chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Electrocardiogram, Headache
Clinical narrative: Blood pressure dramatically increased to 177/115 at its highest.  Symptoms were headache?s.  No other symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Paraesthesia, Rash
Clinical narrative: Tingling/burning in left arm then rash down whole arm appeared that night.  Rash was local to just the left arm.  Also very tired.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Immediate dizziness, faint feeling and nausea
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: Irregular heartbeat, fast rate, pounding heart, shortness of breath
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Alopecia Areata along with major hair fall
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Piloerection, Rash
Clinical narrative: long lasting goose bumps, bruise like rash on legs and soles of feet, pain in feet,
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Vertigo
Clinical narrative: 2 adverse effects 1. Vertigo beginning in January 2022. Have never experienced it prior 2. Intense, sometimes debilitating pain at injection site beginning towards end of Feb 2022
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Mechanical urticaria, Urine analysis, Urticaria
Clinical narrative: Hives/urticaria, severe dermatographia
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Skin warm, Swelling
Clinical narrative: The patient had swelling and hot to the touch.  Went to ER and Nurse there told patient that arm was infected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Alanine aminotransferase increased, Blood creatinine normal, Dizziness, Electronystagmogram
Clinical narrative: Low grade fever for over a week. Followed with dizziness. The dizziness hasn?t stopped. He?s been to a number of specialist. They cannot rule out adverse affect of Covid vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Labyrinthitis, Migraine, Myopia
Clinical narrative: Low grade fever for over a week. Followed with dizziness. The dizziness hasn?t stopped. He?s been to a number of specialist. They cannot rule out adverse affect of Covid vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Ophthalmological examination abnormal, Opticokinetic nystagmus tests abnormal, Pyrexia, Scan
Clinical narrative: Low grade fever for over a week. Followed with dizziness. The dizziness hasn?t stopped. He?s been to a number of specialist. They cannot rule out adverse affect of Covid vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Viral infection, Visual impairment
Clinical narrative: Low grade fever for over a week. Followed with dizziness. The dizziness hasn?t stopped. He?s been to a number of specialist. They cannot rule out adverse affect of Covid vaccine.
Age: 54.0
Sex: F
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt recieved all 3 vaccines on 03/06/2022. Her daughter came in to fill her Rx on 3/09/2022 and informed us she had rx from getting all 3 vaccines and she was seen by Dr at Hospital.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulins, Lip swelling, Peripheral swelling, Rheumatoid factor, Swelling face
Clinical narrative: After two weeks notice swelling on Face, Lips , After couple days swelling on Tongue and Finger  Break out of Hives like Ulticaria
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: After two weeks notice swelling on Face, Lips , After couple days swelling on Tongue and Finger  Break out of Hives like Ulticaria
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Bell's palsy, Ear swelling, Facial paralysis, Fatigue
Clinical narrative: On 1/07/2022-1/09/2022 I had significant swelling in my left armpit and fatigue.  The fatigue remained for two weeks.  Then on 1/20/2022, I had swelling in my gums, which progressed to my ear.  I went to the dentist and then primary care on 1/25/2022 when I was diagnosed with shingles on the mandibular branch of the trigeminal nerve.  On 2/10/2022 I had to go the Emergency room as my right facial muscles were paralyzed.  I received a Bells Palsy diagnosis secondary to my shingles then.  On 3/3/2022 I had an MRI which confirmed the Bells Palsy is still present.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Herpes zoster, Interchange of vaccine products, Magnetic resonance imaging head abnormal, Oedema peripheral
Clinical narrative: On 1/07/2022-1/09/2022 I had significant swelling in my left armpit and fatigue.  The fatigue remained for two weeks.  Then on 1/20/2022, I had swelling in my gums, which progressed to my ear.  I went to the dentist and then primary care on 1/25/2022 when I was diagnosed with shingles on the mandibular branch of the trigeminal nerve.  On 2/10/2022 I had to go the Emergency room as my right facial muscles were paralyzed.  I received a Bells Palsy diagnosis secondary to my shingles then.  On 3/3/2022 I had an MRI which confirmed the Bells Palsy is still present.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast
Clinical narrative: On 1/07/2022-1/09/2022 I had significant swelling in my left armpit and fatigue.  The fatigue remained for two weeks.  Then on 1/20/2022, I had swelling in my gums, which progressed to my ear.  I went to the dentist and then primary care on 1/25/2022 when I was diagnosed with shingles on the mandibular branch of the trigeminal nerve.  On 2/10/2022 I had to go the Emergency room as my right facial muscles were paralyzed.  I received a Bells Palsy diagnosis secondary to my shingles then.  On 3/3/2022 I had an MRI which confirmed the Bells Palsy is still present.
Age: 59.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Decreased appetite, Fatigue, Inflammation, Pyrexia, Skin reaction
Clinical narrative: Red, inflamed left arm, fever, fatigue, loss of appetite
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac flutter, Dyspnoea, Fibrin D dimer increased, Heart rate increased
Clinical narrative: Approximately in November 2021 I began to feel strong heartbeats, even when I was sleeping peacefully I woke up flustered and suddenly with a fluttering heart. At certain moments I felt that my breathing was not adequate. Waking up suddenly became more frequent, so I decided to start going to doctors. In January I saw a doctor for the first time for this situation.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Sleep disorder, Tachycardia, Urine analysis
Clinical narrative: Approximately in November 2021 I began to feel strong heartbeats, even when I was sleeping peacefully I woke up flustered and suddenly with a fluttering heart. At certain moments I felt that my breathing was not adequate. Waking up suddenly became more frequent, so I decided to start going to doctors. In January I saw a doctor for the first time for this situation.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Cough, Fatigue
Clinical narrative: Weakness, fatigue, cough
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Bursitis, Inflammation, Joint range of motion decreased, Rotator cuff syndrome
Clinical narrative: Soon after the injection the shoulder became extremely painful--far more than typical with a shot. The pain did not subside or resolve. It remained very painful and I had limited range of motion for 6-8 weeks; then there was a slight diminishment. I had an ultrasound 2 months after injection and "significant bursitis" and a rotator cuff tear was discovered. The doctor thought it very likely that I was injected into the bursa, not the Deltoid. He prescribed Voltaren gel and there was a significant decrease in inflammation and pain, but it still has not completely resolved, almost 5 months later.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound scan abnormal
Clinical narrative: Soon after the injection the shoulder became extremely painful--far more than typical with a shot. The pain did not subside or resolve. It remained very painful and I had limited range of motion for 6-8 weeks; then there was a slight diminishment. I had an ultrasound 2 months after injection and "significant bursitis" and a rotator cuff tear was discovered. The doctor thought it very likely that I was injected into the bursa, not the Deltoid. He prescribed Voltaren gel and there was a significant decrease in inflammation and pain, but it still has not completely resolved, almost 5 months later.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Laboratory test, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient is a 20 year old male who began having stiffness and soreness in his back approximately 3 weeks after receiving the Moderna booster. Over the next 4 weeks his symptoms progressively got worse to where he was not able to lift his legs or arms. He also had tachycardia along with fevers of up to 103.7. He was hospitalized with a diagnosis of possible acute rheumatic fever or adverse reaction to COVID Booster. He was given IV steroids in the hospital and had remarkable results. He is home now on a tapering dose of Prednisone but continues to have a resting heart rate between 90-100, fatigue, and some muscle stiffness.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Patient is a 20 year old male who began having stiffness and soreness in his back approximately 3 weeks after receiving the Moderna booster. Over the next 4 weeks his symptoms progressively got worse to where he was not able to lift his legs or arms. He also had tachycardia along with fevers of up to 103.7. He was hospitalized with a diagnosis of possible acute rheumatic fever or adverse reaction to COVID Booster. He was given IV steroids in the hospital and had remarkable results. He is home now on a tapering dose of Prednisone but continues to have a resting heart rate between 90-100, fatigue, and some muscle stiffness.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Eye swelling, Pruritus, Rash, Urticaria
Clinical narrative: A week after my booster, I   broke out in severe hives and itchiness. I   also became very swollen from my right ear and eye until I   went to urgent care. They gave me benadryl but I   was itchy for another week with rashes everywhere. The itchiness comes and goes but I   know break out in hives in all areas of my body everyday.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, X-ray normal
Clinical narrative: Lower back pain that increased to such severity that I could not walk for a day. I have had PT and pain meds that have not helped the pain.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Amylase, Anti-thyroid antibody, Antinuclear antibody, Arthralgia, Asthenia
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Computerised tomogram abdomen normal, Constipation, Differential white blood cell count, Discomfort
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Epstein-Barr virus antibody, Flank pain, Flatulence, Full blood count, Immediate post-injection reaction
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Laboratory test, Lipase, Lipids, Loss of personal independence in daily activities
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Musculoskeletal chest pain, Poor quality sleep, Rash macular, Red blood cell sedimentation rate
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Rheumatoid factor, Sexually transmitted disease test, Streptococcus test negative, Thyroid function test, Thyroxine
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Urinary system X-ray, Urine analysis normal, Vitamin D
Clinical narrative: Immediately after vaccine, developed red splotching ~1" under injection site, then developed 3 splotches on her arm. Developed pain under her left ribs and her left shoulder later that night. Did not sleep well. The next night she did not sleep well either. Symptoms improved within 72h and were better within one week.  Mom called the clinic and reported these SE on 2/5, no action was taken as these were expected, instructed Mom to continue to monitor her.  On 3/6, she developed pain on her left side (specifically under her ribs) with questionable involvement of her left shoulder and hip (Mom poor historian and story is scattered) that caused her to "double over" in pain. Was taken to the ED. CT Abd and Pelvis WNL; UA (-). ED suspected constipation and gas pains. On 3/7 f/u in clinic where she presented with no pain, abdominal exam WNL; LUE with full ROM, 5/5 strength, and no lesions, bruising, swelling, or hematomas assessed. Rapid Strep and UA (-). Instructed to increase dose and freq of Miralax and added daily fiber gummies.  On 3/9 Mom called the clinic and reported that her pain had worsened. The pain is skipping around from her left rib cage, left shoulder, and left hip; no pattern. States that she is weak, but then states that it is not weakness but  "tightness"  of the left side which is affecting her ADLs (cannot perform any ADLs that include the use of her "stomach muscles").  Pain now includes her right rib cage.  Sent for KUB and labwork at local hospital (UA, STI panel, CMP, CBC w/ diff, ESR, CRP, Vit D, Lipid Panel, TFTs, TPO, Total T4, Celiac Panel, EBV titers, Amylase, Lipase, ANA, and Rheum Panel) this afternoon. Those results are pending at the time of this submission.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Tonsillar hypertrophy
Clinical narrative: tonsillar swelling, difficulty swallowing, palpable lymph nodes in neck. Started within minutes of getting vaccine. Took 50 of benadryl at 0830. noticed improvement in swelling by 0900. Resolved by end of day.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cardiac stress test, Electrocardiogram, Headache, Laboratory test
Clinical narrative: Headaches, BP rise to 170/100.  Had to start taking blood pressure medication, 50 mg of losartan twice a day now.  Was never on BP medication before or have record of hypertension at regular appointments.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound biliary tract, Urine analysis
Clinical narrative: Headaches, BP rise to 170/100.  Had to start taking blood pressure medication, 50 mg of losartan twice a day now.  Was never on BP medication before or have record of hypertension at regular appointments.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood lactic acid, Dizziness, Fatigue, Full blood count abnormal, Headache
Clinical narrative: (Received Menactra at age 11 w/o problem)  Headache, dizziness, myalgias, fatigue, on menses seen at ED on 3/8/2022 at 7:50pm with HR 125 BP 87/55.  3/18/2022 22.4>11.7<261 - 35.5   82/9 9/0
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Human chorionic gonadotropin, Influenza A virus test, Influenza B virus test, Myalgia, Protein urine present
Clinical narrative: (Received Menactra at age 11 w/o problem)  Headache, dizziness, myalgias, fatigue, on menses seen at ED on 3/8/2022 at 7:50pm with HR 125 BP 87/55.  3/18/2022 22.4>11.7<261 - 35.5   82/9 9/0
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Red blood cells urine positive, Respiratory viral panel, Urine analysis abnormal
Clinical narrative: (Received Menactra at age 11 w/o problem)  Headache, dizziness, myalgias, fatigue, on menses seen at ED on 3/8/2022 at 7:50pm with HR 125 BP 87/55.  3/18/2022 22.4>11.7<261 - 35.5   82/9 9/0
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: HEADACHE STARTED NIGHT OF FIRST VACCINATION AND PERSISTS
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hallucination, Hallucination, visual, Psychotic disorder, Suicidal ideation
Clinical narrative: In September of 2021 I was having more hallucinations and wanted to kill myself.  My doctor prescribed me Celexa but it ended up making me worse.  I had a bad psychosis episode in November2021 where I was getting visits by aliens and demons.  At this point I was already contemplating on my suicide.  I even went into my garage and turned the car on to kill myself, but the cops ended up coming and they were going to arrest me but my wife was able to talk them out of it if I checked my self into an outpatient clinic.  My doctor then changed my medication to Lexapro with Buproprion and that helped.  I am now off of the anti-depressant medication and I am fine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest pain, Computerised tomogram, Contusion
Clinical narrative: PASSED OUT AT WORK; CHEST PAIN; LEFT LEG SWELLING; NECK PAIN; BACK PAIN; NO BALANCE; ONE EYE BLURRY; BRUISING ON CHIN OF LEFT LEG; BAD NAUSEA; This spontaneous report received from a patient concerned a 55 year old female of unspecified race and ethnic origin. The patient's weight was 160 (unit unspecified), and height was 180.3 centimeters. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no allergies, no history of abuse and no other medical history or relevant preexisting conditions. The patient had no illness at the time of vaccination, no history of similar event, no adverse event after any previous vaccination, no history of hospitalization in last 30 days, no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered to left arm on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No issues related to the storage of the vaccine. No concomitant medications were reported. On 04-DEC-2021, the patient experienced chest pain (for 2 days). On the same day, the patient passed out at his work because he was dizzy. On that day, he also experienced neck and back pain, no balance, left leg swelling, one eye blurry, bruising on chin of left leg and bad nausea. On an unspecified date, the patient had physician's room and emergency room (ER) visit and was hospitalized for 4 days (date of discharge unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Computerised tomography (NR: not provided) Not reported, Diagnostic ultrasound (NR: not provided) Not reported, and MRI (Magnetic resonance imaging) (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 06-DEC-2021, and had not recovered from left leg swelling, bad nausea, neck pain, one eye blurry, bruising on chin of left leg, back pain, passed out at work, and no balance. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220314501-Covid-19 vaccine ad26.CoV-2.s- Passed out at work, chest pain, left leg swelling, neck pain, back pain, no balance, one eye blurry, bruising of chin of left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220314501-Covid-19 vaccine ad26.CoV-2.s-Bad nausea. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Loss of consciousness, Magnetic resonance imaging, Nausea, Neck pain
Clinical narrative: PASSED OUT AT WORK; CHEST PAIN; LEFT LEG SWELLING; NECK PAIN; BACK PAIN; NO BALANCE; ONE EYE BLURRY; BRUISING ON CHIN OF LEFT LEG; BAD NAUSEA; This spontaneous report received from a patient concerned a 55 year old female of unspecified race and ethnic origin. The patient's weight was 160 (unit unspecified), and height was 180.3 centimeters. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no allergies, no history of abuse and no other medical history or relevant preexisting conditions. The patient had no illness at the time of vaccination, no history of similar event, no adverse event after any previous vaccination, no history of hospitalization in last 30 days, no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered to left arm on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No issues related to the storage of the vaccine. No concomitant medications were reported. On 04-DEC-2021, the patient experienced chest pain (for 2 days). On the same day, the patient passed out at his work because he was dizzy. On that day, he also experienced neck and back pain, no balance, left leg swelling, one eye blurry, bruising on chin of left leg and bad nausea. On an unspecified date, the patient had physician's room and emergency room (ER) visit and was hospitalized for 4 days (date of discharge unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Computerised tomography (NR: not provided) Not reported, Diagnostic ultrasound (NR: not provided) Not reported, and MRI (Magnetic resonance imaging) (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 06-DEC-2021, and had not recovered from left leg swelling, bad nausea, neck pain, one eye blurry, bruising on chin of left leg, back pain, passed out at work, and no balance. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220314501-Covid-19 vaccine ad26.CoV-2.s- Passed out at work, chest pain, left leg swelling, neck pain, back pain, no balance, one eye blurry, bruising of chin of left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220314501-Covid-19 vaccine ad26.CoV-2.s-Bad nausea. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound scan, Vision blurred
Clinical narrative: PASSED OUT AT WORK; CHEST PAIN; LEFT LEG SWELLING; NECK PAIN; BACK PAIN; NO BALANCE; ONE EYE BLURRY; BRUISING ON CHIN OF LEFT LEG; BAD NAUSEA; This spontaneous report received from a patient concerned a 55 year old female of unspecified race and ethnic origin. The patient's weight was 160 (unit unspecified), and height was 180.3 centimeters. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no allergies, no history of abuse and no other medical history or relevant preexisting conditions. The patient had no illness at the time of vaccination, no history of similar event, no adverse event after any previous vaccination, no history of hospitalization in last 30 days, no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered to left arm on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No issues related to the storage of the vaccine. No concomitant medications were reported. On 04-DEC-2021, the patient experienced chest pain (for 2 days). On the same day, the patient passed out at his work because he was dizzy. On that day, he also experienced neck and back pain, no balance, left leg swelling, one eye blurry, bruising on chin of left leg and bad nausea. On an unspecified date, the patient had physician's room and emergency room (ER) visit and was hospitalized for 4 days (date of discharge unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Computerised tomography (NR: not provided) Not reported, Diagnostic ultrasound (NR: not provided) Not reported, and MRI (Magnetic resonance imaging) (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 06-DEC-2021, and had not recovered from left leg swelling, bad nausea, neck pain, one eye blurry, bruising on chin of left leg, back pain, passed out at work, and no balance. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220314501-Covid-19 vaccine ad26.CoV-2.s- Passed out at work, chest pain, left leg swelling, neck pain, back pain, no balance, one eye blurry, bruising of chin of left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220314501-Covid-19 vaccine ad26.CoV-2.s-Bad nausea. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Fatigue, Headache
Clinical narrative: The next day, I starting getting flu symptoms. I had joint aches and pain. I had fatigue, chills, headaches, and eye pain. These lasted for about 2 days. Then it stop for 1 day and the come back for 2 days. It continued like this for the first week after my vaccine. I could not get out of bed for that whole week. The fatigue has been coming every since March of 2021. It comes and goes. I keep getting cold like symptoms as well.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Mobility decreased, Nasopharyngitis
Clinical narrative: The next day, I starting getting flu symptoms. I had joint aches and pain. I had fatigue, chills, headaches, and eye pain. These lasted for about 2 days. Then it stop for 1 day and the come back for 2 days. It continued like this for the first week after my vaccine. I could not get out of bed for that whole week. The fatigue has been coming every since March of 2021. It comes and goes. I keep getting cold like symptoms as well.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Biopsy breast, Burning sensation, Condition aggravated, Irritable bowel syndrome
Clinical narrative: After taking the shot she started having burning and pain in her right arm then went to the armpits. Aches and muscle pain everywhere. Her IBS got worse. She called her dr and was told by the nurse that that was the side effects. Itching in arm and  upper and lower back.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pruritus
Clinical narrative: After taking the shot she started having burning and pain in her right arm then went to the armpits. Aches and muscle pain everywhere. Her IBS got worse. She called her dr and was told by the nurse that that was the side effects. Itching in arm and  upper and lower back.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Faeces soft, Fall, Hypersomnia, Vomiting
Clinical narrative: SOFT STOOL; ABDOMINAL BELLY PAIN; VOMITING/THREW UP CONSUMED FOOD; SLEPT ALL DAY; FELL TO SIDE OF BED; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient otherwise was healthy and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced fell to side of bed. On 28-MAY-2021, the patient experienced slept all day. On 29-MAY-2021, the patient experienced vomiting/threw up consumed food. On an unspecified date, the patient experienced soft stool, and abdominal belly pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting/threw up consumed food, soft stool, and abdominal belly pain, and the outcome of fell to side of bed and slept all day was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M increased, Borrelia test negative, C-reactive protein increased, Cardiac imaging procedure abnormal, Chest pain
Clinical narrative: #Myopericarditis Patient presented with chest pain, fever, SOB, elevated troponin and CRP consistent with myopericarditis. Etiology remained unclear during hospital stay with Lyme being possible explanation given endemic area, positive IgM antibody, and (? Western blot).  Viral etiology is also possible but PCR tests for associated respiratory virus was negative. Remaining tests were notable for Lyme being negative. TTE (5/17) unremarkable with normal EF of 65%. cMRI (5/18) showed mild abnormalities concerning for myocarditis with on signs of significant pericardial inflammation. Despite negative studies, her clinical syndrome was consistent with myocarditis and negative imaging is favorable prognostic sign.  She was treated with 2g IV ceftriaxone daily for suspected Lyme and ibuprofen 600 mg TID/ colchine 0.6 mg BID for suspected pericardial inflammation. Chest pain improved significantly with these medications. Discharged on colchicine and ibuprofen with followup
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Ejection fraction, Ejection fraction normal, Immunology test
Clinical narrative: #Myopericarditis Patient presented with chest pain, fever, SOB, elevated troponin and CRP consistent with myopericarditis. Etiology remained unclear during hospital stay with Lyme being possible explanation given endemic area, positive IgM antibody, and (? Western blot).  Viral etiology is also possible but PCR tests for associated respiratory virus was negative. Remaining tests were notable for Lyme being negative. TTE (5/17) unremarkable with normal EF of 65%. cMRI (5/18) showed mild abnormalities concerning for myocarditis with on signs of significant pericardial inflammation. Despite negative studies, her clinical syndrome was consistent with myocarditis and negative imaging is favorable prognostic sign.  She was treated with 2g IV ceftriaxone daily for suspected Lyme and ibuprofen 600 mg TID/ colchine 0.6 mg BID for suspected pericardial inflammation. Chest pain improved significantly with these medications. Discharged on colchicine and ibuprofen with followup
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myopericarditis, Pyrexia, Troponin T increased, Troponin increased
Clinical narrative: #Myopericarditis Patient presented with chest pain, fever, SOB, elevated troponin and CRP consistent with myopericarditis. Etiology remained unclear during hospital stay with Lyme being possible explanation given endemic area, positive IgM antibody, and (? Western blot).  Viral etiology is also possible but PCR tests for associated respiratory virus was negative. Remaining tests were notable for Lyme being negative. TTE (5/17) unremarkable with normal EF of 65%. cMRI (5/18) showed mild abnormalities concerning for myocarditis with on signs of significant pericardial inflammation. Despite negative studies, her clinical syndrome was consistent with myocarditis and negative imaging is favorable prognostic sign.  She was treated with 2g IV ceftriaxone daily for suspected Lyme and ibuprofen 600 mg TID/ colchine 0.6 mg BID for suspected pericardial inflammation. Chest pain improved significantly with these medications. Discharged on colchicine and ibuprofen with followup
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: decreased arm mobility; pain in the injected arm; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient had been experiencing pain and decreased mobility in the arm in which the vaccine was injected. The patient was given medical disclaimer. Referred to HCP (health care professional). Spoke per PI and content. Provided MI phone number for HCP reference. The patient consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: decreased arm mobility; pain in the injected arm; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient had been experiencing pain and decreased mobility in the arm in which the vaccine was injected. The patient was given medical disclaimer. Referred to HCP (health care professional). Spoke per PI and content. Provided MI phone number for HCP reference. The patient consented to follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Feeling abnormal, Groin pain
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Lymph node pain, Lymphadenopathy, Muscle twitching
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Visual impairment
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.