chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Received vaccines in left arm 10/19/9 at 6:30 pm. At 3 AM pt woke- with extreme pain in arm, redness, swelling and numbness. Went to work and had chills all day. Went to ER 10/20. Said Staph infection. Started LEVAQUIN, then changed to IV Clindamycin and Doxycycline x 3days inpatient. Then after 3days discharged w/ 2wk course of Doxycycline and clindamycin by mouth. No residual besides slight tenderness and dryness.
Age: 1.38
Sex: M
Vaccine: FLU3
Symptoms: Blood calcium normal, Blood culture negative, Blood glucose, Convulsion, Drug screen negative
Clinical narrative: Pt developed a fever of 104.6 degrees and had a 10 minute seizure. He was seen at a hospital ER and was diagnosed with otitis media and a febrile seizure. (The ear looked ok to me 11/6). On 11-8 hrs fever stopped. 11/9 he had a rash on his thumb.
Age: 1.38
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Full blood count, Influenza serology negative, Otitis media, Pyrexia
Clinical narrative: Pt developed a fever of 104.6 degrees and had a 10 minute seizure. He was seen at a hospital ER and was diagnosed with otitis media and a febrile seizure. (The ear looked ok to me 11/6). On 11-8 hrs fever stopped. 11/9 he had a rash on his thumb.
Age: 1.38
Sex: M
Vaccine: FLU3
Symptoms: Rash, Scan brain, Urine analysis
Clinical narrative: Pt developed a fever of 104.6 degrees and had a 10 minute seizure. He was seen at a hospital ER and was diagnosed with otitis media and a febrile seizure. (The ear looked ok to me 11/6). On 11-8 hrs fever stopped. 11/9 he had a rash on his thumb.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Sudden onset of lower extremity weakness, abnormal gait. 11/12/2009  Neuro consult records and labs/dx studies for 11/9/2009, patient with c/o's lower extremity weakness, numbness of thighs and abnormal gait.  Neuro exam noted decreased DTR's LE's. No DC DX noted.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood pressure increased, Cough, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Patient reported having sxs 2 hours after receiving vaccination. Reported following: difficulty breathing, cough, fever, headache, increased heart rate and blood pressure. Received IM-H1N1 vaccine. F/U with physician/provider 11/4/09 and 11/5/09. Seen by healthcare provider for f/u.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Patient reported having sxs 2 hours after receiving vaccination. Reported following: difficulty breathing, cough, fever, headache, increased heart rate and blood pressure. Received IM-H1N1 vaccine. F/U with physician/provider 11/4/09 and 11/5/09. Seen by healthcare provider for f/u.
Age: 0.6
Sex: U
Vaccine: RV1
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This case was reported by a physician via a GSK representative and described the occurrence of vaccination failure in a 7-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On unknown date, the subject received 1st dose and 2nd dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced vaccination failure and rotavirus. The subject was hospitalised. At the time of reporting, the outcomes of the vaccination failure and rotavirus were unspecified. The subject was administered two doses of ROTARIX. At the age of seven months, the subject was admitted to the hospital after developing rotavirus, and was reported as a product failure. No additional information was provided.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Oedema peripheral, Swelling face
Clinical narrative: Patient called on 09/27/09 and said swelling on arm, face and allergic reaction since 09/26/09. Pt was given BENADRYL AND TYLENOL and the symptoms cured.
Age: 22.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Computerised tomogram normal, Injection site cellulitis, Injection site erythema, Nausea
Clinical narrative: Arm redness, cellulitis at site of injection developed within 24 hours, high fever, nausea, vomiting, abdominal pain.
Age: 22.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Arm redness, cellulitis at site of injection developed within 24 hours, high fever, nausea, vomiting, abdominal pain.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Dehydration, Vomiting
Clinical narrative: Patient with vomiting the evening after giving the vaccination. With dehydration and had to go to ER for rehydration by IV.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Patient died in sleep. presumptive diagnosis is "SIDS".
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Raised red rash with 4-5 quarter size hives, itchy and hot, was sore to touch. BENADRYL prescribed.
Age: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chills, Cough, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Patient complained of cough, fever, runny nose, headache, chills, vomiting.
Age: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Patient complained of cough, fever, runny nose, headache, chills, vomiting.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Local reaction
Clinical narrative: Local inflammatory reaction - no cellulitis.  Treatment: ice, MOTRIN, elevation, recheck 48 hrs.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site eschar
Clinical narrative: 2-3cm eschar  right upper arm.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient complained of cough, runny nose, fever, sore throat.
Age: 1.76
Sex: M
Vaccine: FLUX
Symptoms: Death, Lethargy, Pyrexia, Unresponsive to stimuli
Clinical narrative: Pt lethargic, with non custodial parent out of town. Febrile 11-8-09 -> 11-9-09. Found unresponsive. Died in AM 11-9-09. ? foul play.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site haematoma, Injection site pain, Muscle tightness, Vertigo
Clinical narrative: Stinging upon administration 11/10 - Husband returns stating Pt. developed bruise at injection site. Continues to have muscle tightness in shoulder and neck, headache + Vertigo.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Pain
Clinical narrative: Pt complained of cough & aching.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Injection site urticaria
Clinical narrative: Hives to both H1N1 & seasonal flu injection. Has never been allergic to eggs. Reaction greater on R side to H1N1 vaccine. Treatment with Benadryl & Claritin.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site vesicles
Clinical narrative: 2 cm blister ~ 5 cm from innoculation site.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Client c/o feeling dizzy and having stomachache approx 1 hr. and 35 mins. after receiving vaccine. BP 120/74 & 110/80. Mother noticed - home with mom referred to PMD. Follow up telephone call doing very well per mother.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash pruritic
Clinical narrative: Itchy rash, treated with Benadryl.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Angiogram, Blood potassium decreased, Bradycardia, Chills, Computerised tomogram normal
Clinical narrative: Started with HA, vomiting, Diarrhea, chills, profuse sweating on 11/1/09 @ 2:12 AM. TYLENOL x 2 nights. Nov. 2 MAXALT and TORADOL - Given TORADOL inject. x 5d.-6d. Went to ER on Nov. 8 @ 9-00AM - Given DILAUDID, PHENERGAN - Admitted. Home on Nov. 9th - Same Sx on 10th. -Given TORADOL and LORTAB, ATIVAN and Sx are continuing. Started Verapamil Nov 9. TID.  11/13/09: Patient summary report and CT head scan received for date of service 11/02/09. Diagnosis: Headache-Migraine  Patient presented with complaint of one day history of headache, which had worsened. Pain located at top and front of head. Orientated X3. Glasgow Coma Scale 15. Pain scale of 6. Treated withToradol and Maxalt and subsequently pain scale of 2. Patient discharged home./rem   11/13/09: Hospital records received for dates of service 11/08/09 -11/09/09. Diagnosis: Recurrent intractable headaches, Malignant hypertension, hypokalemia.  Patient presented with complaint of intense daily headaches staring in the evening and waking her up at night. The patient has experienced sweating, vomiting, nausea, diarrhea, chills and feeling shaky with the headaches. The patient's daughter noted that the patient seemed confused and seemed to contract the abdominal muscles and have difficulty breathing while sleeping. The headaches started two days after receiving H1N1 vaccine. Treatment with Toradol has been helpful. In the emergency room, the patient was bradycardic (HR 53) and blood pressure was 200/90 mmHg. The patient was treated with Latetalol and Dilaudid and admitted. The patient was orientated X4 and was alert. Neurology consult noted possibility of seizure disorder and also noted that symptoms occurred the day after receiving the H1N1 vaccine; whether this was associated with the H1N1 vaccine was not known./rem Hospital admission date 11-8-09. Hospital discharge date 11-9-09. Please update information include discharge date.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Confusional state, Diarrhoea, Dyspnoea, Electrocardiogram abnormal, Electroencephalogram normal
Clinical narrative: Started with HA, vomiting, Diarrhea, chills, profuse sweating on 11/1/09 @ 2:12 AM. TYLENOL x 2 nights. Nov. 2 MAXALT and TORADOL - Given TORADOL inject. x 5d.-6d. Went to ER on Nov. 8 @ 9-00AM - Given DILAUDID, PHENERGAN - Admitted. Home on Nov. 9th - Same Sx on 10th. -Given TORADOL and LORTAB, ATIVAN and Sx are continuing. Started Verapamil Nov 9. TID.  11/13/09: Patient summary report and CT head scan received for date of service 11/02/09. Diagnosis: Headache-Migraine  Patient presented with complaint of one day history of headache, which had worsened. Pain located at top and front of head. Orientated X3. Glasgow Coma Scale 15. Pain scale of 6. Treated withToradol and Maxalt and subsequently pain scale of 2. Patient discharged home./rem   11/13/09: Hospital records received for dates of service 11/08/09 -11/09/09. Diagnosis: Recurrent intractable headaches, Malignant hypertension, hypokalemia.  Patient presented with complaint of intense daily headaches staring in the evening and waking her up at night. The patient has experienced sweating, vomiting, nausea, diarrhea, chills and feeling shaky with the headaches. The patient's daughter noted that the patient seemed confused and seemed to contract the abdominal muscles and have difficulty breathing while sleeping. The headaches started two days after receiving H1N1 vaccine. Treatment with Toradol has been helpful. In the emergency room, the patient was bradycardic (HR 53) and blood pressure was 200/90 mmHg. The patient was treated with Latetalol and Dilaudid and admitted. The patient was orientated X4 and was alert. Neurology consult noted possibility of seizure disorder and also noted that symptoms occurred the day after receiving the H1N1 vaccine; whether this was associated with the H1N1 vaccine was not known./rem Hospital admission date 11-8-09. Hospital discharge date 11-9-09. Please update information include discharge date.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hyperhidrosis, Hypokalaemia, Malignant hypertension, Muscle contractions involuntary, Nausea
Clinical narrative: Started with HA, vomiting, Diarrhea, chills, profuse sweating on 11/1/09 @ 2:12 AM. TYLENOL x 2 nights. Nov. 2 MAXALT and TORADOL - Given TORADOL inject. x 5d.-6d. Went to ER on Nov. 8 @ 9-00AM - Given DILAUDID, PHENERGAN - Admitted. Home on Nov. 9th - Same Sx on 10th. -Given TORADOL and LORTAB, ATIVAN and Sx are continuing. Started Verapamil Nov 9. TID.  11/13/09: Patient summary report and CT head scan received for date of service 11/02/09. Diagnosis: Headache-Migraine  Patient presented with complaint of one day history of headache, which had worsened. Pain located at top and front of head. Orientated X3. Glasgow Coma Scale 15. Pain scale of 6. Treated withToradol and Maxalt and subsequently pain scale of 2. Patient discharged home./rem   11/13/09: Hospital records received for dates of service 11/08/09 -11/09/09. Diagnosis: Recurrent intractable headaches, Malignant hypertension, hypokalemia.  Patient presented with complaint of intense daily headaches staring in the evening and waking her up at night. The patient has experienced sweating, vomiting, nausea, diarrhea, chills and feeling shaky with the headaches. The patient's daughter noted that the patient seemed confused and seemed to contract the abdominal muscles and have difficulty breathing while sleeping. The headaches started two days after receiving H1N1 vaccine. Treatment with Toradol has been helpful. In the emergency room, the patient was bradycardic (HR 53) and blood pressure was 200/90 mmHg. The patient was treated with Latetalol and Dilaudid and admitted. The patient was orientated X4 and was alert. Neurology consult noted possibility of seizure disorder and also noted that symptoms occurred the day after receiving the H1N1 vaccine; whether this was associated with the H1N1 vaccine was not known./rem Hospital admission date 11-8-09. Hospital discharge date 11-9-09. Please update information include discharge date.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Tremor, Vomiting, White blood cell count increased
Clinical narrative: Started with HA, vomiting, Diarrhea, chills, profuse sweating on 11/1/09 @ 2:12 AM. TYLENOL x 2 nights. Nov. 2 MAXALT and TORADOL - Given TORADOL inject. x 5d.-6d. Went to ER on Nov. 8 @ 9-00AM - Given DILAUDID, PHENERGAN - Admitted. Home on Nov. 9th - Same Sx on 10th. -Given TORADOL and LORTAB, ATIVAN and Sx are continuing. Started Verapamil Nov 9. TID.  11/13/09: Patient summary report and CT head scan received for date of service 11/02/09. Diagnosis: Headache-Migraine  Patient presented with complaint of one day history of headache, which had worsened. Pain located at top and front of head. Orientated X3. Glasgow Coma Scale 15. Pain scale of 6. Treated withToradol and Maxalt and subsequently pain scale of 2. Patient discharged home./rem   11/13/09: Hospital records received for dates of service 11/08/09 -11/09/09. Diagnosis: Recurrent intractable headaches, Malignant hypertension, hypokalemia.  Patient presented with complaint of intense daily headaches staring in the evening and waking her up at night. The patient has experienced sweating, vomiting, nausea, diarrhea, chills and feeling shaky with the headaches. The patient's daughter noted that the patient seemed confused and seemed to contract the abdominal muscles and have difficulty breathing while sleeping. The headaches started two days after receiving H1N1 vaccine. Treatment with Toradol has been helpful. In the emergency room, the patient was bradycardic (HR 53) and blood pressure was 200/90 mmHg. The patient was treated with Latetalol and Dilaudid and admitted. The patient was orientated X4 and was alert. Neurology consult noted possibility of seizure disorder and also noted that symptoms occurred the day after receiving the H1N1 vaccine; whether this was associated with the H1N1 vaccine was not known./rem Hospital admission date 11-8-09. Hospital discharge date 11-9-09. Please update information include discharge date.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Acute disseminated encephalomyelitis, CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Headache
Clinical narrative: Headache, nausea, vomiting started on 10/30/09. MRI Brain wo on 11/7/09 showed multifocal T2 hyperactivity in thalamus, basal ganglia, and white matter c/w DA EM. Pt. had R-sided focal SZ on 11/7.  11/13/09 DS received for DOS 11/04/09  11/05/09 and DOS 11/07/09 -  11/12/09 Final DX: Acute disseminated encephalomyelitis (ADEM).  The Pt was admitted initially to the hospital on 11/04/09 after 1 HX week of intermittent headaches and vomiting, neck pain, lethargic and only responsive to painful stimuli.  Pt was discharged on 11/05/09 after his symptoms improved.  After the discharge, Pt's headache and emesis returned and new symptoms appeared of discoordinated movement, left lower extremity weakness, foot dragging and seizures. Upon readmission to the hospital on 11/07/09, Pt experienced 45 mins of tonic-clonic seizure affecting R and L upper and lower extremities, R facial movements, and non responsive to verbal stimuli.  Neck was supple. Pt lethargic. PERRL. Neuro assessment: spontaneous movement, but weak muscle strength, positive Babinski, generalized hyperreflexia with deep tendon reflexes 3+ throughout. Pt was irritable, but no fever. Pt was treated with Ativan and steroids and his neurologic function improved.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea, Nuclear magnetic resonance imaging brain abnormal, Partial seizures, Vomiting
Clinical narrative: Headache, nausea, vomiting started on 10/30/09. MRI Brain wo on 11/7/09 showed multifocal T2 hyperactivity in thalamus, basal ganglia, and white matter c/w DA EM. Pt. had R-sided focal SZ on 11/7.  11/13/09 DS received for DOS 11/04/09  11/05/09 and DOS 11/07/09 -  11/12/09 Final DX: Acute disseminated encephalomyelitis (ADEM).  The Pt was admitted initially to the hospital on 11/04/09 after 1 HX week of intermittent headaches and vomiting, neck pain, lethargic and only responsive to painful stimuli.  Pt was discharged on 11/05/09 after his symptoms improved.  After the discharge, Pt's headache and emesis returned and new symptoms appeared of discoordinated movement, left lower extremity weakness, foot dragging and seizures. Upon readmission to the hospital on 11/07/09, Pt experienced 45 mins of tonic-clonic seizure affecting R and L upper and lower extremities, R facial movements, and non responsive to verbal stimuli.  Neck was supple. Pt lethargic. PERRL. Neuro assessment: spontaneous movement, but weak muscle strength, positive Babinski, generalized hyperreflexia with deep tendon reflexes 3+ throughout. Pt was irritable, but no fever. Pt was treated with Ativan and steroids and his neurologic function improved.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Hand, arm, leg, abdomen - itchy hive- like rash.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dry skin, Rash, Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: Employee called to report that she developed a red elevated, dry, itchy, rash on her trunk and axillar area. States rash area tender to touch. Has no known allergies - received seasonal Flu vaccine in 2008 for the first time - has not received seasonal influenza vaccine this yr. No reaction after.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Treated in emergency room for pain and swelling at H1N1 injection site
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Heart rate increased, Urticaria, Vomiting
Clinical narrative: Hives to arms and abdomen; headache; vomiting x 1; heart rate to 130.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Arthralgia, Blood creatine phosphokinase, Fatigue, Full blood count, Malaise
Clinical narrative: Fever, malaise, joint aches, extreme fatigue muscle weakness/parasthesia above torso and left leg.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Metabolic function test, Muscular weakness, Paraesthesia, Pyrexia, Rheumatoid factor
Clinical narrative: Fever, malaise, joint aches, extreme fatigue muscle weakness/parasthesia above torso and left leg.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase, Erythema, Fatigue
Clinical narrative: Fever, malaise, joint aches, extreme fatigue muscle weakness/parasthesia above torso and left leg.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Full blood count, Headache, Metabolic function test, Muscular weakness, Paraesthesia
Clinical narrative: Fever, malaise, joint aches, extreme fatigue muscle weakness/parasthesia above torso and left leg.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pyrexia, Red blood cell sedimentation rate, Rheumatoid arthritis
Clinical narrative: Fever, malaise, joint aches, extreme fatigue muscle weakness/parasthesia above torso and left leg.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Balance disorder, Diarrhoea, Dizziness, Headache
Clinical narrative: Headache, dizziness, lost balance, diarrhea
Age: 26.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash generalised
Clinical narrative: H1N1 vaccine 1 1/2 wks ago-started breaking out with rash 2 days ago on arms-now all over body. Back, chest -arms and legs.  See by doctor -11/3/09 -ZYRTEC 10mg qd to get allergy testing once rash resolved.
Age: 19.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Muscle pain in arm with slight weakness and "tingling" 2 wks after received immunization.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Computerised tomogram, Dizziness, Heart rate increased
Clinical narrative: Severe dizziness rapid heart rate
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Throat tightness, Vomiting
Clinical narrative: Throat closing, tongue swelling, vomiting. IV BENARYL, SOLUMEDROL, epinephrine.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Guillain-Barre syndrome, Hyperhidrosis, Influenza
Clinical narrative: Initial report was received from a physician on 29 October 2009. A 76-year-old male patient received an intramuscular injection of FLUZONE SV 2009-2010 (lot number U3193AA) on 16 September 2009, and two days post-vaccination experienced suspected influenza. He was subsequently diagnosed with Guillain Barre Syndrome. Medical history included benign prostatic hypertrophy with elevated PSA, and the patient was taking FLOMAX, baby aspirin, FIBERCON, and ZYRTEC concomitantly. He had not received any other vaccines within four weeks of vaccination with FLUZONE, and was not ill at the time of vaccination. The patient received influenza vaccine annually, with no reported adverse events with previous vaccinations. On 18 September 2009, two days post-vaccination, the patient presented to his physician with complaints of chills/rigors, sweats, minimal cough, and sore throat. Testing for influenza was negative, however his physician suspected flu and so the patient was treated with TAMIFLU. On 06 October 2009, 20 days post-vaccination, he presented to the emergency room and was subsequently diagnosed with Guillain Barre Syndrome. He was discharged on 12 October 2009 and at the time of the report was undergoing physical therapy. The event was considered to be ongoing. Documents held by sender: None. 11/13/09 DC summary received for dates 10/6/09 to 10/12/09. Medical records received as well. DX: Probably GBS, neutropenia, benign tumor. Presented with weakness in all extremities. Dysphagia,  Viral syndrome prior to sx. Pt. tx with IVIG x5 days with improvement. Assessment: weakness noted. DC home in stable condition.   11/12/09, 12/18/09 Hospital records and discharge summary received. Service date 10/60/09. Assessment: Guillain-Barre Syndrome. Patient had influenza 1 week prior to admission followed by progressive central weakness. Unable to get off toilet. Proximal muscle strength deficit. Admitted to ICU. Transfer to higher level institution.   12/18/09, 12/22/09 Additional hospital records and discharge summary received. Service dates 10/6/09 to 10/12/09. Assessment: Probable Guillain-Barre Syndrome, neutropenia, benign tremor.  Flu-like symptoms followed by progressive weakness. Transferred from another facility. Was unable to walk, stand, activities of daily living impaired. Perioral paresthesias, metallic taste. Weakness extremities. IVIG administration. Headache.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza serology negative, No reaction on previous exposure to drug, Oropharyngeal pain
Clinical narrative: Initial report was received from a physician on 29 October 2009. A 76-year-old male patient received an intramuscular injection of FLUZONE SV 2009-2010 (lot number U3193AA) on 16 September 2009, and two days post-vaccination experienced suspected influenza. He was subsequently diagnosed with Guillain Barre Syndrome. Medical history included benign prostatic hypertrophy with elevated PSA, and the patient was taking FLOMAX, baby aspirin, FIBERCON, and ZYRTEC concomitantly. He had not received any other vaccines within four weeks of vaccination with FLUZONE, and was not ill at the time of vaccination. The patient received influenza vaccine annually, with no reported adverse events with previous vaccinations. On 18 September 2009, two days post-vaccination, the patient presented to his physician with complaints of chills/rigors, sweats, minimal cough, and sore throat. Testing for influenza was negative, however his physician suspected flu and so the patient was treated with TAMIFLU. On 06 October 2009, 20 days post-vaccination, he presented to the emergency room and was subsequently diagnosed with Guillain Barre Syndrome. He was discharged on 12 October 2009 and at the time of the report was undergoing physical therapy. The event was considered to be ongoing. Documents held by sender: None. 11/13/09 DC summary received for dates 10/6/09 to 10/12/09. Medical records received as well. DX: Probably GBS, neutropenia, benign tumor. Presented with weakness in all extremities. Dysphagia,  Viral syndrome prior to sx. Pt. tx with IVIG x5 days with improvement. Assessment: weakness noted. DC home in stable condition.   11/12/09, 12/18/09 Hospital records and discharge summary received. Service date 10/60/09. Assessment: Guillain-Barre Syndrome. Patient had influenza 1 week prior to admission followed by progressive central weakness. Unable to get off toilet. Proximal muscle strength deficit. Admitted to ICU. Transfer to higher level institution.   12/18/09, 12/22/09 Additional hospital records and discharge summary received. Service dates 10/6/09 to 10/12/09. Assessment: Probable Guillain-Barre Syndrome, neutropenia, benign tremor.  Flu-like symptoms followed by progressive weakness. Transferred from another facility. Was unable to walk, stand, activities of daily living impaired. Perioral paresthesias, metallic taste. Weakness extremities. IVIG administration. Headache.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Headache, Influenza like illness, Injection site cellulitis, Injection site swelling, Neck pain
Clinical narrative: Initial report received 29 October 2009 from a health care professional. This report consisted of a cluster of two patients. The other patient has been captured in case number 2009-04638. A 64-year-old female patient who is also a physician, had received an intramuscular gluteal injection if (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP005AA on 27 October 2009 and later that evening, she developed flu-like symptoms which included a headache and body aches. The patient also developed cellulitis and swelling of the buttock and complained of pain in her neck and legs. The reporter noted that the (H1N1) 2009 Monovalent Vaccine - Preservative had been pre-drawn days earlier at another facility and was sent to the facility where she had been vaccinated. A one inch needle length had been used for vaccine administration. Corrective treatments were not reported. At the time of the report, the symptoms continued and the patient had not recovered. The reporter for this case is the same as for case number 2009-04638.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report received 29 October 2009 from a health care professional. This report consisted of a cluster of two patients. The other patient has been captured in case number 2009-04638. A 64-year-old female patient who is also a physician, had received an intramuscular gluteal injection if (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP005AA on 27 October 2009 and later that evening, she developed flu-like symptoms which included a headache and body aches. The patient also developed cellulitis and swelling of the buttock and complained of pain in her neck and legs. The reporter noted that the (H1N1) 2009 Monovalent Vaccine - Preservative had been pre-drawn days earlier at another facility and was sent to the facility where she had been vaccinated. A one inch needle length had been used for vaccine administration. Corrective treatments were not reported. At the time of the report, the symptoms continued and the patient had not recovered. The reporter for this case is the same as for case number 2009-04638.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial report received 29 October 2009 from a health care professional. This report consisted of a cluster of two patients. The other patient has been captured in case number 2009-04638. A 64-year-old female patient who is also a physician, had received an intramuscular gluteal injection if (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP005AA on 27 October 2009 and later that evening, she developed flu-like symptoms which included a headache and body aches. The patient also developed cellulitis and swelling of the buttock and complained of pain in her neck and legs. The reporter noted that the (H1N1) 2009 Monovalent Vaccine - Preservative had been pre-drawn days earlier at another facility and was sent to the facility where she had been vaccinated. A one inch needle length had been used for vaccine administration. Corrective treatments were not reported. At the time of the report, the symptoms continued and the patient had not recovered. The reporter for this case is the same as for case number 2009-04638.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site warmth, Nasal congestion, Pain
Clinical narrative: Initial report received 29 October 2009 from a health care professional. This report consisted of a cluster of two patients. The other patient has been captured in case number 2009-04638. A 64-year-old female patient who is also a physician, had received an intramuscular gluteal injection if (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP005AA on 27 October 2009 and later that evening, she developed flu-like symptoms which included a headache and body aches. The patient also developed cellulitis and swelling of the buttock and complained of pain in her neck and legs. The reporter noted that the (H1N1) 2009 Monovalent Vaccine - Preservative had been pre-drawn days earlier at another facility and was sent to the facility where she had been vaccinated. A one inch needle length had been used for vaccine administration. Corrective treatments were not reported. At the time of the report, the symptoms continued and the patient had not recovered. The reporter for this case is the same as for case number 2009-04638.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Laboratory test, Nausea, Tremor
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abnormal sensation in eye, Asthenia, Chills, Dizziness
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Dyskinesia, Dyspnoea, Dysstasia, Echocardiogram
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Flushing, Gait disturbance, Headache, Hypersensitivity
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Impaired work ability, Malaise, Muscular weakness, Nausea, Nerve conduction studies
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oxygen supplementation, Palpitations, Paraesthesia, Postural orthostatic tachycardia syndrome, Sensory loss
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tilt table test, Tremor, Vibratory sense increased, Vision blurred, Walking disability
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wheelchair user
Clinical narrative: Initial report received 30 October 2009 from a health care professional. A 50-year-old female patient with a history of orthostatic syndrome, had received an intramuscular injection (site not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 06 October 2009 and immediately following vaccination, she experienced dizziness, faintness, nausea and trembling hands. The patient was taken to the hospital where she was admitted, and subsequently discharged (dates not reported). At unspecified amount of time later, the patient was re admitted and was tested for GBS (Guillain Barre Syndrome) (dates not reported). Test results were unknown at the time of the report. The patient had no concurrent illness and no known allergies. It was unknown if she had been taking any concomitant medications. The patient had received influenza vaccines in the past, however it was unknown if she had experienced any adverse events following prior vaccinations. No further information was known at the time of the report. Documents held by sender: None.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dysphagia, Feeling hot, Headache, Oropharyngeal pain
Clinical narrative: Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identifiable patients who experienced adverse events after receiving H1N1. This serious case represents one patient out of the cluster of 14 patients. A male patient (age and date of birth not reported) had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009 and one hour later he experienced dizziness, headache, sore throat, trouble swallowing (also reported as throat closing) and stated he felt hot. He was administered BENADRYL and taken to the emergency room. The patient was in stable condition when he left the facility he was vaccinated at to go to the emergency room. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2009-04660, -04661, -04662, -04663, -04664, -04665, -04666, -04668, -04669, -04670, -04671, -04672 and -04673. Documents held by sender: None.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Throat tightness
Clinical narrative: Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identifiable patients who experienced adverse events after receiving H1N1. This serious case represents one patient out of the cluster of 14 patients. A male patient (age and date of birth not reported) had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009 and one hour later he experienced dizziness, headache, sore throat, trouble swallowing (also reported as throat closing) and stated he felt hot. He was administered BENADRYL and taken to the emergency room. The patient was in stable condition when he left the facility he was vaccinated at to go to the emergency room. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2009-04660, -04661, -04662, -04663, -04664, -04665, -04666, -04668, -04669, -04670, -04671, -04672 and -04673. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: "Knot" at injection site since injection. 13 days past vaccination (10/17/09) has swelling, redness and knot size of silver dollar at injection site.  15 days post vaccination (10/20/09) arm really sore and says cannot lift it very high.  Doctor visit 10/20/09.  Prescribed PREDNISONE and BENADRYL and 0 more flu vaccinations.  11-6-09 no signs of redness or swelling.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthma, Asthma exercise induced, Pulmonary function test abnormal, Respiratory rate increased, Speech disorder
Clinical narrative: School nurse - called to have me take child to hospital immediately. I took her to clinic to see Dr. She was wheezing uncontrollably. She could not catch her breath. She had trouble speaking this happened 09/15/09. At around 2:45 or so Dr. said she had a physical activity related asthma attack. He prescribed ADVAIR & PROAIR. 11/23/09 Medical records received for date 9/15/09. DX: asthma Presents with asthma symptoms increased. Pt states worse with exercise. Assessment: (+)wheezing.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Wheezing
Clinical narrative: School nurse - called to have me take child to hospital immediately. I took her to clinic to see Dr. She was wheezing uncontrollably. She could not catch her breath. She had trouble speaking this happened 09/15/09. At around 2:45 or so Dr. said she had a physical activity related asthma attack. He prescribed ADVAIR & PROAIR. 11/23/09 Medical records received for date 9/15/09. DX: asthma Presents with asthma symptoms increased. Pt states worse with exercise. Assessment: (+)wheezing.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia oral, Throat tightness
Clinical narrative: Mouth felt numb and tightness in his throat 3 mins after vaccine.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: C/O hives 6 hours after H1N1 shot. Treated with BENADRYL, it was resolved.
Age: 17.0
Sex: F
Vaccine: FLUN3, TDAP
Symptoms: Loss of consciousness, Syncope, Tremor
Clinical narrative: Syncopal episode, shaking, loss of conciousness x 10 minutes.
Age: 1.0
Sex: F
Vaccine: FLU(H1N1), FLU3, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash all over body. (BENADRYL)
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lip swelling, Rash generalised, Swelling face
Clinical narrative: Rash all over body. Swollen face and lips. (BENADRYL)
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Pruritus, Rash, Swelling
Clinical narrative: Onset of itching, numbness, swelling, rash face, neck, arms after receiving H1N1 vaccine. Seen in the ED. IV BENADRYL.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Nausea, Rash, Vomiting
Clinical narrative: 1) Nausea 10:45. 2) Vomiting 11:00. 3) Rash covering both arms, neck, chest, face 1:00. 4) Headache 2:40.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Fever up to 103.3 deg C, Cough, Sore Throat, Vomiting.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: bad shingles outbreak. Never had shingles before. On right side of back and right side of stomach
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Breath sounds abnormal, Chest pain, Cold sweat, Cough, Eye pruritus
Clinical narrative: EYELIDS PUFFINESS, RED ITCHY EYES, NASAL CONGESTION, DRY COUGH, COLD SWEATING, CHEST PAIN, MUSCULAR PAIN, RUFF BREATHING
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Myalgia, Nasal congestion, Ocular hyperaemia
Clinical narrative: EYELIDS PUFFINESS, RED ITCHY EYES, NASAL CONGESTION, DRY COUGH, COLD SWEATING, CHEST PAIN, MUSCULAR PAIN, RUFF BREATHING
Age: 42.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Cough, Pyrexia
Clinical narrative: FEVER OF 101.3, COUGHING
Age: 1.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: PATIENT HAD REDNESS AND HARDENING OF VACCINE SITE (LEG) AND BEGAN TO SHOW POX SPOTS ON BODY.
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: Patient is pregnant and recieved the flu mist for H1N1.  Told by local health department that a VAERS should be completed .11/18/2009 OB-GYN records , patient pregnant, received H1N1 vaccine, no adverse reactions reported.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Anxiety, Dysphonia, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: SOB, voice sounded hoarse, wheezing voice, bp=122/80, heart rate=128. School gave Benadryl. Two hours later no better, school called ambulance (couldn't reach parents), taken to ER. Hospital released on Tylenol 650mg with dx of anxiety. No airway restrictions noted and patient admitted nervous about shot. In school the next day.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives/rash on chest/lower abdomen, itching palms, resolved in 2 hours with 50 mgs of Benadryl.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Hyperhidrosis, Nausea, Pain
Clinical narrative: Administered vaccination at work on 11/09/09 as I am a healthcare worker. On 11/10/09 at 7:45 AM experienced fever 99.7, body aches, dizziness, sweating, nausea, diarrhea. Fever broke at 1:30 PM. body aches and nausea ended at approximately 5:00PM