chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Sleep disorder, Tenderness
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Abasia, Chills, Dizziness, Dysstasia, Fatigue
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Feeling abnormal, Gait disturbance, Migraine, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Tenderness
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Vaccination complication
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 37.0
Sex: F
Vaccine: DPP
Symptoms: Arthralgia, Body temperature increased, Cellulitis, Chills, Erythema
Clinical narrative: Started experiencing chills and arm pain with swelling.  About 2100 i took temperature and it was 102.3, so i took ibuprofen and Tylenol every 4 hours. when i woke up Friday am 12/30 my arm had doubled in size and had a visible red and warm area that measured 3" x3". Picture was taken. i also had severe joint pain and was swelled so much i could not wear rings. i sent CNP a picture with measurements and symptoms via text, she replied this was normal and to give it time and take benadryl and aleve. i still had temp kf 100 despite the Tylenol and ibuprofen every 4 hours. I followed her orders, i was in so much pain. 12/31 am my arm had again swelled bigger and into my neck and right side of my face. i went to urgent care where i was diagnosed with cellulitis and was gjven 10 days of antibiotics and she worried i had reaction to the preservative and the vaccine was in my sq tissue.  antibiotics were finished 1/10/17 and i still have a painful swollen 2" x2" area on my right deltoid.
Age: 37.0
Sex: F
Vaccine: DPP
Symptoms: Injection site pain, Injection site swelling, Local swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Started experiencing chills and arm pain with swelling.  About 2100 i took temperature and it was 102.3, so i took ibuprofen and Tylenol every 4 hours. when i woke up Friday am 12/30 my arm had doubled in size and had a visible red and warm area that measured 3" x3". Picture was taken. i also had severe joint pain and was swelled so much i could not wear rings. i sent CNP a picture with measurements and symptoms via text, she replied this was normal and to give it time and take benadryl and aleve. i still had temp kf 100 despite the Tylenol and ibuprofen every 4 hours. I followed her orders, i was in so much pain. 12/31 am my arm had again swelled bigger and into my neck and right side of my face. i went to urgent care where i was diagnosed with cellulitis and was gjven 10 days of antibiotics and she worried i had reaction to the preservative and the vaccine was in my sq tissue.  antibiotics were finished 1/10/17 and i still have a painful swollen 2" x2" area on my right deltoid.
Age: 37.0
Sex: F
Vaccine: DPP
Symptoms: Skin warm, Swelling face
Clinical narrative: Started experiencing chills and arm pain with swelling.  About 2100 i took temperature and it was 102.3, so i took ibuprofen and Tylenol every 4 hours. when i woke up Friday am 12/30 my arm had doubled in size and had a visible red and warm area that measured 3" x3". Picture was taken. i also had severe joint pain and was swelled so much i could not wear rings. i sent CNP a picture with measurements and symptoms via text, she replied this was normal and to give it time and take benadryl and aleve. i still had temp kf 100 despite the Tylenol and ibuprofen every 4 hours. I followed her orders, i was in so much pain. 12/31 am my arm had again swelled bigger and into my neck and right side of my face. i went to urgent care where i was diagnosed with cellulitis and was gjven 10 days of antibiotics and she worried i had reaction to the preservative and the vaccine was in my sq tissue.  antibiotics were finished 1/10/17 and i still have a painful swollen 2" x2" area on my right deltoid.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood test, Chest pain, Computerised tomogram, Eyelid function disorder
Clinical narrative: Received the flu shot Oct. 3. I started having headaches approximately 2 1/2 weeks later. On October 31st 1/2 of my tongue felt odd on the way home from work and I had a severe headache almost enough to pull over and vomit. I got home and went to bed and woke up at 9:30 am the next morning unable to close my right eye and my right side of my face drooped and a horrid headache. I thought I was having an aneurysm or stroke so I called 911. After blood work and a CT Scan I was DX with bells palsy. I  was started on  an antiviral and prednisone and given Norco 5/325mg. I returned to work about 10 days later after following up with an ENT and my primary Dr.  I continued to have increasing symptons. Numbness in my left arm and tingling and jolts down my left arm. My pulse would run up into the 130's and my BP up into the 140/96. My BP is normally 115/70. While I was at work on Nov 27th,  I felt my heart racing and my left arm ached and felt numb so I went up to the nurses station and they took my blood pressure. 70/40 is the last I heard and then woke up on the nurses station floor with a code team around me and pads attached had I needed shocked. I was taken down to the ER and told I just had a syncope episode and sent home. Headaches continued as well as the numbness and my left arm. I believe on the 17th of December my right arm started to go numb and the chest pains and severe headaches continued so I went to the ER and was admitted for a stroke workup. 3 days later I was discharged with no answers. My Primary Dr had let me know I had a vitamin b12 deficiency, my level is 232 and should be up around 450. Vit B12 deficiency has a lot of the symptoms I have been experiencing.  So I started a supplement. Now the question is why am i deficient A. Stomach stapled = No B. Bowel surgery = No C. Autoimmune disease stirred up by something viral that could have caused the bells palsy and this deficiency. So I am now taking a Vitamin B supplement and continue to take  nortriptoline for nerve pain. All of this...from the Flu shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Headache, Heart rate increased, Hypoaesthesia, Loss of consciousness
Clinical narrative: Received the flu shot Oct. 3. I started having headaches approximately 2 1/2 weeks later. On October 31st 1/2 of my tongue felt odd on the way home from work and I had a severe headache almost enough to pull over and vomit. I got home and went to bed and woke up at 9:30 am the next morning unable to close my right eye and my right side of my face drooped and a horrid headache. I thought I was having an aneurysm or stroke so I called 911. After blood work and a CT Scan I was DX with bells palsy. I  was started on  an antiviral and prednisone and given Norco 5/325mg. I returned to work about 10 days later after following up with an ENT and my primary Dr.  I continued to have increasing symptons. Numbness in my left arm and tingling and jolts down my left arm. My pulse would run up into the 130's and my BP up into the 140/96. My BP is normally 115/70. While I was at work on Nov 27th,  I felt my heart racing and my left arm ached and felt numb so I went up to the nurses station and they took my blood pressure. 70/40 is the last I heard and then woke up on the nurses station floor with a code team around me and pads attached had I needed shocked. I was taken down to the ER and told I just had a syncope episode and sent home. Headaches continued as well as the numbness and my left arm. I believe on the 17th of December my right arm started to go numb and the chest pains and severe headaches continued so I went to the ER and was admitted for a stroke workup. 3 days later I was discharged with no answers. My Primary Dr had let me know I had a vitamin b12 deficiency, my level is 232 and should be up around 450. Vit B12 deficiency has a lot of the symptoms I have been experiencing.  So I started a supplement. Now the question is why am i deficient A. Stomach stapled = No B. Bowel surgery = No C. Autoimmune disease stirred up by something viral that could have caused the bells palsy and this deficiency. So I am now taking a Vitamin B supplement and continue to take  nortriptoline for nerve pain. All of this...from the Flu shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture, Nausea, Neuralgia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Received the flu shot Oct. 3. I started having headaches approximately 2 1/2 weeks later. On October 31st 1/2 of my tongue felt odd on the way home from work and I had a severe headache almost enough to pull over and vomit. I got home and went to bed and woke up at 9:30 am the next morning unable to close my right eye and my right side of my face drooped and a horrid headache. I thought I was having an aneurysm or stroke so I called 911. After blood work and a CT Scan I was DX with bells palsy. I  was started on  an antiviral and prednisone and given Norco 5/325mg. I returned to work about 10 days later after following up with an ENT and my primary Dr.  I continued to have increasing symptons. Numbness in my left arm and tingling and jolts down my left arm. My pulse would run up into the 130's and my BP up into the 140/96. My BP is normally 115/70. While I was at work on Nov 27th,  I felt my heart racing and my left arm ached and felt numb so I went up to the nurses station and they took my blood pressure. 70/40 is the last I heard and then woke up on the nurses station floor with a code team around me and pads attached had I needed shocked. I was taken down to the ER and told I just had a syncope episode and sent home. Headaches continued as well as the numbness and my left arm. I believe on the 17th of December my right arm started to go numb and the chest pains and severe headaches continued so I went to the ER and was admitted for a stroke workup. 3 days later I was discharged with no answers. My Primary Dr had let me know I had a vitamin b12 deficiency, my level is 232 and should be up around 450. Vit B12 deficiency has a lot of the symptoms I have been experiencing.  So I started a supplement. Now the question is why am i deficient A. Stomach stapled = No B. Bowel surgery = No C. Autoimmune disease stirred up by something viral that could have caused the bells palsy and this deficiency. So I am now taking a Vitamin B supplement and continue to take  nortriptoline for nerve pain. All of this...from the Flu shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Paraesthesia, Paraesthesia oral, Scan with contrast, Syncope
Clinical narrative: Received the flu shot Oct. 3. I started having headaches approximately 2 1/2 weeks later. On October 31st 1/2 of my tongue felt odd on the way home from work and I had a severe headache almost enough to pull over and vomit. I got home and went to bed and woke up at 9:30 am the next morning unable to close my right eye and my right side of my face drooped and a horrid headache. I thought I was having an aneurysm or stroke so I called 911. After blood work and a CT Scan I was DX with bells palsy. I  was started on  an antiviral and prednisone and given Norco 5/325mg. I returned to work about 10 days later after following up with an ENT and my primary Dr.  I continued to have increasing symptons. Numbness in my left arm and tingling and jolts down my left arm. My pulse would run up into the 130's and my BP up into the 140/96. My BP is normally 115/70. While I was at work on Nov 27th,  I felt my heart racing and my left arm ached and felt numb so I went up to the nurses station and they took my blood pressure. 70/40 is the last I heard and then woke up on the nurses station floor with a code team around me and pads attached had I needed shocked. I was taken down to the ER and told I just had a syncope episode and sent home. Headaches continued as well as the numbness and my left arm. I believe on the 17th of December my right arm started to go numb and the chest pains and severe headaches continued so I went to the ER and was admitted for a stroke workup. 3 days later I was discharged with no answers. My Primary Dr had let me know I had a vitamin b12 deficiency, my level is 232 and should be up around 450. Vit B12 deficiency has a lot of the symptoms I have been experiencing.  So I started a supplement. Now the question is why am i deficient A. Stomach stapled = No B. Bowel surgery = No C. Autoimmune disease stirred up by something viral that could have caused the bells palsy and this deficiency. So I am now taking a Vitamin B supplement and continue to take  nortriptoline for nerve pain. All of this...from the Flu shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Vitamin B12 deficiency
Clinical narrative: Received the flu shot Oct. 3. I started having headaches approximately 2 1/2 weeks later. On October 31st 1/2 of my tongue felt odd on the way home from work and I had a severe headache almost enough to pull over and vomit. I got home and went to bed and woke up at 9:30 am the next morning unable to close my right eye and my right side of my face drooped and a horrid headache. I thought I was having an aneurysm or stroke so I called 911. After blood work and a CT Scan I was DX with bells palsy. I  was started on  an antiviral and prednisone and given Norco 5/325mg. I returned to work about 10 days later after following up with an ENT and my primary Dr.  I continued to have increasing symptons. Numbness in my left arm and tingling and jolts down my left arm. My pulse would run up into the 130's and my BP up into the 140/96. My BP is normally 115/70. While I was at work on Nov 27th,  I felt my heart racing and my left arm ached and felt numb so I went up to the nurses station and they took my blood pressure. 70/40 is the last I heard and then woke up on the nurses station floor with a code team around me and pads attached had I needed shocked. I was taken down to the ER and told I just had a syncope episode and sent home. Headaches continued as well as the numbness and my left arm. I believe on the 17th of December my right arm started to go numb and the chest pains and severe headaches continued so I went to the ER and was admitted for a stroke workup. 3 days later I was discharged with no answers. My Primary Dr had let me know I had a vitamin b12 deficiency, my level is 232 and should be up around 450. Vit B12 deficiency has a lot of the symptoms I have been experiencing.  So I started a supplement. Now the question is why am i deficient A. Stomach stapled = No B. Bowel surgery = No C. Autoimmune disease stirred up by something viral that could have caused the bells palsy and this deficiency. So I am now taking a Vitamin B supplement and continue to take  nortriptoline for nerve pain. All of this...from the Flu shot.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Rash erythematous, Somnolence
Clinical narrative: He got a huge knot size of golf ball on the injection site with a red spotty rash the size of the knot. Acting fine as of now eating drinking and playing just sleeping a good bit and he is complaining his leg hurts.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Body temperature increased, Electroencephalogram, Seizure
Clinical narrative: Mom reports that pt. taken to daycare after office visit. Parents contacted to pick her up from daycare about 1520 due to temp. 102 degrees. Father was on his way to pick her up when notified pt. having seizure at 1540. Daycare workers told Father seizure lasted less than 5 minutes and was back to normal within 15 minutes. Fever free by evening. "Doing great today," according to mom 1-11-17
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, pain, swelling in (L) left deltoid and surrounding injection site. Treated with MOTRIN, BENADRYL, compresses, and KEFLEX due to being a diabetic.
Age: 67.0
Sex: F
Vaccine: HEPAB, PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: (R) arm red, tender and swollen. Given triamcinolone 0.1% cream x14 days, MOTRIN and ice.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine 10-4-16, developed warmth and redness on arm of injection site October 9, 2016. Left arm with approximately 4x5cm patch red, raised, warm skin square pattern 2 cm below injection site. Treated for reaction with BENADRYL, prednisone and ZPAK.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5X2.2cm injection site reaction noted redness and warm to touch. No fever.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: 2 days post injection developed a red rash that spread from (L) shoulder to (L) elbow. Pruritic and painful. There was no reported systemic symptoms.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experienced pain at injection site after injection of Flu vaccine. Pain has not abated and still persists. Visited family physician on 1/6/17 and was told that possibly a nerve was hit and pain may persist for up to a year.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Abnormal behaviour, Blood glucose normal, Computerised tomogram head normal, Electrocardiogram normal
Clinical narrative: Pt received DTaP and Hib on 12/29/2016. Mother reports on AM of 1/4/17 pt "not acting right". Awoke at 6 AM unable to bear weight/walk/collapsed/"limp" on left side of body. Smiling and interactive at this point - vomited x 3 with eye rolling. Very sleepy afterwards. Episode over 30 min. Mobility returned by end of day. No tonic clonic activity, afebrile.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Eye movement disorder, Full blood count normal, Hypotonia, Metabolic function test normal, Somnolence
Clinical narrative: Pt received DTaP and Hib on 12/29/2016. Mother reports on AM of 1/4/17 pt "not acting right". Awoke at 6 AM unable to bear weight/walk/collapsed/"limp" on left side of body. Smiling and interactive at this point - vomited x 3 with eye rolling. Very sleepy afterwards. Episode over 30 min. Mobility returned by end of day. No tonic clonic activity, afebrile.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Syncope, Vomiting, Weight bearing difficulty
Clinical narrative: Pt received DTaP and Hib on 12/29/2016. Mother reports on AM of 1/4/17 pt "not acting right". Awoke at 6 AM unable to bear weight/walk/collapsed/"limp" on left side of body. Smiling and interactive at this point - vomited x 3 with eye rolling. Very sleepy afterwards. Episode over 30 min. Mobility returned by end of day. No tonic clonic activity, afebrile.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Eye disorder
Clinical narrative: Pt received DTaP and Hib on 12/29/2016. Mother reports on AM of 1/4/17 pt "not acting right". Awoke at 6 AM unable to bear weight/walk/collapsed/"limp" on left side of body. Smiling and interactive at this point - vomited x 3 with eye rolling. Very sleepy afterwards. Episode over 30 min. Mobility returned by end of day. No tonic clonic activity, afebrile.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Paralysis, Seizure, Vomiting
Clinical narrative: Pt received DTaP and Hib on 12/29/2016. Mother reports on AM of 1/4/17 pt "not acting right". Awoke at 6 AM unable to bear weight/walk/collapsed/"limp" on left side of body. Smiling and interactive at this point - vomited x 3 with eye rolling. Very sleepy afterwards. Episode over 30 min. Mobility returned by end of day. No tonic clonic activity, afebrile.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Received vaccine at 830AM. Around 1245p started itching head, arm, neck, face, hands slightly on legs. No rash seen. Has never had a flu vax before.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Received flu vaccine at approx. 630pm and at 945pm she began to develop intense itching to her lower back, arms and hands. She also developed hives on her back and in her abdominal folds. Patient reports she felt her skin was on fire, and developed a "blister like" lesion to her forearms. Received treatment at the ED 9/16/16 and continued treatment for 3 day.
Age: 0.67
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea, Faeces pale, Rash
Clinical narrative: Patient developed rash with yellow diarrhea 24 hrs after vaccines were given.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site plaque, Red blood cell sedimentation rate normal
Clinical narrative: 3x2 cm pink tender plaque Right arm 2+ weeks after immunizations? At site of immunization. Put on Valacyclovir 500g 2 tabs TIDx7days and Prednisone. Improved slightly, then came back. Triamcinolone cream, went away x2wks then returned on 1/9/17.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, red, warm. Headache also.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: Pt stated her (R) deltoid is painful with range of motion.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US139960, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 577458) website on 20 Oct 2015. This report refers to a 70 years old female patient. Medical history and concomitant medication was not reported. Vaccination history included vaccination with first dose of influenza vaccine (manufacturer and batch number: unknown) and experienced swelling of arm, redness, warmth and pain at the injection site after vaccination (See case: PHHY2015US139930). Six months after first dose the patient was vaccinated with second dose of influenza vaccine (manufacturer and batch number: unknown). It was reported that physician had administered one fifth of the actual dose in order to mitigate reactions for the vaccine. The patient experienced same events like swelling or arm, redness, warmth and pain at the injection site after vaccination on an unknown date. Outcome of the events was not reported. Events were reported to be non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US139960, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 577458) website on 20 Oct 2015. This report refers to a 70 years old female patient. Medical history and concomitant medication was not reported. Vaccination history included vaccination with first dose of influenza vaccine (manufacturer and batch number: unknown) and experienced swelling of arm, redness, warmth and pain at the injection site after vaccination (See case: PHHY2015US139930). Six months after first dose the patient was vaccinated with second dose of influenza vaccine (manufacturer and batch number: unknown). It was reported that physician had administered one fifth of the actual dose in order to mitigate reactions for the vaccine. The patient experienced same events like swelling or arm, redness, warmth and pain at the injection site after vaccination on an unknown date. Outcome of the events was not reported. Events were reported to be non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US139930, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 577458) website on 20 Oct 2015. This report refers to a 70 years old female patient. Current illness was reported as unknown. The patient was vaccinated with first dose of influenza vaccine (brand name and manufacturer unknown, batch number: unknown) on an undetermined date (8-10 years ago). On an unknown date after vaccination she experienced swelling, injection site redness and pain. She also felt hot at the injection site. Outcome of the events was reported as complete recovery. Events were reported to be non-serious and causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US139930, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 577458) website on 20 Oct 2015. This report refers to a 70 years old female patient. Current illness was reported as unknown. The patient was vaccinated with first dose of influenza vaccine (brand name and manufacturer unknown, batch number: unknown) on an undetermined date (8-10 years ago). On an unknown date after vaccination she experienced swelling, injection site redness and pain. She also felt hot at the injection site. Outcome of the events was reported as complete recovery. Events were reported to be non-serious and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site vesicles
Clinical narrative: Case number PHHY2016US114769, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 578269) website on 18 Aug 2016. This report refers to a 66 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with H1N1 influenza monovalent vaccine (pandemic influenza vaccine and batch number: not reported) on an unknown date in 2009. On an unknown date, the patient experienced blister at site. The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US137441 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 578969) on 20 Oct 2015. This report refers to a female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient developed Guillain Barre Syndrome. The outcome of the event was not reported. The seriousness of the event was not reported, but the event was upgraded as medically significant based on the NVS-IME list. The causality of the event was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US137440 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 578969) on 20 Oct 2015. This report refers to a male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient developed Guillain Barre Syndrome. The outcome of the event was not reported. The seriousness of the event was not reported, but the event was upgraded as medically significant based on the NVS-IME list. The causality of the event was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number# PHEH2015US021073, is an initial report received from a health care professional on 15 Oct 2015 from a patient oriented program. This report refers to a 46-year-old female patient. Historical condition was not reported. Concurrent condition included contraindication to vaccination. No concomitant medication was reported. The patient received COSENTYX injection for the treatment of plaque psoriasis from an unknown start date at a dose of 300 mg, QMO (subcutaneous). The patient also received influenza Virus Vaccine - Unknown (influenza virus vaccine monovalent, trivalent inactivated influenza virus surface antigen (subunit), egg-derived) from an unknown start date at an unknown dose. It was reported that the patient recently received a flu shot and called her physician in order to report flu-like symptoms. Patient wanted to know if it was okay to continue with her COSENTYX injections. Action taken with COSENTYX was unknown. Outcome of the event influenza like illness was unknown. Seriousness and causality of the events were not reported by the health care professional. No consent was given to contact the reporter for follow up. Following an internal review on 29 Oct 2015, based on the information received on 15 Oct 2015, the following change was done: Deleted the event off label use.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Case number PHHY2016US113857, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 582098) on 18 Aug 2016. This report refers to a 48 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Influenza Virus vaccine Pandemic INN (manufacturer unknown, batch number not reported) on an unknown date. On an unknown date, the patient experienced, leg pain and numbness. Outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US142251, is an initial spontaneous report received from the consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 587201) website on 23 Oct 2015. This report refers to a female patient of unknown age. Medical history and concomitant medication were not reported. Vaccination history included occurrence of sore arm and erythema at vaccination site with unspecified meningitis vaccine (see case: PHHY2015US142264). The patient was vaccinated with an unspecified influenza vaccine (manufacturer and batch number: not reported) on an unknown date. After vaccination, the patient developed sore arm. Outcome of the event was reported as complete recovery. This event was reported as non-serious. Causality was not reported.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pruritus
Clinical narrative: Case number PHHY2015US160699 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 587866) website on 24 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) and ZOSTAVAX (other manufacturer, batch number: not reported) on an unknown date. It was reported that the patient experienced local itching on an unknown date, which lasted for 1 week. The outcome of the event was reported as complete recovery. The event was reported as non-serious and causality was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Body temperature decreased, Chills, Headache
Clinical narrative: Case number PHHY2015US150845, is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 590350) website on 16 Nov 2015. This report refers to a 51 years old polymedicated female patient. Medical history was not reported. Current illness was none. The patient was vaccinated with FLUVIRIN (batch number: 1514501) intramuscularly into left arm on 16 Aug 2015. On the same day after vaccination the patient experienced body temperature of 96.7 degrees F, chills, headache and blood pressure of 146/100 mmHg. Outcome of the events was recovered. The case was assessed as non serious. Causality of the events was not reported. The seriousness assessment of the event blood pressure increased was upgraded (medically significant) based on the information available in the source document. Batch review report (reference number [1009195] received from quality assurance department on 24 Dec 2015: Based on the document review, it was stated that the concerned [FLUVIRIN] batch number [1514501] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received from quality assurance department (QA reference number: 1009195) on 23 Nov 2015: Updated QA reference number only. Non significant follow up information received from quality assurance department on 24 Dec 2015: Added investigation summary.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2015US150884, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 590851) website on 16 Nov 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medications included ACZONE and doxycycline. The patient was vaccinated with FLUVIRIN (batch number: 157003) intramuscularly into left arm on 18 Aug 2015. Within two minutes after the injection the patient had syncope. Outcome of the event was recovered. The case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of syncope was upgraded based on information in the source document.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Syncope
Clinical narrative: Case number PHHY2015US150829, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 592746) website on 16 Nov 2015. This report refers to an 18 year old male patient. No medical history was reported. Concomitant medication included EPIDUO gel pump topically. On 02 Sep 2015, the patient was vaccinated with FLUVIRIN (batch number: 15751P) and TWINRIX (other manufacturer, batch number: 3ED7N) both injected separately intramuscular into left arm. Post vaccination the patient fainted. Blood pressure was monitored, no lab data was reported. Outcome of the event was recovered. The event was reported as non-serious. Seriousness of the event syncope was upgraded based on information available in source document. Causality assessment was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash, Rash pruritic
Clinical narrative: Case number PHHY2015US151446 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 594195) on 16 Nov 2015. This report refers to a 62 year old female patient. Past medical history was not reported. Her current condition included AMBIEN allergy. She had no concomitant medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 31 Aug 2015. On 01 Sep 2015, the patient had headache and rash. There was itching and pain in rash area on left side of face, left arm, midline epigastric area and neck. She had residual rash after 1 week. The events outcome was not reported. The events were reported as non-serious, but the event itchy and painful rash was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Headache, Lymphadenopathy, Nausea
Clinical narrative: Case number PHHY2015US152118 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 594924) on 16 Nov 2015. This report refers to a 47 year old female patient. Her current condition included sulfa allergy. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly in the right arm on 12 Sep 2015 at 1:10 pm. On the same day after vaccination at 1:15 pm, she had signs of nausea and dizziness. At 1:25 pm, the patient experienced signs of headache and gland swelling. At 1:30 pm, the patient had tongue and slight throat swelling. She also had difficulty in breathing. At 1:30 pm, emergency medical technician (EMT) was called. EPIPEN 0.3 mg injection was administered in left thigh at 1:33 pm. The patient experienced improvement in symptoms and breathing at 1:35 pm. At 1:45 pm, fire and rescue arrived and began assessing the patient. EMT arrived at 1:50 pm and took over the patient care. The patient was transported to the emergency room. The final outcome of events was unknown. The events were reported as non-serious, but the events difficulty breathing and tongue and throat swelling were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Case number PHHY2015US152118 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 594924) on 16 Nov 2015. This report refers to a 47 year old female patient. Her current condition included sulfa allergy. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly in the right arm on 12 Sep 2015 at 1:10 pm. On the same day after vaccination at 1:15 pm, she had signs of nausea and dizziness. At 1:25 pm, the patient experienced signs of headache and gland swelling. At 1:30 pm, the patient had tongue and slight throat swelling. She also had difficulty in breathing. At 1:30 pm, emergency medical technician (EMT) was called. EPIPEN 0.3 mg injection was administered in left thigh at 1:33 pm. The patient experienced improvement in symptoms and breathing at 1:35 pm. At 1:45 pm, fire and rescue arrived and began assessing the patient. EMT arrived at 1:50 pm and took over the patient care. The patient was transported to the emergency room. The final outcome of events was unknown. The events were reported as non-serious, but the events difficulty breathing and tongue and throat swelling were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US164700 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 595503) website on 14 Dec 2015. This report refers to a 36 years old male patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157701) into left arm on 10 Sep 2015. On 11 Sep 2015 the patient developed full body hives. Outcome of the event was recovered on 14 Sep 2015. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "full body hives" was upgraded based on information in the source document.