chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Rhinorrhoea
Clinical narrative: Mild Cough; runny nose; fatigue; Mild Cough; Runny Nose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COUGH (Mild Cough), RHINORRHOEA (Runny Nose), FATIGUE (Fatigue), the second episode of COUGH (Mild Cough) and RHINORRHOEA (runny nose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced the first episode of COUGH (Mild Cough), RHINORRHOEA (Runny Nose) and FATIGUE (Fatigue). On 10-Feb-2021, the patient experienced the second episode of COUGH (Mild Cough), RHINORRHOEA (runny nose) and FATIGUE (fatigue). At the time of the report, RHINORRHOEA (Runny Nose), FATIGUE (Fatigue), the last episode of COUGH (Mild Cough), RHINORRHOEA (runny nose) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Achiness; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achiness) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported) since an unknown date.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Achiness) and HEADACHE (headache). At the time of the report, PAIN (Achiness) and HEADACHE (headache) had not resolved.            Treatment includes Tylenol.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Head discomfort, Headache
Clinical narrative: Felt heady, immediately after injection; Sluggish; Lethargic; Bones hurt; Insomnia; Shallow breath; Needed to lay down/ Unable to drive; Body pain; Very sore at site of injection; Headache; Chills/Shivering; Muscle pain; Head rush, immediately after injection; Pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Head rush, immediately after injection), HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic) and BONE PAIN (Bones hurt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), MAGNESIUM, VITAMIN D [VITAMIN D NOS], CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and ZINC for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Head rush, immediately after injection) and VACCINATION SITE PAIN (Pain in arm of injection). On 26-Feb-2021, the patient experienced HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic), BONE PAIN (Bones hurt), INSOMNIA (Insomnia), HYPOPNOEA (Shallow breath), VACCINATION COMPLICATION (Needed to lay down/ Unable to drive), PAIN (Body pain), VACCINATION SITE REACTION (Very sore at site of injection), HEADACHE (Headache), CHILLS (Chills/Shivering) and MYALGIA (Muscle pain). At the time of the report, DIZZINESS (Head rush, immediately after injection), HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic), BONE PAIN (Bones hurt), INSOMNIA (Insomnia), HYPOPNOEA (Shallow breath), VACCINATION COMPLICATION (Needed to lay down/ Unable to drive), PAIN (Body pain), VACCINATION SITE REACTION (Very sore at site of injection), VACCINATION SITE PAIN (Pain in arm of injection), HEADACHE (Headache), CHILLS (Chills/Shivering) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Insomnia, Lethargy, Myalgia, Pain
Clinical narrative: Felt heady, immediately after injection; Sluggish; Lethargic; Bones hurt; Insomnia; Shallow breath; Needed to lay down/ Unable to drive; Body pain; Very sore at site of injection; Headache; Chills/Shivering; Muscle pain; Head rush, immediately after injection; Pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Head rush, immediately after injection), HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic) and BONE PAIN (Bones hurt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), MAGNESIUM, VITAMIN D [VITAMIN D NOS], CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and ZINC for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Head rush, immediately after injection) and VACCINATION SITE PAIN (Pain in arm of injection). On 26-Feb-2021, the patient experienced HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic), BONE PAIN (Bones hurt), INSOMNIA (Insomnia), HYPOPNOEA (Shallow breath), VACCINATION COMPLICATION (Needed to lay down/ Unable to drive), PAIN (Body pain), VACCINATION SITE REACTION (Very sore at site of injection), HEADACHE (Headache), CHILLS (Chills/Shivering) and MYALGIA (Muscle pain). At the time of the report, DIZZINESS (Head rush, immediately after injection), HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic), BONE PAIN (Bones hurt), INSOMNIA (Insomnia), HYPOPNOEA (Shallow breath), VACCINATION COMPLICATION (Needed to lay down/ Unable to drive), PAIN (Body pain), VACCINATION SITE REACTION (Very sore at site of injection), VACCINATION SITE PAIN (Pain in arm of injection), HEADACHE (Headache), CHILLS (Chills/Shivering) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination complication, Vaccination site pain, Vaccination site reaction
Clinical narrative: Felt heady, immediately after injection; Sluggish; Lethargic; Bones hurt; Insomnia; Shallow breath; Needed to lay down/ Unable to drive; Body pain; Very sore at site of injection; Headache; Chills/Shivering; Muscle pain; Head rush, immediately after injection; Pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Head rush, immediately after injection), HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic) and BONE PAIN (Bones hurt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), MAGNESIUM, VITAMIN D [VITAMIN D NOS], CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and ZINC for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Head rush, immediately after injection) and VACCINATION SITE PAIN (Pain in arm of injection). On 26-Feb-2021, the patient experienced HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic), BONE PAIN (Bones hurt), INSOMNIA (Insomnia), HYPOPNOEA (Shallow breath), VACCINATION COMPLICATION (Needed to lay down/ Unable to drive), PAIN (Body pain), VACCINATION SITE REACTION (Very sore at site of injection), HEADACHE (Headache), CHILLS (Chills/Shivering) and MYALGIA (Muscle pain). At the time of the report, DIZZINESS (Head rush, immediately after injection), HEAD DISCOMFORT (Felt heady, immediately after injection), SLUGGISHNESS (Sluggish), LETHARGY (Lethargic), BONE PAIN (Bones hurt), INSOMNIA (Insomnia), HYPOPNOEA (Shallow breath), VACCINATION COMPLICATION (Needed to lay down/ Unable to drive), PAIN (Body pain), VACCINATION SITE REACTION (Very sore at site of injection), VACCINATION SITE PAIN (Pain in arm of injection), HEADACHE (Headache), CHILLS (Chills/Shivering) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest pain, Chills, Dizziness
Clinical narrative: joint pain/ Pains; 101°F temperature; exhausted; Chills; Dizziness when driving; Could not walk; Red rash on arm and chest; chest pain; Pains , muscle , chest and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain) and MYALGIA (Pains , muscle , chest and joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), FATIGUE (exhausted) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (joint pain/ Pains) and PYREXIA (101°F temperature). At the time of the report, DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), ARTHRALGIA (joint pain/ Pains), PYREXIA (101°F temperature), FATIGUE (exhausted) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 f (Inconclusive) 101°F temperature. On 03-Mar-2021, Heart rate: 135-170 (High) The heart is racing , in a range between 135-170.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Heart rate, Myalgia, Pyrexia
Clinical narrative: joint pain/ Pains; 101°F temperature; exhausted; Chills; Dizziness when driving; Could not walk; Red rash on arm and chest; chest pain; Pains , muscle , chest and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain) and MYALGIA (Pains , muscle , chest and joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), FATIGUE (exhausted) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (joint pain/ Pains) and PYREXIA (101°F temperature). At the time of the report, DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), ARTHRALGIA (joint pain/ Pains), PYREXIA (101°F temperature), FATIGUE (exhausted) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 f (Inconclusive) 101°F temperature. On 03-Mar-2021, Heart rate: 135-170 (High) The heart is racing , in a range between 135-170.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: joint pain/ Pains; 101°F temperature; exhausted; Chills; Dizziness when driving; Could not walk; Red rash on arm and chest; chest pain; Pains , muscle , chest and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain) and MYALGIA (Pains , muscle , chest and joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), FATIGUE (exhausted) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (joint pain/ Pains) and PYREXIA (101°F temperature). At the time of the report, DIZZINESS (Dizziness when driving), GAIT DISTURBANCE (Could not walk), RASH ERYTHEMATOUS (Red rash on arm and chest), CHEST PAIN (chest pain), MYALGIA (Pains , muscle , chest and joint pain), ARTHRALGIA (joint pain/ Pains), PYREXIA (101°F temperature), FATIGUE (exhausted) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 f (Inconclusive) 101°F temperature. On 03-Mar-2021, Heart rate: 135-170 (High) The heart is racing , in a range between 135-170.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt a lot of pain on the injection arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt a lot of pain on the injection arm after first dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (felt a lot of pain on the injection arm after first dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (felt a lot of pain on the injection arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Cough
Clinical narrative: bruising; coughing; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) and COUGH (coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 CONTUSION (bruising) and COUGH (coughing). At the time of the report, CONTUSION (bruising) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Induration, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm started hurting, it became swollen, hard, and red; arm started hurting again; the size of a grape at the site of the injection , it was a swollen; headaches after the shot and ongoing, right on the temples; a little redness, the size of a grape at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (arm started hurting, it became swollen, hard, and red), PAIN IN EXTREMITY (arm started hurting again), VACCINATION SITE ERYTHEMA (a little redness, the size of a grape at the site of the injection), VACCINATION SITE SWELLING (the size of a grape at the site of the injection , it was a swollen) and HEADACHE (headaches after the shot and ongoing, right on the temples) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, METOPROLOL, LOSARTAN POTASSIUM, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a little redness, the size of a grape at the site of the injection) and HEADACHE (headaches after the shot and ongoing, right on the temples). On 28-Feb-2021, the patient experienced INDURATION (arm started hurting, it became swollen, hard, and red), PAIN IN EXTREMITY (arm started hurting again) and VACCINATION SITE SWELLING (the size of a grape at the site of the injection , it was a swollen). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 25-Feb-2021, VACCINATION SITE ERYTHEMA (a little redness, the size of a grape at the site of the injection) had resolved. At the time of the report, INDURATION (arm started hurting, it became swollen, hard, and red), PAIN IN EXTREMITY (arm started hurting again), VACCINATION SITE SWELLING (the size of a grape at the site of the injection , it was a swollen) and HEADACHE (headaches after the shot and ongoing, right on the temples) 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Cough, Decreased appetite, Dizziness
Clinical narrative: chest tightness and weakness in her chest which is making her cough more.; chest tightness and weakness in her chest which is making her cough more.; felt lightheaded again and had to stand against the bathroom wall to let it pass; fell and hurt her knee; very fatigue/ sleepy/ no energy.; felt lightheaded and as if she was going to pass out.; no appetite; red, long area on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red, long area on her arm), DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite) and CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-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) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERYTHEMA (red, long area on her arm). On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite) and FATIGUE (very fatigue/ sleepy/ no energy.). On 28-Feb-2021, the patient experienced ARTHRALGIA (fell and hurt her knee). On 01-Mar-2021, the patient experienced DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.) and COUGH (chest tightness and weakness in her chest which is making her cough more.). At the time of the report, ERYTHEMA (red, long area on her arm), DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite), CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.), COUGH (chest tightness and weakness in her chest which is making her cough more.), ARTHRALGIA (fell and hurt her knee) and FATIGUE (very fatigue/ sleepy/ no energy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue
Clinical narrative: chest tightness and weakness in her chest which is making her cough more.; chest tightness and weakness in her chest which is making her cough more.; felt lightheaded again and had to stand against the bathroom wall to let it pass; fell and hurt her knee; very fatigue/ sleepy/ no energy.; felt lightheaded and as if she was going to pass out.; no appetite; red, long area on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red, long area on her arm), DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite) and CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-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) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERYTHEMA (red, long area on her arm). On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite) and FATIGUE (very fatigue/ sleepy/ no energy.). On 28-Feb-2021, the patient experienced ARTHRALGIA (fell and hurt her knee). On 01-Mar-2021, the patient experienced DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.) and COUGH (chest tightness and weakness in her chest which is making her cough more.). At the time of the report, ERYTHEMA (red, long area on her arm), DIZZINESS (felt lightheaded again and had to stand against the bathroom wall to let it pass), DIZZINESS (felt lightheaded and as if she was going to pass out.), DECREASED APPETITE (no appetite), CHEST DISCOMFORT (chest tightness and weakness in her chest which is making her cough more.), COUGH (chest tightness and weakness in her chest which is making her cough more.), ARTHRALGIA (fell and hurt her knee) and FATIGUE (very fatigue/ sleepy/ no energy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Illness, Neck pain
Clinical narrative: I've been sick 8 days, excruciating, awful; head pounding; difficulty breathing; neck pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), NECK PAIN (neck pain), ILLNESS (I've been sick 8 days, excruciating, awful) and HEADACHE (head pounding) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042460) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), NECK PAIN (neck pain) and HEADACHE (head pounding). On an unknown date, the patient experienced ILLNESS (I've been sick 8 days, excruciating, awful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Feb-2021, DYSPNOEA (difficulty breathing) and HEADACHE (head pounding) had resolved. At the time of the report, NECK PAIN (neck pain) and ILLNESS (I've been sick 8 days, excruciating, awful) 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Myalgia, Pain
Clinical narrative: fever of no more than 101°F; Body aches; not feeling well; arm soreness; Chills; Aches; felt like with the flue; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like with the flue), PYREXIA (fever of no more than 101°F), MYALGIA (Body aches), VACCINATION COMPLICATION (not feeling well) and PAIN IN EXTREMITY (arm soreness) in a 74-year-old male 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 Hypertension.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like with the flue). On an unknown date, the patient experienced PYREXIA (fever of no more than 101°F), MYALGIA (Body aches), VACCINATION COMPLICATION (not feeling well), PAIN IN EXTREMITY (arm soreness), CHILLS (Chills) and PAIN (Aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like with the flue), PYREXIA (fever of no more than 101°F), MYALGIA (Body aches), VACCINATION COMPLICATION (not feeling well), PAIN IN EXTREMITY (arm soreness), CHILLS (Chills) and PAIN (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: elevated (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports taking High Blood Pressure medication (NOS), Cholesterol medication (NOS) and Diuretic medication (NOS).     This case was linked to MOD-2021-031349 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: fever of no more than 101°F; Body aches; not feeling well; arm soreness; Chills; Aches; felt like with the flue; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like with the flue), PYREXIA (fever of no more than 101°F), MYALGIA (Body aches), VACCINATION COMPLICATION (not feeling well) and PAIN IN EXTREMITY (arm soreness) in a 74-year-old male 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 Hypertension.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like with the flue). On an unknown date, the patient experienced PYREXIA (fever of no more than 101°F), MYALGIA (Body aches), VACCINATION COMPLICATION (not feeling well), PAIN IN EXTREMITY (arm soreness), CHILLS (Chills) and PAIN (Aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like with the flue), PYREXIA (fever of no more than 101°F), MYALGIA (Body aches), VACCINATION COMPLICATION (not feeling well), PAIN IN EXTREMITY (arm soreness), CHILLS (Chills) and PAIN (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: elevated (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports taking High Blood Pressure medication (NOS), Cholesterol medication (NOS) and Diuretic medication (NOS).     This case was linked to MOD-2021-031349 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature decreased, Chills, Feeding disorder
Clinical narrative: Nauseous; Headache; Pain in the joints; Wanted to vomit, but nothing was coming up; Temperature dropped to 95.8degrees; Not being able to eat; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), CHILLS (Chills), NAUSEA (Nauseous) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). On 26-Feb-2021, the patient experienced BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), NAUSEA (Nauseous), HEADACHE (Headache), ARTHRALGIA (Pain in the joints) and VOMITING (Wanted to vomit, but nothing was coming up). On 25-Feb-2021, CHILLS (Chills) had resolved. On 02-Mar-2021, BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), HEADACHE (Headache), ARTHRALGIA (Pain in the joints) and VOMITING (Wanted to vomit, but nothing was coming up) had resolved. At the time of the report, NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 95.8 (Low) Temperature dropped to 95.8degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. Treatment information were included heating pads and blankets.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nauseous; Headache; Pain in the joints; Wanted to vomit, but nothing was coming up; Temperature dropped to 95.8degrees; Not being able to eat; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), CHILLS (Chills), NAUSEA (Nauseous) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). On 26-Feb-2021, the patient experienced BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), NAUSEA (Nauseous), HEADACHE (Headache), ARTHRALGIA (Pain in the joints) and VOMITING (Wanted to vomit, but nothing was coming up). On 25-Feb-2021, CHILLS (Chills) had resolved. On 02-Mar-2021, BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), HEADACHE (Headache), ARTHRALGIA (Pain in the joints) and VOMITING (Wanted to vomit, but nothing was coming up) had resolved. At the time of the report, NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 95.8 (Low) Temperature dropped to 95.8degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. Treatment information were included heating pads and blankets.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Headache, Lymphadenopathy, Malaise
Clinical narrative: Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw; Heart burn sensations; Did not feel well; Slight sore throat; Nausea; Body aches; Chills; Experienced a headache; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), DYSPEPSIA (Heart burn sensations), MALAISE (Did not feel well), LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat), MALAISE (Did not feel well), NAUSEA (Nausea), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Experienced a headache). On 21-Feb-2021, the patient experienced DYSPEPSIA (Heart burn sensations) and LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, OROPHARYNGEAL PAIN (Slight sore throat), MALAISE (Did not feel well), NAUSEA (Nausea), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Experienced a headache) had resolved. At the time of the report, DYSPEPSIA (Heart burn sensations) and LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw) 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.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14 May 2021 has no new information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw; Heart burn sensations; Did not feel well; Slight sore throat; Nausea; Body aches; Chills; Experienced a headache; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), DYSPEPSIA (Heart burn sensations), MALAISE (Did not feel well), LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat), MALAISE (Did not feel well), NAUSEA (Nausea), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Experienced a headache). On 21-Feb-2021, the patient experienced DYSPEPSIA (Heart burn sensations) and LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, OROPHARYNGEAL PAIN (Slight sore throat), MALAISE (Did not feel well), NAUSEA (Nausea), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Experienced a headache) had resolved. At the time of the report, DYSPEPSIA (Heart burn sensations) and LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw) 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.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14 May 2021 has no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: 101° F fever; Headaches; muscle aches; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 101 f fever, headaches and muscle aches, chills, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 26 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01DM20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) 101° f fever. headaches and muscle aches, chills, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 101° f fever, headaches and muscle aches,chills,fatigue was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101° F fever; Headaches; muscle aches; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 101 f fever, headaches and muscle aches, chills, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 26 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01DM20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) 101° f fever. headaches and muscle aches, chills, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 101° f fever, headaches and muscle aches,chills,fatigue was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site pruritus, Sleep disorder
Clinical narrative: black and blue mark; tinnitus; Vaccination site warmth; itching; red, 3 to 3.5 inches in diameter circle lump; large lump at the injection site; only sleep on my right side; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (large lump at the injection site), INJECTION SITE DISCOLOURATION (black and blue mark), TINNITUS (tinnitus), SLEEP DISORDER (only sleep on my right side) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SLEEP DISORDER (only sleep on my right side). On 17-Feb-2021, the patient experienced INJECTION SITE MASS (large lump at the injection site), TINNITUS (tinnitus), VACCINATION SITE WARMTH (Vaccination site warmth), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red, 3 to 3.5 inches in diameter circle lump). On 28-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (black and blue mark). On 28-Feb-2021, INJECTION SITE PRURITUS (itching) had resolved. At the time of the report, INJECTION SITE MASS (large lump at the injection site), INJECTION SITE DISCOLOURATION (black and blue mark), SLEEP DISORDER (only sleep on my right side) and INJECTION SITE ERYTHEMA (red, 3 to 3.5 inches in diameter circle lump) had not resolved, TINNITUS (tinnitus) had resolved and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No specific follow-up information recorded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site warmth
Clinical narrative: black and blue mark; tinnitus; Vaccination site warmth; itching; red, 3 to 3.5 inches in diameter circle lump; large lump at the injection site; only sleep on my right side; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (large lump at the injection site), INJECTION SITE DISCOLOURATION (black and blue mark), TINNITUS (tinnitus), SLEEP DISORDER (only sleep on my right side) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SLEEP DISORDER (only sleep on my right side). On 17-Feb-2021, the patient experienced INJECTION SITE MASS (large lump at the injection site), TINNITUS (tinnitus), VACCINATION SITE WARMTH (Vaccination site warmth), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red, 3 to 3.5 inches in diameter circle lump). On 28-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (black and blue mark). On 28-Feb-2021, INJECTION SITE PRURITUS (itching) had resolved. At the time of the report, INJECTION SITE MASS (large lump at the injection site), INJECTION SITE DISCOLOURATION (black and blue mark), SLEEP DISORDER (only sleep on my right side) and INJECTION SITE ERYTHEMA (red, 3 to 3.5 inches in diameter circle lump) had not resolved, TINNITUS (tinnitus) had resolved and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No specific follow-up information recorded.