chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Skin warm, Sluggishness, Staring, Swollen tongue
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Tremor
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Gait disturbance
Clinical narrative: CLIENTS FATHER STATED HE NOTICED A RASH APPROX 7 DAYS AFTER RECEIVING MMR AND VARICELLA VACCINES. THEN DAYS LATER NOTED VOMITING AND LIMPING. FATHER STATED THAT DOCTOR ADVISED HIM THAT THIS WAS A RESULT OF THE MMR VACCINE AND SUGGESTED THA CLIENT NOT RECEIVE THE MMR VACCINE.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Gait disturbance, Rash, Vomiting
Clinical narrative: CLIENTS FATHER STATED HE NOTICED A RASH APPROX 7 DAYS AFTER RECEIVING MMR AND VARICELLA VACCINES. THEN DAYS LATER NOTED VOMITING AND LIMPING. FATHER STATED THAT DOCTOR ADVISED HIM THAT THIS WAS A RESULT OF THE MMR VACCINE AND SUGGESTED THA CLIENT NOT RECEIVE THE MMR VACCINE.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Body temperature, Pyrexia, Rash morbilliform, Vomiting
Clinical narrative: CLIENTS FATHER STATED CHILD HAD A RASH APPROX 7 DAYS AFTER MMR AND VARICELLA VACCINES. THEN A FEW DAYS LATER HAD VOMITING. FATHER STATED HE TOOK CHILD TO DOCTOR WHO STATED THIS WAS A RESULT OF MMR VACCINE AND SUGGESTED CLIENT NOT RECEIVE SECOND MMR VACCINE DOSE.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: CLIENTS FATHER STATED CHILD HAD A RASH APPROX 7 DAYS AFTER MMR AND VARICELLA VACCINES. THEN A FEW DAYS LATER HAD VOMITING. FATHER STATED HE TOOK CHILD TO DOCTOR WHO STATED THIS WAS A RESULT OF MMR VACCINE AND SUGGESTED CLIENT NOT RECEIVE SECOND MMR VACCINE DOSE.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Faeces discoloured, Frequent bowel movements, Haematochezia, Mucous stools, Occult blood
Clinical narrative: Information has been received from a physician concerning an approximately 18-week-old female who on approximately 06-APR-2008 was vaccinated orally with a second dose of Rotateq (lot # 659855/1692U).  There was no concomitant medication.  The patient received the first dose of Rotateq (lot # 657985/1244U) on an unspecified date.  Forty-eight hours after the second dose of Rotateq (lot # 659855/1692U) the patient had frequent loose stools with some mucus and blood in her stools.  The patient visited the physician on 08-APR-2008, the physician suggested that since the patient was being breastfed this could be a protein intolerance or an allergy to breast milk.  On 08-APR-2008 a hemoccult test was performed and positive for blood.  At the time of the report the patient was recovering.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.  Upon internal review the patient's bloody stool was determined to be an other important medical event.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Occult blood positive
Clinical narrative: Information has been received from a physician concerning an approximately 18-week-old female who on approximately 06-APR-2008 was vaccinated orally with a second dose of Rotateq (lot # 659855/1692U).  There was no concomitant medication.  The patient received the first dose of Rotateq (lot # 657985/1244U) on an unspecified date.  Forty-eight hours after the second dose of Rotateq (lot # 659855/1692U) the patient had frequent loose stools with some mucus and blood in her stools.  The patient visited the physician on 08-APR-2008, the physician suggested that since the patient was being breastfed this could be a protein intolerance or an allergy to breast milk.  On 08-APR-2008 a hemoccult test was performed and positive for blood.  At the time of the report the patient was recovering.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.  Upon internal review the patient's bloody stool was determined to be an other important medical event.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Frequent bowel movements, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Information has been received from a physician concerning an approximately 18-week-old female who on approximately 06-APR-2008 was vaccinated orally with a second dose of Rotateq (lot # 659855/1692U).  There was no concomitant medication.  The patient received the first dose of Rotateq (lot # 657985/1244U) on an unspecified date.  Forty-eight hours after the second dose of Rotateq (lot # 659855/1692U) the patient had frequent loose stools with some mucus and blood in her stools.  The patient visited the physician on 08-APR-2008, the physician suggested that since the patient was being breastfed this could be a protein intolerance or an allergy to breast milk.  On 08-APR-2008 a hemoccult test was performed and positive for blood.  At the time of the report the patient was recovering.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.  Upon internal review the patient's bloody stool was determined to be an other important medical event.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Headache, Nausea
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Aspartate aminotransferase normal, Asthenia, Basophil count normal
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Carbon dioxide normal, Diarrhoea, Eosinophil count normal, Fatigue, Feeling cold
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Globulin, Haematocrit normal, Haemoglobin normal, Headache, Lymphocyte percentage decreased
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage decreased, Neutrophil count increased
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Neutrophil percentage increased, Platelet count normal, Protein total normal, Red blood cell count normal, Red cell distribution width normal
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Vomiting, Walking disability, White blood cell count normal
Clinical narrative: Vomiting and HA after 4th day PO typhoid fever vaccine;4/7/08 Followup Patient has been oral typhoid vaccinations q.o.d.-last dose of four was yesterday. She woke up this morning with significant headache, chilly sensation, and weak. She's been vomiting. "Feels drained". No diplopia, jaundice, dyspepsia, hematochezia. "One loose stool". No rash or arthralgias. No head pressure, drainage, cough, sputum, dysuria-doesn't see other sign of infection. She continues supplemental thyroid and Fosamax. She and husband scheduled to leave 4/10. He also took the typhoid vaccination-"two days ahead of her". On exam, 140 by report. She looked fatigued. Vomited. She's able to stand independently and walk, slowly. 136/80 right stand. Heart rate 80. Afebrile. No cervical nodes. White sclerae. PERRL. No sinus tenderness. Normal nasal/oral mucosa. Lungs clear. Heart normal. Abdomen soft without masses/organomegaly. Normal BS. Calves negative; no rash seen. Gave Phenergan 25mg IM-tolerated, helped. She was able to tolerate sips of coke, so discharged home-continue clear liquids and rest overnight. Compazine 10mg q.i.d p.r.n. nausea. She doesn't like Darvocet, so use Tylenol p.r.n. headache (she has a supple neck). IMP/PLAN: Appears to be reaction to typhoid (Up to Date suggest 2-5% of patients have headache and vomiting). It's an attenuated vaccine so shouldn't be frank salmonella. Observe overnight; hospitalize for IVF/other if needed. SO:aeb F/U 5-6-08
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil.  On 05-APR-2008, the patient died four days after receiving Gardasil.  The patient sought unspecified medical attention.  An autopsy was performed which ruled out suicide and anything suspicious.  The cause of death is currently unknown and they are performing toxicology tests to try to determine the cause.  No product quality complaint was involved.  The reportable physician considered death to be immediately life-threatening and disabling. Additional information has been requested.7/14/08-autopsy report received-COD:Undetermined. Died unexpectedly while working as a health aid. Postmortem examination reveals focal nodular hyperplasia in liver; this finding though significant, cannot accoutn for sudden death. There is no evidence of pregnancy. Toxicology analysis negative. Based on history, autopys, and toxicological examination, cause of death is undetermined.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning a patient who in approximately April 2008 ("in the past few weeks"), was vaccinated orally with a 2 ml dose of Rotateq.  In approximately April 2008, within one week of vaccination, the patient had blood in their stools.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Upon internal review "blood in their stools" is considered an other medically important event (OME).  This is one of two reports received from the same source.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old male with no known allergies or pertinent medical history who on 02-FEB-2008 was vaccinated orally with a second dose of Rotateq (lot # 659682/1733U).  There was no concomitant medication.  The patient received the first dose of Rotateq (lot # 657673/0904U) on 15-DEC-2007.  On 30-MAR-2008 the patient developed intussusception.  The patient was hospitalized on 30-MAR-2008 and was successfully treated by pneumatic reduction.  The patient was discharged on 31-MAR-2008.  The patient was considered recovered.  There was no product quality complaint involved.  Additional information has been requested.  The reporter considered the patient's intussusception to be serious as an other important medical event, disabling and life threatening.  06/09/2008 MR received for DOS 3/30-31/2008 with D/C DX: Ileocolic Intussusception. Pt presented to ER with 1 day hx of vomiting everything immediately after eating. ? blood in emesis.  Has had diarrhea x several days prior to start of vomiting. (+) rhinorrhea and cough. PE WNL. IS noted on US and reduced by pneumatic floroscopy. D/C next day.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning a patient who in approximately April 2008 ("in the past few weeks"), was vaccinated orally with a 2 ml dose of ROTATEQ.  In approximately April 2008, within one week of vaccination, the patient had blood in their stools.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Upon internal review "blood in their stools" was considered an other medically important event (OME).  This is one of two reports received from the same source.  Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 14 month old female who on 27 DEC 2007 was vaccinated with a first dose of Rotateq, and on 26 FEB 2008 was vaccinated, with a second dose; 2 ml PO, of Rotateq.  The patient developed unspecified symptoms that resulted in the hospitalization of the patient with an unconfirmed diagnosis of intussusception.  Information related to the symptoms, date of onset, treatment and date of hospitalization was not reported.  The status of the patient was unknown at the time of reporting.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.  5/7/2008 MR received for DOS 4/6-10/2008 with DX: Intussusception. Infant presented to ER with 1 day hx of repeated emesis (7-10 times), crying and drawing up of the knees as in pain.  PE (+) for dry mucus membranes and tenderness to palpation of the abdomen. Barium enema attmpted but unsuccessful at fully reducing IS. Taken to OR for R hemicolectomy, Resection of terminal ileum and appendix, Transverse colon and ileum primary anastomosis. Saphenous vein cutdown. Colosigmpid and ileocolic IS found with small serosal tear. Back to normal by POD#4.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a nurse practitioner concerning an infant who in August 2007, was vaccinated PO with the first dose of ROTATEQ. In August 2007, the patient experienced bloody stools. The patient sought unspecified medical attention and was treated with Lactobacillus. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting nurse practitioner indicated that the infant was "doing fine." Upon internal review, bloody stool(s) was determined to be an other important medical event. This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a nurse practitioner concerning an infant who in August 2007, was vaccinated PO with the first dose of ROTATEQ. In August 2007, the patient experienced bloody stools. The patient sought unspecified medical attention and was treated with Lactobacillus. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting nurse practitioner indicated that the infant was "doing fine." Upon internal review, bloody stool (s) was determined to be an other important medical event. This is one of several reports from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received through the pregnancy registry, concerning a 20 year old female patient, a non smoker, with a history of one pregnancy and one live birth, who on 23-OCT-2007 and 21-DEC-2007 was vaccinated with the first and second doses of Gardasil, respectively (Lot # first dose 658560/1062U, second dose 569437/1266U). Subsequently, the patient became pregnant. It was reported that the patient's last menstrual period (LMP) was 10-JAN-2008. The estimated delivery date was 17-OCT-2008. On 10-MAR-2008 the patient experienced a spontaneous abortion, eight weeks from LMP (reported as 6 5/7 weeks). Diagnostic testing performed on 10-MAR-2008 to assess dates indicated fetal demise. No product quality complaint was involved. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Laboratory test, Lethargy, Myalgia, Pain
Clinical narrative: Information has been received from a physician concerning an approximately 25 year old female patient with no known drug allergies or medical history reported, who on 26-MAR-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 mL dose of GARDASIL (Lot #0152X).  There was no concomitant medication.  On approximately 02-APR-2008, the patient developed pain, warmth and diffuse muscle tenderness in her left upper arm.  She was examined by the physician on 02-APR-2008 and prescribed corticosteroids (unspecified).  She was also examined on 08-APR-2008 and reported that her upper body was hot and sore and she was lethargic.  It was reported that there were no abnormal findings on physical exam other than mild injection site tenderness and no fever.  Diagnostic laboratory testing performed included blood tests with unknown results.  No product quality complaint was involved.  The reporting physician considered these events to be disabling/incapacitating.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Physical examination, Skin warm
Clinical narrative: Information has been received from a physician concerning an approximately 25 year old female patient with no known drug allergies or medical history reported, who on 26-MAR-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 mL dose of GARDASIL (Lot #0152X).  There was no concomitant medication.  On approximately 02-APR-2008, the patient developed pain, warmth and diffuse muscle tenderness in her left upper arm.  She was examined by the physician on 02-APR-2008 and prescribed corticosteroids (unspecified).  She was also examined on 08-APR-2008 and reported that her upper body was hot and sore and she was lethargic.  It was reported that there were no abnormal findings on physical exam other than mild injection site tenderness and no fever.  Diagnostic laboratory testing performed included blood tests with unknown results.  No product quality complaint was involved.  The reporting physician considered these events to be disabling/incapacitating.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced seizure and fainting episodes.  The patient sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Upon internal review the seizure episodes were considered to be an other important medical event.  Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male who was vaccinated with MMR II.  The consumer stated that a friend of a friend's son became autistic after administration of "MMR".  The consumer could not provide further information.  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of 1 pregnancy, 0 live births and a history of one elective termination of pregnancy at five weeks, who on 09-AUG-2007, 09-OCT-2007 and 06-FEB-2008 was vaccinated with the first, second and third dose of Gardasil, respectively (Lot # first and second doses 658094/0524U, third dose 659441/1446U).  There was no concomitant medication.  It was reported that the patient's last menstrual period (LMP) was on 19-JAN-2008.  The estimated delivery date was 26-OCT-2008.  In approximately March 2008, reported as "6 weeks from LMP," the patient had an elective termination of pregnancy.  At the time of this report the patient's outcome was unknown.  Upon internal review elective termination was considered to be an other important medical event.  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site pain, Musculoskeletal pain
Clinical narrative: The pt received anthrax #4 on 8/10/07 in left arm. The next day the pt had about 4cm of erythema, 1cm of induration and tenderness at the site of injection. No decrease in ROM/numbness/tingling or fever. These symptoms lasted 4-5 days and then started to resolve. About 8/17/07 the patient had left shoulder pain (2/10) no decrease ROM, no decrease in sensation/numbness/tingling. Around 8/28/07 the patient had steady 4/10 left shoulder pain. He had difficulty lifting objects. No decrease in ROM. Patient noted a "lump" on the superior aspect of his shoulder. Pt saw a PA on 9/8/07. The patient was given an ortho appt on 20 Sept 07. Dr. ordered pt to be transferred to another country for further testing (diagnosis scapular dyskenesis/ left shoulder scapular winging). Sept 24, 2007 seen in orthopedics. C-spine done. Pt transferred to home country. 28 Sept 07 seen by Dr. Consult for Neurosurgery, EMG, MRI, and NCS. Started on neurotonin. Light duty for 30 days. EMG/NCS 10/18/07. Seen in neurology 10/18/07. Seen in neurosurgery 10/19/07. (idiopathic neuritis of the spinal accessory nerve and of the long thoracic nerve). 20 Nov 07 seen in PT. The patient continues with constant 2/10 level pain in left shoulder, scapular region. Pain worsens to 4/10 intermittently about 10-20 times per day, lasting 5 minutes to 3 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PARENT REPORTED INCREASED SWELLING IN LEFT ARM WITH PAIN, REDNESS, AND WARM TO TOUCH ON 04/19/2008. ON 04/20/2008 PARENT REPORTED A DECREASE IN SWELLING BUT STILL RED AND PAINFUL. PATIENT WAS SEEN IN OFFICE ON 04/20/2008 AND DIAGNOSED WITH CELLULITIS AT THE ABOVE MENTIONED SITE. PATIENT WAS PRESCRIBED CLINDAMYCIN AND WARM COMPRESSES TO AREA.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Headache, Muscle spasms, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Symptoms patient had were fever, chills, muscle cramping, headache, and sore throat; symptoms lasted 1 week.
Age: 4.0
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Seen back in the office one week after she received DTaP, MMR, V. Presented with rash c/w measles rash - no fever and otherwise well.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines given on 4/18/2008. Patient followed up on 4/21/2008 with complaint of redness and swelling at injection site. Treated with compresses, Benadryl, and Keflex.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Truncal rash, papular, of various sizes, typical appearance for varicella, sparing the face and extremities, 10 lesions, no other signs or symptoms.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Conjunctivitis infective, Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Received vaccine on Friday, April 18, 2008 at around 1pm.  By Friday evening, was a round, raised, hot bug-bite looking area.  By Saturday, April 19th was the size of a fifty cent piece.  By Sunday, April 20th, was about 3/4 the size of a dollar bill, raised & swollen, very hot to the touch, was painful to patient and very itchy as well.  We tried Cortisone cream for the itchiness and ice on the affected area on and off all day with no benefit.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash, Skin warm
Clinical narrative: Received vaccine on Friday, April 18, 2008 at around 1pm.  By Friday evening, was a round, raised, hot bug-bite looking area.  By Saturday, it was about the size of a 50 cent piece, painful, and very hot to the touch.  We applied Cortisone cream and used ice on and off, but is still getting bigger.  Doctor said to use Benedryl.  Her sister had a similar yet more severe reaction to this vaccine on the same date.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Immunization reaction at injection site of DTaP: right arm swollen from shoulder to elbow, with yellow-fluid filled blister (1 X 3 cm) at site of injection. No fever.  (reaction noted 2 days after administration).  Pt was seen by Dr on 4/17, and due to concern for infection he was treated with Amoxicillin and Benadryl, in addition to Tylenol as needed.  Pt continued to have swelling, so went to Urgent care on 4/19 where the blister was unroofed and sent for culture. (at this date, no cells/organisms noted, no growth).  He was switched from Amoxicillin to Keflex.  Mother of Pt applied triple antibiotic ointment.  Pt seen in follow-up on 4/21 with resolution of symptoms.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Injection site oedema, Pyrexia
Clinical narrative: Pain, Fever, and +3 edema starting at injection site (right arm) starting on day of vaccination and continuing into forearm 2 days later.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Pruritus, Rash vesicular
Clinical narrative: Received vaccine on 4/16 and developed itching back for 2 days. On 4/17 ankles swelled.  On 4/17 developed varicella like like lesions of her lower extremities and upper chest.
Age: 42.0
Sex: F
Vaccine: YF, YF
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated, Blood bilirubin unconjugated, Blood chloride normal
Clinical narrative: Deployed to another country, on ship at time of vaccination.  Patient in usual state of excellent health on day prior to vaccination.  Initial symptoms: erythema, pruritis around injection site and affecting right arm, starting within 1hr of administration, and persisting for approx 10 days; Subsequent symptoms: headache, fevers to 103, chills, drenching sweats, myalgias, beginning approx 10 days after vaccination, and shortly followed by bilateral axillary lymphadenopathy, slightly raised, scattered, circumscribed, erythematous nonscaling plaques, tender to palpation, affecting bilateral lower extremities and sparing remaining body surface; no cough/nausea/vomiting/abdominal pain; treated by provider on site for presumed, unspecified infection with azithromycin 500mg x1/250mg x4, indomethacin; presented to current provider approx 27 days after initial vaccination site reaction, symptoms improving.  7/1/08 MR received from cdc which show pt initially developed YF injection site cellulitis. Later developed fevers, drenching sweats and lymphadenopathy with tenderness.  Pt the developed rash on lower extremities and a single tender lesion below the umbilicus.
Age: 42.0
Sex: F
Vaccine: YF, YF
Symptoms: Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal, Chest X-ray abnormal, Chills
Clinical narrative: Deployed to another country, on ship at time of vaccination.  Patient in usual state of excellent health on day prior to vaccination.  Initial symptoms: erythema, pruritis around injection site and affecting right arm, starting within 1hr of administration, and persisting for approx 10 days; Subsequent symptoms: headache, fevers to 103, chills, drenching sweats, myalgias, beginning approx 10 days after vaccination, and shortly followed by bilateral axillary lymphadenopathy, slightly raised, scattered, circumscribed, erythematous nonscaling plaques, tender to palpation, affecting bilateral lower extremities and sparing remaining body surface; no cough/nausea/vomiting/abdominal pain; treated by provider on site for presumed, unspecified infection with azithromycin 500mg x1/250mg x4, indomethacin; presented to current provider approx 27 days after initial vaccination site reaction, symptoms improving.  7/1/08 MR received from cdc which show pt initially developed YF injection site cellulitis. Later developed fevers, drenching sweats and lymphadenopathy with tenderness.  Pt the developed rash on lower extremities and a single tender lesion below the umbilicus.
Age: 42.0
Sex: F
Vaccine: YF, YF
Symptoms: Haematocrit decreased, Haemoglobin decreased, Headache, Hyperhidrosis, Infection
Clinical narrative: Deployed to another country, on ship at time of vaccination.  Patient in usual state of excellent health on day prior to vaccination.  Initial symptoms: erythema, pruritis around injection site and affecting right arm, starting within 1hr of administration, and persisting for approx 10 days; Subsequent symptoms: headache, fevers to 103, chills, drenching sweats, myalgias, beginning approx 10 days after vaccination, and shortly followed by bilateral axillary lymphadenopathy, slightly raised, scattered, circumscribed, erythematous nonscaling plaques, tender to palpation, affecting bilateral lower extremities and sparing remaining body surface; no cough/nausea/vomiting/abdominal pain; treated by provider on site for presumed, unspecified infection with azithromycin 500mg x1/250mg x4, indomethacin; presented to current provider approx 27 days after initial vaccination site reaction, symptoms improving.  7/1/08 MR received from cdc which show pt initially developed YF injection site cellulitis. Later developed fevers, drenching sweats and lymphadenopathy with tenderness.  Pt the developed rash on lower extremities and a single tender lesion below the umbilicus.
Age: 42.0
Sex: F
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site pruritus, Lymphadenopathy, Mean cell volume abnormal, Myalgia
Clinical narrative: Deployed to another country, on ship at time of vaccination.  Patient in usual state of excellent health on day prior to vaccination.  Initial symptoms: erythema, pruritis around injection site and affecting right arm, starting within 1hr of administration, and persisting for approx 10 days; Subsequent symptoms: headache, fevers to 103, chills, drenching sweats, myalgias, beginning approx 10 days after vaccination, and shortly followed by bilateral axillary lymphadenopathy, slightly raised, scattered, circumscribed, erythematous nonscaling plaques, tender to palpation, affecting bilateral lower extremities and sparing remaining body surface; no cough/nausea/vomiting/abdominal pain; treated by provider on site for presumed, unspecified infection with azithromycin 500mg x1/250mg x4, indomethacin; presented to current provider approx 27 days after initial vaccination site reaction, symptoms improving.  7/1/08 MR received from cdc which show pt initially developed YF injection site cellulitis. Later developed fevers, drenching sweats and lymphadenopathy with tenderness.  Pt the developed rash on lower extremities and a single tender lesion below the umbilicus.
Age: 42.0
Sex: F
Vaccine: YF, YF
Symptoms: Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Red cell distribution width increased, Skin plaque
Clinical narrative: Deployed to another country, on ship at time of vaccination.  Patient in usual state of excellent health on day prior to vaccination.  Initial symptoms: erythema, pruritis around injection site and affecting right arm, starting within 1hr of administration, and persisting for approx 10 days; Subsequent symptoms: headache, fevers to 103, chills, drenching sweats, myalgias, beginning approx 10 days after vaccination, and shortly followed by bilateral axillary lymphadenopathy, slightly raised, scattered, circumscribed, erythematous nonscaling plaques, tender to palpation, affecting bilateral lower extremities and sparing remaining body surface; no cough/nausea/vomiting/abdominal pain; treated by provider on site for presumed, unspecified infection with azithromycin 500mg x1/250mg x4, indomethacin; presented to current provider approx 27 days after initial vaccination site reaction, symptoms improving.  7/1/08 MR received from cdc which show pt initially developed YF injection site cellulitis. Later developed fevers, drenching sweats and lymphadenopathy with tenderness.  Pt the developed rash on lower extremities and a single tender lesion below the umbilicus.