chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Pt had cough on am of 10-16-09 and went to ER @ 5:00 on 10-17-09 presenting with cough, sob, temp 102.9 F post tussive vomiting, dg: acute bronchitis. Rx AMOXICILLIN, ALBUTEROL (per neb) and tamiflu. Pt well after 5 days.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Arthralgia, Full blood count, Henoch-Schonlein purpura, Metabolic function test, Urine analysis
Clinical narrative: 8/5/9 Hep A/Varicella. 9/23/9 HSPE joint pain. BMP, CBC, Multiple UA, 3 office visits.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Throat tightness
Clinical narrative: Redness around eyes; throat closing; trouble breathing (started about 3 hrs after shot given)
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Screaming
Clinical narrative: Pt mother states after 1st dose of DTaP on 10/15/09, that child screamed non-stop for 6 hours.
Age: 68.0
Sex: M
Vaccine: TDAP
Clinical narrative: No symptoms that we know of. I gave a Tdap to a 68 yr old male. on accident.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Ear infection, Pyrexia, Rhinorrhoea
Clinical narrative: 12/7/09 Received H1N1 flu vaccine. 12/10/09 started with runny nose, progressed to coughing, fever 12/16/09. Dx: ear infection both 12/16/09. Treated with Omnicef.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction rash 24 hours following vaccinations. Rx: ZYRTEC.
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Fall, Gait disturbance, Immediate post-injection reaction, Vision blurred
Clinical narrative: Says going back to class upstairs missed a step and fell. Says her vision had blurry when got in stair well- had sat 15 min in library after H1N1 shot. C/O (L) knee sore from fall. No swelling. BP 118/80-P96-Walking with difficulty. Admin x3 tried to call parent. Left a message. Back to class. 1:39 Mom called back notified.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood pressure decreased, Dry skin, Pallor, Skin warm, Vomiting
Clinical narrative: About 5 minutes after vaccine administration the student vomited. Pale v/s 68/44 R 14 P 60 11:22. Had lunch-12:05 feels better B/P 94/70. Color good skin warm/dry. Mother present. Back to class.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dysphagia
Clinical narrative: Child described difficulty swallowing. Gave 25mg BENADRYL - shortly after child states he feels fine. Observation for 45min.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Groin pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red, tender rt gluteal site swollen & painful rt groin, left less tender. Yesterday more systemic reaction with chills & painful "lymph nodes" in chest wall, axilla & groin.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain
Clinical narrative: Swollen, red, tender rt gluteal site swollen & painful rt groin, left less tender. Yesterday more systemic reaction with chills & painful "lymph nodes" in chest wall, axilla & groin.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Hep. A vaccine given instead of Hep. B
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug hypersensitivity, Hypersensitivity, Skin lesion, Urticaria
Clinical narrative: Raised itchy rash (Urticaria) appeared initially around neck and spread to entire body.  Patient took Benadryl at home without relief over the weekend.  Patint reported to Clinic on 12/14/2009 at 13:30 PM for treatment of allergic reaction.  Patient presented awake, alert and orientated to time, place and person. Multiple skin lesions present, wheals were identified on neck and shoulders (Urticaria).  Assessment of injection site showed no abnormalities. Treatment included 125mg/2ml Solumedrol IM to left deltoid at 14:35 PM.  Patient provided with Prednisone 10mg Tablets and Hydroxyzine 10mg Tablets (1-2 QHS for itching) to take home.  Patient reported symptoms completely resolved on 12/16/2009.  Patient exempt from future H1N1 vaccinations based on reaction.
Age: 19.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea began 3 weeks prior to vaccination. Evaluated by physician at University of Central Missouri Health Center in Warrensburg MO 64093. Was prescribed Cipro. Diarrhea worsened and then started to resolve after he finished course of Cipro. Diarrhea resolved one day prior to vaccination. Diarrhea returned (and color different) and developed abdominal pain evening after he was vaccinated. Returned to clinic and was prescribed a different antibiotic. He says that the abdominal pain has resolved but that the diarrhea continues.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Lip swelling, Nasal congestion
Clinical narrative: Patient received nasal H1N1 vaccine at a school clinic. The following day he woke up with mild nasal swelling and upper lip swelling.He was seen in the ED and no interventions were needed.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Disturbance in attention, Social avoidant behaviour, Tic
Clinical narrative: non-interactive and withdrawn/not paying attention in class.  Head, shoulder/arm and eye "ticks" lasting 2-15 seconds per episode.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Asthenia, Dizziness, Erythema, Headache, Nausea
Clinical narrative: Same day after getting shot pt. started c/o headache, nausea, hurting all over; no energy, dizziness at times. C/o redness/soreness rt. arm- 4 inch diameter- hurt when moves, can't hold anything heavy- Continues to be sore.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Same day after getting shot pt. started c/o headache, nausea, hurting all over; no energy, dizziness at times. C/o redness/soreness rt. arm- 4 inch diameter- hurt when moves, can't hold anything heavy- Continues to be sore.
Age: 1.25
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Wheezing
Clinical narrative: patient received intranasal H1N1 vaccine and approximately 24-48 hours later developed cough and wheezing.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Depressed level of consciousness, Feeling abnormal, Posture abnormal, Pulse pressure decreased
Clinical narrative: Slumped over desk, slow response to verbal stimuli, weak pulse reported. When I arrived few minutes later patient was responsive, strong regular pulse of 90, was speaking coherently but stated did not feel right. EMS transported patient to hospital.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Corneal reflex decreased, Dyskinesia, Ear pain, Facial palsy, Hypoaesthesia
Clinical narrative: Bells Palsy, numbness and paralysis on left side of face, unable to close left eye, use left side of mouth, smile, wrinkle forehead, blink, wink, pain in left ear and down neck, started at about 10 am with a watery eye then numbness then inablity to move left side of face.  occurred in about 30 min.  have appointment with neurologist to determine treatment on dec 28th
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Hypoaesthesia facial, Lacrimation increased, Neck pain, Ophthalmoplegia
Clinical narrative: Bells Palsy, numbness and paralysis on left side of face, unable to close left eye, use left side of mouth, smile, wrinkle forehead, blink, wink, pain in left ear and down neck, started at about 10 am with a watery eye then numbness then inablity to move left side of face.  occurred in about 30 min.  have appointment with neurologist to determine treatment on dec 28th
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Facial paresis, Hypoaesthesia facial, Lacrimal disorder
Clinical narrative: Bells Palsy, numbness and paralysis on left side of face, unable to close left eye, use left side of mouth, smile, wrinkle forehead, blink, wink, pain in left ear and down neck, started at about 10 am with a watery eye then numbness then inablity to move left side of face.  occurred in about 30 min.  have appointment with neurologist to determine treatment on dec 28th
Age: 1.02
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: INCORRECT DOSE OF H1N1 GIVEN TO PATIENT. .5 mL DOSE GIVEN.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Tendonitis, X-ray
Clinical narrative: Patient was having pain in her left shoulder.  Patient had return to pharmacy at some point over the next week or so and asked if it could have been the vaccination.  She spoke with me, I told her I had not had anyone report any problems and told her to speak with her MD.  After approximately 2 months (11/20/09) the patient went to the physician and the physician diagnosed her with tendonitis.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased
Clinical narrative: Adverse Events described to RN by pt's mother. 12/3/09 10 PM Pt. complains of Stomach ache. 12/4/09 7 AM Pt. complains of Stomach pain given Miralax for possible constipation and sent to school. In the PM decreased appetite. 12/5/09 3 AM pt. developed fever 101 F Treated with Tyenol. Temperature 104.4 at 9 PM. Treatment tepid bath. Temp down to 99.9 F. 12/6/09 Vomiting x 1 after eating at 8 AM. Increased abdominal pain. Refused PO fluids. Onset of rash at 6PM over entire body with exception of the face. 12/6/09 7:25 PM Taken to ER and admitted with diagnosis of Hepatitis R/O Rocky Mountain Spotted Fever. Liver enzymes elevated. Treatment was Protonix, Zofran, Zantac, Benadryl, and Motrin. 12/12/09 Discharged home from hospital. 12/14/09 Pt. to Hospital for liver biopsy.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased, Decreased appetite, Fluid intake reduced, Hepatitis
Clinical narrative: Adverse Events described to RN by pt's mother. 12/3/09 10 PM Pt. complains of Stomach ache. 12/4/09 7 AM Pt. complains of Stomach pain given Miralax for possible constipation and sent to school. In the PM decreased appetite. 12/5/09 3 AM pt. developed fever 101 F Treated with Tyenol. Temperature 104.4 at 9 PM. Treatment tepid bath. Temp down to 99.9 F. 12/6/09 Vomiting x 1 after eating at 8 AM. Increased abdominal pain. Refused PO fluids. Onset of rash at 6PM over entire body with exception of the face. 12/6/09 7:25 PM Taken to ER and admitted with diagnosis of Hepatitis R/O Rocky Mountain Spotted Fever. Liver enzymes elevated. Treatment was Protonix, Zofran, Zantac, Benadryl, and Motrin. 12/12/09 Discharged home from hospital. 12/14/09 Pt. to Hospital for liver biopsy.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hepatitis viral test, Laboratory test, Liver function test abnormal, Pyrexia, Rash generalised
Clinical narrative: Adverse Events described to RN by pt's mother. 12/3/09 10 PM Pt. complains of Stomach ache. 12/4/09 7 AM Pt. complains of Stomach pain given Miralax for possible constipation and sent to school. In the PM decreased appetite. 12/5/09 3 AM pt. developed fever 101 F Treated with Tyenol. Temperature 104.4 at 9 PM. Treatment tepid bath. Temp down to 99.9 F. 12/6/09 Vomiting x 1 after eating at 8 AM. Increased abdominal pain. Refused PO fluids. Onset of rash at 6PM over entire body with exception of the face. 12/6/09 7:25 PM Taken to ER and admitted with diagnosis of Hepatitis R/O Rocky Mountain Spotted Fever. Liver enzymes elevated. Treatment was Protonix, Zofran, Zantac, Benadryl, and Motrin. 12/12/09 Discharged home from hospital. 12/14/09 Pt. to Hospital for liver biopsy.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Adverse Events described to RN by pt's mother. 12/3/09 10 PM Pt. complains of Stomach ache. 12/4/09 7 AM Pt. complains of Stomach pain given Miralax for possible constipation and sent to school. In the PM decreased appetite. 12/5/09 3 AM pt. developed fever 101 F Treated with Tyenol. Temperature 104.4 at 9 PM. Treatment tepid bath. Temp down to 99.9 F. 12/6/09 Vomiting x 1 after eating at 8 AM. Increased abdominal pain. Refused PO fluids. Onset of rash at 6PM over entire body with exception of the face. 12/6/09 7:25 PM Taken to ER and admitted with diagnosis of Hepatitis R/O Rocky Mountain Spotted Fever. Liver enzymes elevated. Treatment was Protonix, Zofran, Zantac, Benadryl, and Motrin. 12/12/09 Discharged home from hospital. 12/14/09 Pt. to Hospital for liver biopsy.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site rash, Pruritus
Clinical narrative: client started itching and developed rash from injection site up to base of neck
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dry mouth, Eye swelling, Headache, Heart rate increased, Hypertension
Clinical narrative: Headache, dry mouth, swollen eyes, rapid pulse, high blood pressure.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: extremely sore right arm, barely able to move it
Age: 65.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blister, Body temperature decreased, Rash
Clinical narrative: Facial, chest, and back rash 27 hours after vaccination--no temperature elevation(96.8)No labs performed. Cream given for rash
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Joint effusion, Laboratory test normal, Nuclear magnetic resonance imaging normal, Oedema peripheral
Clinical narrative: Left Knee joint effusion, subsequently drained on 11/25/09 by ortho sample sent for analysis was negative for crystals and infection. Within 1.5wks effusion returned and left lower extremeity edema developed.  The lower extremity edema resolved after about 1 week but knee effusion persisted. MRI of left knee was obtained which did not reveal any clear cause of the recurrent effusion per orthopedic.  Currently starting 1 month trial of Naproxen.
Age: 1.08
Sex: F
Vaccine: FLU(H1N1), FLUX, HEPA, HIBV, MMR, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Mom called clinic after 4 PM stating that daycare notified her that child had temperature of 104F. Mom was advised by immunization nurse to check temperature after she picks child from daycare. Give tylenol or motrin according to After Shot directions. To ER if temp. stays high or higher. 12/16/09. Mom was called. Stated temp. was 103F. Advised to bring child to clinic. MD eveluated patient. Temp.99.8F rectal. Sent to ER for evaluation.
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Anxiety, Blood carbon monoxide increased, Blood gases abnormal, Carbon monoxide poisoning, Carboxyhaemoglobin increased
Clinical narrative: The woman received injectable H1N1 vaccine at approx 1330 on 11/19 at the Health Dept. She states that this evening she began 'feeling really weird.' She has received seasonal influenza vaccinations in the past without incident. The woman is a 44 year old female, she complains of lightheadedness, dizzy and 'almost passed out'. She states that she feels anxious, has tremors and a dry mouth. She states that her 'heart is racing'. Also complained of 'a little bit' of nausea without vomiting. Denies shortness of breath (no more than usual SOB related to chronic bronchitis), denies chest pain or pressure or discomfort. Denies pain, or pressure or discomfort to neck, jaw, back or arms.  Not currently taking any medications. Allergic to PCN. Caller has an occasional cough. Denies alcohol and recreational drug use. She states that she had one cup of coffee this morning. States that she ate breakfast but has not eaten since approx noon. She states that she is drinking water right now. She is currently at her place of business (pool hall). The woman was evaluated in emergency room on  the evening of 11/19. Physician diagnosis: CO Toxicity, CO HGB 9.5% at time of initial ABG. Caller states that she 'had my head in the woodstove' earlier in the day, 'obviously for too long.'
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Dizziness, Dry mouth, Feeling abnormal, Nausea
Clinical narrative: The woman received injectable H1N1 vaccine at approx 1330 on 11/19 at the Health Dept. She states that this evening she began 'feeling really weird.' She has received seasonal influenza vaccinations in the past without incident. The woman is a 44 year old female, she complains of lightheadedness, dizzy and 'almost passed out'. She states that she feels anxious, has tremors and a dry mouth. She states that her 'heart is racing'. Also complained of 'a little bit' of nausea without vomiting. Denies shortness of breath (no more than usual SOB related to chronic bronchitis), denies chest pain or pressure or discomfort. Denies pain, or pressure or discomfort to neck, jaw, back or arms.  Not currently taking any medications. Allergic to PCN. Caller has an occasional cough. Denies alcohol and recreational drug use. She states that she had one cup of coffee this morning. States that she ate breakfast but has not eaten since approx noon. She states that she is drinking water right now. She is currently at her place of business (pool hall). The woman was evaluated in emergency room on  the evening of 11/19. Physician diagnosis: CO Toxicity, CO HGB 9.5% at time of initial ABG. Caller states that she 'had my head in the woodstove' earlier in the day, 'obviously for too long.'
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Palpitations, Tremor
Clinical narrative: The woman received injectable H1N1 vaccine at approx 1330 on 11/19 at the Health Dept. She states that this evening she began 'feeling really weird.' She has received seasonal influenza vaccinations in the past without incident. The woman is a 44 year old female, she complains of lightheadedness, dizzy and 'almost passed out'. She states that she feels anxious, has tremors and a dry mouth. She states that her 'heart is racing'. Also complained of 'a little bit' of nausea without vomiting. Denies shortness of breath (no more than usual SOB related to chronic bronchitis), denies chest pain or pressure or discomfort. Denies pain, or pressure or discomfort to neck, jaw, back or arms.  Not currently taking any medications. Allergic to PCN. Caller has an occasional cough. Denies alcohol and recreational drug use. She states that she had one cup of coffee this morning. States that she ate breakfast but has not eaten since approx noon. She states that she is drinking water right now. She is currently at her place of business (pool hall). The woman was evaluated in emergency room on  the evening of 11/19. Physician diagnosis: CO Toxicity, CO HGB 9.5% at time of initial ABG. Caller states that she 'had my head in the woodstove' earlier in the day, 'obviously for too long.'
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives over body. Benadryl pill and Benadryl cream applied daily. Helped to clear it up.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, nasal congestion, severe sore throat
Age: 14.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Abdominal discomfort, Dizziness, Headache, Loss of consciousness, Pyrexia
Clinical narrative: Mother calling about her  14 year old son ; he received an injection of h1n1 vaccine on 11/19/2009.  The next morning 11/20/2009 he had a fever, a headache, and  an upset stomach, these symptoms lasted for 48 hrs.    Then one week later he was talking and  everything went black ;he became really dizzy and eventually passed out for a short period, a matter of seconds, then got back up and "appeared to be fine".  All symptoms resolved on their own.
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: LEFT ELBOW (ARM WHERE INJECTION WAS GIVEN) FELT SORE. IBUPROFEN TAKEN. SEEN DR. DECEMBER 11, 09. BECAUSE ELBOW BECAME INCREASING SORE, SWELLING, PAINFUL LIFTING OBJECTS AND OPENING DOORS. ICY HOT/HEAT PAD AND ICE USED.  CURRENT 12/16/09 USING ICE ONLY TO REDUCE SWELLING AND PAIN WITH SOME SUCESS.  STILL CAN'T LIFT OBJECTS WITHOUT DISCOMFORT OR SEVERE PAIN, DEPENDING ON HEAVINESS.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Woman received on 12/09/2009  in her Left arm H1N1 vaccine with no discomfort. The next day 12/10/2209 she received the Seasonal Flu  vaccine in  her right arm. About  6 hours later,  her arm was doubled in size, red and painful.  Hurt in arm, neck and leg all on right side.  She called her boss ( an RN) the next day,  the boss  looked at it.   The redened area was marked and  the woman was advised to  go to the emregency room if  the redness went outside of the mark.   The next day at work,she felt hot and the redness spread outside the circle.  The woman called the emergency room , she states the ER  advised  her there was nothing to do about it.  Then on Sunday evening the area decreased in size and the redness was gone.    All  is fine now.  the woman has Thyroid disease  and High BP.  Medications: lisinopril and synthroid.
Age: 1.92
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Injection site reaction, Nasal congestion, Rash erythematous
Clinical narrative: Caller states her 23 month old received the H1N1 vaccine in one arm and the seasonal flu vaccine in the opposite arm yesterday morning at 1130.  She is concerned because the child has a stuffy nose now.  The site where the H1N1 vaccine was given is red with a bump. No fever.  mother refused follow-up call.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Began with abdominal cramping and bleeding.  Completed miscarriage on Dec. 2nd, 2009.  Was in contact with doctor by phone.
Age: 6.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was scheduled for a flu clinic with brother and sister.  Sister was to get a varicella booster, Davanika received the vaccine by mistake.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1), FLUX
Symptoms: Computerised tomogram normal, Convulsion, Dyskinesia, Fall, Grand mal convulsion
Clinical narrative: Patient's words: post injections patient fell, hit head and then had a seizure. The patient is a 6 year old male who presents with a complaint of loss of consciousness. The onset of the loss of consciousness has been acute and has been occurring for 30 seconds. The course has been decreasing. The symptoms have been associated with abnormal movements, convulsions and trauma, while the symptoms have not been associated with bleeding, fever, focal neurological deficit or history of neurological disease. Patient received influenza immunization x2.  When standing to leave, lost consciousness.  Hit forehead on counter.  Proceeded with tonic clonic seizure lasting approximately 30 seconds.  Patient was very pale.  No postictal period.  Alert and oriented minutes after fall.  No prior history of seizures or epilepsy.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1), FLUX
Symptoms: Head injury, Injury, Loss of consciousness, Pallor
Clinical narrative: Patient's words: post injections patient fell, hit head and then had a seizure. The patient is a 6 year old male who presents with a complaint of loss of consciousness. The onset of the loss of consciousness has been acute and has been occurring for 30 seconds. The course has been decreasing. The symptoms have been associated with abnormal movements, convulsions and trauma, while the symptoms have not been associated with bleeding, fever, focal neurological deficit or history of neurological disease. Patient received influenza immunization x2.  When standing to leave, lost consciousness.  Hit forehead on counter.  Proceeded with tonic clonic seizure lasting approximately 30 seconds.  Patient was very pale.  No postictal period.  Alert and oriented minutes after fall.  No prior history of seizures or epilepsy.
Age: 6.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: Pt had near syncople episode at the front desk while mom was checking out. Color was pale, remained awake. BP 88/58 awake, alert and walked out of office 15 min after episode.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site papule, Rash pruritic
Clinical narrative: next morning noted 3 erythemetous papular lesions at area of injection. very pruritic
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Vomiting
Clinical narrative: nausea and vomiting requiring admission.
Age: 4.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Nasopharyngitis, Rash
Clinical narrative: DELTOID BECAME SWOLLEN WITHIN HOURS OF SHOT; SWELLING SUBSIDED IN APPROX. 24HOURS, BUT LEFT A FAINT (ITCHY) RASH AROUND THE INJECTION SITE. AFTER ANOTHER 24HOURS, SAME RASH SPREAD TO FACE. (CONTAINED TO LEFT CHEEK, SAME SIDE AS SHOT). ALL OF RASH SEEMED TO FADE AFTER ABOUT 48HOURS FROM ONSET.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Inflammation, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Injection was administered too high in shoulder. Severe shoulder pain, with limited swelling.  Orthopedist diagnosed shoulder impingement as a result of inflammation from poor shot administration.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Injection was administered too high in shoulder. Severe shoulder pain, with limited swelling.  Orthopedist diagnosed shoulder impingement as a result of inflammation from poor shot administration.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Erythema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: soreness at injection site since 11/15/2009.  morning of 12/15/2009 arm very painfull, swollen,hot and red. temperature of 100 degrees.  visit to primary MD, antibiotics prescribed, follow up visit in 6 days.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Skin warm
Clinical narrative: soreness at injection site since 11/15/2009.  morning of 12/15/2009 arm very painfull, swollen,hot and red. temperature of 100 degrees.  visit to primary MD, antibiotics prescribed, follow up visit in 6 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient reports generalized rash and pruritus
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oedema peripheral, Pain in extremity, X-ray
Clinical narrative: My right hand swelled up.  Not able to touch the hand or use the hand in any way without severe pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hot flush, Paraesthesia
Clinical narrative: "Hot Flashes" twice a week.  Skin turned from white to cherry red on neck arms chest and thighs.  Was not painful but annoying like "pins and needles."  In 1997 started taking amino acid Arginine 500 mg daily.  Had no problems with it until the Shingles Shot.  Then the "hot flashes" started until 21 November 2009 when I quit the L-Arginine and the "hot flashes" immediatly stopped.  The Shingles Shot is a weakened virus.  Googling L-Arginine you learn it will react with viruses.  Since I've spoken to several people who have had shingles, I am foregoing L-Arginine.
Age: 74.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Balance disorder, Vertigo positional
Clinical narrative: VERTIGO, WHEN STANDING OR MOVING, FEELING OF WEAKNESS AND UNSTEADY. LASTED UNTIL LATE AFTERNOON OF THE SAME DAY.
Age: 1.63
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives all over body.  Benadryl administered orally.
Age: 55.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives around injection site on left arm, spreading across back on left side.
Age: 22.0
Sex: F
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Unevaluable event
Clinical narrative: I filed a VAERS report on 12/16/09 due to the fact that the H1N1 mist was charted as given to a pregnant female. The doctor phoned the patient to inform her and she claims that she received two shots and no mist. She received season and H1N1 at the same influenza exercise.
Age: 1.65
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia, Urticaria
Clinical narrative: Sun evening developed fever lasting through Tue. Wed developed hives. Treated with Benadryl. Hives returned exactly 6 hrs from initial dose of Benadryl. Administered second dose of Benadryl, contacted PCP, and this is where we are now.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Formication
Clinical narrative: Feel like skin is crawling and chills in upper back and neck.  Feels like something is crawling on my skin.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site reaction, Injection site swelling
Clinical narrative: Patient noticed blistering and swelling at injection site the day after the vaccine was given. She did not seek medical attention. Patient applied ABREVA to the site of RxN and took BENADRYL. Patient does have known Hx of herpes and feels that's what was the cause.
Age: 1.2
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient developed herpes Zoster 12/12/09. Under treatment now
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Dysphagia, Pharyngeal oedema
Clinical narrative: Throat feels like it's swelling up. Chest fells like it got a lot of pressure. Got mist @ approx 1030 AM stated hard to swallow @ 12 noon @ lunch - came to PHN @ 1 pm pulse 76 lungs clear. PHN took student to office in school. 12/16/09 TC - student did not check back in with school staff as suggested. T.C. to home on 12/16 @ 1600 left vm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature, Erythema
Clinical narrative: 3 cm erythema, temp 102.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Fatigue, Pyrexia, Rash
Clinical narrative: Developed abd cramping x 1 day - relieved with tums. Then fever to 103, fatigue, rash on bottom. No Rx Tx: symptomatic treatment.
Age: 51.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Culture negative, Dehydration, Dyspnoea, Haemoptysis
Clinical narrative: A serious spontaneous report of immunocompromised patient had been in contact with recipient of H1N1 LAIV presenting with shortness of breath, dehydration, coughing up blood, abdominal pain, influenza A with symptoms of fever of 103 F, nausea and vomiting has been received from a physician concerning a 51-year-old male, subsequent to H1N1 2009 vaccine, intranasal. The patient was reported as immunocompromised. No concomitant medications have been reported for this patient. The patient did not receive H1N1 vaccine. The patient was in contact with a recipient of H1N1 vaccine, intranasal, several days prior to development of symptoms. On an unknown date patient was admitted to ER, then on 02-Dec-2009, the patient was hospitalized for the symptoms of 103 F, abdominal pain, nausea, vomiting, shortness of breath and dehydration. Patient was tested positive for Influenza A on 03-Dec-2009. The patient was coughing up blood five days after hospital admission. A nasal wash on 03-Dec-2009 was antigen and culture negative; PCR test was positive for Influenza A. Diagnostic test on 07-Dec-2009, was antigen and culture positive and PCR test was positive for Influenza A. Influenza A subtype was pending state lab results. The outcome of the secondary transmission and for all the reported adverse events was unknown.
Age: 51.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Influenza, Influenza serology positive, Nausea, Polymerase chain reaction, Pyrexia
Clinical narrative: A serious spontaneous report of immunocompromised patient had been in contact with recipient of H1N1 LAIV presenting with shortness of breath, dehydration, coughing up blood, abdominal pain, influenza A with symptoms of fever of 103 F, nausea and vomiting has been received from a physician concerning a 51-year-old male, subsequent to H1N1 2009 vaccine, intranasal. The patient was reported as immunocompromised. No concomitant medications have been reported for this patient. The patient did not receive H1N1 vaccine. The patient was in contact with a recipient of H1N1 vaccine, intranasal, several days prior to development of symptoms. On an unknown date patient was admitted to ER, then on 02-Dec-2009, the patient was hospitalized for the symptoms of 103 F, abdominal pain, nausea, vomiting, shortness of breath and dehydration. Patient was tested positive for Influenza A on 03-Dec-2009. The patient was coughing up blood five days after hospital admission. A nasal wash on 03-Dec-2009 was antigen and culture negative; PCR test was positive for Influenza A. Diagnostic test on 07-Dec-2009, was antigen and culture positive and PCR test was positive for Influenza A. Influenza A subtype was pending state lab results. The outcome of the secondary transmission and for all the reported adverse events was unknown.
Age: 51.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Secondary transmission, Virus serology test positive, Vomiting
Clinical narrative: A serious spontaneous report of immunocompromised patient had been in contact with recipient of H1N1 LAIV presenting with shortness of breath, dehydration, coughing up blood, abdominal pain, influenza A with symptoms of fever of 103 F, nausea and vomiting has been received from a physician concerning a 51-year-old male, subsequent to H1N1 2009 vaccine, intranasal. The patient was reported as immunocompromised. No concomitant medications have been reported for this patient. The patient did not receive H1N1 vaccine. The patient was in contact with a recipient of H1N1 vaccine, intranasal, several days prior to development of symptoms. On an unknown date patient was admitted to ER, then on 02-Dec-2009, the patient was hospitalized for the symptoms of 103 F, abdominal pain, nausea, vomiting, shortness of breath and dehydration. Patient was tested positive for Influenza A on 03-Dec-2009. The patient was coughing up blood five days after hospital admission. A nasal wash on 03-Dec-2009 was antigen and culture negative; PCR test was positive for Influenza A. Diagnostic test on 07-Dec-2009, was antigen and culture positive and PCR test was positive for Influenza A. Influenza A subtype was pending state lab results. The outcome of the secondary transmission and for all the reported adverse events was unknown.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Blood thyroid stimulating hormone normal, Computerised tomogram abnormal, Condition aggravated, Dysphonia, Fatigue
Clinical narrative: A serious spontaneous report of vocal cord paralysis with symptoms of hoarseness of voice and sore throat has been received from a physician concerning 47-year-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 27-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal for an unknown indication. On the same day, immediately after vaccination, the patient had vocal cord paralysis with symptom of hoarseness of voice and sore throat. The outcome of vocal paralysis with symptom of hoarseness of voice was not resolved and outcome of sore throat was resolved.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Free thyroxine index normal, Goitre, Haemoglobin normal, Immediate post-injection reaction, Nocturia
Clinical narrative: A serious spontaneous report of vocal cord paralysis with symptoms of hoarseness of voice and sore throat has been received from a physician concerning 47-year-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 27-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal for an unknown indication. On the same day, immediately after vaccination, the patient had vocal cord paralysis with symptom of hoarseness of voice and sore throat. The outcome of vocal paralysis with symptom of hoarseness of voice was not resolved and outcome of sore throat was resolved.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Oropharyngeal pain, Pathology test, Poor quality sleep, Temperature intolerance, Thyroid neoplasm
Clinical narrative: A serious spontaneous report of vocal cord paralysis with symptoms of hoarseness of voice and sore throat has been received from a physician concerning 47-year-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 27-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal for an unknown indication. On the same day, immediately after vaccination, the patient had vocal cord paralysis with symptom of hoarseness of voice and sore throat. The outcome of vocal paralysis with symptom of hoarseness of voice was not resolved and outcome of sore throat was resolved.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Vocal cord disorder, Vocal cord paralysis, Weight increased
Clinical narrative: A serious spontaneous report of vocal cord paralysis with symptoms of hoarseness of voice and sore throat has been received from a physician concerning 47-year-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 27-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal for an unknown indication. On the same day, immediately after vaccination, the patient had vocal cord paralysis with symptom of hoarseness of voice and sore throat. The outcome of vocal paralysis with symptom of hoarseness of voice was not resolved and outcome of sore throat was resolved.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Dysphonia, Laryngitis, Laryngoscopy, Vocal cord paralysis
Clinical narrative: A serious spontaneous report of vocal cord paralysis with symptoms of hoarseness of voice and sore throat has been received from a physician concerning 47-year-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 27-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal for an unknown indication. On the same day, immediately after vaccination, the patient had vocal cord paralysis with symptom of hoarseness of voice and sore throat. The outcome of vocal paralysis with symptom of hoarseness of voice was not resolved and outcome of sore throat was resolved.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Bronchial hyperreactivity, Pyrexia, Urinary tract infection, Wheezing
Clinical narrative: A serious report of asthma has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included obesity. The subject had no family history of asthma and no history of previous wheezing episodes. No concomitant medications were reported. On 30-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event. On 28-Oct-2009, the subject began to wheeze and had symptoms of urinary tract infection with fever; he was seen at emergency room. On 29-Oct-2009, the subject was admitted to the hospital for asthma. on 30-Oct-2009, he was discharged from the hospital "in good condition". Discharge medications included beclomethasone and albuterol, which he used for four days. On 05-Nov-2009, at follow-up examination, the subject was doing well. He did not have cough or fever, was playful and had good appetite. Although reactive airway disease was coded in the hospital, the follow-up exam states reluctance to define the event as asthma since it was a first episode. The outcome of the event was resolved on 30-Oct-2009. The investigator assessed the causality for the event of asthma to FLUMIST as none. The severity of the event was mild. The alternative etiology was upper respiratory infection. The sponsor assessed the causality for the event of asthma as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood electrolytes normal, Blood glucose normal, Computerised tomogram head, Computerised tomogram normal, Constipation
Clinical narrative: A serious report of dehydration and constipation has been received from a study investigator concerning a four-year-old female (subject number 03402040) participating in a post marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included iron deficiency anemia. No concomitant medications were reported. On 14-Sep-2009, the subject received FLUMIST 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 14-Sep-2009. The subject's mother reported that one week prior to hospitalization, the subject had cough and runny nose with intermittent fever of low grade. On 14-Sep-2009, the subject was diagnosed with otitis media and began taking AMOXICILLIN orally. One day prior to the hospital presentation, on 16-Sep-2009, the subject had nausea and began vomiting while febrile and could not keep down water. She was brought to emergency room, The subject was given three normal saline boluses for a total of 60 ml/kg in the emergency department, and she received ondansetron orally and intravenously. She continued to vomit and failed two oral challenges. Her white blood cell count had left shift, and urinalysis was positive for ketone. Other laboratory test results (electrolyte count, glucose and complete blood count) were normal. On 17-Sep-2009, the subject was admitted to the hospital for hydration. Due to intermittent discomfort and protracted vomiting as well as the report of low grade fevers, a KUB was done and showed no sign of obstruction but was significant for constipation. An abdominal ultrasound was obtained to rule out intussusception or an abnormal appendicitis and was normal. She continued to vomit and a non-contrast head computerised tomogram was performed, and the results ruled out intracranial abnormality as a potential cause of acute onset vomiting. The subject had fleets enema x 2 with stool output for constipation. She had persistent vomiting the day of admission which ceased overnight with return of bowel sounds. She was able to tolerate clear liquids as Jell-O and crackers with no pain or nausea, and intravenous fluids were discontinued. Follow-up electrolytes and complete blood count were normal. At discharge, the subject was tolerating diet described above with no intravenous fluid requirement, alert and active playing in the playroom. She was afebrile with normal vital signs. The events of dehydration and constipation were resolved on 18-Sep-2009. The investigator assessed the causality for the events of dehydration and constipation to FLUMIST as none. The severity of the event was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the event of dehydration and constipation as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Dehydration, Enema administration, Fluid replacement, Full blood count normal
Clinical narrative: A serious report of dehydration and constipation has been received from a study investigator concerning a four-year-old female (subject number 03402040) participating in a post marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included iron deficiency anemia. No concomitant medications were reported. On 14-Sep-2009, the subject received FLUMIST 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 14-Sep-2009. The subject's mother reported that one week prior to hospitalization, the subject had cough and runny nose with intermittent fever of low grade. On 14-Sep-2009, the subject was diagnosed with otitis media and began taking AMOXICILLIN orally. One day prior to the hospital presentation, on 16-Sep-2009, the subject had nausea and began vomiting while febrile and could not keep down water. She was brought to emergency room, The subject was given three normal saline boluses for a total of 60 ml/kg in the emergency department, and she received ondansetron orally and intravenously. She continued to vomit and failed two oral challenges. Her white blood cell count had left shift, and urinalysis was positive for ketone. Other laboratory test results (electrolyte count, glucose and complete blood count) were normal. On 17-Sep-2009, the subject was admitted to the hospital for hydration. Due to intermittent discomfort and protracted vomiting as well as the report of low grade fevers, a KUB was done and showed no sign of obstruction but was significant for constipation. An abdominal ultrasound was obtained to rule out intussusception or an abnormal appendicitis and was normal. She continued to vomit and a non-contrast head computerised tomogram was performed, and the results ruled out intracranial abnormality as a potential cause of acute onset vomiting. The subject had fleets enema x 2 with stool output for constipation. She had persistent vomiting the day of admission which ceased overnight with return of bowel sounds. She was able to tolerate clear liquids as Jell-O and crackers with no pain or nausea, and intravenous fluids were discontinued. Follow-up electrolytes and complete blood count were normal. At discharge, the subject was tolerating diet described above with no intravenous fluid requirement, alert and active playing in the playroom. She was afebrile with normal vital signs. The events of dehydration and constipation were resolved on 18-Sep-2009. The investigator assessed the causality for the events of dehydration and constipation to FLUMIST as none. The severity of the event was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the event of dehydration and constipation as not related to FLUMIST.