chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea exertional, Haemoglobin, Haemoglobin decreased, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; LOW HEMOGLOBIN; SHORTNESS OF BREATH/  COULDN'T WALK 25 FEET WITHOUT BEING OUT OF BREATH; SNIFFLE; POST NASAL DRIP; CRAMPING IN LEGS; RED BLOOD CELL COUNT IS ONLY 3; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included ckd ( chronic kidney disease ), and heart issues. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered in left deltoid on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, Laboratory data included: Hemoglobin (NR: not provided) 9.3. On an unspecified date, the patient experienced high blood pressure, low hemoglobin, shortness of breath/ couldn't walk 25 feet without being out of breath, sniffle, post nasal drip, cramping in legs, and red blood cell count is only 3. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 180/85 mmHg, over 200, 155- 145, 150/80 mmHg, Haemoglobin (NR: not provided) 11.3, and Red blood cell count (NR: not provided) 3. Treatment medications (dates unspecified) included: hydralazine, and epoetin alfa. It was reported that 3 days later from the vaccination, he started experiencing dizziness. He also experienced headache that is still there. The patient further reported that dizziness comes and goes, it was constant before, but now it suddenly shows up and was not linked to his meals or standing up or sitting down. The patient did not found a link between his dizziness and activities.  The action taken with  COVID-19 VACCINE AD26.COV2.S was not applicable. The reporter assessed the causality between Janssen COVID-19 VACCINE AD26.COV2.S suspension for injection and cramping in legs as not related,. The patient recovered from sniffle, post nasal drip, and cramping in legs, had not recovered from high blood pressure, low hemoglobin, and shortness of breath/ couldn't walk 25 feet without being out of breath, and the outcome of red blood cell count is only 3 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343260 -covid-19 vaccine ad26.cov2.s- high blood pressure, low hemoglobin. 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: UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Red blood cell count, Red blood cell count abnormal, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: HIGH BLOOD PRESSURE; LOW HEMOGLOBIN; SHORTNESS OF BREATH/  COULDN'T WALK 25 FEET WITHOUT BEING OUT OF BREATH; SNIFFLE; POST NASAL DRIP; CRAMPING IN LEGS; RED BLOOD CELL COUNT IS ONLY 3; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included ckd ( chronic kidney disease ), and heart issues. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered in left deltoid on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, Laboratory data included: Hemoglobin (NR: not provided) 9.3. On an unspecified date, the patient experienced high blood pressure, low hemoglobin, shortness of breath/ couldn't walk 25 feet without being out of breath, sniffle, post nasal drip, cramping in legs, and red blood cell count is only 3. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 180/85 mmHg, over 200, 155- 145, 150/80 mmHg, Haemoglobin (NR: not provided) 11.3, and Red blood cell count (NR: not provided) 3. Treatment medications (dates unspecified) included: hydralazine, and epoetin alfa. It was reported that 3 days later from the vaccination, he started experiencing dizziness. He also experienced headache that is still there. The patient further reported that dizziness comes and goes, it was constant before, but now it suddenly shows up and was not linked to his meals or standing up or sitting down. The patient did not found a link between his dizziness and activities.  The action taken with  COVID-19 VACCINE AD26.COV2.S was not applicable. The reporter assessed the causality between Janssen COVID-19 VACCINE AD26.COV2.S suspension for injection and cramping in legs as not related,. The patient recovered from sniffle, post nasal drip, and cramping in legs, had not recovered from high blood pressure, low hemoglobin, and shortness of breath/ couldn't walk 25 feet without being out of breath, and the outcome of red blood cell count is only 3 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343260 -covid-19 vaccine ad26.cov2.s- high blood pressure, low hemoglobin. 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: UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypotension, Influenza, White blood cell count decreased
Clinical narrative: LOW BLOOD PRESSURE 65/50; LOW WHITE BLOOD CELL COUNT(2.5); FLU LIKE SYNDROME; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced low blood pressure 65/50, low white blood cell count (2.5) and flu like syndrome. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 65/50 LOW, Pulse rate (NR: not provided) 90, and white blood cell count decreased (NR: not provided) 2.5 LOW. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low blood pressure 65/50, low white blood cell count(2.5), and flu like syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345110-covid-19 vaccine ad26.cov2.s-Low blood pressure 65/50; Low white blood cell count (2.5). These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Facial paralysis, Feeling hot, Paraesthesia
Clinical narrative: BELL'S PALSY EXACERBATED; TINGLING IN PALMS OF HANDS; HOT IN PALMS; PAIN IN BETWEEN SHOULDER BLADES; EXTREME WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bells palsy. 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-MAR-2021 for prophylactic vaccination on right 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 19-MAR-2021, the patient stated that she experienced extreme weakness and pain in between shoulder blades within 48 hours of vaccination and ambulance took her to the emergency room where she got tested for stroke but confirmed bell's palsy diagnosis. She has bell's palsy seven years ago and it was reported that vaccine seemed to exacerbated the condition. Patient also experienced tingling and hotness in palms of hands within 48 hours of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme weakness, and had not recovered from bell's palsy exacerbated, pain in between shoulder blades, tingling in palms of hands, and hotness in palms of hands. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 23/Mar/2021. Upon review, the following information was amended: Age group updated as unknown, Reporter causality updated as possible, narrative updated.; Sender's Comments: V1: Version created to amend age group, reporter causality and narrative. This updated information does not alter the causality of previously reported event.  20210345589-Covid-19 vaccine ad26.cov2.s-Bell's palsy exacerbated. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Bradyphrenia, Chills, Fatigue, Pain, Syncope
Clinical narrative: FAINTED; SLOW MIND; BODY ACHE; CHILLS; FATIGUE; 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's past medical condition included patient typically faints after receiving vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fainted, slow mind, body ache, chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, chills, body ache, fatigue and slow mind was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210346239-covid-19 vaccine ad26.cov2.s-Fainted. 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Haematemesis, Heart rate, Hypoaesthesia
Clinical narrative: BLOOD IN VOMIT (VOMITING); ASTHMA (PULSE 130, BLOOD OXYGEN DOWN TO 97); TINGLING ALL OVER BODY; BODY WENT NUMB; FEVER; NAUSEA; This spontaneous report received from a consumer 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 was not reported, administered on 23-MAR-2021 for prophylactic vaccination on Left Deltoid around 10-12 p.m. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced blood in vomit (vomiting), asthma (pulse 130, blood oxygen down to 97), tingling all over body, body went numb, fever, nausea. After vaccination It was reported that patient experienced vomiting along with some blood in vomit, pulse at 130 and blood oxygen went down to 97 along with that started experiencing asthma. The consumer had to visit to emergency room with patient. Laboratory data included: Body temperature (NR: not provided) 102 F, Oxygen saturation low (NR: not provided) 97 (units unspecified), and Pulse rate (NR: not provided) 130 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, blood in vomit (vomiting), tingling all over body, fever, asthma (pulse 130, blood oxygen down to 97) and body went numb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210346726-covid-19 vaccine ad26.cov2.s-Blood in vomit. 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: Nausea, Oxygen saturation decreased, Paraesthesia, Pyrexia
Clinical narrative: BLOOD IN VOMIT (VOMITING); ASTHMA (PULSE 130, BLOOD OXYGEN DOWN TO 97); TINGLING ALL OVER BODY; BODY WENT NUMB; FEVER; NAUSEA; This spontaneous report received from a consumer 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 was not reported, administered on 23-MAR-2021 for prophylactic vaccination on Left Deltoid around 10-12 p.m. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced blood in vomit (vomiting), asthma (pulse 130, blood oxygen down to 97), tingling all over body, body went numb, fever, nausea. After vaccination It was reported that patient experienced vomiting along with some blood in vomit, pulse at 130 and blood oxygen went down to 97 along with that started experiencing asthma. The consumer had to visit to emergency room with patient. Laboratory data included: Body temperature (NR: not provided) 102 F, Oxygen saturation low (NR: not provided) 97 (units unspecified), and Pulse rate (NR: not provided) 130 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, blood in vomit (vomiting), tingling all over body, fever, asthma (pulse 130, blood oxygen down to 97) and body went numb was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210346726-covid-19 vaccine ad26.cov2.s-Blood in vomit. 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: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYZED FROM  WAIST TO  ALL THE WAY DOWN LEGS; This spontaneous report received from a patient via a company representative 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 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 paralyzed from waist to all the way down legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed from waist to all the way down legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210347177-covid-19 vaccine ad26.cov2.s-paralyzed from waist to all the way down legs. 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: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Fatigue, Heart rate
Clinical narrative: INCREASED BLOOD PRESSURE; DIZZINESS; CHILLS; LITTLE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, and high blood pressure.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included clonidine for high blood pressure which the patient takes four times daily. On 23-MAR-2021 11:00, the patients blood pressure was 204/105 (units not specified) and heart rate was 76 (units not specified) and started experiencing dizziness after which the patient was instructed by her doctor to recheck the blood pressure reading in 40 minutes and if got a higher reading, was advised to take an extra dose of clonidine. The patient stated that her doctor had given permission for her to get vaccinated considering her concurrent conditions. The patient was not sure if the high blood pressure was caused by covid-19 vaccine ad26.cov2.s as she had not experienced such high blood pressure before. On 23-MAR-2021, the patient experienced chills and was only a little tired. The patient had called her doctor for medical advice and was waiting to hear back from him before she took the extra dose of clonidine. Laboratory data included: Heart rate: 76 (units not specified). Laboratory data included: Blood pressure: 240/105 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from little tired, had not recovered from increased blood pressure, and the outcome of dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210347232-covid-19 vaccine ad26.cov2.s -increased blood pressure. 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: UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: INCREASED BLOOD PRESSURE; DIZZINESS; CHILLS; LITTLE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, and high blood pressure.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included clonidine for high blood pressure which the patient takes four times daily. On 23-MAR-2021 11:00, the patients blood pressure was 204/105 (units not specified) and heart rate was 76 (units not specified) and started experiencing dizziness after which the patient was instructed by her doctor to recheck the blood pressure reading in 40 minutes and if got a higher reading, was advised to take an extra dose of clonidine. The patient stated that her doctor had given permission for her to get vaccinated considering her concurrent conditions. The patient was not sure if the high blood pressure was caused by covid-19 vaccine ad26.cov2.s as she had not experienced such high blood pressure before. On 23-MAR-2021, the patient experienced chills and was only a little tired. The patient had called her doctor for medical advice and was waiting to hear back from him before she took the extra dose of clonidine. Laboratory data included: Heart rate: 76 (units not specified). Laboratory data included: Blood pressure: 240/105 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from little tired, had not recovered from increased blood pressure, and the outcome of dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210347232-covid-19 vaccine ad26.cov2.s -increased blood pressure. 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: UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On an unspecified date, the subject experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. The case was serious (Other Medically Important Condition).  Version created to amend previously reported information on 23/Mar/2021. Upon review the following information was amended: Non serious case updated to serious.; Sender's Comments: V1: 20210348431-COVID-19 VACCINE AD26.COV2.S -Suspected Immunological Vaccine Failure. Follow-up received regarding Other Information: Event upgraded from Non-Serious to Serious. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Deep vein thrombosis, Hypochromasia, Injection site pain, Lacrimation increased
Clinical narrative: HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Ultrasound scan, Urinary tract infection, Urine analysis, White blood cell count increased
Clinical narrative: HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: VOMITING  AFTER GETTING THE COVID VACCINE; NAUSEA  AFTER GETTING THE COVID VACCINE; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 59.1 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient was treated with macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30-NOV-2023) 10 mg, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included treprostinil sodium.  On 21- MAR-2021, the patient was admitted to loyola hospital due to nausea and vomiting after getting the Covid vaccine and still hospitalized.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the nausea after getting the Covid vaccine and vomiting after getting the Covid vaccine was not reported..  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210349126- Covid-19 vaccine ad26.cov2.s-Vomiting. 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. 20210349126- Covid-19 vaccine ad26.cov2.s-nausea. This event is labeled and is therefore considered potentially related. 20210349126-macitentan-nausea and vomiting. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: LOSS OF VISION; 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 and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient had symptoms of loosing vision. and at 19:30, she experienced loss of vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of vision. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210349284-COVID-19 VACCINE AD26.COV2.s-loss of vision. 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: F
Vaccine: COVID19
Symptoms: Adverse event, Blood test, Body temperature, Chills, Computerised tomogram
Clinical narrative: BLACKED OUT/FAINTED AGAIN; BODY ACHE; CHILLS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: Unknown) dose was not reported, administered on 22-MAR-2021 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, patient experienced chills, body ache, nausea, Fever, Headache. On 23-Mar-2021, Tuesday patient woke up in am - had few glasses of water, went back to bed, at 10 am had cup of tea and around 2 pm setting in chair and blacked out. Patient did not fall, daughter tried to wake up however after no response daughter called ambulance, when EMT (Emergency Medical Technicians) came patient woke up and told EMT that she did not want to go to hospital however patient fainted again in front of EMT and they took her to ER (emergency room), checked vitals, boold work, urine test , CAT Scan, moitored heart, IV saline administered twise. All reports came to negative so ER concluded it as reaction to COVID vaccine. Patient was in ER for total 6 hours. On 24-Mar-2021, patient felt much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body ache, nausea, fever, headache and blacked out/fainted again was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210349895-COVID-19 VACCINE AD26.COV2.S -Blacked Out/Fainted Again. 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: Headache, Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: BLACKED OUT/FAINTED AGAIN; BODY ACHE; CHILLS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: Unknown) dose was not reported, administered on 22-MAR-2021 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, patient experienced chills, body ache, nausea, Fever, Headache. On 23-Mar-2021, Tuesday patient woke up in am - had few glasses of water, went back to bed, at 10 am had cup of tea and around 2 pm setting in chair and blacked out. Patient did not fall, daughter tried to wake up however after no response daughter called ambulance, when EMT (Emergency Medical Technicians) came patient woke up and told EMT that she did not want to go to hospital however patient fainted again in front of EMT and they took her to ER (emergency room), checked vitals, boold work, urine test , CAT Scan, moitored heart, IV saline administered twise. All reports came to negative so ER concluded it as reaction to COVID vaccine. Patient was in ER for total 6 hours. On 24-Mar-2021, patient felt much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body ache, nausea, fever, headache and blacked out/fainted again was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210349895-COVID-19 VACCINE AD26.COV2.S -Blacked Out/Fainted Again. 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: Urine analysis abnormal, Vital signs measurement
Clinical narrative: BLACKED OUT/FAINTED AGAIN; BODY ACHE; CHILLS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: Unknown) dose was not reported, administered on 22-MAR-2021 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, patient experienced chills, body ache, nausea, Fever, Headache. On 23-Mar-2021, Tuesday patient woke up in am - had few glasses of water, went back to bed, at 10 am had cup of tea and around 2 pm setting in chair and blacked out. Patient did not fall, daughter tried to wake up however after no response daughter called ambulance, when EMT (Emergency Medical Technicians) came patient woke up and told EMT that she did not want to go to hospital however patient fainted again in front of EMT and they took her to ER (emergency room), checked vitals, boold work, urine test , CAT Scan, moitored heart, IV saline administered twise. All reports came to negative so ER concluded it as reaction to COVID vaccine. Patient was in ER for total 6 hours. On 24-Mar-2021, patient felt much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body ache, nausea, fever, headache and blacked out/fainted again was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210349895-COVID-19 VACCINE AD26.COV2.S -Blacked Out/Fainted Again. 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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned multiple 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, 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. The reported called for an agency, during call she had mentioned "several deaths were reported with the vaccine". She read it on a website. The cause of the deaths was not reported. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210350272-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Back pain, Bone pain, Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; JOINT PAIN  IN WRISTS AND FINGERS; MUSCLE ACHE; CARDIAC ARRHYTHMIAS; BONE ACHE; LOT OF STIFFNESS; LOT OF BACK PAIN LIKE A VERY SENSITIVE, LOT OF PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and operation, and concurrent conditions included cardiac arrhythmias. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lot of stiffness, lot of back pain like a very sensitive, lot of pain. On 17-MAR-2021, the patient experienced cardiac arrhythmias, bone ache, joint pain in wrists and fingers, muscle ache. On 22-MAR-2021, the subject experienced pain at injection site. The patient stated that he had pain at the injection site, muscle and bone ache, and joint ache after receiving the vaccine. He also stated that he had some cardiac arrhythmias after 1 hour of the vaccine. He had a history of A-Fib, had operation, and took medications for it. The patient stated regarding cardiac arrhythmia had not sure if the vaccine caused it "  it went away. Had them just periodically over 3-4 days. He got arrhythmias every now and then, it seems to had gotten worse after vaccine. He also stated had lot of back pain like a very sensitive, lot of pain, lot of stiffness like sometimes when he got a flu back pain, intense back pain, also joint pain in wrists and finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, joint pain in wrists and fingers, and muscle ache on 22-MAR-2021, and was recovering from cardiac arrhythmias, pain at injection site, lot of stiffness, and lot of back pain like a very sensitive, lot of pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350444-COVID-19 VACCINE AD26.COV2.s-Cardiac arrhythmia. 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: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: PAIN AT INJECTION SITE; JOINT PAIN  IN WRISTS AND FINGERS; MUSCLE ACHE; CARDIAC ARRHYTHMIAS; BONE ACHE; LOT OF STIFFNESS; LOT OF BACK PAIN LIKE A VERY SENSITIVE, LOT OF PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and operation, and concurrent conditions included cardiac arrhythmias. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lot of stiffness, lot of back pain like a very sensitive, lot of pain. On 17-MAR-2021, the patient experienced cardiac arrhythmias, bone ache, joint pain in wrists and fingers, muscle ache. On 22-MAR-2021, the subject experienced pain at injection site. The patient stated that he had pain at the injection site, muscle and bone ache, and joint ache after receiving the vaccine. He also stated that he had some cardiac arrhythmias after 1 hour of the vaccine. He had a history of A-Fib, had operation, and took medications for it. The patient stated regarding cardiac arrhythmia had not sure if the vaccine caused it "  it went away. Had them just periodically over 3-4 days. He got arrhythmias every now and then, it seems to had gotten worse after vaccine. He also stated had lot of back pain like a very sensitive, lot of pain, lot of stiffness like sometimes when he got a flu back pain, intense back pain, also joint pain in wrists and finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, joint pain in wrists and fingers, and muscle ache on 22-MAR-2021, and was recovering from cardiac arrhythmias, pain at injection site, lot of stiffness, and lot of back pain like a very sensitive, lot of pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350444-COVID-19 VACCINE AD26.COV2.s-Cardiac arrhythmia. 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Seizure
Clinical narrative: POSSIBLE SEIZURES; BODY ACHE; FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 22-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced possible seizures, body ache, fever and headache after receiving the vaccine. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible seizures, fever, and headache, and had not recovered from body ache. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210350457-COVID-19 VACCINE AD26.COV2.S-Possible seizures. 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: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fluid retention, Gastrointestinal pain, Generalised oedema, Rash
Clinical narrative: SWELLING OF AIRWAY; FEELING OF SUFFOCATION; SWELLING OF ENTIRE BODY; SHORTNESS OF BREATH; RASHES THROUGHOUT BODY; HIVES THROUGHOUT  BODY; WATER RETENTION; GI PAIN; This spontaneous report received from a consumer concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non-smoker, and seasonal allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the Patient experienced water retention, gi pain, rashes throughout body and hives throughout body. On 20-MAR-2021, the patient experienced swelling of airway, feeling of suffocation, swelling of entire body and shortness of breath. Treatment medications included: epinephrine and antihistamines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of airway, and feeling of suffocation, had not recovered from swelling of entire body, water retention, gi pain, rashes throughout body, and hives throughout body, and the outcome of shortness of breath was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210350470-covid-19 vaccine ad26.cov2.s- Rashes throughout body, Hives throughout body. This events are labeled and is therefore considered potentially related.  20210350470-covid-19 vaccine ad26.cov2.s-Swelling of airway, Shortness of breath ,Swelling of entire body ,Feeling of suffocation, Water retention ,GI Pain. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.