chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Patient got the 2nd dose, stated she had swelling, pain and heat at the injection site. After 2 weeks pt. have a red mark at injection site, 2" in diameter. Now say she feels arm weakness.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphonia, Erythema, Headache, Insomnia, Myalgia
Clinical narrative: Pt got the flu shot on 9/6/18 around 10 am and started to have symptoms including hoarse throat, body aches, red face, bloodshot eyes, headaches and swollen neck. He also reported not being able to sleep that night. He took 1 cyclobenzaprine 10 mg tablet for muscle pain. The symptoms resolved on 9/7/18 around midafternoon. He reports feeling a lot better since then. Pt reported 9/8/18.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Pain, Swelling
Clinical narrative: Pt got the flu shot on 9/6/18 around 10 am and started to have symptoms including hoarse throat, body aches, red face, bloodshot eyes, headaches and swollen neck. He also reported not being able to sleep that night. He took 1 cyclobenzaprine 10 mg tablet for muscle pain. The symptoms resolved on 9/7/18 around midafternoon. He reports feeling a lot better since then. Pt reported 9/8/18.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Bit of swelling since 9/7/18; No TX yet.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives still present.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, swelling and redness at injection site. About 10 hours after the injection intense shivering, fever, and headache.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness, swelling and redness at injection site. About 10 hours after the injection intense shivering, fever, and headache.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Injection site pain
Clinical narrative: Sharp pain at injection site for 48 hours. Anaphylaxis approx. 15 minutes after injection. Treated by OTC medication (antihistamine & bronchodilator).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Developed extreme fussiness (inconsolability) 5hrs after vaccine administration with fever to 102.3 (7pm the evening of the 4th). Around 11pm on the 4th had first episode of diarrhea which continued for the next 16hrs (until the afternoon of the 5th). Had 1 episode of diarrhea with red mucous in it the afternoon of 9/5.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: Inoculation 2 of SHINGRIX Vial Kit administered in the morning of 9/08/18. I did not have a reaction to the first shot in the series, just a sore arm. Ten hours later I began with uncontrollable shivering, no fever. This was followed by a bad headache, vomiting and diaherea. These symptoms continued until 6 am the next morning. I did not contact my physician because the symptoms subsided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bone pain, Chills, Fatigue, Myalgia
Clinical narrative: Had vaccine Friday at 2:00 pm by 10:00 pm started aching then by midnight had fever about 102 with chills the remainder of the night. Next morning Saturday every muscle and bone in body hurting and had temperature until about 9:00pm which was day after injection. This is now Sunday morning, no fever but very tired and sore in neck and back.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Had vaccine Friday at 2:00 pm by 10:00 pm started aching then by midnight had fever about 102 with chills the remainder of the night. Next morning Saturday every muscle and bone in body hurting and had temperature until about 9:00pm which was day after injection. This is now Sunday morning, no fever but very tired and sore in neck and back.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Erythema, Eyelid oedema, Pruritus, Swelling face
Clinical narrative: Swelling of the left side of the face and eye area. Red and itchy. Patient stated that it was much worst the day after vaccination but have gotten significantly better today. No reaction at injection site.
Age: 30.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Member reported swelling and redness to Left deltoid 2 days s/p anthrax administration. Denies f/c but has soreness. Exam: the entire left deltoid and lateral/supsension biceps is indurated and there is errythemia and the same location. There is no wound present. Recommend rest, ice/heat, OTC anti inflammatories. (Dr.)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Muscle aches, headache, fatigue, fever (100-101), soreness at site (arm). Started with fatigue and flight body aches on same day. Worse in AM with fever and headache and more body aches.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle aches, headache, fatigue, fever (100-101), soreness at site (arm). Started with fatigue and flight body aches on same day. Worse in AM with fever and headache and more body aches.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: ARM SWELLING (SIGNIFICANT) FROM JUST ABOVE ELBOW TO SHOULDER. MD VISIT 9/7/18 PRESCRIBED CEPHALEXIN 500MG QID FOR 5 DAYS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 101F fever, chills, headache, louder than usual tinnitus, muscle aches, 8 cm diameter swelling, redness, soreness at injection site. Most symptoms abated after 24 hours; injection site swelling and redness lasted three days.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: 101F fever, chills, headache, louder than usual tinnitus, muscle aches, 8 cm diameter swelling, redness, soreness at injection site. Most symptoms abated after 24 hours; injection site swelling and redness lasted three days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Erythema and tenderness (at 8 cm x 7 cm) was present for 3-4 days at the site of injection. On Day 5, severe fatigue began and I stayed in bed most of the day (holiday) and this fatigue waxed and waned through Day 11, which was the most severe episode of it. I experienced odd myalgias (thighs aching), headaches, and a decreased ability to concentrate Days 5-11. On Day 11, I woke up after 10 hours of sleep with a headache and slight vertigo and spent most of that day in bed, resting. Today is Day 12, and I feel significantly better. I had ZOSTAVAX at age 60, and had no side effects, and having read that no research has been done on people who have ZOSTAVAX and SHINGRIX less than 5 years apart, I wonder if the short time between the two might put one at risk for more side effects. I am a nurse practitioner and very much an advocate for vaccines. I had a flu vaccine a week before the SHINGRIX.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Vertigo
Clinical narrative: Erythema and tenderness (at 8 cm x 7 cm) was present for 3-4 days at the site of injection. On Day 5, severe fatigue began and I stayed in bed most of the day (holiday) and this fatigue waxed and waned through Day 11, which was the most severe episode of it. I experienced odd myalgias (thighs aching), headaches, and a decreased ability to concentrate Days 5-11. On Day 11, I woke up after 10 hours of sleep with a headache and slight vertigo and spent most of that day in bed, resting. Today is Day 12, and I feel significantly better. I had ZOSTAVAX at age 60, and had no side effects, and having read that no research has been done on people who have ZOSTAVAX and SHINGRIX less than 5 years apart, I wonder if the short time between the two might put one at risk for more side effects. I am a nurse practitioner and very much an advocate for vaccines. I had a flu vaccine a week before the SHINGRIX.
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling cold, Nausea, Pollakiuria, Pyrexia
Clinical narrative: The patient received her second dose of the SHINGRIX vaccine on 9/7/18. Then early in the morning on 9/8/18 the patient went to the hospital. The patient had a fever, felt weak, felt nauseous, had two large stools, was very cold, and had frequent urination. The hospital believed her symptoms were due to the SHINGRIX vaccine. She had no injection site reaction. They gave her IV fluids and she stayed for 4 or 5 hours. Then they discharged her. Later that day she felt better.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Anal incontinence, Skin abrasion, Syncope
Clinical narrative: Pt describes going to the bathroom to get ready to take a shower. Then out of nowhere she lost complete control of her bowels (released excrement) and then collapsed. The only injury (other than cleanliness and embarrassment) was a scrape on the patient's left arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Chest discomfort, Chest pain, Dehydration, Peripheral swelling
Clinical narrative: Swelling in arm and hot to touch, patient also reported chest pain and heaviness in her chest. She called the pharmacy on 9-8-18 and after describing her symptoms I recommended she call her doctor. She then was instructed to go to ER. She was dehydrated and was diagnosed with cellulitis. She was given cephalexin and doxycycline. Her daughter picked up the prescriptions on 9-9-18 and stated she was doing much better.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Swelling in arm and hot to touch, patient also reported chest pain and heaviness in her chest. She called the pharmacy on 9-8-18 and after describing her symptoms I recommended she call her doctor. She then was instructed to go to ER. She was dehydrated and was diagnosed with cellulitis. She was given cephalexin and doxycycline. Her daughter picked up the prescriptions on 9-9-18 and stated she was doing much better.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Abdominal pain upper, Burning sensation, Dizziness, Full blood count normal
Clinical narrative: Intense symptoms including: Fever 102+ for three days; Severe shakes (could not hold cup of water without spilling) 3 days; Stomach pain (most intense ever experienced "like on fire") 2days; Nights sweats (necessitating full change of bed linens) 8/29 and 30/2018 2 nights; Headache 3days; Dizziness 2days.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hepatic enzyme increased, Hepatitis A virus test, Hepatitis B test negative, Hepatitis C test negative
Clinical narrative: Intense symptoms including: Fever 102+ for three days; Severe shakes (could not hold cup of water without spilling) 3 days; Stomach pain (most intense ever experienced "like on fire") 2days; Nights sweats (necessitating full change of bed linens) 8/29 and 30/2018 2 nights; Headache 3days; Dizziness 2days.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Hepatitis viral test negative, Night sweats, Pyrexia, Tremor, Ultrasound liver normal
Clinical narrative: Intense symptoms including: Fever 102+ for three days; Severe shakes (could not hold cup of water without spilling) 3 days; Stomach pain (most intense ever experienced "like on fire") 2days; Nights sweats (necessitating full change of bed linens) 8/29 and 30/2018 2 nights; Headache 3days; Dizziness 2days.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: Intense symptoms including: Fever 102+ for three days; Severe shakes (could not hold cup of water without spilling) 3 days; Stomach pain (most intense ever experienced "like on fire") 2days; Nights sweats (necessitating full change of bed linens) 8/29 and 30/2018 2 nights; Headache 3days; Dizziness 2days.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site abscess, Injection site mass, Injection site pain
Clinical narrative: Service member states a lump began to show up on R arm where injection was. He states he noticed a lump about a month after the injection which has continued to increase. He denies any pain but is tender to the touch. 2" round 1cm raised, moveable abscess. He has not currently received medical treatment. He is being sent to his primary for treatment.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Injection site reaction, Lethargy, Pain
Clinical narrative: Patient stated she had soreness at the injection site that evening and woke up to see a red rash (not painful or itchy just red and hot) the next morning. She said that day (15 hours after vaccine) she felt tired, lethargic, and achy so she went to take a nap for 2 hours. She said the rash seems to be spreading and currently is located from the injection site area (left deltoid) down to about 3 inches above the elbow on the back side of her arm.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous
Clinical narrative: Patient stated she had soreness at the injection site that evening and woke up to see a red rash (not painful or itchy just red and hot) the next morning. She said that day (15 hours after vaccine) she felt tired, lethargic, and achy so she went to take a nap for 2 hours. She said the rash seems to be spreading and currently is located from the injection site area (left deltoid) down to about 3 inches above the elbow on the back side of her arm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Activated partial thromboplastin time normal, Amino acid level normal, Angiogram cerebral abnormal, Arteriogram carotid, Atrial septal defect
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Basal ganglia infarction, Blood homocysteine normal, Blood thyroid stimulating hormone normal, Borrelia test negative, CSF culture negative
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: CSF immunoglobulin, Cerebral artery stenosis, Coagulation test, Computerised tomogram head abnormal, Coronavirus test positive
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Dyskinesia, Echocardiogram abnormal, Electroencephalogram normal, Hemiparesis, Herpes simplex test
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site movement impairment, Intensive care, Lumbar puncture, Metabolic function test, Mobility decreased
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Nasal congestion, Nasopharyngitis, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Posture abnormal
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Prothrombin time normal, Respirovirus test positive, Thyroxine free normal, Varicella virus test negative, Viral test negative
Clinical narrative: Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Soreness in left shoulder, patient states it started night of immunization, sore when she lies on it, pain comes and goes, no stiffness, no redness, no bruising at injection site
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry throat, Dysphagia, Urticaria
Clinical narrative: Patient had welt on arm immediately after vaccination, pt received 50mg of BENADRYL and reported feeling a dryness in her throat with inability to swallow afterward. Pt referred to ER, pt refused EPIPEN at that time and was taken to ER by her husband for observation.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Patient felt pain during vaccination, then had a tingling sensation along her left jaw. Administered liquid benadryl oral.
Age: 1.17
Sex: F
Vaccine: FLUX
Symptoms: Ear swelling, Swelling face, Urticaria
Clinical narrative: To be honest I am not sure of the brand or name of the flu shot my daughter received. We were visiting family in another country over the holidays, for a month long visit, and there was a lot of scare and concern about the flu season, and travelling by plane. There was a horrible flu going around. We decided to get her the flu shot, which was at a public health clinic. I am not sure of the address and Dr's name, nor the brand name. She later had a bad reaction and was covered in severe hives, like some sort of systemic reaction. This lasted several days, and I have photos of the progression of it. The hives were on her torso, face, neck, legs, back, and were hot and raised. Very bad hives! Very scary! She was not having breathing difficulty thank God! Her face also swelled, and ears swelled two times the size. I took a good amount of photos to record it. We did not take her to the hospital due to not having any breathing difficulty.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Computerised tomogram head normal, Condition aggravated, Dysarthria
Clinical narrative: Evening of vaccination chills, whole body aches, inability to sleep, uncontrolled tremors. Next morning loss of balance, left sided hemiparesis, dysarthria, tremors, and whole body aches, fatigue.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hemiparesis, Insomnia, Laboratory test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Evening of vaccination chills, whole body aches, inability to sleep, uncontrolled tremors. Next morning loss of balance, left sided hemiparesis, dysarthria, tremors, and whole body aches, fatigue.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: Evening of vaccination chills, whole body aches, inability to sleep, uncontrolled tremors. Next morning loss of balance, left sided hemiparesis, dysarthria, tremors, and whole body aches, fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, slight swelling and soreness in the arm where PNEUMOVAX was administered. Goes down along the inside of the upper arm but stops before the elbow, presentation is similar to those of other patients who got PNEUMOVAX and influenza vaccine at the same time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cold sweat, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Arm pain within 5-6 hours followed by chills, cold sweats, weakness, whole body aches, fatigue, inability to function for activities of daily living. Symptoms and signs resolved by noon the next day. Note: separate event form filled out for spouse who had vaccine at same time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain within 5-6 hours followed by chills, cold sweats, weakness, whole body aches, fatigue, inability to function for activities of daily living. Symptoms and signs resolved by noon the next day. Note: separate event form filled out for spouse who had vaccine at same time.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient had severe rash on the arm which he got the shot for about 1 week. It is getting better now.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient vaccinated 9/7. Patient presented 9/9 to pharmacy displaying redness and swelling in the right arm. Swelling mainly just above the elbow on the posterior surface of the arm. Redness starting just below the vaccination site to the elbow. On 9/9 I recommended the patient take BENADRYL and follow up if the symptoms do not improve.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient's right arm feel tender to the touch, hot to the touch, and redness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Chills, Dyspnoea, Heart rate increased
Clinical narrative: Pt started feeling unwell in the afternoon. She had increased heart rate and blood pressure, heaviness in chest (labored breathing), numbness in legs and feet, fever, chills, excessive shaking. The symptoms started to alleviate later that evening and she is feeling better now.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Pyrexia, Tremor
Clinical narrative: Pt started feeling unwell in the afternoon. She had increased heart rate and blood pressure, heaviness in chest (labored breathing), numbness in legs and feet, fever, chills, excessive shaking. The symptoms started to alleviate later that evening and she is feeling better now.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient says her arm has been itching since she received the vaccination. She does not have any other symptoms. Also no redness or rash.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Aphasia, Asthenia, Fear of death, Myalgia, Somnolence
Clinical narrative: 9/1: Felt fine day of vaccine, went to sleep about 10pm. 9/2: Could not awaken at usual wake time of 5am, couldn't talk, profoundly weak, low grade fever ~100 degrees F, pt thought he was dying. Finally able to waken at about 5pm 9/2, still profoundly weak and muscle pain. Muslce pain lasted through 9/9 about 5am.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received the vaccine on 9/6/18. Patient stated that on 9/7/18 the area looked like a mosquito bite. Then on 9/8/19 the redness has increased to a large portion of her arm, it is tender to touch, the area is very warm and itchy with a raised, hardened bump. Patient is afebrile. She has tried ibuprofen and did not notice a difference. She stated it doesn't look like it's getting better and it isn't getting worse. Patient was instructed to try a cold compresses to the area and instructed to take Benadryl in the evening. Patient also instructed to contact her prescriber on Monday for further direction.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Patient received the vaccine on 9/6/18. Patient stated that on 9/7/18 the area looked like a mosquito bite. Then on 9/8/19 the redness has increased to a large portion of her arm, it is tender to touch, the area is very warm and itchy with a raised, hardened bump. Patient is afebrile. She has tried ibuprofen and did not notice a difference. She stated it doesn't look like it's getting better and it isn't getting worse. Patient was instructed to try a cold compresses to the area and instructed to take Benadryl in the evening. Patient also instructed to contact her prescriber on Monday for further direction.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Injection site pain, Myalgia
Clinical narrative: Patient first had a sore arm at the injection site for 2-3 days, she was massaging the area and after 4-5 days seems like the pain went down to her elbow area/muscle. There was never pain in the shoulder only injection site. There is no pain in the arm just the elbow area and she feels lightheaded.
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient reported pain in the arm and there was visible red patches around vaccination site.
Age: 34.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: REDNESS AROUND INJECTION SITE. RASH- PERSISTED FOR 3 DAYS.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Pain in shoulder night of, next morning-headache, shivering, fatigue, light fever, ringing in ears, diarrhea.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Pain in shoulder night of, next morning-headache, shivering, fatigue, light fever, ringing in ears, diarrhea.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Metabolic function test, Rash generalised, Urticaria
Clinical narrative: Developed large areas of hives/rash all over body that lasted for 2 1/2 - 3 weeks.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Inflammation, Nausea, Pain
Clinical narrative: Very painful, very red and inflamed, swollen, nauseous, tired. Went away Monday.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Very painful, very red and inflamed, swollen, nauseous, tired. Went away Monday.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Fever, Headache, in bed.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Pain, swelling and redness in Arm, headache, tired, nausea, shivering and fever.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Pain, swelling and redness in Arm, headache, tired, nausea, shivering and fever.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient is experiencing redness, swelling, soreness, and localised heat at site of injection.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient stated he was having swelling the night he received the injections on 9/7/18. He woke up with fever over 103 so he went to the ER. He received a shot of antibiotics and was discharged with BACTRIM for UTI and pain meds with stool softener. He did not pick up pain meds and stool softener. He will follow up with his PCP in a few days. I noticed swelling on the inner side of his right arm but not on the outside where he received the shot. Patient stated the swelling has gotten down and no longer has fever on 9/9/18.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The following vaccination, the patient found their right arm to be swollen and in pain (the left arm was fine).
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She had an burning, "fire" sensation at the time of time of the injection. The surrounding area turned red right away and it was swollen and hot feeling. She came in on 9/9/2018 and her arm was still a little swollen and slightly red. The surrounding area looked bruised. She said she had been having headaches and was having trouble sleeping. Not sure if that was an adverse reaction to the injection.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site warmth, Sleep disorder
Clinical narrative: She had an burning, "fire" sensation at the time of time of the injection. The surrounding area turned red right away and it was swollen and hot feeling. She came in on 9/9/2018 and her arm was still a little swollen and slightly red. The surrounding area looked bruised. She said she had been having headaches and was having trouble sleeping. Not sure if that was an adverse reaction to the injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Confusional state, Fatigue, Feeling abnormal, Headache
Clinical narrative: Quite a bit of pain to shoulder at injection site immediately after receiving. Within a few hours was barely able to move my arm, entire upper right quadrant was still and sore. Felt extreme fatigue as day continued and overnight, as well as fever (101.9), extreme joint pain, ears ringing, headache, confusion, restlessness and absolute misery; had to miss work the following day. Have generally not been phased at all  by any immunizations in the past. Had a very very light case of chicken pox as a child. Had the ZOSTAVAX vaccine in 2015 with zero side effects. Symptoms from SHINGRIX were nearly gone in 48 hours, beyond lingering headache.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pyrexia
Clinical narrative: Quite a bit of pain to shoulder at injection site immediately after receiving. Within a few hours was barely able to move my arm, entire upper right quadrant was still and sore. Felt extreme fatigue as day continued and overnight, as well as fever (101.9), extreme joint pain, ears ringing, headache, confusion, restlessness and absolute misery; had to miss work the following day. Have generally not been phased at all  by any immunizations in the past. Had a very very light case of chicken pox as a child. Had the ZOSTAVAX vaccine in 2015 with zero side effects. Symptoms from SHINGRIX were nearly gone in 48 hours, beyond lingering headache.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Tinnitus
Clinical narrative: Quite a bit of pain to shoulder at injection site immediately after receiving. Within a few hours was barely able to move my arm, entire upper right quadrant was still and sore. Felt extreme fatigue as day continued and overnight, as well as fever (101.9), extreme joint pain, ears ringing, headache, confusion, restlessness and absolute misery; had to miss work the following day. Have generally not been phased at all  by any immunizations in the past. Had a very very light case of chicken pox as a child. Had the ZOSTAVAX vaccine in 2015 with zero side effects. Symptoms from SHINGRIX were nearly gone in 48 hours, beyond lingering headache.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Severe headache approximately 12 hours after vaccination. The patient self-treated with 800mg ibuprofen without relief. The patient also experienced mild muscle aches and pains.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: Over the course of several days post vaccine patient experienced increase discomfort in arm. Heat and swelling down to elbow by Sunday (9/2) 4 days post vaccine. MD diagnosed patient with cellulitis and prescribed 7 day course of Doxycycline 100 mg twice daily. Patient reports
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient was given immunization on 8/21/18 and returned to the pharmacy on 9/8/18 showing a dime sized rash around the injection site that was itchy and not resolving. I referred patient to see her physician and she said she was going to call to get seen.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anti-thyroid antibody, Antinuclear antibody, Blood thyroid stimulating hormone, Body temperature increased, C-reactive protein
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Full blood count, Induration, Injection site erythema, Injection site oedema
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site warmth, Laboratory test, Lip swelling, Metabolic function test
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Rash, Rash erythematous, Rash pruritic, Red blood cell sedimentation rate
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Swelling face, Thyroxine, Ultrasound scan, Urticaria
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria chronic
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives, so doctor for treatment, cleared up for months then came back and Dr. stating due to SHINGRIX shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Night sweats, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 60-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the cellulitis, headache, injection site induration, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.  It was unknown if the reporter considered the cellulitis, fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: At 11:08 hours, the patient experienced on left deltoid. On the same evening, the patient experienced shaking, fever, chills and a headache. Next day after vaccination, the patient also experienced redness, pain, warmth and induration at the injection site. The caller stated that the redness was approximately the size of her full hand. The caller states that the site was hot as well. The caller states that she did seek medical attention and was prescribed Keflex and believed she might had cellulitis. The patient stated that she reported this to the pharmacy where she received the vaccine and they reported the event to the vaccine hotline.