chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pulmonary embolism
Clinical narrative: CEREBRAL SINUS VEIN THROMBOSIS; LOW PLATELET; STROKE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a company representative concerned a 43 year-old female. Initial information received on 20-APR-2021, processed along with information receive on 23-APR-2021, via telephone communication.  The patient's weight and height were not reported. The patient's medical history included obesity. The patient was not on birth control. The patient did not have autoimmune disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, frequency 1 total, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patients symptoms started on 13-APR-2021 (also reported as 05-APR-2021), with headache, dizziness and mild shortness of breath.  On 16-APR-2021, the patient developed cerebral venous sinus thrombosis (CVST), had stroke, bilateral lobar pulmonary embolism and had low platelet. On the same day, the patient was admitted to the hospital and was still hospitalized at the time of reporting. The patient's platelet count was 17,000, anti platelet factor 4 was positive (the physician reported as 2.5 or 2.7 OD). The patient started on Intravenous immunoglobulin (IVIG) and responded well. Anticoagulation was not mentioned. A repeat scan, 4 days later did not show a venous thrombosis. Hemoglobin was 12.5, platelets increased to 137. The patient was discharged after approximately 4 days on 22-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral sinus vein thrombosis, stroke, pulmonary embolism, and low platelet. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: This case concerns a 43-year-old female who experienced cerebral venous sinus thrombosis (CVST), platelet count decreased, bilateral pulmonary embolism, and stroke 8 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient's medical history included obesity. The patient does not have autoimmune disease and was not taking birth control. Her symptoms started as headache, dizziness, and mild dyspnea. After seeking medical attention, she was found to have a CVST and bilateral lobar pulmonary embolism. Her platelet count was noted to be 17,000 and the anti-PF-4 antibody was positive. She was treated with IVIG. A repeat scan 4 days later did not show the venous thrombosis. The platelet count was noted to increase to 137,000. The patient was discharged after approximately 4 days. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from a non-profit global vaccine safety research network) and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet factor 4, Protein C, Protein S, Prothrombin time, Pulmonary embolism
Clinical narrative: CEREBRAL SINUS VEIN THROMBOSIS; LOW PLATELET; STROKE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a company representative concerned a 43 year-old female. Initial information received on 20-APR-2021, processed along with information receive on 23-APR-2021, via telephone communication.  The patient's weight and height were not reported. The patient's medical history included obesity. The patient was not on birth control. The patient did not have autoimmune disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, frequency 1 total, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patients symptoms started on 13-APR-2021 (also reported as 05-APR-2021), with headache, dizziness and mild shortness of breath.  On 16-APR-2021, the patient developed cerebral venous sinus thrombosis (CVST), had stroke, bilateral lobar pulmonary embolism and had low platelet. On the same day, the patient was admitted to the hospital and was still hospitalized at the time of reporting. The patient's platelet count was 17,000, anti platelet factor 4 was positive (the physician reported as 2.5 or 2.7 OD). The patient started on Intravenous immunoglobulin (IVIG) and responded well. Anticoagulation was not mentioned. A repeat scan, 4 days later did not show a venous thrombosis. Hemoglobin was 12.5, platelets increased to 137. The patient was discharged after approximately 4 days on 22-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral sinus vein thrombosis, stroke, pulmonary embolism, and low platelet. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: This case concerns a 43-year-old female who experienced cerebral venous sinus thrombosis (CVST), platelet count decreased, bilateral pulmonary embolism, and stroke 8 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient's medical history included obesity. The patient does not have autoimmune disease and was not taking birth control. Her symptoms started as headache, dizziness, and mild dyspnea. After seeking medical attention, she was found to have a CVST and bilateral lobar pulmonary embolism. Her platelet count was noted to be 17,000 and the anti-PF-4 antibody was positive. She was treated with IVIG. A repeat scan 4 days later did not show the venous thrombosis. The platelet count was noted to increase to 137,000. The patient was discharged after approximately 4 days. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from a non-profit global vaccine safety research network) and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Transient ischaemic attack, Troponin, Ultrasound Doppler, White blood cell count
Clinical narrative: CEREBRAL SINUS VEIN THROMBOSIS; LOW PLATELET; STROKE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a company representative concerned a 43 year-old female. Initial information received on 20-APR-2021, processed along with information receive on 23-APR-2021, via telephone communication.  The patient's weight and height were not reported. The patient's medical history included obesity. The patient was not on birth control. The patient did not have autoimmune disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, frequency 1 total, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patients symptoms started on 13-APR-2021 (also reported as 05-APR-2021), with headache, dizziness and mild shortness of breath.  On 16-APR-2021, the patient developed cerebral venous sinus thrombosis (CVST), had stroke, bilateral lobar pulmonary embolism and had low platelet. On the same day, the patient was admitted to the hospital and was still hospitalized at the time of reporting. The patient's platelet count was 17,000, anti platelet factor 4 was positive (the physician reported as 2.5 or 2.7 OD). The patient started on Intravenous immunoglobulin (IVIG) and responded well. Anticoagulation was not mentioned. A repeat scan, 4 days later did not show a venous thrombosis. Hemoglobin was 12.5, platelets increased to 137. The patient was discharged after approximately 4 days on 22-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral sinus vein thrombosis, stroke, pulmonary embolism, and low platelet. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: This case concerns a 43-year-old female who experienced cerebral venous sinus thrombosis (CVST), platelet count decreased, bilateral pulmonary embolism, and stroke 8 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient's medical history included obesity. The patient does not have autoimmune disease and was not taking birth control. Her symptoms started as headache, dizziness, and mild dyspnea. After seeking medical attention, she was found to have a CVST and bilateral lobar pulmonary embolism. Her platelet count was noted to be 17,000 and the anti-PF-4 antibody was positive. She was treated with IVIG. A repeat scan 4 days later did not show the venous thrombosis. The platelet count was noted to increase to 137,000. The patient was discharged after approximately 4 days. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from a non-profit global vaccine safety research network) and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Pulmonary embolism, Scan with contrast abnormal
Clinical narrative: Heart beating forcefully accompanied with SOB.  Right Lower Lobe Pulmonary embolism.  Hospitalized for 2 days on heparin drip
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Computerised tomogram thorax abnormal, Dyspnoea, Echocardiogram, Heart rate increased
Clinical narrative: Heart beating forcefully accompanied with SOB.  Right Lower Lobe Pulmonary embolism.  Hospitalized for 2 days on heparin drip
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker, Pulmonary embolism, Scan with contrast abnormal, Ultrasound Doppler
Clinical narrative: Heart beating forcefully accompanied with SOB.  Right Lower Lobe Pulmonary embolism.  Hospitalized for 2 days on heparin drip
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Herpes zoster, Rash
Clinical narrative: SHINGLES(LEFT EAR HOT AND THROBBING); This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, penicillin allergy, and sulphur allergy, and other pre-existing medical conditions included patient on antibiotic for shingles. The patient experienced drug allergy when treated with codeine non-company. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 16:45 for prophylactic vaccination on left arm. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shingles (left ear hot and throbbing). Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shingles (left ear hot and throbbing). This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES(LEFT EAR HOT AND THROBBING); This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, penicillin allergy, and sulphur allergy, and other pre-existing medical conditions included patient on antibiotic for shingles. The patient experienced drug allergy when treated with codeine non-company. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 16:45 for prophylactic vaccination on left arm. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shingles (left ear hot and throbbing). Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shingles (left ear hot and throbbing). This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Hemiparesis, Hypoaesthesia, Thalamic infarction
Clinical narrative: Numbness of mouth and hands; uncontrollable movement of left hand; loss of balance/equillibrium; sharp pain shooting down from left hip down to left legs.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriosclerosis, Arthralgia, Balance disorder, Dyskinesia, Echocardiogram normal
Clinical narrative: Numbness of mouth and hands; uncontrollable movement of left hand; loss of balance/equillibrium; sharp pain shooting down from left hip down to left legs.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction normal, Glycosylated haemoglobin, Grip strength decreased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness of mouth and hands; uncontrollable movement of left hand; loss of balance/equillibrium; sharp pain shooting down from left hip down to left legs.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Stenosis, Ultrasound Doppler abnormal
Clinical narrative: Numbness of mouth and hands; uncontrollable movement of left hand; loss of balance/equillibrium; sharp pain shooting down from left hip down to left legs.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray of pelvis and hip, X-ray of pelvis and hip normal
Clinical narrative: Numbness of mouth and hands; uncontrollable movement of left hand; loss of balance/equillibrium; sharp pain shooting down from left hip down to left legs.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Echocardiogram, Laboratory test, Pulmonary embolism
Clinical narrative: I am hospitalized since Wednesday with blood clots in my lungs I have no underlying condition s
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Laboratory test, Pulmonary embolism, Ultrasound scan
Clinical narrative: I am hospitalized since Wednesday with blood clots in my lungs I have no underlying condition s
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: I am hospitalized since Wednesday with blood clots in my lungs I have no underlying condition s
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Heart rate increased, Malaise, Musculoskeletal chest pain, Pain
Clinical narrative: I am hospitalized since Wednesday with blood clots in my lungs I have no underlying condition s
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Painful respiration, Pneumothorax, Pulmonary thrombosis
Clinical narrative: I am hospitalized since Wednesday with blood clots in my lungs I have no underlying condition s
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk
Clinical narrative: CHILD EXPOSED VIA BREAST MILK; This spontaneous report received from a patient via a company representative concerned a 38 year old female. The patient's weight was 61 kilograms, and height was 175 centimeters. The patient's concurrent conditions included alcohol consumption, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no medical history regarding drug abuse or illicit drug use. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced child exposed via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of child exposed via breast milk was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Urinary retention, Vaccination site pain, Vaccination site swelling
Clinical narrative: feel a little weakness; my arm was swollen, painful for two days; my arm was swollen, painful for two days; initially being unable to urinate; This spontaneous case was reported by a patient and describes the occurrence of URINARY RETENTION (initially being unable to urinate) in a 63-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.     Previously administered products included for an unreported indication: TYLENOL.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced URINARY RETENTION (initially being unable to urinate) (seriousness criterion medically significant). On 14-Apr-2021, the patient experienced ASTHENIA (feel a little weakness), VACCINATION SITE SWELLING (my arm was swollen, painful for two days) and VACCINATION SITE PAIN (my arm was swollen, painful for two days). On 13-Apr-2021, URINARY RETENTION (initially being unable to urinate) had resolved. On 16-Apr-2021, VACCINATION SITE SWELLING (my arm was swollen, painful for two days) and VACCINATION SITE PAIN (my arm was swollen, painful for two days) had resolved. At the time of the report, ASTHENIA (feel a little weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Historical medication included vitamins . she takes cholesterol medication, Tylenol and vitamins.  Patient was scheduled for second dose on 28-May-2021 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.; 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.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Inappropriate schedule of product administration
Clinical narrative: Hospitalized after first dose for Other reason; Patient was hospitalized for quite a while so she could not receive her second dose as per scheduled; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalized after first dose for Other reason) in a 93-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 No adverse event (No medical history reported).  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalized after first dose for Other reason) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was hospitalized for quite a while so she could not receive her second dose as per scheduled). At the time of the report, HOSPITALISATION (Hospitalized after first dose for Other reason) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was hospitalized for quite a while so she could not receive her second dose as per scheduled) had resolved.     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.   No concomitant medications reported by investigator. Treatment of the events were not reported. The reason for the hospitalization not reported.  Company comment: Very limited information regarding this event has been provided at this time. No further information is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 COVID-19 (Tested positive for Covid) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to COVID-19. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  There is very limited information provided in this case as temporal association cannot be established due to missing therapy and onset date.  However, based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.; Sender's Comments: There is very limited information provided in this case as temporal association cannot be established due to missing therapy and onset date.  However, based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Conjunctival haemorrhage, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; she blew a blood vessel in her right eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (she blew a blood vessel in her right eye) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (she blew a blood vessel in her right eye) (seriousness criterion medically significant). On 12-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (she blew a blood vessel in her right eye) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported. This case concerns a 63-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious expected pyrexia, chills, and headache. Event onset the same day as after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious expected pyrexia, chills, and headache. Event onset the same day as after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vasculitis
Clinical narrative: Vasculitis; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (Vasculitis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGEN NOS;PROGESTERONE for Hormone replacement therapy.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body aches) and FATIGUE (Fatigue). On an unknown date, the patient experienced VASCULITIS (Vasculitis) (seriousness criterion medically significant). On 06-Apr-2021, MYALGIA (Body aches) and FATIGUE (Fatigue) had resolved. At the time of the report, VASCULITIS (Vasculitis) outcome was unknown.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-081400 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. MOD-2021-081400:Dose 1
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Inflammation of her RA; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Inflammation of her RA) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Inflammation of her RA) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Inflammation of her RA) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-081435 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-081435:2nd dose
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram, Headache
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE HD) for Birth control. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headache) (seriousness criterion hospitalization prolonged). On 02-Apr-2021, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to CEREBRAL VENOUS SINUS THROMBOSIS and HEADACHE. At the time of the report, CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) had not resolved, and HEADACHE (headache) outcome was unknown. Not Provided, DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Computerized tomogram: abnormal (abnormal) Cerebral Venus Thrombosis in the brain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of the events included Pradaxa. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's recent history of starting back on oral contraceptives may remain a risk factor for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's recent history of starting back on oral contraceptives may remain a risk factor for this event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Facial paralysis, Rash
Clinical narrative: anaphylactic shock; difficulty breathing; faced was paralyzed; rash on arms and chest; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing) and FACIAL PARALYSIS (faced was paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic shock) (seriousness criterion life threatening), DYSPNOEA (difficulty breathing) (seriousness criterion medically significant), FACIAL PARALYSIS (faced was paralyzed) (seriousness criterion medically significant) and RASH (rash on arms and chest). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing), FACIAL PARALYSIS (faced was paralyzed) and RASH (rash on arms and chest) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included epinephrine injection.  Company comment: based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-081859 (E2B Linked Report).; Sender's Comments: based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-081859:Crossed linked
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: positive for COVID-19; unwell; fever; chills; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MALAISE (unwell), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On 31-Mar-2021, the patient experienced COVID-19 (positive for COVID-19) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to COVID-19. At the time of the report, COVID-19 (positive for COVID-19), MALAISE (unwell), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, COVID-19: positive (Positive) positive.     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.   Patient was treated with Ibuprofen, Nyquil and Dayquil for the symptoms. Patient was discharged the next day. Patient was treated with antibiotics for pneumonia.  Company comment: Based on the information provided including the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.  Malaise is assessed as a symptom of the infection and also assessed as unlikely.  Chills, pyrexia and myalgia, although also considered as symptoms of Covid-19, are temporarily associated with the product administration and consistent with the product safety profile and thus , causality cannot be excluded.   This case was linked to MOD21-079024 (Linked Report).; Sender's Comments: Based on the information provided including the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.  Malaise is assessed as a symptom of the infection and also assessed as unlikely.  Chills, pyrexia and myalgia, although also considered as symptoms of Covid-19, are temporarily associated with the product administration and consistent with the product safety profile and thus , causality cannot be excluded. MOD21-079024:cross linked
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Pyrexia
Clinical narrative: Elbow and breast she is still experiencing cellulitis in these areas; Experienced a fever of 101 degrees fahrenheit; This spontaneous case was reported by a health care professional and describes the occurrence of CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) in a 56-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.     Concomitant products included PREDNISONE for an unknown indication.   On 03-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) (seriousness criterion medically significant) and PYREXIA (Experienced a fever of 101 degrees fahrenheit). At the time of the report, CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) and PYREXIA (Experienced a fever of 101 degrees fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (Inconclusive) 101 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the event included the patient went through two rounds of antibiotic treatment. On 20 Apr 2021, the patient was started on prednisone.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company comment: 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.  However, Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-081503, US-MODERNATX, INC.-MOD-2021-081647 (Linked Report).; 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.  However, Further information has been requested. US-MODERNATX, INC.-MOD-2021-081503: US-MODERNATX, INC.-MOD-2021-081647:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pruritus, Urticaria
Clinical narrative: fell on 2april at a local Walmart; started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching; woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (tripped over a pallet and fell) and FALL (fell on 2april at a local ) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (surgery to repair my elbow) on 08-Apr-2021. Concurrent medical conditions included Allergy. Concomitant products included CITALOPRAM and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (tripped over a pallet and fell) (seriousness criterion medically significant) and FALL (fell on 2april at a local ) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRURITUS (started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching) and URTICARIA (woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone). The patient was treated with Surgery for Fall. At the time of the report, SYNCOPE (tripped over a pallet and fell), PRURITUS (started itching last night in my hands after I took Oxycodone/Every time I take opioids, I have itching) and URTICARIA (woke up with hives on my torso, knees, and my arms/hives are most likely related to oxycodone) outcome was unknown and FALL (fell on 2april at a local  was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drugs included, Oxycodone , Zyrtec, Benadryl. Patient went to see doctor and they put on a new brace called T-form. It was reported that these hives are most likely related to oxycodone.; Sender's Comments: Based on reporter's causality (Tripped over a pallet and fell) the event is assessed as unlikely related to mRNA-1273.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: they did ultrasound and found a blood clot in her right leg behind the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LIRAGLUTIDE (VICTOZA) and INSULIN GLARGINE (TOUJEO) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Ultrasound scan: found a blood clot in her right leg behind the kne (abnormal) found a blood clot in her right leg behind the knee.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included xarelto 15mg.  Concomitant medication included BP medicine.   Her right leg started swelling and turned red a week ago(10Apr2021). She went to the doctor on 12Apr2021 and they did ultrasound and found a blood clot in her right leg behind the knee (12Apr2021). She is scheduled to get 2nd dose on 22Apr2021. She never had blood clot before so wanted to report it.  Company comment: 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. Further information has been requested; 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. Further information has been requested
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue, SARS-CoV-2 test
Clinical narrative: COVID-19; Patient didn't receive her second dose vaccine as of day 49; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 50-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 No adverse event.  On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient didn't receive her second dose vaccine as of day 49). The patient was hospitalized on 25-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (COVID-19) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't receive her second dose vaccine as of day 49) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: covid-19 Positive.     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.   No concomitant medications were reported .  It was unclear about  the duration of hospitalization.   Patient didn't receive her second dose vaccine as of day 49 due to her hospitalization.; Sender's Comments: This case concerns a 50-year-old female hospitalized with a serious unexpected event of COVID-19, and nonserious unexpected Intentional product use issue. Event onset 24 days after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Transient ischaemic attack
Clinical narrative: TIA; Left upper lip is turned down/face does not look normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.  Concomitant products included METOPROLOL for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 12-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) (seriousness criterion medically significant). The patient was hospitalized for 3 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Other concomitant medications included unspecified blood pressure medications.  No treatment information reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081470 (Patient Link).; Sender's Comments: Although a temporal association exist,  the event  of Transient ischemic attack with facial paralysis is confounded by the patient's history of Blood pressure abnormal and advanced age.
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection
Clinical narrative: Chest cold; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and no treatment Medication was provided.  This case concerns an adult female with a serious unexpected event of lower respiratory tract infection. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult female with a serious unexpected event of lower respiratory tract infection. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.