chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Blood test, Diarrhoea, Enema administration, Faeces discoloured, Fatigue
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Haematochezia, Inappropriate schedule of drug administration, Irritability, Mucous stools, Nasal congestion
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Pyrexia, Stool analysis, Vomiting
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Anal fissure, Barium enema, Culture stool positive, Diarrhoea, Enema administration
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Faeces discoloured, Fatigue, Gastroenteritis rotavirus, Haematochezia, Irritability
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Mucous stools, Nasal congestion, Pyrexia, Salmonellosis, Vomiting
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: X-ray normal
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, RV5, RV5
Symptoms: Abdominal distension, Abnormal faeces, Discomfort, Haematochezia, Vomiting
Clinical narrative: My baby was given 4 month shots on 6/12/07 at approximately 12 noon, after shots noticed Irritability, Vomiting in fountain like manner, Fever, Loose Bowels, Blood in the Stools in a "jelly ball" like substance. 6/12/07 at 9pm consulted on-call physician Dr. and was told to go to the Emergency Room at hospital. Arrived and was treated by Dr. and confirmed that there was blood in the stool, exam of stomach was done, blood was taken, IV of saline was started, X-rays were taken and transferred to on-call Radiologist, Dr. via computer. After review of xrays Radiologist did Enema on bowels looking for Intussusception. Put pressure on bowels 3 times. Took more x-rays of abdomen. Drained the enema. Was tested for Salmonella and various other organisms. Released from hospital and returned home with low grade fever. Saw Dr. the next day 6/13/07, stool turned to dark avocado green with mucous. Reported to Dr. stool change. Baby woke in the middle of night with stuffy nose, had to use the bulb to clear the nose of drainage. Baby very tired and slept later than usual. 6/15/07 was called and told Salmonella test was negative and that it was possible our baby had Intussusception at some point which may have worked itself out before arrival in the Emergency Room-or before the enema was done. At approximately 6:30pm on 6/15/07 noticed one small spot of blood in the stool, stool is color is closer to pea green in color-lighter in color. More blood showed up in stool 6/16/07, went to see dr. Dr's opinion was that the diarrhea from the Rotavirus-caught from the vaccine-was causing fissures in the anus and irritation causing the blood. Submitted to VAERS on 6/15/07
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dyskinesia, Feeling abnormal, Pallor, Syncope, Tinnitus
Clinical narrative: I have a 17 year old daughter who received her first shot of the HPV vaccine Gardasil After the shot she ask why did she feel funny She said her ears started to ring then she could not hear anything She said everything went black She was standing up and fainted to the floor The whole time her eyes were open She turned completely blue and green The direction she fell was toward the nurse The nurse fell behind her breaking her fall My daughter was not in a laying down positive ever then she had a seizure. I started calling her name and asking the nurse what was she shaking all over for like that My 15 year old son was with me and my daughter at the appointment He witnessed her faint and have a seizure My son nor my daughter have never ever had any drug allergy nor any side effect to a vaccination shot they're entire lives I do not understand why she blacked out, lost consciousness, lost her hearing, turned blue and green, and had a SEIZURE The rest of the day she was disoriented and had no appetite Her doctor came in and told me all that happened because of the stick of the needle I do not believe that I expressed my concern to the doctor before leaving her office and over the telephone yesterday The doctor gave me instruction to bring her back in two months from now to receive the second injection My daughter has not received any examination, testing, follow-up care absolutely nothing since the shot and seizure Sirs, Can you please explain to me what this drug Gardasil has done to my child I do not understand why this happened My other question is should my daughter receive the second injection in two months considering she blacked out, lost her hearing, fainted, and lost her natural skin color, and had a seizure will she be as fortunate to remain alive with a second or third injection I thought she died her little brother thought she had as well Sirs. I would appreciate a recommendation or referral in this matter as to any follow up care she can receive regarding the seizure as well as an explanation why this happened and reassurance that this will not happen upon completing the whole series of injections I called by local health department and the nurse for the health department took a report for me for Vaccine Adverse Event Reporting System Thus far noone has contacted me I would appreciate any correspondence in this matter as being a concerned mother and citizen in this country I pose to question the true intentions of this vaccination and what may be in store for our youth as we know it One can only wonder if this approved vaccination for the HPV virus causing cervical cancer will also cause any sterilization or any birth defects to a generation of young women such as my daughter Sincerely a concerned and disturbed mother.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Anorexia, Convulsion, Cyanosis, Deafness, Disorientation
Clinical narrative: I have a 17 year old daughter who received her first shot of the HPV vaccine Gardasil After the shot she ask why did she feel funny She said her ears started to ring then she could not hear anything She said everything went black She was standing up and fainted to the floor The whole time her eyes were open She turned completely blue and green The direction she fell was toward the nurse The nurse fell behind her breaking her fall My daughter was not in a laying down positive ever then she had a seizure. I started calling her name and asking the nurse what was she shaking all over for like that My 15 year old son was with me and my daughter at the appointment He witnessed her faint and have a seizure My son nor my daughter have never ever had any drug allergy nor any side effect to a vaccination shot they're entire lives I do not understand why she blacked out, lost consciousness, lost her hearing, turned blue and green, and had a SEIZURE The rest of the day she was disoriented and had no appetite Her doctor came in and told me all that happened because of the stick of the needle I do not believe that I expressed my concern to the doctor before leaving her office and over the telephone yesterday The doctor gave me instruction to bring her back in two months from now to receive the second injection My daughter has not received any examination, testing, follow-up care absolutely nothing since the shot and seizure Sirs, Can you please explain to me what this drug Gardasil has done to my child I do not understand why this happened My other question is should my daughter receive the second injection in two months considering she blacked out, lost her hearing, fainted, and lost her natural skin color, and had a seizure will she be as fortunate to remain alive with a second or third injection I thought she died her little brother thought she had as well Sirs. I would appreciate a recommendation or referral in this matter as to any follow up care she can receive regarding the seizure as well as an explanation why this happened and reassurance that this will not happen upon completing the whole series of injections I called by local health department and the nurse for the health department took a report for me for Vaccine Adverse Event Reporting System Thus far noone has contacted me I would appreciate any correspondence in this matter as being a concerned mother and citizen in this country I pose to question the true intentions of this vaccination and what may be in store for our youth as we know it One can only wonder if this approved vaccination for the HPV virus causing cervical cancer will also cause any sterilization or any birth defects to a generation of young women such as my daughter Sincerely a concerned and disturbed mother.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Skin discolouration, Syncope
Clinical narrative: I have a 17 year old daughter who received her first shot of the HPV vaccine Gardasil After the shot she ask why did she feel funny She said her ears started to ring then she could not hear anything She said everything went black She was standing up and fainted to the floor The whole time her eyes were open She turned completely blue and green The direction she fell was toward the nurse The nurse fell behind her breaking her fall My daughter was not in a laying down positive ever then she had a seizure. I started calling her name and asking the nurse what was she shaking all over for like that My 15 year old son was with me and my daughter at the appointment He witnessed her faint and have a seizure My son nor my daughter have never ever had any drug allergy nor any side effect to a vaccination shot they're entire lives I do not understand why she blacked out, lost consciousness, lost her hearing, turned blue and green, and had a SEIZURE The rest of the day she was disoriented and had no appetite Her doctor came in and told me all that happened because of the stick of the needle I do not believe that I expressed my concern to the doctor before leaving her office and over the telephone yesterday The doctor gave me instruction to bring her back in two months from now to receive the second injection My daughter has not received any examination, testing, follow-up care absolutely nothing since the shot and seizure Sirs, Can you please explain to me what this drug Gardasil has done to my child I do not understand why this happened My other question is should my daughter receive the second injection in two months considering she blacked out, lost her hearing, fainted, and lost her natural skin color, and had a seizure will she be as fortunate to remain alive with a second or third injection I thought she died her little brother thought she had as well Sirs. I would appreciate a recommendation or referral in this matter as to any follow up care she can receive regarding the seizure as well as an explanation why this happened and reassurance that this will not happen upon completing the whole series of injections I called by local health department and the nurse for the health department took a report for me for Vaccine Adverse Event Reporting System Thus far noone has contacted me I would appreciate any correspondence in this matter as being a concerned mother and citizen in this country I pose to question the true intentions of this vaccination and what may be in store for our youth as we know it One can only wonder if this approved vaccination for the HPV virus causing cervical cancer will also cause any sterilization or any birth defects to a generation of young women such as my daughter Sincerely a concerned and disturbed mother.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Tinnitus
Clinical narrative: I have a 17 year old daughter who received her first shot of the HPV vaccine Gardasil After the shot she ask why did she feel funny She said her ears started to ring then she could not hear anything She said everything went black She was standing up and fainted to the floor The whole time her eyes were open She turned completely blue and green The direction she fell was toward the nurse The nurse fell behind her breaking her fall My daughter was not in a laying down positive ever then she had a seizure. I started calling her name and asking the nurse what was she shaking all over for like that My 15 year old son was with me and my daughter at the appointment He witnessed her faint and have a seizure My son nor my daughter have never ever had any drug allergy nor any side effect to a vaccination shot they're entire lives I do not understand why she blacked out, lost consciousness, lost her hearing, turned blue and green, and had a SEIZURE The rest of the day she was disoriented and had no appetite Her doctor came in and told me all that happened because of the stick of the needle I do not believe that I expressed my concern to the doctor before leaving her office and over the telephone yesterday The doctor gave me instruction to bring her back in two months from now to receive the second injection My daughter has not received any examination, testing, follow-up care absolutely nothing since the shot and seizure Sirs, Can you please explain to me what this drug Gardasil has done to my child I do not understand why this happened My other question is should my daughter receive the second injection in two months considering she blacked out, lost her hearing, fainted, and lost her natural skin color, and had a seizure will she be as fortunate to remain alive with a second or third injection I thought she died her little brother thought she had as well Sirs. I would appreciate a recommendation or referral in this matter as to any follow up care she can receive regarding the seizure as well as an explanation why this happened and reassurance that this will not happen upon completing the whole series of injections I called by local health department and the nurse for the health department took a report for me for Vaccine Adverse Event Reporting System Thus far noone has contacted me I would appreciate any correspondence in this matter as being a concerned mother and citizen in this country I pose to question the true intentions of this vaccination and what may be in store for our youth as we know it One can only wonder if this approved vaccination for the HPV virus causing cervical cancer will also cause any sterilization or any birth defects to a generation of young women such as my daughter Sincerely a concerned and disturbed mother.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Blood test
Clinical narrative: Information has been received from a mother concerning her son who about a year or two ago was vaccinated with a dose of MMR II. It was reported that a day after receiving the vaccine her child developed autism. He was about to start reciting his ABC's and that all stopped after receiving the vaccine. Unspecified medical attention was sought. Blood work was performed. The patient's status is not recovered. No product quality complaint was involved. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning his 82 year old mother with hypertension who "eleven to twelve weeks ago" on approximately 20-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included unspecified hypertension and heart medications. Five days after vaccination on approximately 25-MAR-2007, the patient had a "very bad reaction" and experienced "very bad pain in her abdominal and hip area". The patient was in the hospital for a day and was sent to a specialist. The consumer reported that his mother was no longer able to live alone and was now in assisted living. A MRI was performed, results not reported. As of 13-JUN-2007 the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Balance disorder, Cerebellar ataxia, Computerised tomogram normal, Coordination abnormal, Fall
Clinical narrative: Information has been received via Sanofi Pasteur from an investigator concerning a 12 month old female with a history of viral tonsillitis on 10-MAR-2007, congenital hip deformity, otitis media and bronchiolitis who entered a study. It was reported that the patient received three doses of study vaccine Pentacel, with the last dose prior to the event on 18-SEP-2006 (Lot# Y0890). On 01-MAR-2007 the patient was vaccinated with a first 0.5 ml subcutaneous dose of ProQuad. Concomitant vaccines administered on the same day included a fourth intramuscular dose in the right thigh of Prevnar and a first intramuscular dose in the right thigh of Vaqta. On 10-MAR-2007 the patient presented to the physician's office with a three-day history of fever, a bright red oropharynx, tonsils size two with mild exudate, and tachycardia. No rashes were noted and a rapid strep test was negative. The patient was diagnosed with viral tonsillitis and treatment included pain medication and hydration. On 23-MAR-2007 the patient experienced several episodes of falling down and bumping her head, and one episode of vomiting. She was noted to have poor balance and could not walk unassisted. The patient was seen in the emergency department and was admitted to the hospital early in the morning on 24-MAR-2007. The patient was noted to be afebrile, and no significant neurologic impairment was found. A CT scan of the head, MRI, and lumbar puncture were all normal. The patient was diagnosed with post-viral cerebellar ataxia, and remained hospitalized until 25-MAR-2007. The patient was considered recovered on 27-MAR-2007, and continued in the trial. The event of post-viral ataxia was reported by the investigator as unrelated to the study vaccine, and related to ProQuad. Other manufacturer numbers included: 2007-02018 and 160-25045.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Gait disturbance, Head injury, Lumbar puncture, Nuclear magnetic resonance imaging normal, Pharyngeal erythema
Clinical narrative: Information has been received via Sanofi Pasteur from an investigator concerning a 12 month old female with a history of viral tonsillitis on 10-MAR-2007, congenital hip deformity, otitis media and bronchiolitis who entered a study. It was reported that the patient received three doses of study vaccine Pentacel, with the last dose prior to the event on 18-SEP-2006 (Lot# Y0890). On 01-MAR-2007 the patient was vaccinated with a first 0.5 ml subcutaneous dose of ProQuad. Concomitant vaccines administered on the same day included a fourth intramuscular dose in the right thigh of Prevnar and a first intramuscular dose in the right thigh of Vaqta. On 10-MAR-2007 the patient presented to the physician's office with a three-day history of fever, a bright red oropharynx, tonsils size two with mild exudate, and tachycardia. No rashes were noted and a rapid strep test was negative. The patient was diagnosed with viral tonsillitis and treatment included pain medication and hydration. On 23-MAR-2007 the patient experienced several episodes of falling down and bumping her head, and one episode of vomiting. She was noted to have poor balance and could not walk unassisted. The patient was seen in the emergency department and was admitted to the hospital early in the morning on 24-MAR-2007. The patient was noted to be afebrile, and no significant neurologic impairment was found. A CT scan of the head, MRI, and lumbar puncture were all normal. The patient was diagnosed with post-viral cerebellar ataxia, and remained hospitalized until 25-MAR-2007. The patient was considered recovered on 27-MAR-2007, and continued in the trial. The event of post-viral ataxia was reported by the investigator as unrelated to the study vaccine, and related to ProQuad. Other manufacturer numbers included: 2007-02018 and 160-25045.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Pyrexia, Spinal X-ray normal, Streptococcal identification test, Tachycardia, Tonsillar hypertrophy
Clinical narrative: Information has been received via Sanofi Pasteur from an investigator concerning a 12 month old female with a history of viral tonsillitis on 10-MAR-2007, congenital hip deformity, otitis media and bronchiolitis who entered a study. It was reported that the patient received three doses of study vaccine Pentacel, with the last dose prior to the event on 18-SEP-2006 (Lot# Y0890). On 01-MAR-2007 the patient was vaccinated with a first 0.5 ml subcutaneous dose of ProQuad. Concomitant vaccines administered on the same day included a fourth intramuscular dose in the right thigh of Prevnar and a first intramuscular dose in the right thigh of Vaqta. On 10-MAR-2007 the patient presented to the physician's office with a three-day history of fever, a bright red oropharynx, tonsils size two with mild exudate, and tachycardia. No rashes were noted and a rapid strep test was negative. The patient was diagnosed with viral tonsillitis and treatment included pain medication and hydration. On 23-MAR-2007 the patient experienced several episodes of falling down and bumping her head, and one episode of vomiting. She was noted to have poor balance and could not walk unassisted. The patient was seen in the emergency department and was admitted to the hospital early in the morning on 24-MAR-2007. The patient was noted to be afebrile, and no significant neurologic impairment was found. A CT scan of the head, MRI, and lumbar puncture were all normal. The patient was diagnosed with post-viral cerebellar ataxia, and remained hospitalized until 25-MAR-2007. The patient was considered recovered on 27-MAR-2007, and continued in the trial. The event of post-viral ataxia was reported by the investigator as unrelated to the study vaccine, and related to ProQuad. Other manufacturer numbers included: 2007-02018 and 160-25045.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Viral tonsillitis, Vomiting
Clinical narrative: Information has been received via Sanofi Pasteur from an investigator concerning a 12 month old female with a history of viral tonsillitis on 10-MAR-2007, congenital hip deformity, otitis media and bronchiolitis who entered a study. It was reported that the patient received three doses of study vaccine Pentacel, with the last dose prior to the event on 18-SEP-2006 (Lot# Y0890). On 01-MAR-2007 the patient was vaccinated with a first 0.5 ml subcutaneous dose of ProQuad. Concomitant vaccines administered on the same day included a fourth intramuscular dose in the right thigh of Prevnar and a first intramuscular dose in the right thigh of Vaqta. On 10-MAR-2007 the patient presented to the physician's office with a three-day history of fever, a bright red oropharynx, tonsils size two with mild exudate, and tachycardia. No rashes were noted and a rapid strep test was negative. The patient was diagnosed with viral tonsillitis and treatment included pain medication and hydration. On 23-MAR-2007 the patient experienced several episodes of falling down and bumping her head, and one episode of vomiting. She was noted to have poor balance and could not walk unassisted. The patient was seen in the emergency department and was admitted to the hospital early in the morning on 24-MAR-2007. The patient was noted to be afebrile, and no significant neurologic impairment was found. A CT scan of the head, MRI, and lumbar puncture were all normal. The patient was diagnosed with post-viral cerebellar ataxia, and remained hospitalized until 25-MAR-2007. The patient was considered recovered on 27-MAR-2007, and continued in the trial. The event of post-viral ataxia was reported by the investigator as unrelated to the study vaccine, and related to ProQuad. Other manufacturer numbers included: 2007-02018 and 160-25045.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depression, Dizziness, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Anhedonia, Anxiety, Apathy, Blood aluminium normal
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Depressed mood, Depression, Fatigue, Full blood count normal
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test normal, Screaming, Self esteem decreased, Suicidal ideation, Thyroid function test normal
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Local reaction, Medication error, Poor quality drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 13-year-old male who on 11-APR-2007 was vaccinated subcutaneously in the right arm with a 0.5 ml dose of Varivax (lot# 656281/1504F). Concomitant vaccination included a dose of hepatitis B virus vaccine (manufacturer unknown). It was reported that on 11-APR-2007, prior to administration, the vaccine was exposed to 36 degrees Fahrenheit for 4 hours. On 13-APR-2007 the patient was diagnosed with cellulitis and was treated with an unspecified antibiotic. Unspecified medical attention was sought. The outcome was unspecified. no product quality complaint was involved. Follow-up information was received on 14-JUN-2007, indication that cellulitis was ruled out after pediatricians conferred with the CDC. The diagnosis was deemed to be an exaggerated "intense local reaction" after the second varicella booster in an older child. The reporter considered the patient's intense local reaction to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Enema administration, Haematemesis, Intussusception, Laparoscopy, Lethargy
Clinical narrative: 6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Melaena, Pyrexia, Vomiting
Clinical narrative: 6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Band neutrophil count decreased, Blood albumin decreased, Blood culture negative, Blood glucose abnormal, Blood urea increased
Clinical narrative: 6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Bowel sounds abnormal, Enema administration, Gastric pH increased, Haematemesis, Intussusception
Clinical narrative: 6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Laparoscopy, Lethargy, Melaena, Monocyte count decreased, Neutrophil count decreased
Clinical narrative: 6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Pallor, Pyrexia, Vomiting
Clinical narrative: 6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 3 hives on right arm found today. spoke with nurse at retirement home about it.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child received shots Mon 5-7-07. She came back to clinic Wed 5-9-07 with Left arm swollen, red, and hot from shoulder to elbow. It was bad enough that I suggested she go to an instacare, which she did. (We have no Dr, on site to look at it)
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Lip swelling, Swelling face
Clinical narrative: Menactra administered at approximately 2:30 pm on 6/22/07 Facial swelling 1st noted at 7:30 pm on 6/22/07 after patient awoke from nap. mother reported peri-oral swelling/lip swelling/and swelling of bilateral forehead region above both eyes. No respiratory symptoms/ No shortness of breath. Patient was referred to local emergency department for evaluation.
Age: 53.0
Sex: U
Vaccine: TDAP
Symptoms: Back pain, Cold sweat, Disorientation, Insomnia, Muscle spasms
Clinical narrative: Symptoms began 10 hours after injection. Patient c/o disorientation, cold sweats, nausea, insomnia, back pain, fever, muscle spasms. Symptoms resolved in 48 hours.
Age: 53.0
Sex: U
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Symptoms began 10 hours after injection. Patient c/o disorientation, cold sweats, nausea, insomnia, back pain, fever, muscle spasms. Symptoms resolved in 48 hours.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Abdominal pain upper, Blood pressure decreased, Body temperature increased, Dizziness, Injection site pain
Clinical narrative: Dizzy, stomach cramping, Rt arm pain down from deltoid to elbow. Immediate warmth around injection site. Temp 99.2, BP 90/60