chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, TYP
Symptoms: Rash generalised
Clinical narrative: Rash over body through course of vaccine. I didn't do anything for rash except to wait it out.
Age: 15.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Unevaluable event
Clinical narrative: none
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: none
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Injection site pain
Clinical narrative: Received Menactra 8/2/07.  AM 8/3/07, he felt dizzy and weak.  c/o soreness at both injection sites - Right arm more sore than Left arm.  soreness has improved.  Continues to c/o dizziness and weakness, but is improving.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Angina unstable, Bursitis, Chest pain, Discomfort, Fall
Clinical narrative: The client reported discomfort in her R bicept since vaccination day. Around the 23rd of July, she also fell out of bed and landed on her R arm.  She reported extra pain since then.  She also developed chest pain when she walked up stairs or uses her arm more.  Her family brought her to an emergency room at another hospital on 7/28/2007.  Evaluation there showed ECG changes and she was admitted to further evaluate her chest pain with unstable angina and bicept discomfort.  An MRI was done.  See below findings. 8/24/07-records received-7/28/07-Presented to ED with intermittent chest pain, has had right shoulder pain for past week to day days. Right arm pain since vaccines received. Two days after vaccines adminsitered fell out of bed and landed on right arm, extra pain since then. Developed chest pain associated with this. When she goes up stair or uses her arm more she develops chest pain. No shortness of breath, no nausea or vomiting. Feels somewhat weak. This is chronic for patient. Supposedly scheduled in August for some CT angiogram. PE: right upper extremity slightly swollen in deltoid and humeral area, tenderness of glenohumeral joint. Difficulty raising arm above head.  No C/O chest pain in ED. Impression: right bicipital discomfort secondary to immunizations. Chest pain with unstable anginaEdema in deltoid musculature consistent with recent immunization. Small amount fluid in subacrominal/subdeltoid bursa, consistent with recent injury or burisitis. Multiple normal sized lymph nodes in right axilla which are increased in number. these are likely reactive.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: The client reported discomfort in her R bicept since vaccination day. Around the 23rd of July, she also fell out of bed and landed on her R arm.  She reported extra pain since then.  She also developed chest pain when she walked up stairs or uses her arm more.  Her family brought her to an emergency room at another hospital on 7/28/2007.  Evaluation there showed ECG changes and she was admitted to further evaluate her chest pain with unstable angina and bicept discomfort.  An MRI was done.  See below findings. 8/24/07-records received-7/28/07-Presented to ED with intermittent chest pain, has had right shoulder pain for past week to day days. Right arm pain since vaccines received. Two days after vaccines adminsitered fell out of bed and landed on right arm, extra pain since then. Developed chest pain associated with this. When she goes up stair or uses her arm more she develops chest pain. No shortness of breath, no nausea or vomiting. Feels somewhat weak. This is chronic for patient. Supposedly scheduled in August for some CT angiogram. PE: right upper extremity slightly swollen in deltoid and humeral area, tenderness of glenohumeral joint. Difficulty raising arm above head.  No C/O chest pain in ED. Impression: right bicipital discomfort secondary to immunizations. Chest pain with unstable anginaEdema in deltoid musculature consistent with recent immunization. Small amount fluid in subacrominal/subdeltoid bursa, consistent with recent injury or burisitis. Multiple normal sized lymph nodes in right axilla which are increased in number. these are likely reactive.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: REDDNESS, HOT TO TOUCH, WELTED
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Swelling, Tenderness
Clinical narrative: Patient is 41 year old male who had the Anthrax #1 and initially had some local tenderness for the first 72 hours.  The area seemed normal for about one week and then it started to swell again.  He reports tenderness at the sight.  No fevers or chills.  No body aches and no nausea or vomiting.  No dizziness or lightheadedness.  He has never had a reaction like this before.  He reports the swelling seems to be getting worse each day.  He is scheduled for number 2 later this week.
Age: 18.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Rash
Clinical narrative: Client's Mother called and stated client woke up in the middle of the night(8/7) having developed a rash from the lower abdominal area to top of knees.  Also had a few spots on neck and arms. The rash was not a pinpoint rash but was diffuse, flat, circular areas.  Denies fever.  Per Mom, she planned on giving daughter Benadryl but had not done so yet.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Anorexia, Cellulitis, Chills, Dehydration, Dizziness
Clinical narrative: Started feeling a little weird and dizzy about 4 pm on 08/04/07.At 6:30pm I felt nauseated and cold with chills.Around 9pm I was having severe body aches and flu like symptoms with fever and limited range of motion to my RT.arm .I took Ibuprofen and went to bed.Woke up 08/05/07 with continued symptoms and lost of appetite that lasted until 08/07/07. I continued to take Ibuprofen around the clock with little relief. Too nauseated to drink or eat much at all.On 08/06/07 I went to work and reported this to several staff members and Chief Nurse. Noted continued swelling to Rt.deltoid and warmthness to the touch. On 08/07/07 I reported and showed RN and CMA the noticable swelling of my arm through my shirt sleeve that appears to be cellulitis. Also reported to Rn,Chief nurse per tc.Today I continue with swelling and stiffnes with limited range of motion to arm, tenderness and warmthness to the touch,loss of appetite,dehydration, dizziness and queasiness with alternating hot and cold flashes.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Hot flush, Influenza like illness, Musculoskeletal stiffness, Nausea
Clinical narrative: Started feeling a little weird and dizzy about 4 pm on 08/04/07.At 6:30pm I felt nauseated and cold with chills.Around 9pm I was having severe body aches and flu like symptoms with fever and limited range of motion to my RT.arm .I took Ibuprofen and went to bed.Woke up 08/05/07 with continued symptoms and lost of appetite that lasted until 08/07/07. I continued to take Ibuprofen around the clock with little relief. Too nauseated to drink or eat much at all.On 08/06/07 I went to work and reported this to several staff members and Chief Nurse. Noted continued swelling to Rt.deltoid and warmthness to the touch. On 08/07/07 I reported and showed RN and CMA the noticable swelling of my arm through my shirt sleeve that appears to be cellulitis. Also reported to Rn,Chief nurse per tc.Today I continue with swelling and stiffnes with limited range of motion to arm, tenderness and warmthness to the touch,loss of appetite,dehydration, dizziness and queasiness with alternating hot and cold flashes.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pyrexia, Skin warm
Clinical narrative: Started feeling a little weird and dizzy about 4 pm on 08/04/07.At 6:30pm I felt nauseated and cold with chills.Around 9pm I was having severe body aches and flu like symptoms with fever and limited range of motion to my RT.arm .I took Ibuprofen and went to bed.Woke up 08/05/07 with continued symptoms and lost of appetite that lasted until 08/07/07. I continued to take Ibuprofen around the clock with little relief. Too nauseated to drink or eat much at all.On 08/06/07 I went to work and reported this to several staff members and Chief Nurse. Noted continued swelling to Rt.deltoid and warmthness to the touch. On 08/07/07 I reported and showed RN and CMA the noticable swelling of my arm through my shirt sleeve that appears to be cellulitis. Also reported to Rn,Chief nurse per tc.Today I continue with swelling and stiffnes with limited range of motion to arm, tenderness and warmthness to the touch,loss of appetite,dehydration, dizziness and queasiness with alternating hot and cold flashes.
Age: 0.59
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, UNK
Symptoms: Convulsion, Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever developed a few hours after vaccines lasting at least 3 days to a week. Patient suffered lethargy and sleepiness after prolonged high pitched screaming. Seizure possible but unknown. Pain, swelling, and redness at the injection sites on thighs.
Age: 0.59
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, UNK
Symptoms: Lethargy, Screaming, Somnolence
Clinical narrative: Fever developed a few hours after vaccines lasting at least 3 days to a week. Patient suffered lethargy and sleepiness after prolonged high pitched screaming. Seizure possible but unknown. Pain, swelling, and redness at the injection sites on thighs.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: 12 mo old inadvertantly given Zostavax yesterday with other vaccines at 12 mo instead of Proquad. The vial had been placed in a Proquad box and the medical assistant did not realize it was the wrong bottle until the vaccine had been given. No unusual signs or symptoms yet.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Balance disorder, Deafness unilateral, Dysstasia, Headache
Clinical narrative: In perfect health on 6/6/07. On 6/7, seven days after Zostavax shot, I woke up with a totally deaf right ear. Left ear hearing was impaired. Was prescribed to take Prednisone Pack and ValTrex. On 6/13/07, I went to the hospital by ambulance with SEVERE Vertigo, tinnitus and headaches. I could not even stand up. Was in hospital 10 days; the point at which I could take a few steps, I went home. 8/20/07-records received for DOS 6/13-6/22/07-DC DX: Dyslipidemia. Chronic Tinnitus. Presented with sudden onset of vertigo and right hearing loss about 1 week prior to admission.Vertigo worsened. Unable to stand or ambulate. No nystagmus. PE: severe vertigo and inability to stand or ambulate
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster oticus, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: In perfect health on 6/6/07. On 6/7, seven days after Zostavax shot, I woke up with a totally deaf right ear. Left ear hearing was impaired. Was prescribed to take Prednisone Pack and ValTrex. On 6/13/07, I went to the hospital by ambulance with SEVERE Vertigo, tinnitus and headaches. I could not even stand up. Was in hospital 10 days; the point at which I could take a few steps, I went home. 8/20/07-records received for DOS 6/13-6/22/07-DC DX: Dyslipidemia. Chronic Tinnitus. Presented with sudden onset of vertigo and right hearing loss about 1 week prior to admission.Vertigo worsened. Unable to stand or ambulate. No nystagmus. PE: severe vertigo and inability to stand or ambulate
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram abnormal, Computerised tomogram normal, Deafness unilateral, Headache, Hearing impaired
Clinical narrative: In perfect health on 6/6/07. On 6/7, seven days after Zostavax shot, I woke up with a totally deaf right ear. Left ear hearing was impaired. Was prescribed to take Prednisone Pack and ValTrex. On 6/13/07, I went to the hospital by ambulance with SEVERE Vertigo, tinnitus and headaches. I could not even stand up. Was in hospital 10 days; the point at which I could take a few steps, I went home. 8/20/07-records received for DOS 6/13-6/22/07-DC DX: Dyslipidemia. Chronic Tinnitus. Presented with sudden onset of vertigo and right hearing loss about 1 week prior to admission.Vertigo worsened. Unable to stand or ambulate. No nystagmus. PE: severe vertigo and inability to stand or ambulate
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Tinnitus, Vertigo
Clinical narrative: In perfect health on 6/6/07. On 6/7, seven days after Zostavax shot, I woke up with a totally deaf right ear. Left ear hearing was impaired. Was prescribed to take Prednisone Pack and ValTrex. On 6/13/07, I went to the hospital by ambulance with SEVERE Vertigo, tinnitus and headaches. I could not even stand up. Was in hospital 10 days; the point at which I could take a few steps, I went home. 8/20/07-records received for DOS 6/13-6/22/07-DC DX: Dyslipidemia. Chronic Tinnitus. Presented with sudden onset of vertigo and right hearing loss about 1 week prior to admission.Vertigo worsened. Unable to stand or ambulate. No nystagmus. PE: severe vertigo and inability to stand or ambulate
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Abdominal pain, Appendicectomy, Appendix disorder, Blood test abnormal, Colonoscopy
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Computerised tomogram, Constipation, Contraindication to vaccination, Endoscopy, Hyperplasia
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Inflammation, Intussusception, Intussusception, Irritable bowel syndrome, Laboratory test
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Laparotomy, Lymphoid tissue hyperplasia, Platelet count decreased, Pneumonia, Psoriatic arthropathy
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Selective IgA immunodeficiency, Sinusitis
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Abdominal pain, Appendicectomy, Arteritis, Arthritis, Blood test
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Colonoscopy, Computerised tomogram, Constipation, Endoscopy, Intussusception
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Irritable bowel syndrome, Platelet count decreased, Pneumonia, Sinusitis, Surgery
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 17.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Ultrasound abdomen, X-ray
Clinical narrative: Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.
Age: 4.0
Sex: M
Vaccine: MEA, RUB
Symptoms: Blood test abnormal, Chest X-ray abnormal, Cough, Cyanosis, Diet refusal
Clinical narrative: Pt. described as hyper, agitated and aching in a bizarre fashion. Eye blinking "halting speech pattern." Physician exam showed occus eye blinking that decreased with distraction and a silly, hyper neurologically intact child. Grandparents arrives same time period and child
Age: 4.0
Sex: M
Vaccine: MEA, RUB
Symptoms: Dyspnoea, Hypotonia, Lethargy, Pyrexia, Unresponsive to stimuli
Clinical narrative: Pt. described as hyper, agitated and aching in a bizarre fashion. Eye blinking "halting speech pattern." Physician exam showed occus eye blinking that decreased with distraction and a silly, hyper neurologically intact child. Grandparents arrives same time period and child
Age: 4.0
Sex: M
Vaccine: MEA, RUB
Symptoms: Agitation, Eye movement disorder, Pain, Psychomotor hyperactivity
Clinical narrative: Pt. described as hyper, agitated and aching in a bizarre fashion. Eye blinking "halting speech pattern." Physician exam showed occus eye blinking that decreased with distraction and a silly, hyper neurologically intact child. Grandparents arrives same time period and child
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Burning sensation, Cough, Crying, Dyspnoea, Oral discomfort
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Stomatitis, Wheezing
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Oral discomfort, Wheezing
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Immediate post-injection reaction, Oral discomfort, Wheezing
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Stomatitis, Wheezing
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Crying, Dyspnoea, No reaction on previous exposure to drug, Oral discomfort
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from another manufacturer (other manufacturer report " A0666380A) from a health professional concerning a 4 year old male who on 23-JUL-2007 at 2:45 pm was vaccinated with the second dose of Varivax (Lot # 656566/1511F). Concomitant suspect vaccination also received on 23-JUL-2007 included the second dose of MMR II (Lot # 656612/0282U), HAVRIX (Lot # AHAVB172BA) in left arm, the fourth dose of poliovirus vaccine (Lot # A0110), the fifth dose of INFANRIX IM in the left deltoid and the third dose of PREVNAR (Lot # B50413K). The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23-JUL-2007 at 2:47, two minutes after vaccination the patient experienced coughing and crying while still in the physician's office. THe mother of the subject just thought that her child was upset and took the child out to the car. The child complained that the roof of his mouth was burning. The patient was taken back to the physician's office for examination. The physician heard wheezing upon examination. The patient also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine injection and Albuterol via nebulizer. On 23-JUL-2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which of the vaccines caused these events." Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Body temperature increased, CSF white blood cell count increased, Cough, Dysphonia
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient was "immediately hospitalized with meningitis." The exact amount of time between vaccination and diagnosis was unknown. No further information was provided. There was no product quality complaint involved. The patient's meningitis was considered serious for hospitalization and life threatening. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Lumbar puncture, Meningitis, Pneumonia
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient was "immediately hospitalized with meningitis." The exact amount of time between vaccination and diagnosis was unknown. No further information was provided. There was no product quality complaint involved. The patient's meningitis was considered serious for hospitalization and life threatening. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Polymerase chain reaction, Rash, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient was "immediately hospitalized with meningitis." The exact amount of time between vaccination and diagnosis was unknown. No further information was provided. There was no product quality complaint involved. The patient's meningitis was considered serious for hospitalization and life threatening. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Meningitis
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient was "immediately hospitalized with meningitis." The exact amount of time between vaccination and diagnosis was unknown. No further information was provided. There was no product quality complaint involved. The patient's meningitis was considered serious for hospitalization and life threatening. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Meningitis, Pneumonia, Trigeminal neuralgia
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently the patient was "immediately hospitalized with meningitis." The exact amount of time between vaccination and diagnosis was unknown. No further information was provided. There was no product quality complaint involved. The patient's meningitis was considered serious for hospitalization and life threatening. Additional information has been requested.
Age: 38.0
Sex: U
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella
Clinical narrative: 4 days after receiving varicella vaccine developed varicella on chest dont know yet if its going to be worst.5 postules so far.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Skin striae
Clinical narrative: Information has been received from a health professional concerning a patient (8 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives legs and arms mostly at night
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Hyperhidrosis, Laryngeal oedema, Muscle spasms, Pruritus, Urticaria
Clinical narrative: Laryngeal edema/spasm, hives, pruritus, wheals, sweaty 1/2-1 hour post Anthrax shot.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: fever 104 deg
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Rash macular, Skin warm, Swelling, Tenderness
Clinical narrative: (L) thigh 7-10 cm red, swollen, tender, warm macular patch
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red bump, 3 cm in diameter. Warm to touch.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Injection site pruritus, Swelling
Clinical narrative: Received shot 7/25/07. Immediate redness and swelling noted by bedtime had 3 inch red raised area with large site on 7-27-07. Gradually has gone down. 7-30-07 no longer raised or red, but c/o itching and pain at site.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: 48 hr after VVX had 12 cm x 9 cm red swollen area around injection site
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Skin lesion
Clinical narrative: Pox-30 lesions
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Pruritus, Urticaria
Clinical narrative: 1/2 hr after receiving immunization, pt started having hives, rash, coughing and severe itching. Benadryl given and symptoms went away within 2 hrs. Medical treatment was recommended.
Age: 1.5
Sex: F
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Rash with face and neck flushed and warm. Ears red and slightly swollen. Chest exam with increased upper airway noise. No wheezing. Seen in doctor's office around 3pm
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Flushing, Ocular hyperaemia, Urticaria
Clinical narrative: Pt had hives on rt arm and left lower leg; red eyes and flushed cheeks. Gave 1/2 tsp Benadryl PO; 30 min later redness decreasing. No redness or swelling at injection site. Unsure if child got into stingweed or stung by bee.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling, redness at site. Dx with cellulitis in ER. No evidence on f/u.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Hyperventilation, Tremor, Vaccination complication
Clinical narrative: Immunizations given 7/20/07. 8:30 pm took child to hospital with complaint of - had shots today. Mom states "child started shaking, breathing heavy for about 20 minutes". Doctors impression (1) Generalized seizure (2) Fever (3) DTP immunization side effect.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Skin warm
Clinical narrative: Rash around vaccinated area and redness. As per pt felt warm. Mother return to clinic on 7-26-07, and receive instructions and treatment for conditions.
Age: 0.5
Sex: M
Vaccine: MMR, PNC
Symptoms: Inappropriate schedule of drug administration, Nasopharyngitis, Pyrexia, Wheezing
Clinical narrative: Parents report 105-106 fever within 12 hours of vaccines on 7/27/07. Fever resolved within 12 hours. No seizures. Mild cold with wheezing within 2 days of immunizations
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella, Vomiting
Clinical narrative: Fever x 5 days. St. red bumps on tongue, vomiting. Rash started this AM 8/2/07
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Injection site erythema, Oedema peripheral
Clinical narrative: Redness, swelling, 101 temp left arm. Varivax given sub-q back of left arm. Softball size red area (immunization given with 25g 5/8 needle)
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: Aphonia, Dysphonia, Nasopharyngitis
Clinical narrative: Cold like symptom, hoarseness, loss voice last 7 days.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Pt developed fever and fine rash over body, night immunizations was administered.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Local reaction, Oedema peripheral
Clinical narrative: Local reaction right deltoid red/swollen and hot 3 1/2 x 2 1/4mm Benadryl, Motrin and ice.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Oedema peripheral, Pain in extremity, Skin discolouration
Clinical narrative: Pain started in afternoon which I thought was normal. by the next day arm was excruciating, so swollen that I couldn't bend it. Looked like, huge red, inflamed arm from armpit to elbow. Took ice packs, and Motrin - discoloration is ever so slight today 7/31/07
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Cold compress therapy, Induration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, erythema to (R) deltoid at site of vaccine. Induration approx 6 cm (B). Told to take TYLENOL for pain and place ice on red/swollen areas.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Parents presented child to ER with c/o rash. Recent hx of receiving varicella vaccine. Rash appeared 3-4 days after vaccine given.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: local wheal in area of vaccine injection with in minutes after administered-no respiratory sx. (Varivax) Benadryl administered-next day 7/31/07 Sx (rxn resolved)
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Induration, Swelling
Clinical narrative: Left thigh swollen, non-tender, no redness. 6.7 cm of induration; otherwise no other sequelae.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Varivax injection given 8-2-07 called office 8-3-07 with c/o red raised quarter to halk dollar size bump, warm to touch & itchy @ injection site. Pt seen in office on 8-4-07 for worsening symptoms of 9x9cm area of reddness, @ right tricep area with a more central 3x4cm deeper reddness and swelling with itching, fever and soreness. To use ice, advil, or script for vicoden given.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Convulsion, Headache
Clinical narrative: Within 5 minutes of recieving the Gardasil vaccine, my daughter had a seizure in the car leaving the parking lot of the doctors office.  She complained of a stomach ache and a headache just before the seizure began.  It lasted only a few minutes.  I took her immediately back into the office, where Dr had a nurse check her blood pressure, and gave her some water and sent us home.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Within 5 minutes of recieving the Gardasil vaccine, my daughter had a seizure in the car leaving the parking lot of the doctors office.  She complained of a stomach ache and a headache just before the seizure began.  It lasted only a few minutes.  I took her immediately back into the office, where Dr had a nurse check her blood pressure, and gave her some water and sent us home.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Red raised area/blisterlike area appeared under varicella vaccine 5 minutes after vaccine given.  Pt given Attarax with instructions to return if area does not decrease in size or gets larger in size.
Age: 1.0
Sex: M
Vaccine: HBHEPB, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Skin lesion
Clinical narrative: 24 hours of fever (101.8-102.4) and five varicelliform lesions
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Mass
Clinical narrative: Mother of patient reports that child has a large "knot" under right underarm.  Mother of patient states that child will not let anyone touch the arm. Shots were given on 08/03/2007 and mother noticed the "knot" on 08/08/2007. Mother told to take child to PCP or ER
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Circulatory collapse, Gaze palsy, Tremor
Clinical narrative: my daughter was given her first Guardisil vaccine.  within 2 minutes of injection she began to ask me if it was normal....when she collapsed and fainted.  her eyes rolled back into her head and she began to shake almose as if she were on the edge of a seizure.  within 45 seconds to one minute she awoke wondering what had happened to her.  we are very concerned about the safety of this vacccine and do not intend to continue treatment
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Patient stated that injection site sore and swollen beginning 2 days after administration and lasting for a week, used heat. Was out of town. Developed itching at the site, then had one small "blister".  On 8/1 itching very severe with more blisters and during the night scratched the site. Cleaned site with alcohol and put on a Band-aid. On 8/2 came to Employee Health, injection site had 15x15mm circle with vesicles at edges. Seen in Emergency Dept. treated with hydrocortisone cream 1%, Zyrtec 10mg daily X 3wk, Keflex 750 mg daily X 10 days.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, crying night and morning after administration. Mother gave tylenol.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Vaccinee states she develops itching at vaccine site on 8/7/2007. On 8/8/2007 she presents to Employee health.  Employee Health nurse notes erythema 4" X 2" at vaccination site, site is warm and hard over the red area, skin intact, still complaint of some itchy feeling.  Nurse advised to monitor, take anti inflammatory oral medicine, topical over the counter cortisone for itching as a personl choice.  Advised to report back to employee health if symptoms get worse.
Age: 30.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Induration, Paraesthesia
Clinical narrative: Patient states that she has altered sensation to her left arm and hand. She describes this feeling as a pins and needles sensation that occurs sporadically and reminds her of when her arm has "fallen asleep" and is regaining sensation. She states that she also has radiation of her symptoms from the shoulder to her midscapular area and neck to the base of the head. Physical exam of her arm reveals that she has decreased sensation in the distal C7 dermatome.  She has no loss of strength on exam. She had a 4cm by 8cm area of induration that was tender to palpation.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Abdominal pain, Headache, Pain in extremity, Pyrexia, Sensation of heaviness
Clinical narrative: Mother states patient awoke at 1 am 8/8/07 with a severe headache, fever greater then 102 and abdominal pain.  He also reported that his arms and legs felt heavy and sore.  Tylenol was given at 1 am 8/8/07 with no decrease in temperature.  His mother called the Hospital, who told her to try to get his temp down.  Tepid bath and Motrin was given at 4:30 am 8/8/07.  At 11:30 am 8/8/07 patient's mother reports that his temperature is at 99.7, still has a headache (but it's better), arms and legs feel better but remain sore, and adbominal pain is gone.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Arthritis, Chills, Fatigue, Headache, Laboratory test
Clinical narrative: Pt has fatigue, fever, chills, athritis, orchitis and headache after receiving vacination last over a week. He was seen today at Family Practice.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Orchitis, Pyrexia
Clinical narrative: Pt has fatigue, fever, chills, athritis, orchitis and headache after receiving vacination last over a week. He was seen today at Family Practice.