chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN LEFT LUNG; This spontaneous report received from a consumer concerned a female of unspecified age (in late 40's or early 50's) and ethnicity unspecified. 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: Unknown, Expiry: UNKNOWN) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with blood clot in her left lung after receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This female patient of unspecified ethnicity, in her late 40's or realy 50's, was reported to have blood clot in h er lungs after an unspecified duration from receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No other details was reported.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information will be requested once contact information is obtained
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cerebral artery occlusion, Computerised tomogram head, Dysarthria, Facial paralysis
Clinical narrative: Patient received first dose of COVID19 Moderna vaccine on 04/07/2021 and reportedly had slurred speech and fell due to left side paralysis. He was taken to a local hospital where an MRI was performed discovering a brain CVT and TPA was given. Patient then arrived by med flight to a facility where brain CVT was confirmed. He was released on 04/12/2021 to home and outpatient rehab in which he is now walking with a cane due to weakness.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis
Clinical narrative: Patient received first dose of COVID19 Moderna vaccine on 04/07/2021 and reportedly had slurred speech and fell due to left side paralysis. He was taken to a local hospital where an MRI was performed discovering a brain CVT and TPA was given. Patient then arrived by med flight to a facility where brain CVT was confirmed. He was released on 04/12/2021 to home and outpatient rehab in which he is now walking with a cane due to weakness.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cerebral venous thrombosis, Dysarthria, Fall, Hemiplegia
Clinical narrative: Patient received first dose of COVID19 Moderna vaccine on 04/07/2021 and reportedly had slurred speech and fell due to left side paralysis. He was taken to a local hospital where an MRI was performed discovering a brain CVT and TPA was given. Patient then arrived by med flight to a facility where brain CVT was confirmed. He was released on 04/12/2021 to home and outpatient rehab in which he is now walking with a cane due to weakness.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: Patient received first dose of COVID19 Moderna vaccine on 04/07/2021 and reportedly had slurred speech and fell due to left side paralysis. He was taken to a local hospital where an MRI was performed discovering a brain CVT and TPA was given. Patient then arrived by med flight to a facility where brain CVT was confirmed. He was released on 04/12/2021 to home and outpatient rehab in which he is now walking with a cane due to weakness.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arterial rupture, Full blood count, Headache, Platelet count normal
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subarachnoid haemorrhage
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Agitation, Angiogram cerebral abnormal, Aphasia, Areflexia
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arterial angioplasty, Blood culture, Blood sodium increased, Brain death, Brain herniation
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain oedema, Brain stem syndrome, CSF culture, Cardiac index, Cerebral endovascular aneurysm repair
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral infarction, Cerebral mass effect, Cerebral vasoconstriction, Computerised tomogram head abnormal, Condition aggravated
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Device occlusion, Diabetes insipidus, Electroencephalogram abnormal, Electrolyte imbalance
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Haemodynamic instability, Head discomfort, Headache, Hypercoagulation
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Intensive care, Intracranial aneurysm, Intracranial pressure increased, Mean arterial pressure
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mental disorder, Mental status changes, Phonophobia, Photophobia, Pupil fixed
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Sinus bradycardia, Subarachnoid haemorrhage, Ultrasound skull, Urine analysis
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine output decreased, Ventricular drainage, White blood cell count normal
Clinical narrative: Pt presented to ED with subarachnoid hemorrhage.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Liquid product physical issue
Clinical narrative: FATIGUE; MILKY PRESENSE IN THE VACCINE; This spontaneous report received from a patient and concerned an 83 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject noticed the syringe had milky presence (coded to PT of Product quality issue). Patient also noted that the health care provider did not fill the syringe in front of her and syringe was already prefilled with milky presence.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 07-MAR-2021, and had not recovered from milky presense in the vaccine. This report was non-serious.      C
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Product quality issue
Clinical narrative: FATIGUE; MILKY PRESENSE IN THE VACCINE; This spontaneous report received from a patient and concerned an 83 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject noticed the syringe had milky presence (coded to PT of Product quality issue). Patient also noted that the health care provider did not fill the syringe in front of her and syringe was already prefilled with milky presence.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 07-MAR-2021, and had not recovered from milky presense in the vaccine. This report was non-serious.      C
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Malaise, Myalgia
Clinical narrative: SLEEPING PROBLEM; TINNITUS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHES; NIGHTMARES; MOVEMENTS REDUCED; WEIGHT LOSS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 140 pounds, and height was 69 inches. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid for drug used for unknown indication, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication. On APR-2021, the subject experienced weight loss. On 07-APR-2021, the subject experienced nightmares. On 07-APR-2021, the subject experienced movements reduced. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headaches. On 18-APR-2021, the subject experienced sleeping problem. On 18-APR-2021, the subject experienced tinnitus. Treatment medications included: cannabinoids nos/cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares on 07-APR-2021, had not recovered from headaches, fatigue, nausea, muscle aches, movements reduced, and tinnitus, and the outcome of weight loss and sleeping problem was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: SLEEPING PROBLEM; TINNITUS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHES; NIGHTMARES; MOVEMENTS REDUCED; WEIGHT LOSS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 140 pounds, and height was 69 inches. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid for drug used for unknown indication, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication. On APR-2021, the subject experienced weight loss. On 07-APR-2021, the subject experienced nightmares. On 07-APR-2021, the subject experienced movements reduced. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headaches. On 18-APR-2021, the subject experienced sleeping problem. On 18-APR-2021, the subject experienced tinnitus. Treatment medications included: cannabinoids nos/cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares on 07-APR-2021, had not recovered from headaches, fatigue, nausea, muscle aches, movements reduced, and tinnitus, and the outcome of weight loss and sleeping problem was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hypokinesia, Myalgia, Nausea
Clinical narrative: SLEEPING PROBLEM; TINNITUS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHES; NIGHTMARES; MOVEMENTS REDUCED; WEIGHT LOSS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 140 pounds, and height was 69 inches. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid for drug used for unknown indication, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication. On APR-2021, the subject experienced weight loss. On 07-APR-2021, the subject experienced nightmares. On 07-APR-2021, the subject experienced movements reduced. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headaches. On 18-APR-2021, the subject experienced sleeping problem. On 18-APR-2021, the subject experienced tinnitus. Treatment medications included: cannabinoids nos/cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares on 07-APR-2021, had not recovered from headaches, fatigue, nausea, muscle aches, movements reduced, and tinnitus, and the outcome of weight loss and sleeping problem was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nightmare, Sleep disorder, Tinnitus, Weight decreased
Clinical narrative: SLEEPING PROBLEM; TINNITUS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHES; NIGHTMARES; MOVEMENTS REDUCED; WEIGHT LOSS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 140 pounds, and height was 69 inches. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid for drug used for unknown indication, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication. On APR-2021, the subject experienced weight loss. On 07-APR-2021, the subject experienced nightmares. On 07-APR-2021, the subject experienced movements reduced. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headaches. On 18-APR-2021, the subject experienced sleeping problem. On 18-APR-2021, the subject experienced tinnitus. Treatment medications included: cannabinoids nos/cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares on 07-APR-2021, had not recovered from headaches, fatigue, nausea, muscle aches, movements reduced, and tinnitus, and the outcome of weight loss and sleeping problem was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood culture, Blood gases, Blood lactic acid, Brain stem syndrome, C-reactive protein
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram neck, Dizziness, Double stranded DNA antibody, Dysphagia
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Full blood count, Headache, Hypoglossal nerve paralysis, Joint stiffness
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Metabolic function test, Myalgia, Nausea, Neck pain
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, Spinal X-ray
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram neck, Dysarthria, Fatigue, Headache
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Myalgia, Nausea, Neck pain
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Pyrexia, Rash, Scan with contrast, Tongue paralysis
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Blood test, Computerised tomogram, Dizziness, Eyelid disorder
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Intervertebral disc degeneration, Lumbar puncture, Magnetic resonance imaging, Neck pain
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Spinal stenosis, Tinnitus, X-ray
Clinical narrative: side effects started with in 4-hours of receiving the vaccine, starting with chills.  Fever of 100.6 started within 30-hours, followed by chills, achy muscles, fatigue, rash [not near injection site], nausea and headache.  Ten days after receiving the vaccine  hospitalized for a constellation of neurologic symptoms including tongue deviation to the left, slurred speech, severe headache, neck pain.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Nausea, Pain, Urticaria
Clinical narrative: Day after Janssen vaccine: Patient called the Health Department on 4-9-21 at 11:45am to report that last night she reported that her face and lips were "hot" to touch, felt sunburnt, and when applying lotion it burns her face. I encouraged her to use cold compresses to face and if short of breath or swelling of tongue to immediately seek emergency medical attention. Encouraged her to reach out to PCP if rash symptoms worsen.  Patient, presented to the ER on 4-16-21 due to rash to her neck, torso, and BUE and pain to her joints. The patient reported that she received  the Janssen Vaccine 8 days ago and within 15 minutes of receiving it she became flushed and feeling unwell.  The nurse at the vaccination clinic monitored her. The patient saw her PCP 4-15-21 and was started on Hydroxyzine q6.  The patient states that she was feeling better, but now her symptoms are increasing with severity.  The patient denies that she is currently on steroids and says she does better with liquid steroids. The patient BP  was elevated on arrival at 171/107.  The patient reports that her BP is high in clinical settings .  She had a stress test by Dr that was normal and her PCP is going to have her monitor her BP at home before starting antihypertensives. No other complaints at this time.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Burning sensation, Cardiac stress test, Condition aggravated
Clinical narrative: Day after Janssen vaccine: Patient called the Health Department on 4-9-21 at 11:45am to report that last night she reported that her face and lips were "hot" to touch, felt sunburnt, and when applying lotion it burns her face. I encouraged her to use cold compresses to face and if short of breath or swelling of tongue to immediately seek emergency medical attention. Encouraged her to reach out to PCP if rash symptoms worsen.  Patient, presented to the ER on 4-16-21 due to rash to her neck, torso, and BUE and pain to her joints. The patient reported that she received  the Janssen Vaccine 8 days ago and within 15 minutes of receiving it she became flushed and feeling unwell.  The nurse at the vaccination clinic monitored her. The patient saw her PCP 4-15-21 and was started on Hydroxyzine q6.  The patient states that she was feeling better, but now her symptoms are increasing with severity.  The patient denies that she is currently on steroids and says she does better with liquid steroids. The patient BP  was elevated on arrival at 171/107.  The patient reports that her BP is high in clinical settings .  She had a stress test by Dr that was normal and her PCP is going to have her monitor her BP at home before starting antihypertensives. No other complaints at this time.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Malaise, Oral discomfort, Rash
Clinical narrative: Day after Janssen vaccine: Patient called the Health Department on 4-9-21 at 11:45am to report that last night she reported that her face and lips were "hot" to touch, felt sunburnt, and when applying lotion it burns her face. I encouraged her to use cold compresses to face and if short of breath or swelling of tongue to immediately seek emergency medical attention. Encouraged her to reach out to PCP if rash symptoms worsen.  Patient, presented to the ER on 4-16-21 due to rash to her neck, torso, and BUE and pain to her joints. The patient reported that she received  the Janssen Vaccine 8 days ago and within 15 minutes of receiving it she became flushed and feeling unwell.  The nurse at the vaccination clinic monitored her. The patient saw her PCP 4-15-21 and was started on Hydroxyzine q6.  The patient states that she was feeling better, but now her symptoms are increasing with severity.  The patient denies that she is currently on steroids and says she does better with liquid steroids. The patient BP  was elevated on arrival at 171/107.  The patient reports that her BP is high in clinical settings .  She had a stress test by Dr that was normal and her PCP is going to have her monitor her BP at home before starting antihypertensives. No other complaints at this time.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: Day after Janssen vaccine: Patient called the Health Department on 4-9-21 at 11:45am to report that last night she reported that her face and lips were "hot" to touch, felt sunburnt, and when applying lotion it burns her face. I encouraged her to use cold compresses to face and if short of breath or swelling of tongue to immediately seek emergency medical attention. Encouraged her to reach out to PCP if rash symptoms worsen.  Patient, presented to the ER on 4-16-21 due to rash to her neck, torso, and BUE and pain to her joints. The patient reported that she received  the Janssen Vaccine 8 days ago and within 15 minutes of receiving it she became flushed and feeling unwell.  The nurse at the vaccination clinic monitored her. The patient saw her PCP 4-15-21 and was started on Hydroxyzine q6.  The patient states that she was feeling better, but now her symptoms are increasing with severity.  The patient denies that she is currently on steroids and says she does better with liquid steroids. The patient BP  was elevated on arrival at 171/107.  The patient reports that her BP is high in clinical settings .  She had a stress test by Dr that was normal and her PCP is going to have her monitor her BP at home before starting antihypertensives. No other complaints at this time.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of left arm after injection 3/26/21 at injection site. Sore to touch. Sore to use. Sore to bear weight on. Was NOT sore before injection. Has remained sore to this date. 4/23/21.  Muscle fatigue and mild pain in right knee 2 weeks (noted by patient and by physical therapist) after injection to this date (4/23/21).  No known reason for muscle fatigue  but fatigue causing right knee to collapse while upright and weight bearing.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Muscle fatigue, Muscular weakness, Pain
Clinical narrative: Soreness of left arm after injection 3/26/21 at injection site. Sore to touch. Sore to use. Sore to bear weight on. Was NOT sore before injection. Has remained sore to this date. 4/23/21.  Muscle fatigue and mild pain in right knee 2 weeks (noted by patient and by physical therapist) after injection to this date (4/23/21).  No known reason for muscle fatigue  but fatigue causing right knee to collapse while upright and weight bearing.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: Soreness of left arm after injection 3/26/21 at injection site. Sore to touch. Sore to use. Sore to bear weight on. Was NOT sore before injection. Has remained sore to this date. 4/23/21.  Muscle fatigue and mild pain in right knee 2 weeks (noted by patient and by physical therapist) after injection to this date (4/23/21).  No known reason for muscle fatigue  but fatigue causing right knee to collapse while upright and weight bearing.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, four days after the vaccination the patient experienced atrial fibrillation. The patient was confused with the event occurred due to the vaccine or the fact that the patient was concerned about the vaccine and misinformation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atrial fibrillation. This report was serious (Other Medically Important Condition).   .; Sender's Comments: V0: 20210424331-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Atrial fibrillation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, four days after the vaccination the patient experienced atrial fibrillation. The patient was confused with the event occurred due to the vaccine or the fact that the patient was concerned about the vaccine and misinformation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atrial fibrillation. This report was serious (Other Medically Important Condition).   .; Sender's Comments: V0: 20210424331-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Atrial fibrillation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Pain, Paraesthesia
Clinical narrative: Tingling throw out body. Diarrhea. Occasional skin redness
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Diarrhoea, Erythema, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Tingling throw out body. Diarrhea. Occasional skin redness
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Chills, Hypoaesthesia, Laboratory test
Clinical narrative: Admitted to hospital with weakness, paresthesias, sweats severe back pain
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Paraesthesia, Pyrexia
Clinical narrative: Admitted to hospital with weakness, paresthesias, sweats severe back pain
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Hyperhidrosis, Paraesthesia
Clinical narrative: Admitted to hospital with weakness, paresthesias, sweats severe back pain
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Cough, Diarrhoea, Headache
Clinical narrative: BLOOD IN STOOL; SKULL PAIN; FEVER; NAUSEA; FATIGUE; CHILLS; VOMITING; BODY ACHES; FACIAL SWELLING; DIARRHEA; STOMACH PAIN; JAW PAIN; FACIAL AREA PAIN; This spontaneous report was received from a 58-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent condition included allergy to narcotics. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vomiting, body aches, facial swelling, diarrhea, stomach pain, chills, fever, nausea and fatigue. On an unspecified date, in APR-2021, after the vaccination, the patient experienced jaw pain and pain in facial area. On 11-APR-2021, the patient experienced skull pain. On 12-APR-2021, the patient discovered blood in her stool and her doctor sent the stool for testing. The doctor did not prescribe any treatment. On an unspecified date, the patient saw her doctor who said it was 'too much' for the patient's immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, body aches, fever, chills, skull pain, facial swelling, diarrhea, stomach pain, fatigue, and blood in stool, and the outcome of nausea, jaw pain and facial area pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-BLOOD IN STOOL. This event(s) is considered unassessable. 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).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: BLOOD IN STOOL; SKULL PAIN; FEVER; NAUSEA; FATIGUE; CHILLS; VOMITING; BODY ACHES; FACIAL SWELLING; DIARRHEA; STOMACH PAIN; JAW PAIN; FACIAL AREA PAIN; This spontaneous report was received from a 58-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent condition included allergy to narcotics. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vomiting, body aches, facial swelling, diarrhea, stomach pain, chills, fever, nausea and fatigue. On an unspecified date, in APR-2021, after the vaccination, the patient experienced jaw pain and pain in facial area. On 11-APR-2021, the patient experienced skull pain. On 12-APR-2021, the patient discovered blood in her stool and her doctor sent the stool for testing. The doctor did not prescribe any treatment. On an unspecified date, the patient saw her doctor who said it was 'too much' for the patient's immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, body aches, fever, chills, skull pain, facial swelling, diarrhea, stomach pain, fatigue, and blood in stool, and the outcome of nausea, jaw pain and facial area pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-BLOOD IN STOOL. This event(s) is considered unassessable. 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).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Facial pain, Fatigue
Clinical narrative: BLOOD IN STOOL; SKULL PAIN; FEVER; NAUSEA; FATIGUE; CHILLS; VOMITING; BODY ACHES; FACIAL SWELLING; DIARRHEA; STOMACH PAIN; JAW PAIN; FACIAL AREA PAIN; This spontaneous report was received from a 58-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent condition included allergy to narcotics. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vomiting, body aches, facial swelling, diarrhea, stomach pain, chills, fever, nausea and fatigue. On an unspecified date, in APR-2021, after the vaccination, the patient experienced jaw pain and pain in facial area. On 11-APR-2021, the patient experienced skull pain. On 12-APR-2021, the patient discovered blood in her stool and her doctor sent the stool for testing. The doctor did not prescribe any treatment. On an unspecified date, the patient saw her doctor who said it was 'too much' for the patient's immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, body aches, fever, chills, skull pain, facial swelling, diarrhea, stomach pain, fatigue, and blood in stool, and the outcome of nausea, jaw pain and facial area pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-BLOOD IN STOOL. This event(s) is considered unassessable. 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).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematochezia, Headache, Nausea, Pain, Pain in jaw
Clinical narrative: BLOOD IN STOOL; SKULL PAIN; FEVER; NAUSEA; FATIGUE; CHILLS; VOMITING; BODY ACHES; FACIAL SWELLING; DIARRHEA; STOMACH PAIN; JAW PAIN; FACIAL AREA PAIN; This spontaneous report was received from a 58-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent condition included allergy to narcotics. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vomiting, body aches, facial swelling, diarrhea, stomach pain, chills, fever, nausea and fatigue. On an unspecified date, in APR-2021, after the vaccination, the patient experienced jaw pain and pain in facial area. On 11-APR-2021, the patient experienced skull pain. On 12-APR-2021, the patient discovered blood in her stool and her doctor sent the stool for testing. The doctor did not prescribe any treatment. On an unspecified date, the patient saw her doctor who said it was 'too much' for the patient's immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, body aches, fever, chills, skull pain, facial swelling, diarrhea, stomach pain, fatigue, and blood in stool, and the outcome of nausea, jaw pain and facial area pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-BLOOD IN STOOL. This event(s) is considered unassessable. 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).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: BLOOD IN STOOL; SKULL PAIN; FEVER; NAUSEA; FATIGUE; CHILLS; VOMITING; BODY ACHES; FACIAL SWELLING; DIARRHEA; STOMACH PAIN; JAW PAIN; FACIAL AREA PAIN; This spontaneous report was received from a 58-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent condition included allergy to narcotics. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vomiting, body aches, facial swelling, diarrhea, stomach pain, chills, fever, nausea and fatigue. On an unspecified date, in APR-2021, after the vaccination, the patient experienced jaw pain and pain in facial area. On 11-APR-2021, the patient experienced skull pain. On 12-APR-2021, the patient discovered blood in her stool and her doctor sent the stool for testing. The doctor did not prescribe any treatment. On an unspecified date, the patient saw her doctor who said it was 'too much' for the patient's immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, body aches, fever, chills, skull pain, facial swelling, diarrhea, stomach pain, fatigue, and blood in stool, and the outcome of nausea, jaw pain and facial area pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-BLOOD IN STOOL. This event(s) is considered unassessable. 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).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hot flush, Night sweats, Pain
Clinical narrative: HOT FLASHES; NIGHT SWEATING WHILE SLEEPING; BODY ACHE; SORE ARM; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and covid-19 infection, and concurrent conditions included hashimotos, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 02-APR-2021, the subject experienced body ache. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced night sweating while sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, tired, and headache on APR-2021, had not recovered from hot flashes, and night sweating while sleeping, and the outcome of sore arm was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hot flush, Night sweats, Pain
Clinical narrative: HOT FLASHES; NIGHT SWEATING WHILE SLEEPING; BODY ACHE; SORE ARM; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and covid-19 infection, and concurrent conditions included hashimotos, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 02-APR-2021, the subject experienced body ache. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced night sweating while sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, tired, and headache on APR-2021, had not recovered from hot flashes, and night sweating while sleeping, and the outcome of sore arm was not reported. This report was non-serious.