chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pulmonary thrombosis
Clinical narrative: CONFIRMED COVID-19 INFECTION; BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was hospitalized. The patient was diagnosed with corona virus disease a week after vaccination. On an unspecified date, the patient experienced blood clots in lungs. The patient was moved to intensive care this week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in lungs, and the outcome of confirmed covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000183689.; Sender's Comments: V0: 20210648173-COVID-19 VACCINE AD26.COV2.S-Confirmed COVID-19 infection. 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 20210648173-COVID-19 VACCINE AD26.COV2.S-Blood clots in lungs. 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).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Pyrexia
Clinical narrative: SLEPT FOR ABOUT 14 HOURS (SPENT MOST OF THE DAY IN BED); CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 18-JUN-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 19-JUN-2021, the subject experienced slept for about 14 hours (spent most of the day in bed). On 19-JUN-2021, the subject experienced chills. On 19-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, fever, and slept for about 14 hours (spent most of the day in bed). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea
Clinical narrative: BLOATING; STOMACH CRAMPS; DIARRHEA AFTER EATING FOOD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 bloating, stomach cramps, and diarrhea after eating food. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bloating, stomach cramps and diarrhea after eating food was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: LITTLE SICKNESS; FEVER 100F; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUN-2021, the subject experienced little sickness. On 22-JUN-2021, the subject experienced fever 100f. 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 100f and little sickness was not reported. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Tremor
Clinical narrative: Systemic: Seizure-Medium, Systemic: Shakiness-Medium
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Angioedema, Anti-thyroid antibody, Autoimmune disorder, Autoimmune thyroiditis
Clinical narrative: Angioedema 3 days past 2nd shot, 2 weeks later, complete allergic reaction, ended up in ED.  Newly diagnosed with Autoimmune Angioedema, Autoimmune Uticaria and Thyroiditis  since vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, Thyroid function test, Urticaria
Clinical narrative: Angioedema 3 days past 2nd shot, 2 weeks later, complete allergic reaction, ended up in ED.  Newly diagnosed with Autoimmune Angioedema, Autoimmune Uticaria and Thyroiditis  since vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: Fever-like feeling, and painful headache.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Swelling to injection site, presents similar to cellulitis, pt states no significant history of adverse reactions but discloses sensitive skin and recurrent reactions with various environment exposures.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Colitis ischaemic, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: 17 days after 2nd shot I was taken to Hospital by ambulance.  I was diagnosed with ischemic colitis, spent 6 days then released
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic lymphocytic leukaemia, Condition aggravated, Death, Nucleic acid test
Clinical narrative: Died 5/11/2021 Causes of death listed on death certificate: 1) covid  2) chronic lymphocytic leukemia
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Died 5/11/2021 Causes of death listed on death certificate: 1) covid  2) chronic lymphocytic leukemia
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Asthenia, Blood creatinine increased, Blood potassium decreased, Blood pressure increased
Clinical narrative: About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood urea increased, Chest discomfort, Computerised tomogram head abnormal, Cranial nerve disorder
Clinical narrative: About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Dizziness, Electrocardiogram abnormal, Eye pain, Fatigue
Clinical narrative: About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Glomerular filtration rate decreased, Headache, Heart rate increased, Magnetic resonance imaging head abnormal, Malaise
Clinical narrative: About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Scan with contrast abnormal, Tinnitus, Urine analysis, Venogram abnormal
Clinical narrative: About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White matter lesion
Clinical narrative: About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination.   Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide normal, Chest X-ray normal, Chest pain, Ejection fraction decreased, Electrocardiogram normal
Clinical narrative: Initially, myalgias and fatigue.  This was soon followed by acute chest pain.  The symptoms all completely resolved by 6/24/21.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Left ventricular dysfunction, Magnetic resonance imaging heart, Myalgia, Myocardial fibrosis
Clinical narrative: Initially, myalgias and fatigue.  This was soon followed by acute chest pain.  The symptoms all completely resolved by 6/24/21.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Toxoplasma serology negative, Troponin increased
Clinical narrative: Initially, myalgias and fatigue.  This was soon followed by acute chest pain.  The symptoms all completely resolved by 6/24/21.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Frequent heart palpitations, particularly noticeable during exercise when laying down. Heaviness and pressure in chest and heart. Uncharacteristically out of breath and distressed during exercise and exertion. Exacerbated existing EIVT (Exercise Induced Ventricular Tachycardia). Symptoms persisted for the following four weeks. I did not seek a diagnosis but I believe I experienced a mild form of myocarditis.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Death, Nucleic acid test, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Death   4/21/2021 Causes of death listed on death certificate: 1) respiratory failure  2) covid 19 pneumonia
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac pacemaker insertion, Cardioversion, Condition aggravated
Clinical narrative: 1- Palpetations and Aflutter which was controlled prior to second shot was exacerbated and evolved into AFIB within 1-week of second shot.  (26-March-2021)  2- Sought treatment subsequently and required cardioversion.  (3-April-2021) 3- Another cardioversion was undertaken and finally, the installation of a pacemaker was completed to avoid total heart block condition which evolved. 4- Placed on maintenance dose of Amioderone beginning 2-April. Palpetations continue
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: 1- Palpetations and Aflutter which was controlled prior to second shot was exacerbated and evolved into AFIB within 1-week of second shot.  (26-March-2021)  2- Sought treatment subsequently and required cardioversion.  (3-April-2021) 3- Another cardioversion was undertaken and finally, the installation of a pacemaker was completed to avoid total heart block condition which evolved. 4- Placed on maintenance dose of Amioderone beginning 2-April. Palpetations continue
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Client received moderna the first vaccine Lot 004c21a  And received pfizer second dose.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease, Death, Diabetic nephropathy, End stage renal disease, Hypertension
Clinical narrative: Death  04/23/2021 Causes of death listed on death certificate: 1) End Stage Renal Disease  2) Diabetes Type 2 with nephropathy  3) Hypertension  4) Coronary Artery Disease
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Nucleic acid test, SARS-CoV-2 test, Type 2 diabetes mellitus
Clinical narrative: Death  04/23/2021 Causes of death listed on death certificate: 1) End Stage Renal Disease  2) Diabetes Type 2 with nephropathy  3) Hypertension  4) Coronary Artery Disease
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Anxiety, Feeling abnormal
Clinical narrative: EXPERIENCE ISSUES; HORRIBLE; WORRIED ABOUT VACCINE MANUFACTURING UNIT; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, and alcohol use. 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 21-MAR-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 experience issues, horrible, and worried about vaccine manufacturing unit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the experience issues, horrible and worried about vaccine manufacturing unit was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648458.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: RECEIVED VACCINE TWICE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 02-JUN-2021, and dose was not reported, administered on 22-JUN-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 22-JUN-2021, the subject experienced received vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received vaccine twice was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Muscle tightness, Nausea, Pain
Clinical narrative: MUSCLE TIGHTNESS; ACHES; FELT PRETTY CRAPPY; NAUSEA; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced muscle tightness, aches, felt pretty crappy, nausea, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt pretty crappy, nausea, muscle tightness, aches and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Bedridden, Dysphagia, Fatigue, Feeling abnormal
Clinical narrative: THOUGHT SHE WAS GOING TO DIE; COULDN'T GET OUT OF BED; SICK FOR 72 HOURS; EXTREME REACTION; COULDN'T KEEP FOOD OR DRINK DOWN; FEVERISH; FATIGUED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced thought she was going to die. On APR-2021, the subject experienced couldn't get out of bed. On APR-2021, the subject experienced sick for 72 hours. On APR-2021, the subject experienced extreme reaction. On APR-2021, the subject experienced couldn't keep food or drink down. On APR-2021, the subject experienced feverish. On APR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought she was going to die, couldn't get out of bed, sick for 72 hours, couldn't keep food or drink down, feverish, and fatigued, and the outcome of extreme reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: THOUGHT SHE WAS GOING TO DIE; COULDN'T GET OUT OF BED; SICK FOR 72 HOURS; EXTREME REACTION; COULDN'T KEEP FOOD OR DRINK DOWN; FEVERISH; FATIGUED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced thought she was going to die. On APR-2021, the subject experienced couldn't get out of bed. On APR-2021, the subject experienced sick for 72 hours. On APR-2021, the subject experienced extreme reaction. On APR-2021, the subject experienced couldn't keep food or drink down. On APR-2021, the subject experienced feverish. On APR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought she was going to die, couldn't get out of bed, sick for 72 hours, couldn't keep food or drink down, feverish, and fatigued, and the outcome of extreme reaction was not reported. This report was non-serious.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Vomiting
Clinical narrative: THROWING UP; LOW BLOOD PRESSURE 98/68; This spontaneous report received from a consumer concerned a 97 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced throwing up. On 21-JUN-2021, the subject experienced low blood pressure 98/68. Laboratory data included: Blood pressure (NR: not provided) low blood pressure 98/68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, and low blood pressure 98/68. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Thrombocytopenia
Clinical narrative: THROMBOCYTOPENIA; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 15-JUN-2021 12:00 PM for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-JUN-2021 at 21:30, the patient had a bruise with a radius of 15 centimeters on forearm and not on the site of vaccination. On an unspecified date, the patient had thrombocytopenia. The patient visited emergency room for a blood test, but he was in the category of normal thrombocytopenia and thrombosis-related levels. At the time of this report, the patient's thrombocytopenia trend was being monitored by taking blood tests every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210649091 - Covid-19 vaccine ad26.cov2.s- thrombocytopenia. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Energy increased
Clinical narrative: COUGH IN MIDDLE OF CHEST IN HEART AREA AND IT LIKE SUNBURST; BURST OF ENERGY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 cough in middle of chest in heart area and it like sunburst, and burst of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough in middle of chest in heart area and it like sunburst, and the outcome of burst of energy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced sore arm. On JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and sore arm was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia
Clinical narrative: TONGUE TINGLING; FEVER; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery. 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, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, the subject experienced tongue tingling. On 23-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and tongue tingling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FELT PRETTY CRAPPY; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, felt pretty crappy, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, felt pretty crappy, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Insomnia, Muscle spasms, Pain in extremity
Clinical narrative: MUSCLE CRAMPS  IN LEGS, ARMS, FEET; COULD NOT MOVE ARM /HAVE DIFFICULTY MOVING ARM; DISRUPTING SLEEP; RIGHT ARM BEING  SORE EVERY OTHER DAY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included major surgery - aorta bypass, legs cramping prior to the surgery, and almost no blood circulating towards legs, and concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced muscle cramps in legs, arms, feet. On 04-JUN-2021, the subject experienced could not move arm /have difficulty moving arm. On 04-JUN-2021, the subject experienced disrupting sleep. On 04-JUN-2021, the subject experienced right arm being sore every other day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramps in legs, arms, feet, right arm being sore every other day, disrupting sleep, and could not move arm /have difficulty moving arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus, Vomiting
Clinical narrative: TALKED MYSELF OUT OF THROWING UP; NAUSEA THAT CREEPS UP WITHOUT WARNING; ON AND OFF HEADACHE RIGHT BEHIND EYES; ITCHING FOR NO REASON THAT BECAME MORE INTENSE TO TORSO AND BACK; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included patient did not seek medical attention. patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced itching for no reason that became more intense to torso and back. On 18-JUN-2021, the subject experienced on and off headache right behind eyes. On 19-JUN-2021, the subject experienced talked myself out of throwing up. On 19-JUN-2021, the subject experienced nausea that creeps up without warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off headache right behind eyes, itching for no reason that became more intense to torso and back, nausea that creeps up without warning, and talked myself out of throwing up. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced fever, sore arm, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, sore arm, and body aches. This report was non-serious.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Hypertension, Loss of consciousness
Clinical narrative: in and out of consciousness; blood pressure was 170/112; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (in and out of consciousness) and HYPERTENSION (blood pressure was 170/112) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI and Chronic heart failure. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (in and out of consciousness) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (blood pressure was 170/112) (seriousness criterion hospitalization prolonged) and CHILLS (severe chills). At the time of the report, LOSS OF CONSCIOUSNESS (in and out of consciousness), HYPERTENSION (blood pressure was 170/112) and CHILLS (severe chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/112 (High) Increased.         No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patients underlying chronic heart failure and advanced age are confounders.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information was received on 27-Apr-2021 contains information regarding follow-up consent (follow-up and consent was denied for follow-up).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patients underlying chronic heart failure and advanced age are confounders.
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: Sharp pain when breathing after having her first dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (Sharp pain when breathing after having her first dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAINFUL RESPIRATION (Sharp pain when breathing after having her first dose of the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, PAINFUL RESPIRATION (Sharp pain when breathing after having her first dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient experienced sharp pain when breathing with Moderna vaccine even after having it.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Gastric infection
Clinical narrative: Stomach infection; This spontaneous case was reported by a physician and describes the occurrence of GASTRIC INFECTION (Stomach infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history was provided by the reporter.  Concomitant products included CALCIUM, VITAMIN D3, GABAPENTIN, OMEPRAZOLE, DICLOFENAC, METHOTREXATE SODIUM, METOPROLOL TARTRATE, LOSARTAN POTASSIUM and SIMVASTATIN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In January 2021, the patient experienced GASTRIC INFECTION (Stomach infection) (seriousness criterion medically significant). At the time of the report, GASTRIC INFECTION (Stomach infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: normal (normal) No infections found in body. On 19-May-2021, Blood test: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   At end of Jan 2021, the patient had stomach infection around the time she got the first Moderna Vaccine.  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-216522 (Patient Link).; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Myalgia
Clinical narrative: Loss of consciousness; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A2 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and MYALGIA (Muscle pain). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and MYALGIA (Muscle pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.  Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-125319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: follow-up received on 23-Jun-2021 contains non significant information; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: has a sinus infection for which he is taking antibiotics; This is a spontaneous report received from contactable male consumer (patient) from a Pfizer-sponsored program .  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unspecified), via unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient was taking antibiotics for his sinus infection, second dose of the vaccine was scheduled on 06Feb2021 (Saturday). The outcome of the event was unknown. Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: The morning after my covid-19 shot I have a sore throat; This is a spontaneous report from a contactable consumer (patient himself). A 73 (unit: unknown) old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 03Feb2021 as 1st dose, single for COVID-19 immunization. Vaccine facility type was reported as Hospital. Patient did not receive any other vaccine within four weeks. Patient did not had COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Patient medical history and concomitant medications were not reported. Patient had no known allergies. On 04Feb2021 at 00:00, the morning after patient's covid-19 shot he had a sore throat. Patient did not receive any treatment for the adverse events. The outcome of the event was resolving.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.