chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.84
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Death
Clinical narrative: Pt. deceased 10/11/2010. Unknown cause at present time; per mo-pt found in crib, prone, not breathing on morning of 10/11/2010. Past history significant for spinal muscular atrophy Type II. Treated for pneumonia 9/20-9/22/2010.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Headache, Induration, Injection site erythema
Clinical narrative: 4x4 inch area of erythema and increased warmth, slt induration. Client c/o pain of "8" on 0-10 pain. Also c/o headache, chills & body aches. Occ nausea. Relates c/o began the day after injection. Pain, redness, heat at injection site persist to present (6 days post injection) but are improved. Rates pain as a 1-2 on 0-10 scale. Other c/o resolved by day 3 post injection. Also noted night sweats either night of the injection or night after.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Nausea, Night sweats, Pain
Clinical narrative: 4x4 inch area of erythema and increased warmth, slt induration. Client c/o pain of "8" on 0-10 pain. Also c/o headache, chills & body aches. Occ nausea. Relates c/o began the day after injection. Pain, redness, heat at injection site persist to present (6 days post injection) but are improved. Rates pain as a 1-2 on 0-10 scale. Other c/o resolved by day 3 post injection. Also noted night sweats either night of the injection or night after.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: 4x4 inch area of erythema and increased warmth, slt induration. Client c/o pain of "8" on 0-10 pain. Also c/o headache, chills & body aches. Occ nausea. Relates c/o began the day after injection. Pain, redness, heat at injection site persist to present (6 days post injection) but are improved. Rates pain as a 1-2 on 0-10 scale. Other c/o resolved by day 3 post injection. Also noted night sweats either night of the injection or night after.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Tenderness
Clinical narrative: R arm redness & Swelling, moved down to forearm, tender. Had pneumo shot 2 yrs ago. Allergic reaction treated with inj. of decadron.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pt reports fist like pain as soon as injection administered with progression of pain down the left arm to elbow. States pain is shooting pain of the elbow with movement; decreased ROM, weakness left arm only. Required office visit. Treated with NSAIDS and medrol dose pack. Will follow up in two days.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt reports fist like pain as soon as injection administered with progression of pain down the left arm to elbow. States pain is shooting pain of the elbow with movement; decreased ROM, weakness left arm only. Required office visit. Treated with NSAIDS and medrol dose pack. Will follow up in two days.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Chills, Deafness, Ear infection
Clinical narrative: Sore throat, swollen throat, Eye infection, severe ear infection, mid high to high fever, chills, hearing loss (degree YTBD), loss of taste, loss of smell, Patient still recovering
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Eye infection, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Sore throat, swollen throat, Eye infection, severe ear infection, mid high to high fever, chills, hearing loss (degree YTBD), loss of taste, loss of smell, Patient still recovering
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Feeling cold, Headache, Pain in jaw
Clinical narrative: Freezing, shaking, headache, increased temp, joint pain in jaw, shoulder and hips most of the night.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Freezing, shaking, headache, increased temp, joint pain in jaw, shoulder and hips most of the night.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspraxia, Hypoaesthesia, Muscular weakness
Clinical narrative: Presented to the ED with sx of weakness to right hand, and numbness, right leg not affected. Day before reports he had dyspraxia.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Feeling abnormal, Nasal congestion, Rash, Throat irritation
Clinical narrative: Weird feeling in throat, stuffy nose, rash on neck, chest, and waistband. Eyelid swelling.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Soft tissue arm pain that radiates down arm to hand.  Hand feels weak at times. no improvement over 2 weeks.  No sign of infection or hematoma.  No indication of nerve pain.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Acute myocardial infarction, Arterial occlusive disease, Coronary arterial stent insertion, Cyanosis, Electrocardiogram abnormal
Clinical narrative: Soft tissue arm pain that radiates down arm to hand.  Hand feels weak at times. no improvement over 2 weeks.  No sign of infection or hematoma.  No indication of nerve pain.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Malaise, Pain in extremity
Clinical narrative: Soft tissue arm pain that radiates down arm to hand.  Hand feels weak at times. no improvement over 2 weeks.  No sign of infection or hematoma.  No indication of nerve pain.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Intensive care, Muscular weakness
Clinical narrative: Patient woke up with left arm and hand weakness and numbness and headache over right eye.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Oral pruritus, Swollen tongue
Clinical narrative: TONGUE ITCHY, SWOLLEN.  LIPS SWELLING.  SOB.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Muscular weakness, Myalgia, Nodule
Clinical narrative: Patient said she had small nodule following initial vaccination this lasted a few days. Then had no symptoms up to a few days ago. Then she had pain in her muscle. She also reported muscle weakness and inability to grip items due to muscle weakness and pain.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Received vaccine 9/29/10 around 4pm - patient stated she went to bed (felt fine then) woke up the next morning with sweats drenched, chills, nausea, & dizziness.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Mouth haemorrhage, Tooth loss
Clinical narrative: Got flu shot. Left area with aide - supervisor was asked to come; man had fallen. Bleeding  from mouth. Knocked out 2 upper front teeth. PHN helped nurse clean his face. Teeth put in milk. Man to go to dentist.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Shaking chills x 2 hrs 102 - 105 degrees F temp after TYLENOL & Ibuprofen, fever down to 102 degrees F at 3am shaking chills & fever increased. Seen in fast care clinic the next day with no apparent cause.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Deep pain & numbness to (L) buttock & down front & back of thigh, appeared after injection given & not improved. No other explanation for symptoms. Pt was restless at time of visit - difficult to administer to pt.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Angina pectoris, Pruritus, Rash
Clinical narrative: Rash, itching, pain in heart. I did not seek treatment. Itching stopped after a few days. Rash is almost gone. One spot still on Oct. 8, 2010.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Patient complained of swelling and heat and pain in his arm.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Fainted about 1 1/2 hours after the vaccine - no other symptoms.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Patient reported fever, sweating, weakness, shivers 4 hours after vaccine which continued for another 8 hours.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Asthenia, Crying, Guillain-Barre syndrome, Irritability, Lumbar puncture
Clinical narrative: Began with fussiness and emesis. Parents noted weak cry, generalized weakness, poor sleep, poor head control. Approx. 1 week following immunizations. Symptoms persisted and worsened. Dx with Guillain-Barre at hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Poor quality sleep, Posture abnormal, Scan brain
Clinical narrative: Began with fussiness and emesis. Parents noted weak cry, generalized weakness, poor sleep, poor head control. Approx. 1 week following immunizations. Symptoms persisted and worsened. Dx with Guillain-Barre at hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Began with fussiness and emesis. Parents noted weak cry, generalized weakness, poor sleep, poor head control. Approx. 1 week following immunizations. Symptoms persisted and worsened. Dx with Guillain-Barre at hospital.
Age: 1.26
Sex: M
Vaccine: DTAP, PNC
Symptoms: Abnormal behaviour, Acoustic stimulation tests normal, Agitation, Autism spectrum disorder, DNA test for fragile X
Clinical narrative: Completely stopped talking; stopped playing w/ kids; became an extremely picky eater; hates to be dirty; shuts down in groups of ppl; easily frustrated or over excited. He was diagnosed at the facility. Gets O.T. and speech therapy. Attends family therapy.
Age: 1.26
Sex: M
Vaccine: DTAP, PNC
Symptoms: Eating disorder, Frustration, Laboratory test normal, Social avoidant behaviour, Speech disorder
Clinical narrative: Completely stopped talking; stopped playing w/ kids; became an extremely picky eater; hates to be dirty; shuts down in groups of ppl; easily frustrated or over excited. He was diagnosed at the facility. Gets O.T. and speech therapy. Attends family therapy.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLU3
Symptoms: Asthenia, Dizziness, Feeling drunk, Feeling hot, Headache
Clinical narrative: 2 hours after vaccination started to feel dizzy and see "stars". As the day went on I developed a headache and I felt as if I was "drugged".  I felt weak and sick.  I became very warm. My heart "hurt" and had a rapid heartbeat. My thought processes were affected, my reactions slow.  I felt sick all day Wednesday, Thursday and most of Friday.  I called my doctor.  RN stated that if I continued to feel sick, I should report to the Emergency Department.  I am worried about residual effects froms the vaccination.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLU3
Symptoms: Heart rate increased, Malaise, Mental impairment, Slow response to stimuli, Visual impairment
Clinical narrative: 2 hours after vaccination started to feel dizzy and see "stars". As the day went on I developed a headache and I felt as if I was "drugged".  I felt weak and sick.  I became very warm. My heart "hurt" and had a rapid heartbeat. My thought processes were affected, my reactions slow.  I felt sick all day Wednesday, Thursday and most of Friday.  I called my doctor.  RN stated that if I continued to feel sick, I should report to the Emergency Department.  I am worried about residual effects froms the vaccination.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLU3
Symptoms: Asthenia, Dizziness, Headache, Heart rate increased, Malaise
Clinical narrative: 2 hours after vaccination started to feel dizzy and see "stars". As the day went on I developed a headache and I felt as if I was "drugged".  I felt weak and sick.  I became very warm. My heart "hurt" and had a rapid heartbeat. My thought processes were affected, my reactions slow.  I felt sick all day Wednesday, Thursday and most of Friday.  I called my doctor.  RN stated that if I continued to feel sick, I should report to the Emergency Department.  I am worried about residual effects froms the vaccination.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLU3
Symptoms: Non-cardiac chest pain, Scotoma
Clinical narrative: 2 hours after vaccination started to feel dizzy and see "stars". As the day went on I developed a headache and I felt as if I was "drugged".  I felt weak and sick.  I became very warm. My heart "hurt" and had a rapid heartbeat. My thought processes were affected, my reactions slow.  I felt sick all day Wednesday, Thursday and most of Friday.  I called my doctor.  RN stated that if I continued to feel sick, I should report to the Emergency Department.  I am worried about residual effects froms the vaccination.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Infuenza shot was given on 10/15/2010 at aprox 8:45AM.  On 10/16/2010 at aprox 7:30AM pt. started itching and hives developed.  10/17/2010  itching intensified and she took Benadryl 50mg at aprox 10:30am and 7:00pm on 10/17/2010.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF protein increased, Demyelinating polyneuropathy, Electromyogram abnormal, Gait disturbance
Clinical narrative: Guillain-Barre Syndrome (Acute Inflammatory Demyelinating Polyneuropathy); Tingling in toes and difficulty walking with slowly progressive, ascending numbness and weakness evolving to the fingertips over 10 days.  Currently evaluated for treatment with intravenous immunoglobulin.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Guillain-Barre Syndrome (Acute Inflammatory Demyelinating Polyneuropathy); Tingling in toes and difficulty walking with slowly progressive, ascending numbness and weakness evolving to the fingertips over 10 days.  Currently evaluated for treatment with intravenous immunoglobulin.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Guillain-Barre Syndrome (Acute Inflammatory Demyelinating Polyneuropathy); Tingling in toes and difficulty walking with slowly progressive, ascending numbness and weakness evolving to the fingertips over 10 days.  Currently evaluated for treatment with intravenous immunoglobulin.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Posture abnormal
Clinical narrative: Head dropping spells started within 8 hours of vaccines; frequency of spells decreased over next 48 hours and resolved.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Neck mass
Clinical narrative: Redness and itch on injection site. There is a bump on the back of patient's neck. Treatment: Patient will visit MD today (10/19/2010).
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Gaze palsy, Loss of consciousness
Clinical narrative: After the first HPV vaccine was given, within 3 minutes my son passed out with his eyes rolled up.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Headache, Tunnel vision, Visual field defect, Visual impairment
Clinical narrative: white spots in vision, peripheral vision disturbances, slight tunneling vision, then headache over Left eye for several hours (8-10 hours)
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Immediate post-injection reaction, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: I immediately had soreness and raised bump at the site of injection. I got a an itchy throat and cough within a couple hours and the pain in the arm has yet to subside.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Throat irritation
Clinical narrative: I immediately had soreness and raised bump at the site of injection. I got a an itchy throat and cough within a couple hours and the pain in the arm has yet to subside.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Acne, Pruritus, Urticaria
Clinical narrative: Patient described a few pimples on torsel on second day after vaccines. Since then, she has had additional pimples and itchy raised welts on the back of her back and lower legs. Treated with OTC allergy medication.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Eye haemorrhage, Vitreous floaters
Clinical narrative: Patient states within 15 to 20 minutes after receiving vaccine and leaving pharmacy he noticed a blood floater spot which appeared in his left eye. Patient made appointment and saw his eye doctor who didn't do anything for his eye. The doctor stated the blood would eventually drain, but it was hard to say if the floater would resolve.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Hypotension, Presyncope, Respiration abnormal, Restlessness
Clinical narrative: syncope, apprehension, low blood pressure
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: syncope, apprehension, low blood pressure
Age: 1.75
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash maculo-papular, Swelling face, Swollen tongue
Clinical narrative: Swelling of face/tongue, red rash to neck, face, axillae, and chest, maculopapular rash to chest, legs, and groin.
Age: 27.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Myalgia, Oropharyngeal pain
Clinical narrative: sore muscles, sore throat, cough
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye discharge, Pyrexia
Clinical narrative: fever, eye congestion, "tight" chest
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Headache, Hypophagia, Pain, Pyrexia
Clinical narrative: Fever Severe Upper Abdominal Cramps Severe Headache Body Aches (entire body) Unable to eat/drink for 36 hours
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Syncope at time of injection responded to elevation of legs while supine
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode. No loss of consciousness. Lasted about a minute per mom. No additional symptoms.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Pt. reported very sick to stomach, nausea, dizziness, sweating.  Sudden onset lasted about 1 hour and then he felt fine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Rash erythematous
Clinical narrative: Developed a red rash on both arms, trunk both legs and back.  She saw provider on Sept 30 who started her in Benadryl and cream for allergic reaction of unknown etiology.  She was seen again on Oct 1 because rash became very uncomfortabe.  She was given prednisone and referred to allergist.  Allergist did testing and determined the rash was due to flu vaccine she received on Sept 24th.  Rash is still present today Oct 19 2010.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: PATIENT HAD A 2 INCH DIAMETER HARD NODULE AT THE INJECTION SITE ON 10/16/10. ON 10/19/10 PATIENT SAYS SWELLING HAS GONE DOWN.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Blood glucose fluctuation, Bursa removal, Drug administered at inappropriate site, Immediate post-injection reaction
Clinical narrative: Flu Injection was given (too high) in the joint of my Left shoulder. I experienced severe shooting pains immediately following the injection. My arm proceeded to swell up over the next few hours. I was unable to move or raise my arm and continued to have severe pain and swelling from the time of the injection to the present. I have seen three physicians for my shoulder pain and inflammation. I have been treated with pain medication, anti-inflammatory medication, nerve medication, electric stimulation therapy, physical therapy, MRI before and after surgery, Left shoulder decompression and excision of bursa. Since surgery my MRI shows further deterioration of the joint and tendon and excessive inflammation. I have also had problems controlling my blood glucose since the injection. The doctor has tested me for diabetes several times since the injection and I am not a diabetic but my sugars have to be maintained through the use of medication (Metformin 500mg daily). I have not been able to perform my duties as a nurse since I had the shot last year.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Inflammation, Injected limb mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Flu Injection was given (too high) in the joint of my Left shoulder. I experienced severe shooting pains immediately following the injection. My arm proceeded to swell up over the next few hours. I was unable to move or raise my arm and continued to have severe pain and swelling from the time of the injection to the present. I have seen three physicians for my shoulder pain and inflammation. I have been treated with pain medication, anti-inflammatory medication, nerve medication, electric stimulation therapy, physical therapy, MRI before and after surgery, Left shoulder decompression and excision of bursa. Since surgery my MRI shows further deterioration of the joint and tendon and excessive inflammation. I have also had problems controlling my blood glucose since the injection. The doctor has tested me for diabetes several times since the injection and I am not a diabetic but my sugars have to be maintained through the use of medication (Metformin 500mg daily). I have not been able to perform my duties as a nurse since I had the shot last year.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain, Pain in extremity, Rotator cuff repair, Surgery
Clinical narrative: Flu Injection was given (too high) in the joint of my Left shoulder. I experienced severe shooting pains immediately following the injection. My arm proceeded to swell up over the next few hours. I was unable to move or raise my arm and continued to have severe pain and swelling from the time of the injection to the present. I have seen three physicians for my shoulder pain and inflammation. I have been treated with pain medication, anti-inflammatory medication, nerve medication, electric stimulation therapy, physical therapy, MRI before and after surgery, Left shoulder decompression and excision of bursa. Since surgery my MRI shows further deterioration of the joint and tendon and excessive inflammation. I have also had problems controlling my blood glucose since the injection. The doctor has tested me for diabetes several times since the injection and I am not a diabetic but my sugars have to be maintained through the use of medication (Metformin 500mg daily). I have not been able to perform my duties as a nurse since I had the shot last year.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Tendon disorder, X-ray
Clinical narrative: Flu Injection was given (too high) in the joint of my Left shoulder. I experienced severe shooting pains immediately following the injection. My arm proceeded to swell up over the next few hours. I was unable to move or raise my arm and continued to have severe pain and swelling from the time of the injection to the present. I have seen three physicians for my shoulder pain and inflammation. I have been treated with pain medication, anti-inflammatory medication, nerve medication, electric stimulation therapy, physical therapy, MRI before and after surgery, Left shoulder decompression and excision of bursa. Since surgery my MRI shows further deterioration of the joint and tendon and excessive inflammation. I have also had problems controlling my blood glucose since the injection. The doctor has tested me for diabetes several times since the injection and I am not a diabetic but my sugars have to be maintained through the use of medication (Metformin 500mg daily). I have not been able to perform my duties as a nurse since I had the shot last year.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Blood urea nitrogen/creatinine ratio increased, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Hypophagia
Clinical narrative: Severe myalgias leading to decreased intake, ultimately leading to hospitalization with acute renal failure; new onset seizure with no clear etiology.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Renal failure acute
Clinical narrative: Severe myalgias leading to decreased intake, ultimately leading to hospitalization with acute renal failure; new onset seizure with no clear etiology.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: He had a seizure and we called 911 and the paramedics came to our house and transported him to the hospital for follow-up
Age: 18.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Recd. 3 Vaccines-TDAP, Varicella, MCV4, in Health Clinic. Had received same vaccines in another clinic 5 days apart, not in his original record, found in system, after the vaccines was given.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Headache
Clinical narrative: Pain and aches in all joints. Pt. had to stay home from work but did not take any pain relievers. No fever, cough, bruising or pain at injection site. Headache also reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: Fatigue and malaise at 6pm, low-grade fever overnight, headache and scratchy throat at 6:30 am. Soreness at injection site from injection onward.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: Fatigue and malaise at 6pm, low-grade fever overnight, headache and scratchy throat at 6:30 am. Soreness at injection site from injection onward.
Age: 44.0
Sex: F
Vaccine: FLUX, HEPAB
Symptoms: Headache, Nausea, Pain
Clinical narrative: Nausea, headache, body aches
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cardiac monitoring normal, Chest pain, Chills, Electrocardiogram normal
Clinical narrative: I started getting very cold - teeth chattering cold.  I went to bed with extra blankets.  About 30 minutes later I was awoken by a very hard hit to my right chest - right above my breast.  The pain felt like a baseball hit me then webbed out in all directions.  It only lasted a couple of minutes.  I didn't have any more pains that night and finally got warm about 4 am.  I continued to have short, much lighter pains throughout the next day, evening, and next day until aprox. 11 am.  I called my doctor and was told to go to the ER.  The ER treated it as a possible heart issue.  They ran an EKG and blood work.  I was admitted with a heart monitor, kept overnight, and had to do a nuclear stress test the next morning.  All test came back clear.  I was released apx. 4:30 Friday afternoon.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Laboratory test normal, No reaction on previous exposure to drug, Scan myocardial perfusion
Clinical narrative: I started getting very cold - teeth chattering cold.  I went to bed with extra blankets.  About 30 minutes later I was awoken by a very hard hit to my right chest - right above my breast.  The pain felt like a baseball hit me then webbed out in all directions.  It only lasted a couple of minutes.  I didn't have any more pains that night and finally got warm about 4 am.  I continued to have short, much lighter pains throughout the next day, evening, and next day until aprox. 11 am.  I called my doctor and was told to go to the ER.  The ER treated it as a possible heart issue.  They ran an EKG and blood work.  I was admitted with a heart monitor, kept overnight, and had to do a nuclear stress test the next morning.  All test came back clear.  I was released apx. 4:30 Friday afternoon.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash started on right ear and spread down to the right side of neck. Donor complained about itching on face and head as well as neck and back at 6:00 PM. At 6:30 PM she started to complain about itching on both arms. Benadryl was prescribed by center physican and was told to go home and rest.
Age: 0.55
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (lot # not reported) and on an unknown date had intussusception. The physician stated that he had seen the patient one time. The physician stated the patient did not receive any vaccination in his office. The patient went to the hospital. The physician was not sure if the patient had received the ROTATEQ. Upon internal review intussusception was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Oedema
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot#665708/0651Z). On the next day, the patient developed edema and cellulitis. At the time of this report, the patient's outcomes was not reported. Follow up information has been received which reported that the patient developed cellulitis following vaccination with PNEUMOVAX 23. Edema and cellulitis were considered to be disabling by the reporter. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Erythema, Flushing, Inflammation
Clinical narrative: Report received from a nurse on 06-OCT-2010 (received via Merck WAES: 1009USA00666). A 44 year old female patient received a 0.5ml dose of AFLURIA injection (batch number: M52208, expiry date: 30-JUN-2011) via intramuscular (IM) route of administration and it was offered to teachers at the school on 05-OCT-2010 at 10am. The patient has a medical history of Stevens Johnson syndrome and allergies to sulfa and pineapple. No concomitant medications were reported. On 05-OCT-2010 at 2pm, 4 hour post vaccination with the suspect drug AFLURIA, the patient complained of arm and shoulder pain at the injection site, dizziness, little nausea and lightheadedness. The patient sought medical attention by visiting a nurse and was treated with ADVIL (dose and route of administration not specified). The patient was flushed with no fever (98.8F), however her blood pressure was slightly elevated from 129/79 then went to 134/90 (units or normal range not provided). She then laid down to sleep. At around 3:30pm the patient woke complaining of itching and hives over the chest area neck which was inflamed. She was then treated with 25mg of BENADRYL (dose and route of administration not specified), at this stage her blood pressure was at 144/90 or 144/91 (units or normal range not provided). The patient then complained of her tongue swelling and was given another 25 mg of BENADRYL. The nurse took the patient to the emergency room (ER) and during this period, the teacher started to improve rapidly. The patient at the ER had light flushing, redness and a blood pressure of 155/90 (units or normal range not provided). At the ER the patient was treated with a steroid which she was to continue to take for 4 days once home, PEPCID and instructed to take BENADRYL for 24-48 hours once home (dose and route of administration not specified). The patient received FLUARIX (manufacturer unknown) last year with no problems. The patient's outcome was recovered on an unknown date. No further information provided. The case was reported as serious due to intervention and was life-threatening. The reporter did not provide a causality assessment in relation to the suspect drug, AFLURIA. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Report received from a nurse on 06-OCT-2010 (received via Merck WAES: 1009USA00666). A 44 year old female patient received a 0.5ml dose of AFLURIA injection (batch number: M52208, expiry date: 30-JUN-2011) via intramuscular (IM) route of administration and it was offered to teachers at the school on 05-OCT-2010 at 10am. The patient has a medical history of Stevens Johnson syndrome and allergies to sulfa and pineapple. No concomitant medications were reported. On 05-OCT-2010 at 2pm, 4 hour post vaccination with the suspect drug AFLURIA, the patient complained of arm and shoulder pain at the injection site, dizziness, little nausea and lightheadedness. The patient sought medical attention by visiting a nurse and was treated with ADVIL (dose and route of administration not specified). The patient was flushed with no fever (98.8F), however her blood pressure was slightly elevated from 129/79 then went to 134/90 (units or normal range not provided). She then laid down to sleep. At around 3:30pm the patient woke complaining of itching and hives over the chest area neck which was inflamed. She was then treated with 25mg of BENADRYL (dose and route of administration not specified), at this stage her blood pressure was at 144/90 or 144/91 (units or normal range not provided). The patient then complained of her tongue swelling and was given another 25 mg of BENADRYL. The nurse took the patient to the emergency room (ER) and during this period, the teacher started to improve rapidly. The patient at the ER had light flushing, redness and a blood pressure of 155/90 (units or normal range not provided). At the ER the patient was treated with a steroid which she was to continue to take for 4 days once home, PEPCID and instructed to take BENADRYL for 24-48 hours once home (dose and route of administration not specified). The patient received FLUARIX (manufacturer unknown) last year with no problems. The patient's outcome was recovered on an unknown date. No further information provided. The case was reported as serious due to intervention and was life-threatening. The reporter did not provide a causality assessment in relation to the suspect drug, AFLURIA. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain in left arm at surrounding area, shot given. ADE reported 10/18/10, pain when lifting arm (has decreased over time but still painful).
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Condition aggravated, Heart rate increased, Palpitations, Pyrexia
Clinical narrative: Report received from a pharmacist (via a company partner, 1010USA00940). An 80 year old female patient received AFLURIA by intramuscular injection on 07-SEP-2010 for seasonal flu prevention. The batch number was 09949121B with an expiry of 30-JUN-2011. The patient had a pertinent medical history including hypothyroidism, osteoporosis and high blood pressure. Concomitant medications included FOSAMAX, PREMARIN, DIAZIDE, and SYNTHROID. Doses are unknown. The patient had no allergies. On 14-SEP-2010, 8 days following AFLURIA vaccination, the patient developed increased blood pressure, a racing heart rate and fever. The patient sought medical attention. The physician recommended to avoid any further flu injections. The patient outcome was reported as recovered on an unknown date. This case was considered serious due to medical significance. The events were considered possible to the suspect drug AFLURIA, however the patient had pre-existing hypertension. Information derived from this AE report does not change the current safety profile of the product.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Rash, Swelling face
Clinical narrative: Report received from a nurse on 06-OCT-2010 (report via license partner, 1010USA00658). A female patient received AFLURIA (batch number 10749111A, expiry 29-JUN-2011) for flu vaccination on 04-OCT-2010. The 0.5 mL dose was administered in the right deltoid intra-muscularly. It is unknown if the patient had a relevant history or was taking concomitant medication. On 04-OCT-2010, approximately 8-10 hours after AFLURIA administration, the patient broke out with a systemic rash and experienced swelling in her hands and face. The patient went to her local emergency room and was treated with unspecified antihistamines which failed to clear up the rash and swelling. The patient sought medical attention. On 06-OCT-2010, the patient's physician started her on steroids for treatment. No further information provided. The patient outcome was not recovered at the time of reporting. This case was considered serious due to intervention to prevent serious criteria. The company considered events possible to AFLURIA administration due to short time to onset of events. Information derived from this AE report does not change the current safety profile of the product.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face, Throat tightness
Clinical narrative: Felt like throat closing, lip & facial swelling. Tx: BENADRYL 25 mg IM ZANTAC 150 mg PO DECADRON 10 IM.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Body temperature increased, Immunisation reaction, Musculoskeletal pain
Clinical narrative: Four hours after flu shot pt developed temp of 104 degrees and blood pressure was 223/93. Went to ER where he was admitted, and given antibiotics. MD thought pt had pneumonia, then said it was from flu shot. Pt was given VANTIN 200mg to take at home, but didn't take it. Pt says he is now suffering from no energy and cold/sore shoulders from shot.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis
Clinical narrative: Four hours after flu shot pt developed temp of 104 degrees and blood pressure was 223/93. Went to ER where he was admitted, and given antibiotics. MD thought pt had pneumonia, then said it was from flu shot. Pt was given VANTIN 200mg to take at home, but didn't take it. Pt says he is now suffering from no energy and cold/sore shoulders from shot.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea developed a few hours after receiving flu vaccine. Symptoms continued through most of the night. By noon, patient was tolerating fluids and soft food.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Apnoea, Death, Pulse absent, Resuscitation
Clinical narrative: Patient was found pulseless and apneic in her bed by mom in the morning (0500). CPR performed and pt taken to ED. Unable to resuscitate.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Fever to 103 approximately 9 hrs after receipt of vaccine resulting in generalized T-C seizure lasting approximately 10 min. Taken to ER and admitted overnight for obsv.
Age: 0.98
Sex: F
Vaccine: FLU3, HEPA, HIBV
Symptoms: Demyelination, Encephalitis, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt diagnosed as ADES [Acute Demyelinating Encephalitis syndrome]. Currently in hospital.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunisation reaction
Clinical narrative: Patient had reaction to the influenza vaccination received on 9/16/10 and said that she was told as a result of the flu shot she contracted GUILLAIN BARRE Syndrome.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Back pain, Blood test, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Tingling in feet and legs, back ache and pain, 10/6/10, severe pain onset, 10/9/10 ER visit, diagnosed with GUILLAIN-BARRE syndrome. Unable to walk, still has tingling and pain. Currently in hospital receiving treatment.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Scan brain
Clinical narrative: Tingling in feet and legs, back ache and pain, 10/6/10, severe pain onset, 10/9/10 ER visit, diagnosed with GUILLAIN-BARRE syndrome. Unable to walk, still has tingling and pain. Currently in hospital receiving treatment.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Cardiac monitoring, Chest X-ray, Computerised tomogram
Clinical narrative: Tongue swelled, couldn't breath, weakness, extreme dizziness, incontinence. Called 911 for help - couldn't stay awake. Paramedics took me by Ambulance to ER - I vomited in ambulance and fainted. Blood pressure fell very low.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Hypotension, Incontinence, Somnolence
Clinical narrative: Tongue swelled, couldn't breath, weakness, extreme dizziness, incontinence. Called 911 for help - couldn't stay awake. Paramedics took me by Ambulance to ER - I vomited in ambulance and fainted. Blood pressure fell very low.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Syncope, Vomiting
Clinical narrative: Tongue swelled, couldn't breath, weakness, extreme dizziness, incontinence. Called 911 for help - couldn't stay awake. Paramedics took me by Ambulance to ER - I vomited in ambulance and fainted. Blood pressure fell very low.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Joint swelling, Rash, Rash pruritic
Clinical narrative: Pt presented 10-12-10 w/ a large red rash around injection site & a significant rash down (L) arm. Small rash on (R) arm & states rash on chest as well. She said it's very itchy. Pt also states her (L) wrist is swollen.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Pyrexia, Swelling
Clinical narrative: Cellulitis at injection site with fever & swelling KEFLEX 500mg 1 po BID x 10d.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Cyanosis, Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: Difficulty breathing. Swollen, bluish lips. Tongue swelling. Abdominal pains
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Ocular hyperaemia
Clinical narrative: Pt on warfarin. Developed blood shot eyes. Pt went to hospital Dr recommended BENADRYL. Pt eyes better Fri AM 10/8/10.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itching, pain, and rash at injection site. Nausea, dizziness, and tired.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Itching, pain, and rash at injection site. Nausea, dizziness, and tired.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Paraesthesia, Paraesthesia oral, Reaction to preservatives
Clinical narrative: 10 minutes after receiving reported tingling around lips & arms with heaviness in chest. Sent via 911 to hospital. Told reaction to preservative in vaccine most likely cause.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dizziness, Headache, Nausea
Clinical narrative: Severe dizziness & severe headache; don't feel comfortable walking around, even experiences while laying down; nauseated but no vomiting.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: 10/6 received pneumonia & flu in same arm due to surgery in (L) arm. Received approx 2 p.m. Arm became painful pm of 10/6, 10/7 am arm became swollen & painful.
Age: 72.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Rash, Tenderness
Clinical narrative: Had PPV in (R)ight arm 9/17. States arm still tender. No redness. Also has rash on both lower legs.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Pt received AFLURIA vaccination on Tues, Oct 12 at about 11:00 am along w/six other patients. She called & reported: shaking, lightening bolts up my arm thru my head, "had" fever & face look like someone punched me.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Approximately 1hr after injection reported hives to posterior arm. Raised large whelps (6 or so) noted. Sent to facility for medical attention/evaluation given Dexamethasone 8mg IM.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Shot given Monday afternoon OK thru Wed nite, Thurs AM noticed lips swollen upon awakening, did not feel real well rest of Thurs. On Fri AM Temp 99.1 up to 101.5 by nite w/ HA, weakness, could hardly walk. Took fluids and rested, called nurse Fri eve. Sat = feeling better but noticed fiery red blotch on right leg size of her hand (lower leg) no discomfort. Felt bad about a day and a half. Recovered by Saturday AM.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Malaise, Rash macular
Clinical narrative: Shot given Monday afternoon OK thru Wed nite, Thurs AM noticed lips swollen upon awakening, did not feel real well rest of Thurs. On Fri AM Temp 99.1 up to 101.5 by nite w/ HA, weakness, could hardly walk. Took fluids and rested, called nurse Fri eve. Sat = feeling better but noticed fiery red blotch on right leg size of her hand (lower leg) no discomfort. Felt bad about a day and a half. Recovered by Saturday AM.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Erythema, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: Had severe redness and itch on the arm where received shot and for 2 1/2 weeks. On third or fourth day I started having back pains and pain on the arm (right) where administered. The pains worsened and continued for four days - pains shooting down my legs - swelling of the knees I realized it was an allergic reaction and started taking BENADRYL. The BENADRYL reversed the reaction and I started feeling better - It was like the sciatic nerve had been affected.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Had severe redness and itch on the arm where received shot and for 2 1/2 weeks. On third or fourth day I started having back pains and pain on the arm (right) where administered. The pains worsened and continued for four days - pains shooting down my legs - swelling of the knees I realized it was an allergic reaction and started taking BENADRYL. The BENADRYL reversed the reaction and I started feeling better - It was like the sciatic nerve had been affected.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Vertigo
Clinical narrative: Vaccine administered 10/5/10 began having slight dizzy spells in morning - got worse to all day vertigo - taking BONINE as per pharmacist condition still in effect 10/9/10.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Experienced marked dizziness on morning following flu shot (had at 4:30pm the previous day).
Age: 11.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Urticaria
Clinical narrative: General hive through out body approximately few hours (1-4 hrs) after administration of vaccines, patient went to ER & received BEBADRYL per mom.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: 104.1 ax temp at 4AM today.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Chills, Dizziness, Pyrexia
Clinical narrative: Approximately 12 hrs post vaccine, developed arthralgias, chills, fever, dizziness, lasting approximately 36 hrs.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, HIBV, MMR, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ROTATEQ administered outside of age parameters (2-8 mos). No known injury.