chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chest discomfort, Computerised tomogram abnormal, Cough, Death
Clinical narrative: death Narrative:  70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hyperhidrosis, Hypotension, Mental status changes
Clinical narrative: death Narrative:  70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, N-terminal prohormone brain natriuretic peptide increased, Nausea, Orthopnoea, Palpitations
Clinical narrative: death Narrative:  70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema, Tachycardia, Troponin increased, Vomiting
Clinical narrative: death Narrative:  70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; SORE INJECTION SITE; NAUSEA; This spontaneous report received from a patient 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: not reported) dose was not reported, administered on 06-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced sore injection site. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore injection site, body aches and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION; 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: Unknown) dose, 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 subject experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: ACUTE SORENESS; LETHARGIC; This spontaneous report received from a vaccine facility via a company representative concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood cancer. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for blood cancer. On APR-2021, the subject experienced acute soreness. On APR-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute soreness, and lethargic on 07-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Chills, Feeling hot, Myalgia, Peripheral coldness
Clinical narrative: FEET ARE VERY COLD; FEEL LIKE PETER PARKER AFTER GOT BIT BY SPIDER; FEEL LIKE HAVE A HEATING PAD UNDER SKIN; BODY CHILLS; MUSCLE ACHES; 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feet are very cold, feel like peter parker after got bit by spider, feel like have a heating pad under skin, body chills, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, body chills, feel like have a heating pad under skin, feet are very cold and feel like peter parker after got bit by spider was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Myalgia, Tinnitus
Clinical narrative: BURNING SENSATION DURING URINATION; REALLY BAD TINNITUS; GENERAL MUSCLE ACHES; 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  was not reported) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced really bad tinnitus. On APR-2021, the subject experienced general muscle aches. On 07-APR-2021, the subject experienced burning sensation during urination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation during urination, and general muscle aches, and the outcome of really bad tinnitus was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain
Clinical narrative: WARMTH; ACHINESS; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 62 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: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, warmth, headache, and achiness. This report was non-serious. This case, from the same reporter is linked to 20210413415.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: DIZZINESS; VOMITING; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; NAUSEA; IN BED X 3 DAYS; 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: Unknown) 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 an unspecified date, the subject experienced dizziness, vomiting, fever, muscle aches, headache, fatigue, nausea, and in bed x 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, fever, muscle aches, headache, fatigue, nausea, and in bed x 3 days. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: DIZZINESS; VOMITING; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; NAUSEA; IN BED X 3 DAYS; 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: Unknown) 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 an unspecified date, the subject experienced dizziness, vomiting, fever, muscle aches, headache, fatigue, nausea, and in bed x 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, fever, muscle aches, headache, fatigue, nausea, and in bed x 3 days. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: SORE THROAT; EXTREME MUSCLE ACHE; FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 50-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and hysterectomy, and concurrent conditions included fibromyalgia, and non-smoker, and other pre-existing medical conditions included no known allergies.  The patient was previously treated with Magnesium, Cimicifuga racemosa rhizome/cimicifuga racemosa root, Fluoxetine, Topiramate, and Estradiol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced extreme muscle ache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 06-APR-2021, and was recovering from extreme muscle ache, fatigue, sore throat, and headache. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Body aches; Did not sleep well; feeling woozy; BURNING AT INJECTION SITE WHICH STUNG; fever; Headache; very tired; Joint ache; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included arthritis, pre-diabetic, alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 04ZAZ1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 11:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced joint ache. On 06-APR-2021, the patient experienced body aches. On 06-APR-2021, the patient experienced did not sleep well. On 06-APR-2021, the patient experienced feeling woozy. On 06-APR-2021, the patient experienced burning at injection site which stung. On 06-APR-2021, the patient experienced fever. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site which stung on 06-APR-2021, had not recovered from fever, body aches, headache, and did not sleep well, and the outcome of joint ache, feeling woozy and very tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Body aches; Did not sleep well; feeling woozy; BURNING AT INJECTION SITE WHICH STUNG; fever; Headache; very tired; Joint ache; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included arthritis, pre-diabetic, alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 04ZAZ1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 11:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced joint ache. On 06-APR-2021, the patient experienced body aches. On 06-APR-2021, the patient experienced did not sleep well. On 06-APR-2021, the patient experienced feeling woozy. On 06-APR-2021, the patient experienced burning at injection site which stung. On 06-APR-2021, the patient experienced fever. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site which stung on 06-APR-2021, had not recovered from fever, body aches, headache, and did not sleep well, and the outcome of joint ache, feeling woozy and very tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Feeling hot, Pain
Clinical narrative: WARMTH; BODY ACHES; CHILLS FOR 2 HOURS; FEELING TIRED; ANXIETY; This spontaneous report received from a patient concerned a 62 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On APR-2021, the subject experienced feeling tired. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced chills for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth, body aches, and chills for 2 hours on 07-APR-2021, and the outcome of anxiety and feeling tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413340.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: "KNOT" ON THE INJECTION SITE; ERYTHEMA ON INJECTION SITE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 60 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, and batch number: 10808987 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 15:59 at right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced "knot" on the injection site. On 30-MAR-2021, the subject experienced erythema on injection site. On 30-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erythema on injection site on 03-APR-2021, and had not recovered from "knot" on the injection site, and injection site pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error
Clinical narrative: PRODUCT DISPENSING ERROR; This spontaneous report received from a physician 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: UNKNOWN) dose, 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 subject experienced product dispensing error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product dispensing error was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: STILL HAVE SORE ARM; 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: Unk) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced still have sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from still have sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Eye pain, Fatigue, Hypersomnia
Clinical narrative: SLEPT A LOT; EYES HURT; DIARRHEA; JOINTS ACHED; FATIGUE; This spontaneous report received from a consumer 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 was not reported, administered on 03-APR-2021 08:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, the subject experienced slept a lot. On 04-APR-2021, the subject experienced eyes hurt. On 04-APR-2021, the subject experienced diarrhea. On 04-APR-2021, the subject experienced joints ached. On 04-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, slept a lot, eyes hurt, diarrhea and joints ached was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN THE LEFT ARM; NUMBNESS IN THE LEFT LEG UNTIL THE TOES; TINGLING; 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination to left arm. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced numbness in the left arm. On 07-APR-2021, the subject experienced numbness in the left leg until the toes. On 07-APR-2021, the subject experienced tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the left arm, numbness in the left leg until the toes, and tingling. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: ERYTHEMA ON INJECTION SITE ON RIGHT ARM; SORENESS ON INJECTION SITE ON RIGHT ARM; This spontaneous report received from a consumer concerned a 66 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: 10808987, and expiry: UNKNOWN) dose was not reported, administered to the right deltoid, on 30-MAR-2021 15:59 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced erythema on injection site on right arm. On 30-MAR-2021, the subject experienced soreness on injection site on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erythema on injection site on right arm on 31-MAR-2021, and soreness on injection site on right arm on 02-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Palpitations, Vomiting
Clinical narrative: HEART BEATING OUT OF HER CHEST/RACING; SICK; THROWING UP; 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: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, the subject experienced throwing up. On 04-APR-2021, the subject experienced sick. On an unspecified date, the subject experienced heart beating out of her chest/racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, heart beating out of her chest/racing, and sick. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site bruising
Clinical narrative: HEADACHE; A BRUISE AT THE SITE OF INJECTION THAT HAS THE SIZE OF A QUARTER; This spontaneous report received from a patient concerned a 51 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: 18053, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced a bruise at the site of injection that has the size of a quarter. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 02-APR-2021, and had not recovered from a bruise at the site of injection that has the size of a quarter. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: LOCALIZED PAIN; FELT COLD, CHATTERING, AND CHILLS; HEADACHE; MUSCLE ACHES; FEVER; LACK OF APPETITE; QUEASY; FELT EXHAUSTED; DIZZY AND ROOM FEELS LIKE ITS SPINNING; This spontaneous report received from a patient concerned a 50 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: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced localized pain. On APR-2021, the subject experienced felt cold, chattering, and chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced lack of appetite. On APR-2021, the subject experienced queasy. On APR-2021, the subject experienced felt exhausted. On APR-2021, the subject experienced dizzy and room feels like its spinning. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the localized pain, felt cold, chattering, and chills, headache, muscle aches, fever, lack of appetite, queasy, felt exhausted and dizzy and room feels like its spinning was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: LOCALIZED PAIN; FELT COLD, CHATTERING, AND CHILLS; HEADACHE; MUSCLE ACHES; FEVER; LACK OF APPETITE; QUEASY; FELT EXHAUSTED; DIZZY AND ROOM FEELS LIKE ITS SPINNING; This spontaneous report received from a patient concerned a 50 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: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced localized pain. On APR-2021, the subject experienced felt cold, chattering, and chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced lack of appetite. On APR-2021, the subject experienced queasy. On APR-2021, the subject experienced felt exhausted. On APR-2021, the subject experienced dizzy and room feels like its spinning. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the localized pain, felt cold, chattering, and chills, headache, muscle aches, fever, lack of appetite, queasy, felt exhausted and dizzy and room feels like its spinning was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: CHILLS; ARM PAIN; UNSPECIFIED HEADACHE/ PIERCING HEADACHE; FATIGUE; NAUSEA; MUSCLE ACHES; This spontaneous report received from a consumer concerned nine patients. 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 and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced arm pain. On 06-APR-2021, the subject experienced unspecified headache/ piercing headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified headache/ piercing headache, chills, fatigue, nausea, arm pain, and muscle aches. This report was non-serious. This case, from the same reporter is linked to 20210413715.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CHILLS; ARM PAIN; UNSPECIFIED HEADACHE/ PIERCING HEADACHE; FATIGUE; NAUSEA; MUSCLE ACHES; This spontaneous report received from a consumer concerned nine patients. 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 and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced arm pain. On 06-APR-2021, the subject experienced unspecified headache/ piercing headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified headache/ piercing headache, chills, fatigue, nausea, arm pain, and muscle aches. This report was non-serious. This case, from the same reporter is linked to 20210413715.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: JOINT PAIN; THROBBING HEADACHE; This spontaneous report received from a patient 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: Unknown) dose, 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 subject experienced joint pain, and throbbing headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing headache, and joint pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: SORENESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, on the left arm, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced soreness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED SIDE EFFECTS; 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) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 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. This case, from the same reporter is linked to 20210413272.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: STINGING AND TINGLING SKIN; HEADACHE; This spontaneous report received from a patient concerned a 62 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: 180898, and expiry: UNKNOWN) dose was not reported, administered in right deltoid on 06-APR-2021 12:28 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced stinging and tingling skin. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stinging and tingling skin, and the outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a patient concerned a 53 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 and expiry: unknown) dose was not reported, administered on 06-APR-2021 on left Deltoid 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 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Nausea
Clinical narrative: BODY HOT; BODY ACHES; CHILLS; FEVER; HEADACHE; NAUSEA; SWEAT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, food allergy, seasonal allergies, and animal allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number not reported) dose was not reported, administered on 02-APR-2021 17:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sweat. On 02-APR-2021 22:45, the subject experienced body hot. On 02-APR-2021 22:45, the subject experienced body aches. On 02-APR-2021 22:45, the subject experienced chills. On 02-APR-2021 22:45, the subject experienced fever. On 02-APR-2021 22:45, the subject experienced headache. On 02-APR-2021 22:45, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body hot, body aches, chills, fever, and nausea on 07-APR-2021, and had not recovered from headache, and sweat. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY HOT; BODY ACHES; CHILLS; FEVER; HEADACHE; NAUSEA; SWEAT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, food allergy, seasonal allergies, and animal allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number not reported) dose was not reported, administered on 02-APR-2021 17:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sweat. On 02-APR-2021 22:45, the subject experienced body hot. On 02-APR-2021 22:45, the subject experienced body aches. On 02-APR-2021 22:45, the subject experienced chills. On 02-APR-2021 22:45, the subject experienced fever. On 02-APR-2021 22:45, the subject experienced headache. On 02-APR-2021 22:45, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body hot, body aches, chills, fever, and nausea on 07-APR-2021, and had not recovered from headache, and sweat. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Fatigue, Gait disturbance, Hypokinesia
Clinical narrative: HURT; COULDN'T FOCUS; COULDN'T LIFT A STEP; SHUFFLING; THROAT CLEARING; SINUSES; CHILLS; EXHAUSTED; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hurt, couldn't focus, couldn't lift a step, shuffling, throat clearing, sinuses, chills, exhausted, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, exhausted, nausea, hurt, couldn't focus, shuffling, throat clearing, couldn't lift a step and sinuses was not reported. This report was non-serious.