chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: Feels like I have Pneumonia; Breathing trouble; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Feels like I have Pneumonia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Feels like I have Pneumonia) (seriousness criterion medically significant) and DYSPNOEA (Breathing trouble). At the time of the report, PNEUMONIA (Feels like I have Pneumonia) and DYSPNOEA (Breathing trouble) had not resolved.            Concomitant medications were not provided. No treatment information was provided.    This case was linked to MOD-2021-054008 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Joint dislocation, Joint hyperextension
Clinical narrative: buckling and hyperextending; dislocated finger; all foot bones moving; every joint slipped out of place; can't bend; sacrum and buttock burning; light headed; Body tender; Felt jowly and loose; Migraine; headaches; Searing left knee pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (light headed) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A16M20 and 030L20A) 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 reported medical history). Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MIGRAINE (Migraine; headaches) and ARTHRALGIA (Searing left knee pain). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (Felt jowly and loose). On an unknown date, the patient experienced DIZZINESS (light headed) (seriousness criterion medically significant), JOINT HYPEREXTENSION (buckling and hyperextending), JOINT DISLOCATION (dislocated finger; all foot bones moving; every joint slipped out of place), JOINT RANGE OF MOTION DECREASED (can't bend), SKIN IRRITATION (sacrum and buttock burning) and MYALGIA (Body tender). At the time of the report, DIZZINESS (light headed), MIGRAINE (Migraine; headaches), FEELING ABNORMAL (Felt jowly and loose), JOINT HYPEREXTENSION (buckling and hyperextending), JOINT DISLOCATION (dislocated finger; all foot bones moving; every joint slipped out of place), JOINT RANGE OF MOTION DECREASED (can't bend), SKIN IRRITATION (sacrum and buttock burning), ARTHRALGIA (Searing left knee pain) and MYALGIA (Body tender) outcome was unknown.            The patient received treatment with prednisone and sumatriptan.  Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-058046 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Migraine, Myalgia, Skin irritation
Clinical narrative: buckling and hyperextending; dislocated finger; all foot bones moving; every joint slipped out of place; can't bend; sacrum and buttock burning; light headed; Body tender; Felt jowly and loose; Migraine; headaches; Searing left knee pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (light headed) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A16M20 and 030L20A) 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 reported medical history). Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MIGRAINE (Migraine; headaches) and ARTHRALGIA (Searing left knee pain). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (Felt jowly and loose). On an unknown date, the patient experienced DIZZINESS (light headed) (seriousness criterion medically significant), JOINT HYPEREXTENSION (buckling and hyperextending), JOINT DISLOCATION (dislocated finger; all foot bones moving; every joint slipped out of place), JOINT RANGE OF MOTION DECREASED (can't bend), SKIN IRRITATION (sacrum and buttock burning) and MYALGIA (Body tender). At the time of the report, DIZZINESS (light headed), MIGRAINE (Migraine; headaches), FEELING ABNORMAL (Felt jowly and loose), JOINT HYPEREXTENSION (buckling and hyperextending), JOINT DISLOCATION (dislocated finger; all foot bones moving; every joint slipped out of place), JOINT RANGE OF MOTION DECREASED (can't bend), SKIN IRRITATION (sacrum and buttock burning), ARTHRALGIA (Searing left knee pain) and MYALGIA (Body tender) outcome was unknown.            The patient received treatment with prednisone and sumatriptan.  Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-058046 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypercapnia, Peripheral swelling
Clinical narrative: Carbon dioxide narcosis; legs swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERCAPNIA (Carbon dioxide narcosis) and PERIPHERAL SWELLING (legs swelling) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERCAPNIA (Carbon dioxide narcosis) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelling) (seriousness criterion medically significant). On 26-Mar-2021, HYPERCAPNIA (Carbon dioxide narcosis) had resolved. At the time of the report, PERIPHERAL SWELLING (legs swelling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment of the events were not reported.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mental disorder
Clinical narrative: Psychiatric illness; Patient received another shot after 14days of her 1st dose; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MENTAL DISORDER (Psychiatric illness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. O  n 03-Mar-2021, the patient experienced MENTAL DISORDER (Psychiatric illness) (seriousness criterion hospitalization). On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received another shot after 14days of her 1st dose). The patient was hospitalized from 03-Mar-2021 to 23-Mar-2021 due to MENTAL DISORDER. On 23-Mar-2021, MENTAL DISORDER (Psychiatric illness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received another shot after 14days of her 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disease, unspecified.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's underlying heart disease and pacemaker insertion may have been contributory.   This case was linked to MOD21-065383 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's underlying heart disease and pacemaker insertion may have been contributory. MOD21-065383:Crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: triggered shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (triggered shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (triggered shingles) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (triggered shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information provided. Concomitant medication information not provided.  Company comment: Limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.  It is not confirmed that the patient received mRNA-1273 (Moderna COVID-19 Vaccine)   This case was linked to US-MODERNATX, INC.-MOD-2021-028695 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-028695:Patient case
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Dizziness, Fatigue, Gait disturbance
Clinical narrative: He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got; He could hardly walk; Lightheaded and dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 007M20A) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue). On 22-Mar-2021, the patient experienced ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) (seriousness criterion hospitalization) and GAIT DISTURBANCE (He could hardly walk). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to ANAEMIA. At the time of the report, ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got), GAIT DISTURBANCE (He could hardly walk), DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included blood transfusions. Concomitant product use was not provided by the reporter.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Philadelphia chromosome positive
Clinical narrative: elevated BCR-ABL after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PHILADELPHIA CHROMOSOME POSITIVE (elevated BCR-ABL after vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history was not provided.  Concurrent history include leukemia (CML)  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 09-Mar-2021, the patient experienced PHILADELPHIA CHROMOSOME POSITIVE (elevated BCR-ABL after vaccine) (seriousness criterion medically significant). The patient gets routine blood drawn and it was elevated .   At the time of the report, PHILADELPHIA CHROMOSOME POSITIVE (elevated BCR-ABL after vaccine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.      No treatment details were provided.; Sender's Comments: Based on the information provided, a causal association between the event of elevated BCR-ABL  and the administration of the vaccine is assessed as not related.  Event is inherent to the nature of the underlying malignancy.  Patient has a history of leukemia.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: Had rheumatoid arthritis, have had flares before but it's never been that bad; Can't move shoulder, can't move arm half way up; Blistering headache; Pain on her right elbow down to the wrist, now it is upto the shoulder, pain in her knee as well; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Had rheumatoid arthritis, have had flares before but it's never been that bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (Pain on her right elbow down to the wrist, now it is upto the shoulder, pain in her knee as well). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Had rheumatoid arthritis, have had flares before but it's never been that bad) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Can't move shoulder, can't move arm half way up) and HEADACHE (Blistering headache). At the time of the report, RHEUMATOID ARTHRITIS (Had rheumatoid arthritis, have had flares before but it's never been that bad), MUSCULOSKELETAL STIFFNESS (Can't move shoulder, can't move arm half way up), ARTHRALGIA (Pain on her right elbow down to the wrist, now it is upto the shoulder, pain in her knee as well) and HEADACHE (Blistering headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included injection for rheumatoid arthritis on 27-MAR-2021.  Treatment for the event included prednisone 10 mg start date 01 Apr 2021 and an anti-inflammatory, and it is not helping.  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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-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 FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Prednisone 50 mg/day and Advair 550 breathing treatment.; 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Pulmonary embolism
Clinical narrative: Cardiac arrest; pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and PULMONARY EMBOLISM (pulmonary embolism) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Resuscitation.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening) and PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and life threatening). At the time of the report, CARDIAC ARREST (Cardiac arrest) and PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Myalgia, Pain in extremity
Clinical narrative: atrial fibrillation; achy; hand pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) 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.     The patient's past medical history included Atrial fibrillation.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant), MYALGIA (achy) and PAIN IN EXTREMITY (hand pain). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), MYALGIA (achy) and PAIN IN EXTREMITY (hand pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Although the patient has history of atrial fibrillation, based on a strong temporal association, a causal relationship between the administration of and the event s reported cannot be excluded.; Sender's Comments: Although the patient has history of atrial fibrillation, based on a strong temporal association, a causal relationship between the administration of and the event s reported cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear disorder, Fatigue
Clinical narrative: wiped out; dizziness; problems with ears; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (wiped out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting hypersensitivity (anaphylaxis after bee stings). Concomitant products included METOPROLOL, BUDESONIDE (PULMICORT) and ZOLPIDEM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (wiped out) (seriousness criterion medically significant), DIZZINESS (dizziness) and EAR DISORDER (problems with ears). At the time of the report, FATIGUE (wiped out), DIZZINESS (dizziness) and EAR DISORDER (problems with ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   This case was linked to MOD-2021-065503 (Patient Link).; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage intracranial, Headache
Clinical narrative: severe headache; Iintercranial bleed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) and HAEMORRHAGE INTRACRANIAL (Iintercranial bleed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood transfusion.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache) (seriousness criterion hospitalization) and HAEMORRHAGE INTRACRANIAL (Iintercranial bleed) (seriousness criterion hospitalization). At the time of the report, HEADACHE (severe headache) and HAEMORRHAGE INTRACRANIAL (Iintercranial bleed) outcome was unknown. Not Provided  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Unspecified blood disorder may have been contributory.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Consistent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Consistent diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 011a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient was taking high blood pressure pills.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Consistent diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Consistent diarrhea) had not resolved.            Action taken with mRNA-1273 was not applicable.  Concomitant medications included high blood pressure pills.   Treatment information was not provided.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of Diarrhea. Event onset 2 hours after second dose mRNA-1273. Event ongoing. 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA (small stroke); This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L02A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) (seriousness criterion hospitalization). The patient was hospitalized on 05-Jan-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) outcome was unknown.        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.   Treatment information included she was currently under medical examination for the causes and treatment of the stroke.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of TIA, a causal relationship cannot be excluded.   This case was linked to MOD-2021-066107 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of TIA, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Breathlessness got worse; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathlessness got worse) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     Concurrent medical conditions included Heart attack (recently diagnosed with Heart Attack and started new medication of blood thinners) and Breathlessness (was little breathless before receiving the Moderna vaccine 1st dose.). Concomitant products included ALPRAZOLAM (XANAX) for COVID-19 vaccination, METOPROLOL SUCCINATE (TOPROL), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) and PARACETAMOL (TYLENOL).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Breathlessness got worse) (seriousness criterion hospitalization). The patient was hospitalized from 18-Mar-2021 to 22-Mar-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Breathlessness got worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included unspecified blood thinners and unspecified oral regular medications. No treatment information was provided.  Based on the current 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 information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypotension, Neoplasm malignant, Pruritus, Rash
Clinical narrative: Has Cancer; itching on his lower back/hip area which has been getting worse/entire chest is red and itchy; low BP.; Serious headaches; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEOPLASM MALIGNANT (Has Cancer) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced NEOPLASM MALIGNANT (Has Cancer) (seriousness criterion medically significant), PRURITUS (itching on his lower back/hip area which has been getting worse/entire chest is red and itchy), HYPOTENSION (low BP.), HEADACHE (Serious headaches) and RASH (Rash). At the time of the report, NEOPLASM MALIGNANT (Has Cancer), PRURITUS (itching on his lower back/hip area which has been getting worse/entire chest is red and itchy), HYPOTENSION (low BP.), HEADACHE (Serious headaches) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included chemotherapy.  Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. There is very little information regarding the event of Neoplasm Malignant and additional information has been requested.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. There is very little information regarding the event of Neoplasm Malignant and additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: COVID-19 pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Injury, Limb discomfort
Clinical narrative: unable to use arm; stuttered speech; very traumatizing; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (unable to use arm) in a 49-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (unable to use arm) (seriousness criterion disability) and DYSPHEMIA (stuttered speech). On an unknown date, the patient experienced INJURY (very traumatizing). On 15-Mar-2021, LIMB DISCOMFORT (unable to use arm) and DYSPHEMIA (stuttered speech) had resolved. At the time of the report, INJURY (very traumatizing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant list provided.  Treatment included as PCP visit, emergency Room visit, CAT Scan Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Fatigue
Clinical narrative: Stroke due to a blood clot on the left side of my brain; had a dizzy spell; felt very tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain) in a 71-year-old female patient who 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 (Intramuscular) at an unspecified dose. On 05-Mar-2021, the patient experienced DIZZINESS (had a dizzy spell) and FATIGUE (felt very tired). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain) (seriousness criteria medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain), DIZZINESS (had a dizzy spell) and FATIGUE (felt very tired) outcome was unknown.               No concomitant medications were reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported 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 onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Chills, Delirium, Fatigue, Nausea
Clinical narrative: Borderline Delirius; Thyroid antibodies elevated; Body chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Borderline Delirius) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder (Guillian-Barre Syndrome).   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Borderline Delirius) (seriousness criterion medically significant), THYROIDITIS (Thyroid antibodies elevated), CHILLS (Body chills), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, DELIRIUM (Borderline Delirius) outcome was unknown, THYROIDITIS (Thyroid antibodies elevated) was resolving, CHILLS (Body chills) had not resolved and NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-thyroid antibody: high.         Treatment was not reported/ unknown. Company Comment : Based on the current available infor:mation and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis
Clinical narrative: Borderline Delirius; Thyroid antibodies elevated; Body chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Borderline Delirius) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder (Guillian-Barre Syndrome).   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Borderline Delirius) (seriousness criterion medically significant), THYROIDITIS (Thyroid antibodies elevated), CHILLS (Body chills), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, DELIRIUM (Borderline Delirius) outcome was unknown, THYROIDITIS (Thyroid antibodies elevated) was resolving, CHILLS (Body chills) had not resolved and NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-thyroid antibody: high.         Treatment was not reported/ unknown. Company Comment : Based on the current available infor:mation and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Headache, Myalgia, Palpitations, Peripheral swelling
Clinical narrative: Arrhythmia; palpitation; site is warm to touch; Injection site is silver dollar in size and get double size in the evening; Red in colour; Headache; Pain all over body; Very swollen hand; Painful rash; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes, Acid reflux (esophageal), Arthritis and Hyperlipidemia.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), MYALGIA (Pain all over body) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (palpitation), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour). On 31-Mar-2021, HEADACHE (Headache) had resolved. On 01-Apr-2021, ARRHYTHMIA (Arrhythmia) and PALPITATIONS (palpitation) had resolved. At the time of the report, PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour) outcome was unknown and MYALGIA (Pain all over body) was resolving.        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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arrhythmia; palpitation; site is warm to touch; Injection site is silver dollar in size and get double size in the evening; Red in colour; Headache; Pain all over body; Very swollen hand; Painful rash; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes, Acid reflux (esophageal), Arthritis and Hyperlipidemia.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), MYALGIA (Pain all over body) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (palpitation), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour). On 31-Mar-2021, HEADACHE (Headache) had resolved. On 01-Apr-2021, ARRHYTHMIA (Arrhythmia) and PALPITATIONS (palpitation) had resolved. At the time of the report, PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour) outcome was unknown and MYALGIA (Pain all over body) was resolving.        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.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Fatigue, Vomiting
Clinical narrative: A little delirious; Very tired; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (A little delirious) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 provided.).    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DELIRIUM (A little delirious) (seriousness criterion medically significant), FATIGUE (Very tired) and VOMITING (Vomiting). At the time of the report, DELIRIUM (A little delirious), FATIGUE (Very tired) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Postoperative thrombosis, Vaccination site pain
Clinical narrative: Minor surgery on foot that caused blood clot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of POSTOPERATIVE THROMBOSIS (Minor surgery on foot that caused blood clot) in a male patient of an unknown age 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 was reported.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Mar-2021, the patient experienced POSTOPERATIVE THROMBOSIS (Minor surgery on foot that caused blood clot) (seriousness criterion medically significant). At the time of the report, POSTOPERATIVE THROMBOSIS (Minor surgery on foot that caused blood clot) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication  were not provided. Treatment medications included blood thinner, rivaroxaban for blood clot.  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.