chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072) dose was not reported, once a total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 years and 10 months at the time of administration of vaccine.  No adverse side effects to date.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began the evening of the vaccination and to date has not stopped.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Hives that had been predominately dormant flared up that night and a week+ later continue on trunk, arms and legs and continue to today.  If not getting better will be put on steroids.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Had chills and could not get warm all night.  Lasted for about 6-8 hours.  Got headache in the morning at 7 a.m..  Went back to bed, woke up around 4 p.m.  feeling much better.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Fatigue, Hypersensitivity, Lethargy
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: Head ache, Body ache ,exhausted, short breath
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Facial paresis, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness of face, arm and leg (right side of the face became droopy), closed-eye hallucination, vision blurriness, difficulty breathing, brain fog, tingling sensations on the chest and neck.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Numbness of face, arm and leg (right side of the face became droopy), closed-eye hallucination, vision blurriness, difficulty breathing, brain fog, tingling sensations on the chest and neck.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Heart rate irregular, Hypertension, Myalgia
Clinical narrative: FEVER; MUSCLE ACHE; FATIGUE; ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle ache. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced elevated blood pressure. On 09-MAR-2021, the subject experienced elevated heart rate. On 09-MAR-2021, the subject experienced irregular heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle ache, fatigue, elevated blood pressure, elevated heart rate, and irregular heart beat on 11-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; MUSCLE ACHE; FATIGUE; ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle ache. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced elevated blood pressure. On 09-MAR-2021, the subject experienced elevated heart rate. On 09-MAR-2021, the subject experienced irregular heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle ache, fatigue, elevated blood pressure, elevated heart rate, and irregular heart beat on 11-MAR-2021. This report was non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: an 87 y/o female with PMH significant for right MCA CVA s/p thrombectomy 12/27/2020 with left sided residual, left ophthalmic CVA, type 2 DM, HTN, HLD, obesity who complains of twitching.   History is obtained from pt's sister at bedside. She states over the past 3 days the pt has had twitching of her left face and arm which she says is basically constant. Unknown if there have been any recent medication changes. Pt had a telephone appointment with NES today who referred her to stroke neurology. Today pt's sister asked her neighbor who is an RN to come take a look at her, who advised that she bring the pt to the ER.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: tingling in LLE left lower extremity-Mild
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Lymphadenopathy, Rash
Clinical narrative: My husband got a headache and a rash on his temple, starting the Wednesday after his second shot. His headache and the rash got worse, along with swollen lymph nosed on his neck and head. He went to an urgent care clinic on Saturday, a week after his second Moderna shot, and was diagnosed with shingles. He was given gabapentin, a generic of Valtrex and prednisone.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paresis
Clinical narrative: On 19 April 2021 patient developed left-sided facial weakness in the afternoon, seen in the ER that evening and diagnosed with left-sided Bell's palsy. No associated loss of hearing or taste. No other symptoms of weakness or diplopia. Does have a history of multiple sclerosis (on disease modifying treatment).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haematoma, Injection site haemorrhage
Clinical narrative: Recipient began to bleed at the vaccine administration site immediately upon administration. She developed a hematoma the size of a quarter. Direct pressure applied along with an ice pack. She was monitored for 30 minutes and the bleeding had stopped at that point and the hematoma size had decreased.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: For days 1-7, post-vaccine:  Headache, fatigue, joint pain, severe.  For days 14-16 post-vaccine:  Fever, 101.1-101.4, severe joint pain, headache  For days 17-19 post-vaccine, severe joint pain  Day 20 post-vaccine, moderating joint pain, hopefully recovering, but uncertain whether or not symptoms will reappear.  Joint pain was most severe in fingers, elbows, shoulders.  It even affected my "good" knee.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: PERSISTENT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced persistent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bacteraemia, Hypotension, Sepsis, Tachycardia, Urinary tract infection
Clinical narrative: Patient with extensive PMH- rectal adenocarcinoma with colostomy, sacral ulcers, cardiomyopathy, from Nursing Home. Sent from nursing home due to persistent hypotension for 2 days which did not respond to IV fluids,  sepsis since patient was tachycardic and hypotensive. Urinalysis positive, sepsis possibly due to urinary tract infection, patient also with bacteremia- gram-negative. Patient still hospitalized on antibiotics.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: Patient with extensive PMH- rectal adenocarcinoma with colostomy, sacral ulcers, cardiomyopathy, from Nursing Home. Sent from nursing home due to persistent hypotension for 2 days which did not respond to IV fluids,  sepsis since patient was tachycardic and hypotensive. Urinalysis positive, sepsis possibly due to urinary tract infection, patient also with bacteremia- gram-negative. Patient still hospitalized on antibiotics.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: The day after the vaccine I woke up with a red, raised, warm, itchy circular rash on my arm at the injection site. It was about 2 inches by 2 inches. It is currently 3 days after my vaccine and I still have it. I am 7 weeks pregnant with EDD of 12/1/21.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache, sore arm
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypersomnia, Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes.  I was just about to call for the nurse when it seemed to subside. I felt fine that afternoon, but the following day I had no energy and slept for 12 hours.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: after receiving 2nd shot, patient feels dizziness and swating, feels like passing out. but he was alert. asked about diabetes issue and he denied. offered gatoraid and he said he would like to drink that and provided one bottle with store manager's authorization and after 20 minuts he was feeling better.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: I had chills, still do. I can't get warm.  I stayed covered with clothes and a blanket all day Saturday and Sunday.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Nausea, fatigue, pain and weakness in/at vaccine site
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Continuous positive airway pressure, Cough, Dyspnoea
Clinical narrative: Patient was seen and examined at the bedside. The patient is a 91 yr/o male with a history of CHF, NSVT, aortic stenosis, atrial fibrillation, HTN, hypothyroidism, DM2 who presents to the emergency room with complaints of chest pain and worsening shortness of breath.  He reports he got his second Covid vaccine yesterday and was feeling well until about 1 AM when he woke up acutely short of breath.  His wife checked his oxygen and reports he was 90% on his home 2 L.  He felt he could not breathe unless he was sitting straight up.  He changed over to his CPAP and was able to breathe and fall asleep comfortably.  Today throughout the day his shortness of breath has persisted and he was due to see his cardiologist so they went to his appointment.  While at the appointment he developed substernal chest pressure.  It did not radiate.  It resolved with 2 sublingual nitroglycerin.  Patient was transferred to the emergency room for further evaluation.  Patient denies any fever or chills.  He has a chronic cough with clear sputum unchanged.  He reports worsening lower extremity edema over the past few days.  He reports he has been taking all of his cardiac medications as prescribed.   Work-up in the emergency room concerning for acute on chronic CHF exacerbation.  Troponins mildly elevated but are plateaued.  No further chest pain while in the emergency room.  Patient to be admitted for further evaluation and treatment
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oedema peripheral, Troponin increased
Clinical narrative: Patient was seen and examined at the bedside. The patient is a 91 yr/o male with a history of CHF, NSVT, aortic stenosis, atrial fibrillation, HTN, hypothyroidism, DM2 who presents to the emergency room with complaints of chest pain and worsening shortness of breath.  He reports he got his second Covid vaccine yesterday and was feeling well until about 1 AM when he woke up acutely short of breath.  His wife checked his oxygen and reports he was 90% on his home 2 L.  He felt he could not breathe unless he was sitting straight up.  He changed over to his CPAP and was able to breathe and fall asleep comfortably.  Today throughout the day his shortness of breath has persisted and he was due to see his cardiologist so they went to his appointment.  While at the appointment he developed substernal chest pressure.  It did not radiate.  It resolved with 2 sublingual nitroglycerin.  Patient was transferred to the emergency room for further evaluation.  Patient denies any fever or chills.  He has a chronic cough with clear sputum unchanged.  He reports worsening lower extremity edema over the past few days.  He reports he has been taking all of his cardiac medications as prescribed.   Work-up in the emergency room concerning for acute on chronic CHF exacerbation.  Troponins mildly elevated but are plateaued.  No further chest pain while in the emergency room.  Patient to be admitted for further evaluation and treatment
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: SHORTNESS OF BREATH; HEADACHE; MUSCLE ACHES; FATIGUE; SINUS (CONGESTION/RUNNY NOSE); LITTLE COUGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. Batch numbers have been requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced shortness of breath. On 04-MAR-2021, the patient experienced headache. On 04-MAR-2021, the patient experienced muscle aches. On 04-MAR-2021, the patient experienced fatigue. On 04-MAR-2021, the patient experienced sinus (congestion/runny nose). On 04-MAR-2021, the patient experienced little cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, muscle aches, fatigue, sinus (congestion/runny nose), and little cough, and the outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: SHORTNESS OF BREATH; HEADACHE; MUSCLE ACHES; FATIGUE; SINUS (CONGESTION/RUNNY NOSE); LITTLE COUGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. Batch numbers have been requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced shortness of breath. On 04-MAR-2021, the patient experienced headache. On 04-MAR-2021, the patient experienced muscle aches. On 04-MAR-2021, the patient experienced fatigue. On 04-MAR-2021, the patient experienced sinus (congestion/runny nose). On 04-MAR-2021, the patient experienced little cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, muscle aches, fatigue, sinus (congestion/runny nose), and little cough, and the outcome of headache was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Back pain, COVID-19, Ear pain, Pyrexia
Clinical narrative: Tested positive for covid 19. Took test on 4/14 and 4/16. Both positive. Symptoms include runny nose, congestion in head, back ache, ear ache, low grade fever (99.2) loss of smell.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Tested positive for covid 19. Took test on 4/14 and 4/16. Both positive. Symptoms include runny nose, congestion in head, back ache, ear ache, low grade fever (99.2) loss of smell.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Since the day after receiving the 2nd dose of Moderna, I have had buzzing in my ears, particularly on the Left side (same side as vaccination).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy period and clumps the next day which was my second day of my periods. Usually the first two days are heavy but I had never seen as much flow as I saw after the vaccine. I literally I had to change every couple of hours and wear double pads.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Arm Pain (first vaccine on April 3rd on right arm, pain began on rt side arm about 2-3 days after words, fingers get numb when holding phone, gets especially bad when laying down and going to bed, shooting burning and numbing pain, rt hand and arm are weak)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Burning sensation, Chest pain
Clinical narrative: Arm Pain (first vaccine on April 3rd on right arm, pain began on rt side arm about 2-3 days after words, fingers get numb when holding phone, gets especially bad when laying down and going to bed, shooting burning and numbing pain, rt hand and arm are weak)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscular weakness, Myositis, Neck pain, Neuralgia
Clinical narrative: Arm Pain (first vaccine on April 3rd on right arm, pain began on rt side arm about 2-3 days after words, fingers get numb when holding phone, gets especially bad when laying down and going to bed, shooting burning and numbing pain, rt hand and arm are weak)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Arm Pain (first vaccine on April 3rd on right arm, pain began on rt side arm about 2-3 days after words, fingers get numb when holding phone, gets especially bad when laying down and going to bed, shooting burning and numbing pain, rt hand and arm are weak)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Extreme fatigue. Inflamed muscle, nerve pain, from fingers to shoulder blade, including pain in neck, right side of chest and breast, right armpit, arm, hand, finger, shoulder and shoulder blade, tingling in right fingers, fingers and hand extremely cold, sometimes burning sensation up and down arm, right arm range of motion is not high, grip is very weak, arm is very weak.  Treatment: taking Ibuprofen.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Burning sensation, Chest pain
Clinical narrative: Extreme fatigue. Inflamed muscle, nerve pain, from fingers to shoulder blade, including pain in neck, right side of chest and breast, right armpit, arm, hand, finger, shoulder and shoulder blade, tingling in right fingers, fingers and hand extremely cold, sometimes burning sensation up and down arm, right arm range of motion is not high, grip is very weak, arm is very weak.  Treatment: taking Ibuprofen.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscular weakness, Myositis, Neck pain, Neuralgia
Clinical narrative: Extreme fatigue. Inflamed muscle, nerve pain, from fingers to shoulder blade, including pain in neck, right side of chest and breast, right armpit, arm, hand, finger, shoulder and shoulder blade, tingling in right fingers, fingers and hand extremely cold, sometimes burning sensation up and down arm, right arm range of motion is not high, grip is very weak, arm is very weak.  Treatment: taking Ibuprofen.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Extreme fatigue. Inflamed muscle, nerve pain, from fingers to shoulder blade, including pain in neck, right side of chest and breast, right armpit, arm, hand, finger, shoulder and shoulder blade, tingling in right fingers, fingers and hand extremely cold, sometimes burning sensation up and down arm, right arm range of motion is not high, grip is very weak, arm is very weak.  Treatment: taking Ibuprofen.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash, swelling, itchy
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Lightheaded, change in skin color, Sweaty.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Fatigue, headache, nausea, body aches
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspnoea, Fatigue, Muscular weakness
Clinical narrative: WEAKNESS IN THE LEGS; CHILLS; FEVER; LOWER BACK PAIN; SHORTNESS OF BREATH; NAUSEA; SORENESS OF THE ARM; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced soreness of the arm. On 07-MAR-2021, the subject experienced fatigue. On 08-MAR-2021, the subject experienced lower back pain. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced weakness in the legs. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chills, fever, fatigue, and nausea on 08-MAR-2021, was recovering from weakness in the legs, and soreness of the arm, and had not recovered from lower back pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: WEAKNESS IN THE LEGS; CHILLS; FEVER; LOWER BACK PAIN; SHORTNESS OF BREATH; NAUSEA; SORENESS OF THE ARM; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced soreness of the arm. On 07-MAR-2021, the subject experienced fatigue. On 08-MAR-2021, the subject experienced lower back pain. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced weakness in the legs. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chills, fever, fatigue, and nausea on 08-MAR-2021, was recovering from weakness in the legs, and soreness of the arm, and had not recovered from lower back pain. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient with PMH of epilepsy, alcohol use disorder, CVA, dementia presented to ED with witnessed seizures while in bed. History of non-compliance, multiple admissions for seizures previously.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Throat irritation
Clinical narrative: 9 days after the vaccine I still have a very inflamed throat, chronically and visibly inflamed lymph nodes. I have 4 days of anti-inflammatory treatment but no results.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Aphasia, Condition aggravated, Echocardiogram, Hypertension
Clinical narrative: expressive aphasia for one day. In emergency department, noted to be hypertensive to ~200/100 with HR to 100s.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head
Clinical narrative: expressive aphasia for one day. In emergency department, noted to be hypertensive to ~200/100 with HR to 100s.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Gastrointestinal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Presented to emergency department for GI bleed and was found to be COVID-19 positive during screening prior to hospital admission. No symptoms reported at time of writing and no treatment required for infection.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal tenderness, Dizziness, Headache, Injection site haemorrhage, Vision blurred
Clinical narrative: As soon as I received it, about 2 minutes after, it was a drive thru event and my mom was also with me in the car receiving the vaccine also. I was still waiting for the nurse to replace her bandaid since she was bleeding a little more than normal. As soon as the car got out of the tent, I was driving, it felt like my head was being drilled, my vision blurred, everything turned dark, I could not hear, I had a bad headache almost about to faint but I kept on driving slowly to get to the waiting area. By the time I parked, I removed my mask, open the car window and relaxed and just started inhaling deeply.  I felt better soon after and spoke to the nurse there and she recommended drinking fluids the next 48 hrs.  I felt dizzy,  tired but not very sore like the first dose.  2 days later, I still feel dizzy, vision is blurry sometimes and occasional headache, a little tenderness on abdomen and feeling like I am catching my breath sometimes.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes simplex, Injection site pain
Clinical narrative: Arm soreness at injection site for 1.5 days following vaccine; fatigue within 4 hours of shot; severe HSV1 outbreak on upper lip began 2 days after shot
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain
Clinical narrative: Sore throat and ear ache for 2 plus weeks
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills, aches
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: The morning I received vaccine 4/6/21, I had no ill effects. I received the vaccine about 4 and 1/2 weeks after having Covid. The next morning 4/7/21  I had severe aches and pains and a fever of 99-100.5. I stayed in bed all day, the fever ended at 7 pm that evening. That evening I went to bed feeling weak tossed and turned the enter night had very  severe aches and pains worse than normal my entire body from my neck to my legs,  the aches and pains were unbearable. I took cipro at 5 am that morning 4/8/21  due to a UTI infection with a lot of water no food. I got up with the aches and pains I had and felt very nauseous.  I decided to shower and felt faint. I passed out for 30-40 seconds on my bed according to my husband when I came to I had no recollection of fainting, This all happened at around 7am. I ate a few bites of a half of a ham sandwich and  had juice which helped to get me to feeling a bit better. My husband took my pressure that was very low my doctor who I spoke to said this may have caused me to faint but that the vaccine may have led to this as well.  I was weak from it all but started to feel better and I?m fine now.  My next vaccine is April 27, I?m afraid to take it but the doctor advised to take  it.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: The morning I received vaccine 4/6/21, I had no ill effects. I received the vaccine about 4 and 1/2 weeks after having Covid. The next morning 4/7/21  I had severe aches and pains and a fever of 99-100.5. I stayed in bed all day, the fever ended at 7 pm that evening. That evening I went to bed feeling weak tossed and turned the enter night had very  severe aches and pains worse than normal my entire body from my neck to my legs,  the aches and pains were unbearable. I took cipro at 5 am that morning 4/8/21  due to a UTI infection with a lot of water no food. I got up with the aches and pains I had and felt very nauseous.  I decided to shower and felt faint. I passed out for 30-40 seconds on my bed according to my husband when I came to I had no recollection of fainting, This all happened at around 7am. I ate a few bites of a half of a ham sandwich and  had juice which helped to get me to feeling a bit better. My husband took my pressure that was very low my doctor who I spoke to said this may have caused me to faint but that the vaccine may have led to this as well.  I was weak from it all but started to feel better and I?m fine now.  My next vaccine is April 27, I?m afraid to take it but the doctor advised to take  it.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphatic disorder, Pyrexia
Clinical narrative: Extreme chills - needed heating pad, 2 socks, 2 pants, 4 tops, 2 blankets and a warm body next to me 102 fever fatigue Fever and chills lasted approximately 24 hours and fatigue total 36 hours Felt like every lymphatic in my body was doing fireworks at the same time.  Venous/lymphatic congestion throughout the body.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Tested positive greater than 14 days from second dose of vaccine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Culture urine negative, Perineal pain, Pruritus
Clinical narrative: 4/13- itching began in perineal area. 4/14- blisters appeared. Burning and itching. 4/15- more blisters, more burning and itching. 4/16- ER trip. Tested for herpes and other STIs. Given Valtrex and Lidocaine. - set f/up appointment with OB/GYN ()on Wed 4/21/21 4/17- area slightly improved. 4/18-  Negative results  on tests. Area slightly improved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Night sweats, Pain
Clinical narrative: Strong body aches starting 7 hours after shot lasting 24 hours, mild body aches for following 36 hours Night sweats for 3 nights following shot  Heartburn starting 24 hours after shot, ongoing
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: headache, body ache, chills, fever
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: LOCAL PAIN; NECK, BACK, AND SHOULDER STIFFNESS; This spontaneous report received from a patient via a company representative concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 07-MAR-2021, the subject experienced local pain. On 07-MAR-2021, the subject experienced neck, back, and shoulder stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from local pain, and neck, back, and shoulder stiffness on 09-MAR-2021. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Subclavian vein thrombosis, Ultrasound Doppler
Clinical narrative: Patient has been having left arm pain. Developed acute, partially occlusive left subclavian deep vein thrombosis found on duplex on 4/16/21. She was started on lovenox  and will have further work-up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Appendicectomy, Appendicitis, Back pain
Clinical narrative: Within days of receiving vaccine started feeling mild discomfort on right side of lower abdomen while doing light abdominal exercises. This continued for about 10 days and then flu-like symptoms started - bloating, continual abdominal discomfort, back pain, lack of appetite for 3 days.  On Friday, April 16, I went to doctor who sent me to the ER for further tests which showed appendicitis resulting an appendectomy on Saturday, April 17 at 7:30 AM.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram abnormal, Decreased appetite, Influenza like illness, Scan with contrast
Clinical narrative: Within days of receiving vaccine started feeling mild discomfort on right side of lower abdomen while doing light abdominal exercises. This continued for about 10 days and then flu-like symptoms started - bloating, continual abdominal discomfort, back pain, lack of appetite for 3 days.  On Friday, April 16, I went to doctor who sent me to the ER for further tests which showed appendicitis resulting an appendectomy on Saturday, April 17 at 7:30 AM.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Chest X-ray normal, Computerised tomogram head normal, Computerised tomogram neck
Clinical narrative: 86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8.  Patient's last known well was at 10 AM on 4/8.  GCS on arrival 15.  NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria).   In the EMS blood glucose was 122, no meds were given.  Patient is not on any anticoagulation.  Patient's blood pressure was elevated at 233/78.  Patient denying any headaches, nausea, vomiting.  Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit.   Neurology contacted in the ED for stroke code.  Patient outside of TPA window.  CT head was negative.  CT head negative for acute intracranial infarction.  Chest x-ray negative for any acute cardiopulmonary findings.  Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off.  CBC showed mild leukocytosis (14.8) likely reactive.  CMP unremarkable.  PT/INR was also obtained.   After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke.  After discussion with family and the physicians the patient refused admission.   Upon reexamination no further worsening of her initial symptoms, blood pressure controlled.  Patient was discharged in a stable condition.  She was discharged AMA.  Patient was thoroughly explained the risks and benefits of leaving AMA.  Patient said she understood and was advised to come back if the symptoms worsen.  Patient was discharged with aspirin, Plavix and atorvastatin.  Recommended to follow-up with the PCP tomorrow soon as possible.  Also advised to return to the ED if any of the symptoms return.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysarthria, Facial paralysis, International normalised ratio, Leukocytosis
Clinical narrative: 86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8.  Patient's last known well was at 10 AM on 4/8.  GCS on arrival 15.  NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria).   In the EMS blood glucose was 122, no meds were given.  Patient is not on any anticoagulation.  Patient's blood pressure was elevated at 233/78.  Patient denying any headaches, nausea, vomiting.  Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit.   Neurology contacted in the ED for stroke code.  Patient outside of TPA window.  CT head was negative.  CT head negative for acute intracranial infarction.  Chest x-ray negative for any acute cardiopulmonary findings.  Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off.  CBC showed mild leukocytosis (14.8) likely reactive.  CMP unremarkable.  PT/INR was also obtained.   After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke.  After discussion with family and the physicians the patient refused admission.   Upon reexamination no further worsening of her initial symptoms, blood pressure controlled.  Patient was discharged in a stable condition.  She was discharged AMA.  Patient was thoroughly explained the risks and benefits of leaving AMA.  Patient said she understood and was advised to come back if the symptoms worsen.  Patient was discharged with aspirin, Plavix and atorvastatin.  Recommended to follow-up with the PCP tomorrow soon as possible.  Also advised to return to the ED if any of the symptoms return.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Prothrombin time, White blood cell count increased
Clinical narrative: 86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8.  Patient's last known well was at 10 AM on 4/8.  GCS on arrival 15.  NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria).   In the EMS blood glucose was 122, no meds were given.  Patient is not on any anticoagulation.  Patient's blood pressure was elevated at 233/78.  Patient denying any headaches, nausea, vomiting.  Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit.   Neurology contacted in the ED for stroke code.  Patient outside of TPA window.  CT head was negative.  CT head negative for acute intracranial infarction.  Chest x-ray negative for any acute cardiopulmonary findings.  Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off.  CBC showed mild leukocytosis (14.8) likely reactive.  CMP unremarkable.  PT/INR was also obtained.   After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke.  After discussion with family and the physicians the patient refused admission.   Upon reexamination no further worsening of her initial symptoms, blood pressure controlled.  Patient was discharged in a stable condition.  She was discharged AMA.  Patient was thoroughly explained the risks and benefits of leaving AMA.  Patient said she understood and was advised to come back if the symptoms worsen.  Patient was discharged with aspirin, Plavix and atorvastatin.  Recommended to follow-up with the PCP tomorrow soon as possible.  Also advised to return to the ED if any of the symptoms return.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Hypoaesthesia, Nausea
Clinical narrative: 04/18/2021  Typical symptoms... Fever 102-103, headache, nausea, fatigue...  NonTypical symptoms.... left side of face by mouth felt numb (like getting numbing at dentist); Slept all day but kept waking up because left arm, right arm, left leg fell asleep or numb.    04/19/2021 Today  Fever Broke and just feel fatigued.  Numbness and limbs falling asleep seems to have gone away.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 04/18/2021  Typical symptoms... Fever 102-103, headache, nausea, fatigue...  NonTypical symptoms.... left side of face by mouth felt numb (like getting numbing at dentist); Slept all day but kept waking up because left arm, right arm, left leg fell asleep or numb.    04/19/2021 Today  Fever Broke and just feel fatigued.  Numbness and limbs falling asleep seems to have gone away.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: HEADACHE; BODY ACHE; LOW GRADE FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included heart transplant, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have drug abuse or illicit drug usage. The patient was previously treated with tacrolimus for heart transplant, and mycophenolate sodium for heart transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced headache, body ache and low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, body ache, and low grade fever on 11-MAR-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash erythematous, Vaccination site reaction, Vaccination site swelling
Clinical narrative: On Sunday 4/18 starting at 4:15pm, my vaccine site began to itch, developed a red rash, and became swollen.  It is still itchy and swollen, however it is not as extreme as it was when symptoms abruptly began.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: Chills, body aches, pain at injection sight
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Confusional state, Memory impairment
Clinical narrative: Cognitive impairment, lower brain function, confusion, memory impairment and other impairments related to overall brain function.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Computerised tomogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: I was given the vaccine at 11:10am and by 5:30pm I was beginning to feel tired and unwell. At 6:45 I had a fever, body aches, pain in my arm, headache, and chest pain. These symptoms continued for three days and my fever reached 102.7.  After three days the fever and body aches subsided but the fatigue and chest pain continued. The chest pain has continued with increased heart rate during small bursts of activity. I called the clinic that administered my shot on April 9th and was told chest pain was normal up to 10 days and if it continued to be a problem to go to the ER. After 11 days of chest pain I went to the ER on April 13th and they did an EKG, CT with contrast, and blood work. They concluded I was fine. I was told it could be esophagitis so to take 2 15mg Prevacid a day which I have done with no relief. I was also informed it could be muscle related so I have iced, taken anti-inflammatory medication, and have not exerted myself.  It is now April 19th and I am still experiencing chest pain and racing heart rate with minimal exertion.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Myalgia, Oesophagitis
Clinical narrative: I was given the vaccine at 11:10am and by 5:30pm I was beginning to feel tired and unwell. At 6:45 I had a fever, body aches, pain in my arm, headache, and chest pain. These symptoms continued for three days and my fever reached 102.7.  After three days the fever and body aches subsided but the fatigue and chest pain continued. The chest pain has continued with increased heart rate during small bursts of activity. I called the clinic that administered my shot on April 9th and was told chest pain was normal up to 10 days and if it continued to be a problem to go to the ER. After 11 days of chest pain I went to the ER on April 13th and they did an EKG, CT with contrast, and blood work. They concluded I was fine. I was told it could be esophagitis so to take 2 15mg Prevacid a day which I have done with no relief. I was also informed it could be muscle related so I have iced, taken anti-inflammatory medication, and have not exerted myself.  It is now April 19th and I am still experiencing chest pain and racing heart rate with minimal exertion.