chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: secondary immune thrombocytopenia; Based on the current case data, this case has been classified as invalid. This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: unknown 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.   The case pertains to 11 patients from a literature article review.  Concomitant medication use was not reported Treatment information was not reported.  Very limited information regarding the event has been provided at this time.   Very limited information regarding the event has been provided at this time.   This case was linked to MOD-2021-096709 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time. MOD-2021-096709:Same literature article (37-yo male)
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival hyperaemia, Fatigue
Clinical narrative: Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not reported.  The patient reported that she experienced the adverse event in the left eye, 12 hours after  the administration of the second dose of the vaccine. The right eye was completely fine.  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.  Treatment medication included Tylenol (acetaminophen).   This case was linked to US-MODERNATX, INC.-MOD-2021-102880 (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 events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dyskinesia, Eye disorder, Eye movement disorder, Feeling abnormal
Clinical narrative: My feet were swollen last week; Headache; Bell's palsy; Could not open an eye on left side; Can't talk great; Can't blink; Mouth was crooked.; Feeling  something wrong; Mouth still numb and twisted; Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 62-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.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling  something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted) and INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping). On an unknown date, the patient experienced PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache). At the time of the report, FACIAL PARALYSIS (Bell's palsy), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling  something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted), INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping), PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Lab details were not provided. Treatment medication for the symptoms included. prednisone 20 mg for 7 days valacyclovir 500 mg for 7 days white petrolatum to lubricate under the patch muscle relaxant for sleep - described as effective  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.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Insomnia, Peripheral swelling, Speech disorder
Clinical narrative: My feet were swollen last week; Headache; Bell's palsy; Could not open an eye on left side; Can't talk great; Can't blink; Mouth was crooked.; Feeling  something wrong; Mouth still numb and twisted; Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 62-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.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling  something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted) and INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping). On an unknown date, the patient experienced PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache). At the time of the report, FACIAL PARALYSIS (Bell's palsy), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling  something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted), INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping), PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Lab details were not provided. Treatment medication for the symptoms included. prednisone 20 mg for 7 days valacyclovir 500 mg for 7 days white petrolatum to lubricate under the patch muscle relaxant for sleep - described as effective  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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Had a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endocrine disorder (Unspecified neuroendocrine condition.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  Reporter states patient was rushed to the hospital due a reaction to the vaccine and was treated with ctreotide (unknown dose) for 24 hours and received 3 shots of epinephrine.  Very limited information regarding this event has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-100633, MOD-2021-104568 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. MOD-2021-100633:Reporter's First Dose MOD-2021-104568:Reporter's Second Dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Heart rate increased, Influenza like illness, Migraine
Clinical narrative: Having heart arrhythmia every day; Rapid Heart Beat; Flu-like symptoms; Migraines; Iitchy throat; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Having heart arrhythmia every day) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia (Heart arrhythmias was reported.). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (Having heart arrhythmia every day) (seriousness criterion medically significant), HEART RATE INCREASED (Rapid Heart Beat), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat). On 11-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat) had resolved. At the time of the report, ARRHYTHMIA (Having heart arrhythmia every day) and HEART RATE INCREASED (Rapid Heart Beat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: rapid heart beat (High) Rapid Heart Beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included for the events were ibuprofen, acetaminophen and diphenhydramine.  The patient had recently relocated so she does not have a primary care physician at this time. 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.; 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Having heart arrhythmia every day; Rapid Heart Beat; Flu-like symptoms; Migraines; Iitchy throat; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Having heart arrhythmia every day) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia (Heart arrhythmias was reported.). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (Having heart arrhythmia every day) (seriousness criterion medically significant), HEART RATE INCREASED (Rapid Heart Beat), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat). On 11-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat) had resolved. At the time of the report, ARRHYTHMIA (Having heart arrhythmia every day) and HEART RATE INCREASED (Rapid Heart Beat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: rapid heart beat (High) Rapid Heart Beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included for the events were ibuprofen, acetaminophen and diphenhydramine.  The patient had recently relocated so she does not have a primary care physician at this time. 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.; 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: Immune thrombocytopenia, Oral mucosal blistering, Platelet count decreased
Clinical narrative: Immune thrombocytopenia (ITP); Blisters in the mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) in a 61-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history has not been reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) (seriousness criterion hospitalization) and ORAL MUCOSAL BLISTERING (Blisters in the mouth). The patient was hospitalized on 22-Mar-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) had not resolved and ORAL MUCOSAL BLISTERING (Blisters in the mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Platelet count decreased: (Low) Admitted to the hospital with NO platelet counts.         Patient was not on any concomitant medications before being admitted into the hospital.  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.
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Transient ischaemic attack
Clinical narrative: mini stroke prior to second dose; Second dose outside 42 day window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose outside 42 day window). The patient was hospitalized on 13-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Second dose outside 42 day window) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications reported. No treatment information was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Hearing loss) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUDDEN HEARING LOSS (Hearing loss) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Arm hurt a bit). On 07-Apr-2021, SUDDEN HEARING LOSS (Hearing loss) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes many concomitant medications but details were not provided.   Patient took Tylenol (paracetamol) for her arm pain.  Reporter states that when experiencing the sudden hearing loss event, she couldn't hear a single thing. She also noted that the event had resolved before she went to bed that same day.  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Gait disturbance, Hyperhidrosis, Intentional product use issue
Clinical narrative: Neuropathy; Sweating; barely can walk; Fogginess in her mind; sleep problems; canceled appointment for second shot even though her HCP advised her to get it; Chilis; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind), SLEEP DISORDER (sleep problems), INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) and CHILLS (Chilis). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind) and CHILLS (Chilis) had not resolved, SLEEP DISORDER (sleep problems) was resolving and INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were provided. No treatment information was provided. This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273.  The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile.   This case was linked (E2B Linked Report).; Sender's Comments: This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273.  The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Sleep disorder
Clinical narrative: Neuropathy; Sweating; barely can walk; Fogginess in her mind; sleep problems; canceled appointment for second shot even though her HCP advised her to get it; Chilis; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind), SLEEP DISORDER (sleep problems), INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) and CHILLS (Chilis). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind) and CHILLS (Chilis) had not resolved, SLEEP DISORDER (sleep problems) was resolving and INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were provided. No treatment information was provided. This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273.  The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile.   This case was linked (E2B Linked Report).; Sender's Comments: This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273.  The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical History not reported.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down) (seriousness criterion hospitalization). At the time of the report, FALL (Fell down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was due for second dose today. She fell and was now is in the hospital.  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.; 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gastritis, Inflammatory bowel disease, Influenza like illness, Rhinorrhoea, Vaccination site pain
Clinical narrative: inflammation of bowels; inflammation of stomach; flu like symptoms; runny nose; local pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY BOWEL DISEASE (inflammation of bowels) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029k20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac ablation on 27-Jun-2019. Concurrent medical conditions included Atrial fibrillation (resolved with meds and ablation), Blood pressure high and Allergic rhinitis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Atrial fibrillation, AMLODIPINE and BISOPROLOL for Blood pressure high, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, FENOFIBRATE for Hyperlipidemia, ZOLPIDEM for Insomnia.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RHINORRHOEA (runny nose) and VACCINATION SITE PAIN (local pain). On 13-Feb-2021, the patient experienced INFLAMMATORY BOWEL DISEASE (inflammation of bowels) (seriousness criterion medically significant) and GASTRITIS (inflammation of stomach). On 30-Apr-2021, INFLAMMATORY BOWEL DISEASE (inflammation of bowels) and GASTRITIS (inflammation of stomach) had resolved with sequelae. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (local pain) had resolved and RHINORRHOEA (runny nose) outcome was unknown.            The patient went to their doctor who referred him to a gastrointestinal specialist.  The patient had an endoscopy and ABD CT (abdominal computerized tomogram) scan.  The patient stated that diverticulitis was suspected.  The scans were reported as cleared, and an obstruction was cleared as well.  There was inflammation of the stomach and bowels.  Additional treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Piloerection, Seizure, Tremor
Clinical narrative: it was convulsive shaking; I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes; chill bumps; I could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (it was convulsive shaking) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced SEIZURE (it was convulsive shaking) (seriousness criterion medically significant), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up). On 20-Apr-2021, SEIZURE (it was convulsive shaking), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that, patient was scared to take the 2nd vaccine.  Patient almost fell back.   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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Myalgia
Clinical narrative: Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it; Headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) (seriousness criterion medically significant), HEADACHE (Headache) and MYALGIA (Muscle aches). At the time of the report, MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) outcome was unknown and HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medicine for high blood pressure everyday (unspecified name).  The patient might go to emergency room  because her doctor was concerned if she was having a stroke.  No treatment information was provided.  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.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Fatigue, Heart rate, Loss of consciousness
Clinical narrative: almost passed out; blood pressure was 40/60; tired after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (almost passed out) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Breast cancer (11 years ago). Concomitant products included VENLAFAXINE, ROSUVASTATIN and LEVOTHYROXINE for an unknown indication.    On 25-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 LOSS OF CONSCIOUSNESS (almost passed out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure was 40/60) and FATIGUE (tired after the shot.). At the time of the report, LOSS OF CONSCIOUSNESS (almost passed out), BLOOD PRESSURE DECREASED (blood pressure was 40/60) and FATIGUE (tired after the shot.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 40/60 Low. On an unknown date, Heart rate: 50 (Low) went down.     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 details were 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. Further information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-103634 (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 events, a causal relationship cannot be excluded. Further information has been requested US-MODERNATX, INC.-MOD-2021-103634:Case for dose 2
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after receiving the Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after receiving the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant medications were not reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.  Company comment: This is a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. died on an unknown date after the first dose of vaccine. No Medical History or Concomitant medications were reported. Very limited information has been reported at this time. Further information is not expected.   This case was linked to US-MODERNATX, INC.-MOD-2021-012533, US-MODERNATX, INC.-MOD-2021-020196, MOD21-10588, MOD21-086364, MOD21-086368 (Linked Report).; Sender's Comments: This is a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. died on an unknown date after the first dose of vaccine. No Medical History or Concomitant medications were reported. Very limited information has been reported at this time. Further information is not expected. US-MODERNATX, INC.-MOD-2021-012533: US-MODERNATX, INC.-MOD-2021-020196: MOD21-10588: MOD21-086364: MOD21-086368:; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Loss of consciousness
Clinical narrative: If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-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.     Concurrent medical conditions included Allergy to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal.   Treatment information was not reported.; 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Vomiting
Clinical narrative: If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-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.     Concurrent medical conditions included Allergy to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal.   Treatment information was not reported.; 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: developed lupus three days after her second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (developed lupus three days after her second dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 06-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (developed lupus three days after her second dose) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 20 milligram. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (developed lupus three days after her second dose) outcome was unknown. Not Provided          Patient reported she was prescribed prednisone 20 mg all of last week, but she does not think it helped.  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-2021-040998 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Epistaxis
Clinical narrative: Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup); Blood pressure was 175/85; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination.   No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and VITAMINS NOS for an unknown indication.  On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) (seriousness criterion medically significant). At the time of the report, EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 175/85 (High) 175/85. On an unknown date, Blood pressure measurement: 144/70 (Inconclusive) 144/70.  The reporter had she noticed a large amount of blood (estimates about 1/4 cup) around her computer tray and that her nose was bleeding like a faucet. Her husband took her to the ER, where her blood pressure was 175/85. Caller does not normally have high blood pressure, and is not on blood pressure medication. When she left the ER, her blood pressure was 144/70 and they clamped her nose and gave her some oxymetazoline nose spray for any break-through bleeding. Her husband maintains that the nose bleed was caused by the vaccine.  Treatment procedure in the Emergency Room (ER) included nose clamped and medication included oxymetazoline.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) 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 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.