chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Pharyngeal oedema, Pyrexia, Rash, X-ray abnormal
Clinical narrative: Left thigh was red, swollen, and hot to the touch. Rash on chest, back, and right side of face. Loss of consciousness and gasping for air. Fever of 99.6. Xrays were taken at the hospital of soft tissue neck to confirm swelling of throat, subsided in a few hours. Symptoms came on about 4 hours after vaccines given. Pt was observed with monitors overnight in hospital. 8/20/07-records received for DOS 7/27/07-seen in ED-per parent patient has had nasal discharge for 1 week, difficulty breathing enroute to ED with increased noise of breathing now resolved. Has had skin rash. No fever, cough, vomiting or diarrhea. PE: WNL-skin mild erythematous, tender, macular skin rash with an erythematous base located on trunk abdomen, right leg and left leg. Clinical Impression:Skin rash. Dyspnea.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Pt has had a 3 inchX 1 inch red, indurated area of skin on his left lateral thigh, near the site of his DTAP injection that was given yesterday.  Red swelling has been present since this morning at 9 am.  He has had no fever or pain from the area.  The region may itch.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: syncope likely w/ carpal spasm approx. 10 minutes following administration, 30 seconds duration; r/o seizure
Age: 78.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Chills, Death, Feeling cold, Pain
Clinical narrative: 7/26/07 routine exam, TD & Zostavax immun given, 7/28/2007 reported to family members aches, chills, "can't get warm", did not contact medical personnel nor feel need to seek emergent care. retrospective report from family member.  7/29/2007found by family member in AM within a few hours after death.  8/3/07 Received pcp medical records which reveal patient seen 7/5 & 7/26 in office for right foot pain, RUQ abdominal pain. X-ray of right foot revealed arthritic changes. US of gallbladder revealed sludge.  Labs revealed decreased kidney function c/w chronic kidney disease III.  Urine c/s neg.  Lipids significantly increased as patient had stopped on her own the statin drug presribed.  CXR was WNL w/streaking due to scarring.  EKG unchanged from prior tracings revealed right axis deviation & borderline R-wave progression.  Last seen by nephrologist 4/06 & was d/c from service due to resolution of condition.  Records include vax records which confirm dose & lot #s as reported. 9/11/07 Received Autopsy Report which states COD as hemopericardium w/cardiac tamponade due to acute MI w/cardiac rupture due to arteriosclerotic heart disease.  Pathological diagnoses included: I. Arteriosclerotic heart disesae    A. Atherosclerosis of coronary arteries w/acute thrombus.    B. Acute MI w/cardiac rupture.    C. Hemopericardium w/cardiac tamponade. II. Systemic atherosclerosis    A. Atherosclerosis of cerebral arteries.    B. Atherosclerosis of aorta. III. Nephrosclerosis. IV. Fibroma of ovary. V. Hyperlipidemia by clinical history. VI. IBS by clinical history. VII.  Osteoporosis by clinical history.
Age: 43.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Diarrhoea, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: nausea within 48 hours of vaccination, lasting 3+ days (acerbated by heat and humidity); diarrhea within 8 days of vaccination, lasting 2+ days symptom still present; sweating within 48 hours of vaccination, lasting 7+ days (acerbated by heat and humidity); sensation of warmth within 8 days of vaccination, lasting 2+ days symptom still present; lightheadedness within 8 days of vaccination, lasting 2+ days; and flushing within 8 days of vaccination, lasting 2+ days symptom still present
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Facial paresis, Full blood count, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00714 / VAERS # 279425) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient, on 16 May 2007, was vaccinated IM in the left arm with a second dose of Gardasil (lot# 655617/1447F) and in the right arm with Menactra (Lot# U2158AA). On 16 May 2007 the patient experienced weakness of her legs and upper extremities, facial weakness and a rash all over her body. She was diagnosed with Guillain-Barre syndrome, and was hospitalized for intravenous immune globin (IVIG) and lumbar puncture (LP). The outcome of the event was unknown. The original reporting source was not provided." the patient's medical history and concomitant medications were unknown.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Facial paresis, Guillain-Barre syndrome, Immunoglobulins, Lumbar puncture, Muscular weakness
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00714 / VAERS # 279425) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient, on 16 May 2007, was vaccinated IM in the left arm with a second dose of Gardasil (lot# 655617/1447F) and in the right arm with Menactra (Lot# U2158AA). On 16 May 2007 the patient experienced weakness of her legs and upper extremities, facial weakness and a rash all over her body. She was diagnosed with Guillain-Barre syndrome, and was hospitalized for intravenous immune globin (IVIG) and lumbar puncture (LP). The outcome of the event was unknown. The original reporting source was not provided." the patient's medical history and concomitant medications were unknown.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Rash generalised
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00714 / VAERS # 279425) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient, on 16 May 2007, was vaccinated IM in the left arm with a second dose of Gardasil (lot# 655617/1447F) and in the right arm with Menactra (Lot# U2158AA). On 16 May 2007 the patient experienced weakness of her legs and upper extremities, facial weakness and a rash all over her body. She was diagnosed with Guillain-Barre syndrome, and was hospitalized for intravenous immune globin (IVIG) and lumbar puncture (LP). The outcome of the event was unknown. The original reporting source was not provided." the patient's medical history and concomitant medications were unknown.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Confusional state, Psychiatric symptom, Speech disorder, Thinking abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with a first dose of Gardasil dose and date not reported. Subsequently the patient experienced strange behavior and was diagnosed with a "psychotic outbreak" and was hospitalized in the "psychiatric ward". An unspecified therapy was initiated. The physician reported the patient was at camp prior to the administration of Gardasil and was unsure if the event was due to something she may have experienced at camp. At the time of the report the patient was recovering. The reporting physician considered the "psychotic outbreak" to be a disabling event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Abnormal behaviour, Psychotic disorder
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with a first dose of Gardasil dose and date not reported. Subsequently the patient experienced strange behavior and was diagnosed with a "psychotic outbreak" and was hospitalized in the "psychiatric ward". An unspecified therapy was initiated. The physician reported the patient was at camp prior to the administration of Gardasil and was unsure if the event was due to something she may have experienced at camp. At the time of the report the patient was recovering. The reporting physician considered the "psychotic outbreak" to be a disabling event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Dehydration, Gastrooesophageal reflux disease, Haematochezia, Rotavirus test positive, Ultrasound abdomen normal
Clinical narrative: Information has been received from a physician concerning a 13-week-old female with no pertinent medical history and no drug reactions/allergies who on 26-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot # 656833/0407U). Concomitant therapy that day included a dose of DTaP, Hib and a dose of Prevnar. There were no other concomitant medications. On 23-JUL-2007, the patient developed increasing amounts of spit up and frequency. The patient at the time of vaccine administration had on occasions been spitting up and was on Good Start formula. On 23-JUL-2007, the patient was seen in the office and had vomiting with every feeding. On occasion, the patient had projectile vomiting. There was no blood in the stools shown on hemocult. The patient was placed on ZANTAC and alimentum formula and stopped the Good Start formula. The patient continued to vomit. An abdominal ultrasound was done on 24-JUL-2007 and was found to be normal. The patient became dehydrated and was admitted to the hospital later in the day on 24-JUL-2007. IV fluids were given for dehydration. It was found on 25-JUL-2007 that the patient tested positive for rotavirus. An upper GI showed that the patient has gastroesophageal reflux. There were no signs of intussusception or malrotation. The patient may be discharged from the hospital today. No further information was available. The outcome was recovering. There  was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Vomiting, Vomiting projectile, X-ray gastrointestinal tract abnormal
Clinical narrative: Information has been received from a physician concerning a 13-week-old female with no pertinent medical history and no drug reactions/allergies who on 26-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot # 656833/0407U). Concomitant therapy that day included a dose of DTaP, Hib and a dose of Prevnar. There were no other concomitant medications. On 23-JUL-2007, the patient developed increasing amounts of spit up and frequency. The patient at the time of vaccine administration had on occasions been spitting up and was on Good Start formula. On 23-JUL-2007, the patient was seen in the office and had vomiting with every feeding. On occasion, the patient had projectile vomiting. There was no blood in the stools shown on hemocult. The patient was placed on ZANTAC and alimentum formula and stopped the Good Start formula. The patient continued to vomit. An abdominal ultrasound was done on 24-JUL-2007 and was found to be normal. The patient became dehydrated and was admitted to the hospital later in the day on 24-JUL-2007. IV fluids were given for dehydration. It was found on 25-JUL-2007 that the patient tested positive for rotavirus. An upper GI showed that the patient has gastroesophageal reflux. There were no signs of intussusception or malrotation. The patient may be discharged from the hospital today. No further information was available. The outcome was recovering. There  was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Dehydration, Gastrooesophageal reflux disease, Haematology test, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning a 13-week-old female with no pertinent medical history and no drug reactions/allergies who on 26-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot # 656833/0407U). Concomitant therapy that day included a dose of DTaP, Hib and a dose of Prevnar. There were no other concomitant medications. On 23-JUL-2007, the patient developed increasing amounts of spit up and frequency. The patient at the time of vaccine administration had on occasions been spitting up and was on Good Start formula. On 23-JUL-2007, the patient was seen in the office and had vomiting with every feeding. On occasion, the patient had projectile vomiting. There was no blood in the stools shown on hemocult. The patient was placed on ZANTAC and alimentum formula and stopped the Good Start formula. The patient continued to vomit. An abdominal ultrasound was done on 24-JUL-2007 and was found to be normal. The patient became dehydrated and was admitted to the hospital later in the day on 24-JUL-2007. IV fluids were given for dehydration. It was found on 25-JUL-2007 that the patient tested positive for rotavirus. An upper GI showed that the patient has gastroesophageal reflux. There were no signs of intussusception or malrotation. The patient may be discharged from the hospital today. No further information was available. The outcome was recovering. There  was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen normal, Vomiting, Vomiting projectile, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a physician concerning a 13-week-old female with no pertinent medical history and no drug reactions/allergies who on 26-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot # 656833/0407U). Concomitant therapy that day included a dose of DTaP, Hib and a dose of Prevnar. There were no other concomitant medications. On 23-JUL-2007, the patient developed increasing amounts of spit up and frequency. The patient at the time of vaccine administration had on occasions been spitting up and was on Good Start formula. On 23-JUL-2007, the patient was seen in the office and had vomiting with every feeding. On occasion, the patient had projectile vomiting. There was no blood in the stools shown on hemocult. The patient was placed on ZANTAC and alimentum formula and stopped the Good Start formula. The patient continued to vomit. An abdominal ultrasound was done on 24-JUL-2007 and was found to be normal. The patient became dehydrated and was admitted to the hospital later in the day on 24-JUL-2007. IV fluids were given for dehydration. It was found on 25-JUL-2007 that the patient tested positive for rotavirus. An upper GI showed that the patient has gastroesophageal reflux. There were no signs of intussusception or malrotation. The patient may be discharged from the hospital today. No further information was available. The outcome was recovering. There  was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis of his shoulder upper arm and chest 10 days after vaccination. Patient given antibiotics due to severity of cellulitis.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature decreased, Dysphagia, Pharyngeal oedema, Pharyngolaryngeal pain, Rash
Clinical narrative: Reports 1 week after immunization developed swelling and pain left side of throat.  Reports eyes becames swollen and puffy for a few days.  Had a rash on upper torso. Also complains that left ear feels blocked. Reports low grad temperature.  Saw her physician on Thursday July 26th for persistant symtpms and was placed her on a Medrol dose pack and zovirax. On 7/31 still has swelling in Left throat gland and difficulty swallowing. Reprts medicaton took rash away and has only had slight relief of symtpoms.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: 7/20/07: Phone conversation (report from patient).  7/19/07:  "Knot on left arm - area sore and itching about the size of a nickel" 7/20/07:  Patient noted a tiny red spot on right side of hip - "itched a little. By evening, rash looked like little red bumps or poison ivy". Went to private MD on 7/30/07, who provided cream and Benadryl.
Age: 79.0
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 a 79 year old female with an allergy to sulfa and a history of meningitis and chicken pox and measles during childhood who on 10-JUL-2007 was vaccinated with Zostavax vaccine live 0.65ml subcutaneously (Lot # 658081/0743U) in the left arm. Concomitant therapy included LASIX, therapy unspecified and diclofenac. On 10-JUL-2007 the patient developed herpes zoster. The physician reported that on the evening of 11-JUL-2007 the patient began to experience hoarseness, coughing and fatigue. The patient's maximum reported temperature was 38.6C. The physician also reported the patient developed pneumonia. A herpes zoster rash developed on the right side of her head on 15-JUL-2007. The herpes zoster was diffuse and began at the trigeminal nerve. The physician reported that the patient had 30 vesicles which were distributed on the abdomen, back, cheek, face, ear (external auditory canal). The physician reported a lumbar puncture was done on 17-JUL-2007 and revealed an elevated white cell count. The patient was initially started on FAMVIR but has been switched to acyclovir. The physician confirmed the diagnosis of meningitis. The physician reported that the patient had been discharged from the hospital and was "doing much better." It was reported that a specimen was tested at a lab and was VZV positive, however not typed (+40,000 copies). No recent exposure to chicken pox or herpes zoster was noted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if present to identify if it was associated with the wild-type(WT) VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 18-JUL-2007. The sample was taken from cerebral spinal fluid. The results were PCR negative. On an unspecified date the patient had a DFA of a lesion which was negative (This was not done through the VZVIP). The physician reported that meningitis, herpes zoster and pneumonia were other important medical events. Additional information has been requested. 8/27/07-records received 07/18-07/24/07-DX: varicella infection. VZV meningitis. Two days after vaccination c/o fatigue, vomiting and right sided facial pain. Prescribed famvir and took 1st dose and developed increasing confusion and fatigue. Chills, cough, non productive, hoarse voice, sore throat, watery eyes, right sided facial pain radiating to right side neck. Clear vesicles on erythematous base found on right neck, right shoulder, left face, back and right abdomen.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Lumbar puncture, Meningitis, Pneumonia
Clinical narrative: Information has been received from a physician concerning a 79 year old female with an allergy to sulfa and a history of meningitis and chicken pox and measles during childhood who on 10-JUL-2007 was vaccinated with Zostavax vaccine live 0.65ml subcutaneously (Lot # 658081/0743U) in the left arm. Concomitant therapy included LASIX, therapy unspecified and diclofenac. On 10-JUL-2007 the patient developed herpes zoster. The physician reported that on the evening of 11-JUL-2007 the patient began to experience hoarseness, coughing and fatigue. The patient's maximum reported temperature was 38.6C. The physician also reported the patient developed pneumonia. A herpes zoster rash developed on the right side of her head on 15-JUL-2007. The herpes zoster was diffuse and began at the trigeminal nerve. The physician reported that the patient had 30 vesicles which were distributed on the abdomen, back, cheek, face, ear (external auditory canal). The physician reported a lumbar puncture was done on 17-JUL-2007 and revealed an elevated white cell count. The patient was initially started on FAMVIR but has been switched to acyclovir. The physician confirmed the diagnosis of meningitis. The physician reported that the patient had been discharged from the hospital and was "doing much better." It was reported that a specimen was tested at a lab and was VZV positive, however not typed (+40,000 copies). No recent exposure to chicken pox or herpes zoster was noted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if present to identify if it was associated with the wild-type(WT) VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 18-JUL-2007. The sample was taken from cerebral spinal fluid. The results were PCR negative. On an unspecified date the patient had a DFA of a lesion which was negative (This was not done through the VZVIP). The physician reported that meningitis, herpes zoster and pneumonia were other important medical events. Additional information has been requested. 8/27/07-records received 07/18-07/24/07-DX: varicella infection. VZV meningitis. Two days after vaccination c/o fatigue, vomiting and right sided facial pain. Prescribed famvir and took 1st dose and developed increasing confusion and fatigue. Chills, cough, non productive, hoarse voice, sore throat, watery eyes, right sided facial pain radiating to right side neck. Clear vesicles on erythematous base found on right neck, right shoulder, left face, back and right abdomen.
Age: 79.0
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 a 79 year old female with an allergy to sulfa and a history of meningitis and chicken pox and measles during childhood who on 10-JUL-2007 was vaccinated with Zostavax vaccine live 0.65ml subcutaneously (Lot # 658081/0743U) in the left arm. Concomitant therapy included LASIX, therapy unspecified and diclofenac. On 10-JUL-2007 the patient developed herpes zoster. The physician reported that on the evening of 11-JUL-2007 the patient began to experience hoarseness, coughing and fatigue. The patient's maximum reported temperature was 38.6C. The physician also reported the patient developed pneumonia. A herpes zoster rash developed on the right side of her head on 15-JUL-2007. The herpes zoster was diffuse and began at the trigeminal nerve. The physician reported that the patient had 30 vesicles which were distributed on the abdomen, back, cheek, face, ear (external auditory canal). The physician reported a lumbar puncture was done on 17-JUL-2007 and revealed an elevated white cell count. The patient was initially started on FAMVIR but has been switched to acyclovir. The physician confirmed the diagnosis of meningitis. The physician reported that the patient had been discharged from the hospital and was "doing much better." It was reported that a specimen was tested at a lab and was VZV positive, however not typed (+40,000 copies). No recent exposure to chicken pox or herpes zoster was noted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if present to identify if it was associated with the wild-type(WT) VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 18-JUL-2007. The sample was taken from cerebral spinal fluid. The results were PCR negative. On an unspecified date the patient had a DFA of a lesion which was negative (This was not done through the VZVIP). The physician reported that meningitis, herpes zoster and pneumonia were other important medical events. Additional information has been requested. 8/27/07-records received 07/18-07/24/07-DX: varicella infection. VZV meningitis. Two days after vaccination c/o fatigue, vomiting and right sided facial pain. Prescribed famvir and took 1st dose and developed increasing confusion and fatigue. Chills, cough, non productive, hoarse voice, sore throat, watery eyes, right sided facial pain radiating to right side neck. Clear vesicles on erythematous base found on right neck, right shoulder, left face, back and right abdomen.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Meningitis
Clinical narrative: Information has been received from a physician concerning a 79 year old female with an allergy to sulfa and a history of meningitis and chicken pox and measles during childhood who on 10-JUL-2007 was vaccinated with Zostavax vaccine live 0.65ml subcutaneously (Lot # 658081/0743U) in the left arm. Concomitant therapy included LASIX, therapy unspecified and diclofenac. On 10-JUL-2007 the patient developed herpes zoster. The physician reported that on the evening of 11-JUL-2007 the patient began to experience hoarseness, coughing and fatigue. The patient's maximum reported temperature was 38.6C. The physician also reported the patient developed pneumonia. A herpes zoster rash developed on the right side of her head on 15-JUL-2007. The herpes zoster was diffuse and began at the trigeminal nerve. The physician reported that the patient had 30 vesicles which were distributed on the abdomen, back, cheek, face, ear (external auditory canal). The physician reported a lumbar puncture was done on 17-JUL-2007 and revealed an elevated white cell count. The patient was initially started on FAMVIR but has been switched to acyclovir. The physician confirmed the diagnosis of meningitis. The physician reported that the patient had been discharged from the hospital and was "doing much better." It was reported that a specimen was tested at a lab and was VZV positive, however not typed (+40,000 copies). No recent exposure to chicken pox or herpes zoster was noted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if present to identify if it was associated with the wild-type(WT) VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 18-JUL-2007. The sample was taken from cerebral spinal fluid. The results were PCR negative. On an unspecified date the patient had a DFA of a lesion which was negative (This was not done through the VZVIP). The physician reported that meningitis, herpes zoster and pneumonia were other important medical events. Additional information has been requested. 8/27/07-records received 07/18-07/24/07-DX: varicella infection. VZV meningitis. Two days after vaccination c/o fatigue, vomiting and right sided facial pain. Prescribed famvir and took 1st dose and developed increasing confusion and fatigue. Chills, cough, non productive, hoarse voice, sore throat, watery eyes, right sided facial pain radiating to right side neck. Clear vesicles on erythematous base found on right neck, right shoulder, left face, back and right abdomen.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Meningitis, Pneumonia, Trigeminal neuralgia
Clinical narrative: Information has been received from a physician concerning a 79 year old female with an allergy to sulfa and a history of meningitis and chicken pox and measles during childhood who on 10-JUL-2007 was vaccinated with Zostavax vaccine live 0.65ml subcutaneously (Lot # 658081/0743U) in the left arm. Concomitant therapy included LASIX, therapy unspecified and diclofenac. On 10-JUL-2007 the patient developed herpes zoster. The physician reported that on the evening of 11-JUL-2007 the patient began to experience hoarseness, coughing and fatigue. The patient's maximum reported temperature was 38.6C. The physician also reported the patient developed pneumonia. A herpes zoster rash developed on the right side of her head on 15-JUL-2007. The herpes zoster was diffuse and began at the trigeminal nerve. The physician reported that the patient had 30 vesicles which were distributed on the abdomen, back, cheek, face, ear (external auditory canal). The physician reported a lumbar puncture was done on 17-JUL-2007 and revealed an elevated white cell count. The patient was initially started on FAMVIR but has been switched to acyclovir. The physician confirmed the diagnosis of meningitis. The physician reported that the patient had been discharged from the hospital and was "doing much better." It was reported that a specimen was tested at a lab and was VZV positive, however not typed (+40,000 copies). No recent exposure to chicken pox or herpes zoster was noted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if present to identify if it was associated with the wild-type(WT) VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 18-JUL-2007. The sample was taken from cerebral spinal fluid. The results were PCR negative. On an unspecified date the patient had a DFA of a lesion which was negative (This was not done through the VZVIP). The physician reported that meningitis, herpes zoster and pneumonia were other important medical events. Additional information has been requested. 8/27/07-records received 07/18-07/24/07-DX: varicella infection. VZV meningitis. Two days after vaccination c/o fatigue, vomiting and right sided facial pain. Prescribed famvir and took 1st dose and developed increasing confusion and fatigue. Chills, cough, non productive, hoarse voice, sore throat, watery eyes, right sided facial pain radiating to right side neck. Clear vesicles on erythematous base found on right neck, right shoulder, left face, back and right abdomen.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a nurse concerning an "approximately 5 month old" male who on "11-MAY-2007" was vaccinated with a second dose of Rotateq (Lot # not provided). Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB. Subsequently the patient experienced intussusception. Unspecified medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. Upon internal review, intussusception is considered an other important medical event. Additional information has been requested. 10/02/07-records received for DOS 7/26-7/31/07-DC DX: Terminal ileum resection with cecal resection, appendix removal, partial right colon resection. lymphoid hyperplasia of the iliococal valve with intussusception and ulceration of overlying mucosa. Seen in ER for abdominal pain and discomfort for 3 days and started vomiting 2 days prior. Multiple episodes of bilious emesis. Evaluated for pyloric stenosis in June with upper GI that was normal.  Had currant jelly stool.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, UNK
Symptoms: Convulsion, Eye rolling, Inappropriate schedule of drug administration, Muscle rigidity
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no drug allergies and no medical history, who on 06-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant suspect therapy on 06-JUN-2007 included "a hepatitis shot" (manufacturer unknown). Concomitant therapy on 06-JUN-2007 included "a tetanus shot" (manufacturer unknown). Subsequently, the patient began to have convulsions. Her body became rigid and her eyes "rolled backward." The entire episode lasted approximately thirty seconds. No laboratory diagnostics were performed. The patient recovered on an unspecified date "and is fine." No product quality complaint was involved. Additional information is not available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Initial report received on 19 July 2007 from a consumer, who is the patient's parents. A  17 year old male patient, with no medical history, received Menactra (lot# unknown) (route/site of administration were unknown) on 01 May 2007. Immediately after vaccination, the patient had passed out. Approximately in June 2007, ("approximately 3 weeks ago") the patient experienced headache and lightheadedness that had been increasing with time. The patient had been evaluated by a physician and was hospitalized for approximately 4 days, however no diagnosis was made. MRI and CT scans were negative. No other vaccines were given at the same time. The patient had no illnesses at vaccination time and was not on any medications. Treatment was not reported. Prior exposure to Menactra was not reported. The patient had not recovered at the time of the report.  08/03/2007 Received patient name from CDC., VAERS database updated w/same. 8/7/07 Received vax records & VAERS database updated w/same. 8/31/07 Reviewed hospital ER records of 7/2/07 which reveal patient experienced dizziness & HA x 3 days.  C/O intermittent lightheadedness, periods of overwhelming fatigue w/tingling/numbness of finger tips since vax 5/1/07.  Tx w/oral antibiotics & d/c to home. FINAL DX: none provided. 10/5/07 Neurologist office does not have any records for this patient. Case closed & will reopen should additional information become available.
Age: 18.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Nurse administered IPV intradermally-inner aspect of (L) forearm, instead of PPD for tuberculosis screening.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Left arm (deltoid area) red, swollen warm to touch
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Fine morbilliform rash - resolving by the time patient was seen on 7/25/07. (Also has a h/o eczema)
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Menstruation irregular, Pregnancy test positive, Smear cervix normal
Clinical narrative: Received AVA #1 in preparation for deployment on 5 Jun 07. On 19 Jun 07 she had a positive HCG test. Her LMP was 7 May 07. She says her periods are irregular. She was seen for well-woman evaluation on 31 May 07 that was recorded as normal. A PAP test was done which was also normal. She was started on pre-natal vitamins on 2 Jul 07 and advised to call for an OB appointment.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Colposcopy, Human papilloma virus test positive, Injection site nodule, Injection site pain, Papilloma viral infection
Clinical narrative: Received AVA #6 on 15 Mar 07 with no untoward result except for the usual soreness with a small lump at the injection site. On 9 Apr 07 she had an HCG test which was positive. On 31 May she had a OB PAP test done which was positive for epithelium cell abnormalities. Atypical squamous cells of undetermined significance (ASCUS) with positive HPV, high risk. EDC 18 Dec 07.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Pregnancy test positive
Clinical narrative: Received AVA #6 on 15 Mar 07 with no untoward result except for the usual soreness with a small lump at the injection site. On 9 Apr 07 she had an HCG test which was positive. On 31 May she had a OB PAP test done which was positive for epithelium cell abnormalities. Atypical squamous cells of undetermined significance (ASCUS) with positive HPV, high risk. EDC 18 Dec 07.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Haematoma, Skin necrosis, Swelling
Clinical narrative: Right lateral thigh erythema positive firmness/swelling positive hematoma.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Lymphadenopathy, Pyrexia
Clinical narrative: one week after administration she developed joint pain and swollen glands and low grade fevers.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Cough, Dysphonia, Ear discomfort, Eyelid oedema
Clinical narrative: one week after administration she developed joint pain and swollen glands and low grade fevers.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Headache, Local swelling, Neck pain, Pyrexia
Clinical narrative: one week after administration she developed joint pain and swollen glands and low grade fevers.
Age: 26.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: PT REDNESS, SORENESS, AND ERYTHEMA AROUND SITE OF VACCINATION ON LEFT ARM WITH A LARGE KNOT AT VACCINATION SITE. PT STATES SORENESS AT SITE AND STATES THAT REDNESS AND ERYTHEMA SPREAD THREE DAYS AGO. TODAY IS 7 DAYS FROM DATE VACCINE GIVEN ON 25 JULY 07. PT DENIES DENIES ANY ADDITIONAL SYMPTOMS AND DOES NOT NEED ANY TREATMENT AT THIS TIME. PT HAD ANTHRAX #1 AT 28 SEPT 05. THIS SHOT WAS #2 IN ANTHRAX SERIES.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Tenderness
Clinical narrative: 5x5 cm area or erythema at site of Varivax injection. Slight tenderness
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, PPV, TD
Symptoms: Allergy test negative, Cystic fibrosis, Immune system disorder, Influenza like illness, Nasopharyngitis
Clinical narrative: She got flu/cold-like  symptoms for 1 month and then after she got lots on flu-like symptoms last for 2.5 months. Her immune system was very weak. This happen right after she received her pediatrix shot. Doctor did an environmental allegy test and she was normal and other tests and the doctor could not explain what was wrong with her.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Oedema peripheral
Clinical narrative: Vaccine given 7/30/07 at approximately 11am. Approximately 24 hours later, she complained of itching at the injection site.  Site on 7/31/07 at noon was red, hot to touch, with a 1"x2" hive.  The upper arm was slightly swollen and she complained of itching and slight pain.  Redness has now decreased, but hive remains.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pruritus
Clinical narrative: Vaccine given 7/30/07 at approximately 11am. Approximately 24 hours later, she complained of itching at the injection site.  Site on 7/31/07 at noon was red, hot to touch, with a 1"x2" hive.  The upper arm was slightly swollen and she complained of itching and slight pain.  Redness has now decreased, but hive remains.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Patient received Adacel (adult Tdap) in Left deltoid muscle on 7/31/07.  Patient called office this morning c/o increased pain, inability to move arm away from body, pain in the neck and left shoulder area.  Patient given appointment to have follow-up in office.  At follow-up arm is noted to have a small red area at injection site no increase in swelling of left arm.  No increase in temperature.  Patient unable to have normal ROM of the left arm without severe pain. Treatment plan:  Tordol 60mg given IM in office apply sling to left arm.  Script for prn Darvocet N-100 given along with instructions for patient to apply warm soaks to the arm.  Follow-up on Friday as to condition even if condition has improved.  Patient understands if symptoms worsen to follow-up sooner.  Patient also expressed understanding of instructions given.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT RECEIVED PNUEMOVAX VACCINE ON 7/27/07 AT 1425 ON RIGHT UPPER ARM. AT 7/28 2330 PATIENT WAS NOTED TO HAVE SORENESS,REDNESS AND SWELLING, HOT TO TOUCH- AT INJECTION SITE. TEMP 100.9. REDNESS CONTINUED DOWN THE ARM TO THE ELBOW. CELLULITIS WAS DIAGNOSED. KEFLEX WAS STARTED FOR A 10 DAY COURSE. ELEVATION OF EXTREMITY AND HEAT WERE UTILIZED. BY 7/29 THE ERYTHEMA WAS RESOLVING AND HAD RESOLVED BY 7/31 PER MD NOTE.  PATIENT'S HISTORY WITH OTHER IMMUNIZATIONS UNKNOWN. MANUFACTURER OF THE VACCINE WAS MERCK
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: PATIENT RECEIVED PNUEMOVAX VACCINE ON 7/27/07 AT 1425 ON RIGHT UPPER ARM. AT 7/28 2330 PATIENT WAS NOTED TO HAVE SORENESS,REDNESS AND SWELLING, HOT TO TOUCH- AT INJECTION SITE. TEMP 100.9. REDNESS CONTINUED DOWN THE ARM TO THE ELBOW. CELLULITIS WAS DIAGNOSED. KEFLEX WAS STARTED FOR A 10 DAY COURSE. ELEVATION OF EXTREMITY AND HEAT WERE UTILIZED. BY 7/29 THE ERYTHEMA WAS RESOLVING AND HAD RESOLVED BY 7/31 PER MD NOTE.  PATIENT'S HISTORY WITH OTHER IMMUNIZATIONS UNKNOWN. MANUFACTURER OF THE VACCINE WAS MERCK
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Pt called back to clinic reporting Nausea, Dizziness, and "my head doesn't feel right" within 60 minutes of vaccination.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Blister, Body temperature, Dysphagia, Neck pain
Clinical narrative: temp, blistering bumps over body, sore neck and back pains, hard to swollow,and swelling in the face area.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling face
Clinical narrative: temp, blistering bumps over body, sore neck and back pains, hard to swollow,and swelling in the face area.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: red, swelling, itching starting on 8/1/07
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Arthropod bite, Body temperature increased, Diarrhoea, Headache
Clinical narrative: 7/14/07 awakened with severe abdominal cramping, nausea,diarrhea, general body aches, headache, rapid heart rate. Went to Urgent Care and was "dismissed as having a virus". Later in the evening with the symptoms "getting worse" went to ER and was again dismissed as "having flu". 7/17/07 headache and neck pain increased and she felt "like my heart was going to pound our of her chest" went to her family physician practice(Family Medicine). She was seen by 3 different physicians over the next several days. Had mosquito bites. One doctor told she "probably had viral meningitis" since it was a possible reaction from MMR.Referred to cardiologist due  heart rate(117 bpm) & arrythmias. Started wearing a heart monitor 7/31/07 to continue for 30 days with daily multiple electronic monitoring by MD. Lost 14 pounds since onset of syx. Given Atavan .5mg (1-2 tabs TID)for anxiety started in the last week. Symptoms improving since then, heart rate still at 117. Beginning to eat, continued diarrhea. Took Imodium AD twice, diarrhea abatted,then recurred. No local reaction at inject site. Cold syx started 8 days into "reaction" , temp highest 99 degrees F.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Nasopharyngitis, Nausea, Neck pain, Pain
Clinical narrative: 7/14/07 awakened with severe abdominal cramping, nausea,diarrhea, general body aches, headache, rapid heart rate. Went to Urgent Care and was "dismissed as having a virus". Later in the evening with the symptoms "getting worse" went to ER and was again dismissed as "having flu". 7/17/07 headache and neck pain increased and she felt "like my heart was going to pound our of her chest" went to her family physician practice(Family Medicine). She was seen by 3 different physicians over the next several days. Had mosquito bites. One doctor told she "probably had viral meningitis" since it was a possible reaction from MMR.Referred to cardiologist due  heart rate(117 bpm) & arrythmias. Started wearing a heart monitor 7/31/07 to continue for 30 days with daily multiple electronic monitoring by MD. Lost 14 pounds since onset of syx. Given Atavan .5mg (1-2 tabs TID)for anxiety started in the last week. Symptoms improving since then, heart rate still at 117. Beginning to eat, continued diarrhea. Took Imodium AD twice, diarrhea abatted,then recurred. No local reaction at inject site. Cold syx started 8 days into "reaction" , temp highest 99 degrees F.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Weight decreased
Clinical narrative: 7/14/07 awakened with severe abdominal cramping, nausea,diarrhea, general body aches, headache, rapid heart rate. Went to Urgent Care and was "dismissed as having a virus". Later in the evening with the symptoms "getting worse" went to ER and was again dismissed as "having flu". 7/17/07 headache and neck pain increased and she felt "like my heart was going to pound our of her chest" went to her family physician practice(Family Medicine). She was seen by 3 different physicians over the next several days. Had mosquito bites. One doctor told she "probably had viral meningitis" since it was a possible reaction from MMR.Referred to cardiologist due  heart rate(117 bpm) & arrythmias. Started wearing a heart monitor 7/31/07 to continue for 30 days with daily multiple electronic monitoring by MD. Lost 14 pounds since onset of syx. Given Atavan .5mg (1-2 tabs TID)for anxiety started in the last week. Symptoms improving since then, heart rate still at 117. Beginning to eat, continued diarrhea. Took Imodium AD twice, diarrhea abatted,then recurred. No local reaction at inject site. Cold syx started 8 days into "reaction" , temp highest 99 degrees F.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Eye swelling, Rash pruritic
Clinical narrative: Patient awoke day after receiving HPV with eyes swollen shut, red itchy periorbital rash.  Seen early afternoon approximately 24 hrs after injection.  Eyes open, rash represent with residual swelling.  Rx:  Applications of cold, benedryl or claritin, motrin for inflammation. Photo taken of pt.
Age: 44.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: C/O flat red rash beginning 2 hours after vaccines. Increased itching. Progressed from ankles to legs to stomach to hands. No respiratory symptoms. Took Benadryl at bedtime. States plans to talk to PCP at 3 PM 8/1/07.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Pt felt dizzy and light headed about 5 minutes after vaccine - BP/HR WNL - no LOC - No syncope. Pt rested about 10 minutes and then left with mother in stable condition.
Age: 0.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV
Symptoms: Medication error, Unevaluable event
Clinical narrative: None stated
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abscess, Erythema, Skin warm, Swelling
Clinical narrative: 4 y/o - rt deltoid swelling, warmth, redness 1 day post DTaP - likely DTaP sterile abscess reaction. Motrin/1cc received.
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Erythema
Clinical narrative: Leg erythema - 3.5x2.5 upper outer (Prevnar) - 3.5.3.5 lower media (Hib)
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Light-headed and dizzy about 30 minutes after immunizations. No treatment needed. Patient felt better the next day.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Child age 5 yr was given an Tdap instead of a DTaP. No adverse reaction occurred to patient.  I left that blank because there was not an adverse affect for the shot that was given, if that should be the time and date shot was given then it would be 7/31/07 at approx. 10:30 AM.  If that should be the date & time we noted the mistake it would be 8-1-07 at about 8:45 AM.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Large local reaction with swelling at site of injection - left arm.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Fear, Nausea, Paraesthesia
Clinical narrative: Lightheaded nausea dizzy, tingling face down arms and legs. Approx time till pt could safely sit up 25 minutes. HR 60-80, - SOB, pt scared, + diff breathing
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives after expose to cold plasting  24 hours after vaccine given.