chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Dizziness and mental fogginess within minutes of injection followed by extreme sharp pain in arm. Later fatigue and next day full flu symptoms sore throat congestion low grade fever achy pain cough stuffy the following day sick in bed right eye swollen plus headache congestion and full flu illness extreme fatigue with inability to concentrate.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Had a seizure.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Patient had seizure.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: States hives started next morning on 10/01/2014. Took 1 Benadryl and hives resolved some. Next morning 10/02/2014 more hives on back, legs, chest, arms, face and torso. 1 Benadryl taken and did not resolve the hives. Hives are itchy and moderate and covering body at time of report. She is going to her doctor immediately.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Localized reaction.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash erythematous, Rash pustular
Clinical narrative: Patient was given flu shot about 8:15 am. She then went to help a patient with breathing treatments in his room. She was masked and gloved.  When she came out of his room face was red pus bumps, itching on entire face but worse under mask. Today 10/03/2014 went into same persons room and came out red again, itching down arms. sent to ER.  Patient was given Solu Medrol in the ER.  We are thinking most likely a reaction to patients med he is getting instead of influenza shot. do to after talking with other staff when they are in patients room they start coughing, SOB, watery eyes. But because of also getting flu shot prior wanted to report.  Patients medication was a tube of Capsicum Oleoresine with 0.075% capsaicin.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Intense muscle pain that is still persistent 3 weeks after administration; treated with ibuprofen 800mg TID + IcyHot patch topically PRN.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Enlarged uvula, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Local tenderness, cough, sore throat, swelling of uvula, malaise, myalgia, fever up to 101.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tenderness
Clinical narrative: Local tenderness, cough, sore throat, swelling of uvula, malaise, myalgia, fever up to 101.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Autopsy, Cardiac arrest, Death, Irritability, Respiratory arrest
Clinical narrative: Was at daycare - had taken nap/aroused fussy - consoled/but then noted not breathing 911 - to ER/dx with cardiac arrest ELLD.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Aches, fever.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: On 9/23 patient came in the pharmacy and complained of pain and brusing at the injection site. I asked her to talked to her MD.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Severe erythema in the left arm (injection arm), complicated with blisters and heat.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Pt developed redness around her left deltoid area that was red, warm to touch, no streaking. Doctor stated it was possible cellulitis. Started Cephalexin 500mg BID x10. Nurse administered Pneumovax23 in same arm as influenza vaccine in the afternoon after the influenza shot (Pharmacy) 9/29/2014. Severe pain which affected ADL's with left arm.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Injection site swelling, Mobility decreased
Clinical narrative: I experienced pain and swelling of the area surrounding the injection site within two hours of the injection on 10/01/2014.  The pain and swelling have continued until now.  Then, last night, I woke up with severe shooting nerve pain in the shoulder where I received the injection, as well as up through my neck and upper back on the side of the injection (my left).  The pain is so severe that it's difficult to get up and move around, and I have stayed home in bed to keep my head, neck and shoulder as still as possible to avoid the shooting pain.  The shoulder still has the sore, hard lump where the flu vaccine was administered.   Please let me know what I should do, I contacted the health clinic at school where I got the shot and they were unable to help me.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Neuralgia
Clinical narrative: I experienced pain and swelling of the area surrounding the injection site within two hours of the injection on 10/01/2014.  The pain and swelling have continued until now.  Then, last night, I woke up with severe shooting nerve pain in the shoulder where I received the injection, as well as up through my neck and upper back on the side of the injection (my left).  The pain is so severe that it's difficult to get up and move around, and I have stayed home in bed to keep my head, neck and shoulder as still as possible to avoid the shooting pain.  The shoulder still has the sore, hard lump where the flu vaccine was administered.   Please let me know what I should do, I contacted the health clinic at school where I got the shot and they were unable to help me.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness 50mm in diameter pain on touch. No treatment.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Bald spot on head. Alopecia aereata. No treatment.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction, Swelling
Clinical narrative: Immediate swelling, bruising.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood creatine phosphokinase, Full blood count, Mobility decreased, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Right calf pain, unable to extend leg or bear weight on right leg.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Weight bearing difficulty
Clinical narrative: Right calf pain, unable to extend leg or bear weight on right leg.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Big red itchy patch, approx. 6"x3" which continued to today, Oct. 3, 2014. No treatment.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Head titubation, Heart rate increased, Tremor, Vomiting
Clinical narrative: Vomiting, shortness of breath, fast heartbeat, leg, hands and head tremors.
Age: 68.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Dysphonia, Fatigue, Headache, Musculoskeletal pain, Pain
Clinical narrative: Extreme shoulder pain, hoarseness, fever, aches, headache, itching, fatigue. Fifth day.
Age: 68.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Pruritus, Pyrexia
Clinical narrative: Extreme shoulder pain, hoarseness, fever, aches, headache, itching, fatigue. Fifth day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash to chest, breast, and neck. Hives.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: fever to 102
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, HIBV
Symptoms: CSF glucose normal, CSF protein increased, Dyspnoea, Full blood count normal, Gait disturbance
Clinical narrative: Leg weakness, unsteady gait. Ascending paralysis with difficulty breathing and holding up head. Given IVIG with some clinical improvement most notably with improved respiratory effort.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, HIBV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Posture abnormal
Clinical narrative: Leg weakness, unsteady gait. Ascending paralysis with difficulty breathing and holding up head. Given IVIG with some clinical improvement most notably with improved respiratory effort.
Age: 26.0
Sex: F
Vaccine: MEN
Symptoms: Chest discomfort, Dyspnoea, Injection site swelling, Injection site warmth
Clinical narrative: Shortness of breath, chest tightness, and injection site reaction warm to touch with swelling.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: loss of consciousness
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Dyspnoea, Ear pain, Eye pain
Clinical narrative: Sharp pain - right side of head; right eye, ear, neck and shoulder pain, shortness of breath, intermittent fevers, chills.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Neck pain, Pyrexia
Clinical narrative: Sharp pain - right side of head; right eye, ear, neck and shoulder pain, shortness of breath, intermittent fevers, chills.
Age: 1.27
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: DEVELOPED CHICKENPOX AT SAME TIME WITH MOTHER.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 4-5 inches of marked redness, swelling and warm to touch. Treatment:  Benadryl and Ibuprofen.
Age: 20.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Confusional state, Convulsion, Electrocardiogram normal, Fall, Feeling hot
Clinical narrative: Patient had received 3 injections, influenza, Hep A, and Hep B.  He was standing while receiving the injections.  Immediately following the Hep B injection, he passed out and fell to the floor, hit his head on a chair leg, and convulsed for about 5 seconds.  Patient awoke with confusion and was directed to sit in a chair.  He reported no memory of the event, feeling very unwell and hot, and was sweaty and pale.  His BP at 11:30 was 92/58 and HR 58bpm.  Patient did not have any difficulty breathing or hives.  No epinephrine was administered.  EMS responded at appx 11:40 AM.  His BP was within normal range.  He was given an EKG, results within normal range.  His HR remained appx 58 bpm, patient is in good cardiovascular condition.  EMS suspected the reaction was a vasovagal response.  Patient's father was present immediately following the episode and transported him to the clinic.
Age: 20.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Head injury, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: Patient had received 3 injections, influenza, Hep A, and Hep B.  He was standing while receiving the injections.  Immediately following the Hep B injection, he passed out and fell to the floor, hit his head on a chair leg, and convulsed for about 5 seconds.  Patient awoke with confusion and was directed to sit in a chair.  He reported no memory of the event, feeling very unwell and hot, and was sweaty and pale.  His BP at 11:30 was 92/58 and HR 58bpm.  Patient did not have any difficulty breathing or hives.  No epinephrine was administered.  EMS responded at appx 11:40 AM.  His BP was within normal range.  He was given an EKG, results within normal range.  His HR remained appx 58 bpm, patient is in good cardiovascular condition.  EMS suspected the reaction was a vasovagal response.  Patient's father was present immediately following the episode and transported him to the clinic.
Age: 20.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Pallor, Presyncope
Clinical narrative: Patient had received 3 injections, influenza, Hep A, and Hep B.  He was standing while receiving the injections.  Immediately following the Hep B injection, he passed out and fell to the floor, hit his head on a chair leg, and convulsed for about 5 seconds.  Patient awoke with confusion and was directed to sit in a chair.  He reported no memory of the event, feeling very unwell and hot, and was sweaty and pale.  His BP at 11:30 was 92/58 and HR 58bpm.  Patient did not have any difficulty breathing or hives.  No epinephrine was administered.  EMS responded at appx 11:40 AM.  His BP was within normal range.  He was given an EKG, results within normal range.  His HR remained appx 58 bpm, patient is in good cardiovascular condition.  EMS suspected the reaction was a vasovagal response.  Patient's father was present immediately following the episode and transported him to the clinic.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Immunization was given at an employee flu shot clinic. Was given very high up on left arm, almost at shoulder joint. Arm and shoulder began to ache 10-12 hrs after shot which I assumed was normal tenderness experienced after this immunization. However over the next few days the tenderness in the arm resolved but the shoulder joint pain persisted, making moving the joint difficult. Pain is relieved by taking 800 mg ibuprofen, but reoccurs 5-6 hrs after taking dose. On 9/29/14 I reported the above to the facility's occupational health nurse who sent me to the facility's occupational health clinic on 10/3/14. The doctor did not prescribe any treatment, stated pain was not due to the immunization and declined to file a VAERS report. At this time, I am still experiencing the shoulder pain which is temporarily relieved by 800 mg ibuprofen.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Immunization was given at an employee flu shot clinic. Was given very high up on left arm, almost at shoulder joint. Arm and shoulder began to ache 10-12 hrs after shot which I assumed was normal tenderness experienced after this immunization. However over the next few days the tenderness in the arm resolved but the shoulder joint pain persisted, making moving the joint difficult. Pain is relieved by taking 800 mg ibuprofen, but reoccurs 5-6 hrs after taking dose. On 9/29/14 I reported the above to the facility's occupational health nurse who sent me to the facility's occupational health clinic on 10/3/14. The doctor did not prescribe any treatment, stated pain was not due to the immunization and declined to file a VAERS report. At this time, I am still experiencing the shoulder pain which is temporarily relieved by 800 mg ibuprofen.
Age: 49.0
Sex: F
Vaccine: FLU4, YF
Symptoms: Arthropathy, Back pain, Fatigue, Hyperhidrosis, Joint swelling
Clinical narrative: She woke August 24, the morning after her YF shot, drenched and achy. Assumed it would go away but a few days later had back pain "It locked" and then developed problems in her knees, first one and then the other. Continued to have various problems with her knees and started to feel very tired,"Drained" and both knees swelled. She tried OTC meds and cold packs, etc, as she is a runner and treats herself frequently for such things and didn't think it would last. She just muscled through because she has children and is very busy, but realized today that it all started after YF shot almost 6 weeks ago. Knee swelling and other sx are a little better and not gone. Has not sought any medical help.
Age: 49.0
Sex: F
Vaccine: FLU4, YF
Symptoms: Mobility decreased, Pain
Clinical narrative: She woke August 24, the morning after her YF shot, drenched and achy. Assumed it would go away but a few days later had back pain "It locked" and then developed problems in her knees, first one and then the other. Continued to have various problems with her knees and started to feel very tired,"Drained" and both knees swelled. She tried OTC meds and cold packs, etc, as she is a runner and treats herself frequently for such things and didn't think it would last. She just muscled through because she has children and is very busy, but realized today that it all started after YF shot almost 6 weeks ago. Knee swelling and other sx are a little better and not gone. Has not sought any medical help.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site nodule, Pain, Skin discolouration
Clinical narrative: Immediately after the vaccine was administered, the patient's arm turned blue and purple. The discoloration spread and did not improve over the following 2 days. A knot formed under the skin where the injection entered the arm. There was also prolonged pain associated with the injection.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Urticaria
Clinical narrative: HIVES, BURNING TO FACE AND NECK.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Body temperature, Gait disturbance, Injected limb mobility decreased, Injection site pain
Clinical narrative: My body ached all over--from my feet to my head. Shoulder where vaccine was hurt the worst couldn't even raise my arm. I was so weak could hardly walk.  I had mild temp and was nauseated.  I laid in bed from 10:30 pm until 8:00 am moaning and groaning because I hurt so bad.  At approx. 2:00 pm 10/3/2014 I was able to sit up and move around more.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Moaning, Nausea, Pain
Clinical narrative: My body ached all over--from my feet to my head. Shoulder where vaccine was hurt the worst couldn't even raise my arm. I was so weak could hardly walk.  I had mild temp and was nauseated.  I laid in bed from 10:30 pm until 8:00 am moaning and groaning because I hurt so bad.  At approx. 2:00 pm 10/3/2014 I was able to sit up and move around more.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram, Head discomfort, Headache, Heart rate increased, Paraesthesia
Clinical narrative: About 5 minutes after the shot I felt a quick moving tingling sensation near site of shot, which was the left arm, then the sensation radiated up and down the same arm and then up to my neck. It then radiated to my left side near my back and stayed there. My heart beat was a little fast and my head began to feel overtly heavy but not dizzy. After an hour symptoms subsided and I was left with a very bad headache.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Headache developed that night, and again the next night. Dizziness began mid-morning 10/03, followed by nausea and vomiting. Dizziness persists at 3pm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Urticaria
Clinical narrative: Approximately 7 days after receiving flu vaccine, patient presents with few hive resembling spots on her lower back. Primary care physician subsequently diagnosed as shingles.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain numbness began in fingers and progressed to forearms/upper arms over next several weeks.  Numbness also occurred I legs and lasted weeks after.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Flushing, Headache, Nausea
Clinical narrative: Nausea occurred around 30 minutes post vaccine. Then headache, dizziness,raised red area, flushed face. Given Prednisone
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Nausea occurred around 30 minutes post vaccine. Then headache, dizziness,raised red area, flushed face. Given Prednisone
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Injection site pain, Insomnia, Myalgia
Clinical narrative: Started with site of shot getting really sore, followed by general muscle and body aches everywhere, followed by (presumed) fever, chills, and racing heartbeat, followed by nausea and sleeplessness, accompanied by extreme fatigue? Symptoms began lessoning by noon the next day.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: Started with site of shot getting really sore, followed by general muscle and body aches everywhere, followed by (presumed) fever, chills, and racing heartbeat, followed by nausea and sleeplessness, accompanied by extreme fatigue? Symptoms began lessoning by noon the next day.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Blepharospasm, Convulsion, Crying, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: High pitch crying uncontrollably. Fever of 102. Then seizure. Lasting 5 seconds. Same occurred three more times with a fever at 102, 101.9, 99.9 and 100 degree temperatures. Each one lasted 3-7 seconds. Eyes rolled and eye lids fluttered. Last seizure around 6:45am eyes remained open without blinking and no eye movement. Body started stiff as a board then convulsed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Pyrexia
Clinical narrative: High pitch crying uncontrollably. Fever of 102. Then seizure. Lasting 5 seconds. Same occurred three more times with a fever at 102, 101.9, 99.9 and 100 degree temperatures. Each one lasted 3-7 seconds. Eyes rolled and eye lids fluttered. Last seizure around 6:45am eyes remained open without blinking and no eye movement. Body started stiff as a board then convulsed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Excessive eye blinking, Injection site swelling, Irritability, Musculoskeletal stiffness, Pyrexia
Clinical narrative: High pitch crying uncontrollably. Fever of 102. Then seizure. Lasting 5 seconds. Same occurred three more times with a fever at 102, 101.9, 99.9 and 100 degree temperatures. Each one lasted 3-7 seconds. Eyes rolled and eye lids fluttered. Last seizure around 6:45am eyes remained open without blinking and no eye movement. Body started stiff as a board then convulsed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Screaming
Clinical narrative: High pitch crying uncontrollably. Fever of 102. Then seizure. Lasting 5 seconds. Same occurred three more times with a fever at 102, 101.9, 99.9 and 100 degree temperatures. Each one lasted 3-7 seconds. Eyes rolled and eye lids fluttered. Last seizure around 6:45am eyes remained open without blinking and no eye movement. Body started stiff as a board then convulsed.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Hypersensitivity, Paraesthesia, Swollen tongue
Clinical narrative: She started having dizziness, fatigue, tingling in arms and swollen tounge.  She went to ER was given steroids and benadryl was told was an allergic reaction to vaccine, never to have another.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed swelling, redness at injection site. Warm to touch. Also complains of headache, diarrhea. Self treated with alcohol.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling, Myalgia
Clinical narrative: Muscle aches started the afternoon of 9/27/14 then woke up in the middle of the night with a fever and muscle aches that had progressed from minor to severe, increased arm pain, and nickel-sized redness and swelling at the injection site.  I iced my shoulder area and took Tylenol every 4 hours but the fever would not break. The fever continued into Monday, 9/29/14, and the redness had more than doubled in size.  I went to urgent care, they diagnosed me with cellulitis, and put me on Keflex 500mg, 4 times a day for 10 days.  The swelling still persists with a large lump in the deltoid area.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Muscle aches started the afternoon of 9/27/14 then woke up in the middle of the night with a fever and muscle aches that had progressed from minor to severe, increased arm pain, and nickel-sized redness and swelling at the injection site.  I iced my shoulder area and took Tylenol every 4 hours but the fever would not break. The fever continued into Monday, 9/29/14, and the redness had more than doubled in size.  I went to urgent care, they diagnosed me with cellulitis, and put me on Keflex 500mg, 4 times a day for 10 days.  The swelling still persists with a large lump in the deltoid area.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling cold, Muscular weakness, Nausea, Tremor
Clinical narrative: Extreme coldness, violent uncontrollable shaking for three hours.  Muscle weakness has lasted, so far, through 5:50 on 10/03/2014.  Mild nausea continues along with extreme fatigue.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Red rash on most of my upper body with extreme itchiness.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed swollen, burning rash one inch below injection site. Rash is not to touch and painful when touched. Patient states it does not itch. Patient also developed headache night of vaccination.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache
Clinical narrative: Patient reported waking up with the worst headache she has ever had with chills. Years past patient stated she developed a slight headache and chills, but never anything like this.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Convulsion, Hypoglycaemia, Syncope
Clinical narrative: Hypoglycemic reaction with seizure and syncope
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Arm was read and warm. Patient was told to see her md and after calling her she said that she was given a course of antibiotics.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Induration, Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: Sudden fever of 103. Could not control with febrile drugs. Discomfort/pain in various extremities. Nausea.  Red, swollen ring around inj. site.  ITCHY and still itchy with hard bump.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Nausea, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Sudden fever of 103. Could not control with febrile drugs. Discomfort/pain in various extremities. Nausea.  Red, swollen ring around inj. site.  ITCHY and still itchy with hard bump.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Patient had Zostavax Immunization on 9/24, around 10 red bumps appeared on her legs on 10/2/2014  She applied benadryl cream to help with the itching.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient feels clammy, lightheaded, and has hot sweats.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Chills, Exposure to vaccinated person, Influenza, Pain
Clinical narrative: For the past three years I have noticed a pattern in my children; A display of sudden FLU symptoms such as: fever, body ache, weakness, chills when their classmates get the FLU MIST vaccine at school.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: For the past three years I have noticed a pattern in my children; A display of sudden FLU symptoms such as: fever, body ache, weakness, chills when their classmates get the FLU MIST vaccine at school.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: PATIENT COMPLAINING OF PAIN ONLEFT ARM. NO SWELLING AT INJECTION SITE. ONLY COMPLAINING OF MUSCLE PAIN.
Age: 26.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Allergy test, Dyspnoea, Lip swelling, Paraesthesia oral, Urticaria
Clinical narrative: Hives shortness of breath tingling on lips & swollen.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Affect lability, Arthralgia, Asthenia, Coordination abnormal, Decreased appetite
Clinical narrative: Dramatic facial swelling that persisted despite the use of Benadryl every 6 hours for 2-3 days.  Eyes were nearly swelled shut, red and watery.  Low energy and low appetite.  Fever of 103.5 on 10/10/2011.  Fever of 101.5 on 10/11/2011.  10/11/2011 - 10/12/2011 patient was clearly ill, moving slowly, very emotionaly labile.  He began clapping hands "tic" and vocal tic of "Hmm".  Began having trouble holding a pencil and writing.  He became uncoordinated- tripped and falling, bumping into things.  He complained of sudden, sharp, pain in knee, elbow, knuckle.  Hmm and clapping tics became more frequent 10/13/2011 - 10/16/2011.  A lot of movement, some movement appeared to be involuntary.  Movement stopped when he slept.  Low appetite but very high energy.  He complained of headache, neck pain, and that his left cheek felt "spacy".  He began describing sensations with colors.  10/18/2011- 10/21/2011 overflow movements, poor concentration and memory.  A few bouts of walking on his tip toes noticed both by parents and teacher at school.  Dragging of right leg when tired when walking or running.  A feeling of being "struck by lightening" in his chest.  In handwriting with new letter reversals.  Patient was given Cephalexin 250 mg/ 5 ml 4x/ day for 10 days on 10/13/2011.  Patient continued to experience hyperactivity, extra movements, emotional lability, sensory abnormalities, deteriorated fine motor skills for at least 7 months.  His handwriting has never fully recovered.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Disturbance in attention, Dyskinesia, Eyelid oedema, Fall, Feeling abnormal
Clinical narrative: Dramatic facial swelling that persisted despite the use of Benadryl every 6 hours for 2-3 days.  Eyes were nearly swelled shut, red and watery.  Low energy and low appetite.  Fever of 103.5 on 10/10/2011.  Fever of 101.5 on 10/11/2011.  10/11/2011 - 10/12/2011 patient was clearly ill, moving slowly, very emotionaly labile.  He began clapping hands "tic" and vocal tic of "Hmm".  Began having trouble holding a pencil and writing.  He became uncoordinated- tripped and falling, bumping into things.  He complained of sudden, sharp, pain in knee, elbow, knuckle.  Hmm and clapping tics became more frequent 10/13/2011 - 10/16/2011.  A lot of movement, some movement appeared to be involuntary.  Movement stopped when he slept.  Low appetite but very high energy.  He complained of headache, neck pain, and that his left cheek felt "spacy".  He began describing sensations with colors.  10/18/2011- 10/21/2011 overflow movements, poor concentration and memory.  A few bouts of walking on his tip toes noticed both by parents and teacher at school.  Dragging of right leg when tired when walking or running.  A feeling of being "struck by lightening" in his chest.  In handwriting with new letter reversals.  Patient was given Cephalexin 250 mg/ 5 ml 4x/ day for 10 days on 10/13/2011.  Patient continued to experience hyperactivity, extra movements, emotional lability, sensory abnormalities, deteriorated fine motor skills for at least 7 months.  His handwriting has never fully recovered.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Gait disturbance, Grip strength decreased, Headache, Lacrimation increased, Malaise
Clinical narrative: Dramatic facial swelling that persisted despite the use of Benadryl every 6 hours for 2-3 days.  Eyes were nearly swelled shut, red and watery.  Low energy and low appetite.  Fever of 103.5 on 10/10/2011.  Fever of 101.5 on 10/11/2011.  10/11/2011 - 10/12/2011 patient was clearly ill, moving slowly, very emotionaly labile.  He began clapping hands "tic" and vocal tic of "Hmm".  Began having trouble holding a pencil and writing.  He became uncoordinated- tripped and falling, bumping into things.  He complained of sudden, sharp, pain in knee, elbow, knuckle.  Hmm and clapping tics became more frequent 10/13/2011 - 10/16/2011.  A lot of movement, some movement appeared to be involuntary.  Movement stopped when he slept.  Low appetite but very high energy.  He complained of headache, neck pain, and that his left cheek felt "spacy".  He began describing sensations with colors.  10/18/2011- 10/21/2011 overflow movements, poor concentration and memory.  A few bouts of walking on his tip toes noticed both by parents and teacher at school.  Dragging of right leg when tired when walking or running.  A feeling of being "struck by lightening" in his chest.  In handwriting with new letter reversals.  Patient was given Cephalexin 250 mg/ 5 ml 4x/ day for 10 days on 10/13/2011.  Patient continued to experience hyperactivity, extra movements, emotional lability, sensory abnormalities, deteriorated fine motor skills for at least 7 months.  His handwriting has never fully recovered.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Memory impairment, Neck pain, Nuclear magnetic resonance imaging brain, Ocular hyperaemia, Pain in extremity
Clinical narrative: Dramatic facial swelling that persisted despite the use of Benadryl every 6 hours for 2-3 days.  Eyes were nearly swelled shut, red and watery.  Low energy and low appetite.  Fever of 103.5 on 10/10/2011.  Fever of 101.5 on 10/11/2011.  10/11/2011 - 10/12/2011 patient was clearly ill, moving slowly, very emotionaly labile.  He began clapping hands "tic" and vocal tic of "Hmm".  Began having trouble holding a pencil and writing.  He became uncoordinated- tripped and falling, bumping into things.  He complained of sudden, sharp, pain in knee, elbow, knuckle.  Hmm and clapping tics became more frequent 10/13/2011 - 10/16/2011.  A lot of movement, some movement appeared to be involuntary.  Movement stopped when he slept.  Low appetite but very high energy.  He complained of headache, neck pain, and that his left cheek felt "spacy".  He began describing sensations with colors.  10/18/2011- 10/21/2011 overflow movements, poor concentration and memory.  A few bouts of walking on his tip toes noticed both by parents and teacher at school.  Dragging of right leg when tired when walking or running.  A feeling of being "struck by lightening" in his chest.  In handwriting with new letter reversals.  Patient was given Cephalexin 250 mg/ 5 ml 4x/ day for 10 days on 10/13/2011.  Patient continued to experience hyperactivity, extra movements, emotional lability, sensory abnormalities, deteriorated fine motor skills for at least 7 months.  His handwriting has never fully recovered.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Psychomotor hyperactivity, Psychomotor skills impaired, Pyrexia, Swelling face, Tic
Clinical narrative: Dramatic facial swelling that persisted despite the use of Benadryl every 6 hours for 2-3 days.  Eyes were nearly swelled shut, red and watery.  Low energy and low appetite.  Fever of 103.5 on 10/10/2011.  Fever of 101.5 on 10/11/2011.  10/11/2011 - 10/12/2011 patient was clearly ill, moving slowly, very emotionaly labile.  He began clapping hands "tic" and vocal tic of "Hmm".  Began having trouble holding a pencil and writing.  He became uncoordinated- tripped and falling, bumping into things.  He complained of sudden, sharp, pain in knee, elbow, knuckle.  Hmm and clapping tics became more frequent 10/13/2011 - 10/16/2011.  A lot of movement, some movement appeared to be involuntary.  Movement stopped when he slept.  Low appetite but very high energy.  He complained of headache, neck pain, and that his left cheek felt "spacy".  He began describing sensations with colors.  10/18/2011- 10/21/2011 overflow movements, poor concentration and memory.  A few bouts of walking on his tip toes noticed both by parents and teacher at school.  Dragging of right leg when tired when walking or running.  A feeling of being "struck by lightening" in his chest.  In handwriting with new letter reversals.  Patient was given Cephalexin 250 mg/ 5 ml 4x/ day for 10 days on 10/13/2011.  Patient continued to experience hyperactivity, extra movements, emotional lability, sensory abnormalities, deteriorated fine motor skills for at least 7 months.  His handwriting has never fully recovered.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Severe headache, no treatment given.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Persistent headache that wouldn't go away after taking over the counter (generic Sudafed, not the PE version), acetaminophen and Ibuprofen - these last two were taken a couple hours apart. Also, chills and fatigue.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Itching, redness, swelling, tenderness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unknown number of patients were vaccinated with ROTATEQ, vial (lot # and expiration date not provided) (dose not reported) (reported as "vaccine"). It was reported that GARDASIL and ROTATEQ were exposed to 34F for 48 hours and (Oka/Merck) VARIVAX was exposed to 32F for 48 hours. The reporter stated that she did not have access to specific patient or vaccine information but she was able to state that all products had been administered post excursion. No adverse effects have been reported by any patient.  It was reported that the unknown number of patients did not seek medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unknown number of patients were vaccinated with GARDASIL (lot# and expiration date not provided) (dose not reported). It was reported that GARDASIL and ROTATEQ were exposed to 34F for 48 hours and VARIVAX was exposed to 32F for 48 hours. The reporter stated that she did not have access to specific patient or vaccine information but she was able to state that all products had been administered post excursion. No adverse effects have been reported by any patient. It was reported that the unknown number of patient did not seek medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Redness at site of injection, radiating to arm following vaccine, large area of bruising.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A) also reported as  healthcare worker who refers to a female patient of unknown age. On 03-MAY-2014 the patient was vaccinated with the first dose of RECOMBIVAX HB (route of administration, anatomical location and lot # not provided). On 12-SEP-2014 (also reported as today), the patient was getting the second dose of RECOMBIVAX HB (route of administration, anatomical location and lot # not provided). No concomitant medication ws reported. No adverse effects were reported at the  lime of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain below injection site on left arm presented 48 hours after administration.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash
Clinical narrative: Had vaccine at MD office in am - returned to school. After school c/o dizziness and rash to mom. Patient was taken to hospital by mom. Was treated with oral BENADRYL and released. Provider was notified by hospital on 10/2/14.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm swelling and soreness, (+) redness, inflammation and warmth to (L) outer and inner bicep region. Tx = cool compresses and KEFLEX 500 mg  and PO Q 12 hrs x 7 days.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 18-JUN-2014 at 10:34 AM, the patient was vaccinated with the first dose of RECOMIBAX HB (Thimerosal Free) (intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 18-JUN-2014 at 10:34 AM, the patient received the RECOMBIVAX HB stored to 0-1 of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were with 2-8 degrees.  The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordingly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was identified and has not been used after 21-JUL-2014. This is one of several reports received from the same reporter.  Additional information is not expected, because all follow up information has been received.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Immediate post-injection reaction, Induration, Local swelling, Nodule
Clinical narrative: Immediately after vaccne arm swollen hard not. 10/2/14: c/o of HA all night.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough
Clinical narrative: Cough and chest tightness, patient reports developed about 2 hrs after vaccine. She took po diphenhydramine and sought medical attention at 1:30 pm. Minimal response to medication/diphenhydramine. Epipen administrator, Transfer to ED.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Persistent severe muscle pain at injection site L deltoid.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (lot # and expiration date not provided) (dose not reported).   It was reported that GARDASIL and ROTATEQ were exposed to 34F for 48 hours and (Oka/Merck) VARIVAX was exposed to 32F for 48 hours. The reporter stated that she did not have access to specific patient or vaccine information but she was able to state that all products had been administered post excursion. No adverse effects have been reported by any patient.  It was reported that the unknown number of patients did not seek medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 01-OCT-2014 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (dose, route and lot # were not provided, expiration date : 10-SEP-2014). No adverse effect reported. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pruritus, Skin warm
Clinical narrative: Day after vaccine started itching and was red. Applied cream for itchy skin and it helped. Arm is hot and red and there is bruising.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 09-JUL-2014 at 10:58 AM, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 09-JUL-2014 at 10:58 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 20-JUN-2014 at 02:44, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 09-JUL-2014 at 10:58 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 2 hours red circle around/below injection area. 2 night later pink ring around red, raised area. Warm to touch.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen, painful (R) deltoid - 4 days total now prednisone rx.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner, via a sales representative, refers to a 13 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that on 09-SEP-2014, patient received a dose of ZOSTAVAX (route, lot # and expiration date were not provided) instead of second dose of (Oka/Merck) VARIVAX. The nurse while preparing to give a vaccination to another unspecified patient, nurse realized that a former 13 year old female patient received ZOSTAVAX instead of (Oka/Merck) VARIVAX. The nurse practitioner stated that three was product confusion in the labeling of the two vaccines. The patient on 09-SEP-2014 was coming in for the second dose of (Oka/Merck) VARIVAX and was given ZOSTAVAX in error. Additional information has been requested.