chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Pitting oedema, Pleural effusion, Proteinuria, Pulmonary haemosiderosis, Rash erythematous
Clinical narrative: This case was reported in a literature article and described the occurrence of Henoch-Schonlein purpura in a 26-year-old male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of HEPATITIS B vaccine (unknown route and injection site), lot number not provided. One week after vaccination with HEPATITIS B vaccine, the subject experienced arthralgias, bilateral lower extremity edema and a painful erythematous rash. The physical examination revealed normal vital signs and a comfortable appearing subject. He had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. The subject was hospitalised. At admission, the chest X-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, computed tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloody aliquors and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage (DAH). A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of Henoch-Schonlein purpura (HSP). The subject was treated with cyclophosphamide and corticosteroid. After treatment with corticosteroids and cyclophosphamide, the DAH resolved and the glomerulonephritis stabilized. At the time of reporting the outcome of the events was unspecified. The author considered the events were possibly related to vaccination with HEPATITIS B vaccine.
Age: 26.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Rash papular, Renal failure acute
Clinical narrative: This case was reported in a literature article and described the occurrence of Henoch-Schonlein purpura in a 26-year-old male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of HEPATITIS B vaccine (unknown route and injection site), lot number not provided. One week after vaccination with HEPATITIS B vaccine, the subject experienced arthralgias, bilateral lower extremity edema and a painful erythematous rash. The physical examination revealed normal vital signs and a comfortable appearing subject. He had multiple healing erythematous papules on the lower extremities and moderate pitting edema of the feet and ankles. Initial laboratory studies were remarkable for acute renal failure and nephrotic range proteinuria. The subject was hospitalised. At admission, the chest X-ray was normal. On the second day of admission, the patient developed acute respiratory distress with cough and hemoptysis. At that time, computed tomography (CT) of the chest demonstrated bilateral patchy infiltrates and pleural effusions. Bronchoscopy was performed and serial bronchoalveolar lavages returned increasingly bloody aliquors and numerous hemosiderin-laden macrophages. Transbronchial biopsy demonstrated gross hemorrhage, destruction of the alveolar architecture and acute and chronic inflammation. These studies, combined with the patient's clinical course and chest CT, confirmed a diagnosis of diffuse alveolar hemorrhage (DAH). A subsequent renal biopsy revealed diffuse crescentic glomerulonephritis and mesangial immunoglobulin A (IGA) deposition, establishing a diagnosis of Henoch-Schonlein purpura (HSP). The subject was treated with cyclophosphamide and corticosteroid. After treatment with corticosteroids and cyclophosphamide, the DAH resolved and the glomerulonephritis stabilized. At the time of reporting the outcome of the events was unspecified. The author considered the events were possibly related to vaccination with HEPATITIS B vaccine.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Abdominal distension, Diarrhoea, Intussusception, Surgery, Vomiting
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 3 month old female with reflux, but off medication and doing well on 03-JUN-2008 was vaccinated with her second dose of ROTATEQ oral, Lot#: 660286/1830U. Concomitant therapy included her second dose of PEDIARIX intramuscular into her right leg (Lot# AC21B141AA), her second dose of HIBV intramuscular into her left leg (Lot#UF349AA) and her second dose of PREVENAR in intramuscular into her left leg. One month and 1 week post vaccine administration, on 08-JUL-2008, the patient developed vomiting, diarrhea and abdominal distention and was diagnosed with intussusception requiring emergency surgery. On 03-OCT-2008, reviewed hospital D/C summary of 11-JUL-2008 to 17-JUL-2008. Final diagnosed: intussusception, explorative laparotomy with small bowel resection and primary anastomosis. Records reveal patient experienced fever and persistent emesis for 3-4 days, constipation, lethargy, abdominal distended and taut, dark red stool. Findings in or included small segment of necrotic bowel which was resected. Admitted PICU, PICC line placed and started on parenteral nutrition. Gradually returned to normal BMs and diet advanced to full formula. D/C to home w/surgery clinic follow up. On 17-OCT-2008 reviewed additional hospital records of 11-JUL-2008 to 17-JUL-2008. Included path report which reveals necrotizing enterocolitis. Laboratory data included: air enema (+) for IS but could not reduce. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot 660286/1830U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The VAERS ID# is: 326440. The original reporter was not provided.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Abdominal distension, Barium double contrast, Constipation, Diarrhoea, Explorative laparotomy
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 3 month old female with reflux, but off medication and doing well on 03-JUN-2008 was vaccinated with her second dose of ROTATEQ oral, Lot#: 660286/1830U. Concomitant therapy included her second dose of PEDIARIX intramuscular into her right leg (Lot# AC21B141AA), her second dose of HIBV intramuscular into her left leg (Lot#UF349AA) and her second dose of PREVENAR in intramuscular into her left leg. One month and 1 week post vaccine administration, on 08-JUL-2008, the patient developed vomiting, diarrhea and abdominal distention and was diagnosed with intussusception requiring emergency surgery. On 03-OCT-2008, reviewed hospital D/C summary of 11-JUL-2008 to 17-JUL-2008. Final diagnosed: intussusception, explorative laparotomy with small bowel resection and primary anastomosis. Records reveal patient experienced fever and persistent emesis for 3-4 days, constipation, lethargy, abdominal distended and taut, dark red stool. Findings in or included small segment of necrotic bowel which was resected. Admitted PICU, PICC line placed and started on parenteral nutrition. Gradually returned to normal BMs and diet advanced to full formula. D/C to home w/surgery clinic follow up. On 17-OCT-2008 reviewed additional hospital records of 11-JUL-2008 to 17-JUL-2008. Included path report which reveals necrotizing enterocolitis. Laboratory data included: air enema (+) for IS but could not reduce. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot 660286/1830U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The VAERS ID# is: 326440. The original reporter was not provided.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Faeces hard, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intussusception
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 3 month old female with reflux, but off medication and doing well on 03-JUN-2008 was vaccinated with her second dose of ROTATEQ oral, Lot#: 660286/1830U. Concomitant therapy included her second dose of PEDIARIX intramuscular into her right leg (Lot# AC21B141AA), her second dose of HIBV intramuscular into her left leg (Lot#UF349AA) and her second dose of PREVENAR in intramuscular into her left leg. One month and 1 week post vaccine administration, on 08-JUL-2008, the patient developed vomiting, diarrhea and abdominal distention and was diagnosed with intussusception requiring emergency surgery. On 03-OCT-2008, reviewed hospital D/C summary of 11-JUL-2008 to 17-JUL-2008. Final diagnosed: intussusception, explorative laparotomy with small bowel resection and primary anastomosis. Records reveal patient experienced fever and persistent emesis for 3-4 days, constipation, lethargy, abdominal distended and taut, dark red stool. Findings in or included small segment of necrotic bowel which was resected. Admitted PICU, PICC line placed and started on parenteral nutrition. Gradually returned to normal BMs and diet advanced to full formula. D/C to home w/surgery clinic follow up. On 17-OCT-2008 reviewed additional hospital records of 11-JUL-2008 to 17-JUL-2008. Included path report which reveals necrotizing enterocolitis. Laboratory data included: air enema (+) for IS but could not reduce. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot 660286/1830U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The VAERS ID# is: 326440. The original reporter was not provided.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Lethargy, Necrotising colitis, Parenteral nutrition, Pyrexia, Small intestinal resection
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 3 month old female with reflux, but off medication and doing well on 03-JUN-2008 was vaccinated with her second dose of ROTATEQ oral, Lot#: 660286/1830U. Concomitant therapy included her second dose of PEDIARIX intramuscular into her right leg (Lot# AC21B141AA), her second dose of HIBV intramuscular into her left leg (Lot#UF349AA) and her second dose of PREVENAR in intramuscular into her left leg. One month and 1 week post vaccine administration, on 08-JUL-2008, the patient developed vomiting, diarrhea and abdominal distention and was diagnosed with intussusception requiring emergency surgery. On 03-OCT-2008, reviewed hospital D/C summary of 11-JUL-2008 to 17-JUL-2008. Final diagnosed: intussusception, explorative laparotomy with small bowel resection and primary anastomosis. Records reveal patient experienced fever and persistent emesis for 3-4 days, constipation, lethargy, abdominal distended and taut, dark red stool. Findings in or included small segment of necrotic bowel which was resected. Admitted PICU, PICC line placed and started on parenteral nutrition. Gradually returned to normal BMs and diet advanced to full formula. D/C to home w/surgery clinic follow up. On 17-OCT-2008 reviewed additional hospital records of 11-JUL-2008 to 17-JUL-2008. Included path report which reveals necrotizing enterocolitis. Laboratory data included: air enema (+) for IS but could not reduce. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot 660286/1830U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The VAERS ID# is: 326440. The original reporter was not provided.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Surgery, Vomiting
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 3 month old female with reflux, but off medication and doing well on 03-JUN-2008 was vaccinated with her second dose of ROTATEQ oral, Lot#: 660286/1830U. Concomitant therapy included her second dose of PEDIARIX intramuscular into her right leg (Lot# AC21B141AA), her second dose of HIBV intramuscular into her left leg (Lot#UF349AA) and her second dose of PREVENAR in intramuscular into her left leg. One month and 1 week post vaccine administration, on 08-JUL-2008, the patient developed vomiting, diarrhea and abdominal distention and was diagnosed with intussusception requiring emergency surgery. On 03-OCT-2008, reviewed hospital D/C summary of 11-JUL-2008 to 17-JUL-2008. Final diagnosed: intussusception, explorative laparotomy with small bowel resection and primary anastomosis. Records reveal patient experienced fever and persistent emesis for 3-4 days, constipation, lethargy, abdominal distended and taut, dark red stool. Findings in or included small segment of necrotic bowel which was resected. Admitted PICU, PICC line placed and started on parenteral nutrition. Gradually returned to normal BMs and diet advanced to full formula. D/C to home w/surgery clinic follow up. On 17-OCT-2008 reviewed additional hospital records of 11-JUL-2008 to 17-JUL-2008. Included path report which reveals necrotizing enterocolitis. Laboratory data included: air enema (+) for IS but could not reduce. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot 660286/1830U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The VAERS ID# is: 326440. The original reporter was not provided.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood product transfusion, Computerised tomogram abnormal, Cough, Diplopia
Clinical narrative: 11/12 c/o cold symptoms. 11/13 cold symptoms went away developed double vision & weakness when walking to ER. Hospitalized slurry speech inability to walk vision worse tap dx Guillain Barre. Transferred to neuro at hosp. Tx IgG started to reverse 11/20 +/- maximum assistance needed. 11/25 transferred to rehab. 1/29/2010 Residual ataxia and diplopia.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Miller Fisher syndrome, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: 11/12 c/o cold symptoms. 11/13 cold symptoms went away developed double vision & weakness when walking to ER. Hospitalized slurry speech inability to walk vision worse tap dx Guillain Barre. Transferred to neuro at hosp. Tx IgG started to reverse 11/20 +/- maximum assistance needed. 11/25 transferred to rehab. 1/29/2010 Residual ataxia and diplopia.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Upper respiratory tract infection, Vision blurred
Clinical narrative: 11/12 c/o cold symptoms. 11/13 cold symptoms went away developed double vision & weakness when walking to ER. Hospitalized slurry speech inability to walk vision worse tap dx Guillain Barre. Transferred to neuro at hosp. Tx IgG started to reverse 11/20 +/- maximum assistance needed. 11/25 transferred to rehab. 1/29/2010 Residual ataxia and diplopia.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Ataxia, Blood product transfusion, Diplopia
Clinical narrative: 11/12 c/o cold symptoms. 11/13 cold symptoms went away developed double vision & weakness when walking to ER. Hospitalized slurry speech inability to walk vision worse tap dx Guillain Barre. Transferred to neuro at hosp. Tx IgG started to reverse 11/20 +/- maximum assistance needed. 11/25 transferred to rehab. 1/29/2010 Residual ataxia and diplopia.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diplopia, Dysarthria, Guillain-Barre syndrome, Lumbar puncture, Nasopharyngitis
Clinical narrative: 11/12 c/o cold symptoms. 11/13 cold symptoms went away developed double vision & weakness when walking to ER. Hospitalized slurry speech inability to walk vision worse tap dx Guillain Barre. Transferred to neuro at hosp. Tx IgG started to reverse 11/20 +/- maximum assistance needed. 11/25 transferred to rehab. 1/29/2010 Residual ataxia and diplopia.
Age: 20.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Death
Clinical narrative: Initial fatal report received from a healthcare professional on 12 December 2008. A 19-year-old male patient, with history of meningitis at age ten, received a dose of MENOMUNE (lot number not reported) on an unspecified date prior to college entrance. The patient contracted meningitis and passed away at age 19 on 20 November 2008. No further details were provided. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Death, Meningitis
Clinical narrative: Initial fatal report received from a healthcare professional on 12 December 2008. A 19-year-old male patient, with history of meningitis at age ten, received a dose of MENOMUNE (lot number not reported) on an unspecified date prior to college entrance. The patient contracted meningitis and passed away at age 19 on 20 November 2008. No further details were provided. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Amnesia, Back pain, Blindness unilateral, Fall, Fatigue
Clinical narrative: Information has been received from a patient's mother concerning her 17 year old daughter with penicillin allergy and a history of erythematous multiforme (about 10 years ago) who was vaccinated with the first dose of GARDASIL on 04-MAY-2007, she received the second dose of GARDASIL on 06-JUL-2007 and then received the third dose of GARDASIL on 06-NOV-2008. Vaccinations also received on 04-MAY-2007 included a first dose of Hep A (manufacturer unknown) and a second dose of Hep A (manufacturer unknown) on 06-NOV-2007. Concomitant therapy included YASMIN and vitamins (unspecified). It was reported that the patient started complaining of extreme back pain that went from the head down to the spine in May-2008 and then on 22-SEP-2008 the patient started to have vision loss in her one eye, which eye was unspecified. The patient was then admitted to the hospital on 06-OCT-2008 because of the vision problem, she could not control her bladder, very moody, tired, extreme head and back pain. At the hospital she had spinal test done. MRI of her brain and spine, and numerous blood work was done. The patient was diagnosed with optic neuritis and is totally blind in the one eye, and was then sent home from the hospital on 11-OCT-2008. It was reported that the patient still was having problems with the back pain, she also had short term memory loss, she falls a lot, and had tingling and numbing of the hands and feet. It was noted that the patient still had most of the symptoms and they were trying to rule out multiple sclerosis. The patient's mother reported that lot # that she had was 655165/1425F, but she was unsure what dose that lot # was for. At the time of the report the patient had not recovered. Additional information has been requested.  1/06/09 Received hospital medical records of 12/16-12/17/2008. FINAL DX: blurred vision left eye, not optic neuritis; optic neuritis right eye.  Records reveal patient seen for loss of vision in right eye beginning 9/08 & tunnel vision left eye beginning 12/16/08.  Did not feel well day before admit & had bloody nose then developed tunnel vision left eye w/halos, nausea, photophobia, phonophobia, lightheadedness.  Exam revealed pain in eyes w/blurred double vision.  Neuro-ophtho consult done.   Tx w/steroids initially but d/c when neuroophtho determined not optic neuritis after review of MRI which revealed abnormality of right optic nerve.  2/18/09 Received hospital medical recods of 10/6-10/11/2008. FINAL DX: right optic neuritis Records reveal patient experienced right side visual change, fatigue, 8# wt gain, intermittent feet, back & wrist pain, urinary urgency & frequency.  Had been seen by PCP, chiropractor, neurologist & optometrist who noted pinhole & referred.  Exam revealed right cranial nerve II & III impairment w/vision 20/200.  LP done.  Tx w/IV steroids, no improvement & d/c to home on tapering oral steroids.  Was to f/u w/neurologist & PCP.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache, Hypoaesthesia, Lumbar puncture, Mood altered, Optic neuritis
Clinical narrative: Information has been received from a patient's mother concerning her 17 year old daughter with penicillin allergy and a history of erythematous multiforme (about 10 years ago) who was vaccinated with the first dose of GARDASIL on 04-MAY-2007, she received the second dose of GARDASIL on 06-JUL-2007 and then received the third dose of GARDASIL on 06-NOV-2008. Vaccinations also received on 04-MAY-2007 included a first dose of Hep A (manufacturer unknown) and a second dose of Hep A (manufacturer unknown) on 06-NOV-2007. Concomitant therapy included YASMIN and vitamins (unspecified). It was reported that the patient started complaining of extreme back pain that went from the head down to the spine in May-2008 and then on 22-SEP-2008 the patient started to have vision loss in her one eye, which eye was unspecified. The patient was then admitted to the hospital on 06-OCT-2008 because of the vision problem, she could not control her bladder, very moody, tired, extreme head and back pain. At the hospital she had spinal test done. MRI of her brain and spine, and numerous blood work was done. The patient was diagnosed with optic neuritis and is totally blind in the one eye, and was then sent home from the hospital on 11-OCT-2008. It was reported that the patient still was having problems with the back pain, she also had short term memory loss, she falls a lot, and had tingling and numbing of the hands and feet. It was noted that the patient still had most of the symptoms and they were trying to rule out multiple sclerosis. The patient's mother reported that lot # that she had was 655165/1425F, but she was unsure what dose that lot # was for. At the time of the report the patient had not recovered. Additional information has been requested.  1/06/09 Received hospital medical records of 12/16-12/17/2008. FINAL DX: blurred vision left eye, not optic neuritis; optic neuritis right eye.  Records reveal patient seen for loss of vision in right eye beginning 9/08 & tunnel vision left eye beginning 12/16/08.  Did not feel well day before admit & had bloody nose then developed tunnel vision left eye w/halos, nausea, photophobia, phonophobia, lightheadedness.  Exam revealed pain in eyes w/blurred double vision.  Neuro-ophtho consult done.   Tx w/steroids initially but d/c when neuroophtho determined not optic neuritis after review of MRI which revealed abnormality of right optic nerve.  2/18/09 Received hospital medical recods of 10/6-10/11/2008. FINAL DX: right optic neuritis Records reveal patient experienced right side visual change, fatigue, 8# wt gain, intermittent feet, back & wrist pain, urinary urgency & frequency.  Had been seen by PCP, chiropractor, neurologist & optometrist who noted pinhole & referred.  Exam revealed right cranial nerve II & III impairment w/vision 20/200.  LP done.  Tx w/IV steroids, no improvement & d/c to home on tapering oral steroids.  Was to f/u w/neurologist & PCP.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Paraesthesia, Urinary incontinence
Clinical narrative: Information has been received from a patient's mother concerning her 17 year old daughter with penicillin allergy and a history of erythematous multiforme (about 10 years ago) who was vaccinated with the first dose of GARDASIL on 04-MAY-2007, she received the second dose of GARDASIL on 06-JUL-2007 and then received the third dose of GARDASIL on 06-NOV-2008. Vaccinations also received on 04-MAY-2007 included a first dose of Hep A (manufacturer unknown) and a second dose of Hep A (manufacturer unknown) on 06-NOV-2007. Concomitant therapy included YASMIN and vitamins (unspecified). It was reported that the patient started complaining of extreme back pain that went from the head down to the spine in May-2008 and then on 22-SEP-2008 the patient started to have vision loss in her one eye, which eye was unspecified. The patient was then admitted to the hospital on 06-OCT-2008 because of the vision problem, she could not control her bladder, very moody, tired, extreme head and back pain. At the hospital she had spinal test done. MRI of her brain and spine, and numerous blood work was done. The patient was diagnosed with optic neuritis and is totally blind in the one eye, and was then sent home from the hospital on 11-OCT-2008. It was reported that the patient still was having problems with the back pain, she also had short term memory loss, she falls a lot, and had tingling and numbing of the hands and feet. It was noted that the patient still had most of the symptoms and they were trying to rule out multiple sclerosis. The patient's mother reported that lot # that she had was 655165/1425F, but she was unsure what dose that lot # was for. At the time of the report the patient had not recovered. Additional information has been requested.  1/06/09 Received hospital medical records of 12/16-12/17/2008. FINAL DX: blurred vision left eye, not optic neuritis; optic neuritis right eye.  Records reveal patient seen for loss of vision in right eye beginning 9/08 & tunnel vision left eye beginning 12/16/08.  Did not feel well day before admit & had bloody nose then developed tunnel vision left eye w/halos, nausea, photophobia, phonophobia, lightheadedness.  Exam revealed pain in eyes w/blurred double vision.  Neuro-ophtho consult done.   Tx w/steroids initially but d/c when neuroophtho determined not optic neuritis after review of MRI which revealed abnormality of right optic nerve.  2/18/09 Received hospital medical recods of 10/6-10/11/2008. FINAL DX: right optic neuritis Records reveal patient experienced right side visual change, fatigue, 8# wt gain, intermittent feet, back & wrist pain, urinary urgency & frequency.  Had been seen by PCP, chiropractor, neurologist & optometrist who noted pinhole & referred.  Exam revealed right cranial nerve II & III impairment w/vision 20/200.  LP done.  Tx w/IV steroids, no improvement & d/c to home on tapering oral steroids.  Was to f/u w/neurologist & PCP.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram abnormal, Postictal state, Tongue biting
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with a history of motor vehicle accident in 2003 (CT scan at that time was normal) and minor head injuries due to sports that required stitches who on 03-MAR-2008 was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscularly, lot # 660387/1967U), and on 07-JUL-2008 the second dose of GARDASIL (0.5 ml, intramuscularly, lot # 660553/0070X).  On 10-OCT-2008 the patient experienced a petit mal seizure and on 18-OCT-2008 had a second seizure.  The nurse stated that each seizure lasted 2 to 3 minutes and it took 30 minutes post seizure for the patient to fully  recover.  Patient was seen in Emergency Room after the 2nd seizure because she bit her tongue which required treatment.  The 3rd GARDASIL dose was delayed pending neurologist's decision.  EEG showed bilateral seizure activity.  Patient is now taking TOPAMAX.  Upon internal review, petit mal seizure, and seizure were determined to be other important medical events.  Additional information has been requested. 12/29/08 Received ER medical records for 10/11/2008. FINAL DX: new onset seizures & hypothyroidism. Records reveal patient experienced HA followed by LOC & parent witnessed generalized seizure lasting approx 2-3 min followed by postictal period of approx 15-20 min.  Had 1 prior seizure on 10/10/08 & seen by PCP.  Referred to neuro.  No further seizure activity while in ER & d/c to home.  2/26/09 Received Neuro consut of 10/16/2008. FINAL DX: solitary seizure & migraines Records reveal patient experienced witnessed seizure activity w/tongue biting & postictal period & preceeded by emesis.  Tx w/meds & referred for EEG.  No further records available.  3/3/09 Received Neuro consult of 10/22/2008. FINAL DX: Epilepsy Records reveal patient had 2 generalized tonic-clonic events c/w epilepsy but unable to determine if partial onset or primary generlized.  Was to continue meds & obtain copy of MRI & EEG done at outlying hospital for review.  No further records available.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date experienced intussusception 8 months after completing their oral series of ROTATEQ.  The patient was hospitalized but it was unknown for how long or at which hospital.  At the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 7 year old female patient who on 30-JAN-2008 was vaccinated with her second dose of VARIVAX (Merck) (Lot# 658586/1272U) by SQ route. On 01-FEB-2008 the patient developed a small area of red around the site of vaccination. Significantly increased in size through the day to 5x3 1/2 cm area of induration and warmth increased. The patient started on KEFLEX and recovered on 03-FEB-2008. The physician considered the patient's experiences to be Other Important Medical Events. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Gave vaccination, child's leg had a reaction that evening. Went to ER and was hospitalized for two days.  2/2/09 MR received for DOS 12/9-11/2008 with D/C DX:  L thigh cellulitis. Pt presented with 1 day hx of swelling and erythema of the L thigh following vaccines given on 12/8/08.  Swelling and redness noted below the knee. Leg is tender and pt favoring when walking.  Tx with abx and Benadryl with resolution.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Facial redness and pruritis.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Day after receiving vaccines parent called. Fever 102.8. Body aches. Diarrhea - persisted x 4 days. Nausea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Syncope
Clinical narrative: Reported 4 month after #2 GARDASIL. Temp. 101. Nausea and fainting episode.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Dyskinesia
Clinical narrative: Client closed eyes, looked like she was going to faint and then she had two jerky movements. She then opened her eyes and asked what happened. Jerky movements lasted three seconds. Involved head and upper body.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Rt. upper leg has a 1 cm red raised area with blister-like bumps around it. No fever. No increase warmth to area.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt received pre-deployment vaccine requirements then found confirmation of pregnancy. TYPHOID Vi caps (x1), ANTHRAX (x3), INFLUENZA (x1), SMALLPOX (x2), TDAP (x1)
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, HIBV, IPV, PNC, TDAP
Symptoms: Stem cell transplant, Wrong drug administered
Clinical narrative: Pt. was given Tdap instead of Td, no adverse reactions occurred
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LARGE AREA OF REDNESS AND SWELLING ON HER LEFT THIGH WITHIN 12 TO 24 HOURS AFTER IMMUNIZATIONS
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Right ELBOW AND POSTERIOR FOREARM - RASH -MACULAR PAPULAR wAISTLINE- ITCHY only no rash
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose, CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Convulsion
Clinical narrative: 11/18/08 Headache;11/19/08 Rhinitis, Malaise, Dizziness, Edema in eyes.  Note: This symtoms continues until 12/10/08.   12/10/08 2:00 a.m. convulsions and patient was hospitalized with R/O TIA vs CNS infection. Note: Patient still at Hospital.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Eyelid oedema, Gram stain negative, Headache, Herpes simplex
Clinical narrative: 11/18/08 Headache;11/19/08 Rhinitis, Malaise, Dizziness, Edema in eyes.  Note: This symtoms continues until 12/10/08.   12/10/08 2:00 a.m. convulsions and patient was hospitalized with R/O TIA vs CNS infection. Note: Patient still at Hospital.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Protein total increased, Red blood cell count normal, Rhinitis
Clinical narrative: 11/18/08 Headache;11/19/08 Rhinitis, Malaise, Dizziness, Edema in eyes.  Note: This symtoms continues until 12/10/08.   12/10/08 2:00 a.m. convulsions and patient was hospitalized with R/O TIA vs CNS infection. Note: Patient still at Hospital.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Surgery
Clinical narrative: Bloody diarrhea; Surgery for bowel obstruction, intusseption.  2/2/09 Received hospital medical records of 10/27-10/29/2008. FINAL DX: complete small bowel obstruction, ileocolic intussusception, s/p open laparotomy. Records reveal patient experienced abdominal pain, vomiting, diet refusal, decreased activity & rectal bleeding x 1 day.  Had been seen at outlying ER & transferred to higher level of care.  Noted to have mild dehydration on admit.  Surgical consult & taken to OR.  Progressed well & d/c to home.
Age: 1.58
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap vaccine was inadvertantly administered instead of DTap vaccine. No reactions noted at this time.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Acute disseminated encephalomyelitis, Hypoaesthesia, Influenza like illness, Lumbar puncture
Clinical narrative: Became sick with flu like symptoms the day of shot, went home from work sick.  A couple of weeks after shot, began to have tingling sensation in bottom of both feet.  Slowly progressed to numbness in legs, feet, ankles.  Has no feeling in legs but can still walk.  Saw first MD on 11/20/08 and again on 11/26/08 then referred to neurologist. After numerous tests Dr diagnosed client with ADEM (Acute Disseminated Encephalomyelitis). Symptoms have not improved. No treatment at this time.   3/20/08 Received Neuro consult medical records of 12/16-12/29/2008. FINAL DX: ADEM w/peripheral & central demyelination Records reveal patient experienced insidious onset plantar numbness bilaterally which ascended up legs x 4 wks.  Had experienced GI prodrome after foreign travel approx 2 wks prior to onset of symptoms.  Neuro exam revealed bilateral LE dysesthesias, distal sensory loss, DTRs brisk on L.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Became sick with flu like symptoms the day of shot, went home from work sick.  A couple of weeks after shot, began to have tingling sensation in bottom of both feet.  Slowly progressed to numbness in legs, feet, ankles.  Has no feeling in legs but can still walk.  Saw first MD on 11/20/08 and again on 11/26/08 then referred to neurologist. After numerous tests Dr diagnosed client with ADEM (Acute Disseminated Encephalomyelitis). Symptoms have not improved. No treatment at this time.   3/20/08 Received Neuro consult medical records of 12/16-12/29/2008. FINAL DX: ADEM w/peripheral & central demyelination Records reveal patient experienced insidious onset plantar numbness bilaterally which ascended up legs x 4 wks.  Had experienced GI prodrome after foreign travel approx 2 wks prior to onset of symptoms.  Neuro exam revealed bilateral LE dysesthesias, distal sensory loss, DTRs brisk on L.
Age: 51.0
Sex: F
Vaccine: HEP, TD
Symptoms: Anxiety, Dizziness, Joint stiffness, Sleep disorder, Vision blurred
Clinical narrative: After the initial Hep B injection on 10-7-18 I became extremely anxious, my sleep was disrupted, was unable to concentrate, and cried easily. All symptoms were abnormal as I am typically a very upbeat, well-adjusted person. Also noticed that I was feeling stiff in my joints over my entire body but especially my neck. When the second in the series of Hep B injections was given on 11-04-08, all the above symptoms increased exponentially. Had I not known it was in response to the immunization, my reaction was so sever I would have sought psychiatric help for my symptoms. These symptoms began within the day of each injection and seem to increase over several weeks, plateauing aproximately 3 to 4 weeks out. To this date they have slightly decreased maybe 10%. On 11-4-08 I also recieved a Td immunization. About 5 or so minutes after these two injections were recieved, I started to feel odd, like I would pass out. Thus, I sat in the waiting room for about 20 minutes hoping it would pass. No one asked about my condition and I felt too poorly to seek help. Eventually I went to my car and reclined for at least another 30 minutes as I was afraid to drive in my condition. Initially I self treated, eliminating any stressors possible, took magnesium at bedtime to enhance sleep, and vitamins and bioflavinoids to bolster my immune system and deal with inflammation. I was not ill at the time of the immunizations nor was I taking any drugs. Eventually I spoke with a PA who advised I discontinue receiving the full series of Hep B given my personal response.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pruritus generalised
Clinical narrative: complains  of itching all  over his body he has  caused bruises on his arms He got flu shot three days ago.Hesays the  itching strted soon after receiving the shot.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: GAVE PEDIARIX,PCV7 TO EARLY
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy brain abnormal, Death, Demyelination, Gait disturbance, Hemiparesis
Clinical narrative: Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness.  Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability.  Pt. transferred to hospital on 11/23/08 for a brain biopsy.  Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy.  Pt's neurological status deteriorated until pt expired on 12/11/08.  11/22/2008 MR received for multiple admissions beginning ~10/20/2008.  Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis.  COPD, Dyslipidemia.  Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC.  Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received.  COD:  Progressive Multifocal Leukoencephalopathy.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: JC virus infection, Laboratory test abnormal, Nuclear magnetic resonance imaging brain abnormal, Progressive multifocal leukoencephalopathy, Speech disorder
Clinical narrative: Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness.  Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability.  Pt. transferred to hospital on 11/23/08 for a brain biopsy.  Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy.  Pt's neurological status deteriorated until pt expired on 12/11/08.  11/22/2008 MR received for multiple admissions beginning ~10/20/2008.  Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis.  COPD, Dyslipidemia.  Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC.  Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received.  COD:  Progressive Multifocal Leukoencephalopathy.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Client called office on 12/12/08 to report she had developed hives on 12/9/08.  Denied any respiratory difficulty or other symptoms.  Recommended she seek medical care.  Called client on 12/17/08.  She did not seek medical care and stated the hives resolved without any treatment.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: pt given vaccine past recommended age.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Eye swelling, Flushing, Throat tightness
Clinical narrative: TREATED BY PA 3 HRS AFTER INJECTION C SOB, PUFFY, CHILLS, SWOLLEN EYES, TIGHT THROAT, & FLUSHED. RX BENADRYL PO ONLY KEPT FOR 2-3 HRS FOR OBSERVATION. PATIENT HAS MANY ALLERGIES BUT NON TO NEOMYCIN, GELATIN.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema and warmth 2-3cm distal to site of injection noticed 1 day after injection. Area of erythema and warmth spread around arm by day#2. No systemic signs/symptoms. Site is painful to touch.  Site is indurated and warm but not fluctuant.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: Ct. states that he had nosebleed for one month following administration of intranasal influenza vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: red area on upper left arm and knot 2cm by 2.5cm monitored for 20 min no change
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Cough, Fatigue, Feeling cold, Headache
Clinical narrative: Two days after a flu-shot on Oct. 2nd, I got headache, fever, sneezing and terribly fatigue, later on coughing which lasted for almost 10 days. The same symptomes repeated 3 times. The last one was just immiediately after the Thanksgiving and it lasted longer than the previous two with coughing and sputum till early this week (Dec 15th, 2008). I was happy to went through this terrible sickness. Unfortunately, I got headeche sneezing, fatigue and chilly again since this morning. These symptoms make me feel that the 4th cycle comes back to me again. I used to be a very heathy and seldomly sick person. This was the first time in my life that the terrible sickness made me lay in bed for so long repeatedly since I got the vaccine.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia, Sneezing
Clinical narrative: Two days after a flu-shot on Oct. 2nd, I got headache, fever, sneezing and terribly fatigue, later on coughing which lasted for almost 10 days. The same symptomes repeated 3 times. The last one was just immiediately after the Thanksgiving and it lasted longer than the previous two with coughing and sputum till early this week (Dec 15th, 2008). I was happy to went through this terrible sickness. Unfortunately, I got headeche sneezing, fatigue and chilly again since this morning. These symptoms make me feel that the 4th cycle comes back to me again. I used to be a very heathy and seldomly sick person. This was the first time in my life that the terrible sickness made me lay in bed for so long repeatedly since I got the vaccine.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Arthropathy, Bursa disorder, Pain, Tenderness
Clinical narrative: ADMINISTERED INJECTION ON 11/15/08.  PT CALLED ON 11/30 SAYING BOTH HE & HIS WIFE HAVE EXPERIENCED SEVERE PAIN/SORENESS IN RIGHT UPPER ARM. HE FEARS THAT THE SHOT WAS GIVEN IN WRONG PLACE (HIGH-TOP OF SHOULDER)& THAT THE PAIN CONTINUES TO WORSEN. PT STATED THAT IBUPROFEN & SPORTS CREAM ARE NOT HELPING. ON 12/1/08, I RETURNED HIS CALL & TOLD HIM TO SEE A DOCTOR. ON 12/2, PT TOLD ME HE HAD SEEN HIS DOCTOR & WAS GIVEN AN ORAL CORTICOSTEROID FOR 1 WEEK. DOCTOR SPECULATED THAT THE JOINT OR BURSA SACK MAY HAVE BEEN HIT.  (HIS WIFE DID NOT SEE A DOCTOR. HE STATED THAT SHE CANNOT TAKE A CORTICOSTEROID BECAUSE OF A CURRENT HEALTH CONDITION). ON 12/17, PATIENT SAYS HE HAD COMPLETED THE CORTICOSTEROID. PAIN SUBSIDED WHILE ON MED,BUT NOW HAS RETURNED. HIS WIFE IS SOMEWHAT BETTER.  THE DOCTOR HAS TOLD PATIENT THAT HE SHOULD HAVE AN MRI.  PATIENT SAYS HE WILL DO THIS AFTER THE HOLIDAYS ARE OVER.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Loss of consciousness, Syncope vasovagal
Clinical narrative: About a few minutes after the vaccination, patient stood up in the clinic.  After a few more minutes of minor activity, patient lost consciousness and fell down in the clinic.  Recovered consciousness within a few seconds after the fall; luckily did not hit any hard surfaces.  NOTE: the event did not happen immediately after standing up.  In total it happened within ten minutes of the vaccination and should be attributable to it.