chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: DIAPHORETIC, NAUSEA,SYNCOPE,PALE CLAMMY. PT HAD SUDDEN ONSET OF THESE SYMPTOMS. WAS PLACED IN SUPINE POSITION WITH LEGS ELEVATED. TOOK APPROXIMATELY 30 MINS TO RECOVER LEFT WITH RESIDUAL WEAKNESS  FOR REMAINDER OF THE DAY.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Cold compress therapy, Dizziness, Nausea
Clinical narrative: Shat was administered by a nurse at the Elementary/Middle School.  Shot was given.  Child was sent back to class.  Child ate lunch and returned to school nurse complaining of dizziness and chest pain.  Pulse 106, blood pressure 98/60.  Respirations non-labored at 34 per minute.  C/o's some nausea.  Denies numbness, tingling, itching, no rash or hives noted.  Child laid down with cool compress.  Approximately 15 minutes late pulse 82, respiration 28 per minute.  Still c/o's some dizziness and but feels some better.  Father notified by school nurse and is coming to pick up child.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Fatigue, Migraine, Muscle spasms, Pain
Clinical narrative: "Severe body aches, entire body, migraine level headache, foot cramps, toes locked-up, chills, and fatigue.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal stiffness, Rash, Urticaria
Clinical narrative: Child's hands red, hives to hands bilat, "hard to bend fingers".  Reaction isolated to hands.  No other reaction noted.  Evaluated by physician on call.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Headache, Migraine
Clinical narrative: Headache and 99.6 temp for 1 day followed by migraine on 11/08/2009 at 6:00 AM.  OTC meds taken, symptoms subsided.  11/12/2009 Migraine at 10:00 AM to 6:00 PM OTC meds again.  No further issues.
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dysarthria, Face oedema, Facial pain, Facial palsy, Hypoaesthesia facial
Clinical narrative: Woke up with facial numbness and droop, speech slurred, Facial ache like a bruise.  Face appears swollen at times, but resolves and comes back. 11/24/2009 MD records for 11/13/2009,  Dx Bell's palsy patient with c/o's numb lips, can't close lt eye, rx'd prednisone
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Swelling face
Clinical narrative: Woke up with facial numbness and droop, speech slurred, Facial ache like a bruise.  Face appears swollen at times, but resolves and comes back. 11/24/2009 MD records for 11/13/2009,  Dx Bell's palsy patient with c/o's numb lips, can't close lt eye, rx'd prednisone
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Neck pain, Pyrexia
Clinical narrative: Neck pain, 102.6 fever.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood pressure increased, Cough, Dysphagia, Throat irritation
Clinical narrative: Coughing, C/O back of throat burning.  Had H1N1 shot 3.5 hours ago.  Also c/o trouble swallowing.  B/P 182/106 HR 82.  Epinephrine 0.3 cc to lateral rt. thigh.  12:30 PM BP 180/86 HR 100 T 98.4.  EMS called.  12:40 person feeling better. Throat burning going away.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Drug exposure during pregnancy, Feeling hot, Headache
Clinical narrative: C/O feeling dizzy and hot 10 min. after receipt of vaccine.  At 15 min post vaccine, c/o headache as if a migraine were beginning.  Person left with spouse.   12/7/09:  Prenatal records received for dates of service 9/21/09 to 12/7/09. Gravida 3, Para 1 EDC 5/13/10, shows normal course of pregnancy with no AE noted.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Vaccination complication, Visual impairment
Clinical narrative: Headache, seeing spots.  Mother requested EMS transport.  EMS assessment was unremarkable, no vital sign issues.  Follow-up with parent indicates ER MD found no relationship to the vaccine.  Classified as a nervous reaction to the injection.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Dizziness, Hypoaesthesia, Injected limb mobility decreased, Muscular weakness
Clinical narrative: After receiving the vaccine, the client stayed at the vaccine clinic site (VCS) for about 10 minutes for observation.  She left without any expressed concerns.  She returned to VCS about 15 minutes later with complaints of dizziness, feeling shakey, and arms feeling heavy.  She reported having a cough that week.  Her mother was in the building and stayed with her daughter.  After about 30 minutes, her mother reported that daughter could not move left arm well. Client reported that while she was in resting area, her left arm pregressively became more numb or weak. She states legs feel "weird". Vaccine clinic staff referred her to her physician and assisted with the arrangements.  Approximately 10 minutes later, she left the building to go to doctor's appointment.  11/30/09 hospital records and discharge summary received. Service dates 11/18/09 to 11/19/09. Assessment: Extremity weakness involving the left arm and both legs, status post H1N1 vaccination. Patient felt nauseated and did not feel well. Weakness, dizziness, fainted. Indicated that she couldn't move left arm and both legs. Indicated that she could not bear weight. Decreased sensation lower extremities. Headache. Transferred to a higher level facility.  11/25/09 hospital records received. Service dates 11/19/09 to 11/21/09. Assessment: Consistant with conversion reaction. Progressive numbness and weakness of arms. No sensation or control of lower extremities. Has developed cough, chest pain / heaviness, shortness of breath. Transported from another hospital. Poor inspiratory effort. Feet and left hand cold to touch. Neurological examination subjective and nonconsistant.    11/30/09 County Health Care Clinic medical records. Service date 11/18/09. Additional information abstracted. Assessment: Syncopal episode and weakness. Patient presented with complaints of having passed out and being very weak. Abrupt weakness in left upper extremity and both lower extremities. To a lesser degree the right upper extremity. Consider transfer.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Sensation of heaviness, Tremor
Clinical narrative: After receiving the vaccine, the client stayed at the vaccine clinic site (VCS) for about 10 minutes for observation.  She left without any expressed concerns.  She returned to VCS about 15 minutes later with complaints of dizziness, feeling shakey, and arms feeling heavy.  She reported having a cough that week.  Her mother was in the building and stayed with her daughter.  After about 30 minutes, her mother reported that daughter could not move left arm well. Client reported that while she was in resting area, her left arm pregressively became more numb or weak. She states legs feel "weird". Vaccine clinic staff referred her to her physician and assisted with the arrangements.  Approximately 10 minutes later, she left the building to go to doctor's appointment.  11/30/09 hospital records and discharge summary received. Service dates 11/18/09 to 11/19/09. Assessment: Extremity weakness involving the left arm and both legs, status post H1N1 vaccination. Patient felt nauseated and did not feel well. Weakness, dizziness, fainted. Indicated that she couldn't move left arm and both legs. Indicated that she could not bear weight. Decreased sensation lower extremities. Headache. Transferred to a higher level facility.  11/25/09 hospital records received. Service dates 11/19/09 to 11/21/09. Assessment: Consistant with conversion reaction. Progressive numbness and weakness of arms. No sensation or control of lower extremities. Has developed cough, chest pain / heaviness, shortness of breath. Transported from another hospital. Poor inspiratory effort. Feet and left hand cold to touch. Neurological examination subjective and nonconsistant.    11/30/09 County Health Care Clinic medical records. Service date 11/18/09. Additional information abstracted. Assessment: Syncopal episode and weakness. Patient presented with complaints of having passed out and being very weak. Abrupt weakness in left upper extremity and both lower extremities. To a lesser degree the right upper extremity. Consider transfer.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Back pain, Blood creatine phosphokinase increased, CSF culture negative, CSF white blood cell count negative, Cough
Clinical narrative: The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Differential white blood cell count normal, Full blood count normal, Gait disturbance, Groin pain, Guillain-Barre syndrome
Clinical narrative: The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Hepatic enzyme, Hyporeflexia, Influenza serology negative, Laboratory test normal, Liver function test normal
Clinical narrative: The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Polymerase chain reaction
Clinical narrative: The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Rhinorrhoea, Skin warm, Somnolence
Clinical narrative: The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Tenderness, Viral test negative, Weight bearing difficulty
Clinical narrative: The study subject was a 5-year-old male who was seen in the urgent clinic on 21Sep09 for fever, increased sleepiness and leg pain for the last two days. His pain started in the feet progressing to the legs and then to his groin area. He was having difficulty walking. The pain was relieved with Motrin. One day prior to this urgent care visit he developed fever up to 101 F. Review of system was remarkable for new onset of runny nose and cough for the last several days and occasional back pain. Patient was admitted to Hospital on 21Sep2009. PE was remarkable for temperature of 102F and an alert boy in no acute distress. Positive finding were increase warmth of both lower extremities, pain on weight bearing, full range of motion of hips, knees and ankle joints, and point tenderness upon palpation of the calves and groin bilaterally. He had normal sensation and his deep tendon reflexes were difficult to elicit. Cranial nerves II- XII were intact. X-ray of the hip was normal, sed rate was 18 and CRP was elevated at 10.5. CBC with differential, chemistry panel and liver enzyme profile were within normal limits. Respiratory panel by Qiagen QIAplex PCR was negative for influenza A & B, RSV, PIV types 1-4, hMPV, rhinovirus, adenovirus, bocavirus, coronavirus and enteroviruses. CSF fluid was negative by PCR for enteroviruses. CSF fluid: no WBC, no RBC, glucose 63 mg/dl and protein 16.8 mg/dl. CSF culture was sterile for organisms. MRI of brain and cervical, thoracic and lumbar spine with and without contract did not reveal any abnormal pathology. A neurology consult was obtained on the second hospital day. There was no definitive progression of leg weakness and with minimal inflammatory marker elevation. CK was elevated at 1094 U/ml. Nerve conduction study performed on 24September demonstrated mild decreased amplitude of the peroneal compound motor action bilaterally without an F wave response. The peroneal distal motor latencies and motor nerve conduction were normal. The left peroneal, left median and left ulnar F-wave responses were not obtained although the remainder of the F wave responses was easily obtained with normal latencies. Patient received IVIG on 24September and 25September. Patient was discharged home on 27September2009. Final diagnosis: Guillain-Barré Syndrome. Discharge medication: Lyrica (pregabalin) 1/2 capsule (25mg/capsule) twice a day for pain as needed 12/0209 Urgent Care, ED and Hospital Records received for DOS 9/21/09-09/27/09. Pt admitted with ascending paralysis, pain in legs x2 days, fever, bilat LE weakness, blunted ankle and knee reflexes, headache, sleepiness. Received IVIG x2.  Pediatric neurology consult obtained. Continued to improve and dc home. DC DX: Guillain-Barre syndrome.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Metallic taste in mouth right after and lasted about five minutes.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Dizziness, Vision blurred
Clinical narrative: Dizzy, Blurry vision.  Administered ammonia inhalant.  Person recovered.
Age: 33.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea
Clinical narrative: Hard to breathe.  Did not advance to more severe issues.  P- 70, B/P 117/75.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Eye pruritus, Injection site rash, Injection site swelling, Palpitations
Clinical narrative: swelling at injection site, rash at injection site and several other places on body - with itching and burning, wheezing, itchy eyes, heart palpitations
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Rash generalised, Wheezing
Clinical narrative: swelling at injection site, rash at injection site and several other places on body - with itching and burning, wheezing, itchy eyes, heart palpitations
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain, 24 hrs. post vaccination. Persistent, with increased area of pain and intensity with movement of arm.  Duration of about 20 days.  Seasonal shot given in the same arm without issue.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), HEP
Symptoms: Dizziness, Dysgeusia
Clinical narrative: Immediately after receiving H1N1 vaccine (IM) client became light headed and stated she had an alcohol/metal taste in mouth.  Had to lay down for 20 min. and sat in chair for another 20 min. before leaving the clinic.  Also given juice to drink.  Never had this reaction when receiving vaccines, in the past.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Malaise, Vomiting
Clinical narrative: Pt. received the vaccine at approx. 8:50 AM. At 9:10 AM the pt. began vomiting. Pt. stated that she didn't feel good prior to the administration of the vaccine but did not tell anyone. Vital signs stable pulse 80, Temp 96.9, Resp 22, BP 80/68. We had the pt. to lay down on cot with legs elevated. Continued to monitor. Grandfather came to the school to pick child up. Discussed the situation and instructed to cont. to monitor.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Lethargy
Clinical narrative: Came home from school about 2 hours post vaccine with 101 temp.  Father says quickly went up to 104.1 axillary with lethargy. No other symptoms reported.  Father called about 4:00pm.  I spoke with him at 5:15 and she was sleeping and fever down to 102.0.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Feeling hot, Musculoskeletal stiffness, Nausea
Clinical narrative: Within a minute of receiving IM injection in R deltoid heat and stiffness ran up neck toward head, feeling of nausea and redness observed over neck and face.  Symptoms lasted about 30 minutes.  No treatment administered.
Age: 41.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Feeling hot, Pain in extremity, Paraesthesia
Clinical narrative: Arm extremely sore, tingling in fingers, feeling of heat rushing down to my hand.  Today is 11/23/09 and there has been no relief in the pain.  I am visiting my physician today for the pain.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Dysphonia, Headache, Pyrexia, Respiratory distress
Clinical narrative: Initially developed fever in early morning; had fever off and on during course of day with associated voice hoarseness, cough and headache. At 10 PM developed stridor and mild respiratory distress.  Was taken to local emergency department and treated with intra-muscular dexamethasone and inhaled albuterol/ipatropium.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Stridor
Clinical narrative: Initially developed fever in early morning; had fever off and on during course of day with associated voice hoarseness, cough and headache. At 10 PM developed stridor and mild respiratory distress.  Was taken to local emergency department and treated with intra-muscular dexamethasone and inhaled albuterol/ipatropium.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Itching at right superior back for few days after injection and rash appeared 11/21/2009.  Patient evaluated 11/23/2009 and diagnosed with Herpes Zoster
Age: 9.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain upper, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, headache, stomach ache, body ache, runny nose.
Age: 69.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: Rash on forehead, Neck, Chest. Itching on forehead. General Fatigue. Low grade fever (99).
Age: 24.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Recieved H1N1 vaccine.  10 minutes later, had subjective shortness of breath and eye puffiness.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Colectomy, Enema administration, Gastrointestinal necrosis, Haematochezia, Intensive care
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 concerning a 20 week old female with no medical history, who on 25-AUG-2009 was vaccinated with a third dose of ROTATEQ (lot # 663264/1485X), oral. Suspect vaccination given intramuscularly into the left leg on the same date included a third dose of RECOMBIVAX HB (lot # 665366/0890Y) (thimerosal free). Concomitant vaccination given on the same date included third dose of PENTACEL (lot # C3428AB), intramuscularly into the left leg and PREVNAR (lot # D57303), intramuscularly into the right leg. Two days later the patient presented to the emergency department with emesis and currant jelly stools. She was found to have intussusception which was not reducible by air enema. She went to the operating room where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 27-AUG-2009 to 01-SEP-2009. Four days were in the intensive care unit and the remainder was on the floor. On 15-OCT-2009 hospital records were received. Discharge summary received service dates 27-AUG-2009 to 01-SEP-2009. Assessment: intussusception status post bowel resection. The parents stated that the baby refused to eat. Episodes of yellow emesis. Bright red blood per rectum without stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Currant jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussusception converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum serosal tears of proximal transverse colon with patchy necrosis. The patient was stable upon discharge. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is: 356992-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663264/1485X for ROTATEQ 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. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception, Mucous stools, 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 concerning a 20 week old female with no medical history, who on 25-AUG-2009 was vaccinated with a third dose of ROTATEQ (lot # 663264/1485X), oral. Suspect vaccination given intramuscularly into the left leg on the same date included a third dose of RECOMBIVAX HB (lot # 665366/0890Y) (thimerosal free). Concomitant vaccination given on the same date included third dose of PENTACEL (lot # C3428AB), intramuscularly into the left leg and PREVNAR (lot # D57303), intramuscularly into the right leg. Two days later the patient presented to the emergency department with emesis and currant jelly stools. She was found to have intussusception which was not reducible by air enema. She went to the operating room where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 27-AUG-2009 to 01-SEP-2009. Four days were in the intensive care unit and the remainder was on the floor. On 15-OCT-2009 hospital records were received. Discharge summary received service dates 27-AUG-2009 to 01-SEP-2009. Assessment: intussusception status post bowel resection. The parents stated that the baby refused to eat. Episodes of yellow emesis. Bright red blood per rectum without stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Currant jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussusception converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum serosal tears of proximal transverse colon with patchy necrosis. The patient was stable upon discharge. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is: 356992-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663264/1485X for ROTATEQ 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. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal tenderness, Colectomy, Decreased activity, Dehydration, Diet refusal
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 concerning a 20 week old female with no medical history, who on 25-AUG-2009 was vaccinated with a third dose of ROTATEQ (lot # 663264/1485X), oral. Suspect vaccination given intramuscularly into the left leg on the same date included a third dose of RECOMBIVAX HB (lot # 665366/0890Y) (thimerosal free). Concomitant vaccination given on the same date included third dose of PENTACEL (lot # C3428AB), intramuscularly into the left leg and PREVNAR (lot # D57303), intramuscularly into the right leg. Two days later the patient presented to the emergency department with emesis and currant jelly stools. She was found to have intussusception which was not reducible by air enema. She went to the operating room where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 27-AUG-2009 to 01-SEP-2009. Four days were in the intensive care unit and the remainder was on the floor. On 15-OCT-2009 hospital records were received. Discharge summary received service dates 27-AUG-2009 to 01-SEP-2009. Assessment: intussusception status post bowel resection. The parents stated that the baby refused to eat. Episodes of yellow emesis. Bright red blood per rectum without stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Currant jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussusception converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum serosal tears of proximal transverse colon with patchy necrosis. The patient was stable upon discharge. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is: 356992-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663264/1485X for ROTATEQ 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. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Enema administration, Gastrointestinal gangrene, Gastrointestinal necrosis, Haematochezia, Intensive care
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 concerning a 20 week old female with no medical history, who on 25-AUG-2009 was vaccinated with a third dose of ROTATEQ (lot # 663264/1485X), oral. Suspect vaccination given intramuscularly into the left leg on the same date included a third dose of RECOMBIVAX HB (lot # 665366/0890Y) (thimerosal free). Concomitant vaccination given on the same date included third dose of PENTACEL (lot # C3428AB), intramuscularly into the left leg and PREVNAR (lot # D57303), intramuscularly into the right leg. Two days later the patient presented to the emergency department with emesis and currant jelly stools. She was found to have intussusception which was not reducible by air enema. She went to the operating room where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 27-AUG-2009 to 01-SEP-2009. Four days were in the intensive care unit and the remainder was on the floor. On 15-OCT-2009 hospital records were received. Discharge summary received service dates 27-AUG-2009 to 01-SEP-2009. Assessment: intussusception status post bowel resection. The parents stated that the baby refused to eat. Episodes of yellow emesis. Bright red blood per rectum without stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Currant jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussusception converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum serosal tears of proximal transverse colon with patchy necrosis. The patient was stable upon discharge. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is: 356992-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663264/1485X for ROTATEQ 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. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Laparoscopic surgery, Necrosis, Rectal haemorrhage
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 concerning a 20 week old female with no medical history, who on 25-AUG-2009 was vaccinated with a third dose of ROTATEQ (lot # 663264/1485X), oral. Suspect vaccination given intramuscularly into the left leg on the same date included a third dose of RECOMBIVAX HB (lot # 665366/0890Y) (thimerosal free). Concomitant vaccination given on the same date included third dose of PENTACEL (lot # C3428AB), intramuscularly into the left leg and PREVNAR (lot # D57303), intramuscularly into the right leg. Two days later the patient presented to the emergency department with emesis and currant jelly stools. She was found to have intussusception which was not reducible by air enema. She went to the operating room where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 27-AUG-2009 to 01-SEP-2009. Four days were in the intensive care unit and the remainder was on the floor. On 15-OCT-2009 hospital records were received. Discharge summary received service dates 27-AUG-2009 to 01-SEP-2009. Assessment: intussusception status post bowel resection. The parents stated that the baby refused to eat. Episodes of yellow emesis. Bright red blood per rectum without stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Currant jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussusception converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum serosal tears of proximal transverse colon with patchy necrosis. The patient was stable upon discharge. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is: 356992-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663264/1485X for ROTATEQ 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. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Ultrasound scan abnormal, 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 concerning a 20 week old female with no medical history, who on 25-AUG-2009 was vaccinated with a third dose of ROTATEQ (lot # 663264/1485X), oral. Suspect vaccination given intramuscularly into the left leg on the same date included a third dose of RECOMBIVAX HB (lot # 665366/0890Y) (thimerosal free). Concomitant vaccination given on the same date included third dose of PENTACEL (lot # C3428AB), intramuscularly into the left leg and PREVNAR (lot # D57303), intramuscularly into the right leg. Two days later the patient presented to the emergency department with emesis and currant jelly stools. She was found to have intussusception which was not reducible by air enema. She went to the operating room where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 27-AUG-2009 to 01-SEP-2009. Four days were in the intensive care unit and the remainder was on the floor. On 15-OCT-2009 hospital records were received. Discharge summary received service dates 27-AUG-2009 to 01-SEP-2009. Assessment: intussusception status post bowel resection. The parents stated that the baby refused to eat. Episodes of yellow emesis. Bright red blood per rectum without stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Currant jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussusception converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum serosal tears of proximal transverse colon with patchy necrosis. The patient was stable upon discharge. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is: 356992-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663264/1485X for ROTATEQ 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. No further information is available.
Sex: M
Vaccine: FLU3, FLUN(H1N1), FLUN(H1N1)
Symptoms: Blood alkaline phosphatase normal, Blood glucose normal, Death, Death, Full blood count abnormal
Clinical narrative: A serious spontaneous report of child died of wild-type H1N1 and S. pneumonia in his lungs has been received from a physician concerning a male child (age unknown) subsequent to FLUMIST. The patient's past medical history includes Down's Syndrome, congenital heart disease and cough. No concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date for unknown indication. The patient developed cough a day before receiving FLUMIST, and the patient's family was also reported as being sick. On an unknown date, the patient died (further information not provided). The reporter stated that the patient had "s. pneumonia" in his lungs. An autopsy was performed, but the result was not provided. The cause of death was reported as wild-type H1N1 which was confirmed by the Centers for Disease Control (CDC). The outcome of the events of wild-type H1N1 and S. pneumonia was fatal.
Sex: M
Vaccine: FLU3, FLUN(H1N1), FLUN(H1N1)
Symptoms: Haematocrit decreased, Haemoglobin decreased, Immunohistochemistry, Neisseria test positive, Pupil fixed
Clinical narrative: A serious spontaneous report of child died of wild-type H1N1 and S. pneumonia in his lungs has been received from a physician concerning a male child (age unknown) subsequent to FLUMIST. The patient's past medical history includes Down's Syndrome, congenital heart disease and cough. No concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date for unknown indication. The patient developed cough a day before receiving FLUMIST, and the patient's family was also reported as being sick. On an unknown date, the patient died (further information not provided). The reporter stated that the patient had "s. pneumonia" in his lungs. An autopsy was performed, but the result was not provided. The cause of death was reported as wild-type H1N1 which was confirmed by the Centers for Disease Control (CDC). The outcome of the events of wild-type H1N1 and S. pneumonia was fatal.