chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Mononucleosis heterophile test negative, Nausea, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Fever of 102.3F, dizziness, headache, nausea at 12:55 PM, responded to Tylenol 2 1/2 teaspoons given at 1:15 PM. Patient was in office at 2:30 PM with fever of 99.2. Per patient's mother, patient developed red rash around 4:30 PM. Patient was given Benadryl. On 10/26/2010 patient was seen again in the office at 9:30 AM with a temperature of 98.1F and diffuse macular papular rash on face, neck, arms, legs, abdomen, and back. Patient was given Decadron 4/Depomedrol 40 IM and will start Orapred 15/5 2 teaspoons BID x 5 days starting 10/27/2010 along with Benadryl.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Streptococcus test, White blood cell count normal
Clinical narrative: Fever of 102.3F, dizziness, headache, nausea at 12:55 PM, responded to Tylenol 2 1/2 teaspoons given at 1:15 PM. Patient was in office at 2:30 PM with fever of 99.2. Per patient's mother, patient developed red rash around 4:30 PM. Patient was given Benadryl. On 10/26/2010 patient was seen again in the office at 9:30 AM with a temperature of 98.1F and diffuse macular papular rash on face, neck, arms, legs, abdomen, and back. Patient was given Decadron 4/Depomedrol 40 IM and will start Orapred 15/5 2 teaspoons BID x 5 days starting 10/27/2010 along with Benadryl.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site rash, Muscle tightness
Clinical narrative: Rash at site 3-4", tightening in left side of neck, right lower quadrant. Mother declined treatment with epinephrine, declined ER service.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site rash, Skin tightness
Clinical narrative: Rash at site 3-4", tightening in left side of neck, right lower quadrant. Mother declined treatment with epinephrine, declined ER service.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: 104 degree fever, chills, arm pain.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shot was given to me very high on my left arm. I was very sore where the shot was given. My arm and shoulder are in constant pain it is hard to lift with left arm.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Paraesthesia oral
Clinical narrative: Patient states he felt "a rush," his cheeks felt warm and flushed, and his tongue had a "tingling feeling."
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: ABOUT 3 DAYS AFTER GETTING THE SHOT, I FELT WEAK THEN PROGRESSED TO VOMITING, EXTREMELY PROJECTILE, WITH DIARRHEA, SHIVERS, FEVER, CHILLS, HEADACHE, MUSCLE ACHE, EXTREME FATIGUE FOR ABOUT 3 DAYS STILL A KNOT REMAINED AT SITE OF INJECTION FOR ABOUT 1 WEEK.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Myalgia, Pyrexia, Vomiting projectile
Clinical narrative: ABOUT 3 DAYS AFTER GETTING THE SHOT, I FELT WEAK THEN PROGRESSED TO VOMITING, EXTREMELY PROJECTILE, WITH DIARRHEA, SHIVERS, FEVER, CHILLS, HEADACHE, MUSCLE ACHE, EXTREME FATIGUE FOR ABOUT 3 DAYS STILL A KNOT REMAINED AT SITE OF INJECTION FOR ABOUT 1 WEEK.
Age: 3.0
Sex: F
Vaccine: HEP, HEPA, HIBV, VARCEL
Symptoms: Allergy test positive, Food allergy, Gait disturbance, Injected limb mobility decreased, Injection site nodule
Clinical narrative: Huge knot on patient's thigh where she received varicella shot.  She expressed not being able to walk.  She could walk, but it gave her great discomfort.  Over the coming days this developed into a horrible rash.  She now has a life threatening allergy to peanuts.
Age: 3.0
Sex: F
Vaccine: HEP, HEPA, HIBV, VARCEL
Symptoms: Injection site rash
Clinical narrative: Huge knot on patient's thigh where she received varicella shot.  She expressed not being able to walk.  She could walk, but it gave her great discomfort.  Over the coming days this developed into a horrible rash.  She now has a life threatening allergy to peanuts.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Adverse reaction, Crying, Injection site mass, Injection site pain, Pain
Clinical narrative: A few hours after receiving her immunizations my daughter began crying inconsolably for 5+ hours non stop, had a large painful bump at injection site, and a mild fever. It was also clear that it was painful for her to move because every time she shifted she would scream from the pain. The bump on her leg was about the size of a large marble and lasted over a week. I gave her infant Tylenol and paced with her but it didn't help much. It was clearly a reaction to the vaccine because this type of behavior is a complete departure from her usual.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: A few hours after receiving her immunizations my daughter began crying inconsolably for 5+ hours non stop, had a large painful bump at injection site, and a mild fever. It was also clear that it was painful for her to move because every time she shifted she would scream from the pain. The bump on her leg was about the size of a large marble and lasted over a week. I gave her infant Tylenol and paced with her but it didn't help much. It was clearly a reaction to the vaccine because this type of behavior is a complete departure from her usual.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: The patient is having arm pain after 3 weeks.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Leg pain (left), fever.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Sensation of foreign body
Clinical narrative: 5 minutes post flu shot started to cough, and stated it felt like there was a bubble in her throat. Felt like she had to belch and could not. Hospital unknown that she was transported to.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Flu shot administered within 15 minutes c/o tingling in jaws bilaterally & feeling feverish. No SOB or breathing problems. Went to the ER & symptoms progressively worse. Hospital unknown.
Age: 34.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: 1 hour post flu shot c/o redness to right arm, chest, face, back & stomach & c/o warmth. Transported to E.R. BENADRYL & PEPCID for 5 days. Hospital unknown.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing
Clinical narrative: Post flu shot felt very hot & face flushed. BP 180/90 epinephrine administered 911 called & EMS transported to hospital. Hospital unknown.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Post flu shot patient reported throat tightness. No breathing difficulty. 911 called - Transferred to E.R. Hospital unknown.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia oral
Clinical narrative: Post flu shot, developed tingling tongue and chest tightness. Increased shortness of breath. 911 called - EMT gave IM BENADRYL. Refused ER transport.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Post flu shot - expressed chest pain. Physician called & instructed to call 911 & transport to hospital. Hospital unknown.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Flushing
Clinical narrative: Post flu shot felt dizziness, chest pain, flushing. Epinephrine administered 911 called - she refused transport - was feeling better.
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed erythema & swelling to (L) thigh; area is warm to the touch had some mild cellulitis.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: AFLURIA administered at approx. 4:00 PM on 10/25/10. Patient's mother called pharmacy at approx. 7:30 PM to report hives on pt's legs... not injection site. Vaccine administrator told patient's mother to start oral BENADRYL and to go ER if symptoms worsened or pt developed S.O.B. Also advised follow-up with primary care physician in the morning.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Convulsion, Epistaxis, Full blood count, Laboratory test
Clinical narrative: 2 hours after vaccination, about 1100 on 10/14/10, severe migraine began felt like face was on fire. Reports at 1600 had seizure, mom & grandmother present nosebleed that noc. Visit to ER about 2200. DC from ER at 0300. Fever of 100 degrees. ER reports unsure if vaccine related. At home nosebleed at times when blowing nose. Hx of past seizures x 3.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Pyrexia
Clinical narrative: 2 hours after vaccination, about 1100 on 10/14/10, severe migraine began felt like face was on fire. Reports at 1600 had seizure, mom & grandmother present nosebleed that noc. Visit to ER about 2200. DC from ER at 0300. Fever of 100 degrees. ER reports unsure if vaccine related. At home nosebleed at times when blowing nose. Hx of past seizures x 3.
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR
Symptoms: Immunisation reaction, Peripheral coldness, Pyrexia, Vomiting
Clinical narrative: Around 11:45 pm 10/13/10 parents called reporting patient with fever 102 degrees F, cool extremities & vomiting. In the ED (hospital) temp 103.9 degrees F & HR 177 & ED reported normal physical exam, & treated fever with 100mg ibuprofen. ED impression -> reaction to flu shot.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received PNEUMOVAX and Flu shot in same arm. On 10/15/2010 received the immunizations. On 10/18/2010 noted with localized pain and erythema.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Abdominal pain, Body temperature increased, Decreased appetite, Delirium, Poor quality sleep
Clinical narrative: Vaccines at 1200 evening T 103.8 - Acute belly pain restless sleep. Delirium decreased appetite today.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Menstruation delayed, Pain in extremity
Clinical narrative: Whole arm was sore the next day, pain swelling and itching at the injection area for two weeks menstrual was due 10/19/2010 caused delayed menstrual cycle.
Age: 16.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ
Symptoms: Blepharospasm, Dizziness, Lack of spontaneous speech, Tremor
Clinical narrative: I gave an HPV on 10/25/10 to a 16 year old female in the left deltoid.   I had just given her hep A and a MCV4 in the right deltoid without any incident.  Within minutes after giving the HPV she stated she felt dizzy, I told her to lie down, as she was lying down with her eyes still open they began to flicker and her entire arms did a mild tremor.   I continued talking to her during the tremors, asking her to pick up her legs to place them on the table because they were dangling at the end of the exam table and she followed instructions but was not verbal during that short time.   The tremors lasted approximately 5 - 7 seconds.  After the tremors,  I asked if she was alright she stated "yes."   She continued to answer questions and be appropriate.  I kept her lying down for about 5 min. while carrying on a conversation then sat her up.  Her heart rate was in the 70's, her color was good and she was not diaphoretic.   She sat on the exam table for another 5 min. before standing.  She was able to ambulate without any difficulty and stated she felt fine.  The following day she went to school without any complaint.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: ERYTHEMATOUS PRURITIC MACULAR PAPULAR RASH ON LEFT FOREARM, RIGHT FOREARM AND DORSAL SURFACE OF LEFT FOOT.  RASH BEGAN TUESDAY EVEINING AFTER SHOT GIVEN EARLIER THAT DAY (10/12) SITE OF INJECTION COMPLETELY UNAFFECTED.  FREE OF RASH, SWELLING, ERYTHEMA OR INCREASED TEMPERATURE.  LEFT FOREAREM MOST PRURITIC-TREATED WITH TRAIMCINOLONE CREAM 0.1% BID SPARINGLY
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysgeusia, Injection site warmth, Paraesthesia
Clinical narrative: Patient received a flu shot at the at 1531 on 10/22/10.  She reported no problems at time of administration.  .5 ml of sanofi pasteur Fluzone injection was administered in the deltoid muscle of the Left arm with a 23 X 1 inch needle attached to a sterilized syringe.  She reported no problems and demonstrated no reaction symptoms at time of administration.  At 1609 she returned to the conference room stating that she was expirencing a "metal taste in my mouth".  She also stated that she felt "warm in the arm where I got the shot and my fingers are tingling".  Patient was encouraged to drink some cool water and sit with the nurse to further evaluate her.  She drank approximately 1/2 cup of water and stated "Im fine".  She was encouraged to call her primary care doctor to inform of the problem.  She also was informed to call 911 if she experinced any further problems.  She expressed understanding and returned to work.  On 10/23/10 at 0845 I called her home number to check with her and left an answering machine message for patient to call the nurse.  At 1156 on 10/23/10 patient returned the nurses phone call.  Patient stated that she had called her primary care doctor and informed him of her condition.  She stated that he told her there were no tests available to determine if she was indeed having a reaction to the injection.  She stated that he told her if her symptoms worsen or change that she should go to the emergency room at the hospital.  The nurse restated the doctors instructions and patient again expressed understanding.  She also stated that she had researched this injection on the internet and would never again receive a flu injection.  On 10/25/10 the nurse left a message at patient's home number for patient to call if she was still having problems.  At 1423 on 10/25/10 patient phoned the nurse.  Patient explained that she was still feeling warmth in her left arm and she was also having "chest pain".  The nurse told patient that if she is having chest pain she needs to call 911 or go to the emergency room immediately.  Patient explained "I just don't have time this week to go".  Patient was again encouraged to call 911 or go to the emergency room by the nurse.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: child had fever 103, lethargy, and stomach symptoms (nausea/vomiting)
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal discomfort, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: child had fever of 101, lethargy, and stomach symptoms (nausea/vomiting)
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, No reaction on previous exposure to drug
Clinical narrative: Patient received influenza vaccine 10/7/2010.  Patient has not had problems with prior influenza vaccines.  He presented to the ER on 10/14/2010 for gradual LUE numbness and weakness after receiving the shot.  Patient is still being monitored for this reaction as it has not subsided.  Differential from MD include:  ulnar neuropathy after influenza immunization question of adverse reaction to influenza vs technique vs idiopathic reaction.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Headache, Urticaria
Clinical narrative: Headache, flashing, dizziness, hives on neck, face and back. Taking Benadryl.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Ocular hyperaemia, Swelling
Clinical narrative: C/O EYE RED, SWELLING
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Nasal congestion, Ocular hyperaemia, Pyrexia
Clinical narrative: EYE RED SWELLING, STUFFY NOSE, FEVER
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nasal congestion, Nasal discomfort, Pain
Clinical narrative: Sore nose and stuffiness followed by extreme fatigue, achiness and headaches.  Axtually, the headaches started 10/20/2010.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Patient stated she felt hot at injection site. RN (self) felt site-very hot,  slight swelling. No redness No difficulty breathing. Placed ice at site, took Claritin 10mg. BP and HR taken, with in normal limits. Observed for 30min. Swelling decreased. Site cool to touch (due to ice at site). No redness, difficulty breathing, rash, increase heart rate or RR rate.  Instructed to go to ER if any swelling, redness, rash, throat swelling, increase heart rate, difficulty breathing or other concerns later. At end of time She stated in past when getting flu vaccine at day time, that  night site became hot. Instructed in future to inform provider of this reaction prior to getting future vaccines.
Age: 4.0
Sex: F
Vaccine: FLUN3, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Pain, Pain in extremity
Clinical narrative: Extreme pain in legs when walking or moving legs.  Child could only shuffle feet or waddle.  Expressed pain when knees were slightly bent.  Mild elevated temperature of 100 after acetaminophen.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Blurred Vision right eye no pain
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Convulsion, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever and seizure
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Fever and seizure
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal discomfort, Asthenia, Blood pressure systolic increased, Cough, Dizziness
Clinical narrative: New onset of persistent cough, throat tightening, nausea, felt sick to my stomach, heart rate 100, usually 60, SBP 124, usually in the 90's.  Flushed face, bloodshot eyes, dizziness and weak. I told employee health nurse, same one who administered the vaccine and she took my vitals signs, but didn't readily admit it was a reaction and suggested I was anxious and had caught a cold, and could be from asthma and I repeatedly told her I do not have asthma, nor does anyone in my family.  I was very happy in the morning and had no reason for anxiety.  I also felt perfectly healthy in the morning. The coughing was strong and throat tightness for the first 1-2 hours and I was afraid it would get worse.  Thankfully around 3 pm the coughing lessened, but the dizziness got worse.  I had a reaction to the live H1N1 vaccine in 2009 and had the dizzy symptoms for 5 days, but never before in my life have I had my throat tighten.  I have had strep throat many times and it hurt, but never tightened.  I had one of the doctors examine my throat and he said there was no swelling and heard no wheezing when he listened to my lungs. The next day when I woke up I no longer had symptoms.  I notitifed employee health.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Flushing, Heart rate increased, Nausea, Ocular hyperaemia, Throat tightness
Clinical narrative: New onset of persistent cough, throat tightening, nausea, felt sick to my stomach, heart rate 100, usually 60, SBP 124, usually in the 90's.  Flushed face, bloodshot eyes, dizziness and weak. I told employee health nurse, same one who administered the vaccine and she took my vitals signs, but didn't readily admit it was a reaction and suggested I was anxious and had caught a cold, and could be from asthma and I repeatedly told her I do not have asthma, nor does anyone in my family.  I was very happy in the morning and had no reason for anxiety.  I also felt perfectly healthy in the morning. The coughing was strong and throat tightness for the first 1-2 hours and I was afraid it would get worse.  Thankfully around 3 pm the coughing lessened, but the dizziness got worse.  I had a reaction to the live H1N1 vaccine in 2009 and had the dizzy symptoms for 5 days, but never before in my life have I had my throat tighten.  I have had strep throat many times and it hurt, but never tightened.  I had one of the doctors examine my throat and he said there was no swelling and heard no wheezing when he listened to my lungs. The next day when I woke up I no longer had symptoms.  I notitifed employee health.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Nausea, Throat tightness
Clinical narrative: New onset of persistent cough, throat tightening, nausea, felt sick to my stomach, heart rate 100, usually 60, SBP 124, usually in the 90's.  Flushed face, bloodshot eyes, dizziness and weak. I told employee health nurse, same one who administered the vaccine and she took my vitals signs, but didn't readily admit it was a reaction and suggested I was anxious and had caught a cold, and could be from asthma and I repeatedly told her I do not have asthma, nor does anyone in my family.  I was very happy in the morning and had no reason for anxiety.  I also felt perfectly healthy in the morning. The coughing was strong and throat tightness for the first 1-2 hours and I was afraid it would get worse.  Thankfully around 3 pm the coughing lessened, but the dizziness got worse.  I had a reaction to the live H1N1 vaccine in 2009 and had the dizzy symptoms for 5 days, but never before in my life have I had my throat tighten.  I have had strep throat many times and it hurt, but never tightened.  I had one of the doctors examine my throat and he said there was no swelling and heard no wheezing when he listened to my lungs. The next day when I woke up I no longer had symptoms.  I notitifed employee health.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Fluzone Vaccine administered Left deltoid. The next day, patient had pain, swelling, and itch below the injection site which increased the following day. Pt came to MD on 10/25/10 and parent claims it has improved slightly.  Site below injection site reddened, warm to touch, blanching and NT.  Patient's parents instructed to apply cool compresses, and return to clinic if no improvement in 2-3 days.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Fluzone Vaccine administered Left deltoid. The next day, patient had pain, swelling, and itch below the injection site which increased the following day. Pt came to MD on 10/25/10 and parent claims it has improved slightly.  Site below injection site reddened, warm to touch, blanching and NT.  Patient's parents instructed to apply cool compresses, and return to clinic if no improvement in 2-3 days.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over body.  Treated with OTC Benadryl.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Syncope, Vomiting
Clinical narrative: Received Flumist morning of 10/21/10. Evening of 10/23 vomiting started.  Appeared better next morning, but more vomiting after awake a few hours. Appeared better 10/25 so went to school. After school at home pt. collapsed & fell for no apparent reason. Mom says no loss of consciousness. Vomiting again that evening. No fever, no lethargy. No one else in family ill. Able to eat some and drink. Kept home from school 10/26 with no vomiting as of 2PM. Mother made doctor appointment for 11/3.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pain in right arm, referring to hand
Age: 0.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Wrong drug administered
Clinical narrative: Adult Boostrix given istead Pediarix/Tripedia
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Red pin point rash area at injection site about the size of a tennis ball and it is larger then yesterday. Patient went to go see her Dr. and he informed her to taking Advil or Tylenol and also take Benadryl at night and also gave the patient a perscription for steroid. The Dr. also told her to never again to get the flu shot again or it could be fatal.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, with stools 4-5 x per day - loose & watery. No fever, vomiting, or weight loss. This started the day after her flu shot and has continued for 3 weeks. Will try LACTINEX, avoiding milk products, & following BRAT diet will order stool studies if diarrhea persists.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Pt daughter described "breathing difficulties" approx 4 hours after vaccine was administered.
Sex: U
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient returned to pharmacy about an hr later w/chief complaint of redness. Her arm did not present w/a severe redness.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pt noticed increasing pain in (L) arm after vaccination on 10/21/10, also pt describes increasing fatigue & chills then body aches. Pt states she had a temp of 102: (L) arm began to swell & become warm to touch, which then extended to (L) neck, shoulder blade, & back.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Oedema peripheral, Pain, Pain in extremity, Skin warm
Clinical narrative: Pt noticed increasing pain in (L) arm after vaccination on 10/21/10, also pt describes increasing fatigue & chills then body aches. Pt states she had a temp of 102: (L) arm began to swell & become warm to touch, which then extended to (L) neck, shoulder blade, & back.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Electrolyte imbalance, Endotracheal intubation, Loss of consciousness
Clinical narrative: Felt ill after injections (within minutes). He continued to be ill next day.  He presented to hospital ER in respiratory failure - he was intubated. Rhabdomyolysis, acute renal failure, fever unconscious.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Pyrexia, Renal failure acute, Respiratory failure, Rhabdomyolysis
Clinical narrative: Felt ill after injections (within minutes). He continued to be ill next day.  He presented to hospital ER in respiratory failure - he was intubated. Rhabdomyolysis, acute renal failure, fever unconscious.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Adverse event, Intensive care
Clinical narrative: Felt ill after injections (within minutes). He continued to be ill next day.  He presented to hospital ER in respiratory failure - he was intubated. Rhabdomyolysis, acute renal failure, fever unconscious.
Age: 88.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Rash generalised
Clinical narrative: Severe rash all over body. Arm where vaccine give red, swollen down to hand all happened w/in 24 hours after injection.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Hypoaesthesia, Throat irritation, Urticaria
Clinical narrative: Post vaccination - c/o numbness & pain (L) lower back, chills, itchiness in throat, hives. Epinephrine administered x 1. 911 activated - transported to hospital.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Endotracheal intubation, Intensive care, Respiratory distress, Respiratory failure
Clinical narrative: Seizure, resp. distress -> failure intubation - hospitalized at PICU 10/22/10.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash-arms, neck, face, legs, back.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: (R) arm became red and had welts - itchy. Took BENADRYL PO. & redness reduced.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen, left arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Woke up this morning & noticed redness & soreness to Lt upper arm (deltoid - injection site) (area 68mm W x 60mm L). Area warm to touch & slightly swollen. Patient reports she had a red area last year with flu shot but did not come back to have it looked at.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Pt given Flu Vaccine High Dose 65+ at 1033; pt's wife called at 1544 stating pt c/o difficulty breathing; advised ER for evaluation; spoke with pt's wife on 10/26 at 428 pm, pt recovered without tx.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Severe redness & irritation at site of injection, swelling from shoulder to elbow, heat noticed, about 15 cm. temp of 101.4 - severe headache, malaise.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Severe redness & irritation at site of injection, swelling from shoulder to elbow, heat noticed, about 15 cm. temp of 101.4 - severe headache, malaise.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash papular
Clinical narrative: Fine, papular rash to trunk, extremities, face & head.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Fatigue, Irritability, Pain, Screaming
Clinical narrative: Within 3 hours -> fatigue/pain/crying/lack focus on parents/fussy for 1 week/high pitched scream.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling, Vomiting
Clinical narrative: Vomiting, redness, swelling to area.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: RASH/HIVES
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Laboratory test abnormal
Clinical narrative: Shingles diagnosis
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: AREA SWOLLEN- QUARTER SIZED. WARM TO TOUCH, HARD TO TOUCH. NO RASH, NO ITCH.
Age: 1.71
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling at site of injection-red, swollen, hard, painful.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt began with redness, warmth, and swelling to right arm when Pneumonia vaccine was admin- lasted for 4 days, slowly improved each day
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Pain in extremity
Clinical narrative: Patient states that he had pain on his left arm. Per patient, he walk in 10/19 w/ c/o pain on left arm d/t cheratussin medication. RN did not note that its due from the flu vaccine received 10/18.
Age: 12.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Chest pain, Rash
Clinical narrative: Rash, chest pain
Age: 12.0
Sex: F
Vaccine: FLUN3, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Red Swollen area approximately 4.5 x 3.5 in size. Warm compresses to area. No other treatment.
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site urticaria
Clinical narrative: 2 IN BY 3 IN WELT AROUND INJECTION SITE, RIGHT DELTOID
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: 2 IN BY 3 IN WELT AROUND INJECTION SITE, RIGHT DELTOID
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Lip oedema, Nausea, Pruritus, Vomiting
Clinical narrative: Patient return back to Flu Clinic and reported she started to itch and felt nausea. Starching herself on the chest, arms, and to chin area. NP quickly assess patient and patient given Benadryl 50 mg, PO. Observed patient and patient emesis approximately 20 ml with Benadryl noted. 13:48 patient given Benadryl 75mg, IM, Right Deltoid. Patient felt better after "throwing up." 13:49 airway patent. No stridor, no wheezing noted. Breath sounds are clear. 14:02 patient feeling better. Itching decrease and lip edema decrease. Airway Patent, no stridor, no wheezing noted. No rash noted. Patient escorted home with d/c instruction. Patient verbalized understanding to the instruction.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Fever of 101 and higher with vomiting and dizziness.  Given Children's Tylenol and fever dropped slightly, but not completely.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Rash
Clinical narrative: My right shoulder (near vaccination site) started hurting the next day and still does 4 days later. Last night, I broke out in a bilateral upper extremity and back rash. I saw my MD who prescribed corticosteroid cream and an antihistamine. Rash is improving now.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Syncope, Urinary incontinence
Clinical narrative: Patient fainted, his skin turned very pale and he urinated on himself.  Paramedics were called, they took vitals and said he was fine now but should take it easy for the next few hours.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Started running fever and had aches approx. 12:00am until approx. 10am next day. Also had nausea all next day.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Chills, Fatigue, Gait disturbance, Urticaria
Clinical narrative: Developed urticarial rash, spread throughout day.  Also developed chills.  Developed knee pain and limp.  Developed fatigue.  Most impressive was the rash, which was diffuse and spreading throughout the day.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Malaise, Nausea
Clinical narrative: Felt very ill - shivering a lot and could not eat or even want to talk felt so bilious!!!!!
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: 6 year old daughter's deltoid started to swell and was red and hot to the touch.  Gave Benadryl but next morning shoulder is still swollen.  Have given her Benadryl during the day but still swollen on 2nd day.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: Patient reported that her right hand has a painful rash.  Told her if it was an allergic reaction Benadryl will help, but reccommended she contact her Dr for treatment.  Also recommended she go to the ER if the reaction progresses including any swelling of the lips, tongue, or throat or difficulty breathing.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Migraine, Pyrexia
Clinical narrative: 101 degree fever difficulty breathing joint pains (all joints) migraine
Age: 43.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: lethargy muscle aches febrile 103.0 temp
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Swelling
Clinical narrative: Pt reported redness and swelling that was descending down the (R) arm, still present 3 days after administration. General malaise/ill feeling. Tx doxycycline x 10 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Pain
Clinical narrative: Numbness radiating into the hand & up into neck. Numbness to pain to sick.
Age: 1.52
Sex: M
Vaccine: HIBV
Symptoms: Computerised tomogram normal, Gait disturbance, Nuclear magnetic resonance imaging normal, Sensorimotor disorder, Tremor
Clinical narrative: Child seen for WCC on 9/23/10 - received HIB vaccines in rt arm. More shots the next day. Child stood - then started walking uncharacteristic wide-based gate. Took to ER - was cold was fine - seen in clinic 9/26/10 - Child observed to have difficulty walking. Seen 10/26/10 child not walking - started shaking upon walking. No hypotonia in both upper extremities. Motor regression to crawling. Referred to neurology - MRI negative -
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm sore day after vaccination increasing soreness 10/24 and 10/25 "so sore cannot life up". 10-26-10 same (no worse), no fever no other sore areas, no redness, no swelling.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Blood glucose normal, Chills, Dyskinesia, Fall, Feeling cold
Clinical narrative: Client received HEP A, HEP B, TDAP. Immediately after TDAP she leaned over in chair and fell on floor. Began seizure like movement for approx. 1 min and began to hyperventilate. Stopped jerking movement and began shivering after c/o being cold. Breathing returned to normal and client able to communicate normally. EMS arrived and transported to ER. Client returned approx 2 hrs later ambulatory and without any effects from earlier episode. States ER physician stated that it was not likely a reaction from vaccine, but a fainting episode.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Hyperventilation, Immediate post-injection reaction, Movement disorder, Syncope
Clinical narrative: Client received HEP A, HEP B, TDAP. Immediately after TDAP she leaned over in chair and fell on floor. Began seizure like movement for approx. 1 min and began to hyperventilate. Stopped jerking movement and began shivering after c/o being cold. Breathing returned to normal and client able to communicate normally. EMS arrived and transported to ER. Client returned approx 2 hrs later ambulatory and without any effects from earlier episode. States ER physician stated that it was not likely a reaction from vaccine, but a fainting episode.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Full blood count, Hypophagia, Lethargy, Pyrexia, Streptococcus test
Clinical narrative: 12 hrs after DTAP, Flu, HIB, Pneumococcal developed fever, 102, relative lethargy, decreased po intake. Temp fluctuating past 5 days still temp 103 at peak no nausea vomiting.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: 10/26/10 body aches especially both hip joints, front of thigh "feels like I ran all day"; also c/o slight headache - feel high "without really being high 4pm - employee feels much better.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abasia, Injection site swelling
Clinical narrative: Pt had (L) thigh swelling. No warmth, no redness. Pt unable to walk. Spoke with MOC pt recovered next day.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Oedema peripheral, Oropharyngeal pain, Pain
Clinical narrative: (L) arm 4 inch across swelling & redness. H/A body aches, sore throat.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Carcinoma in situ, Colposcopy, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 08-JAN-2010, a 23 year old female patient with no pertinent medical history was vaccinated with the third dose of GARDASIL (Lot # 659054/0311Y) intramuscularly into her left arm. It was reported that the patient was HPV (+), Type 16. PAP test was negative on 17-JUN-2009 and on 06-AUG-2010, PAP  test showed "carcinoma in situ". On 17-AUG-2010, a colposcopy with biopsies was performed and on 16-SEP-2010, a surgery was scheduled. The following information was obtained through follow up and/or provided by the government. On 02-SEP-2010, the primary care physician received the office records and laboratory diagnostics for dates of service 17-AUG-2009 to 02-SEP-2010. The patient was seen by her primary care physician for routine PAP, pelvic and breast exam. Thin prep PAP was abnormal and the colposcopy done revealed carcinoma in situ. The patient was scheduled for surgery on 16-SEP-2010. At the time of the report, the outcome of the patient was not reported. Carcinoma in situ and papilloma viral infection were considered immediately life threatening. The original reporting source was not provided. The VAERS ID # is 397085. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 08-JAN-2010, a 23 year old female patient with no pertinent medical history was vaccinated with the third dose of GARDASIL (Lot # 659054/0311Y) intramuscularly into her left arm. It was reported that the patient was HPV (+), Type 16. PAP test was negative on 17-JUN-2009 and on 06-AUG-2010, PAP  test showed "carcinoma in situ". On 17-AUG-2010, a colposcopy with biopsies was performed and on 16-SEP-2010, a surgery was scheduled. The following information was obtained through follow up and/or provided by the government. On 02-SEP-2010, the primary care physician received the office records and laboratory diagnostics for dates of service 17-AUG-2009 to 02-SEP-2010. The patient was seen by her primary care physician for routine PAP, pelvic and breast exam. Thin prep PAP was abnormal and the colposcopy done revealed carcinoma in situ. The patient was scheduled for surgery on 16-SEP-2010. At the time of the report, the outcome of the patient was not reported. Carcinoma in situ and papilloma viral infection were considered immediately life threatening. The original reporting source was not provided. The VAERS ID # is 397085. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy site unspecified abnormal, Carcinoma in situ, Colposcopy abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 08-JAN-2010, a 23 year old female patient with no pertinent medical history was vaccinated with the third dose of GARDASIL (Lot # 659054/0311Y) intramuscularly into her left arm. It was reported that the patient was HPV (+), Type 16. PAP test was negative on 17-JUN-2009 and on 06-AUG-2010, PAP  test showed "carcinoma in situ". On 17-AUG-2010, a colposcopy with biopsies was performed and on 16-SEP-2010, a surgery was scheduled. The following information was obtained through follow up and/or provided by the government. On 02-SEP-2010, the primary care physician received the office records and laboratory diagnostics for dates of service 17-AUG-2009 to 02-SEP-2010. The patient was seen by her primary care physician for routine PAP, pelvic and breast exam. Thin prep PAP was abnormal and the colposcopy done revealed carcinoma in situ. The patient was scheduled for surgery on 16-SEP-2010. At the time of the report, the outcome of the patient was not reported. Carcinoma in situ and papilloma viral infection were considered immediately life threatening. The original reporting source was not provided. The VAERS ID # is 397085. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Flu shot administered 9/4/10. On 9/24/10 client became completely paralyzed and dizzy. Rushed to hospital diagnosed with Guillain Barre Syndrome.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Guillain-Barre syndrome, Paralysis
Clinical narrative: Flu shot administered 9/4/10. On 9/24/10 client became completely paralyzed and dizzy. Rushed to hospital diagnosed with Guillain Barre Syndrome.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test, Cardiac stress test, Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Flu shot administered 9/4/10. On 9/24/10 client became completely paralyzed and dizzy. Rushed to hospital diagnosed with Guillain Barre Syndrome.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Flu shot administered 9/4/10. On 9/24/10 client became completely paralyzed and dizzy. Rushed to hospital diagnosed with Guillain Barre Syndrome.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Back pain, Catheterisation cardiac normal, Condition aggravated, Dizziness postural, Electromyogram abnormal
Clinical narrative: Pt received flu vaccine on 9/23/10. On 9/28/10, pt seen in private hospital. Diagnosed with Guillain Barre Miller Fisher Type II. EMG + for Guillain Barre. 09/23/2010 ADDENDUM STATUS: COMPLETED Flu Shot FY11: Patient received flu shot at this encounter. Prior to receiving an influenza vaccination the patient was informed of the nature of the procedure, expected benefits, reasonably foreseeable associated risks, complications or side effects, and anticipated results if influenza vaccine is not given. During this encounter, the patient also received a copy of the most current CDC Vaccine Information Statement titled Inactivated influenza Vaccine 2010-11 (08/18/2010). The patient consented to the influenza vaccination. 0.5 ml IM Right Deltoid Lot Number: UH184AA Manufacturer: Sanofi Pasteur Expiration Date: 06/30/11 Tolerated well. Patient instructed to remain in area for 30 minutes after injection. 09/29/2010 ADDENDUM STATUS: COMPLETED Patient calling back to let PCP know that his chest congestion is getting worse again. Reports he is coughing up yellow sputum again. States he told PCP he thought he was thought he was getting better but now he feels like he is getting worse and PCP told him to call back and she would order ABX. He will call outpatient pharmacy later today to see if ABX has been ordered for pick up. 10/20/2010 ADDENDUM STATUS: COMPLETED received fax from hospital patient admitted in 9/2010 for back pain, noted similar to prior anginal equivalent w/prior mi cardiac cath done 9/29 lad 20-30% liminal irreg, patent lad stent from prior cath; distal lad w/3 lesions 60-70% stenotic, circumflex 30-35% narrowing, rca dominant 20% luminal irreg, preserved lv systolic function of 50-55% recs for medical management further eval of back pain w/ ct/bone scan unrevealing he had generalized weakness during admission and was seen by neuro, apparently he was unable to even get out of bed diagnosed w/guillan barre and given ivig treatment x 5 days seen by p.t. filed in paper chart influenza vaccine ade already entered in oprs.