chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: HIBV, PNC
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia, Somnolence
Clinical narrative: Patient began running a fever the afternoon she recieved her vaccinations. Mom reports the fever rose to 104 degrees F. rectally by the late evening. She spoke with the physician on call who instructed her to go to the Emergency Room. Patient was seen by ER physician who evaluated patient. Tylenol and ibuprofen was administered in the ER and fever was brought down to 99.4. Patient was discharged home with instructions to continue administering infant Motrin and Tylenol until fever resolved. Patient continued to run a fever of 102-103 degress F. rectally the day after with decreased appetite, increased sleepiness and irritability. Per primary pediatrician, mom to continue with infant motrin and tylenol and use cool baths PRN. Mom instructed to call pediatrician if fever =/>104 degrees, increased lethargy or fever persists.
Age: 1.54
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: The evening of the day of vaccination, there developed a red, hard, warm area on the ant/lat R thigh, with pain on palpation and difficulty ambulating.  By 02/07/05, he was walking normally, had no pain to touch, and had a mildly pink and indurated area at site.
Age: 3.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Difficulty in walking, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Red, hot , hard at vaccination site on R ant. thigh, hard to walk, painful to touch.  Began evening of Vaccinations, and at f/u 02/07/05. was still mildly re, hard and sore to touch, but walking without difficulty.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: The enclosed photos are the youngster with what is either a reaction to MMR or Varivax.  On 1/24/05 she received: Varivax, MMR, Comvax, IPV, DTaP.  She presented 2/4/05 with a rash of 2 days duration.  She also has eczema and no known phone number.  I will try to submit this to VAERS also.
Age: 1.11
Sex: M
Vaccine: FLU3, MMR, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Approx 12 hr after receiving 12's child became febrile (103 R) and irritable x 13 hrs and again the next night. Parent gave Advil gtts Q6H. Afebrile during daytime.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site mass, Injection site oedema, Tenderness
Clinical narrative: Received vaccine 2/2/05-seen by MD on 2/3/05 in which L leg swollen 2 inches more than R slightly pinkish. Indurated all throughout entire middle third of thigh. Limping some is able to walk. Full ROM mild to moderately tender.
Age: 48.0
Sex: F
Vaccine: HEP, IPV, TYP
Symptoms: Anorectal disorder, Coagulopathy, Constipation, Diverticulitis, Haemorrhoids
Clinical narrative: Constipation, exacerbation of hemorrhoids, 10c size clots, rectally after oral typhoid vaccines 3 of 4 pills. Pt HX= hemorrhoids, diverticulitis, Hiatal hernia
Age: 48.0
Sex: F
Vaccine: HEP, IPV, TYP
Symptoms: Hiatus hernia
Clinical narrative: Constipation, exacerbation of hemorrhoids, 10c size clots, rectally after oral typhoid vaccines 3 of 4 pills. Pt HX= hemorrhoids, diverticulitis, Hiatal hernia
Age: 59.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Medication error, Myalgia, Nasal congestion
Clinical narrative: Patient came into clinic for Flu shot appointment.  After inputing information for Flu shot into computer, patient began reading VIS on my desk about the Intranasal Flu Vaccine.  He asked about SE and cost.  I informed him of this information.  I asked if he had any medical problems and he stated "no."  He continued to read the information as I changed the information in the computer to give him Flu Mist.  While doing this, I did not check his age.  Then....I inadvertently gave Flu Mist intranasal flu vaccine to him - a 58yo who was above the 49yo limit for this vaccine.  After he left the Clinic, I realized my mistake and began reporting procedures to the Immunization Coordinator for Public Health  and then called the patient to apologize.  The coordinator checked with CDC and was informed it would be okay for the patient to receive the Flu shot despite just getting Flu Mist.  We offered that to the patient, but he has not yet responded and may wait the 2 weeks as recommended on the Flu Mist web site.  At this point, he has not reported any adverse SE to the Flu Mist vaccine.
Age: 59.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Medication error
Clinical narrative: Patient came into clinic for Flu shot appointment.  After inputing information for Flu shot into computer, patient began reading VIS on my desk about the Intranasal Flu Vaccine.  He asked about SE and cost.  I informed him of this information.  I asked if he had any medical problems and he stated "no."  He continued to read the information as I changed the information in the computer to give him Flu Mist.  While doing this, I did not check his age.  Then....I inadvertently gave Flu Mist intranasal flu vaccine to him - a 58yo who was above the 49yo limit for this vaccine.  After he left the Clinic, I realized my mistake and began reporting procedures to the Immunization Coordinator for Public Health  and then called the patient to apologize.  The coordinator checked with CDC and was informed it would be okay for the patient to receive the Flu shot despite just getting Flu Mist.  We offered that to the patient, but he has not yet responded and may wait the 2 weeks as recommended on the Flu Mist web site.  At this point, he has not reported any adverse SE to the Flu Mist vaccine.
Age: 43.0
Sex: F
Vaccine: ANTH, DTPIHI, FLU3, SMALL
Symptoms: Cerebrovascular accident, Laboratory test abnormal
Clinical narrative: WAS GIVEN ANTHRAX SHOT (3RD ONE) AND SMALL POX AND 3 OTHER SHOTS ON MAR 23, 2003 AND HAD STROKE (BRAIN STEM STROKE) ON MAR 28,2003.  WAS PUT ON MEDICAL HOLD AND PROCESSED OUT OF SERVICE ON TDRL.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Blister, Brain neoplasm malignant, Drug ineffective, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no significant medical history who on 2/24/98, at 13 months of age was vaccinated with a first dose of varicella virus vaccine live. In November 2004, the patient was diagnosed with an inoperable, malignant brain ependymoma. The treatment plan was to shrink the tumor with chemotherapy, followed by radiation therapy. The patient began chemotherapy in November 2004 and was tolerating it well on an outpatient basis. On 12/28/04 she presented at the hospital with a chief complaint of low back pain and was afebrile with no other reported signs and symptoms. An MRI was done which showed a subcutaneous area of enhancement in the low back; there was no spine, bone or meningeal enhancement. The patient was admitted to the hospital. On 12/29/04, at approximately noon, the patient was noted to have several vesicles on the crown of the head. That same day she was started on IV acyclovir at a herpes simplex dose and was transferred to the ICU. Subsequently a skin biopsy was done and an Infectious Disease consult was requested. As a precaution while awaiting the results of the skin biopsy, the acyclovir dose was increased for varicella. Later in the day on 12/29/04, the patient developed fulminant liver failure, with ALT >6000, AST 3620 and an INR of 5.6. She was given lots of blood and cryoprecipates; however, the liver failure persisted. On 12/30/04 her transaminases were over 13,000. The physician reported that the patient's anti-varicella IgG was negative. On 12/30/04 she developed multi-system organ failure and was intubated. On 12/31/04, life support was withdrawn and the patient died. The physician reported that he did not know if an autopsy was done, but believes that the child died from multiorgan failure resulting from disseminated varicella. He noted that some lesion specimens were sent for PCR analysis. The physician reported that there was no known varicella exposure prior to the child's hospitalization. The physician reported that he felt most certain that this was wild type VZV in an immunocompromised patient. Discharge Summary reviewed stated patient experienced sepsis, hypoxia, respiratory distress and GI bleed.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Gastrointestinal haemorrhage, Hepatic failure, Hypoxia, Laboratory test abnormal, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no significant medical history who on 2/24/98, at 13 months of age was vaccinated with a first dose of varicella virus vaccine live. In November 2004, the patient was diagnosed with an inoperable, malignant brain ependymoma. The treatment plan was to shrink the tumor with chemotherapy, followed by radiation therapy. The patient began chemotherapy in November 2004 and was tolerating it well on an outpatient basis. On 12/28/04 she presented at the hospital with a chief complaint of low back pain and was afebrile with no other reported signs and symptoms. An MRI was done which showed a subcutaneous area of enhancement in the low back; there was no spine, bone or meningeal enhancement. The patient was admitted to the hospital. On 12/29/04, at approximately noon, the patient was noted to have several vesicles on the crown of the head. That same day she was started on IV acyclovir at a herpes simplex dose and was transferred to the ICU. Subsequently a skin biopsy was done and an Infectious Disease consult was requested. As a precaution while awaiting the results of the skin biopsy, the acyclovir dose was increased for varicella. Later in the day on 12/29/04, the patient developed fulminant liver failure, with ALT >6000, AST 3620 and an INR of 5.6. She was given lots of blood and cryoprecipates; however, the liver failure persisted. On 12/30/04 her transaminases were over 13,000. The physician reported that the patient's anti-varicella IgG was negative. On 12/30/04 she developed multi-system organ failure and was intubated. On 12/31/04, life support was withdrawn and the patient died. The physician reported that he did not know if an autopsy was done, but believes that the child died from multiorgan failure resulting from disseminated varicella. He noted that some lesion specimens were sent for PCR analysis. The physician reported that there was no known varicella exposure prior to the child's hospitalization. The physician reported that he felt most certain that this was wild type VZV in an immunocompromised patient. Discharge Summary reviewed stated patient experienced sepsis, hypoxia, respiratory distress and GI bleed.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Sepsis, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no significant medical history who on 2/24/98, at 13 months of age was vaccinated with a first dose of varicella virus vaccine live. In November 2004, the patient was diagnosed with an inoperable, malignant brain ependymoma. The treatment plan was to shrink the tumor with chemotherapy, followed by radiation therapy. The patient began chemotherapy in November 2004 and was tolerating it well on an outpatient basis. On 12/28/04 she presented at the hospital with a chief complaint of low back pain and was afebrile with no other reported signs and symptoms. An MRI was done which showed a subcutaneous area of enhancement in the low back; there was no spine, bone or meningeal enhancement. The patient was admitted to the hospital. On 12/29/04, at approximately noon, the patient was noted to have several vesicles on the crown of the head. That same day she was started on IV acyclovir at a herpes simplex dose and was transferred to the ICU. Subsequently a skin biopsy was done and an Infectious Disease consult was requested. As a precaution while awaiting the results of the skin biopsy, the acyclovir dose was increased for varicella. Later in the day on 12/29/04, the patient developed fulminant liver failure, with ALT >6000, AST 3620 and an INR of 5.6. She was given lots of blood and cryoprecipates; however, the liver failure persisted. On 12/30/04 her transaminases were over 13,000. The physician reported that the patient's anti-varicella IgG was negative. On 12/30/04 she developed multi-system organ failure and was intubated. On 12/31/04, life support was withdrawn and the patient died. The physician reported that he did not know if an autopsy was done, but believes that the child died from multiorgan failure resulting from disseminated varicella. He noted that some lesion specimens were sent for PCR analysis. The physician reported that there was no known varicella exposure prior to the child's hospitalization. The physician reported that he felt most certain that this was wild type VZV in an immunocompromised patient. Discharge Summary reviewed stated patient experienced sepsis, hypoxia, respiratory distress and GI bleed.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Coma, Cyanosis, Hypotonia, Hypoventilation, Pallor
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Somnolence
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Agitation, Coma, Crying, Cyanosis, Hypotonia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Hypoventilation, Loss of consciousness, Pallor, Somnolence, Tension
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Coma, Cyanosis, Gaze palsy, Hypotonia, Hypoventilation
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Pallor
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Coma, Cyanosis, Hypotonia, Hypoventilation, Pallor
Clinical narrative: Information has been received from a helath professional concerning a 9 week old male with a history of breath holding and no drug reactions or allergies who on 1/31/05 was vaccinated in the left leg with a dose of hepatitis B virus vaccine (lot # 646433/0928N). Concomitant therapy included a dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 1/31/05, immediately after vaccination, the patient began to cry and became tense. He then got a blank look on his face and passed out. He was cyanotic around the mouth and was unresponsive. The nurse rubbed his back and tapped him but he remained flaccid for about 30 seconds. They rolled him on his side and saw shallow breathing. He started to cry and the cyanosis lessened. They drove him to a nearby clinic to see the physician's assistant there. By then, he was pink but pale. About one hour later they went to draw blood and he developed a blank stare and some cyanosis. The child's grandmother reported that he appears well on 2/1/05, but had an appointment to see a pediatrician. The patient's experiences were considered to be immediately life threatening by the reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Somnolence
Clinical narrative: Information has been received from a helath professional concerning a 9 week old male with a history of breath holding and no drug reactions or allergies who on 1/31/05 was vaccinated in the left leg with a dose of hepatitis B virus vaccine (lot # 646433/0928N). Concomitant therapy included a dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 1/31/05, immediately after vaccination, the patient began to cry and became tense. He then got a blank look on his face and passed out. He was cyanotic around the mouth and was unresponsive. The nurse rubbed his back and tapped him but he remained flaccid for about 30 seconds. They rolled him on his side and saw shallow breathing. He started to cry and the cyanosis lessened. They drove him to a nearby clinic to see the physician's assistant there. By then, he was pink but pale. About one hour later they went to draw blood and he developed a blank stare and some cyanosis. The child's grandmother reported that he appears well on 2/1/05, but had an appointment to see a pediatrician. The patient's experiences were considered to be immediately life threatening by the reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Agitation, Coma, Crying, Cyanosis, Hypotonia
Clinical narrative: Information has been received from a helath professional concerning a 9 week old male with a history of breath holding and no drug reactions or allergies who on 1/31/05 was vaccinated in the left leg with a dose of hepatitis B virus vaccine (lot # 646433/0928N). Concomitant therapy included a dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 1/31/05, immediately after vaccination, the patient began to cry and became tense. He then got a blank look on his face and passed out. He was cyanotic around the mouth and was unresponsive. The nurse rubbed his back and tapped him but he remained flaccid for about 30 seconds. They rolled him on his side and saw shallow breathing. He started to cry and the cyanosis lessened. They drove him to a nearby clinic to see the physician's assistant there. By then, he was pink but pale. About one hour later they went to draw blood and he developed a blank stare and some cyanosis. The child's grandmother reported that he appears well on 2/1/05, but had an appointment to see a pediatrician. The patient's experiences were considered to be immediately life threatening by the reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Hypoventilation, Loss of consciousness, Pallor, Somnolence, Tension
Clinical narrative: Information has been received from a helath professional concerning a 9 week old male with a history of breath holding and no drug reactions or allergies who on 1/31/05 was vaccinated in the left leg with a dose of hepatitis B virus vaccine (lot # 646433/0928N). Concomitant therapy included a dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 1/31/05, immediately after vaccination, the patient began to cry and became tense. He then got a blank look on his face and passed out. He was cyanotic around the mouth and was unresponsive. The nurse rubbed his back and tapped him but he remained flaccid for about 30 seconds. They rolled him on his side and saw shallow breathing. He started to cry and the cyanosis lessened. They drove him to a nearby clinic to see the physician's assistant there. By then, he was pink but pale. About one hour later they went to draw blood and he developed a blank stare and some cyanosis. The child's grandmother reported that he appears well on 2/1/05, but had an appointment to see a pediatrician. The patient's experiences were considered to be immediately life threatening by the reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Coma, Cyanosis, Gaze palsy, Hypotonia, Hypoventilation
Clinical narrative: Information has been received from a helath professional concerning a 9 week old male with a history of breath holding and no drug reactions or allergies who on 1/31/05 was vaccinated in the left leg with a dose of hepatitis B virus vaccine (lot # 646433/0928N). Concomitant therapy included a dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 1/31/05, immediately after vaccination, the patient began to cry and became tense. He then got a blank look on his face and passed out. He was cyanotic around the mouth and was unresponsive. The nurse rubbed his back and tapped him but he remained flaccid for about 30 seconds. They rolled him on his side and saw shallow breathing. He started to cry and the cyanosis lessened. They drove him to a nearby clinic to see the physician's assistant there. By then, he was pink but pale. About one hour later they went to draw blood and he developed a blank stare and some cyanosis. The child's grandmother reported that he appears well on 2/1/05, but had an appointment to see a pediatrician. The patient's experiences were considered to be immediately life threatening by the reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEP, PNC, HEP, PNC, IPV
Symptoms: Pallor
Clinical narrative: Information has been received from a helath professional concerning a 9 week old male with a history of breath holding and no drug reactions or allergies who on 1/31/05 was vaccinated in the left leg with a dose of hepatitis B virus vaccine (lot # 646433/0928N). Concomitant therapy included a dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 1/31/05, immediately after vaccination, the patient began to cry and became tense. He then got a blank look on his face and passed out. He was cyanotic around the mouth and was unresponsive. The nurse rubbed his back and tapped him but he remained flaccid for about 30 seconds. They rolled him on his side and saw shallow breathing. He started to cry and the cyanosis lessened. They drove him to a nearby clinic to see the physician's assistant there. By then, he was pink but pale. About one hour later they went to draw blood and he developed a blank stare and some cyanosis. The child's grandmother reported that he appears well on 2/1/05, but had an appointment to see a pediatrician. The patient's experiences were considered to be immediately life threatening by the reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Back pain, Diarrhoea, Difficulty in walking
Clinical narrative: Pt is a 67 year old male who was in his normal state of health until approx three weeks ago. He began to experience aching on the backs of his legs and in his low back. He then developed numbness that started in his feet but extended approx 2" up his shins. He now has difficulty walking and feels as though he is slightly weak in his legs. He does have mild tingling in his fingertips bilaterally. Approx one week prior to the onset of his symptoms he did receive a Pneumococcal vaccine. On brief physical examination he has full strength of his upper extremities. In his lower extremities he has full strength in all muscle groups except for toe extension and flexion, which are 4+/5 bilaterally. He has 1+ reflex in his right biceps otherwise he has no reflexes in any of his extremities. He has decreased sensation from the toe to 2" above the ankle bilaterally. This history and physical are consistent with Guillain Barre Syndrome, CIDP, or a toxic polyneuropathy. Electrodiagnostic studies were designed to test for these possibilities. He had no significant change is symptoms. Still has persistent paresthesias and numbness in both lower extremities and both hands and forearms. Still requires the walker to walk. He has had no significant falls. He has had no progressive weakness. He does not a right foot drop. He is unaware of significant difference in size of muscles in the right leg and thigh and calf comparing to his left. His chronic mild diarrhea three or four stools a day persists. He has nocturia X1 or X2. He has chronic leg pain and his leg pain is significantly improved, but he still has posterior medial pain in the right thigh. He has had a temp to 100.7F associated with nasal congestion and a feeling of stuffiness and pressure back into his ears. He was confined to bed for 6 days straight and got very weak.  Pt's goal for therapy : walk normal again, be able to return to work at least part time if able. Follow up 02/22/05: Exact date and time of onset of adverse event not known. No success contacting patient. 60 Day Follow up: Has been placed in leg braces, still going to physical therapy. Still has "numb" areas on both legs; is not in leg braces anymore-but gait is "staggered".  Is still on a heart pill to prevent dysrrythimias - all per telephone call to wite 4/13/06 still seeing Neuro MD at hosp.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Ear discomfort, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
Clinical narrative: Pt is a 67 year old male who was in his normal state of health until approx three weeks ago. He began to experience aching on the backs of his legs and in his low back. He then developed numbness that started in his feet but extended approx 2" up his shins. He now has difficulty walking and feels as though he is slightly weak in his legs. He does have mild tingling in his fingertips bilaterally. Approx one week prior to the onset of his symptoms he did receive a Pneumococcal vaccine. On brief physical examination he has full strength of his upper extremities. In his lower extremities he has full strength in all muscle groups except for toe extension and flexion, which are 4+/5 bilaterally. He has 1+ reflex in his right biceps otherwise he has no reflexes in any of his extremities. He has decreased sensation from the toe to 2" above the ankle bilaterally. This history and physical are consistent with Guillain Barre Syndrome, CIDP, or a toxic polyneuropathy. Electrodiagnostic studies were designed to test for these possibilities. He had no significant change is symptoms. Still has persistent paresthesias and numbness in both lower extremities and both hands and forearms. Still requires the walker to walk. He has had no significant falls. He has had no progressive weakness. He does not a right foot drop. He is unaware of significant difference in size of muscles in the right leg and thigh and calf comparing to his left. His chronic mild diarrhea three or four stools a day persists. He has nocturia X1 or X2. He has chronic leg pain and his leg pain is significantly improved, but he still has posterior medial pain in the right thigh. He has had a temp to 100.7F associated with nasal congestion and a feeling of stuffiness and pressure back into his ears. He was confined to bed for 6 days straight and got very weak.  Pt's goal for therapy : walk normal again, be able to return to work at least part time if able. Follow up 02/22/05: Exact date and time of onset of adverse event not known. No success contacting patient. 60 Day Follow up: Has been placed in leg braces, still going to physical therapy. Still has "numb" areas on both legs; is not in leg braces anymore-but gait is "staggered".  Is still on a heart pill to prevent dysrrythimias - all per telephone call to wite 4/13/06 still seeing Neuro MD at hosp.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test abnormal, Muscle atrophy, Myalgia, Nasal congestion, Nocturia
Clinical narrative: Pt is a 67 year old male who was in his normal state of health until approx three weeks ago. He began to experience aching on the backs of his legs and in his low back. He then developed numbness that started in his feet but extended approx 2" up his shins. He now has difficulty walking and feels as though he is slightly weak in his legs. He does have mild tingling in his fingertips bilaterally. Approx one week prior to the onset of his symptoms he did receive a Pneumococcal vaccine. On brief physical examination he has full strength of his upper extremities. In his lower extremities he has full strength in all muscle groups except for toe extension and flexion, which are 4+/5 bilaterally. He has 1+ reflex in his right biceps otherwise he has no reflexes in any of his extremities. He has decreased sensation from the toe to 2" above the ankle bilaterally. This history and physical are consistent with Guillain Barre Syndrome, CIDP, or a toxic polyneuropathy. Electrodiagnostic studies were designed to test for these possibilities. He had no significant change is symptoms. Still has persistent paresthesias and numbness in both lower extremities and both hands and forearms. Still requires the walker to walk. He has had no significant falls. He has had no progressive weakness. He does not a right foot drop. He is unaware of significant difference in size of muscles in the right leg and thigh and calf comparing to his left. His chronic mild diarrhea three or four stools a day persists. He has nocturia X1 or X2. He has chronic leg pain and his leg pain is significantly improved, but he still has posterior medial pain in the right thigh. He has had a temp to 100.7F associated with nasal congestion and a feeling of stuffiness and pressure back into his ears. He was confined to bed for 6 days straight and got very weak.  Pt's goal for therapy : walk normal again, be able to return to work at least part time if able. Follow up 02/22/05: Exact date and time of onset of adverse event not known. No success contacting patient. 60 Day Follow up: Has been placed in leg braces, still going to physical therapy. Still has "numb" areas on both legs; is not in leg braces anymore-but gait is "staggered".  Is still on a heart pill to prevent dysrrythimias - all per telephone call to wite 4/13/06 still seeing Neuro MD at hosp.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Paraesthesia
Clinical narrative: Pt is a 67 year old male who was in his normal state of health until approx three weeks ago. He began to experience aching on the backs of his legs and in his low back. He then developed numbness that started in his feet but extended approx 2" up his shins. He now has difficulty walking and feels as though he is slightly weak in his legs. He does have mild tingling in his fingertips bilaterally. Approx one week prior to the onset of his symptoms he did receive a Pneumococcal vaccine. On brief physical examination he has full strength of his upper extremities. In his lower extremities he has full strength in all muscle groups except for toe extension and flexion, which are 4+/5 bilaterally. He has 1+ reflex in his right biceps otherwise he has no reflexes in any of his extremities. He has decreased sensation from the toe to 2" above the ankle bilaterally. This history and physical are consistent with Guillain Barre Syndrome, CIDP, or a toxic polyneuropathy. Electrodiagnostic studies were designed to test for these possibilities. He had no significant change is symptoms. Still has persistent paresthesias and numbness in both lower extremities and both hands and forearms. Still requires the walker to walk. He has had no significant falls. He has had no progressive weakness. He does not a right foot drop. He is unaware of significant difference in size of muscles in the right leg and thigh and calf comparing to his left. His chronic mild diarrhea three or four stools a day persists. He has nocturia X1 or X2. He has chronic leg pain and his leg pain is significantly improved, but he still has posterior medial pain in the right thigh. He has had a temp to 100.7F associated with nasal congestion and a feeling of stuffiness and pressure back into his ears. He was confined to bed for 6 days straight and got very weak.  Pt's goal for therapy : walk normal again, be able to return to work at least part time if able. Follow up 02/22/05: Exact date and time of onset of adverse event not known. No success contacting patient. 60 Day Follow up: Has been placed in leg braces, still going to physical therapy. Still has "numb" areas on both legs; is not in leg braces anymore-but gait is "staggered".  Is still on a heart pill to prevent dysrrythimias - all per telephone call to wite 4/13/06 still seeing Neuro MD at hosp.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Oedema, Pain, Pyrexia
Clinical narrative: Left arm pain reported since receiving the flu shot (reported to health department 2/4/05). During follow up call, 2/7/05, from health department, Dad states child was evaluated and hospitalized. Medical Record received on 2/14/2005 states fever, decreased mobility and edema. 60 Day follow up: we have had no additional contact from childs family.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pain in muscle of upper arm and forearm; spread to general muscle aches over the rest of body, approx 10 days after getting shot. Now after 3 weeks, Pain is localized in upper arm muscle (took Advil)
Age: 1.05
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Cellulitis
Clinical narrative: Right leg cellulitis
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Rash, Tenderness
Clinical narrative: Erythema, warmth and tenderness 10cm diameter rash.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: 2-3 hours broke out in hives and headache and fever lasted 8-7 hours. Benadryl was not given/and Advil was given.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Pt ran a fever of 103 and fussy evening of shots given.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Erythema to injection site that is warm to touch and painful. Symptoms developed approx 24 hours after vaccine administration.
Age: 1.27
Sex: F
Vaccine: DTAP, MMR, PPV, VARCEL
Symptoms: Erythema, Lethargy, Pyrexia, Rash, Urticaria
Clinical narrative: Notice a few spots (3-4) around body on chest area. On 02/3/05 noticed more spots (faint) lower in body. 2/4/05 more spots appeared and called nurse to inquiry whether could be pox, she recommended to watch it.  2/2 and 2/3 also had low grade fever and given Infant Tylenol and fever decreased. On 2/5 red was face and had welt on side of face, disappeared after 1 hour, was lethargic. 2/6 was also lethargic, mom nursed baby for 1 hour and noticed that had welts and red rash. Mom discovered the rash/welts were all over body, there were 2-3 spots together like clusters and some individual. At about 10AM baby was not lethargic, called doctor who recommended Benadryl and it really helped and at least redness was gone and started to clear up. Reaction different to allergy to amoxicillin. 2/8 only a few spots remain.
Age: 1.36
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Lymphadenopathy, Pyrexia
Clinical narrative: Low grade fever, inguinal adenopathy, ataxia Jan14-Jan16
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Fluid retention
Clinical narrative: Persistent L shoulder pain, MRI consisted with minimal fluid deep to the deltoid muscle. Rest of the shoulder  MRI was normal.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Feeling hot, Hypokinesia, Oedema peripheral, Pain
Clinical narrative: I received the mist at approximately 1415 hours.  I was not directed to keep my head tilted back, the "mist" began to run out my nose.  I stopped it from running using my right pointer finger.  The drug saturated my cortical area.  About 3 hours later the area surrounding my fingernail turned a slight red color, began to feel warm and had a slight pain.  At approximately 0300 hours the next day, the finger (two end digits) were a darker red color, swollen, hot, with a throbbing pain.  Bending the finger was difficult and gently touching the area cause considerable pain.  I soaked the finger in H2O2 for about 5 minutes, then put a triple antibiotic on it and put a band aid over it.  As of today 3 days later, the finger is a little better, still warm, pink in color, and sensitive to touch.  I have been keeping a band aid on it with a triple antibiotic.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR
Symptoms: Convulsion, Lacrimation increased, Nasal congestion, Pyrexia, Rash
Clinical narrative: Prolonged fever (approx 13 days), congestion, watering eyes, rash, seizure.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Hypotonia, Irritability, Lethargy
Clinical narrative: 2 month old received Pediarix, HIB and Prevnar at 1:30P on 01/31/05. He cried right away and fell asleep for 3-4 hours. Mother woke him to try and feed him and he was extremely irritable, feeding poorly. Mother repeated Tylenol dose and child fell back asleep for 2 hours. Mom tried to wake him again and he again was irritable (high pitched cry) and drowsy-poor feeding. Child was brought to ER where he was monitored for 5 hours. Pt was found to be irritable when moved or touched and otherwise very pale and limp with poor feeding. No significant increase in fever was noted. About 11-12 hours after episode he began to wake up per mother and feed better.  The following day we saw him in the office and found him to be neurologically intact, however acting more irritable than usual. He had a temp of 100.8 and was feeding much better. By phone call that evening the pt was acting normally and remains to be doing so.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Oral intake reduced, Pallor, Pyrexia
Clinical narrative: 2 month old received Pediarix, HIB and Prevnar at 1:30P on 01/31/05. He cried right away and fell asleep for 3-4 hours. Mother woke him to try and feed him and he was extremely irritable, feeding poorly. Mother repeated Tylenol dose and child fell back asleep for 2 hours. Mom tried to wake him again and he again was irritable (high pitched cry) and drowsy-poor feeding. Child was brought to ER where he was monitored for 5 hours. Pt was found to be irritable when moved or touched and otherwise very pale and limp with poor feeding. No significant increase in fever was noted. About 11-12 hours after episode he began to wake up per mother and feed better.  The following day we saw him in the office and found him to be neurologically intact, however acting more irritable than usual. He had a temp of 100.8 and was feeding much better. By phone call that evening the pt was acting normally and remains to be doing so.
Age: 7.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash, Vomiting
Clinical narrative: Mother called and states that client has rash over his whole body. Some of the spots are quite big and red.  Fever last night was 104 degrees and he has been throwing up.  Mother states that the family has been sick with stomach virus and high fever.