conversion disorder, no adverse event at all!
Age: 31.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Fatigue, Gait disturbance, Malaise, Paraesthesia, Tremor
Clinical narrative: Multiple neurological symptoms after multiple vaccines and exacerbation after Hep B #3. Head bobbing, gait abnormality (loss of balance at times), memory loss short term, tremors, paresthesia, sensation decrease (in feet), cognitive deficiency, weakness, joint pain isolated (back pain), fatigue/malaise >60 days, burred vision, diplopia, depression, hoarseness. Follow up on 8/01/05: Member has probable diagnosis of dopamine dependent dystonia and cervical dystonia and has responded to sinemet. Has to take sinemet regularly to function normally. Will be medically separated from military. Total reaction was a conversion disorder, no adverse event at all!
Age: 31.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Vision blurred
Clinical narrative: Multiple neurological symptoms after multiple vaccines and exacerbation after Hep B #3. Head bobbing, gait abnormality (loss of balance at times), memory loss short term, tremors, paresthesia, sensation decrease (in feet), cognitive deficiency, weakness, joint pain isolated (back pain), fatigue/malaise >60 days, burred vision, diplopia, depression, hoarseness. Follow up on 8/01/05: Member has probable diagnosis of dopamine dependent dystonia and cervical dystonia and has responded to sinemet. Has to take sinemet regularly to function normally. Will be medically separated from military. Total reaction was a conversion disorder, no adverse event at all!
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Kawasaki's disease, Oral intake reduced, Pyrexia, Rash
Clinical narrative: Patient presented about 48 hours later with morbilliform exanthem and fever to 101. Increasing fussiness and poor oral intake over next 24 hours. Now with diagnosis of Kawasaki Disease.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash morbilliform
Clinical narrative: Patient presented about 48 hours later with morbilliform exanthem and fever to 101. Increasing fussiness and poor oral intake over next 24 hours. Now with diagnosis of Kawasaki Disease.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Rash macular
Clinical narrative: Redness of skin macular upper deltoid.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Pruritus, Viral infection
Clinical narrative: Received TC from mom, child broke out with chicken pox after receiving varicella 1 mm on 4/25/2005. Seem by PCP on 4/27/2005 who ordered Benadryl Syrup, use calamine lotion on body. Mom c/o pt still itching. Reported to MD, she ordered Aveeno bath PRN, to call if any problem.
Age: 1.13
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash occurring at day 12 with normal progression, fever and three C's rash started on head.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: 12 hours after vaccination temp 103.3 in ER.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Positive maculopapular rash - forehead/face/upper back, both upper and lower extremity positive itching on rash started 5/12/2005 _ Benadryl PO and calamine lotion.
Age: 1.11
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: On May 14, 2005 had fine rash and 102 degree fever, Mom is on vacation with pt and family. Pt was taken to Emergency Care Clinic, doctor did not know what pt had, on May 16th he broke out in whelps, no fever.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site abscess, Injection site infection, Injection site nodule, Injection site oedema
Clinical narrative: Swelling at injection site left, palpable nodule abscess formation with 2 degree infection requiring antibiotic on 4th day following injection - left arm.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Reaction site of injection, red, swollen, cries when touched. Benadryl and Tylenol.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema
Clinical narrative: Has been running around, playing this AM with no complaint of pain. Mom saw small area of redness yesterday PM about 30 hours after vaccine given, about 1/2 inch in diameter. Late this AM redness increased to 5 - 6 inches in diameter about 44 hours after vaccine.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Rash pruritic
Clinical narrative: Approximately 7 - 7.5 hours after vaccine administered developed "mosquito bite" like itching bumps on neck and both inner elbows. Lasted one hour or so, then would disappear, then re-occur off and on - last episode 3/23/2005 PM.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Hypoaesthesia, Pain
Clinical narrative: Pain left arm, weakness left arm, numbness and tingling and winging of left scapula.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Parent called 4/21/2005 to report adverse event. Pt complained to parents about itching arm, right deltoid on 4/17/2005. Mom observed hives around the injection site, hard lump and raised red area about 2 inches in diameter. Itching started about 4/12/2005 however. Went to MD on 4/18/2005 who instructed parent to continue with topical Benadryl and take oral Benadryl for three days.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Pruritus
Clinical narrative: Parent called 4/21/2005 to report adverse event. Pt complained to parents about itching arm, right deltoid on 4/17/2005. Mom observed hives around the injection site, hard lump and raised red area about 2 inches in diameter. Itching started about 4/12/2005 however. Went to MD on 4/18/2005 who instructed parent to continue with topical Benadryl and take oral Benadryl for three days.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Received a telephone call from mother stating pt's left thigh swelled up, extended down to the knee with red blotches. Took to ER 4/29/2005. The child was given Benadryl. Mom states that swelling subsides and redness went away 48 hours later. Denies any fever.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 8 x 9 cm patch of erythema and induration left thigh.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling, redness about 3 inches in diameter around injection, with redness spreading down upper arm toward elbow.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: Redness right leg at injection site 7 cm long x 3.5 cm, tender to touch and hot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site reaction, Oedema peripheral
Clinical narrative: Redness, swelling, slight warm to left arm. Seen 05/21/05, DX: with local immunization reaction, TX: Motrin Q 6-8 H PRN, ice pack, and Benadryl Q 6-8 H PRN.
Age: 44.0
Sex: F
Vaccine: MMR, TD
Symptoms: Hypoaesthesia, Hypokinesia, Muscular weakness, Oedema peripheral, Pain
Clinical narrative: Swelling and numbness of right hand progressing to point of not being able to sleep on that side. Both hands painful and swelling now- Dropping eating utensils due to numbness. Can't squeeze fingers together. Pain wakes her from sleep.
Age: 44.0
Sex: F
Vaccine: MMR, TD
Symptoms: Paraesthesia
Clinical narrative: Swelling and numbness of right hand progressing to point of not being able to sleep on that side. Both hands painful and swelling now- Dropping eating utensils due to numbness. Can't squeeze fingers together. Pain wakes her from sleep.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Body temperature increased, Erythema multiforme
Clinical narrative: Erythema over left forearm 14cm x 8 cm with elevation in temperature. Gave Prednisone.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Generalised oedema, Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: Localized reaction at RUE with erythema, induration, and generalized edema from DTaP, treated symptomatically.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort
Clinical narrative: One day after MMR immunization, pt reports discomfort in her arm near injection site. PT applied cold packs and icy hot, which helped. Discomfort subsided after 1 week. Reported to nurse 05/23/2005.
Age: 0.05
Sex: M
Vaccine: TD
Symptoms: Medication error
Clinical narrative: Adult tetanus given. Mom reports no problems after 48 hours.
Age: 1.01
Sex: F
Vaccine: HBHEPB, MMR, PNC
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme- minor. 05/16/2005
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Respiratory disorder
Clinical narrative: Pt states she had tightness in her chest 48 hours after receiving Td. States,  couldnt get a full breath- used Benadryl and Primatene Mist- Notified us today of RX.
Age: 0.37
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Drooling, Torticollis
Clinical narrative: Several minutes after vaccination on way home, mom noticed infant lifeless, head hanging down, drooling and unresponsive. Believes he was like this for a few minutes. By the time he came back to office, he was active and alert.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Swelling to left shoulder and especially upper arm on second day when awoke. Patient has been allergic to PNC in past. No previous problems with immunizations or eggs.
Sex: F
Vaccine: DTAPH, OPV, VARCEL
Symptoms: Rash pustular
Clinical narrative: Spoke with parent via phone. Multiple pustule lesions on trunk, groin area and cheek.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Office visit 5/25/05. Notices 4-5 lesions on cheek, arms, and abdomen; not blistered.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Dyskinesia, Irritability, Pyrexia
Clinical narrative: On 5/27/03 mom phoned health department stating child was very fussy for 2 weeks after receiving vaccines (first set of vaccines). S/S started about 2-3 days after immunizations. Could somewhat console, but not completely. Slight fevers. Seemed to be a little more jerky; never had jerks prior to immunizations. Not seizures. Tylenol given for treatment.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Eye swelling, Face oedema, Irritability, Oral intake reduced
Clinical narrative: Skin problem: Facial swelling 1 hour after vaccine yesterday. Symptoms reported: eyes swollen shut with slow improvement overnight. Decreased ability to nurse (took an hour to complete a 4oz bottle last night) better, but not completely resolved this morning and fussy.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: 2 days after routine immunizations, awoke with 12cmx15cm redness at injection site right thigh. Diagnosed as cellulitis versus large local reaction. Given Keflex and Ibuprofen.
Age: 1.21
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Drug ineffective, Rash papular, Skin ulcer, Viral infection
Clinical narrative: 5/23/05 Child woke up with few varicella lesions. Seen by this office for confirmation of diagnosis. 5/24/05. Child had 15+ lesions papular in nature over body. Diagnosed as chicken pox.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Hypersensitivity, Pyrexia, Rash, Wheezing
Clinical narrative: Generalized rash 1 week. Prednisone, Epi, Benadryl. SOB and wheezing for 4 hours. Temp 99.9 for 3 days. Took Tylenol. Pulse 106 BPM 1 week on exertion.
Age: 0.98
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Breakthrough varicella.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Two hours after receiving Td vaccine, redness and pruritus of skin, hives, some swelling of ears and scalp. Patient took Benadryl.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Oedema peripheral, Pain
Clinical narrative: Patient arm swollen from shoulder to elbow; heated to touch and uncomfortable. Given Allegra 180mg PO.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Noted 1 day after vaccine DTaP/IPV, left upper arm, area red, swollen and warm to touch. No pain. Brought to ER 5/18/05 and told to follow up with PMD. Brought into clinic 5/19/05; treated with cool compresses and Benadryl for itching. Motrin for pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: 2 days after immunization, induration, erythema, warmth at site of injection 9cmx7cm. Increased pain with movement of upper right arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Received MMR II on 5/12/05. On 5/23/05 developed a low grade fever with body wide measles like rash all over. Child is not acting ill or pruritic. Still happy and smiling.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling left arm 5.5x4.75 inches at injection site down left arm. Warm to the touch. Used ice and Tylenol.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: 5/13 as per phone conversation with patient's mother, redness and swelling present left deltoid region size of fist. I instructed her to take son to be seen by provider. 5/14 Patient seen by provider; Benadryl 12.5 3 times a day. 5/15 swelling and redness decreasing as per mother (phone conversation). Patient active; no temp, nausea/vomiting. 5/17 Swelling and redness still decreasing as per phone conversation. 5/24 As per phone conversation with mother, rash and swelling gone.
Age: 1.62
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Injection site rash, Livedo reticularis
Clinical narrative: Approximately 10 minutes after administration of varicella vaccine in left thigh, mother drew my attention to a red, mottled rash around injection site approximately 1.5" wide and 1" long. Rash remained.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Erythema, Injection site swelling
Clinical narrative: Vaccine given. Less than 12 hours later, patient noted to have erythema and swelling at site. Treated with Keflex for cellulitis left leg.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Drug ineffective, Rash, Rash morbilliform
Clinical narrative: Patient contracted rubeola from MMR vaccine approximately 24 hours after administration she developed rash all over body.
Age: 1.48
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Agitation, Dyskinesia, Screaming, Urticaria
Clinical narrative: Within 24 hours screaming, agitated, tongue thrusting, grabbing at arms followed by urticaria.
Age: 17.0
Sex: F
Vaccine: MEN, MMR
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: 5/27/05 0930 vaccine received. 1000 Increased SOB and tight chest. 1030 ER and medicated.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Drug ineffective
Clinical narrative: Child received 3 doses of Pediarix at appropriate times. Doctor did a titer which came back negative; we are now repeating Hep B series again.
Age: 1.02
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Elevated temperature to 103.4 axillary, redness and swelling left leg. Elevated temperature for over 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6cm red swollen area right upper thigh. Mother took patient to ER. Rx of Prednisone, Keflex then followed with doctor. Discharged with Prednisone.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local skin reaction 2 days after injection started small area of redness then expanding all upper arm and down to arm. Swelling, redness, hot with touch. Rx Benadryl, Caladryl, Hydrocortisone cream 2.5%. Pediapred.
Age: 64.0
Sex: M
Vaccine: TYP
Symptoms: Rash erythematous, Rash morbilliform
Clinical narrative: Rash on lower legs; erythematous, morbilliform.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Oedema, Pruritus
Clinical narrative: Patient developed edema and itching around injection site within 12 hours; area about 10cmx6cm. No rupture symptoms.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Pruritus
Clinical narrative: Pt developed signifgant edema around injection site with itching - no systemic s/s.
Age: 17.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Temp= 100 F, nausea and chills. Temp at 1:00PM=100
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Myalgia, Oedema peripheral
Clinical narrative: Left arm swelling, red, and warm biceps,(pain raising arm- no pain in tri/biceps). Pain on deltoid/ biceps- with cellulitis and no lymphadenopathy.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a LPN concerning a male who was vaccinated with a dose of varicella virus vaccine live. Subsequently, 12 days later, he developed chickenpox. It was also noted the pt's sister developed an adverse event (WAES0410USA03564). Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash pruritic, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 4 yr old Caucasian male with asthma, acid reflux, penicillin allergy, allergy to Pertussis vaccine (gets a rash) and environmental allergies and a history of heart murmur and obesity (25lbs. 7ox at the time of vaccination) who on 01Jun01 was vaccinated SC in his right arm with his first dose of varicella virus vaccine live (lot 635461/1246K); illness at the time of vaccination included clear rhinorrhea. Concomitant therapy included asthma medications (composition unspecified) and lansoprazole (Prevacid). Concomitant vaccinations included: the third dose of Hib conj vaccine (lot 628914/1618H) given IM in the left thigh, the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 636400/1276K) given SC in the left arm, and the second dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) (lot474732) given IM in the left thigh. On 09Oct04 the pt developed widely scattered, itchy rash and a fever that lasted 3 days. The pt was seen in the office 11Oct04 the physician noted development of less than 50 lesions and diagnosed as mild varicella. It has been reported that, prior to this he had been playing with children (cousins) who later developed chicken pox. The pt was treated with calamine (+) diphenhydramine hydrochloride (Calamine Lotion), diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol) as needed. The pt recovered as of 21Oct04. There was no product quality complaint. Additional information is not expected.
Age: 1.28
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Drug ineffective, Infection, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old white female with allergies who on 05/04/2004 between 4 to 6pm, was vaccinated subcutaneously in the right thigh with a 0.5ml first dose of varicella virus vaccine live.  Concomitant vaccination the same day included a fourth dose of diphtheria toxoid, pertussis acellular biken vaccine, tetanus toxoid, which was given intramuscularly in the left thigh.  Other concomitant therapy included cetirizine hydrochloride for allergies.  On 08/12/2004, the patient developed a few red raised bumps on her tummy, half the size of an eraser head.  On 08/13/2004, six to seven were noted on her belly and six to seven were on the back of her arms and legs.  Some were noted on her face.  There were no blisters and no fever was noted.  She denies itching and no pus filled spots were noted.  The patient was seen by the physician who was not sure if it was chickenpox or vaccine related.  No treatment was rendered.  It was reported that the lesions were fading away with time.  A product quality complaint was not involved.  Follow up information was received from a registered nurse who indicated that on 08/12/2004, the patient's mother reported that the child had raised spots on her abdomen about half an eraser size.  The next day she had pustules on her abdomen, back, arms, and legs.  She was seen by her physician and possible varicella was diagnosed.  No diagnostic laboratory tests were performed.  Additional information is not expected. '
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male with no allergies or medical conditions who on 07/21/2004 was vaccinated subcutaneously in his left deltoid with the first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 08/16/2004, the patient developed a varicella type rash characterized by pimple like lesions without fever.  Unspecified medical attention was sought.  The lesions lasted for approximately 3 days and then dried up; it was reported that the child recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female nursing student with TMJ who on 08/10/2004 was vaccinated with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  There were no concomitant medications.  On 08/27/2004 at 3:00PM the patient developed what was considered a breakthrough case of chickenpox.  It was between 25-30 pox which did not seem to be progressing.  Unspecified medical attention was sought.  There was no product quality complaint.  No further information was available.  Follow up information received from a registered nurse indicated that the patient developed a fever, headache, and pox rash on 08/29/2004.  The AE onset date was noted to be 08/27/2004 at 3:00PM.  The outcome was reported as recovered.  There were no relevant diagnostic tests or laboratory data.  It was noted that the patient was hospitalized for swelling in her temples and legs at 6 months of age after vaccination with the first dose of the whooping cough vaccine.  No additional information is expected.
Age: 1.57
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 18 month old white male who on 10/05/2004 at 10:15AM was vaccinated subcutaneously in his left arm with a first dose of varicella virus vaccine live.  Concomitant vaccinations that day included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, given subcutaneously in his right arm, a fourth dose of HIB, given intramuscularly in his right thigh, a third dose of pneumococcal vaccine (Prevnar) given intramuscularly in his right thigh, a fourth dose of diphtheria toxoid pertussis acellular 5 component vaccine, tetanus toxoid, given intramuscularly in his left thigh and a third dose of poliovirus vaccine inactivated given subcutaneously in his left leg.  There was no illness at the time of vaccination.  At 12:15pm the child developed a fever of 103 degrees.  The child's mother took him to the emergency room and was advised to continue treatment with acetaminophen or ibuprofen and bring him back if the fever did not go down.  There was no product quality complaint involved.  Follow up information from the registered nurse indicated that there was no rash and that the fever resolved on 10/08/2004.  It was reported that there was no adverse event follow prior vaccination.  No further information is available.