chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, TYP, YF
Symptoms: Hepatic enzyme abnormal, No adverse effect
Clinical narrative: Pt had history of receiving Hepatitis B series several years ago. Desired vaccination with Hepatitis A and was given Twinrix. Pt concerned about liver status and wanted maximum  Hepatitis A protection for trip out of country. On 4/8/07 pt denies problems.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Blindness, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of multiple sclerosis in a 11-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown). It was reported that the subject either received two or three doses of the hepatitis B series. About two years after receiving the hepatitis B vaccine, the subject developed multiple sclerosis. The initial symptoms was blindness, and it was initially thought that the subject had mitochrondrial disease, but that was ruled out. The healthcare professional considered the events were disabling. An MRI performed on an unspecified date showed lesions indicative of multiple sclerosis. The reporter stated that the subject was "not doing well", but she stated that she did not known what that meant since she isn't working with the subject directly. At the time of reporting the events were unresolved. No additional information was reported.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Echocardiogram abnormal
Clinical narrative: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center.  T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced.  Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism.  Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle.  6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive     a. pulmonary trunk, left hilar & peripheral vessels     b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera    a. no evidence of anomalous coronary artery distribution    b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Circulatory collapse, Coronary artery thrombosis, Echocardiogram abnormal, Pulmonary embolism, Sudden cardiac death
Clinical narrative: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center.  T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced.  Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism.  Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle.  6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive     a. pulmonary trunk, left hilar & peripheral vessels     b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera    a. no evidence of anomalous coronary artery distribution    b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thrombosis
Clinical narrative: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center.  T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced.  Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism.  Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle.  6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive     a. pulmonary trunk, left hilar & peripheral vessels     b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera    a. no evidence of anomalous coronary artery distribution    b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Very tender, swollen at injection site L upper arm
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Convulsion, Tremor
Clinical narrative: A few hours after receiving vaccine mom noticed Right arm and Right leg seizure and tremors pursue Paramedics arrived gave IM Benadryl Patient taken to ER given PO Benadryl with resolution.
Age: 1.19
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Agitation, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Parents & child came over the clinic after 2 days of vaccinating stated child both thighs are sore and child was fussy. Noted both thighs are swollen with redness and hot to touch. No temp reported high. Told parents will have moderate soreness welling and redness and normal after having shots. No treatment done.
Age: 1.12
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 3/30/07 fever 103 rectal; continues as low grad as of 4/2/07. 3/31/07 light cough and runny nose; cough progressing. 4/1/07 rash - lower abd and back.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pain in extremity
Clinical narrative: Sore R arm after vaccine received on 3/22/07. It has continued and not changed in intensity.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Patient passed out. Blood pressure remained too low for patient to get off floor for 1% 1/2 hrs.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site rash
Clinical narrative: Raised/circumscribed rash over left deltoid area at ER. Several inches in diameter.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypersensitivity, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Day after vaccine administered, awakened with stiff neck on left side. Unable to touch head, pain from back of head to deltoid went home from work, took Advil and slept. Next day improved, but not resolved. Symptoms for 3 days.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eye rolling
Clinical narrative: Received MMR and Varicella on 2/19/07 and next day noted to have upward rolling of eyelids lasting only for a few seconds. No color change, no tonic/clonic movement of extremities.
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Rash generalised, Swelling
Clinical narrative: Notices 4/3/07 at 7:00 pm swollen red small induration 4/14/02. 4 1/2 cm x 5 1/2 cm induration right hand, body rashes
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: hives after varicella vaccine. Had previous diagnosis of similar reaction after immunization Pt. allergic to gelatin.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: after vaccines 3/26/07 patient had onset of redness and swelling on left anterior thigh around site of Pediarix and pneumo vaccines.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: left arm with edema erythema, tenderness and increased warmth x 1 day. No fever-subjective Rx: Motrin and Hydroxyzine
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site scar, Injection site swelling, Injection site warmth
Clinical narrative: DTap given at left thigh- 3-29-07. 3-30-07 Today appt- with Dr left thigh swollen, warm to touch. Played last night and had scrapes on the site.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever to 104, body aches, nausea/vomiting with few hours of vaccine. Prescribed with Tylenol and Ibuprofen
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever to 104, body aches, nausea/vomiting with few hours of vaccine. Prescribed with Tylenol and Ibuprofen
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV, DTAP, HIBV, IPV, PNC, RV
Symptoms: Crying, Oedema peripheral, Pyrexia
Clinical narrative: Initial report received from a health care professional in the USA on 29, January 2007. A 2 month old, male patient developed leg swelling, fever (100.3 - 101.0) and excessive crying after he received Daptacel (lot number C2650AA) intramuscularly in the left leg; Act-HIB (lot number reported UE999AK, corresponding sp SA lot number Z0760-2) intramuscularly in the left leg; IPOL (lot number Z0018) intradermally in the right leg; Prevnar (Lederle, lot number B08670D) intramuscularly in the right leg and RotaShield (Merck, lot number 0940F) per os, on 22 January 2007 at 4:00 PM. The patient did not have any illness at the time of vaccination. He also received Recombivax (Merck, lot number 0610F) intramuscularly in the left leg on 22 December 2006. It was not reported the patient recovered. This case has the same reporter as cases 2007-00288 and 2007-00290
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
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: Initial report received on 12 January 2007 from the study. This subject, a 6-month-old male diagnosed with "intussusception" and was admitted to the hospital. The subject received on 12 December 2006 the third dose of study vaccines: IPOL (lot number Y0575-2) subcutaneous into the left upper arm, ActHib (lot number UE709AA, corresponds to lot number Y0890) intra-muscular into the lower left thigh and Daptacel (lot number C2377A) intra-muscular into the upper left thigh. On 10 January 2007 at 05:00 hours, 29 days post third vaccination, the subject was extremely fussy and did not tolerate oral feeding. "Intussusception" was diagnosed. Subject admitted to the hospital and the diagnosis was confirmed via x-ray. The subject was treated with barium enema and discharged on 11 January 2007. The subject had diarrhea and fever since. At the time of this report, 12 January 2007, the subject's outcome was unknown. The event of "intussusception" was reported by the investigator as unrelated to the study vaccines. Follow-up information received on 29 January 2007. The subject experienced fussiness, feeding refusal, and vomiting 29 days post-immunization and was subsequently admitted to the hospital with intussusception. Because the subject was admitted to the hospital for less than 24 hours, there was no discharge summary. Abdominal x-ray showed findings suspicious for intussusception in the right upper quadrant, and abdominal ultrasound showed right upper quadrant colonic intussusception. Radiology report of enema with 17% cysto Conray contrast revealed successful intussusception reduction. According to the investigator, the event was not related to the study vaccines Daptacel, IPOL, and ActHib or the concomitant vaccines Recombivax and Prevnar. The subject had also received a concomitant, third dose, oral administration of Rotateq, lot number not reported, on 12 December 2006. The investigator reported Rotateq as having a positive causal relationship to the event of intussusception. The reporting of this case was upgraded secondary to this new information. The subject recovered from the event on 11 January 2007 and continued in the study trial.
Age: 22.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Asthenia, Body temperature fluctuation, Body temperature increased, Diarrhoea, Dizziness
Clinical narrative: Took oral Typhoid 3/18 at 0400, 0800 feeling cold, shaking, generalized body aching and headache, T= 99; throat sore later, difficulty ambulating due to lack of energy; persistent dizziness, temperature rose during day; at 2030, in ER temp 103; no home care prior to ER, in ER, no care, no tests, no labs, no exam; was given Motrin x 3 tabs; released at 4AM, temp at that time = 99; on 3/19 at home lack of energy persisted, temp off/on up to 101, responded to Motrin; diarrhea and vomiting several times; missed work 3/20 due to continued symptoms; called our clinic and reported situation on 3/19; advised to d/c. Vivotif and continue home/symptomatic care.
Age: 22.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Feeling cold, Gait disturbance, Headache, Pain, Pharyngolaryngeal pain
Clinical narrative: Took oral Typhoid 3/18 at 0400, 0800 feeling cold, shaking, generalized body aching and headache, T= 99; throat sore later, difficulty ambulating due to lack of energy; persistent dizziness, temperature rose during day; at 2030, in ER temp 103; no home care prior to ER, in ER, no care, no tests, no labs, no exam; was given Motrin x 3 tabs; released at 4AM, temp at that time = 99; on 3/19 at home lack of energy persisted, temp off/on up to 101, responded to Motrin; diarrhea and vomiting several times; missed work 3/20 due to continued symptoms; called our clinic and reported situation on 3/19; advised to d/c. Vivotif and continue home/symptomatic care.
Age: 22.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Tremor, Vomiting
Clinical narrative: Took oral Typhoid 3/18 at 0400, 0800 feeling cold, shaking, generalized body aching and headache, T= 99; throat sore later, difficulty ambulating due to lack of energy; persistent dizziness, temperature rose during day; at 2030, in ER temp 103; no home care prior to ER, in ER, no care, no tests, no labs, no exam; was given Motrin x 3 tabs; released at 4AM, temp at that time = 99; on 3/19 at home lack of energy persisted, temp off/on up to 101, responded to Motrin; diarrhea and vomiting several times; missed work 3/20 due to continued symptoms; called our clinic and reported situation on 3/19; advised to d/c. Vivotif and continue home/symptomatic care.
Age: 40.0
Sex: F
Vaccine: IPV, YF
Symptoms: Axillary mass, Axillary pain, Erythema, Lymphadenopathy, Mammogram normal
Clinical narrative: C/O Pain, left armpit lump; "node" enlarged red, and painful. "Very large" 1 inch. 3/19 Saw MD, no infection noted. Never had mammogram - sent for one (negative) still painful 3/28 enlargement less. No redness
Age: 0.12
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Body temperature increased, CSF culture negative, Culture stool negative, Culture urine positive
Clinical narrative: 3/14/07 - At 1pm developed generalized rash. 3/15/07 At 6:00am, T.100.4 at 7:30 increase 101.5. Seen in primary care office. Fever and diffuse erythema multiforme - sent to E.D04/17/07-records received from facility for DOS 3/21/07-DX:Fever, erythema multiforme, urinary tract infection. Temp in ER 100.7 (R) repeat 101.Seen in ER nine days prior with same complaints. Treated with antibiotics. Diarrhea developed. Urticarial looking rash 24 hours after vaccine.
Age: 0.12
Sex: F
Vaccine: HEP
Symptoms: Erythema multiforme, Influenza serology negative, Pyrexia, Rash generalised, Urinary tract infection
Clinical narrative: 3/14/07 - At 1pm developed generalized rash. 3/15/07 At 6:00am, T.100.4 at 7:30 increase 101.5. Seen in primary care office. Fever and diffuse erythema multiforme - sent to E.D04/17/07-records received from facility for DOS 3/21/07-DX:Fever, erythema multiforme, urinary tract infection. Temp in ER 100.7 (R) repeat 101.Seen in ER nine days prior with same complaints. Treated with antibiotics. Diarrhea developed. Urticarial looking rash 24 hours after vaccine.
Age: 0.12
Sex: F
Vaccine: HEP
Symptoms: Urine analysis normal, Virus serology test
Clinical narrative: 3/14/07 - At 1pm developed generalized rash. 3/15/07 At 6:00am, T.100.4 at 7:30 increase 101.5. Seen in primary care office. Fever and diffuse erythema multiforme - sent to E.D04/17/07-records received from facility for DOS 3/21/07-DX:Fever, erythema multiforme, urinary tract infection. Temp in ER 100.7 (R) repeat 101.Seen in ER nine days prior with same complaints. Treated with antibiotics. Diarrhea developed. Urticarial looking rash 24 hours after vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Chest X-ray, Dehydration, Febrile convulsion, Fluid replacement, Full blood count
Clinical narrative: Received immunizations 3/20/07, Approx 0930, Febrile that evening. Parent managed with Tylenol and Motrin. Approx 0400 on  3/21/07 parents reported seizure lasting approx 5 minutes & called ambulance. Evaluated in ER - CXR, UA, CBC, BMP - received IV fluids & baby remained postical for prolonged periods & not taking Good PO & admitted to pediatric unit for observation. Discharged 3/22/07 Assessment: Febrile seizure, Dehydration, Otitis Media. 05/15/07-records received for DOS 3/21-3/22/07-DC DX:Febrile seizure, status post immunizations. Otitis media. Viral illness at time of immunization included fever, conjunctivitis, runny nose and cough. On day of admission fever and 5 minute tonic-clonic seizure resolved with some lasting pallor and cyanosis. max temp in hospital 37.2.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Metabolic function test, Oral intake reduced, Otitis media, Postictal state, Pyrexia
Clinical narrative: Received immunizations 3/20/07, Approx 0930, Febrile that evening. Parent managed with Tylenol and Motrin. Approx 0400 on  3/21/07 parents reported seizure lasting approx 5 minutes & called ambulance. Evaluated in ER - CXR, UA, CBC, BMP - received IV fluids & baby remained postical for prolonged periods & not taking Good PO & admitted to pediatric unit for observation. Discharged 3/22/07 Assessment: Febrile seizure, Dehydration, Otitis Media. 05/15/07-records received for DOS 3/21-3/22/07-DC DX:Febrile seizure, status post immunizations. Otitis media. Viral illness at time of immunization included fever, conjunctivitis, runny nose and cough. On day of admission fever and 5 minute tonic-clonic seizure resolved with some lasting pallor and cyanosis. max temp in hospital 37.2.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Urine analysis
Clinical narrative: Received immunizations 3/20/07, Approx 0930, Febrile that evening. Parent managed with Tylenol and Motrin. Approx 0400 on  3/21/07 parents reported seizure lasting approx 5 minutes & called ambulance. Evaluated in ER - CXR, UA, CBC, BMP - received IV fluids & baby remained postical for prolonged periods & not taking Good PO & admitted to pediatric unit for observation. Discharged 3/22/07 Assessment: Febrile seizure, Dehydration, Otitis Media. 05/15/07-records received for DOS 3/21-3/22/07-DC DX:Febrile seizure, status post immunizations. Otitis media. Viral illness at time of immunization included fever, conjunctivitis, runny nose and cough. On day of admission fever and 5 minute tonic-clonic seizure resolved with some lasting pallor and cyanosis. max temp in hospital 37.2.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Convulsion
Clinical narrative: Hosp 3/14/07 for seizure observed by mom 05/15/07-records received from facility. 2 month old with cluster of short paroxysmal episodes consistent with generalized tonic-clonic seizures in otherwise healthy infact with no neurologic or developmental issues. If true seizure probably related to DTaP given 2 days prior to admission. Seizures otherwise isolated and patient would be unlikely to have long term sequelae. Monitored overnight for seizures.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Pain
Clinical narrative: 2 Days after vaccine (Adacel) patient had fatigue, headache, body aches.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dizziness, Dry mouth, Dyspnoea, Lethargy
Clinical narrative: Chest pains, rapid breathing, vomiting, neck, arm and shoulder pains. Fever of 104, lethargic, very dry mouth, swollen arm (arm injected), dizziness and more.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Chest pains, rapid breathing, vomiting, neck, arm and shoulder pains. Fever of 104, lethargic, very dry mouth, swollen arm (arm injected), dizziness and more.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Chest pains, rapid breathing, vomiting, neck, arm and shoulder pains. Fever of 104, lethargic, very dry mouth, swollen arm (arm injected), dizziness and more.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Right arm large (13x9 cm) red, hot, painful area. No fever. Tx: Keflex 250/5ml 1 tsp PO 96 hours x 7 days, Benadryl 12.5/5ml 1/2 tsp PO q4-6 PRN itching PRN ice/ Tylenol. Follow-up 4-5 days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: Left arm red, swollen from elbow to upper arm. Central blanching (4 cm diameter) at injection site. Low grade fever 24 hours after shot. Arm is swollen significantly now 2 days after shot.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Pruritus
Clinical narrative: Day after Tdap patient started itching on right supraorbital region with progressed to swelling over the weekend. Started on Prednisone 60mg x 5 days.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction left deltoid site of Pneumovax injection, administered along with Influenza vaccination on 3/23, started 3/25 symptoms resolved by 3/28.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash, Itchy
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Severe headache, dizziness, fever of 104 deg (decreasing after 2 days) Given at ER: Ibuprofen 500MG Q 3-4 HRS.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site cellulitis, White blood cell count increased
Clinical narrative: Pt given Pneumovax & Influenza vaccine in left deltoid IM 1 inch apart. Pt to ER on 3-11-07. Treated with Rocephin 1 gm IM and Toradol 60mg IM. Pt seen again on 3-12-07 in clinic - treated with Augmentin 875 mg PO Q 12 hrs x 10 days. Pt has not been seen in clinic since this visit.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Lt thigh 3cm indurated, mobile, non tender, swelling, no redness.
Age: 27.0
Sex: M
Vaccine: MEN
Symptoms: Back pain, Chest pain, Injection site cellulitis, Injection site pain, Joint range of motion decreased
Clinical narrative: Left shoulder injection site cellulitis pain 7/10. Decreased left arm range of motion. Left chest shoulder and back pain 7/10.
Age: 27.0
Sex: M
Vaccine: MEN
Symptoms: Musculoskeletal pain
Clinical narrative: Left shoulder injection site cellulitis pain 7/10. Decreased left arm range of motion. Left chest shoulder and back pain 7/10.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and erythema right upper arm
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Headache, Muscular weakness
Clinical narrative: headache, dizziness when walks, legs/arms weak
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hypokinesia, Injection site rash, Nausea, Pain in extremity
Clinical narrative: Gave shot 3-27-07 that night arm very sore could not lift. 3-28-97 started with fever of 101.9 and rash just below injection site. Very tired, nauseous, no rash present when seen in office at 1845 on 3/28/07.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Gave shot 3-27-07 that night arm very sore could not lift. 3-28-97 started with fever of 101.9 and rash just below injection site. Very tired, nauseous, no rash present when seen in office at 1845 on 3/28/07.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Red induration  on Left deltoid area. Measures about 24x12 area. Patient able to move extremities. Recommended local measurement to local reaction. No treatment needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Rash all over body
Age: 23.0
Sex: F
Vaccine: ANTH, HPV4, SMALL
Symptoms: Abdominal pain, Back pain, Pyrexia, Rash pruritic
Clinical narrative: 1-2 wk-fever, lower back pain, lower abdominal pain. 23-MAR-broke out in small red bumps that got bigger and itched really bad.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Chest X-ray normal, Dizziness, Dyspnoea, Headache
Clinical narrative: Presented to ER with c/o pain in left arm, unable to raise arm, headache, throat swelling, mild SOB, dizzy. Temp to 101, cough, sneezing. Diagnosis - acute URI with local reaction to Pneumovax. Patient given Darvocet, Benadryl and Albuterol med nebulizer. Discharged home.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site reaction, Pain in extremity, Pharyngeal oedema, Sneezing
Clinical narrative: Presented to ER with c/o pain in left arm, unable to raise arm, headache, throat swelling, mild SOB, dizzy. Temp to 101, cough, sneezing. Diagnosis - acute URI with local reaction to Pneumovax. Patient given Darvocet, Benadryl and Albuterol med nebulizer. Discharged home.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Upper respiratory tract infection
Clinical narrative: Presented to ER with c/o pain in left arm, unable to raise arm, headache, throat swelling, mild SOB, dizzy. Temp to 101, cough, sneezing. Diagnosis - acute URI with local reaction to Pneumovax. Patient given Darvocet, Benadryl and Albuterol med nebulizer. Discharged home.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Oedema peripheral
Clinical narrative: Patient received zoster vaccine right triceps on 3/28/07, on 3/29/07 awakened with swollen hand, then developed blister without redness. (No bruising at injection site or down the arm)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Irritability, Pyrexia
Clinical narrative: Irritable in 24 hours. Low grade fever - Tylenol given small bumps
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: The patient's first dose of Rotateq was inadvertently administered last week on 3/21/07, patient was 17 weeks of age. Parent is. At the time of this report, attempts to contact parent by telephone have been successful. We will mail an appointment card for catchup immunizations next month and notify her of this administration error recommendation to complete the Rotavirus vaccination series per schedule. Please see attached email correspondence.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Wed March 21, 2007 at 6:55pm. His whole arm around the injection site is swollen. No fever, no streaking. Using cool compresses and Benadryl 12.5 mg 1 tsp q4-6 hours.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient received Varicella vaccine on 3-22-07. Moc returned to clinic on 3/26/07 to show vac site with 2" round, red, raised soft, no tender reaction right post arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: 16 Year old female received a 2nd dose of Gardasil vaccination next morning she woke up with generalized body aches.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Hot flush, Nasopharyngitis, Skin lesion
Clinical narrative: Cold symptoms, dry ear canals, lesion legs, arms, stomach, back (15-20 lesions), hot flashes given Benadryl, ear drops.
Age: 59.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: About 30 seconds after administration of Pediarix#2, HIB#2, Prevnar #2 & Tylenol patient developed hive-like rash on face and body. Resolved with Benadryl injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Started with itching at site R thigh, red and swollen next day, worse on 3rd day. Patient seen in urgent care 3/22/07. 14x12cm induration with erythema to Right thigh. No other symptoms.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Inflammation
Clinical narrative: Localized inflammation within 12 hours. Cellulitis, put on Keflex antibiotic
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: 1 hour after injection-arm red and swollen and stiff not painful.