chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient states she received the first dose of the Pfizer COVID vaccine on 5-5. Patient states she has the feeling of her throat closing on 5-5, but then resolved into a sore throat which has affected her eating. Patient woke yesterday with urticaria allover causing itching and a burning sensation. Patient has been taking Benadryl and using hydrocortisone cream with little relief of itching, but no relief of the urticaria. Patient denies changes in lotions, soaps or detergents. Patient has not eaten anything new. Patient states the only thing different recently was being put on Bactrim and Keflex for an abscess on 4-30. Patient stopped taking the antibiotics yesterday when she saw the rash.  Patient received the vaccine at pharmacy.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram thorax, Deep vein thrombosis, Dyspnoea
Clinical narrative: Started with increased heart rate, fatigue and shortness of breath. Didn?t go to Dr until April 23, 2021 & April 26, 2021, syncope, multiple large bilateral pulmonary  Emboli & DVT & right heart strain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Heart rate increased, Myocardial strain, Pulmonary embolism
Clinical narrative: Started with increased heart rate, fatigue and shortness of breath. Didn?t go to Dr until April 23, 2021 & April 26, 2021, syncope, multiple large bilateral pulmonary  Emboli & DVT & right heart strain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Thrombolysis, Ultrasound Doppler abnormal
Clinical narrative: Started with increased heart rate, fatigue and shortness of breath. Didn?t go to Dr until April 23, 2021 & April 26, 2021, syncope, multiple large bilateral pulmonary  Emboli & DVT & right heart strain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold
Clinical narrative: Freezing (Freezing) during the night, then woke up with all the same feeling & symptoms of Covid
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine vial remained in freezer one day longer than reccommended per manufacturer. Should have been pulled from freezer and refrigerated before 3pm Thursday 5/6/2021 but was not; Administered Friday 05/07/2021 after removal from freezer that morning. "USE BY DATE" on "FREEZER" sticker on original container was noticed Friday afternoon after injection had been admistered.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I am experiencing pins and needles sensation in both feet which is continuing a month later.  It seems to be worsening and affecting both leg shins as well.  I need to seek medical advice as I thought this would be temporary and now that does not seem to be the case.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood test, Computerised tomogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Biopsy brain abnormal, Blindness, Burning sensation, Central nervous system lesion
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Confusional state, Deafness, Diplopia
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Dyskinesia, Dysphagia, Dyspnoea
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fine motor skill dysfunction, Functional residual capacity decreased, Headache, Hemiparesis, Hyperacusis
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Hypoaesthesia, Infusion, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Lymphodepletion, Magnetic resonance imaging, Muscular weakness, Obstructive airways disorder
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Optic nerve disorder, Pain in extremity, Paraesthesia, Positron emission tomogram, Sensory overload
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Tremor, Urinary hesitation, Vision blurred, Weight decreased
Clinical narrative: Suffered an ischemic stroke in the pons region of the brain stem
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to a minor under the age of 18 years of age due to administration error.  As of May 10th, 2021 the Moderna Covid vaccine is only indicated for adults aged 18 years and older.  No adverse events were reported by the patient.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase normal, Cough, Dyspnoea, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: The patient is a 56 y.o. male who presents to the Emergency Department with cough and SOB for 2-3 days. The patient states he was vaccinated with the johnson and johnson COVID-19 vaccine two weeks ago. He denies any vomiting diarrhea, fevers, leg swelling, or chest pain. The patient additionally denies being around any sick contacts or any recent travel.     The patient is a 56 y.o. male evaluated for cough and SOB for 2-3 days. Possibility of pneumonia. I have lower suspicion for PE, however his oxygen saturation is less than 94%, so we will obtain a D-dimer. I have lower suspicion for ACS. Will also check COVID swab to rule out COVID despite recent vaccination.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Influenza virus test negative, Metabolic function test normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: The patient is a 56 y.o. male who presents to the Emergency Department with cough and SOB for 2-3 days. The patient states he was vaccinated with the johnson and johnson COVID-19 vaccine two weeks ago. He denies any vomiting diarrhea, fevers, leg swelling, or chest pain. The patient additionally denies being around any sick contacts or any recent travel.     The patient is a 56 y.o. male evaluated for cough and SOB for 2-3 days. Possibility of pneumonia. I have lower suspicion for PE, however his oxygen saturation is less than 94%, so we will obtain a D-dimer. I have lower suspicion for ACS. Will also check COVID swab to rule out COVID despite recent vaccination.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: The patient is a 56 y.o. male who presents to the Emergency Department with cough and SOB for 2-3 days. The patient states he was vaccinated with the johnson and johnson COVID-19 vaccine two weeks ago. He denies any vomiting diarrhea, fevers, leg swelling, or chest pain. The patient additionally denies being around any sick contacts or any recent travel.     The patient is a 56 y.o. male evaluated for cough and SOB for 2-3 days. Possibility of pneumonia. I have lower suspicion for PE, however his oxygen saturation is less than 94%, so we will obtain a D-dimer. I have lower suspicion for ACS. Will also check COVID swab to rule out COVID despite recent vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site swelling
Clinical narrative: Swelling at injection site however swelling has moved and is currently way below the injection and is now in the upper arm a little above elbow.   I have taken. Tylenol and applied heat to the area
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Laboratory test, Leukaemia, Pyrexia
Clinical narrative: Per pt's wife 1 hour within receiving the vaccine, pt got a fever, headache, and dizziness. She states he took ibuprofen at home . She states that on April 26,2021 pt's primary care physician - was contacted. She states that on April 28,2021 she heard back from him . She states hat on April 29,2021 he went to get lab work (WBC) that md ordered. she states that  pt was contacted on May 1,2021 by primary care physician to go to the ER . She states that he was admitted to hospital from May 1,2021- May 4,2021 and diagnosed with Leukemia (CML)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell disorder
Clinical narrative: Per pt's wife 1 hour within receiving the vaccine, pt got a fever, headache, and dizziness. She states he took ibuprofen at home . She states that on April 26,2021 pt's primary care physician - was contacted. She states that on April 28,2021 she heard back from him . She states hat on April 29,2021 he went to get lab work (WBC) that md ordered. she states that  pt was contacted on May 1,2021 by primary care physician to go to the ER . She states that he was admitted to hospital from May 1,2021- May 4,2021 and diagnosed with Leukemia (CML)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat irritation
Clinical narrative: Back of throat started to get small pimple-like bumps.  As time passed, the back of my throat started to swell.  I took 2 benadryl capsules which seemed to stop the swelling.  By the following morning, the symptoms resolved.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Brain operation, Computerised tomogram head, Electrocardiogram, Full blood count abnormal
Clinical narrative: Progressively worse headaches culminating in seizure, unconsciousness, and subdural hematoma requiring helicoptering to the ER and brain surgery to drain the hematoma.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Metabolic function test abnormal, Platelet disorder, Prothrombin time
Clinical narrative: Progressively worse headaches culminating in seizure, unconsciousness, and subdural hematoma requiring helicoptering to the ER and brain surgery to drain the hematoma.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Subdural haematoma, Subdural haematoma evacuation
Clinical narrative: Progressively worse headaches culminating in seizure, unconsciousness, and subdural hematoma requiring helicoptering to the ER and brain surgery to drain the hematoma.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: The pt. was treated for shingles and other zoster-related conditions; The pt. was treated for shingles and other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt.) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JAN-2015, the pt. was inoculated by a health care provider (HCP) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, (reported as subsequently after vaccination with zoster vaccine live (ZOSTAVAX)), the pt. was treated by a physician for shingles (herpes zoster) and zoster-related conditions (ill-defined disorder). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Oxygen saturation increased, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; METALLIC TASTE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and the patient have no other health history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Frequency: 1 total, batch number: 1808978 expiry: Unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient experienced suspected covid-19. On 01-MAY-2021, On the same day the patient underwent rapid swab test and tested positive for COVID-19 (suspected clinical vaccination failure, Stuffiness, Runny nose, Drainage, Congestion, Anosmia, Ageusia). It was reported that, the symptoms started about 4 days prior, but it was hard to discern due to allergies. On the same day, the patient went to gym for about 45 minutes and felt okay except for slight metallic taste in mouth. Later, he went home and tried smelling whiskey and realized he had lost his sense of smell and experienced loss of taste. The patient did not present with typical symptoms and had felt okay because he had been working out prior. It was reported that, the patient could smell firewood burning but nothing else. Later, all vitals checked at urgent care and all was normal. The patient's laboratory data revealed blood pressure was normal, Oxygen level on Oximeter 99%, Smell and Taste was 90-95% gone. At the time of this report, the patient had a tiny amount of fatigue and was in quarantine for the next ten days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210504165-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; METALLIC TASTE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and the patient have no other health history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Frequency: 1 total, batch number: 1808978 expiry: Unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient experienced suspected covid-19. On 01-MAY-2021, On the same day the patient underwent rapid swab test and tested positive for COVID-19 (suspected clinical vaccination failure, Stuffiness, Runny nose, Drainage, Congestion, Anosmia, Ageusia). It was reported that, the symptoms started about 4 days prior, but it was hard to discern due to allergies. On the same day, the patient went to gym for about 45 minutes and felt okay except for slight metallic taste in mouth. Later, he went home and tried smelling whiskey and realized he had lost his sense of smell and experienced loss of taste. The patient did not present with typical symptoms and had felt okay because he had been working out prior. It was reported that, the patient could smell firewood burning but nothing else. Later, all vitals checked at urgent care and all was normal. The patient's laboratory data revealed blood pressure was normal, Oxygen level on Oximeter 99%, Smell and Taste was 90-95% gone. At the time of this report, the patient had a tiny amount of fatigue and was in quarantine for the next ten days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210504165-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 67 year old male. 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) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient did not show antibodies when he got tested using the serology IgG test on 31-MAR-2021. Laboratory data included: Serology Immunoglobulin G (NR: not provided) did not found Antibodies. Also he did not show antibodies when he got tested using SARS-COV2-Antibody IgG, spike ,semi quantitative on 20APR-2021 and 27-APR-2021 as well (confirmed immunological vaccine failure.) . Laboratory data included: COVID-19 antibody test (NR: not provided) did not found Antibodies. It was not known where he got vaccinated or his personal information.  The action taken COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210509824- COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: SHORTNESS OF BREATH; NUMBNESS TO BOTH HANDS; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 20 year old male. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced nausea. On an unspecified date, the subject experienced shortness of breath, numbness to both hands, chills, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105.0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and the outcome of headache, nausea, numbness to both hands and shortness of breath was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; NUMBNESS TO BOTH HANDS; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 20 year old male. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced nausea. On an unspecified date, the subject experienced shortness of breath, numbness to both hands, chills, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105.0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and the outcome of headache, nausea, numbness to both hands and shortness of breath was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS LIKE FORMATIONS ALL OVER SKIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 2021, the subject experienced psoriasis like formations all over skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis like formations all over skin. This report was non-serious.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Middle ear effusion
Clinical narrative: MUFFLED HEARING IN BOTH EARS; FULLNESS ON BOTH EARS; WATER IN THE EARS; This spontaneous report received from a patient concerned a 24 year old of unspecified sex. 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, the subject experienced muffled hearing in both ears. On 23-APR-2021, the subject experienced fullness on both ears. On 23-APR-2021, the subject experienced water in the ears. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muffled hearing in both ears, fullness on both ears, and water in the ears. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Eating disorder, Eye irritation, Headache
Clinical narrative: FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 64 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 64 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Headache, Heart rate increased
Clinical narrative: HEADACHES; HEART RATE INCREASED; FEELING HOT; SORE LEFT ARM AND LEGS ACHY; CHILLS; FEELING WEAK; This spontaneous report received from a patient concerned a 23 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: 207A212A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 18:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart rate increased. On 06-MAY-2021, the subject experienced feeling hot. On 06-MAY-2021, the subject experienced sore left arm and legs achy. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced feeling weak. On 06-MAY-2021 04:00, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rate increased, had not recovered from feeling hot, headaches, sore left arm and legs achy, and feeling weak, and the outcome of chills was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HEADACHES; HEART RATE INCREASED; FEELING HOT; SORE LEFT ARM AND LEGS ACHY; CHILLS; FEELING WEAK; This spontaneous report received from a patient concerned a 23 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: 207A212A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 18:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart rate increased. On 06-MAY-2021, the subject experienced feeling hot. On 06-MAY-2021, the subject experienced sore left arm and legs achy. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced feeling weak. On 06-MAY-2021 04:00, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rate increased, had not recovered from feeling hot, headaches, sore left arm and legs achy, and feeling weak, and the outcome of chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: KNUCKLE SORENESS; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. On an unspecified date, the subject experienced knuckle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knuckle soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Injection site pain, Pain in extremity, X-ray
Clinical narrative: AGGRAVATED SHOULDER  ARTHRITIS; CANNOT LIFT ARM WITHOUT PAIN; INTENSE PAIN IN RIGHT SHOULDER; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. 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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced aggravated shoulder arthritis. On 2021, the subject experienced cannot lift arm without pain. On 2021, the subject experienced intense pain in right shoulder. Laboratory data included: X-ray (NR: not provided) arthritis in both shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense pain in right shoulder, and the outcome of aggravated shoulder arthritis and cannot lift arm without pain was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain in extremity, Pyrexia
Clinical narrative: NAUSEA; FEVER; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 63 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: 180890 expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99.8. On 02-MAY-2021, the subject experienced slight arm pain. On 04-MAY-2021, the subject experienced nausea. On 04-MAY-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 02-MAY-2021, and had not recovered from nausea, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Insomnia, Vomiting
Clinical narrative: VOMITING; ABDOMINAL CRAMPS; CANT SLEEP AT NIGHT, SLEEPY DURING THE DAY; HEADACHE; FEELING TIRED; 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 type 1 diabetes, and other pre-existing medical conditions included the patient had unspecified allergies. 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 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced abdominal cramps. On MAY-2021, the subject experienced cant sleep at night, sleepy during the day. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, abdominal cramps, cant sleep at night, sleepy during the day, and feeling tired, and the outcome of vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID-19; 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, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive for covid (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: FLARE UP OF RA; This spontaneous report received from a health care professional via concerned a 38 year old male. 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, and batch number were not reported) dose was not reported, frequency once total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient experienced flare up of Rheumatoid Arthritis (RA). Patient stated that physician told that flare up of RA caused by COVID vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flare up of RA was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210512871-covid-19 vaccine ad26.cov2.s-Flare up of rheumatoid arthritis. 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Testicular swelling
Clinical narrative: SWOLLEN TESTICLES TO 3 TIMES THEIR NORMAL SIZE; SWEATS; CHILLS OR TEETH CHATTERING; FEVER; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient did not have known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 05-MAY-2021 11:38 for prophylactic vaccination. Concomitant medications included testosterone. On 05-MAY-2021, the subject experienced sweats. On 05-MAY-2021, the subject experienced chills or teeth chattering. On 05-MAY-2021, the subject experienced fever. On 06-MAY-2021, the subject experienced swollen testicles to 3 times their normal size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills or teeth chattering, fever, sweats, and swollen testicles to 3 times their normal size. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Pulmonary embolism
Clinical narrative: CHEST PAIN  Other pulmonary embolism without acute cor pulmonale
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Hyperhidrosis, Skin warm, Syncope
Clinical narrative: WITHIN 5 MINUTES OF RECEIVNG FIRST DOSE OF COVID19 PFIZER VACCINE, PATIENT RETURNED TO PHARMACY STATING HE WAS FEELING DIZZY, AND COLLAPSED INTO COUNTER. MANAGER WAS ABLE TO HELP HIM TO A CHAIR SO HE DID NOT FALL, PATIENT CAUGHT HIMSELF WITH THE SHIELD/COUNTER. CALLED 911 AND EMS ARRIVED WITHIN A FEW MINUTES. ASKED PATIENT TO DESCRIBE SYMPTOMS, PATIENT RELAYED FEELING DIZZY, TROUBLE SEEING, VERY WARM, SWEATY. PATIENTS VITALS WERE CHECKED BY EMS, PARENTS AND PATIENT CHOSE NOT TO TRANSPORT AFTER ABOUT 30  MINUTES PATIENT WAS CLEAR OF ALL SYMPTOMS.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Almost two weeks later I developed a rash that was later confirmed as shingles.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: The patient was  given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM. The respective time the shot was given outside this window was 4:51 PM.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: The patient was  given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM. The respective time the shot was given outside this window was 4:51 PM.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Product storage error
Clinical narrative: Vaccine vial remained in freezer one day longer than reccommended per manufacturer. Should have been pulled from freezer and refrigerated before 3pm Thursday 5/6/2021 but was not; Administered Friday 05/07/2021 after removal from freezer that morning. "USE BY DATE" on "FREEZER" sticker on original container was noticed Friday afternoon after injection had been admistered.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Herpes zoster, Hyperaesthesia
Clinical narrative: Starting on 3rd day after the first vaccine shot, I felt sharp pain on my left chest and left back, two days later, rashes appeared, diagnosed as Shingles. Treated with antiviral medication. As today, rashes almost gone, but part of my chest is still sensitive to touch, temperature. The injection site of my left arm still feel mild pain and weak.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: Starting on 3rd day after the first vaccine shot, I felt sharp pain on my left chest and left back, two days later, rashes appeared, diagnosed as Shingles. Treated with antiviral medication. As today, rashes almost gone, but part of my chest is still sensitive to touch, temperature. The injection site of my left arm still feel mild pain and weak.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Insomnia, Mobility decreased
Clinical narrative: My appointment was on time, 4pm on 4/3 at the Pharmacy.  The young girl that gave me the shot told me she was certified, and she gave me the shot in the presence of her manager.  I have given  myself shots for years with diabetes, plus many flu shots, and have never felt pain like that.  I expressed this to her, how painful it was, and she just said "I know, I know..." as if it was normal for the shot to be so painful. I knew instantly something was wrong.  They were more worried, it seemed, about a potential adverse reaction such as an allergy shock, since I'm allergic to a few things, but I did not experience that.  I waited 15 minutes, my arm hurting the whole time, and they suggested I go buy Tylenol for the pain, which I did.  My left arm has hurt since then. I got a horrible bruise from this shot (will send picture) that took weeks to heal.  Since then I've continued to feel pain and don't have full mobility of my left arm. I can type, but not lifting anything heavy and have to go easy with anything on the left side.  I thought at first it might be what people were calling "covid arm" but I discovered that was more about soreness, not pain.  I tried ibuprofin, but after three weeks I'd had enough and made a doctors appointment.  Since I was also noticing my left shoulder was very tense and tight, and I was starting to get neck stiffness in same area, I started googling before my appointment.  When I entered my symptoms, SIRVA kept popping up, so I wondered if that was what I now had because of the improper vaccine administration.  I asked my doctor for an MRI order to find out, but she said we needed to do an Xray first (which only showed mild issues related to osteo).  She offered a prescription of taking Advil 400 mg three times and day and to use a muscle relaxer when I needed it, such as at night (Cyclobenzaprine).  She said to try that for a week, and if it wasn't better, that another Dr could order MRI.  Since then I've also added a pain spot under my left shoulder blade. Insurance called and said the order was "under review" so that's where things stand now. If they don't approve, I guess I will go next to an orthopedist for guidance?  This has cost me health, due to lack of sleep also - I wake up with pain in the middle of the night, even when I take the meds. Praying for a diagnosis, and solution, soon.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Osteoarthritis, Sleep disorder, X-ray
Clinical narrative: My appointment was on time, 4pm on 4/3 at the Pharmacy.  The young girl that gave me the shot told me she was certified, and she gave me the shot in the presence of her manager.  I have given  myself shots for years with diabetes, plus many flu shots, and have never felt pain like that.  I expressed this to her, how painful it was, and she just said "I know, I know..." as if it was normal for the shot to be so painful. I knew instantly something was wrong.  They were more worried, it seemed, about a potential adverse reaction such as an allergy shock, since I'm allergic to a few things, but I did not experience that.  I waited 15 minutes, my arm hurting the whole time, and they suggested I go buy Tylenol for the pain, which I did.  My left arm has hurt since then. I got a horrible bruise from this shot (will send picture) that took weeks to heal.  Since then I've continued to feel pain and don't have full mobility of my left arm. I can type, but not lifting anything heavy and have to go easy with anything on the left side.  I thought at first it might be what people were calling "covid arm" but I discovered that was more about soreness, not pain.  I tried ibuprofin, but after three weeks I'd had enough and made a doctors appointment.  Since I was also noticing my left shoulder was very tense and tight, and I was starting to get neck stiffness in same area, I started googling before my appointment.  When I entered my symptoms, SIRVA kept popping up, so I wondered if that was what I now had because of the improper vaccine administration.  I asked my doctor for an MRI order to find out, but she said we needed to do an Xray first (which only showed mild issues related to osteo).  She offered a prescription of taking Advil 400 mg three times and day and to use a muscle relaxer when I needed it, such as at night (Cyclobenzaprine).  She said to try that for a week, and if it wasn't better, that another Dr could order MRI.  Since then I've also added a pain spot under my left shoulder blade. Insurance called and said the order was "under review" so that's where things stand now. If they don't approve, I guess I will go next to an orthopedist for guidance?  This has cost me health, due to lack of sleep also - I wake up with pain in the middle of the night, even when I take the meds. Praying for a diagnosis, and solution, soon.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Initial dose 1/4/2021 second 1/29/2021. I was a little over 8 weeks pregnant when I had a miscarriage on or around 2/09.  I was not aware that the baby did not have a heart beat at that time but learned at an ultrasound on 3/9. I had an d and c. The baby was due on 9/23/2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of personal independence in daily activities, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
Clinical narrative: Shortness of breath 5 days after the vaccine that persisted 2 weeks, limiting the ability to talk, eat a full plate of food, or walk to the bathroom without stopping to catch my breath. Shortness of breath still comes and goes at this time currently in my daily life.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Facial paresis
Clinical narrative: CEREBROVASCULAR ACCIDENT R29.810 - Facial weakness
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM.The respective time the shot was given outside this window was 4:54 PM.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: The patient was given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM.The respective time the shot was given outside this window was 4:54 PM.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes simplex, Herpes virus infection, Nasal herpes, Oral herpes
Clinical narrative: Fatigue next day and severe outbreak of herpes simplex on lips inside and out; nares
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral infarction
Clinical narrative: Stroke-like symptoms  Other cerebral infarction due to occlusion or stenosis of small artery
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine vial remained in freezer one day longer than reccommended per manufacturer. Should have been pulled from freezer and refrigerated before 3pm Thursday 5/6/2021 but was not; Administered Friday 05/07/2021 after removal from freezer that morning. "USE BY DATE" on "FREEZER" sticker on original container was noticed Friday afternoon after injection had been admistered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Janssen COVID-19 vaccine to a 17 year old but the minimum age is 18 years old.