chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, IPV, DTAP, FLU3, IPV
Symptoms: X-ray limb
Clinical narrative: Initial report received from a health care professional on 01 February 2007. A 3 year old, male patient (with a history of pulmonary stenosis and environmental allergies) developed a large red area on the right thigh and could not stand on leg, within 24 hours after he received his fourth dose of Ipol (lot number Z0240) subcutaneously in the right thigh; his third dose of Fluzone (lot number U2249AA) intramuscularly in the left thigh and his fifth dose of Infanrix (lot number AC14B040BA) intramuscularly in the left thigh, on 29 January 2007. He did not have any illness at the time of vaccination. X-rays were taken of the right leg - the results were not provided. At the time of the report, the patient had not recovered. Follow up information received on 15 March 2007, from a health care professional. The patient did not have illness at the time of vaccination. The patient required hospitalization. Admitted on 31 January 2007 and discharged on 01 February 2007. The following information was taken from the hospital and clinical records. Patient developed pain, swelling and redness in the right thigh following IPV vaccination the day before. He was originally seen on 30 January 2007, where he was reportedly afebrile with normal white count, normal plain films and was discontinued home. Then on 31 January 2007, he increased swelling and pain and was walking with a limp, still afebrile and nontoxic. Physical examination was remarkable only for the right lower extremity, he had anterior thigh erythema, along with some posterior thigh erythema and some diffuse swelling over the thigh. He was tender tp palpitation mostly over the anterior thigh and mildly over the right knee. Area where the injection was given had surrounding erythema and swelling. CBC showed a white count of 11, Blood cultures were negative. Patient started on Clindamycin IV empirically. On 01 February 2007 he was walking around the room with slight limp, complaining only of some mild right knee pain. Plain films showed evidence of diffuse soft tissue swelling about the right knee. A small effusion could not be ruled out and per Radiology there were no bony abnormalities appreciated. Normal labs, normal vital signs. Discharge with Keflex b.i.d for 7 days along with Motrin p.r.n for pain and warm compress p.r.n. Concomitant medication included Flonase. the patient was seen in a clinic on 13 February 2007. The leg had healed well with no residual problems from it. The patient also experienced cough and green nasal drainage for six days. Cough at bedtime was worse. He was diagnosed with allergic rhinitis / sinus and otitis media.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Constipation, Haematochezia, Surgery, Vomiting
Clinical narrative: Initial report receive on 15 March 2007, from another manufacturer (reference number WAES0703USA00770). A 5 month old male patient, with no medical history or allergies, received on 04 November 2006 first dose of ActHib (Lot# UE861AA, which corresponds to Lot # Z0319-2), intramuscular, into the left leg, first dose of IPOL (lot #Y0991-2), first dose of Prevnar (lot # B08646C), intra-muscular into the right leg, second oral dose of Rotateq (lot # unknown), first dose Infanrix (lot # AC14B040CA), intra-muscular into the left leg and first dose of Engerix (lot # AHBVB346AB), intra-muscular into the right leg. First oral dose of Rotateq was given on 01 November 2006. On 14 February 2007, 41 days post vaccination with IPOL, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days and questionable blood in the diaper "four days ago". He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. No further information was available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Constipation, Haematochezia, Infrequent bowel movements, Intussusception
Clinical narrative: Initial report receive on 15 March 2007, from another manufacturer (reference number WAES0703USA00770). A 5 month old male patient, with no medical history or allergies, received on 04 November 2006 first dose of ActHib (Lot# UE861AA, which corresponds to Lot # Z0319-2), intramuscular, into the left leg, first dose of IPOL (lot #Y0991-2), first dose of Prevnar (lot # B08646C), intra-muscular into the right leg, second oral dose of Rotateq (lot # unknown), first dose Infanrix (lot # AC14B040CA), intra-muscular into the left leg and first dose of Engerix (lot # AHBVB346AB), intra-muscular into the right leg. First oral dose of Rotateq was given on 01 November 2006. On 14 February 2007, 41 days post vaccination with IPOL, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days and questionable blood in the diaper "four days ago". He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. No further information was available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Surgery, Vomiting
Clinical narrative: Initial report receive on 15 March 2007, from another manufacturer (reference number WAES0703USA00770). A 5 month old male patient, with no medical history or allergies, received on 04 November 2006 first dose of ActHib (Lot# UE861AA, which corresponds to Lot # Z0319-2), intramuscular, into the left leg, first dose of IPOL (lot #Y0991-2), first dose of Prevnar (lot # B08646C), intra-muscular into the right leg, second oral dose of Rotateq (lot # unknown), first dose Infanrix (lot # AC14B040CA), intra-muscular into the left leg and first dose of Engerix (lot # AHBVB346AB), intra-muscular into the right leg. First oral dose of Rotateq was given on 01 November 2006. On 14 February 2007, 41 days post vaccination with IPOL, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days and questionable blood in the diaper "four days ago". He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. No further information was available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Bowel sounds abnormal, Constipation, Haematochezia, Infrequent bowel movements
Clinical narrative: Initial report receive on 15 March 2007, from another manufacturer (reference number WAES0703USA00770). A 5 month old male patient, with no medical history or allergies, received on 04 November 2006 first dose of ActHib (Lot# UE861AA, which corresponds to Lot # Z0319-2), intramuscular, into the left leg, first dose of IPOL (lot #Y0991-2), first dose of Prevnar (lot # B08646C), intra-muscular into the right leg, second oral dose of Rotateq (lot # unknown), first dose Infanrix (lot # AC14B040CA), intra-muscular into the left leg and first dose of Engerix (lot # AHBVB346AB), intra-muscular into the right leg. First oral dose of Rotateq was given on 01 November 2006. On 14 February 2007, 41 days post vaccination with IPOL, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days and questionable blood in the diaper "four days ago". He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. No further information was available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Surgery, Vomiting
Clinical narrative: Initial report receive on 15 March 2007, from another manufacturer (reference number WAES0703USA00770). A 5 month old male patient, with no medical history or allergies, received on 04 November 2006 first dose of ActHib (Lot# UE861AA, which corresponds to Lot # Z0319-2), intramuscular, into the left leg, first dose of IPOL (lot #Y0991-2), first dose of Prevnar (lot # B08646C), intra-muscular into the right leg, second oral dose of Rotateq (lot # unknown), first dose Infanrix (lot # AC14B040CA), intra-muscular into the left leg and first dose of Engerix (lot # AHBVB346AB), intra-muscular into the right leg. First oral dose of Rotateq was given on 01 November 2006. On 14 February 2007, 41 days post vaccination with IPOL, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days and questionable blood in the diaper "four days ago". He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. No further information was available.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, X-ray with contrast lower gastrointestinal tract
Clinical narrative: Information has been received concerning a 3 month old female, with no medical history and no allergies, who on 12-JAN-2007, at 10:00 a.m., was vaccinated with a first oral dose of Rotateq (lot #655865/1109F). Concomitant vaccines administered on the same day included a first intramuscular dose of PedvaxHib (lot #654399/0785F), an intramuscular first dose of Pediarix (lot #AC1B092AA) and a first intramuscular dose of Prevnar (lot #B08670F). There was no illness at the tiem of vaccination. On 15-FEB-2007, at 7:00 p.m., the patient experienced pain and on 16-FEB-2007 the patient had an ilocecal intussusception reduced by barium enema. Subsequently, the patient recovered. Upon internal review, the patient's intussusception was considered to be an other important medical event. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Pain, X-ray
Clinical narrative: Information has been received concerning a 3 month old female, with no medical history and no allergies, who on 12-JAN-2007, at 10:00 a.m., was vaccinated with a first oral dose of Rotateq (lot #655865/1109F). Concomitant vaccines administered on the same day included a first intramuscular dose of PedvaxHib (lot #654399/0785F), an intramuscular first dose of Pediarix (lot #AC1B092AA) and a first intramuscular dose of Prevnar (lot #B08670F). There was no illness at the tiem of vaccination. On 15-FEB-2007, at 7:00 p.m., the patient experienced pain and on 16-FEB-2007 the patient had an ilocecal intussusception reduced by barium enema. Subsequently, the patient recovered. Upon internal review, the patient's intussusception was considered to be an other important medical event. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea haemorrhagic, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Initial report received on 15 March 2007 from another manufacturer, report# WAES0702USA04336. The initial reporter to the manufacturer. Verbatim from the report: "Information  has been received concerning a 9 week old male with no medical history or allergies who on 18-Sep-2006 at 15:00 was vaccinated with a first oral dose of Rotateq (lot# 654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot# AC21B055AA0, a first IM dose in the right arm of ActHib (lot# UE830AA), and a first IM dose in the right arm of Prevnar (lot# B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-Sep-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The lot met the requirements and was released. Additional information has been requested." ActHib lot number was UE830AA (lot number Z0185-2).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium double contrast, Diarrhoea haemorrhagic, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 15 March 2007 from another manufacturer, report# WAES0702USA04336. The initial reporter to the manufacturer. Verbatim from the report: "Information  has been received concerning a 9 week old male with no medical history or allergies who on 18-Sep-2006 at 15:00 was vaccinated with a first oral dose of Rotateq (lot# 654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot# AC21B055AA0, a first IM dose in the right arm of ActHib (lot# UE830AA), and a first IM dose in the right arm of Prevnar (lot# B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-Sep-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The lot met the requirements and was released. Additional information has been requested." ActHib lot number was UE830AA (lot number Z0185-2).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 15 March 2007 from another manufacturer, report# WAES0702USA04336. The initial reporter to the manufacturer. Verbatim from the report: "Information  has been received concerning a 9 week old male with no medical history or allergies who on 18-Sep-2006 at 15:00 was vaccinated with a first oral dose of Rotateq (lot# 654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot# AC21B055AA0, a first IM dose in the right arm of ActHib (lot# UE830AA), and a first IM dose in the right arm of Prevnar (lot# B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-Sep-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The lot met the requirements and was released. Additional information has been requested." ActHib lot number was UE830AA (lot number Z0185-2).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium double contrast, Diarrhoea haemorrhagic, Hospitalisation, Intussusception
Clinical narrative: Initial report received on 15 March 2007 from another manufacturer, report# WAES0702USA04336. The initial reporter to the manufacturer. Verbatim from the report: "Information  has been received concerning a 9 week old male with no medical history or allergies who on 18-Sep-2006 at 15:00 was vaccinated with a first oral dose of Rotateq (lot# 654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot# AC21B055AA0, a first IM dose in the right arm of ActHib (lot# UE830AA), and a first IM dose in the right arm of Prevnar (lot# B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-Sep-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The lot met the requirements and was released. Additional information has been requested." ActHib lot number was UE830AA (lot number Z0185-2).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Initial report received on 15 March 2007 from another manufacturer, report# WAES0702USA04336. The initial reporter to the manufacturer. Verbatim from the report: "Information  has been received concerning a 9 week old male with no medical history or allergies who on 18-Sep-2006 at 15:00 was vaccinated with a first oral dose of Rotateq (lot# 654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot# AC21B055AA0, a first IM dose in the right arm of ActHib (lot# UE830AA), and a first IM dose in the right arm of Prevnar (lot# B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-Sep-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The lot met the requirements and was released. Additional information has been requested." ActHib lot number was UE830AA (lot number Z0185-2).
Age: 0.37
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Stool analysis abnormal
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 15 March 2007 from another manufacturer, report# WAES0702USA03829. The initial report to this manufacturer had been a health care professional. Verbatim from the report: "This is in follow-up to report (s) previously submitted on 3/2/07; 3/9/2007. Information has been received from a health professional concerning a 19 week old female, with no allergies and a medical history of cardiac problem at birth and respiratory syncytial virus infection in November 2006, who was vaccinated with a first and second dose of Rotateq on 13-Dec-2006 (lot# 655050/0778F) and 13-Feb-2007 (Lot# 655865/1109F), respectively. Concomitant vaccines administered on 13-Feb-2007 included a dose of Dtap, PedvaxHib (manufacturer unknown), a dose of Ipol and a dose of Prevnar. It was reported that the patient's mother called and came into the office and stated that the patient had a bloody stool late on the 16-Feb-2007 or early on the 17-Feb-2007. The patient's mother brought the patient's diaper back in on 19-Feb-2007, and it tested positive for bloody stool. Subsequently, the patient was back to normal, and there was only one bloody stool." "Follow-up information from a health professional indicated that on 17-Feb-2007 the patient was seen in the office for a bloody stool. The stool tested positive for blood, but there was not enough to send out for testing for rotavirus. The patient was seen again on 19-Feb-2007 and had made a full recovery. Upon internal review, the patient's bloody stool was considered to be an other important medical event. Additional information has been requested."
Age: 0.18
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Blood test, Feeding disorder of infancy or early childhood, Pyrexia, Vomiting
Clinical narrative: Initial report received on 15 March 2007, from another manufacturer (reference number WAES0702USA04585), who received this report from a healthcare professional. A 9 week old male patient, with no allergies and a history of premature birth, received on 20 February 2007 a dose of IPOL (lot# Unknown), 2 ml first oral dose of Rotateq (lot# 656105/1232F), a dose of DTaP (unspecified) (+) tetanus toxoid (manufacturer and lot# unknown) and a dose of Prevnar (lot# Unknown). The patient's concomitant medications included Synagis. The patient was seen in the office on 24 February 2007, 4 days post vaccination, he was not feeding well and experienced fever. The patient was seen in the office on 26 February 2007 with vomiting, fever, poor feeding and was hospitalized. The patient was admitted for observation only and was discharged within 24 hours. It was reported that the patient was feeding well and had recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Feeding disorder of infancy or early childhood, Hospitalisation, Pyrexia, Vomiting
Clinical narrative: Initial report received on 15 March 2007, from another manufacturer (reference number WAES0702USA04585), who received this report from a healthcare professional. A 9 week old male patient, with no allergies and a history of premature birth, received on 20 February 2007 a dose of IPOL (lot# Unknown), 2 ml first oral dose of Rotateq (lot# 656105/1232F), a dose of DTaP (unspecified) (+) tetanus toxoid (manufacturer and lot# unknown) and a dose of Prevnar (lot# Unknown). The patient's concomitant medications included Synagis. The patient was seen in the office on 24 February 2007, 4 days post vaccination, he was not feeding well and experienced fever. The patient was seen in the office on 26 February 2007 with vomiting, fever, poor feeding and was hospitalized. The patient was admitted for observation only and was discharged within 24 hours. It was reported that the patient was feeding well and had recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Electrocardiogram normal, Headache, Pain, Pain in jaw
Clinical narrative: Signs and symptoms include: shortness of breath, pain radiating to the center of the chest, headache, pain in left jaw, and febrile.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Signs and symptoms include: shortness of breath, pain radiating to the center of the chest, headache, pain in left jaw, and febrile.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received shot 3/2/07-very sore within an hour-swollen, hot, tender within an hour-stayed swollen hot, sore-20cm for 5 days. Then gradually subsided. No fever, chills, malaise, lymphadenopathy, joint pain, other skin no other symptoms.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema (20x13cm), tenderness, warmth left deltoid. Treatment-prednisone, Benadryl, cool compresses.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy of axilla and supraclavicular.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature decreased, Cyanosis, Dehydration, Oxygen saturation, Vomiting
Clinical narrative: Vomit x1, hypoactive, hipotonico, cianotico. Treatment-IV's 17060 in 2 hours. 3:15pm Dl .4555 70cs 2hrs.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash erythematous, Rash papular, Swelling
Clinical narrative: Marked swelling, erythema with multiple erythematous papules, (surrounded by halos) throughout torso/limbs.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Day after receiving Guardasil noted hives throughout body which increased over weekend. Prescribed Keflex and Benadryl.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Day after receiving Guardasil noted hives throughout body which increased over weekend. Prescribed Keflex and Benadryl.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Feeling hot
Clinical narrative: Red warm to the touch right thigh measuring 4xm x 7cm.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hospitalisation, Immunisation reaction, Loss of consciousness
Clinical narrative: This office was informed 3-26-07 that patient "passed out" on Saturday 3-24-07 and was hospitalized at hospital (by patient's mother). Nurse at hospital subsequently called stating that patient had a reaction to DTaP. 4/24/07 Received medical records from hospital which reveal patient experienced fussiness, floppy, limp, difficult to arouse for approx 10 min.  EMS transported to ER & patient admitted overnight 3/25/07-3/26/07 for observation.  No further episodes occured & patient d/c to home in good condition.   FINAL DX: Hypotonic-hyporesponsive episode, probably secondary to vaccine.  Patient not to have pertussis again.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea
Clinical narrative: Patient received Rotateq #2 on 1/3/07. Developed diarrhea 3 days later, lasted 10 days.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Child was given an extra Varicella (3)
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Severe urticartial rash  thigh rubale  baby but not at nite of vaccination. Meconium 1mg adm IM, Benadryl 12.5mg adm  IM.
Age: 0.89
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised, Rash macular
Clinical narrative: 1 Year baby girl who developed macular rash secondary to vaccination. with rash over whole body spring palms and soles. Treatments given at ER was Solumedrol 30mg, IM, Benadryl .
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration with mild erythema at the site of administration - Right lateral thigh. Induration measuring 3 x 4cm.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pain. redness, itching after 2 mos post-injection, specifically at site of injection.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Increased swelling, redness, itching approx. 10 cm in size.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: The day after her shot she got headache,severe body aches and fever. The symptoms lasted 3 days and went away on their own
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Culture stool, Haematochezia, Rotavirus test
Clinical narrative: Blood in stool x2 weeks after administration of Rota vaccine at 2mons and at 4 mos. Blood started both times night after administration
Age: 2.0
Sex: M
Vaccine: SMALL
Symptoms: Culture positive, Eczema vaccinatum, Polymerase chain reaction, Secondary transmission, Vaccinia
Clinical narrative: 2 year old child with severe atopic dermatitis had exposure to father's smallpox vaccination which resulted in his development of eczema vaccinatum. Child has required critical care to include mechanical ventilation, anti-viral therapy, antibiotics and vaccinia immune globulin. 9/7/07 Received D/C summary which reveals patient experienced eczema vaccinatum over approx 70-80% of his body.  Admitted 3/3-4/19/2007.  Was in PICU until 4/7/07 on mechanical ventilation.  Parent had been vaccinated w/smallpox in mid January, had contact w/patient mid February prior to deployment.  Patient developed skin changes early March initially thought to be superinfected eczema.    Tx w/IV antibiotics for MRSA bacteremia.  ID, Allergy, Opthal, Cardio, Derm, Plastic Surg consult.  Received vaccinia immunoglobulin x 8 in March.  Tx w/experimental drug, ST-246 in March.  While in PICU, developed unstable BP, bilateral pleural effusions, fluid overload, severe hypoalbuminemia, ARDS, renal insufficiency, anemia, & abdominal compartment syndrome. Received multiple transfusions of PRBCs & FFP. PMH: severe eczema  FINAL DX: eczema vaccinatum requiring skin grafts
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: On 3/28/07 the right deltoid area is red/inflammed.  The mother of the baby was advised to give him children's motrin.
Age: 40.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Myalgia, Rash papular, Rash pruritic
Clinical narrative: Papular, pruritic rash on back 1"x2" area, muscle aches. Using ibuprofen, dyphenhydramine and hydrocortisone cream.
Age: 47.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Rash, Stomach discomfort
Clinical narrative: Traveler began Oral typhoid vaccine one day after returning from 4-day business trip  on March 23 2007 in the evening. (Traveler was preparing for subsequent travel) By March 24th evening he had upset stomcah, loose stool (2-3/day)stomach cramps, bloating, and rash on arms that was more intense in the folds of his elbows. The symptoms were improved on the 25th, he took 2nd dose of Vivotif eve of 3/25. Symptoms returned/worsened 3/26.  Traveler called to report the symptoms 3/27.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: NAUSEA, DIARRHEA, STOMACH ACHE, HEADACHE, BODY ACHE
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came in to report that her left arm is extremely sore, red, swollen and feeling hot. This started 2 days after she had received the DTAP adult vaccine, in her left deltoid. She was advised to take benedryl and ibuprofen. She had no systemic symptoms. She had no known previous reaction to any vaccines.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site atrophy, Lipoatrophy
Clinical narrative: Patient was seen on 2/12/07 because where she recieved a vaccine she had developed atrophy of the subcutaneous fat. Patient was sent to dermatology and was given the diagnosis of lipoatrophy.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pruritus, Malaise
Clinical narrative: On 03/23/07, ten days after receiving the first dose of varicella vaccine the patient developed a raised reddened area on her left arm approximately the size of 2 quarters.  The area was itchy. On 03/27/07 patient describes "flu-like" symptoms of nausea, headache and malaise.  Patient denies fever.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: On 03/23/07, ten days after receiving the first dose of varicella vaccine the patient developed a raised reddened area on her left arm approximately the size of 2 quarters.  The area was itchy. On 03/27/07 patient describes "flu-like" symptoms of nausea, headache and malaise.  Patient denies fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Pt arm is inflamed from the clavicle to the elbow of the left arm. The arm was tender to touch, red with heat radiating throughout. Mom states that arm was swollen and painful 3/27. Mom states that she doesn't have a doctor here. I advised mom to go to ER for possible treatment of cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Pt arm is inflamed from the clavicle to the elbow of the left arm. The arm was tender to touch, red with heat radiating throughout. Mom states that arm was swollen and painful 3/27. Mom states that she doesn't have a doctor here. I advised mom to go to ER for possible treatment of cellulitis.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Accidental exposure, Culture positive, Exposure to communicable disease, Myalgia, Patient isolation
Clinical narrative: Wife exposed to husband's smallpox vaccination site and child who has eczema vaccinatum. Exhibited multiple facial lesions/right index finger with concomitant fever and generalized myalgia. Treated with VIG,isolation and prn analgesia. Resolution of symptoms and skin lesions after approximately 10 days.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Polymerase chain reaction, Pyrexia, Secondary transmission, Skin lesion, Vaccinia
Clinical narrative: Wife exposed to husband's smallpox vaccination site and child who has eczema vaccinatum. Exhibited multiple facial lesions/right index finger with concomitant fever and generalized myalgia. Treated with VIG,isolation and prn analgesia. Resolution of symptoms and skin lesions after approximately 10 days.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Girl in office with sister who was getting her one year vaccines.  Mom mentioned that chicken pox was going around preschool.  She showed me patient's shot card and only one chicken pox vaccine was recorded on the record, while two MMR were recorded.  We gave the patient a chicken pox vaccine on 3-26-07.  Today she has  9cm of pale redness and swelling and 4.5 cm of intense redness and swelling at the site of the shot.  She has a palpable femoral node, but full ROM of the joins, no fever, and is walking fine.  Mom says the swelling is less today than it was last night.  Now I have her chart, and on 9-12-06 she received a MMRV, but it was not recorded on moms shot card that way.  So, the 3028-07 vaccine was her third chicken pox vaccine.
Age: 1.92
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: MOTHER STATES RED PIN-POINT RASH NOTED ON FACE APPROXIMATELY 1 HOUR AFTER RECEIVING VACCINES. 5--6 HOURS LATER NOTED HIVES ON FACE AND ENTIRE BODY.HIVES GOT LARGER. BABY TAKEN TO E.D AND WAS TREATED WITH ORAPRED AND BENADRYL. RX GIVEN TO CONTINUE MEDS. NEXT DAY BABY DEVELOPPED ITCHING.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Lacrimation increased, Lip swelling, Ocular hyperaemia, Vomiting
Clinical narrative: Pt received MMR vaccine in office on way home about 30 minutes after injection had lip swelling and 1 episode of vomiting, eyes then started to tear and get red, was referred to ER, in ER got 1 dose of oral Benadryl, sx resolved-was observed and sent home
Age: 39.0
Sex: F
Vaccine: DTP
Symptoms: Contusion, Injection site swelling, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: 1 day after-very itchy, swollen.  Progressed to a golf ball sized swelling at the inj. site surrounded by a softball sized swelling.  Bruising, tingling, tightness esp. around elbow area, low grade fevers on and off.Took Motrin and used benadryl cream then was started on Cephalexin & triamcinolone acetonide cream.  Applied reg. ice packs.  Today is day 12 after injection and still not better!
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L upper arm red swollen size of adult palm, warm to touch, no oral temp. Mother instructed to continue Tylenol or Motrin with Benadryl & Cold compresses
Age: 57.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Contusion, Oedema peripheral, Pain in extremity
Clinical narrative: Right arm became swollen & very painful, bruised Temp 100.1. No redness noted Pt reported symptom 3/15/07 given RX for Medrol dose pack.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness on injection area (2in x 2 1/2in), warm to the touch (left thigh).
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Convulsion, Fall, Head injury, Orthostatic intolerance, Syncope
Clinical narrative: Initial report received on 22 March 2007 from an other manufacturer, reference, reference number WAES 0703USA00641. This manufacturer had received the original report from a pharmacist. Verbatim from report: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a  first dose of Gardasil lot # 653735-0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she fell after fainting. The patient was slow to wake and was orthostatic (time line was unspecified. The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. "Upon internal review, seizure was considered to be an other important medical event." Additional information has been requested."
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Vomiting
Clinical narrative: Initial report received on 22 March 2007 from an other manufacturer, reference, reference number WAES 0703USA00641. This manufacturer had received the original report from a pharmacist. Verbatim from report: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a  first dose of Gardasil lot # 653735-0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she fell after fainting. The patient was slow to wake and was orthostatic (time line was unspecified. The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. "Upon internal review, seizure was considered to be an other important medical event." Additional information has been requested."
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Convulsion, Fall, Head injury, Orthostatic hypotension, Syncope
Clinical narrative: Initial report received on 22 March 2007 from an other manufacturer, reference, reference number WAES 0703USA00641. This manufacturer had received the original report from a pharmacist. Verbatim from report: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a  first dose of Gardasil lot # 653735-0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she fell after fainting. The patient was slow to wake and was orthostatic (time line was unspecified. The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. "Upon internal review, seizure was considered to be an other important medical event." Additional information has been requested."
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Blood glucose, Scan brain, Tonic convulsion
Clinical narrative: Received vaccine at 4:30pm. At 7:40pm, patient had a seizure (new onset) lasting approximately 1 minute - no fever (98.1) ambulance to hospital.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Urine analysis normal
Clinical narrative: Received vaccine at 4:30pm. At 7:40pm, patient had a seizure (new onset) lasting approximately 1 minute - no fever (98.1) ambulance to hospital.
Sex: M
Vaccine: RAB
Symptoms: Ankylosing spondylitis, Antinuclear antibody increased, Antinuclear antibody positive, Red blood cell sedimentation rate increased
Clinical narrative: On 22 MAR 2007 we received from Vaccine information Service the following information: A male patient, born on 4 Oct 1962, was bitten by a dog and received therefore a post exposure regime of RabAvert (date and batch no. unknown). Later (interval?) he developed symptoms of ankylosing spondylitis, had increased RNP antibodies titre and his ANA was elevated. His blood sedimentation rate was elevated to 26. No further information available. Company assessment: Seriousness criterion: medically significant. Causality: not related.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Diarrhoea, Haematochezia, Pain, Pyrexia, Renal failure acute
Clinical narrative: Information has been received from a physician concerning a 13 year old female who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Within 24-48 hours, the patient experienced fever, achiness and diarrhea. The physician reported that 1-2 days later, the patient developed blood in the stool and was admitted to the hospital. The physician reported that the patient was diagnosed with acute kidney failure and was still hospitalized. At the time of this report, the patient's fever, achiness and acute kidney failure persisted. Fever, achiness and acute kidney failure were considered to be immediately life-threatening and disabling. Additional information has been requested.    5/18/07 Received medical records from hospital which reveal patient seen at hospital 3/18-3/26/07 for nausea, vomiting, bloody diarrhea & fever starting approx 3/11/07.  Found to have asymptomatic E.coli UTI that traveled to kidneys.  Treated w/IV antibiotics & started on dialysis & placed on kidney transplant list. Progressed well & d/c to home on oral antibiotics.  FINAL DX: acute renal failure, urosepsis, polycystic kidney disease, end stage renal failure, hemodialysis.  3/27-4/2/07 - Re-Admitted to pediatric nephrology with fever, dizziness & orthostasis.  Treated w/multiple IV antibiotics.  Was to continue dialysis but at least 2 sessions cancelled due to hypotension.  Outpatient hemodialysis was arranged closer to her home & was to continue IV antibiotics at dialysis center as well as continue on oral antibiotics.  Plan was to transition to peritoneal dialysis after off antibiotics for 1 week. FINAL DX: posible partially treated urosepsis; end stage renal disease; polysystic kidney disease; rotavirus gastroenteritis; h/o acute renal failure.  4/25/07  Seen in Dialysis at outlying center.  Doing well, last dose of antibiotics on 4/13 & afebrile since then.  Labs were much improved & a trial of decreased dialysis was discussed.  5/4/07 - Seen in surgery clinic for evaluation of peritoneal dialysis catheter for acute renal failure superimposed on chronic renal failure.  HD site noted to possibly be infected & was started on oral antibiotics.  Repeat stool & urine tests ordered & scheduled for PD placement.  5/7/07 MRI of brain was WNL.  6/22/07 Received medical records & vax record from reporter/provider which reveal patient received HPV on 3/14/07 & was 1st dose.  VAERS database updated w/same.  Medical records of 1994-2004.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Renal failure
Clinical narrative: Information has been received from a physician concerning a 13 year old female who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Within 24-48 hours, the patient experienced fever, achiness and diarrhea. The physician reported that 1-2 days later, the patient developed blood in the stool and was admitted to the hospital. The physician reported that the patient was diagnosed with acute kidney failure and was still hospitalized. At the time of this report, the patient's fever, achiness and acute kidney failure persisted. Fever, achiness and acute kidney failure were considered to be immediately life-threatening and disabling. Additional information has been requested.    5/18/07 Received medical records from hospital which reveal patient seen at hospital 3/18-3/26/07 for nausea, vomiting, bloody diarrhea & fever starting approx 3/11/07.  Found to have asymptomatic E.coli UTI that traveled to kidneys.  Treated w/IV antibiotics & started on dialysis & placed on kidney transplant list. Progressed well & d/c to home on oral antibiotics.  FINAL DX: acute renal failure, urosepsis, polycystic kidney disease, end stage renal failure, hemodialysis.  3/27-4/2/07 - Re-Admitted to pediatric nephrology with fever, dizziness & orthostasis.  Treated w/multiple IV antibiotics.  Was to continue dialysis but at least 2 sessions cancelled due to hypotension.  Outpatient hemodialysis was arranged closer to her home & was to continue IV antibiotics at dialysis center as well as continue on oral antibiotics.  Plan was to transition to peritoneal dialysis after off antibiotics for 1 week. FINAL DX: posible partially treated urosepsis; end stage renal disease; polysystic kidney disease; rotavirus gastroenteritis; h/o acute renal failure.  4/25/07  Seen in Dialysis at outlying center.  Doing well, last dose of antibiotics on 4/13 & afebrile since then.  Labs were much improved & a trial of decreased dialysis was discussed.  5/4/07 - Seen in surgery clinic for evaluation of peritoneal dialysis catheter for acute renal failure superimposed on chronic renal failure.  HD site noted to possibly be infected & was started on oral antibiotics.  Repeat stool & urine tests ordered & scheduled for PD placement.  5/7/07 MRI of brain was WNL.  6/22/07 Received medical records & vax record from reporter/provider which reveal patient received HPV on 3/14/07 & was 1st dose.  VAERS database updated w/same.  Medical records of 1994-2004.