chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Rash
Clinical narrative: hematoma on her lower arms and lower legs.; ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (hematoma on her lower arms and lower legs.) and RASH (ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HAEMATOMA (hematoma on her lower arms and lower legs.) and RASH (ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.). At the time of the report, HAEMATOMA (hematoma on her lower arms and lower legs.) outcome was unknown and RASH (ash on both her hands and arms, the rash was very bad at first, now it is not as bad, but it is not going away.) had not resolved.            Patient went to see a dermatologist who prescribed her Keflex and an anti rash cream.  Concomitants medications are reported as Vitamins.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Injection site pain, Rash
Clinical narrative: Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now; Pain in the shoulder at the shot area; Some discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Some discomfort), RASH (Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now) and INJECTION SITE PAIN (Pain in the shoulder at the shot area) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced DISCOMFORT (Some discomfort) and INJECTION SITE PAIN (Pain in the shoulder at the shot area). On 15-Aug-2021, the patient experienced RASH (Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now). On 09-Aug-2021, DISCOMFORT (Some discomfort) and INJECTION SITE PAIN (Pain in the shoulder at the shot area) had resolved. At the time of the report, RASH (Rash on his shoulder, about 3 inches, inconsistent shape, not just round and not consistent in color (some areas darker and some areas lighter). It was about 60 percent dissipated now) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscle tightness
Clinical narrative: Redness  of the face; Tightness of the face; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness  of the face) and MUSCLE TIGHTNESS (Tightness of the face) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced ERYTHEMA (Redness  of the face) and MUSCLE TIGHTNESS (Tightness of the face). At the time of the report, ERYTHEMA (Redness  of the face) and MUSCLE TIGHTNESS (Tightness of the face) 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.   The patient took a medication that causes angioedema (Losartan for more than a year).  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose was given to a patient; vial was moved from the freezer to the refrigerator on 13Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non significant Follow up
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Oropharyngeal pain
Clinical narrative: sore throat; Pressure on the right side of neck; Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included TERBINAFINE and METOCLOPRAMIDE for an unknown indication.    On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). In August 2021, NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved.            Concomitant medication included Birth control.  No treatment medication was reported.  Patient had confirmed she has not visited her primary care yet.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Fatigue, Hypoaesthesia, Hypotonia, Limb discomfort
Clinical narrative: called in to ask if she can still have 2nd dose of Moderna vaccine; Rashes all over body; my arm is still numb; cant even lay on that arm that had injection; my legs feel floppy its like totally numb; could not remember simple words; i got really tired; giant lymph nodes on my chest; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words) and FATIGUE (i got really tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scarlet fever. Concurrent medical conditions included Seasonal allergy, Allergic to cats and Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLLAGEN for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest) and PYREXIA (Fever). In July 2021, the patient experienced RASH (Rashes all over body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine). At the time of the report, HYPOAESTHESIA (my arm is still numb) had not resolved and LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest), PYREXIA (Fever), RASH (Rashes all over body) and PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller also reported that she had fever and rashes all of the body 3 weeks ago. It was like she had Scarlet Fever which she had before.  No treatment medication were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue, Pyrexia, Rash
Clinical narrative: called in to ask if she can still have 2nd dose of Moderna vaccine; Rashes all over body; my arm is still numb; cant even lay on that arm that had injection; my legs feel floppy its like totally numb; could not remember simple words; i got really tired; giant lymph nodes on my chest; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words) and FATIGUE (i got really tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scarlet fever. Concurrent medical conditions included Seasonal allergy, Allergic to cats and Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLLAGEN for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest) and PYREXIA (Fever). In July 2021, the patient experienced RASH (Rashes all over body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine). At the time of the report, HYPOAESTHESIA (my arm is still numb) had not resolved and LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest), PYREXIA (Fever), RASH (Rashes all over body) and PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller also reported that she had fever and rashes all of the body 3 weeks ago. It was like she had Scarlet Fever which she had before.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (wrist on that same side seems very swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (wrist on that same side seems very swollen). At the time of the report, JOINT SWELLING (wrist on that same side seems very swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by the reporter. No information on treatment is provided by the reporter.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  .  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening). At the time of the report, HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: 110 bpm (High) 110 BPM.         No medical history was provided by reporter.  Other concomitant includes blood pressure pills.  No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got the ovid 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got the ovid 3 weeks ago) 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 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got the ovid 3 weeks ago). At the time of the report, COVID-19 (I got the ovid 3 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradyphrenia, Discomfort, Pain in extremity
Clinical narrative: General disconfort; Loss of strength; Leg Aches; Slowed thinking; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General disconfort), ASTHENIA (Loss of strength), PAIN IN EXTREMITY (Leg Aches) and BRADYPHRENIA (Slowed thinking) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DISCOMFORT (General disconfort), ASTHENIA (Loss of strength), PAIN IN EXTREMITY (Leg Aches) and BRADYPHRENIA (Slowed thinking). At the time of the report, DISCOMFORT (General disconfort), ASTHENIA (Loss of strength), PAIN IN EXTREMITY (Leg Aches) and BRADYPHRENIA (Slowed thinking) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No Concomitant medication information was reported.  No treatment medications were provided.  Three weeks after the first shoot of the Moderna vaccine  he started to feel leg aches, loss of strength and a slower thinking speed. A general felling of discomfort was reported. His doctor told him that this events were not related to the vaccine. Second dose 26Apr2021
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-288836 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dyspnoea, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), TACHYCARDIA (increased heart rate), ANXIETY (anxiety) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shortness of breath (Patient used a CPAP machine for shortness of breath (prior to Moderna COVID-19 vaccination)) and Heart rate increased. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced DYSPNOEA (shortness of breath), TACHYCARDIA (increased heart rate), ANXIETY (anxiety) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), TACHYCARDIA (increased heart rate), ANXIETY (anxiety) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: developing digestive issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (developing digestive issues) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 DYSPEPSIA (developing digestive issues). At the time of the report, DYSPEPSIA (developing digestive issues) outcome was unknown.            Concomitant medications were not provided. No treatment information was provided.   This case was linked to MOD-2021-288736 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Inappropriate schedule of product administration, Intentional product use issue
Clinical narrative: Intentional deviation from dosage regimen; Received second dose more than 36 days after first dose; Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine; Never really felt bad and if so, it was subtle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Never really felt bad and if so, it was subtle), COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine), INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SL20A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Barrett's esophagus, Blood pressure high and Diabetes (Diabeties Patient take injection for diabeties.). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Barrett's esophagus, CLOPIDOGREL BISULFATE (PLAVIX) for Blood count abnormal, METFORMIN and INSULIN for Diabetes.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Never really felt bad and if so, it was subtle). On 14-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine). On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose). On 12-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) had resolved. At the time of the report, FEELING ABNORMAL (Never really felt bad and if so, it was subtle) and COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) COVID-19 positive.         Lab data includes - Patient tested COVID-19 positive on 7-jan-2021 or 8-jan-2021 Concomitant medications also included unknown blood thinner and heart medications. Treatment medication include antibody infusion for COVID-19 received around 12-JAN-2021
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine; very ill; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 after first dose of Moderna vaccine and ILLNESS in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ILLNESS. On 14-Jan-2021, the patient experienced COVID-19 diagnosed after first dose of Moderna vaccine. At the time of the report, COVID-19 diagnosed after first dose of Moderna COVID-19 vaccine had resolved and ILLNESS (very ill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not take any concomitant medications.  Patient received antibody infusion for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: I've been in bed for two days; It literally feels like my brain is splitting in two; I had 102.3°F; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (I've been in bed for two days), FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, GABAPENTIN, LEVETIRACETAM, TAMSULOSIN, TOPIRAMATE, CELECOXIB and CHLORZOXAZONE for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced BEDRIDDEN (I've been in bed for two days), FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3°F). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, BEDRIDDEN (I've been in bed for two days) had resolved. At the time of the report, FEELING ABNORMAL (It literally feels like my brain is splitting in two) and PYREXIA (I had 102.3°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, Body temperature: 102.3°f (High) 102.3°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter mentioned that he had seen to a neurologist.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; low grade fever of 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) low grade fever of 100 degrees F.     Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  After first dose, the patient did not get sick.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Condition aggravated, Diarrhoea, Headache
Clinical narrative: Stomach problems; Intestinal problems flared up /Diarrhea; Two Autoimmune diseases flared up; Fibromyalgia flared up; Heard swooshing sounds in her head during fever; Headache; Fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up) and TINNITUS (Heard swooshing sounds in her head during fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia (Autoimmune diseases flared up indicated fibromyalgia) and Intestinal functional disorder NOS (Autoimmune diseases flared up indicated intestinal problems(Diarrhea)).   On 12-Aug-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 102.5 (High) Fever of 102.5.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Stomach problems; Intestinal problems flared up /Diarrhea; Two Autoimmune diseases flared up; Fibromyalgia flared up; Heard swooshing sounds in her head during fever; Headache; Fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up) and TINNITUS (Heard swooshing sounds in her head during fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia (Autoimmune diseases flared up indicated fibromyalgia) and Intestinal functional disorder NOS (Autoimmune diseases flared up indicated intestinal problems(Diarrhea)).   On 12-Aug-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 102.5 (High) Fever of 102.5.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.; The vial was left out at room temperature Sunday night into Monday (16Aug2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)). On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.). At the time of the report, PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Suspect details included: Manufacture date: 21Apr2021  Original refrigeration date: 14Aug2021 (In freezer/frozen prior to that)  Temperature stored in fridge: 38°F  Stored at room temperature at 2:30p on 15Aug2021.  1st puncture: 15Aug2021 at 2:54pm.  At room temp prior to her getting off work  Left out at room temperature from 2:30pm 15Aug2021 through 3:00pm on Mon 16Aug2021.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) 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.   Concomitant medication was not provided.  Treatment information was not reported.  Patient who received the Moderna vaccine 30 minute ago and now has hives, but not all over the body.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Feeling cold, Tremor
Clinical narrative: his body started shaking so much; His whole body was "very very cold" and "extremely cold."; He said his body is in -0 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (his body started shaking so much), FEELING COLD (His whole body was "very very cold" and "extremely cold.") and BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021 at 6:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced TREMOR (his body started shaking so much) and FEELING COLD (His whole body was "very very cold" and "extremely cold."). 17-Aug-2021, the patient experienced BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature). At the time of the report, TREMOR (his body started shaking so much), FEELING COLD (His whole body was "very very cold" and "extremely cold.") and BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature decreased: decreased (Low) -0 degree temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: He hasn't received his 2nd dose.; He became positive for covid after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He became positive for covid after receiving 1st dose) and PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (He became positive for covid after receiving 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.). At the time of the report, COVID-19 (He became positive for covid after receiving 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: mild nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (mild nauseousness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Immunocompromised.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (mild nauseousness). At the time of the report, NAUSEA (mild nauseousness) outcome was unknown.            No treatment medications were provided   This case was linked to MOD-2021-289526.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: He has not received the second dose; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRODUCT DOSE OMISSION ISSUE (He has not received the second dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He has not received the second dose). On 15-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (He has not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: off label- extended time between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 3 and Spinal stenosis. Concomitant products included TRAMADOL for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches). At the time of the report, ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches) outcome was unknown. Treatment details were provided by reporter. She did not take any medications for her symptoms but limited her diet to applesauce, bananas, and rice. She watched her diet to try and help with those symptoms as well. This case was linked to MOD-2021-289553.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count abnormal, Influenza like illness, Peripheral swelling
Clinical narrative: Leg was swollen; Abnormal blood work; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Breast cancer), Lymph node biopsy (Cut lymph nodes), Cancer (cancer.) and Immunodeficiency (Immunodeficiency.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-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). On an unknown date, the patient experienced PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work) outcome was unknown.     No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-289568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Significant Follow up appended on 18-AUG-2021- Patient age & age group updated
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Skin mass
Clinical narrative: knot in my right arm where I took my vaccine; tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired). At the time of the report, SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired) outcome was unknown.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Knot stayed there, never got bigger and never got smaller.