chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Bone pain, Chest X-ray normal, Chest discomfort, Computerised tomogram abnormal
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JUL-2007 was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received the second dose of GARDASIL on 07-FEB-2008 and then received her third dose of GARDASIL on 04-JUN-2009 (dose, route and lot # not reported). The physician reported that on 24-JUN-2009 the patient started to experience painful legs and then on 26-JUN-2009 the patient was unable to walk and by 28-JUN-2009 the patient was walking again. The physician reported that the patient was sent to hospital but it was not specified if the patient was admitted or if she was how long she was in the hospital. At the time of reporting, the patient was recovering. Unable to walk and painful legs were considered to be disabling. Additional information has been requested.  8/31/09 Hospital records received DOS 6/24/09 to 6/28/09. Assessment: Thoracic spine arachnoid cyst without compression of the spinal cord. Lower extremity weakness and pain, cause undetermined.  Patient presented with 1-day history of leg pain which started in her knees, went downward, and then began to ascend to chest, back, and lower trunk. Administered pain medications. Neck stiff, rib tenderness. Nausea after Demerol. Hives and swelling with Fentanyl, codeine and morphine have caused nausea and hypertension. Unable to walk on admission. Abdominal distention. Tender to superficial palpation of abdomen, trunk, and lower extremities. Headache. Adjustment disorder, somatization, generalized anxiety. Much improved and discharged.    10/13/09 ICD9 codes received: 729.89, 729.5, 309.4, 349.2, 493.90, V145, 754.79    10/23/09 Discharge Summary, Medical records, vaccine records and ICD9 Codes received for 06/24-9/26.  Final DX: Thoracic spine arachnoid cyst without compression of spinal cord, Lower extremity weakens and pain, cause undetermined.   Presented in the ED on 6/24 with c/o of lower extremity pain starting at the knees descending, and alternately ascending up to the chest area. In severe pain. Unable to walk. Never requested pain meds.  Did not appear to be in pain.  5/5 strength and 2+ tendon reflexes in ankles. PE positive for mild non-tender abd distension. MRI spine remarkable for arachnoid cyst, no impingement. Lumbar puncture normal.  Behavioral consult revealed adjustment disorder and disturbed emotions, somatization and generalized anxiety. Upon discharge ROM improved. Ambulated with walker.  Discharged to home.  Per the mother's account included in medical records, 6 further episodes occurred intermittently through 9/30, with additional admit in Oct. Mother's account notes more severe pain and paralysis with fleeting blindness L eye. Vision exam normal. Swelling trunk area below ribs. Diaphoresis.  (+) past West Nile Virus exposure, alternately low and high bld sugar, sinus infection, low potassium levels.   ICD9 CODES: 729.1, 300.0, 786.59, 844.9, 078.10, V20.2, 754.70, 682.9, 467.1, 922.1
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug hypersensitivity, Gait disturbance, Headache, Lumbar puncture normal, Muscle spasms
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JUL-2007 was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received the second dose of GARDASIL on 07-FEB-2008 and then received her third dose of GARDASIL on 04-JUN-2009 (dose, route and lot # not reported). The physician reported that on 24-JUN-2009 the patient started to experience painful legs and then on 26-JUN-2009 the patient was unable to walk and by 28-JUN-2009 the patient was walking again. The physician reported that the patient was sent to hospital but it was not specified if the patient was admitted or if she was how long she was in the hospital. At the time of reporting, the patient was recovering. Unable to walk and painful legs were considered to be disabling. Additional information has been requested.  8/31/09 Hospital records received DOS 6/24/09 to 6/28/09. Assessment: Thoracic spine arachnoid cyst without compression of the spinal cord. Lower extremity weakness and pain, cause undetermined.  Patient presented with 1-day history of leg pain which started in her knees, went downward, and then began to ascend to chest, back, and lower trunk. Administered pain medications. Neck stiff, rib tenderness. Nausea after Demerol. Hives and swelling with Fentanyl, codeine and morphine have caused nausea and hypertension. Unable to walk on admission. Abdominal distention. Tender to superficial palpation of abdomen, trunk, and lower extremities. Headache. Adjustment disorder, somatization, generalized anxiety. Much improved and discharged.    10/13/09 ICD9 codes received: 729.89, 729.5, 309.4, 349.2, 493.90, V145, 754.79    10/23/09 Discharge Summary, Medical records, vaccine records and ICD9 Codes received for 06/24-9/26.  Final DX: Thoracic spine arachnoid cyst without compression of spinal cord, Lower extremity weakens and pain, cause undetermined.   Presented in the ED on 6/24 with c/o of lower extremity pain starting at the knees descending, and alternately ascending up to the chest area. In severe pain. Unable to walk. Never requested pain meds.  Did not appear to be in pain.  5/5 strength and 2+ tendon reflexes in ankles. PE positive for mild non-tender abd distension. MRI spine remarkable for arachnoid cyst, no impingement. Lumbar puncture normal.  Behavioral consult revealed adjustment disorder and disturbed emotions, somatization and generalized anxiety. Upon discharge ROM improved. Ambulated with walker.  Discharged to home.  Per the mother's account included in medical records, 6 further episodes occurred intermittently through 9/30, with additional admit in Oct. Mother's account notes more severe pain and paralysis with fleeting blindness L eye. Vision exam normal. Swelling trunk area below ribs. Diaphoresis.  (+) past West Nile Virus exposure, alternately low and high bld sugar, sinus infection, low potassium levels.   ICD9 CODES: 729.1, 300.0, 786.59, 844.9, 078.10, V20.2, 754.70, 682.9, 467.1, 922.1
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Muscle swelling, Muscle tightness, Myositis, Neuralgia, Neurological symptom
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JUL-2007 was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received the second dose of GARDASIL on 07-FEB-2008 and then received her third dose of GARDASIL on 04-JUN-2009 (dose, route and lot # not reported). The physician reported that on 24-JUN-2009 the patient started to experience painful legs and then on 26-JUN-2009 the patient was unable to walk and by 28-JUN-2009 the patient was walking again. The physician reported that the patient was sent to hospital but it was not specified if the patient was admitted or if she was how long she was in the hospital. At the time of reporting, the patient was recovering. Unable to walk and painful legs were considered to be disabling. Additional information has been requested.  8/31/09 Hospital records received DOS 6/24/09 to 6/28/09. Assessment: Thoracic spine arachnoid cyst without compression of the spinal cord. Lower extremity weakness and pain, cause undetermined.  Patient presented with 1-day history of leg pain which started in her knees, went downward, and then began to ascend to chest, back, and lower trunk. Administered pain medications. Neck stiff, rib tenderness. Nausea after Demerol. Hives and swelling with Fentanyl, codeine and morphine have caused nausea and hypertension. Unable to walk on admission. Abdominal distention. Tender to superficial palpation of abdomen, trunk, and lower extremities. Headache. Adjustment disorder, somatization, generalized anxiety. Much improved and discharged.    10/13/09 ICD9 codes received: 729.89, 729.5, 309.4, 349.2, 493.90, V145, 754.79    10/23/09 Discharge Summary, Medical records, vaccine records and ICD9 Codes received for 06/24-9/26.  Final DX: Thoracic spine arachnoid cyst without compression of spinal cord, Lower extremity weakens and pain, cause undetermined.   Presented in the ED on 6/24 with c/o of lower extremity pain starting at the knees descending, and alternately ascending up to the chest area. In severe pain. Unable to walk. Never requested pain meds.  Did not appear to be in pain.  5/5 strength and 2+ tendon reflexes in ankles. PE positive for mild non-tender abd distension. MRI spine remarkable for arachnoid cyst, no impingement. Lumbar puncture normal.  Behavioral consult revealed adjustment disorder and disturbed emotions, somatization and generalized anxiety. Upon discharge ROM improved. Ambulated with walker.  Discharged to home.  Per the mother's account included in medical records, 6 further episodes occurred intermittently through 9/30, with additional admit in Oct. Mother's account notes more severe pain and paralysis with fleeting blindness L eye. Vision exam normal. Swelling trunk area below ribs. Diaphoresis.  (+) past West Nile Virus exposure, alternately low and high bld sugar, sinus infection, low potassium levels.   ICD9 CODES: 729.1, 300.0, 786.59, 844.9, 078.10, V20.2, 754.70, 682.9, 467.1, 922.1
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Red blood cell sedimentation rate normal, Speech disorder, Tremor, Ultrasound scan, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JUL-2007 was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received the second dose of GARDASIL on 07-FEB-2008 and then received her third dose of GARDASIL on 04-JUN-2009 (dose, route and lot # not reported). The physician reported that on 24-JUN-2009 the patient started to experience painful legs and then on 26-JUN-2009 the patient was unable to walk and by 28-JUN-2009 the patient was walking again. The physician reported that the patient was sent to hospital but it was not specified if the patient was admitted or if she was how long she was in the hospital. At the time of reporting, the patient was recovering. Unable to walk and painful legs were considered to be disabling. Additional information has been requested.  8/31/09 Hospital records received DOS 6/24/09 to 6/28/09. Assessment: Thoracic spine arachnoid cyst without compression of the spinal cord. Lower extremity weakness and pain, cause undetermined.  Patient presented with 1-day history of leg pain which started in her knees, went downward, and then began to ascend to chest, back, and lower trunk. Administered pain medications. Neck stiff, rib tenderness. Nausea after Demerol. Hives and swelling with Fentanyl, codeine and morphine have caused nausea and hypertension. Unable to walk on admission. Abdominal distention. Tender to superficial palpation of abdomen, trunk, and lower extremities. Headache. Adjustment disorder, somatization, generalized anxiety. Much improved and discharged.    10/13/09 ICD9 codes received: 729.89, 729.5, 309.4, 349.2, 493.90, V145, 754.79    10/23/09 Discharge Summary, Medical records, vaccine records and ICD9 Codes received for 06/24-9/26.  Final DX: Thoracic spine arachnoid cyst without compression of spinal cord, Lower extremity weakens and pain, cause undetermined.   Presented in the ED on 6/24 with c/o of lower extremity pain starting at the knees descending, and alternately ascending up to the chest area. In severe pain. Unable to walk. Never requested pain meds.  Did not appear to be in pain.  5/5 strength and 2+ tendon reflexes in ankles. PE positive for mild non-tender abd distension. MRI spine remarkable for arachnoid cyst, no impingement. Lumbar puncture normal.  Behavioral consult revealed adjustment disorder and disturbed emotions, somatization and generalized anxiety. Upon discharge ROM improved. Ambulated with walker.  Discharged to home.  Per the mother's account included in medical records, 6 further episodes occurred intermittently through 9/30, with additional admit in Oct. Mother's account notes more severe pain and paralysis with fleeting blindness L eye. Vision exam normal. Swelling trunk area below ribs. Diaphoresis.  (+) past West Nile Virus exposure, alternately low and high bld sugar, sinus infection, low potassium levels.   ICD9 CODES: 729.1, 300.0, 786.59, 844.9, 078.10, V20.2, 754.70, 682.9, 467.1, 922.1
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Walking aid user, West Nile virus test positive, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JUL-2007 was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received the second dose of GARDASIL on 07-FEB-2008 and then received her third dose of GARDASIL on 04-JUN-2009 (dose, route and lot # not reported). The physician reported that on 24-JUN-2009 the patient started to experience painful legs and then on 26-JUN-2009 the patient was unable to walk and by 28-JUN-2009 the patient was walking again. The physician reported that the patient was sent to hospital but it was not specified if the patient was admitted or if she was how long she was in the hospital. At the time of reporting, the patient was recovering. Unable to walk and painful legs were considered to be disabling. Additional information has been requested.  8/31/09 Hospital records received DOS 6/24/09 to 6/28/09. Assessment: Thoracic spine arachnoid cyst without compression of the spinal cord. Lower extremity weakness and pain, cause undetermined.  Patient presented with 1-day history of leg pain which started in her knees, went downward, and then began to ascend to chest, back, and lower trunk. Administered pain medications. Neck stiff, rib tenderness. Nausea after Demerol. Hives and swelling with Fentanyl, codeine and morphine have caused nausea and hypertension. Unable to walk on admission. Abdominal distention. Tender to superficial palpation of abdomen, trunk, and lower extremities. Headache. Adjustment disorder, somatization, generalized anxiety. Much improved and discharged.    10/13/09 ICD9 codes received: 729.89, 729.5, 309.4, 349.2, 493.90, V145, 754.79    10/23/09 Discharge Summary, Medical records, vaccine records and ICD9 Codes received for 06/24-9/26.  Final DX: Thoracic spine arachnoid cyst without compression of spinal cord, Lower extremity weakens and pain, cause undetermined.   Presented in the ED on 6/24 with c/o of lower extremity pain starting at the knees descending, and alternately ascending up to the chest area. In severe pain. Unable to walk. Never requested pain meds.  Did not appear to be in pain.  5/5 strength and 2+ tendon reflexes in ankles. PE positive for mild non-tender abd distension. MRI spine remarkable for arachnoid cyst, no impingement. Lumbar puncture normal.  Behavioral consult revealed adjustment disorder and disturbed emotions, somatization and generalized anxiety. Upon discharge ROM improved. Ambulated with walker.  Discharged to home.  Per the mother's account included in medical records, 6 further episodes occurred intermittently through 9/30, with additional admit in Oct. Mother's account notes more severe pain and paralysis with fleeting blindness L eye. Vision exam normal. Swelling trunk area below ribs. Diaphoresis.  (+) past West Nile Virus exposure, alternately low and high bld sugar, sinus infection, low potassium levels.   ICD9 CODES: 729.1, 300.0, 786.59, 844.9, 078.10, V20.2, 754.70, 682.9, 467.1, 922.1
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Areflexia, Asthenia, Brain oedema, Confusional state
Clinical narrative: Information has been received from a nurse practitioner. The nurse practitioner reported that "she was sent an email by one of her patient's mothers who received it from another mother stated that a 15 year old female patient, who was not patient of the nurse practitioner, on 23-JUL-2008 was vaccinated with the first dose of GARDASIL and then two days later the patient almost passed out and was weak for hours. Through the rest of the summer and school year the patient complained that she could not run as fast and was weak. Then on October 17, 2008 the patient received her second dose of GARDASIL and on October 21st the patients mother received an urgent message from the school nurse to take her daughter immediately to her pediatrician. The patient was experiencing confusion, was disoriented, barely could stand, had no reflexes in her feet, and couldn't remember anything that happened that day. The patient was then taken to her pediatrician's office who advised her to see a neurologist. A week later when she saw the neurologist they did a EEG and a MRI because they thought she had a brain tumor, and the patients memory was slowly coming back. Then a second MRI was done which showed she had a demyelination that usually occurs either with GUILLAIN BARRE or with multiple sclerosis. Then later on the patient was diagnosed with GUILLAIN BARRE. The patient was given a spinal tap which showed no permanent damage, inflammation of her brain is going down, she has no debility". GUILLAIN BARRE was considered to be disabling by the nurse practitioner. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Demyelination, Disorientation, Dysstasia, Electroencephalogram, General physical health deterioration
Clinical narrative: Information has been received from a nurse practitioner. The nurse practitioner reported that "she was sent an email by one of her patient's mothers who received it from another mother stated that a 15 year old female patient, who was not patient of the nurse practitioner, on 23-JUL-2008 was vaccinated with the first dose of GARDASIL and then two days later the patient almost passed out and was weak for hours. Through the rest of the summer and school year the patient complained that she could not run as fast and was weak. Then on October 17, 2008 the patient received her second dose of GARDASIL and on October 21st the patients mother received an urgent message from the school nurse to take her daughter immediately to her pediatrician. The patient was experiencing confusion, was disoriented, barely could stand, had no reflexes in her feet, and couldn't remember anything that happened that day. The patient was then taken to her pediatrician's office who advised her to see a neurologist. A week later when she saw the neurologist they did a EEG and a MRI because they thought she had a brain tumor, and the patients memory was slowly coming back. Then a second MRI was done which showed she had a demyelination that usually occurs either with GUILLAIN BARRE or with multiple sclerosis. Then later on the patient was diagnosed with GUILLAIN BARRE. The patient was given a spinal tap which showed no permanent damage, inflammation of her brain is going down, she has no debility". GUILLAIN BARRE was considered to be disabling by the nurse practitioner. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Hypokinesia, Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Presyncope
Clinical narrative: Information has been received from a nurse practitioner. The nurse practitioner reported that "she was sent an email by one of her patient's mothers who received it from another mother stated that a 15 year old female patient, who was not patient of the nurse practitioner, on 23-JUL-2008 was vaccinated with the first dose of GARDASIL and then two days later the patient almost passed out and was weak for hours. Through the rest of the summer and school year the patient complained that she could not run as fast and was weak. Then on October 17, 2008 the patient received her second dose of GARDASIL and on October 21st the patients mother received an urgent message from the school nurse to take her daughter immediately to her pediatrician. The patient was experiencing confusion, was disoriented, barely could stand, had no reflexes in her feet, and couldn't remember anything that happened that day. The patient was then taken to her pediatrician's office who advised her to see a neurologist. A week later when she saw the neurologist they did a EEG and a MRI because they thought she had a brain tumor, and the patients memory was slowly coming back. Then a second MRI was done which showed she had a demyelination that usually occurs either with GUILLAIN BARRE or with multiple sclerosis. Then later on the patient was diagnosed with GUILLAIN BARRE. The patient was given a spinal tap which showed no permanent damage, inflammation of her brain is going down, she has no debility". GUILLAIN BARRE was considered to be disabling by the nurse practitioner. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Developmental delay, Disturbance in attention, Gene mutation identification test positive
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with no pertinent medical history and drug allergies who in September 2002, was vaccinated with a "standard" dose of MMR II, SC, at his 15 month checkup and regressed developmentally. There was no concomitant medication. The patient had lack of eye contact, low muscle tone, focused on one thing, wouldn't respond to his name, and did things differently than other children in his age "within a week after vaccination". Lab diagnostic studies included "child development inventory test, ADOS". The son was diagnosed with autism 3 years later, in approximately September 2005. The patient had sought medical attention and visited the office. The outcome was unknown at the time of report. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Hypotonia, Neuropsychological test abnormal, Unresponsive to stimuli
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with no pertinent medical history and drug allergies who in September 2002, was vaccinated with a "standard" dose of MMR II, SC, at his 15 month checkup and regressed developmentally. There was no concomitant medication. The patient had lack of eye contact, low muscle tone, focused on one thing, wouldn't respond to his name, and did things differently than other children in his age "within a week after vaccination". Lab diagnostic studies included "child development inventory test, ADOS". The son was diagnosed with autism 3 years later, in approximately September 2005. The patient had sought medical attention and visited the office. The outcome was unknown at the time of report. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Injection site anaesthesia, Injection site swelling, Tinnitus
Clinical narrative: Information has been received from a registered pharmacist concerning a 61 year old male with no medical history who on 10-JUL-2009 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Merck) (lot number 664029/0196Y). There was no concomitant medication. On 11-Jul-2009 after a bike ride, the patient experienced swelling and numbness in the arm where he received ZOSTAVAX (Merck). The patient also had ringing in his ears and deafness in the ear on the same side where ZOSTAVAX (Merck) was administered. The patient was not recovered at the time of report. Unspecified medical attention was sought. Upon internal review, deafness was determined to be other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician assistant concerning a 6 month old male patient who on 25-FEB-2009 was vaccinated with a first dose of ROTATEQ (lot# 662800/1307X). On 24-APR-2009 he received second dose of ROTATEQ (lot # 662800/1307X). On 02-JUL-2009 he developed rotavirus. The same day on 02-JUL-2009 the patient was taken to the Emergency Room and was admitted to the hospital for 2 days. On unspecified date the patient recovered. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: YF
Symptoms: Diarrhoea, No reaction on previous exposure to drug, Rash, Throat irritation, Wheezing
Clinical narrative: Initial report received on 08 July 2009 from a health care professional. A 29-year-old male patient, who had no concurrent illnesses, but who has medical condition of allergy to pollen, dust and soaps; and who has a history of bronchial spasm, had received a first left deltoid subcutaneous injection of YF VAX (lot number UF437AA) on 07 July 2009 at 19:15 pm. Fifteen minutes after receiving the vaccine, the patient developed a rash on his arms and axilla, throat discomfort, wheezing and diarrhea that lasted three hours. The patient took CLARITIN and was seen in the physician's office the following day with no symptoms. No diagnostic tests or laboratory data were performed. The patient had been evaluated by a physician, but it was unclear if the patient had been seen the same day of the event, or the next day only. It is noted the patient had received the month prior (date unknown), a dose of Hep A vaccine (trade name, manufacturer name, lot number, route and site of administration unknown), and a dose of TYPHIM VI (lot number, route and site of administration unknown). It was not reported whether there were any adverse events associated with those vaccinations; however, it was reported the patient had not experienced any adverse events with prior vaccinations in the past. At the time of this report, the patient had recovered. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLUX, HEP, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Childhood disintegrative disorder, Crying, Diarrhoea
Clinical narrative: Loss of eye contact, words, repetitive odd behaviors, crying, sick, diarrhea. Pt was given 18 vaccines until 18 months. Pt was born with a twin-his sister is NT. At birth swallowed fluid-mild pneumonia- given antibiotics and Hep B- another Hep B 2 months later- more vaccines- MMR, Flu, chicken pox all given 11-3-06. (5 vaccines in total notice next month patient lost all skills, words, etc...   7/21/09 Medical records received DOS 11/14/05 to 6/20/08. Assessment: Not verbal. Patient presented with coughing, wheezing. Speaks single words. Reluctant to make eye contact at times. Later not verbal / sign communication. Blisters in mouth - apthous ulcers. Fever. Autism (per mother).
Age: 1.0
Sex: M
Vaccine: FLUX, HEP, MMR, VARCEL
Symptoms: Gastrointestinal disorder, Malaise, Social avoidant behaviour
Clinical narrative: Loss of eye contact, words, repetitive odd behaviors, crying, sick, diarrhea. Pt was given 18 vaccines until 18 months. Pt was born with a twin-his sister is NT. At birth swallowed fluid-mild pneumonia- given antibiotics and Hep B- another Hep B 2 months later- more vaccines- MMR, Flu, chicken pox all given 11-3-06. (5 vaccines in total notice next month patient lost all skills, words, etc...   7/21/09 Medical records received DOS 11/14/05 to 6/20/08. Assessment: Not verbal. Patient presented with coughing, wheezing. Speaks single words. Reluctant to make eye contact at times. Later not verbal / sign communication. Blisters in mouth - apthous ulcers. Fever. Autism (per mother).
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP
Symptoms: Asthenia, Autoantibody positive, Guillain-Barre syndrome, Headache, Hyporeflexia
Clinical narrative: Developed GUILLAIN BARRE Syndrome - MILLER FISHER Syndrome after multiple vaccinations in Basic Training. Symptoms: Neuropathy, Weakness, Hypo-reflexia, Headache, Migraine, Muscle Pain.  7/27/09 Multiple records received including hospital records and f/u consults. Hospital DOS 4/3-6/09 with D/C DX:  Miller-Fisher variant of Guillain-Barre Syndrome.  Pt presented with c/o weakness in legs, lower back pain and stumbling gait as well as diplopia, dysarthria, paresthesias of the fingertips.  PE (+) for  facial nerve paresis, leg weakness, wide-based gait, ataxia with absent DTRs. Tx with IVIG with partial resolution of sx. Transferred to rehab with continued H/A and back pain.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP
Symptoms: Migraine, Miller Fisher syndrome, Myalgia, Neuropathy peripheral
Clinical narrative: Developed GUILLAIN BARRE Syndrome - MILLER FISHER Syndrome after multiple vaccinations in Basic Training. Symptoms: Neuropathy, Weakness, Hypo-reflexia, Headache, Migraine, Muscle Pain.  7/27/09 Multiple records received including hospital records and f/u consults. Hospital DOS 4/3-6/09 with D/C DX:  Miller-Fisher variant of Guillain-Barre Syndrome.  Pt presented with c/o weakness in legs, lower back pain and stumbling gait as well as diplopia, dysarthria, paresthesias of the fingertips.  PE (+) for  facial nerve paresis, leg weakness, wide-based gait, ataxia with absent DTRs. Tx with IVIG with partial resolution of sx. Transferred to rehab with continued H/A and back pain.
Age: 70.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Cerebrovascular accident, Chills, Computerised tomogram abnormal, Death, Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of stroke in a 70-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medication included COREG. The subject's medical history included cataract, hearing loss, pacemaker (atrial fibrillation), quadruple heart bypass and vitrectomy. Previous and/or concurrent vaccination included live attenuated oral poliomyelitis vaccine; manufacturer unspecified; oral given on an unspecified date. Concurrent medications included COUMADIN, PRINIVIL, VITAMIN C and TYSHINI (unknown medication). On an unknown date, the subject started CARVEDILOL (oral) at 3.25 mg twice per day. On 23 July 2007 the subject received unspecified dose of TWINRIX (unknown). On 28 July 2007, five days after vaccination with TWINRIX and while on CARVEDILOL, the subject experienced stroke, subdural hematoma, headache, chills and tiredness. The subject was hospitalised. On 08 August 2007, the subject had Computed axial tomography (CAT) scan and was diagnosed subdural hematoma of the brain. The subject died on 10 August 2007 from stroke. It was unknown whether an autopsy was performed. Vaccine AE template documented during the call, after the call I realized that the patient was also taking COREG at the time of death. Customer stated that the patient received the TWINRIX vaccine on July 23, 2007 and on July 28, 2007 he developed a severe headache, chills, and tiredness that continued to worsen over time. The patient consulted his healthcare provider that recommended a CAT scan because the patient was taking COUMADIN. The CAT scan was performed on 8/8/2007 and a diagnosis of subdural hematoma of the brain was made, the patient was then prepped for surgery which was successful but died on 8/10/2007 due to a stroke.  7/28/09 Death certificate received. Final cause of death: Intracerebral hemorrhage.   8/25/09 DC summary outpatient and hospital records received. Service dates 6/28/07 to 08/10/07. Assessment: Subdural hematoma, atrial fibrillation, hypertension, coronary artery disease, hyperlipidemia, status post craniotomy for evaculation of subdural hematoma, status post right basal ganglia hemmorhage / brain herniation.  Patient was complaining of headache. Hematoma evacuated. Brain herniation. Terminal extubation performed and patient expired.
Age: 70.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Headache, Scan brain, Subdural haematoma, Surgery
Clinical narrative: This case was reported by a consumer and described the occurrence of stroke in a 70-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medication included COREG. The subject's medical history included cataract, hearing loss, pacemaker (atrial fibrillation), quadruple heart bypass and vitrectomy. Previous and/or concurrent vaccination included live attenuated oral poliomyelitis vaccine; manufacturer unspecified; oral given on an unspecified date. Concurrent medications included COUMADIN, PRINIVIL, VITAMIN C and TYSHINI (unknown medication). On an unknown date, the subject started CARVEDILOL (oral) at 3.25 mg twice per day. On 23 July 2007 the subject received unspecified dose of TWINRIX (unknown). On 28 July 2007, five days after vaccination with TWINRIX and while on CARVEDILOL, the subject experienced stroke, subdural hematoma, headache, chills and tiredness. The subject was hospitalised. On 08 August 2007, the subject had Computed axial tomography (CAT) scan and was diagnosed subdural hematoma of the brain. The subject died on 10 August 2007 from stroke. It was unknown whether an autopsy was performed. Vaccine AE template documented during the call, after the call I realized that the patient was also taking COREG at the time of death. Customer stated that the patient received the TWINRIX vaccine on July 23, 2007 and on July 28, 2007 he developed a severe headache, chills, and tiredness that continued to worsen over time. The patient consulted his healthcare provider that recommended a CAT scan because the patient was taking COUMADIN. The CAT scan was performed on 8/8/2007 and a diagnosis of subdural hematoma of the brain was made, the patient was then prepped for surgery which was successful but died on 8/10/2007 due to a stroke.  7/28/09 Death certificate received. Final cause of death: Intracerebral hemorrhage.   8/25/09 DC summary outpatient and hospital records received. Service dates 6/28/07 to 08/10/07. Assessment: Subdural hematoma, atrial fibrillation, hypertension, coronary artery disease, hyperlipidemia, status post craniotomy for evaculation of subdural hematoma, status post right basal ganglia hemmorhage / brain herniation.  Patient was complaining of headache. Hematoma evacuated. Brain herniation. Terminal extubation performed and patient expired.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Red swollen area measuring 4 1/4 " x 3" wide. warm to the touch.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Acute disseminated encephalomyelitis, Intensive care, Laboratory test, Nuclear magnetic resonance imaging abnormal, Vomiting
Clinical narrative: Child began to have emesis around 6/2/08 and progressed neurologically to vent. curd ICU for a time. Dr diagnosed with acute demyelinating encephalomyelitis.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Mom reported blister at injection site on left leg. States slightly red. states fever 99.9 on 7/7/09. No fever or other symptoms this am. Giving TYLENOL every 4 hours.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 3 x 3 cm area of redness at vaccination site  15 minutes after vaccine (L arm). 15 mg ATARAX given.
Age: 29.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of urticaria in a 29-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). There was no concomitant medication and no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included MMR II (Merck, unknown) given on 6 July 2009; ADACEL (Sanofi Pasteur MSD, unknown) given on 6 July 2009. On 6 July 2009, in the morning (reported as possibly 11:00 hours) the subject received 1st dose of TWINRIX (1 ml, unknown route, right deltoid). On 6 July 2009, several hours after vaccination with TWINRIX, the subject experienced "horrible" urticaria, swollen eyes and trouble breathing. The subject immediately went to an urgent care. The healthcare professional considered the events were a systemic reaction. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and ATARAX. At the time of reporting the urticaria and swollen eyes were improved. The trouble breathing resolved on an unspecified date. The vaccination course with TWINRIX was discontinued. The healthcare professional considered the events were probably related to vaccination with TWINRIX. The events occurred several hours after vaccination with TWINRIX, MMR and TDAP, but the healthcare professional only considered TWINRIX as the cause.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Deafness unilateral, Headache, Pyrexia, Rash
Clinical narrative: Dermatologist - gave Valtrex 16m + clobetasol ointment. Headache, rash, blisters open with liquid coming out . 3 day fever to 101.9 . Left ear - cannot hear dial tone - on phone. Did before worried better not yet, ok will, I be?.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pupils unequal
Clinical narrative: Developed severe headache on 7/12/09 that resolved with Motrin 200mg + sleep. Mild headache off and on Monday - Wed. Uneven pupils size 7/13 and not resolved yet, afebrile, no distress or acute s/s. Seen in ER for pupillary difference, examined, seen by Opthamologist and released to home.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Myalgia, Nausea, Syncope
Clinical narrative: Myalgias, nausea, episode of fainting the following day, 7/14/09.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Administration site became red & swollen 7 days after administration (area apx 60 mm X 120 mm)
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Eye swelling, Nasal congestion, Rhinorrhoea
Clinical narrative: Eyes swollen, clear runny nose. Swollen nasal mucosa.
Age: 1.2
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: 10 AM 7/13/2009- Seizure activity- fever 102.3 at OHI- at home- seizure lasted 3-4 min.  Mother brought baby to clinic 2:43 pm.  120mg acetaminophen administered by suppository 415 pm Rx for MOTRIN, TYLENOL given to mother-  follow up appt in AM.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5
Symptoms: Crying
Clinical narrative: Pt start crying inconsolable the day that Pt received vaccines and does this everyday lasting 20-30 min even it Pt's sleep
Age: 1.31
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: C/O LEFT LEG RED AND SWOLLEN/ QUICKLY INCREASE SWELLING WITH WARMTH/ ABLE TO BEAR WEIGHT BUT STIFF LEG WITH WALKING/ LEFT ANT. THIGH WITH 5X6 CIRCULAR WARM ERYTH. AROUND VACCINE SITE WITH CENTRAL AREA INDURATION 24 CM AND TENDER
Age: 1.31
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site warmth, Musculoskeletal stiffness, Skin warm
Clinical narrative: C/O LEFT LEG RED AND SWOLLEN/ QUICKLY INCREASE SWELLING WITH WARMTH/ ABLE TO BEAR WEIGHT BUT STIFF LEG WITH WALKING/ LEFT ANT. THIGH WITH 5X6 CIRCULAR WARM ERYTH. AROUND VACCINE SITE WITH CENTRAL AREA INDURATION 24 CM AND TENDER
Age: 1.31
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/O LEFT LEG RED AND SWOLLEN/ QUICKLY INCREASE SWELLING WITH WARMTH/ ABLE TO BEAR WEIGHT BUT STIFF LEG WITH WALKING/ LEFT ANT. THIGH WITH 5X6 CIRCULAR WARM ERYTH. AROUND VACCINE SITE WITH CENTRAL AREA INDURATION 24 CM AND TENDER
Age: 1.31
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: C/O LEFT LEG RED AND SWOLLEN/ QUICKLY INCREASE SWELLING WITH WARMTH/ ABLE TO BEAR WEIGHT BUT STIFF LEG WITH WALKING/ LEFT ANT. THIGH WITH 5X6 CIRCULAR WARM ERYTH. AROUND VACCINE SITE WITH CENTRAL AREA INDURATION 24 CM AND TENDER
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Pruritus, Rash, Swelling
Clinical narrative: Received vaccine July 10, 2009 with no adverse reactions in left upper arm.  Pt called our facility July 20 to report that in the AM July 19 started to feel itching in both ankles and wrists, and on a line on front of left shoulder and bands around back of neck.  Also has a band on hairline on front of head.  Patient describes tingling and prickling feeling on affected areas, rash looks red, with and raised spots.  Describes as hivish in appearance.  SOne areas not as rashy, but still quite itchy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Received vaccine July 10, 2009 with no adverse reactions in left upper arm.  Pt called our facility July 20 to report that in the AM July 19 started to feel itching in both ankles and wrists, and on a line on front of left shoulder and bands around back of neck.  Also has a band on hairline on front of head.  Patient describes tingling and prickling feeling on affected areas, rash looks red, with and raised spots.  Describes as hivish in appearance.  SOne areas not as rashy, but still quite itchy.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Injection site swelling, Sensation of heaviness, Urticaria, Vomiting
Clinical narrative: Rec'd Boostrix on 7/17/09; reports vomiting, hives, arms feel heavy, wheezing, back burning, swelling at site on 7/20/09 Advised benedryl
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Rec'd Boostrix on 7/17/09; reports vomiting, hives, arms feel heavy, wheezing, back burning, swelling at site on 7/20/09 Advised benedryl
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 1.42
Sex: M
Vaccine: DTPHIB
Symptoms: Blister, Culture, Erythema, Skin warm
Clinical narrative: the next day his leg was blistered, really red and hot dont know if it was from shots or the broken needle i found in his leg
Age: 8.0
Sex: M
Vaccine: IPV, MMR, TD, VARCEL
Symptoms: Headache, Lethargy
Clinical narrative: On 7/19/09 noted lethargy, headache when moves around too much.  No elevated temperature, no vomiting.  Encouraged to give Tylenol or Ibuprophen for pain, to see physician for symptoms.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Platelet count decreased, Thrombocytopenia
Clinical narrative: Pt developed marked thrombocytopenia 4 weeks after receiving MMR, varivax, and Hep A.  Pt was given IVIG in emergency department on 7/17.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site dermatitis, Rash
Clinical narrative: rash on hands, elbows, and chest. contact dermititis at site of injection
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Injection site induration, Injection site swelling, Screaming, Urticaria
Clinical narrative: Patient received Pentacel, Prevnar, & Rotateq on 7/13/09.  Within minutes, patient developed 2 small hives on feet & legs.  No breathing dificulties or any other hives.  At 7PM, patient screamed inconsably for 1 hour the leg where the pentacel was given was firm and swollen.  Tylenol was given. Within 1-2 hours symptoms resolved.  Recheck next AM was completely normal.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling, Screaming, Urticaria
Clinical narrative: Patient received Pentacel, Prevnar, & Rotateq on 7/13/09.  Within minutes, patient developed 2 small hives on feet & legs.  No breathing dificulties or any other hives.  At 7PM, patient screamed inconsably for 1 hour the leg where the pentacel was given was firm and swollen.  Tylenol was given. Within 1-2 hours symptoms resolved.  Recheck next AM was completely normal.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Injection site induration, Injection site swelling, Screaming, Urticaria
Clinical narrative: Patient received PENTACEL, PREVNAR, & ROTATEQ on 7/13/09. Within minutes, patient developed 2 small hives on feet & legs. No breathing difficulties or any other hives. At 7PM, patient screamed inconsolably for 1 hour the leg where the PENTACEL was given was firm and swollen. TYLENOL was given. Within 1-2 hours symptoms resolved. Recheck next AM was completely normal.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling, Screaming, Urticaria
Clinical narrative: Patient received PENTACEL, PREVNAR, & ROTATEQ on 7/13/09. Within minutes, patient developed 2 small hives on feet & legs. No breathing difficulties or any other hives. At 7PM, patient screamed inconsolably for 1 hour the leg where the PENTACEL was given was firm and swollen. TYLENOL was given. Within 1-2 hours symptoms resolved. Recheck next AM was completely normal.
Age: 17.0
Sex: F
Vaccine: DTAP, FLU3, HPV4, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Skin burning sensation
Clinical narrative: Outbreak of vessicular rash in L5/S1 distribution - burning pain with rash consistent with zoster.  Occured at non-vaccination site 1 day after zoster vaccine administered.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Outbreak of vessicular rash in L5/S1 distribution - burning pain with rash consistent with zoster.  Occured at non-vaccination site 1 day after zoster vaccine administered.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Erythema, Injected limb mobility decreased, Injection site induration
Clinical narrative: Patient describes receiving Tetanus/Pertussis shot on 7/10/09 in left arm.  On 7/11/09 around 2 pm, started to feel weak, lightheaded and body aches.  The area where injection was given was very sore, had a large, hard knot at the injection site and it grew in size.  Pt also describes a rash like redness that expanded to the size of her hand, very hot to the touch.  She describes having a fever that went to 101.2 at the highest and she was unable to lift her left arm.  She took Ibuprofen which relieved some of the pain and fever for a short time and also used ice to help relieve the pain which was not too helpful.  The patient never called the MD or office for advice.  Today, 7/20/09, attended an office visit with a friend and reports the above reaction and continues to have a 2 cm round disc shaped mass on left upper arm, nontender, faint residual erythema persists when arm manipulated which is reported by her primary care provider.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Pain, Pyrexia, Rash
Clinical narrative: Patient describes receiving Tetanus/Pertussis shot on 7/10/09 in left arm.  On 7/11/09 around 2 pm, started to feel weak, lightheaded and body aches.  The area where injection was given was very sore, had a large, hard knot at the injection site and it grew in size.  Pt also describes a rash like redness that expanded to the size of her hand, very hot to the touch.  She describes having a fever that went to 101.2 at the highest and she was unable to lift her left arm.  She took Ibuprofen which relieved some of the pain and fever for a short time and also used ice to help relieve the pain which was not too helpful.  The patient never called the MD or office for advice.  Today, 7/20/09, attended an office visit with a friend and reports the above reaction and continues to have a 2 cm round disc shaped mass on left upper arm, nontender, faint residual erythema persists when arm manipulated which is reported by her primary care provider.