chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated by HPV vaccine, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection.  The pain lasted for 2 days and then resolved.  The patient was treated with warm compresses. The patient sough unspecified medical attention.  Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injections. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the tiem of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sough unspecified medical attention. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Gastrointestinal disorder, Stool analysis normal
Clinical narrative: Information has been received from a physician concerning a 6-month-old female with no medical history who on 05-Sep-2006 was vaccinated PO with a 2.0 ml dose of Rotateq (lot #654504/0695F). The physician reported that in 2006 the patient experienced persistant GI symptoms. Unspecified medical attention was sought. Stool studies were negative with positive reducing substances. The patient was placed on a trial Proleen hydrolysate formula. By 13-Oct-2006, the patient was considered to be recovered as her symptoms improved. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, HIBV, IPV, PPV, RV5
Symptoms: Barium enema, Intussusception, Lethargy, Vomiting, X-ray
Clinical narrative: Initial report received on 07 February 2007, from other manufacturer (under the reference number WAES0701USA04389). The other manufacturer received the initial information from the agency through another agency. A 20-week old female patient with no medical history received on the evening of 08 December 2006 the second intramuscular dose of Daptacel, intramuscular into the left leg (lot number C2521AA) second intramuscular dose of ActHib into the right leg (lot number UF051AA, which corresponds to the manufacturer reported lot number Z0990-2), second oral dose of Rotateq (lot number 655406/1114F), second intramuscular dose of IPOL (lot number Y1031) and second intramuscular dose of Prevnar into the right leg (lot number 806681F). Illness at the time of vaccination included vomiting. On the morning of 20 December 2006, 12 days post vaccination, the patient was diagnosed intussusception characterized vomiting and lethargy. The patient was hospitalized for one day and intussusception was reduced with barium enema (on 20 December 2006). The patient underwent a UGI with small bowel swallow through 21 December 2006 to rule out malrotation. The patient subsequently recovered.
Age: 0.35
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, HIBV, IPV, PPV, RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Initial report received on 07 February 2007, from other manufacturer (under the reference number WAES0701USA04389). The other manufacturer received the initial information from the agency through another agency. A 20-week old female patient with no medical history received on the evening of 08 December 2006 the second intramuscular dose of Daptacel, intramuscular into the left leg (lot number C2521AA) second intramuscular dose of ActHib into the right leg (lot number UF051AA, which corresponds to the manufacturer reported lot number Z0990-2), second oral dose of Rotateq (lot number 655406/1114F), second intramuscular dose of IPOL (lot number Y1031) and second intramuscular dose of Prevnar into the right leg (lot number 806681F). Illness at the time of vaccination included vomiting. On the morning of 20 December 2006, 12 days post vaccination, the patient was diagnosed intussusception characterized vomiting and lethargy. The patient was hospitalized for one day and intussusception was reduced with barium enema (on 20 December 2006). The patient underwent a UGI with small bowel swallow through 21 December 2006 to rule out malrotation. The patient subsequently recovered.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 60 year old male with acromegaly, diabetes and mitral valve prolapse who on 21-NOV-2006 was vaccinated SC in the left arm with a 0.65 ml dose of Zostavax (lot #652925/0621F). Two weeks prior to vaccination, on approximately 07-NOV-2006, the patient was vaccainted in the left arm with a dose of influenza virus vaccine (unspecified). On 04-DEC-2006 the patient presented to the office complaining of left arm and shoulder pain. No fever and no other complaints were noted. The patient had symptomatic treatment. At the time of the report, the patient had no recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 60 year old male with acromegaly, diabetes and mitral valve prolapse who on 21-NOV-2006 was vaccinated SC in the left arm with a 0.65 ml dose of Zostavax (lot #652925/0621F). Two weeks prior to vaccination, on approximately 07-NOV-2006, the patient was vaccainted in the left arm with a dose of influenza virus vaccine (unspecified). On 04-DEC-2006 the patient presented to the office complaining of left arm and shoulder pain. No fever and no other complaints were noted. The patient had symptomatic treatment. At the time of the report, the patient had no recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, HIBV, PNC, VARZOS, FLU3, HIBV, PNC, VARZOS
Symptoms: Constipation, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known allergies and a history of diaper rash and lacrimal duct obstruction who on 19-JAN-2007 was vaccinated in the left thigh with a dose of Zostavax (lot #654603/1405F) instead of ProQuad. Other concomitant vaccination given the same day included PedvaxHib (lot #652701/1008R), Prevnar and Fluzone. Subsequently the patient developed constipation and threw up once. Other wise he was doing "okay", she reported that he is an active kid and no other changes were noted. The physician reported that the error was "human error" and not product confusion. The Zostavax was stored in the same box as ProQuad, the vial was picked up and administered to the patient without looking. The practice has since separated the vaccines.
Age: 12.0
Sex: M
Vaccine: FLU3, HIBV, PNC, VARZOS, FLU3, HIBV, PNC, VARZOS
Symptoms: Constipation, Inappropriate schedule of drug administration, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known allergies and a history of diaper rash and lacrimal duct obstruction who on 19-JAN-2007 was vaccinated in the left thigh with a dose of Zostavax (lot #654603/1405F) instead of ProQuad. Other concomitant vaccination given the same day included PedvaxHib (lot #652701/1008R), Prevnar and Fluzone. Subsequently the patient developed constipation and threw up once. Other wise he was doing "okay", she reported that he is an active kid and no other changes were noted. The physician reported that the error was "human error" and not product confusion. The Zostavax was stored in the same box as ProQuad, the vial was picked up and administered to the patient without looking. The practice has since separated the vaccines.
Age: 0.15
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 53 day old female who on 12-JAN-2007, at 1300, was vaccinated PO with a 2.0 ml dose of Rotateq. The nurse reported that on the evening of 12-JAN-2007, the patient developed severe diarrhea and vomiting. On 13-JAN-2007, the patient was taken to the emergency room for dehydration, but was not admitted. On 16-JAN-2007, the patient's events resolved. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: RV5, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 53 day old female who on 12-JAN-2007, at 1300, was vaccinated PO with a 2.0 ml dose of Rotateq. The nurse reported that on the evening of 12-JAN-2007, the patient developed severe diarrhea and vomiting. On 13-JAN-2007, the patient was taken to the emergency room for dehydration, but was not admitted. On 16-JAN-2007, the patient's events resolved. Additional information has been requested.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Abdominal X-ray, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Abdominal X-ray, Enema administration, Feeding disorder of infancy or early childhood, Intussusception, Irritability
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Ultrasound abdomen, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Abdominal X-ray, Barium enema, Diarrhoea, Enema administration, Intussusception
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Barium enema, Blood gases abnormal, Diarrhoea, Diet refusal, Intussusception
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 0.49
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Irritability, Pyrexia, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: This report was received from a manufacturer and was assigned manufacturer report number 2007-00116 for DAPTACEL. The report concerned a 6-month-old male (062-54024) with no past medical history who enrolled in a study reported. On 12-DEC-2006, the patient received study therapies which included the third IM dose in the left thigh of DAPTACEL (Lot#C2377A), the third IM dose in the left thigh of ACTHIB (Lot#Y0890) and the third SC dose in the left arm of IPOL (Lot#Y0575). Concomitant vaccinations administered on that same day included the third PO dose Rotateq (human-bovine) (lot number not reported), the third IM dose in the right thigh of RECOMBIVAX HB (yeast) and the third IM dose in the right thigh of PREVNAR. There was no illness at the time of vaccination. On 10-JAN-2007, at 0500, 29 days post third vaccination, the patient developed vomiting, was extremely fussy and did not tolerate oral feeding. The patient was hospitalized with intussusception. An abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant and an abdominal ultrasound revealed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed as he was considered to be recovered (It was noted that because the patient was admitted to the hospital for less than 24 hours there was no discharge summary). The patient continued in the study trial. The investigator considered Rotateq (human-bovine) as having a positive causal relationship to the intussusception. The investigator did not consider the intussusception to be related to DAPTACEL, ACTHIB, IPOL, RECOMBIVAX HB (yeast) or PREVNAR. This was originally reported by a Healthcare Professional, the study investigator. No further information is available.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Cardiac enzymes increased, Catheterisation cardiac normal, Chest X-ray normal
Clinical narrative: Morning of 28 January patient felt chest pain/tightness with associated SOB. Work-up at ER including chest x-ray/EKG/ABG/labor normal with exception of elevated CK. Echo normal, Patient did well until night of 29 January where had additional CP with cardiac enzyme elevation (CK 426, CKMB 29.4, Troponin 8.31) EKG/Echo normal but patient transferred as ACS and underwent cardiac cath for further eval. Cath normal, patient felt well post procedure and discharged (Feb 07 with diagnosis of myopericarditis secondary to small pox vaccination. Currently on Motrin and pain free.  03/05/2007 MR received.   Patient presented to the ER with c/o substernal chest pain 10 days following smallpox vax.   SOB only when lying supine, and increased pain with deep inspiration. Temp.=101.8'F. Pt. had occasional intermittent chest pain relieved with medication until 01/30/2007 when he had an episode lasting 1.5 hours with SOB, and corresponding cardiac enzyme increases.  Pt. transfered to another facility for cardiac catheterization. Cardiology consult impression: Suspected myopericarditis related to recent small pox vaccine.   04/12/2007 MR received from transfer facility.   D/Cd after 2 nights in good condition. Discharge DX: Myopericarditis 2' to small pox vaccine.  Angiographically normal coronary arteries.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Morning of 28 January patient felt chest pain/tightness with associated SOB. Work-up at ER including chest x-ray/EKG/ABG/labor normal with exception of elevated CK. Echo normal, Patient did well until night of 29 January where had additional CP with cardiac enzyme elevation (CK 426, CKMB 29.4, Troponin 8.31) EKG/Echo normal but patient transferred as ACS and underwent cardiac cath for further eval. Cath normal, patient felt well post procedure and discharged (Feb 07 with diagnosis of myopericarditis secondary to small pox vaccination. Currently on Motrin and pain free.  03/05/2007 MR received.   Patient presented to the ER with c/o substernal chest pain 10 days following smallpox vax.   SOB only when lying supine, and increased pain with deep inspiration. Temp.=101.8'F. Pt. had occasional intermittent chest pain relieved with medication until 01/30/2007 when he had an episode lasting 1.5 hours with SOB, and corresponding cardiac enzyme increases.  Pt. transfered to another facility for cardiac catheterization. Cardiology consult impression: Suspected myopericarditis related to recent small pox vaccine.   04/12/2007 MR received from transfer facility.   D/Cd after 2 nights in good condition. Discharge DX: Myopericarditis 2' to small pox vaccine.  Angiographically normal coronary arteries.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Myopericarditis, Troponin increased
Clinical narrative: Morning of 28 January patient felt chest pain/tightness with associated SOB. Work-up at ER including chest x-ray/EKG/ABG/labor normal with exception of elevated CK. Echo normal, Patient did well until night of 29 January where had additional CP with cardiac enzyme elevation (CK 426, CKMB 29.4, Troponin 8.31) EKG/Echo normal but patient transferred as ACS and underwent cardiac cath for further eval. Cath normal, patient felt well post procedure and discharged (Feb 07 with diagnosis of myopericarditis secondary to small pox vaccination. Currently on Motrin and pain free.  03/05/2007 MR received.   Patient presented to the ER with c/o substernal chest pain 10 days following smallpox vax.   SOB only when lying supine, and increased pain with deep inspiration. Temp.=101.8'F. Pt. had occasional intermittent chest pain relieved with medication until 01/30/2007 when he had an episode lasting 1.5 hours with SOB, and corresponding cardiac enzyme increases.  Pt. transfered to another facility for cardiac catheterization. Cardiology consult impression: Suspected myopericarditis related to recent small pox vaccine.   04/12/2007 MR received from transfer facility.   D/Cd after 2 nights in good condition. Discharge DX: Myopericarditis 2' to small pox vaccine.  Angiographically normal coronary arteries.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count, Injection site swelling, Laboratory test, Pyrexia, Tachypnoea
Clinical narrative: Left thigh swelling (almost doubled in size), high fever Tmax 102.9, tachypnea increased 90/min.  2/20/07 Received medical records from reporter/provider which reveal patient experienced:  Initial vs was 12/20/06 for well child first visit exam.  Next seen on 2/8/07 for well child visit & immunizations.  Next seen 2/9/07 s/p ER visit due to fever, tachypnea & left leg swelling where received PCV & HIB vax.  Temp in office 100.4 & started on Tylenol.  Recommended to give only 1 at a time vax next time.  No final dx given.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Fever/lacey rash, Tylenol given
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Convulsion, Pyrexia, Vaccination complication, Viral infection
Clinical narrative: Child developed fever 9 days after Proquad-105 degree fever possible seizure, child brought to ER by ambulance and lab tests Ne, fever under control. D/C on supportive (stable) care possible vaccine reaction/viral syndrome
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: fever-Tylenol given
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Local reaction
Clinical narrative: Local Iz reaction left arm.  6 cm x 8 cm area of diffuse erythema overlying left deltoid.  Nontender-observe.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Local reaction, Oedema, Tenderness
Clinical narrative: local Iz reaction 6 cm x 8 cm diam area of erythema around injection site on left arm, minimal tenderness and edema.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood amylase increased, Blood bilirubin
Clinical narrative: Several hours after receiving Zostavax, patient ate lunch and developed trouble swallowing, was spitting up mucus.  Went to ER and E&D showed food lodged in distal esophagus with wheely non-obstructing esophageal ring.  3 days later 91/29/07) she returned to ER with diffuse chest sinus, fever blisters, nausea, and profuse diarrhea.  Barium swallow was normal except for small hiatal hernia.  Lab remarkable for AST 149 (8-50), AlT 99 (12-46), total bilirubin 2.3, alkaline phosphatase NL. Lipase 75 (16-63) seen 2/1/07 in my office.  Improved 81 symptoms-no nausea/diarrhea.  AST 22, ALT 42 (5-40), Bilirubin 0.6, Amylase Nl.  Her physician postulates passed CBD stone (through s/p cholg) I am reporting since Zostavax was given in proximity to abnormal liver tests.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Diarrhoea, Dysphagia, Herpes simplex, Hiatus hernia
Clinical narrative: Several hours after receiving Zostavax, patient ate lunch and developed trouble swallowing, was spitting up mucus.  Went to ER and E&D showed food lodged in distal esophagus with wheely non-obstructing esophageal ring.  3 days later 91/29/07) she returned to ER with diffuse chest sinus, fever blisters, nausea, and profuse diarrhea.  Barium swallow was normal except for small hiatal hernia.  Lab remarkable for AST 149 (8-50), AlT 99 (12-46), total bilirubin 2.3, alkaline phosphatase NL. Lipase 75 (16-63) seen 2/1/07 in my office.  Improved 81 symptoms-no nausea/diarrhea.  AST 22, ALT 42 (5-40), Bilirubin 0.6, Amylase Nl.  Her physician postulates passed CBD stone (through s/p cholg) I am reporting since Zostavax was given in proximity to abnormal liver tests.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Lipase increased, Nausea, Oesophageal obstruction, Vomiting
Clinical narrative: Several hours after receiving Zostavax, patient ate lunch and developed trouble swallowing, was spitting up mucus.  Went to ER and E&D showed food lodged in distal esophagus with wheely non-obstructing esophageal ring.  3 days later 91/29/07) she returned to ER with diffuse chest sinus, fever blisters, nausea, and profuse diarrhea.  Barium swallow was normal except for small hiatal hernia.  Lab remarkable for AST 149 (8-50), AlT 99 (12-46), total bilirubin 2.3, alkaline phosphatase NL. Lipase 75 (16-63) seen 2/1/07 in my office.  Improved 81 symptoms-no nausea/diarrhea.  AST 22, ALT 42 (5-40), Bilirubin 0.6, Amylase Nl.  Her physician postulates passed CBD stone (through s/p cholg) I am reporting since Zostavax was given in proximity to abnormal liver tests.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dyspnoea, Pruritus, Rash generalised, Urticaria
Clinical narrative: 1/11/07 patient received inj (Fluzone) influenza vaccine. Patient reported adverse reaction to health dept on 1/16/07 c/o trouble breathing-use of own inhaler more often, hives/rash "all over body"-use of Benadryl cream.  Severe itching, on 1/19/07 seen by PCP-Dr, NP.  Rash better, breathing better, and no other treatments by NP, patient recovering.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Headache, Hypotension, Somnolence, Vomiting
Clinical narrative: Early in the am of 2/2/2007, patient woke with sudden onset of vomiting, dizziness, and severe headaches.  Seen by primary care physician later in the day with noticeable hypotension.  Remained in bed over the weekend, sleeping most of the time and taking Motrin for headache.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red swollen area, warm to touch 1" x 1 1/4" in size, Tylenol for comfort
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, IPV, SMALL, TTOX, TYP
Symptoms: Arthralgia, Cardiac murmur, Cerebrovascular accident, Hypertension, Hypoacusis
Clinical narrative: 1. Permanent hypertension. 2. Stomach problems. 3. Brain disorder unknown causes.  3/19/07 Received medical records from VAMC which reveal patient experienced HTN for approx 13 yrs, traumatic LBP w/radiation to left leg since lifting heavy equip while active duty 2003 w/intermittent exacerbations, herpes labialis, heart murmur & hyperlipidemia/hypercholesterolemia, ETOH abuse.  Had been active duty for 15 mos in Iraq prior to being evaluated. Received multi sessions of PT for back pain w/good results. Had episode of vertigo in 11/06 following cold s/s which required hospitalization. Neuro consult revealed tandem gait ataxia. Final dx: benign positional vertigo vs vestibular neuronitis or viral labyrinthitis.  ENT/audiology w/u was WNL w/mild sensorineural hearing loss right ear & right vestibular hypofunction & patient referred for vestibular rehabilitation. Per annual follow up: Hypertension, articular pain (or joint), had suffered an acute CVA. I am sumitting a copy of my vaccination record with some of the manufacturer and lot number and the amount or cc administered.
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, IPV, SMALL, TTOX, TYP
Symptoms: Scan brain
Clinical narrative: 1. Permanent hypertension. 2. Stomach problems. 3. Brain disorder unknown causes.  3/19/07 Received medical records from VAMC which reveal patient experienced HTN for approx 13 yrs, traumatic LBP w/radiation to left leg since lifting heavy equip while active duty 2003 w/intermittent exacerbations, herpes labialis, heart murmur & hyperlipidemia/hypercholesterolemia, ETOH abuse.  Had been active duty for 15 mos in Iraq prior to being evaluated. Received multi sessions of PT for back pain w/good results. Had episode of vertigo in 11/06 following cold s/s which required hospitalization. Neuro consult revealed tandem gait ataxia. Final dx: benign positional vertigo vs vestibular neuronitis or viral labyrinthitis.  ENT/audiology w/u was WNL w/mild sensorineural hearing loss right ear & right vestibular hypofunction & patient referred for vestibular rehabilitation. Per annual follow up: Hypertension, articular pain (or joint), had suffered an acute CVA. I am sumitting a copy of my vaccination record with some of the manufacturer and lot number and the amount or cc administered.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Throat tightness, Urticaria
Clinical narrative: hives, tightness in throat-started 1 1/2 hour after injection-given Zyrtec 10 mg and Benadryl and Adsar
Age: 15.0
Sex: M
Vaccine: FLU3, HEP, MMRV
Symptoms: Rash papular
Clinical narrative: Rash developed papulovesicular for 2 days 2/10 and 2/11/07
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Skin exfoliation, Swelling
Clinical narrative: 2-1-7 2" size redness with brown center at injection site. No hard not hot, no pain. 2-2 Benadryl for same signs/symptoms-cancelled MD appt. 2-5 at MD appt 4 x 5 cm area of swelling, redness with sloughing of skin in stellate pattern.  No signs/symptoms infection
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination complication
Clinical narrative: Reaction to vaccine-emergency hospital treatment
Age: 56.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Oedema peripheral
Clinical narrative: Left arm swelled down to wrist. Pt saw private physician who put her on steroids and antibiotics
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: 10 min after injection dizziness, lightheaded continued a few hours. Next day, extremely tired.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray, Febrile convulsion, Unresponsive to stimuli
Clinical narrative: Pt brought to ER 11/4/06 by grandma with chief complaint of unresponsiveness. T-101.5 rectally in ER. Dx-probable febrile seizure, probable febrile illness, unresponsive, resolving, probably secondary to the immunization. Thought she had afebrile fever from ER- but since then MRI showed hydrocephalus and a cyst in brain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin discolouration, Skin warm, Swelling
Clinical narrative: Swollen, red, purple bruise, warm to touch/Tylenol given, warm/cool compress
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: "my arm (left) hurts and there is some redness.  .3cm erythema distal and medial to injection site. Warm to touch.
Age: 0.52
Sex: F
Vaccine: HIBV, PNC
Symptoms: Erythema, Induration, Swelling
Clinical narrative: swelling, redness, firm to touch on right thigh
Age: 41.0
Sex: M
Vaccine: BCG, HEP, TTOX, HEP, TD
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Left arm swelling and redness. Pain scale 5 out of 10, area hard.
Age: 41.0
Sex: M
Vaccine: BCG, HEP, TTOX, HEP, TD
Symptoms: Erythema, Injection site induration, Injection site pain, Oedema peripheral
Clinical narrative: Left arm swelling and redness. Pain scale 5 out of 10, area hard.
Age: 41.0
Sex: M
Vaccine: HEP, TTOX, HEP, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Tremor
Clinical narrative: Injection site red, slight swelling, and painful pain scale 4 out of 10. Patient complained of fever 102 and shaking of arm
Age: 26.0
Sex: F
Vaccine: BCG, TD, TD
Symptoms: Injection site nodule
Clinical narrative: Nodule at injection site
Age: 1.5
Sex: M
Vaccine: MMR, PPV
Symptoms: Blood culture, Meningitis pneumococcal, Pyrexia
Clinical narrative: Child had high fever on 12/25/06.  He was treated with Ceftriaxone and Amoxicillin. He recovered quickly without complications.  Doing fine now
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash on the abdomen.  Pen umblical region.  Zyrtec long daily
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Swelling
Clinical narrative: pt received Pediarix, vaccine and had finer, swelling, redness left thigh
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Received Pneumovax approx 10:00 am, by 12:30 pm she noticed swelling, hotness, redness, pain and itching in left arm, fingers, breast area and into neck.  Has gotten worse in pas 24 hours; has tried Aleve (Advil) with some relief.  Dr. recommends by phone to taken Benadryl 25-50 mg every 6 hours as needed. To follow up if not better in 2 days or gets worse.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Eye swelling, Pruritus, Rash, Swelling face
Clinical narrative: Swelling of face and eyes.  Itching of eyes, rash on anterior chest and neck symptoms/symptoms occurred 2 days after vaccine treatment.  OTc Benadryl
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Swelling, Urticaria
Clinical narrative: Client presented to clinic for 2nd MMR upon asking screening questions, she said she did not do well with her 1st MMR vaccine.  States her brother told her that she "broke out in the hives and swelled up" Referred pt for MMR medical or to his private doctor. client will not return my calls to complete this form.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Right arm swollen (patient stated 2-3 times size of left arm). Patient was instructed to put ice on arm and take some Benadryl.
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Nerve conduction studies
Clinical narrative: Seriousness criteria, other medically significant. Initial report received on 01 February 2007 from a consumer. A female patient (demographics not reported) reported that she had received a Tetanus Toxoid injection (date not provided), and since that time has had problems that include loss of feeling in her right hand, that it is gradually coming back. The patient went to the emergency room where she was evaluated by a neurologist who did nerve conduction tests. The trade name, manufacturer name, route and site of administration of the Tetanus Toxoid vaccination was not provided.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Bone densitometry, Chronic inflammatory demyelinating polyradiculoneuropathy, Facial palsy, Hyperaesthesia
Clinical narrative: The patient's problems started about 5 to 6 days ago when she started having some spasms in the back with some numbness, tingling in the legs. She did see a neurosurgeon who ordered MRI of the thoracic spine and the lumbar spine. This appeared to be essentially unremarkable, slight pinching of the sacral sac. While this was going on, she started having more and more weakness and numbness in the legs. She went to the emergency room. She was given pain medication and was sent home. She got worse, went to the emergency room and again was treated with pain medication Norflex and anxiety medication that seems to make her feel a little bit better. She went home and then was unable to walk unsteady. On examination she was found to have no deep tendon reflexes in the lower legs and sensory level to L1. Myelopathy or AIDP diagnoses was made and she was immediately admitted now with neurology consultation. Further work-up will be done here immediately. The patient who is well known to me has no previous neurological problems. She has been treated in the past for hypercholesterolemia but otherwise the labs essentially have been normal. She has been in good health. She is up-to date with her DEXA scan which shows mild osteopenia. She is very active. She had hysterectomy in 2002. Otherwise she has absolutely no medical or surgical problems. She does take vitamins at home. Otherwise, no other pertinent medical/surgical history. Within the last 24-48 hours she has also developed acute left facial palsy. She complains of marked tingling, numbness, hyperesthesias both legs as well as tips of her fingers.  02/19/2007 VAERS report received with accompanying medical records (H&P, labs and diagnostics).  Made call to hospital to see if D/C Summary had been dicated yet, it has not.  TC to admitting MD who stated D/C DX was the same: Acute GBS, Acute left Bells' Palsy.  HPI: Two and 1/2 weeks after receiving flu vax. pt. began having back spasms and numbness/tingling in the legs.  Two ER visits over several days resulted in tx. with pain  meds, muscle relaxers, and anti-anxiety medication. Finally presented to admitting MD when she was unable to walk properly, gait unsteady.  C/o marked numbness, tingling, hyperesthesias of both legs as well as the tips of her fingers PE: No DTRs in lower extremities. Sensory level to L1.  Sensation is lost to the groin.  Gait unsteady and shuffling. On approx. 2/10/2007 she developed acute left facial palsy. Admitted to IMCU for Stat work-up.  Transfered to rehab after 3 days. Admission DX:  1) Acute Guillain-Barre Syndrome, AIDP, r/o CIDP 2) Acute left Bell's Palsy.  (MD states D/C DX is the same.) Per information received from annual, residual sensory and motor neurological symptoms legs & back, otherwise almost complete recovery. Return to work period including rehabilitative physical therapy of almost 1 yr duration.