chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Balance disorder, C-reactive protein normal, Fatigue, Muscular weakness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. it was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot #657006/0188U) and vaccinated in the right arm with a dose of MENACTRA (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently, was told "not to worry about it." The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: "myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect the patient does not have Guillain-Barre syndrome. Reflexes are normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medications. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently here for follow-up visit because there were concerns if she has a relapse of her GBS which was diagnosed in February 2006." Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This report was filed with the FDA. The VAERS number is 279407.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Myalgia, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. it was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot #657006/0188U) and vaccinated in the right arm with a dose of MENACTRA (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently, was told "not to worry about it." The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: "myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect the patient does not have Guillain-Barre syndrome. Reflexes are normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medications. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently here for follow-up visit because there were concerns if she has a relapse of her GBS which was diagnosed in February 2006." Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This report was filed with the FDA. The VAERS number is 279407.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, C-reactive protein normal, Condition aggravated, Fatigue, Guillain-Barre syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. it was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot #657006/0188U) and vaccinated in the right arm with a dose of MENACTRA (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently, was told "not to worry about it." The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: "myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect the patient does not have Guillain-Barre syndrome. Reflexes are normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medications. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently here for follow-up visit because there were concerns if she has a relapse of her GBS which was diagnosed in February 2006." Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This report was filed with the FDA. The VAERS number is 279407.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Muscular weakness, Myalgia, Neurological examination normal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. it was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot #657006/0188U) and vaccinated in the right arm with a dose of MENACTRA (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently, was told "not to worry about it." The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: "myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect the patient does not have Guillain-Barre syndrome. Reflexes are normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medications. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently here for follow-up visit because there were concerns if she has a relapse of her GBS which was diagnosed in February 2006." Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This report was filed with the FDA. The VAERS number is 279407.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Intussusception, Vomiting
Clinical narrative: Information has been received from FDA (VAERS #282594) through the CDC concerning a 22-week-old male with no medical history who on 02-MAY-2007 was vaccinated with the second dose of Rotateq (Lot #656382/0234U). Concomitant vaccinations administered on that same day included the second dose of Daptacel (Lot #C2628AA), the second dose of ACTHIB (Lot #UE991AA), the second dose of IPOL (Lot #Z0547) and the second dose of Prevnar (Lot #B26510E). There was no other concomitant drug therapy. On 28-MAY-2007 the patient was hospitalized for excessive vomiting. A diagnosis of intussusception was made. While hospitalized an abdominal x-ray and air-contrast Barium enema were performed. Subsequently, the patient recovered from the intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologics Evaluation and Research (CBER) and was released by the regulatory agency. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Intussusception, Vomiting
Clinical narrative: Information has been received from FDA (VAERS #282594) through the CDC concerning a 22-week-old male with no medical history who on 02-MAY-2007 was vaccinated with the second dose of Rotateq (Lot #656382/0234U). Concomitant vaccinations administered on that same day included the second dose of Daptacel (Lot #C2628AA), the second dose of ACTHIB (Lot #UE991AA), the second dose of IPOL (Lot #Z0547) and the second dose of Prevnar (Lot #B26510E). There was no other concomitant drug therapy. On 28-MAY-2007 the patient was hospitalized for excessive vomiting. A diagnosis of intussusception was made. While hospitalized an abdominal x-ray and air-contrast Barium enema were performed. Subsequently, the patient recovered from the intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologics Evaluation and Research (CBER) and was released by the regulatory agency. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Enema administration, Haematemesis, Intussusception, Laparoscopy, Lethargy
Clinical narrative: Information has been received from FDA (VAERS #282853) through the CDC concerning an 8-month-old female with no medical history who on 10-APR-2007 was vaccinated with the third dose of Rotateq (Lot #655296/0979F). Concomitant vaccinations administered on that same day included the third dose of Daptacel (Lot #C2554AA), the third dose of IPOL (Lot #Z03262) and the third dose of Prevnar (Lot #E36258). On 12-JUN-2007, the patient developed vomiting and fever. On 13-JUN-2007, at 1000, a number of the episodes of vomiting became coffee-ground in appearance (hematemesis). Melena, fever and lethargy were also noted. There was no diarrhea or stool for one day. On that same day, at 1800, the patient was hospitalized. On physical examination, the patient was pale, her abdomen was soft with diminished bowel sounds and it did not appear to be grossly distended. Ileocolic intussusception was diagnosed with gastrograffin enema which was subsequently reduced by hydrostatics (Barium enema provided partial reduction) and laproscopy. Laboratory/diagnostic tests were also performed (see lab data). On 15-JUN-2007, the patient was discharged from the hospital as she was considered to be recovered. Ileocolic intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Melaena, Pyrexia, Vomiting
Clinical narrative: Information has been received from FDA (VAERS #282853) through the CDC concerning an 8-month-old female with no medical history who on 10-APR-2007 was vaccinated with the third dose of Rotateq (Lot #655296/0979F). Concomitant vaccinations administered on that same day included the third dose of Daptacel (Lot #C2554AA), the third dose of IPOL (Lot #Z03262) and the third dose of Prevnar (Lot #E36258). On 12-JUN-2007, the patient developed vomiting and fever. On 13-JUN-2007, at 1000, a number of the episodes of vomiting became coffee-ground in appearance (hematemesis). Melena, fever and lethargy were also noted. There was no diarrhea or stool for one day. On that same day, at 1800, the patient was hospitalized. On physical examination, the patient was pale, her abdomen was soft with diminished bowel sounds and it did not appear to be grossly distended. Ileocolic intussusception was diagnosed with gastrograffin enema which was subsequently reduced by hydrostatics (Barium enema provided partial reduction) and laproscopy. Laboratory/diagnostic tests were also performed (see lab data). On 15-JUN-2007, the patient was discharged from the hospital as she was considered to be recovered. Ileocolic intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Band neutrophil count decreased, Blood albumin decreased, Blood culture negative, Blood glucose abnormal, Blood urea increased
Clinical narrative: Information has been received from FDA (VAERS #282853) through the CDC concerning an 8-month-old female with no medical history who on 10-APR-2007 was vaccinated with the third dose of Rotateq (Lot #655296/0979F). Concomitant vaccinations administered on that same day included the third dose of Daptacel (Lot #C2554AA), the third dose of IPOL (Lot #Z03262) and the third dose of Prevnar (Lot #E36258). On 12-JUN-2007, the patient developed vomiting and fever. On 13-JUN-2007, at 1000, a number of the episodes of vomiting became coffee-ground in appearance (hematemesis). Melena, fever and lethargy were also noted. There was no diarrhea or stool for one day. On that same day, at 1800, the patient was hospitalized. On physical examination, the patient was pale, her abdomen was soft with diminished bowel sounds and it did not appear to be grossly distended. Ileocolic intussusception was diagnosed with gastrograffin enema which was subsequently reduced by hydrostatics (Barium enema provided partial reduction) and laproscopy. Laboratory/diagnostic tests were also performed (see lab data). On 15-JUN-2007, the patient was discharged from the hospital as she was considered to be recovered. Ileocolic intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Bowel sounds abnormal, Enema administration, Gastric pH increased, Haematemesis, Intussusception
Clinical narrative: Information has been received from FDA (VAERS #282853) through the CDC concerning an 8-month-old female with no medical history who on 10-APR-2007 was vaccinated with the third dose of Rotateq (Lot #655296/0979F). Concomitant vaccinations administered on that same day included the third dose of Daptacel (Lot #C2554AA), the third dose of IPOL (Lot #Z03262) and the third dose of Prevnar (Lot #E36258). On 12-JUN-2007, the patient developed vomiting and fever. On 13-JUN-2007, at 1000, a number of the episodes of vomiting became coffee-ground in appearance (hematemesis). Melena, fever and lethargy were also noted. There was no diarrhea or stool for one day. On that same day, at 1800, the patient was hospitalized. On physical examination, the patient was pale, her abdomen was soft with diminished bowel sounds and it did not appear to be grossly distended. Ileocolic intussusception was diagnosed with gastrograffin enema which was subsequently reduced by hydrostatics (Barium enema provided partial reduction) and laproscopy. Laboratory/diagnostic tests were also performed (see lab data). On 15-JUN-2007, the patient was discharged from the hospital as she was considered to be recovered. Ileocolic intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Laparoscopy, Lethargy, Melaena, Monocyte count decreased, Neutrophil count decreased
Clinical narrative: Information has been received from FDA (VAERS #282853) through the CDC concerning an 8-month-old female with no medical history who on 10-APR-2007 was vaccinated with the third dose of Rotateq (Lot #655296/0979F). Concomitant vaccinations administered on that same day included the third dose of Daptacel (Lot #C2554AA), the third dose of IPOL (Lot #Z03262) and the third dose of Prevnar (Lot #E36258). On 12-JUN-2007, the patient developed vomiting and fever. On 13-JUN-2007, at 1000, a number of the episodes of vomiting became coffee-ground in appearance (hematemesis). Melena, fever and lethargy were also noted. There was no diarrhea or stool for one day. On that same day, at 1800, the patient was hospitalized. On physical examination, the patient was pale, her abdomen was soft with diminished bowel sounds and it did not appear to be grossly distended. Ileocolic intussusception was diagnosed with gastrograffin enema which was subsequently reduced by hydrostatics (Barium enema provided partial reduction) and laproscopy. Laboratory/diagnostic tests were also performed (see lab data). On 15-JUN-2007, the patient was discharged from the hospital as she was considered to be recovered. Ileocolic intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Pallor, Pyrexia, Vomiting
Clinical narrative: Information has been received from FDA (VAERS #282853) through the CDC concerning an 8-month-old female with no medical history who on 10-APR-2007 was vaccinated with the third dose of Rotateq (Lot #655296/0979F). Concomitant vaccinations administered on that same day included the third dose of Daptacel (Lot #C2554AA), the third dose of IPOL (Lot #Z03262) and the third dose of Prevnar (Lot #E36258). On 12-JUN-2007, the patient developed vomiting and fever. On 13-JUN-2007, at 1000, a number of the episodes of vomiting became coffee-ground in appearance (hematemesis). Melena, fever and lethargy were also noted. There was no diarrhea or stool for one day. On that same day, at 1800, the patient was hospitalized. On physical examination, the patient was pale, her abdomen was soft with diminished bowel sounds and it did not appear to be grossly distended. Ileocolic intussusception was diagnosed with gastrograffin enema which was subsequently reduced by hydrostatics (Barium enema provided partial reduction) and laproscopy. Laboratory/diagnostic tests were also performed (see lab data). On 15-JUN-2007, the patient was discharged from the hospital as she was considered to be recovered. Ileocolic intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Hypoaesthesia, Nerve conduction studies, Paraesthesia
Clinical narrative: Initial and follow up information has been received from a nurse concerning an 18 year old female with no pertinent medical history who on 17-MAY-2007 was vaccinated with a first dose of Gardasil (lot #657622/0388U). Subsequently, the patient developed unspecified paralysis and was referred to a local neurologist. The patient's symptoms were severe enough that the patient felt she needed immediate care. The patient wanted to be seen sooner so she found a different neurologist who diagnosed the patient with Guillain Barre Syndrome (GBS). GBS onset date was on 01-JUN-2007. At the time of the report the patient was recovering. Upon internal review GBS and paralysis were considered to be another important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Pregnancy test negative
Clinical narrative: Initial and follow up information has been received from a nurse concerning an 18 year old female with no pertinent medical history who on 17-MAY-2007 was vaccinated with a first dose of Gardasil (lot #657622/0388U). Subsequently, the patient developed unspecified paralysis and was referred to a local neurologist. The patient's symptoms were severe enough that the patient felt she needed immediate care. The patient wanted to be seen sooner so she found a different neurologist who diagnosed the patient with Guillain Barre Syndrome (GBS). GBS onset date was on 01-JUN-2007. At the time of the report the patient was recovering. Upon internal review GBS and paralysis were considered to be another important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Initial and follow up information has been received from a nurse concerning an 18 year old female with no pertinent medical history who on 17-MAY-2007 was vaccinated with a first dose of Gardasil (lot #657622/0388U). Subsequently, the patient developed unspecified paralysis and was referred to a local neurologist. The patient's symptoms were severe enough that the patient felt she needed immediate care. The patient wanted to be seen sooner so she found a different neurologist who diagnosed the patient with Guillain Barre Syndrome (GBS). GBS onset date was on 01-JUN-2007. At the time of the report the patient was recovering. Upon internal review GBS and paralysis were considered to be another important medical event. Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blood pressure normal, Body temperature decreased, Pain in extremity, Skin lesion
Clinical narrative: 2 Days after Anthrax vaccination patient complans of soreness in right arm down into fingers. Lesion size 10 CM X 25 CM extending over elbow patient afebrile, NSR
Age: 40.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pain in extremity, Skin lesion
Clinical narrative: 2 Days after Anthrax vaccination patient complans of soreness in right arm down into fingers. Lesion size 10 CM X 25 CM extending over elbow patient afebrile, NSR
Age: 40.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blood pressure normal, Body temperature decreased, Pain in extremity, Skin lesion
Clinical narrative: 2 days after Anthrax vaccine patient complains of soreness in right arm into fingers. Lesion at 10cm x 25cm extending over the elbow. Patient afebrile, NSR
Age: 40.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pain in extremity, Skin lesion
Clinical narrative: 2 days after Anthrax vaccine patient complains of soreness in right arm into fingers. Lesion at 10cm x 25cm extending over the elbow. Patient afebrile, NSR
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Decreased appetite, Pyrexia, Tremor
Clinical narrative: Shot administered at 10:25 a.m. At 9 p.m. child began having chills followed by 20 hours of fever. The first day the fever averaged 102.4. The second day it was 103.4. The child shook significantly with his chills. Eyes were glassy and he looked tired and didn't have much of an appetite for about three days following shot.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Biopsy intestine, Decreased appetite, Diarrhoea haemorrhagic, Gastroenteritis, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 29-JUN-2007 was vaccinated with Rotateq (LOT # 656845/0409U). On 09-JUL-2007 the patient started vomiting and on 15-JUL-2007, the patient was hospitalized, with bloody diarrhea. He was diagnosed with gastroenteritis. The child had bloody diarrhea during the duration, and was unable to feed, off and on, for 7-8 days, event on nutrimagen, while hospitalized. The child had IV's, intravenous therapy, and a GI biopsy performed (results unknown). The child was seen by GI specialists. On 30-JUL-2007, the patient was discharged from the hospital. On 01-AUG-2007, the child was seen at the physician's office for a post hospitalization follow-up visit. The child's present status was not reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Biopsy intestine, Diarrhoea, Diarrhoea haemorrhagic, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 29-JUN-2007 was vaccinated with Rotateq (LOT # 656845/0409U). On 09-JUL-2007 the patient started vomiting and on 15-JUL-2007, the patient was hospitalized, with bloody diarrhea. He was diagnosed with gastroenteritis. The child had bloody diarrhea during the duration, and was unable to feed, off and on, for 7-8 days, event on nutrimagen, while hospitalized. The child had IV's, intravenous therapy, and a GI biopsy performed (results unknown). The child was seen by GI specialists. On 30-JUL-2007, the patient was discharged from the hospital. On 01-AUG-2007, the child was seen at the physician's office for a post hospitalization follow-up visit. The child's present status was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Convulsion, Electroencephalogram, Eye rolling, Laboratory test
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 15 year old female who on 25-JUN-2007 was vaccinated with a second dose of Gardasil. On 25-JUN-2007 the patient developed seizure like activity shortly after the injection. The physician was summoned to the room, but upon arrival the patient's symptoms stopped. The patient looked confused but her color remained good. Her blood pressure was 104/60 mm/Hg. She stayed at the office for 35 minutes for observation. Her blood pressure was taken again was 110/60 m/Hg. The patient recovered and was sent home. Upon internal review, the patient's seizure like activity was considered an other important medical event. Additional information has been requested. This is in follow-up to report (s) submitted on 8/8/2007; 8/17/2007. Additional information has been received from the Pharm D who reported that the patient with no history of seizures was not diagnosed with seizures. The patient did not have a true seizure. The patient's experience was described as "seizure like" activity. The patient was sitting upright when she received GARDASIL. Within 1 - 2 minutes following adiministration, she leaned back against the chair, her head went against her arm on the side, her eyes rolled back in her head and arms and torso shook. It was reported that the patient was very lucid after the "seizure". The Pharm D. reported that the patient was to have unspecified test and an EEG performed (details unknown). The Pharm D had no additional information regarding the patient's experience. The nurse reported that the patient was contacted on 26-Jun-2007 and 28-Jun-2007 and was doing fine. The nurse stated that she did not think that the patient would be back for the third vaccination. No additinal information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Posture abnormal, Tremor
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 15 year old female who on 25-JUN-2007 was vaccinated with a second dose of Gardasil. On 25-JUN-2007 the patient developed seizure like activity shortly after the injection. The physician was summoned to the room, but upon arrival the patient's symptoms stopped. The patient looked confused but her color remained good. Her blood pressure was 104/60 mm/Hg. She stayed at the office for 35 minutes for observation. Her blood pressure was taken again was 110/60 m/Hg. The patient recovered and was sent home. Upon internal review, the patient's seizure like activity was considered an other important medical event. Additional information has been requested. This is in follow-up to report (s) submitted on 8/8/2007; 8/17/2007. Additional information has been received from the Pharm D who reported that the patient with no history of seizures was not diagnosed with seizures. The patient did not have a true seizure. The patient's experience was described as "seizure like" activity. The patient was sitting upright when she received GARDASIL. Within 1 - 2 minutes following adiministration, she leaned back against the chair, her head went against her arm on the side, her eyes rolled back in her head and arms and torso shook. It was reported that the patient was very lucid after the "seizure". The Pharm D. reported that the patient was to have unspecified test and an EEG performed (details unknown). The Pharm D had no additional information regarding the patient's experience. The nurse reported that the patient was contacted on 26-Jun-2007 and 28-Jun-2007 and was doing fine. The nurse stated that she did not think that the patient would be back for the third vaccination. No additinal information is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Oedema peripheral
Clinical narrative: This case was received from a health professional on 27 July 2007. A four-year-old female patient with no known medical history developed injection site redness, progressing to entire limb swelling and redness, a few hours after receiving an intramuscular right thigh injection of Daptacel (lot number C2569AA), subcutaneous right thigh of IPOL (lot number Z0548-2), and subcutaneous left thigh injection of MMR (Merck, lot number 1168F). The patient had received the vaccinations on 25 July 2007 and began to experience redness at the injection site within a few hours, later developing "entire limb swelling and redness". The event was treated with cold compresses, and at the time of the report the patient had not yet recovered.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood chloride normal, Blood creatinine normal
Clinical narrative: Diagnosed with ductal carcinoma of the right breast in October 2002-T2N0MO, ER negative, PR negative, HER-2/neu positive. Lump noted in October 2002; mammogram and ultrasound confirmed mass. A sentinel node bx was done in November and in December 2002, a right segmental mastectomy with axillary node dissection was performed. She underwent chemotherapy in January 2003 through April 2003. She also had a 5-week course of full breast radiation therapy and pinpoint radiation therapy x 1 1/2 weeks.  8/10/07 Clinical summary from VHC accompanied VAERS report along w/vax record.  Will consider case closed as is.  Patient developed breast cancer in 2002.  Received anthrax vax 1999-2000.  Underwent mastectomy, chemotherapy & radiation therapy in 2003.  Continues f/u every other month w/oncologist. Per 60 day followup: Status unknown, no longer in the military.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Blood glucose increased, Blood lactate dehydrogenase decreased, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Diagnosed with ductal carcinoma of the right breast in October 2002-T2N0MO, ER negative, PR negative, HER-2/neu positive. Lump noted in October 2002; mammogram and ultrasound confirmed mass. A sentinel node bx was done in November and in December 2002, a right segmental mastectomy with axillary node dissection was performed. She underwent chemotherapy in January 2003 through April 2003. She also had a 5-week course of full breast radiation therapy and pinpoint radiation therapy x 1 1/2 weeks.  8/10/07 Clinical summary from VHC accompanied VAERS report along w/vax record.  Will consider case closed as is.  Patient developed breast cancer in 2002.  Received anthrax vax 1999-2000.  Underwent mastectomy, chemotherapy & radiation therapy in 2003.  Continues f/u every other month w/oncologist. Per 60 day followup: Status unknown, no longer in the military.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Breast cancer in situ, Breast mass, Carbon dioxide increased, Haematocrit normal, Haemoglobin normal
Clinical narrative: Diagnosed with ductal carcinoma of the right breast in October 2002-T2N0MO, ER negative, PR negative, HER-2/neu positive. Lump noted in October 2002; mammogram and ultrasound confirmed mass. A sentinel node bx was done in November and in December 2002, a right segmental mastectomy with axillary node dissection was performed. She underwent chemotherapy in January 2003 through April 2003. She also had a 5-week course of full breast radiation therapy and pinpoint radiation therapy x 1 1/2 weeks.  8/10/07 Clinical summary from VHC accompanied VAERS report along w/vax record.  Will consider case closed as is.  Patient developed breast cancer in 2002.  Received anthrax vax 1999-2000.  Underwent mastectomy, chemotherapy & radiation therapy in 2003.  Continues f/u every other month w/oncologist. Per 60 day followup: Status unknown, no longer in the military.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Platelet count normal, Protein total normal, White blood cell count
Clinical narrative: Diagnosed with ductal carcinoma of the right breast in October 2002-T2N0MO, ER negative, PR negative, HER-2/neu positive. Lump noted in October 2002; mammogram and ultrasound confirmed mass. A sentinel node bx was done in November and in December 2002, a right segmental mastectomy with axillary node dissection was performed. She underwent chemotherapy in January 2003 through April 2003. She also had a 5-week course of full breast radiation therapy and pinpoint radiation therapy x 1 1/2 weeks.  8/10/07 Clinical summary from VHC accompanied VAERS report along w/vax record.  Will consider case closed as is.  Patient developed breast cancer in 2002.  Received anthrax vax 1999-2000.  Underwent mastectomy, chemotherapy & radiation therapy in 2003.  Continues f/u every other month w/oncologist. Per 60 day followup: Status unknown, no longer in the military.
Age: 70.0
Sex: M
Vaccine: TTOX
Symptoms: Burning sensation, Condition aggravated, Disorientation, Hypersensitivity, Injection site atrophy
Clinical narrative: On 8/19/07 approx 8:00 AM the following morning I had deep aching pain in upper arms. Went back to emergency room. I was checked and doctor said I had an allergic reaction to Tetanus shot. Gave me pain medication and prescription. /15/07-ER records received for DOS 8/18/06- Presented to ER with fish hook in right small finger. Denies any numbness or tingling.Fish hook removed. Keflex prescribed.  10/10/07-office notes received, note for DOS 10/24/06-C/O left shoulder arm pain radiates to hand symptoms for 2 days. On 10/3/06 C/O bilateral leg muscle pain all the time since August.  Follow-up: Received shot on 8-19-2006 (Friday) on Sat 8-20-07 woke up and my arms (upper) had a terrible hurting like my body were breaking. 1/11/2010 Muscles have wasted in left arm (where vaccine was administered) Still has aching in muscles. At time hard to use arm, burning sensation in back along spine. Sometimes I am disoriented. Follow-up Information 12-DEC-2008: I have went down hill-health wise since receiving vaccination and cannot seem to recoup with muscle and nerve changes. 02/02/2010 My muscles in my arms are wasted and I have deep severe pain in my upper arms. I have wnet down hill since the vaccination including hospitalization.
Age: 70.0
Sex: M
Vaccine: TTOX
Symptoms: Pain in extremity, Pain in extremity, Periodic limb movement disorder, Removal of foreign body
Clinical narrative: On 8/19/07 approx 8:00 AM the following morning I had deep aching pain in upper arms. Went back to emergency room. I was checked and doctor said I had an allergic reaction to Tetanus shot. Gave me pain medication and prescription. /15/07-ER records received for DOS 8/18/06- Presented to ER with fish hook in right small finger. Denies any numbness or tingling.Fish hook removed. Keflex prescribed.  10/10/07-office notes received, note for DOS 10/24/06-C/O left shoulder arm pain radiates to hand symptoms for 2 days. On 10/3/06 C/O bilateral leg muscle pain all the time since August.  Follow-up: Received shot on 8-19-2006 (Friday) on Sat 8-20-07 woke up and my arms (upper) had a terrible hurting like my body were breaking. 1/11/2010 Muscles have wasted in left arm (where vaccine was administered) Still has aching in muscles. At time hard to use arm, burning sensation in back along spine. Sometimes I am disoriented. Follow-up Information 12-DEC-2008: I have went down hill-health wise since receiving vaccination and cannot seem to recoup with muscle and nerve changes. 02/02/2010 My muscles in my arms are wasted and I have deep severe pain in my upper arms. I have wnet down hill since the vaccination including hospitalization.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt felt a little uneasy about immunizations, asking about size of needle, comparing to cortisone injection - had a bad experience - no reaction (doesn't like shots). Immediately after giving Boostrix, passed out, color pale, placed on cortet, administered NC O2 for about 20 minutes. BP 128/74, P 84. Observed for 40 minutes then released with mother. Instructed to notify Primary Care Physician over weekend with any concerns. Upon discharge pt color pink, resp easy unlabored and aware of situation.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury, Syncope, Visual disturbance
Clinical narrative: While pt was leaving the office, pt fainted and fell back into the wall, hitting her head. Within a minute, pt came to/alert but distraught. Pt described seeing black stops and dizziness before fainting episode.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: High fever, severe headache and malaise
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash
Clinical narrative: Rash on left leg-photo attached physician thinks it is contact dermatitis-we do not think so.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Administered Tdap instead of DTaP. Administration site right deltoid. Several attempts to re-contact family to administer DTaP and to get weight. No response from family.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: fever- > Tylenol, Motrin hives -> Benadryl
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch and pain - started 7/27/07 - Rx Levaquin 500mg N 2 tab x8d
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Injection site pain, Listless, Nausea, Pyrexia
Clinical narrative: Sore deltoid at shot site Temp -> 100 F following AM, Listless; Nausea; Dizzy
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dyspnoea, Rash pruritic, Urticaria
Clinical narrative: Given 2 vac-> HPV #1 Tdap on 5/9/07 on 5/13/07 at ER-diffuse rash-itchy "hive like" rash. Breathing difficulty Dx "urticarial rash". 2 hr vac. -> Rx'd Decadron, Benadryl, Pepcid-  Prednisone x 50 mg
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: Given 2 vac-> HPV #1 Tdap on 5/9/07 on 5/13/07 at ER-diffuse rash-itchy "hive like" rash. Breathing difficulty Dx "urticarial rash". 2 hr vac. -> Rx'd Decadron, Benadryl, Pepcid-  Prednisone x 50 mg
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, TD, VARCEL
Symptoms: Hyperhidrosis, Nausea, Pallor, Presyncope
Clinical narrative: Patient turned pale. felt nauseous, and broke out in a sweat for approximately 5 minutes. Patient almost passed out. *As her mother, I believe the long-term benefits of this drug far outweigh the risks.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyspnoea, Feeling hot, Hypoaesthesia, Muscle spasms
Clinical narrative: 30 min after injection - pt became hot - had difficulty breathing - chills- muscle spasms. Went to E.R. Pt was numb feeling - blurred vision - pt not sure what in ER - will send for report.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: 30 min after injection - pt became hot - had difficulty breathing - chills- muscle spasms. Went to E.R. Pt was numb feeling - blurred vision - pt not sure what in ER - will send for report.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hyperaesthesia, Hypersensitivity, Skin warm, Swelling
Clinical narrative: 8-03-07 pt Mom brought in right upper outer deltoid area 2 1/2-3 in circumference, red, hot, swollen and tender to touch. Advised ice to arm, Tylenol or Motrin for discomfort and Benadryl PRN. Dr. confirmed reaction to tetanus was allergic. 8-7-07 checked arm - no redness, swelling or pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt was given DTaP in left upper arm IM and IPV Subc on Tues 7-31-07 - PM; Wed. morning 8-1-07 arm red and sore; Thursday 8-2-07 entire upper arm red and swollen from shoulder to elbow, no fever. Dr placed on Keflex PO.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Skin lesion, Urticaria
Clinical narrative: Received DTaP 7/31/07, 2-3 hrs after receiving DTaP (#4) presented with 2 discrete urticarial lesions on left cheek. Presented to Emergency Room, was given Benadryl and discharged.
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cold compress therapy, Injection site erythema
Clinical narrative: Pt. developed same redness around injection site following administration. Ice applied to site x 10 minutes. Redness subsided. Mother advised to give pt. Benadryl
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: (L) upper arm developed 2 1/2 inch area of redness warmth and induration-Tx with ibuprofen and Benadryl PM Area was painful to touch
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: hives, widespread, 24 hr after administration of Varicella booster
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Flushing
Clinical narrative: Approximately 15 min post injection pt began to feel light headed and dizzy accompanised by flushing. Symptoms were reported to have pealed and diminished shortly after. Within 45 minutes symptoms. Seems to be absent.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema
Clinical narrative: Left arm erythematous.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Chicken pox vaccine (Varivax) given 7/30/07. Inflammation of injection site noted 7/31/07. 8/1/07- (R) upper arm (site of injection) is reddened, inflammed, warm to touch. (3" x 3" area) No fever-Possible cellulitis per Dr on 8/1/07
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: After giving pt school vaccines within 2 min pt's right upper lateral arm approx site of varicella pt began having dime-seized hive that progressed to quarter sized. Pt had no SOB, CP or other hives. Benadryl 12.5mg IM stat per PA order. After 20 minutes, hold pt tolerated well.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dermatitis diaper, Diarrhoea, Irritability, Pain
Clinical narrative: 7/24/07 woke up 10:30 pm fever approx 103 deg Tympanic/crying/inconsolable. Acting like had much pain lt. leg. 7/25/07 rash all over lt. leg and spreading to abdomen. Diaper rash/diarrhea. To ER 7/25/07 AM. Given acetaminophen/ibuprofen and sent home. Some fever that nite and next day 7/26/07. Fussy "not herself" much improved 7/27/07 "Gave only 1 dose Tylenol" on 7/27/07
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: 7/24/07 woke up 10:30 pm fever approx 103 deg Tympanic/crying/inconsolable. Acting like had much pain lt. leg. 7/25/07 rash all over lt. leg and spreading to abdomen. Diaper rash/diarrhea. To ER 7/25/07 AM. Given acetaminophen/ibuprofen and sent home. Some fever that nite and next day 7/26/07. Fussy "not herself" much improved 7/27/07 "Gave only 1 dose Tylenol" on 7/27/07
Age: 0.9
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Crying, Discomfort, Erythema, Local reaction
Clinical narrative: Pt had initial local reaction with redness per Mom. 1st night after vaccine temp 100.6 - crying painful right leg. Cont. to have pain, + discomfort, sl. swelling no movement - Wed - slowly recovery over next 72 hours
Age: 0.9
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pain, Swelling
Clinical narrative: Pt had initial local reaction with redness per Mom. 1st night after vaccine temp 100.6 - crying painful right leg. Cont. to have pain, + discomfort, sl. swelling no movement - Wed - slowly recovery over next 72 hours
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: About 5 minutes after 2nd Varicella vaccine patient developed a firm lump with some assoc. redness and itching. No warmth or tenderness noted.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Left lateral upper arm. Redness, with edema, pain to touch.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Memory impairment, Muscle spasms, Myalgia
Clinical narrative: Cramps leg, Weight gain, Tachycardia, pain on joints and muscles, Back Pain, Memory increase in forgetfulness
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Tachycardia, Weight increased
Clinical narrative: Cramps leg, Weight gain, Tachycardia, pain on joints and muscles, Back Pain, Memory increase in forgetfulness