chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Ear discomfort, Eye pain, Fatigue
Clinical narrative: Left facial paralexia; Not able to hear; Ears are stuffy; Pain in the left eye; Tingling in the left eye; Very dizzy; Fatigue; Not able to focus; Not able to concentrate; Left side of the face like numb; This spontaneous case was reported by a consumer and describes the occurrence of READING DISORDER (Left facial paralexia), HYPOAESTHESIA (Left side of the face like numb), HYPOACUSIS (Not able to hear), EAR DISCOMFORT (Ears are stuffy) and DISTURBANCE IN ATTENTION (Not able to concentrate) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to a stomach medicine but not specified.), Stomach pain and High cholesterol. Concomitant products included ATORVASTATIN and CALCIUM for High cholesterol, ESOMEPRAZOLE for Stomach pain.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Left side of the face like numb), DISTURBANCE IN ATTENTION (Not able to concentrate) and VISION BLURRED (Not able to focus). On 16-Feb-2021, the patient experienced EYE PAIN (Pain in the left eye), PARAESTHESIA (Tingling in the left eye), DIZZINESS (Very dizzy) and FATIGUE (Fatigue). On 18-Feb-2021, the patient experienced HYPOACUSIS (Not able to hear) and EAR DISCOMFORT (Ears are stuffy). On 21-Feb-2021, the patient experienced READING DISORDER (Left facial paralexia). At the time of the report, READING DISORDER (Left facial paralexia), HYPOAESTHESIA (Left side of the face like numb), HYPOACUSIS (Not able to hear), EAR DISCOMFORT (Ears are stuffy), DISTURBANCE IN ATTENTION (Not able to concentrate), EYE PAIN (Pain in the left eye), PARAESTHESIA (Tingling in the left eye), DIZZINESS (Very dizzy), VISION BLURRED (Not able to focus) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Globidoblep   This case was linked to MOD-2021-020813 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Hypoaesthesia, Paraesthesia, Reading disorder, Vision blurred
Clinical narrative: Left facial paralexia; Not able to hear; Ears are stuffy; Pain in the left eye; Tingling in the left eye; Very dizzy; Fatigue; Not able to focus; Not able to concentrate; Left side of the face like numb; This spontaneous case was reported by a consumer and describes the occurrence of READING DISORDER (Left facial paralexia), HYPOAESTHESIA (Left side of the face like numb), HYPOACUSIS (Not able to hear), EAR DISCOMFORT (Ears are stuffy) and DISTURBANCE IN ATTENTION (Not able to concentrate) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to a stomach medicine but not specified.), Stomach pain and High cholesterol. Concomitant products included ATORVASTATIN and CALCIUM for High cholesterol, ESOMEPRAZOLE for Stomach pain.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Left side of the face like numb), DISTURBANCE IN ATTENTION (Not able to concentrate) and VISION BLURRED (Not able to focus). On 16-Feb-2021, the patient experienced EYE PAIN (Pain in the left eye), PARAESTHESIA (Tingling in the left eye), DIZZINESS (Very dizzy) and FATIGUE (Fatigue). On 18-Feb-2021, the patient experienced HYPOACUSIS (Not able to hear) and EAR DISCOMFORT (Ears are stuffy). On 21-Feb-2021, the patient experienced READING DISORDER (Left facial paralexia). At the time of the report, READING DISORDER (Left facial paralexia), HYPOAESTHESIA (Left side of the face like numb), HYPOACUSIS (Not able to hear), EAR DISCOMFORT (Ears are stuffy), DISTURBANCE IN ATTENTION (Not able to concentrate), EYE PAIN (Pain in the left eye), PARAESTHESIA (Tingling in the left eye), DIZZINESS (Very dizzy), VISION BLURRED (Not able to focus) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Globidoblep   This case was linked to MOD-2021-020813 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: Difficulty with arm; Arm was itchy; Arm was swollen; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Difficulty with arm), PRURITUS (Arm was itchy), PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRURITUS (Arm was itchy), PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red). On an unknown date, the patient experienced LIMB DISCOMFORT (Difficulty with arm). At the time of the report, LIMB DISCOMFORT (Difficulty with arm), PRURITUS (Arm was itchy), PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment included Benadryl and Ice
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Fever of 103F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever of 103F), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever of 103F), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 04-Feb-2021, DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Fever of 103F), CHILLS (Chills) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature increased: 103 (Inconclusive) 103F.         No concomitant medications reported. Treatment included Held ice on her head.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Fever of 103F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever of 103F), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever of 103F), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 04-Feb-2021, DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Fever of 103F), CHILLS (Chills) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature increased: 103 (Inconclusive) 103F.         No concomitant medications reported. Treatment included Held ice on her head.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Inflammation, Injection site erythema, Pain in extremity
Clinical narrative: sore arm; red; inflamed; little pinkly; itchy arm, area 2 inches by 5 inches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (red), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (little pinkly) and PRURITUS (itchy arm, area 2 inches by 5 inches) in a 64-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.     The patient's past medical history included Latex allergy. Concomitant products included PANTOPRAZOLE and MONTELUKAST for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (red), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (little pinkly) and PRURITUS (itchy arm, area 2 inches by 5 inches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved and ERYTHEMA (red), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (little pinkly) and PRURITUS (itchy arm, area 2 inches by 5 inches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: sore arm; red; inflamed; little pinkly; itchy arm, area 2 inches by 5 inches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (red), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (little pinkly) and PRURITUS (itchy arm, area 2 inches by 5 inches) in a 64-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.     The patient's past medical history included Latex allergy. Concomitant products included PANTOPRAZOLE and MONTELUKAST for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (red), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (little pinkly) and PRURITUS (itchy arm, area 2 inches by 5 inches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved and ERYTHEMA (red), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (little pinkly) and PRURITUS (itchy arm, area 2 inches by 5 inches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Pain in extremity
Clinical narrative: increased blood pressure which will climb by approximately 20 points from his normal; sore arm; very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (increased blood pressure which will climb by approximately 20 points from his normal), PAIN IN EXTREMITY (sore arm) and NAUSEA (very nauseous) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A, 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), FLECAINIDE ACETATE and DILTIAZEM.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 20-Feb-2021, the patient experienced NAUSEA (very nauseous). On an unknown date, the patient experienced HYPERTENSION (increased blood pressure which will climb by approximately 20 points from his normal) and PAIN IN EXTREMITY (sore arm). At the time of the report, HYPERTENSION (increased blood pressure which will climb by approximately 20 points from his normal), PAIN IN EXTREMITY (sore arm) and NAUSEA (very nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Advil.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: redness in oval shape/ patch on left arm; swelling at injection site; stiffness around his left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (stiffness around his left arm), VACCINATION SITE ERYTHEMA (redness in oval shape/ patch on left arm) and VACCINATION SITE SWELLING (swelling at injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (stiffness around his left arm). On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in oval shape/ patch on left arm) and VACCINATION SITE SWELLING (swelling at injection site). On 28-Jan-2021, VACCINATION SITE SWELLING (swelling at injection site) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (stiffness around his left arm) outcome was unknown and VACCINATION SITE ERYTHEMA (redness in oval shape/ patch on left arm) had not resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included ice(which was put on and off the site of events)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Bump size of an egg at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump size of an egg at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Neck pain. Concomitant products included HYDROCODONE for Neck pain, MELOXICAM 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 15-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump size of an egg at injection site). At the time of the report, VACCINATION SITE MASS (Bump size of an egg at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm hurt that night, it was uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her arm hurt that night, it was uncomfortable) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Her arm hurt that night, it was uncomfortable). At the time of the report, VACCINATION SITE PAIN (Her arm hurt that night, it was uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included medicines for diabetes, high blood pressure, cholesterol, vitamins and blood thinners. patient reported that her arm hurt that night, it was uncomfortable.It's gotten better but it was still tender. she also mentioned that for  first 3-4 days it was very sore, now her arm was a little sore. Treatment for the event included one little aspirin and managed with hot shower, ice and heating pad.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site area became red; injection site area became swollen; injection site area became itchy; injection site area became hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site area became red), VACCINATION SITE SWELLING (injection site area became swollen), VACCINATION SITE PRURITUS (injection site area became itchy) and VACCINATION SITE WARMTH (injection site area became hot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse events were reported).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site area became red), VACCINATION SITE SWELLING (injection site area became swollen), VACCINATION SITE PRURITUS (injection site area became itchy) and VACCINATION SITE WARMTH (injection site area became hot). At the time of the report, VACCINATION SITE ERYTHEMA (injection site area became red), VACCINATION SITE SWELLING (injection site area became swollen), VACCINATION SITE PRURITUS (injection site area became itchy) and VACCINATION SITE WARMTH (injection site area became hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Vaccination site pain
Clinical narrative: the shot it was very painful and the pain continued; her range of motion on the vaccinated arm is limited, she describes it as a frozen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the shot it was very painful and the pain continued) and PERIARTHRITIS (her range of motion on the vaccinated arm is limited, she describes it as a frozen shoulder) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (the shot it was very painful and the pain continued) and PERIARTHRITIS (her range of motion on the vaccinated arm is limited, she describes it as a frozen shoulder). At the time of the report, VACCINATION SITE PAIN (the shot it was very painful and the pain continued) and PERIARTHRITIS (her range of motion on the vaccinated arm is limited, she describes it as a frozen shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Pain/ soreness to the touch; Itches at injection site; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ soreness to the touch), VACCINATION SITE PRURITUS (Itches at injection site) and VACCINATION SITE RASH (Rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Heart failure. Concomitant products included WARFARIN, RAMIPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), CARVEDILOL and FINASTERIDE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Pain/ soreness to the touch), VACCINATION SITE PRURITUS (Itches at injection site) and VACCINATION SITE RASH (Rash). At the time of the report, PAIN (Pain/ soreness to the touch), VACCINATION SITE PRURITUS (Itches at injection site) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided   This case was linked to MOD-2021-021854 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received on 27-APR-2021 contains no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Frequent bowel movements, Myalgia, Vaccination site reaction
Clinical narrative: More frequent bowel movements; Feeling off; Joint pain; Body aches; The injection site the area was raised; Area was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site the area was raised), VACCINATION SITE WARMTH (Area was hot), FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off) and ARTHRALGIA (Joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 REACTION (The injection site the area was raised) and VACCINATION SITE WARMTH (Area was hot). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off), ARTHRALGIA (Joint pain) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE REACTION (The injection site the area was raised), VACCINATION SITE WARMTH (Area was hot), FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off), ARTHRALGIA (Joint pain) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter Email address and report media was updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: More frequent bowel movements; Feeling off; Joint pain; Body aches; The injection site the area was raised; Area was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site the area was raised), VACCINATION SITE WARMTH (Area was hot), FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off) and ARTHRALGIA (Joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 REACTION (The injection site the area was raised) and VACCINATION SITE WARMTH (Area was hot). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off), ARTHRALGIA (Joint pain) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE REACTION (The injection site the area was raised), VACCINATION SITE WARMTH (Area was hot), FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off), ARTHRALGIA (Joint pain) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter Email address and report media was updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Arm) 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 No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Arm). At the time of the report, PAIN IN EXTREMITY (Soreness of Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Minor pain in their shoulder, (same side of the injection); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Minor pain in their shoulder, (same side of the injection)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma.    On 27-Jan-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 ARTHRALGIA (Minor pain in their shoulder, (same side of the injection)). At the time of the report, ARTHRALGIA (Minor pain in their shoulder, (same side of the injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: would like to register pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (would like to register pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Aug-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (would like to register pregnancy). On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (would like to register pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: blurred vision; lot of pain the arm (R arm, injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision) and VACCINATION SITE PAIN (lot of pain the arm (R arm, injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (lot of pain the arm (R arm, injection site). On 25-Feb-2021, the patient experienced VISION BLURRED (blurred vision). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (blurred vision) and VACCINATION SITE PAIN (lot of pain the arm (R arm, injection site) outcome was unknown.            No concomitant product use was reported   This case was linked to US-MODERNATX, INC.-MOD-2020-077981 (E2B Linked Report). This case was linked to MOD-2021-089499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Added Batch No as 028L20A. Also added injection site as Right arm and vaccination place  On 28-May-2021: Non Significant Follow up - contact info updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-077981:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Kind of sick; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Kind of sick), PYREXIA (Fever) and CHILLS (Chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Aphasia (Patient is non verbal and has been since before the vaccine). Concomitant products included DIAZEPAM for an unknown indication.    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 MALAISE (Kind of sick), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MALAISE (Kind of sick), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs include duwalpro and other OTC.  Treatment information include paracetamol and ibuprofen.   This case was linked to MOD-2021-021544 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Dizziness, Emotional disorder, Fatigue
Clinical narrative: stutter step; heightened state of emotion; disconnected feeling from body; diarrhea; dizzy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, IBUPROFEN, GABAPENTIN, OMEPRAZOLE, LISINOPRIL, DULOXETINE, ONDANSETRON, ATORVASTATIN, TRAZODONE, DOCUSATE SODIUM and SALBUTAMOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and FATIGUE (fatigue). On 19-Feb-2021, DIARRHOEA (diarrhea) and FATIGUE (fatigue) outcome was unknown. At the time of the report, GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on treatment medication were included.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: stutter step; heightened state of emotion; disconnected feeling from body; diarrhea; dizzy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, IBUPROFEN, GABAPENTIN, OMEPRAZOLE, LISINOPRIL, DULOXETINE, ONDANSETRON, ATORVASTATIN, TRAZODONE, DOCUSATE SODIUM and SALBUTAMOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and FATIGUE (fatigue). On 19-Feb-2021, DIARRHOEA (diarrhea) and FATIGUE (fatigue) outcome was unknown. At the time of the report, GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on treatment medication were included.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Headache, Pain in extremity, Tremor
Clinical narrative: Shaking; anxiety; arm pain that went worse after the second dose; joint pain; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking), ANXIETY (anxiety), PAIN IN EXTREMITY (arm pain that went worse after the second dose), ARTHRALGIA (joint pain) and HEADACHE (Headaches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and INDOMETHACIN [INDOMETACIN] for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shaking), ANXIETY (anxiety), PAIN IN EXTREMITY (arm pain that went worse after the second dose), ARTHRALGIA (joint pain) and HEADACHE (Headaches). At the time of the report, TREMOR (Shaking) was resolving and ANXIETY (anxiety), PAIN IN EXTREMITY (arm pain that went worse after the second dose), ARTHRALGIA (joint pain) and HEADACHE (Headaches) outcome was unknown.            Treatment information was not provided.  On an unknown date, post-vaccination, the patient was seen by a neurologist for the shaking. Per the reporter, the neurologist stated they were unsure if the patient had a movement disorder but the tremors will slowly go away.   This case was linked to MOD-2021-022325 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07 Jun 2021. Updated reporter information, concomitant medications and events.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen/ puffy; Itchy; Red/ still pinkish; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen/ puffy), PRURITUS (Itchy) and ERYTHEMA (Red/ still pinkish) 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 05-Feb-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 PERIPHERAL SWELLING (Swollen/ puffy), PRURITUS (Itchy) and ERYTHEMA (Red/ still pinkish). At the time of the report, PERIPHERAL SWELLING (Swollen/ puffy) outcome was unknown and PRURITUS (Itchy) and ERYTHEMA (Red/ still pinkish) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: At site of injection: erythema 2 inches across and 2.5 inches shoulder to elbow surrounding injection sight.; At site of injection: intense itching; intermittant tenderness @ the injection sight; Chills; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PRURITUS (At site of injection: intense itching), VACCINATION SITE PAIN (intermittant tenderness @ the injection sight), VACCINATION SITE ERYTHEMA (At site of injection: erythema 2 inches across and 2.5 inches shoulder to elbow surrounding injection sight.) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (Injection site (L bicep)) in 2010. Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (Chills). On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (At site of injection: intense itching) and VACCINATION SITE PAIN (intermittant tenderness @ the injection sight). On 20-Feb-2021 at 4:00 PM, the patient experienced VACCINATION SITE ERYTHEMA (At site of injection: erythema 2 inches across and 2.5 inches shoulder to elbow surrounding injection sight.). On 13-Feb-2021, CHILLS (Chills) had resolved. On 01-Mar-2021, INJECTION SITE PRURITUS (At site of injection: intense itching) and VACCINATION SITE ERYTHEMA (At site of injection: erythema 2 inches across and 2.5 inches shoulder to elbow surrounding injection sight.) had resolved. At the time of the report, VACCINATION SITE PAIN (intermittant tenderness @ the injection sight) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported having strong reactions to seasonal flu vaccines that included tenderness and swollen clavicular lymph nodes lasting 4 to 6 weeks.  The patient continued to experience intermittent vaccination site tenderness.  The patient reported not seeking any treatment for the adverse events.   This case was linked to MOD-2021-201104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received provided event details and outcome, patient history, suspect and concomitant medication dosage details.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site area got red; injection site area got itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site area got red) and VACCINATION SITE PRURITUS (injection site area got itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site area got red) and VACCINATION SITE PRURITUS (injection site area got itchy). At the time of the report, VACCINATION SITE ERYTHEMA (injection site area got red) and VACCINATION SITE PRURITUS (injection site area got itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Cortisone cream, Ice.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Jaw hurts really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw hurts really bad) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN JAW (Jaw hurts really bad). At the time of the report, PAIN IN JAW (Jaw hurts really bad) had resolved.            Concomitant product use included unspecified medications for heart pump. Treatment medication use was not provided by the reporter. Patient wife's reported that there was only a minor problem and no symptoms with the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Correspondence email attached. Outcome of the event added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Rapid raising of heart beat up to 157 beats per minute; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Rapid raising of heart beat up to 157 beats per minute) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Shellfish allergy and Penicillin allergy. Concomitant products included METOPROLOL TARTRATE, LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), VITAMIN D NOS and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Rapid raising of heart beat up to 157 beats per minute). At the time of the report, PALPITATIONS (Rapid raising of heart beat up to 157 beats per minute) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This patient experienced rapid raising heart beat 15 minutes after vaccine administration. Her Cardiologist gave her a "heart rate monitor device" and for one week she had the same rapid heart beat only once. Her Cardiologist recommended she get the second vaccine, while her Immunologist did not. Treatment included the patient's on a beta blocker and was able to take that medication.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow-up information received on 17-Mar-2021 processed at same time as initial report. Follow-up information included update to patient demographics, medical history, concomitant products used, vaccine information update and medical confirmation.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Pain, Pruritus, Vaccination site pain
Clinical narrative: arm was itching; Injection site rash; tender at the injection site; Sore at injection site; minor pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore at injection site), PRURITUS (arm was itching), INJECTION SITE RASH (Injection site rash), PAIN (minor pain) and VACCINATION SITE PAIN (tender at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Indocin).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore at injection site) and PAIN (minor pain). On 19-Feb-2021, the patient experienced PRURITUS (arm was itching), INJECTION SITE RASH (Injection site rash) and VACCINATION SITE PAIN (tender at the injection site). At the time of the report, INJECTION SITE PAIN (Sore at injection site), PRURITUS (arm was itching), INJECTION SITE RASH (Injection site rash), PAIN (minor pain) and VACCINATION SITE PAIN (tender at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included hydrocortisone.    This case was linked to MOD-2021-021818 (Patient Link).