chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Tracheomalacia, Virus serology test
Clinical narrative: EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Wheezing
Clinical narrative: EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Irritability, Nuclear magnetic resonance imaging brain normal, Pyrexia, Scan brain
Clinical narrative: Initial and follow up information has been received from an investigator concerning a 12 month old female with no previous illness, no diagnosed allergies who was enrolled in the study as titled above. On 29-JUN-2006 she was vaccinated with a dose of ProQuad (Oka/Merck upgrade process). On 29-JUN-2007, concomitant suspect therapy included PedvaxHIB (dose not reported). Other concomitant therapy included Prevnar. It was reported that the child developed fever x 7-10 days started "31-JUL-2006" (previously reported as 01-JUL-2006) and had behavior changes consisting of irritability alternating with somnolence. As per the parents the events were from 12-JUL-2006 through approximately 16-JUL-2006. It was reported that on 31-JUL-2006 the patient was hospitalized. Two head computed axial tomography (brain CT) and a brain imaging (brain MRI) with gadolinium were normal as well as all laboratory tests performed was normal. The child's behavior was noted to be normal on admission. On Day 17 following vaccination, her neurologic examination and development were normal on follow up by a Pediatric Neurologist. It was reported that her treatment was observation, unspecified antimicrobial therapy , and one dose of "methylprednisolone". The patient experienced "possible encephalitis" and subsequently, she recovered from fever, irritability and somnolence. The information provided  was based on chart review performed by the study investigators. The study investigators and the review committee felt that, although the event might be related to vaccine, it was more likely related to an intercurrent illness given the rapidity of onset of fever (2 days after vaccination) and the duration of fever (7-10 days). Nevertheless, this event was reported as a post marketing serious adverse event following ProQuad therapy. Upon internal review the possible encephalitis was felt to be an other important medical event.  Additional information is not expected. Information has been received from a physician concerning a 12 month old female child who on 29-JUN-2006 was vaccinated with a third dose of PEDVAX HIB. Concomitant therapy included a fourth dose of PREVNAR. The patient developed fever for 7-10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination. Patient was admitted to the hospital for evaluation and observation. Symptoms resolved by the time of discharge (4 days later). The child had normal development since that time. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Somnolence
Clinical narrative: Initial and follow up information has been received from an investigator concerning a 12 month old female with no previous illness, no diagnosed allergies who was enrolled in the study as titled above. On 29-JUN-2006 she was vaccinated with a dose of ProQuad (Oka/Merck upgrade process). On 29-JUN-2007, concomitant suspect therapy included PedvaxHIB (dose not reported). Other concomitant therapy included Prevnar. It was reported that the child developed fever x 7-10 days started "31-JUL-2006" (previously reported as 01-JUL-2006) and had behavior changes consisting of irritability alternating with somnolence. As per the parents the events were from 12-JUL-2006 through approximately 16-JUL-2006. It was reported that on 31-JUL-2006 the patient was hospitalized. Two head computed axial tomography (brain CT) and a brain imaging (brain MRI) with gadolinium were normal as well as all laboratory tests performed was normal. The child's behavior was noted to be normal on admission. On Day 17 following vaccination, her neurologic examination and development were normal on follow up by a Pediatric Neurologist. It was reported that her treatment was observation, unspecified antimicrobial therapy , and one dose of "methylprednisolone". The patient experienced "possible encephalitis" and subsequently, she recovered from fever, irritability and somnolence. The information provided  was based on chart review performed by the study investigators. The study investigators and the review committee felt that, although the event might be related to vaccine, it was more likely related to an intercurrent illness given the rapidity of onset of fever (2 days after vaccination) and the duration of fever (7-10 days). Nevertheless, this event was reported as a post marketing serious adverse event following ProQuad therapy. Upon internal review the possible encephalitis was felt to be an other important medical event.  Additional information is not expected. Information has been received from a physician concerning a 12 month old female child who on 29-JUN-2006 was vaccinated with a third dose of PEDVAX HIB. Concomitant therapy included a fourth dose of PREVNAR. The patient developed fever for 7-10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination. Patient was admitted to the hospital for evaluation and observation. Symptoms resolved by the time of discharge (4 days later). The child had normal development since that time. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Computerised tomogram normal, Encephalitis, Irritability, Laboratory test
Clinical narrative: Initial and follow up information has been received from an investigator concerning a 12 month old female with no previous illness, no diagnosed allergies who was enrolled in the study as titled above. On 29-JUN-2006 she was vaccinated with a dose of ProQuad (Oka/Merck upgrade process). On 29-JUN-2007, concomitant suspect therapy included PedvaxHIB (dose not reported). Other concomitant therapy included Prevnar. It was reported that the child developed fever x 7-10 days started "31-JUL-2006" (previously reported as 01-JUL-2006) and had behavior changes consisting of irritability alternating with somnolence. As per the parents the events were from 12-JUL-2006 through approximately 16-JUL-2006. It was reported that on 31-JUL-2006 the patient was hospitalized. Two head computed axial tomography (brain CT) and a brain imaging (brain MRI) with gadolinium were normal as well as all laboratory tests performed was normal. The child's behavior was noted to be normal on admission. On Day 17 following vaccination, her neurologic examination and development were normal on follow up by a Pediatric Neurologist. It was reported that her treatment was observation, unspecified antimicrobial therapy , and one dose of "methylprednisolone". The patient experienced "possible encephalitis" and subsequently, she recovered from fever, irritability and somnolence. The information provided  was based on chart review performed by the study investigators. The study investigators and the review committee felt that, although the event might be related to vaccine, it was more likely related to an intercurrent illness given the rapidity of onset of fever (2 days after vaccination) and the duration of fever (7-10 days). Nevertheless, this event was reported as a post marketing serious adverse event following ProQuad therapy. Upon internal review the possible encephalitis was felt to be an other important medical event.  Additional information is not expected. Information has been received from a physician concerning a 12 month old female child who on 29-JUN-2006 was vaccinated with a third dose of PEDVAX HIB. Concomitant therapy included a fourth dose of PREVNAR. The patient developed fever for 7-10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination. Patient was admitted to the hospital for evaluation and observation. Symptoms resolved by the time of discharge (4 days later). The child had normal development since that time. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Nuclear magnetic resonance imaging brain normal, Pyrexia, Somnolence
Clinical narrative: Initial and follow up information has been received from an investigator concerning a 12 month old female with no previous illness, no diagnosed allergies who was enrolled in the study as titled above. On 29-JUN-2006 she was vaccinated with a dose of ProQuad (Oka/Merck upgrade process). On 29-JUN-2007, concomitant suspect therapy included PedvaxHIB (dose not reported). Other concomitant therapy included Prevnar. It was reported that the child developed fever x 7-10 days started "31-JUL-2006" (previously reported as 01-JUL-2006) and had behavior changes consisting of irritability alternating with somnolence. As per the parents the events were from 12-JUL-2006 through approximately 16-JUL-2006. It was reported that on 31-JUL-2006 the patient was hospitalized. Two head computed axial tomography (brain CT) and a brain imaging (brain MRI) with gadolinium were normal as well as all laboratory tests performed was normal. The child's behavior was noted to be normal on admission. On Day 17 following vaccination, her neurologic examination and development were normal on follow up by a Pediatric Neurologist. It was reported that her treatment was observation, unspecified antimicrobial therapy , and one dose of "methylprednisolone". The patient experienced "possible encephalitis" and subsequently, she recovered from fever, irritability and somnolence. The information provided  was based on chart review performed by the study investigators. The study investigators and the review committee felt that, although the event might be related to vaccine, it was more likely related to an intercurrent illness given the rapidity of onset of fever (2 days after vaccination) and the duration of fever (7-10 days). Nevertheless, this event was reported as a post marketing serious adverse event following ProQuad therapy. Upon internal review the possible encephalitis was felt to be an other important medical event.  Additional information is not expected. Information has been received from a physician concerning a 12 month old female child who on 29-JUN-2006 was vaccinated with a third dose of PEDVAX HIB. Concomitant therapy included a fourth dose of PREVNAR. The patient developed fever for 7-10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination. Patient was admitted to the hospital for evaluation and observation. Symptoms resolved by the time of discharge (4 days later). The child had normal development since that time. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Blood creatinine increased, Diarrhoea, Diet refusal, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on approximately 23-NOV-2007 "approximately four weeks ago," was vaccinated PO with his second dose of Rotateq. On approximately 23-NOV-2007 the patient experienced "hemolytic uremic syndrome," characterized by diarrhea and vomiting. The patient was diagnosed with kidney failure, was subsequently admitted to the hospital and put on dialysis. The outcome was unknown at the time of this report. There was no product quality complaint. The physician considered kidney failure and hemolytic uremic syndrome to be immediately life-threatening and other important medical events (dialysis). Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on approximately 23-NOV-2007 "approximately four weeks ago," was vaccinated PO with his second dose of Rotateq. On approximately 23-NOV-2007 the patient experienced "hemolytic uremic syndrome," characterized by diarrhea and vomiting. The patient was diagnosed with kidney failure, was subsequently admitted to the hospital and put on dialysis. The outcome was unknown at the time of this report. There was no product quality complaint. The physician considered kidney failure and hemolytic uremic syndrome to be immediately life-threatening and other important medical events (dialysis). Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Dialysis, Diarrhoea, Haemolytic uraemic syndrome, Renal failure, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on approximately 23-NOV-2007 "approximately four weeks ago," was vaccinated PO with his second dose of Rotateq. On approximately 23-NOV-2007 the patient experienced "hemolytic uremic syndrome," characterized by diarrhea and vomiting. The patient was diagnosed with kidney failure, was subsequently admitted to the hospital and put on dialysis. The outcome was unknown at the time of this report. There was no product quality complaint. The physician considered kidney failure and hemolytic uremic syndrome to be immediately life-threatening and other important medical events (dialysis). Additional information has been requested.
Sex: U
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Chest pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient exhibited pleuritis type chest pain; elevated cardiac markers with peak (CKMB=6.4; Trop I=1.51); echo showing trace pericardial effusion.
Sex: U
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase MB increased, Chest pain, Echocardiogram abnormal, Pericardial effusion
Clinical narrative: Patient exhibited pleuritis type chest pain; elevated cardiac markers with peak (CKMB=6.4; Trop I=1.51); echo showing trace pericardial effusion.
Sex: U
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Troponin I increased
Clinical narrative: Patient exhibited pleuritis type chest pain; elevated cardiac markers with peak (CKMB=6.4; Trop I=1.51); echo showing trace pericardial effusion.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Movement disorder
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who in the first week of December 2007, was vaccinated IM with a dose of Gardasil (lot # not reported). On 18-DEC-2007 the patient experienced "fogginess and had lost the use of her limbs." The patient sought medical attention and it was determined that she had developed Guillain-Barre syndrome. Follow up information received from a nurse, indicated that the patient had no pertinent medical history or allergies, when on 05-DEC-2007, she was vaccinated with the first dose of Gardasil (lot #655503/0012U), and with a dose of secondary suspect Menactra (lot # not reported). On 18-DEC-2007, the patient presented to the emergency room (ER), with numbness from her head to toes and she could not walk. She was hospitalized, and a spinal tap, magnetic resonance imaging (MRI) and diagnostic labs were performed during the hospitalization. All test results were negative or normal. The nurse reported that the final diagnosis was not Guillain-Barre as previously reported, but a "possible reaction to the combination of Gardasil and Menactra," and added that there was "some evidence of psychological problems." On 21-DEC-2007, the patient was discharged from the hospital. On 22-DEC-2007, the nurse spoke with the patient, who reported that she had completely recovered. The nurse indicated that the events were not considered to be life threatening, however one or more of the events (of note "could not walk") was considered to be disabling/incapacitating. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abasia, Feeling abnormal, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who in the first week of December 2007, was vaccinated IM with a dose of Gardasil (lot # not reported). On 18-DEC-2007 the patient experienced "fogginess and had lost the use of her limbs." The patient sought medical attention and it was determined that she had developed Guillain-Barre syndrome. Follow up information received from a nurse, indicated that the patient had no pertinent medical history or allergies, when on 05-DEC-2007, she was vaccinated with the first dose of Gardasil (lot #655503/0012U), and with a dose of secondary suspect Menactra (lot # not reported). On 18-DEC-2007, the patient presented to the emergency room (ER), with numbness from her head to toes and she could not walk. She was hospitalized, and a spinal tap, magnetic resonance imaging (MRI) and diagnostic labs were performed during the hospitalization. All test results were negative or normal. The nurse reported that the final diagnosis was not Guillain-Barre as previously reported, but a "possible reaction to the combination of Gardasil and Menactra," and added that there was "some evidence of psychological problems." On 21-DEC-2007, the patient was discharged from the hospital. On 22-DEC-2007, the nurse spoke with the patient, who reported that she had completely recovered. The nurse indicated that the events were not considered to be life threatening, however one or more of the events (of note "could not walk") was considered to be disabling/incapacitating. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Mental disorder, Movement disorder, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who in the first week of December 2007, was vaccinated IM with a dose of Gardasil (lot # not reported). On 18-DEC-2007 the patient experienced "fogginess and had lost the use of her limbs." The patient sought medical attention and it was determined that she had developed Guillain-Barre syndrome. Follow up information received from a nurse, indicated that the patient had no pertinent medical history or allergies, when on 05-DEC-2007, she was vaccinated with the first dose of Gardasil (lot #655503/0012U), and with a dose of secondary suspect Menactra (lot # not reported). On 18-DEC-2007, the patient presented to the emergency room (ER), with numbness from her head to toes and she could not walk. She was hospitalized, and a spinal tap, magnetic resonance imaging (MRI) and diagnostic labs were performed during the hospitalization. All test results were negative or normal. The nurse reported that the final diagnosis was not Guillain-Barre as previously reported, but a "possible reaction to the combination of Gardasil and Menactra," and added that there was "some evidence of psychological problems." On 21-DEC-2007, the patient was discharged from the hospital. On 22-DEC-2007, the nurse spoke with the patient, who reported that she had completely recovered. The nurse indicated that the events were not considered to be life threatening, however one or more of the events (of note "could not walk") was considered to be disabling/incapacitating. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Blepharospasm, Excessive eye blinking
Clinical narrative: Mother reports that within 48 hours of receiving vaccines, patient developed eye twitching, described by mother as "hard blinking."  She took patient to an opthamologist, who could not find any disease process to explain the problem.  Mother reports opthamologist felt it was a "nerve problem."
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received from a registered nurse through the Pregnancy registry concerning a 24 year old female smoker of 1/2 pack per day who quit on 25-SEP-2007, with a history of cervical cancer in 2001, and with asthma, hypoglycemia diagnosed in April 2005, and no drug allergies, who on 22-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (Lot# 657617/0384U). Concomitant therapy included albuterol inhaler. Subsequently, the patient was pregnant. The patient's last menstrual period was 04-JUL-2007 and her estimated delivery date was 23-APR-2008. The patient had an office visit. A pregnancy test was performed (no results provided). At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up indicated that on 05-NOV-2007 the patient had a spontaneous abortion 16 weeks from her last menstrual period. It was unknown if the products of conception were examined. It was reported that the patient had not seen a doctor for this pregnancy. The patient was seen in the emergency room on 05-NOV-2007 when she learned of the miscarriage. The patient had 3 previous pregnancies with 1 full term delivery, 1 spontaneous abortion, and 1 elective termination. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Inappropriate schedule of drug administration, Insomnia, Laboratory test
Clinical narrative: Information has been received from a consumer concerning his currently 3 1/2 year old daughter with no pertinent medical history and no drug reactions/allergies, who at approximately 11 months old (in approximately 2004) was vaccinated with a single dose of MMR II. Concomitant therapy included "a number of other vaccines" (therapy unspecified) (manufacturer unknown). It was noted that on the day of vaccination the patient took her very first walking steps, however, later that evening that the patient had difficulty sleeping and she was screaming. He stated that her behavior became more and more abnormal, she continued to have difficulty sleeping and became hyperactive. The consumer indicated that his daughter would not make eye contact and would run out of a room for no apparent reason. He stated that the patient seemed to have no fears or feelings and would do things such as running into walls. Subsequently the patient was diagnosed with autism. No  physician information was provided. Lab diagnostic studies performed included "psychiatric evaluation and tests". The outcome was reported as not recovered. There was no product quality complaint. Upon internal review the patient's autism was determined to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Psychiatric evaluation, Psychomotor hyperactivity, Screaming
Clinical narrative: Information has been received from a consumer concerning his currently 3 1/2 year old daughter with no pertinent medical history and no drug reactions/allergies, who at approximately 11 months old (in approximately 2004) was vaccinated with a single dose of MMR II. Concomitant therapy included "a number of other vaccines" (therapy unspecified) (manufacturer unknown). It was noted that on the day of vaccination the patient took her very first walking steps, however, later that evening that the patient had difficulty sleeping and she was screaming. He stated that her behavior became more and more abnormal, she continued to have difficulty sleeping and became hyperactive. The consumer indicated that his daughter would not make eye contact and would run out of a room for no apparent reason. He stated that the patient seemed to have no fears or feelings and would do things such as running into walls. Subsequently the patient was diagnosed with autism. No  physician information was provided. Lab diagnostic studies performed included "psychiatric evaluation and tests". The outcome was reported as not recovered. There was no product quality complaint. Upon internal review the patient's autism was determined to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal distension, Crying, Diagnostic procedure, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 2 month old male with gastroesophageal reflux disease who in approximately November 2007, was vaccinated PO with his first dose of Rotateq. In approximately November 2007 about 3 to 4 hours after vaccination, the patient experienced "relentless crying and abdominal distention." The patient was hospitalized for 2 days and tests showed it was not intussusception. Other lab diagnostic studies performed were unknown. The outcome was unknown. It was also noted that the reporting physician was not the patient's primary care provider and did not administer Rotateq to the patient. There was no product quality complaint. The physician considered relentless crying and abdominal distention to be disabling. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Enema administration, Laboratory test, Oral intake reduced, Vomiting
Clinical narrative: Information has been received from a physician concerning a brestfed 6 month old male with no other pertinent medical history or drug allergies who on 15-AUG-2007, 12-OCT-2007 and 13-DEC-2007 was vaccinated PO with his first, second and third (lot# 656833/0407U) doses of Rotateq. Concomitant vaccinations administered on 13-DEC-2007 included a dose of Pediarix, a dose of Prevnar and a dose of ActHIB. On 13-DEC-2007 the patient vomited four times after being vaccinated and was not eating." The patient sought unspecified medical attention. On 14-DEC-2007 the "patient had been taken to the hospital  and where he tested positive for intussusception. The patient had 2 air enemas, the second was successful)." Other labs or diagnostic studies were performed but not specified. On 17-DEC-2007 the patient was recovered. It was noted that "around the time of vaccination, the patient was transitioning from breast milk to formula." There was no product quality complaint. Additional information has been requested.  02/14/2008 Vax record received and info updated in database./pc 02/19/2008 MR received for DOS 12/14-15/2007 with D/C DX: Intussusception-ileocolic.  Infant presented to ER with 2 day hx of emesis and 1 episode of bloody, jelly-like stool. Pt dehydrated.  IS reduced on 2nd attempt by air contrast enema. Pt did well post procedure and D/Cd home next day.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a nurse concerning an approximately 13 week old male who on 25-OCT-2007 was vaccinated PO with his first dose of Rotateq (lot# 656379/0505U). Concomitant vaccinations administered on that same day included a dose of DTaP, a dose of PedvaxHIB, a dose of Prevnar. On approximately 22-NOV-2007 the patient experienced intussusception, was hospitalized and underwent surgery on 22-NOV-2007 (length of stay and type of surgery not specified). Subsequently, the patient recovered. It was noted that the patient discontinued the series for the second and third doses of Rotateq. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.  01/10/2008 Vax info updated in database. 02/12/2008 MR received for DOS 11/22-23/2007 with D/C DX: Intussusception.  Infant presented with vomiting, bloody, brownish stools, refusal to eat and screaming.  Several day hx of nasal congestion.  Pt underwent reduction of IS via enema in ER.  Admitted for observation post procedure and D/Cd next day.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Anorexia, Asthenia, Choreoathetosis, Diarrhoea
Clinical narrative: This case was received from a health professional on 21 December 2007. A 19-year-old female patient, with a history of mitral valve prolapse and possible iodine allergy, received a Menactra (lot number, route, and dose not provided) on 06 July 2007. Per the reporter, the patient may possibly have had Epstein-Barr Virus prior to vaccination. A short time after receiving the vaccine she developed a sore throat. On 23 July 2007 she traveled out of state, and on 27 July 2007 she suddenly developed extreme weakness, tremors, shaking, and urinary frequency, dry heaves, diarrhea, and weight loss. She was admitted to a hospital for approximately four weeks, where testing showed Epstein-Barr Virus; all other tests were negative. Additional symptoms included tachycardia, with a heart rate of 200, as well as choreoathetosis and blank stares. The patient was treated with steroids and antibiotics, with little effect, and was subsequently discharged from the hospital. At the time of the report, the patient continued to experienced tachycardia and loss of consciousness while walking, twitching of the shoulders, rolling of the eyes, lethargy, shortness of breath, insomnia, and anorexia following exertion. Per the reporter, the patient had improved but "basically remains housebound".
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Epstein-Barr virus infection, Epstein-Barr virus test positive, Eye rolling, Insomnia
Clinical narrative: This case was received from a health professional on 21 December 2007. A 19-year-old female patient, with a history of mitral valve prolapse and possible iodine allergy, received a Menactra (lot number, route, and dose not provided) on 06 July 2007. Per the reporter, the patient may possibly have had Epstein-Barr Virus prior to vaccination. A short time after receiving the vaccine she developed a sore throat. On 23 July 2007 she traveled out of state, and on 27 July 2007 she suddenly developed extreme weakness, tremors, shaking, and urinary frequency, dry heaves, diarrhea, and weight loss. She was admitted to a hospital for approximately four weeks, where testing showed Epstein-Barr Virus; all other tests were negative. Additional symptoms included tachycardia, with a heart rate of 200, as well as choreoathetosis and blank stares. The patient was treated with steroids and antibiotics, with little effect, and was subsequently discharged from the hospital. At the time of the report, the patient continued to experienced tachycardia and loss of consciousness while walking, twitching of the shoulders, rolling of the eyes, lethargy, shortness of breath, insomnia, and anorexia following exertion. Per the reporter, the patient had improved but "basically remains housebound".
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Lethargy, Loss of consciousness, Muscle twitching, Pharyngolaryngeal pain, Pollakiuria
Clinical narrative: This case was received from a health professional on 21 December 2007. A 19-year-old female patient, with a history of mitral valve prolapse and possible iodine allergy, received a Menactra (lot number, route, and dose not provided) on 06 July 2007. Per the reporter, the patient may possibly have had Epstein-Barr Virus prior to vaccination. A short time after receiving the vaccine she developed a sore throat. On 23 July 2007 she traveled out of state, and on 27 July 2007 she suddenly developed extreme weakness, tremors, shaking, and urinary frequency, dry heaves, diarrhea, and weight loss. She was admitted to a hospital for approximately four weeks, where testing showed Epstein-Barr Virus; all other tests were negative. Additional symptoms included tachycardia, with a heart rate of 200, as well as choreoathetosis and blank stares. The patient was treated with steroids and antibiotics, with little effect, and was subsequently discharged from the hospital. At the time of the report, the patient continued to experienced tachycardia and loss of consciousness while walking, twitching of the shoulders, rolling of the eyes, lethargy, shortness of breath, insomnia, and anorexia following exertion. Per the reporter, the patient had improved but "basically remains housebound".
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Retching, Staring, Tachycardia, Tremor, Weight decreased
Clinical narrative: This case was received from a health professional on 21 December 2007. A 19-year-old female patient, with a history of mitral valve prolapse and possible iodine allergy, received a Menactra (lot number, route, and dose not provided) on 06 July 2007. Per the reporter, the patient may possibly have had Epstein-Barr Virus prior to vaccination. A short time after receiving the vaccine she developed a sore throat. On 23 July 2007 she traveled out of state, and on 27 July 2007 she suddenly developed extreme weakness, tremors, shaking, and urinary frequency, dry heaves, diarrhea, and weight loss. She was admitted to a hospital for approximately four weeks, where testing showed Epstein-Barr Virus; all other tests were negative. Additional symptoms included tachycardia, with a heart rate of 200, as well as choreoathetosis and blank stares. The patient was treated with steroids and antibiotics, with little effect, and was subsequently discharged from the hospital. At the time of the report, the patient continued to experienced tachycardia and loss of consciousness while walking, twitching of the shoulders, rolling of the eyes, lethargy, shortness of breath, insomnia, and anorexia following exertion. Per the reporter, the patient had improved but "basically remains housebound".
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Syncope
Clinical narrative: Initial report received on 19 December 2007 from a health care professional.  The health care professional reported this case to another manufacturer (no reference number provided), who forwarded the information to Sanofi Pasteur.  A patient (age and gender not reported) received injections of Menactra and DTaP (manufacturer unknown) on unspecified date.  The lot number and administration information was not reported for either vaccine.  An unspecified amount of time later, the patient fainted.  No other information was provided.  It was not reported whether the patient recovered from the event.
Sex: U
Vaccine: TTOX
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Initial report received on 19 December 2007 from another manufacturer, report number not provided.  The initial reporter to this manufacturer had been a health care professional.  A patient (age, gender, and date of birth not provided) had received an injection of tetanus vaccine, manufacturer not provided, and lot number not provided, on an unspecified date.  At an unspecified time post-vaccination, the patient developed shortness of breath and hives.  Recovery status was not reported.  Additional medically relevant information was not provided.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram normal, Convulsion, Posturing, Scan brain, Syncope
Clinical narrative: Syncope/Collapse; Observed posturing; transfer to Port Orange Emergency Room for evaluation seizure activity and rule out vasovagal response to vaccine.  1/18/08 Reviewed hospital medical records which reveal patient experienced syncopal episode while at pcp office after vaccine.  Struck head when fell & had LOC, jerking of arms.  Exam in ER on 12/28/07 revealed HA, nausea & occipital contusion.  Improved w/meds & d/c to home. FINAL ER DX: vasovagal syncopal episode; concussion; fall.  Patient had several episodes of vomiting, HA & lethargy.  Returned & admitted for observation 12/29/2007-1/1/2008.  Neuro consult done. FINAL DX: post-concussive syndrome s/p syncopal episode; CHI w/fontal contusion; possible post traumatic seizure; subgaleal hematoma.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Initially tenderness at the site.then one week later swelling into upper arm with soreness/ Has taken advil for the past three days with relief fromswelling and pain
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood bicarbonate normal, Blood calcium normal, Blood chloride normal, Blood glucose normal, Blood potassium increased
Clinical narrative: Pediarix, Hib, Prevnar and Rotateq were given at approximately 10:45 am on 12/28/07 following well-child exam.  At approximately 2000 that evening, patient was noted by parents to have twitching of right arm and leg lasting 2 minutes.  No fever present.  Had had some loose stools and thrush noted at exam that morning.  Had been given tylenol that evening at 4 pm.  Was seen in the ER and still had hypotonia and decreased muscle tone of right arm which slowly resolved.  CBC, BMP and Head CT were all normal.  Pt was sent home with instructions for seizure first aid.  Patient experienced another seizure on the left side at 0300 the next morning.  Muscle tone and strength were once again diminished, but improved with time.  Patient was transferred to Hospital where Lumbar puncture and EEG were done.  Patient was started on phenobarbital. 2/7/08-records received for DOS 12/29-12/30/07-DC DX: Complex febrile seizures. Esotropia. Two episodes of seizure-like activity in 24 hours prior to admission. Episode of jerking movements, lasting 1-2 minutes involving right side of body, then began limp on right side. Flaccidity. Temperature 101.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood sodium normal, Computerised tomogram normal, Convulsion, Haemoglobin normal, Hypotonia
Clinical narrative: Pediarix, Hib, Prevnar and Rotateq were given at approximately 10:45 am on 12/28/07 following well-child exam.  At approximately 2000 that evening, patient was noted by parents to have twitching of right arm and leg lasting 2 minutes.  No fever present.  Had had some loose stools and thrush noted at exam that morning.  Had been given tylenol that evening at 4 pm.  Was seen in the ER and still had hypotonia and decreased muscle tone of right arm which slowly resolved.  CBC, BMP and Head CT were all normal.  Pt was sent home with instructions for seizure first aid.  Patient experienced another seizure on the left side at 0300 the next morning.  Muscle tone and strength were once again diminished, but improved with time.  Patient was transferred to Hospital where Lumbar puncture and EEG were done.  Patient was started on phenobarbital. 2/7/08-records received for DOS 12/29-12/30/07-DC DX: Complex febrile seizures. Esotropia. Two episodes of seizure-like activity in 24 hours prior to admission. Episode of jerking movements, lasting 1-2 minutes involving right side of body, then began limp on right side. Flaccidity. Temperature 101.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lumbar puncture, Lymphocyte percentage increased, Monocyte percentage increased, Muscle twitching, Neutrophil percentage decreased
Clinical narrative: Pediarix, Hib, Prevnar and Rotateq were given at approximately 10:45 am on 12/28/07 following well-child exam.  At approximately 2000 that evening, patient was noted by parents to have twitching of right arm and leg lasting 2 minutes.  No fever present.  Had had some loose stools and thrush noted at exam that morning.  Had been given tylenol that evening at 4 pm.  Was seen in the ER and still had hypotonia and decreased muscle tone of right arm which slowly resolved.  CBC, BMP and Head CT were all normal.  Pt was sent home with instructions for seizure first aid.  Patient experienced another seizure on the left side at 0300 the next morning.  Muscle tone and strength were once again diminished, but improved with time.  Patient was transferred to Hospital where Lumbar puncture and EEG were done.  Patient was started on phenobarbital. 2/7/08-records received for DOS 12/29-12/30/07-DC DX: Complex febrile seizures. Esotropia. Two episodes of seizure-like activity in 24 hours prior to admission. Episode of jerking movements, lasting 1-2 minutes involving right side of body, then began limp on right side. Flaccidity. Temperature 101.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Platelet count normal, White blood cell count increased
Clinical narrative: Pediarix, Hib, Prevnar and Rotateq were given at approximately 10:45 am on 12/28/07 following well-child exam.  At approximately 2000 that evening, patient was noted by parents to have twitching of right arm and leg lasting 2 minutes.  No fever present.  Had had some loose stools and thrush noted at exam that morning.  Had been given tylenol that evening at 4 pm.  Was seen in the ER and still had hypotonia and decreased muscle tone of right arm which slowly resolved.  CBC, BMP and Head CT were all normal.  Pt was sent home with instructions for seizure first aid.  Patient experienced another seizure on the left side at 0300 the next morning.  Muscle tone and strength were once again diminished, but improved with time.  Patient was transferred to Hospital where Lumbar puncture and EEG were done.  Patient was started on phenobarbital. 2/7/08-records received for DOS 12/29-12/30/07-DC DX: Complex febrile seizures. Esotropia. Two episodes of seizure-like activity in 24 hours prior to admission. Episode of jerking movements, lasting 1-2 minutes involving right side of body, then began limp on right side. Flaccidity. Temperature 101.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 12-19-07 child received Varicella vaccination in left arm SC.  Mom called 12-21-07 describing small red spot at injection site loking "like a bee sting".  States child complained of pain in arm at injection site.  No fever, drainage, or rash. Mom instructed to try tylenol or motrin for pain and swelling.  Also try warm or cold compresses to injection site 2-3 times a day as child permits.  Also instructed to call Primary Doctor if condition worsens.  Mom arrived at facility about 2:30 pm stating unable to accomplish above instructions as child too painful.  Child very tender to light touch.  Small hard red bump about the size of eraser head, pinpoint noted in center, no drainage. Instructed mom to notify PMD for appt. today.  We called Primary Doctor from our office and there were no appts. available for today. Primary Doctor instructed mom to take child to Promptcare for assessment of potential "sterile abcess". Mom states will followup with us as to outcome. Mom did not call back as of today (12-31-07) and we have made several attempts to contact mom via phone with no answer.  Message left for mom to call us.
Age: 1.17
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site mass
Clinical narrative: Patient had a quarter size lump on her thigh.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Blister, Rash erythematous, Rash macular, Varicella
Clinical narrative: Patient presented with mildly erythematous macular blanching rash on trunk. Three lesions, vesicles, on erythematous base consistent with Varicella per physician exam.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Forwarding information