chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: felt worse; itchy at the injection site; red arm, has extended down and to the bicep area, inside of his right arm; fever; headache; arm hurt; felt terrify; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt worse), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm) in an 89-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.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included UTI, High cholesterol and Blood pressure. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) 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 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify) and HEADACHE (headache). On 07-Feb-2021, the patient experienced PYREXIA (fever). On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt worse), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3 degree F usual temperature is 98 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include urinary tract pills, blood pressure pills and one more medication.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: head on side of the injection was hurting so bad that it felt numb; body ache; chills; slight fever; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events head on side of the injection was hurting so bad that it felt numb, arm in which she got the injection was entirely numb, she felt like the intensity was as close to having stroke,. She also experienced chills, slight fever and body aches.  The patient's medical history include COVID-19. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their unknown dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events head on side of the injection was hurting so bad that it felt numb, arm in which she got the injection was entirely numb, she felt like the intensity was as close to having stroke. and she also experienced chills, slight fever and body aches.  Treatment details were not provided. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events head on side of the injection was hurting so bad that it felt numb, arm in which she got the injection was entirely numb, she felt like the intensity was as close to having stroke, chills, slight fever, body aches was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: extreme pain in the arm; low grade fever; nauseous; arm is very, very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very, very sore), PAIN IN EXTREMITY (extreme pain in the arm), PYREXIA (low grade fever) and NAUSEA (nauseous) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MESALAZINE (ASACOL), URSODIOL, AZATHIOPRINE and GABAPENTIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is very, very sore). On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in the arm), PYREXIA (low grade fever) and NAUSEA (nauseous). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 12-Feb-2021, PYREXIA (low grade fever) and NAUSEA (nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is very, very sore) and PAIN IN EXTREMITY (extreme pain in the arm) outcome was unknown. Not Provided      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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: very dizzy\run out to a piece of furniture\dizziness; pain on the injection site; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy\run out to a piece of furniture\dizziness), VACCINATION SITE PAIN (pain on the injection site), HEADACHE (headache) and FATIGUE (tired) in an 81-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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site), HEADACHE (headache) and FATIGUE (tired). On an unknown date, the patient experienced DIZZINESS (very dizzy\run out to a piece of furniture\dizziness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form at bedtime. On 01-Feb-2021, VACCINATION SITE PAIN (pain on the injection site), HEADACHE (headache) and FATIGUE (tired) had resolved. At the time of the report, DIZZINESS (very dizzy\run out to a piece of furniture\dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included meds for hypertension, depression and osteopenia.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warmth at the injection site; Redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used includes blood pressure medicine NOS and cholesterol medicine NOS. Treatment for the events included ice, which didn't do anything. It's starting to fade away.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: neck stiffness; vertigo; neck was hot to touch; felt unwell; joint pain; injection site pain; headache; chills; fatigue; nausea; swollen lymph nodes on left side of neck; neck muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell) and ARTHRALGIA (joint pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: neck stiffness; vertigo; neck was hot to touch; felt unwell; joint pain; injection site pain; headache; chills; fatigue; nausea; swollen lymph nodes on left side of neck; neck muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell) and ARTHRALGIA (joint pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: neck stiffness; vertigo; neck was hot to touch; felt unwell; joint pain; injection site pain; headache; chills; fatigue; nausea; swollen lymph nodes on left side of neck; neck muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell) and ARTHRALGIA (joint pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Rapid heartbeat; Short breath; Heart was pounding; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), DYSPNOEA (Short breath) and PALPITATIONS (Heart was pounding) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), DYSPNOEA (Short breath) and PALPITATIONS (Heart was pounding). At the time of the report, HEART RATE INCREASED (Rapid heartbeat), DYSPNOEA (Short breath) and PALPITATIONS (Heart was pounding) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Heart rate: 99 (Inconclusive) 99 beats sustained for 12 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Next day felt a little sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Next day felt a little sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Next day felt a little sore). At the time of the report, MYALGIA (Next day felt a little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.   No treatment information was provided.   This case was linked to MOD-2021-035031 (Linked Report).; Sender's Comments:  MOD-2021-035031:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was received via COVID (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2th dose was rescheduled for 3/5/21 which is going to be 44 days; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and due to storm 2nd dose was rescheduled for 3/5/21 which is going to be 44 days after the 1 shot/inappropriate schedule of product administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient received 1st dose of Moderna covid vaccine and due to storm 2nd dose was rescheduled for 5 Mar 2021 which was going to be 44 years days after the 1st shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, due to storm 2nd dose was rescheduled for 3/5/21 which is going to be 44 days after the 1 shot was considered resolved.; Sender's Comments: This report refers to a case of a male patient who experienced Inappropriate schedule of vaccine administered for mRNA-1273, (Batch number unknown) with no associated AEs. His second dose was rescheduled for administration 44 days after the first dose which is beyond the recommended window period.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site bruising
Clinical narrative: A little dizzy; eel where the injection was at as it feels like a little bruise; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (A little dizzy) and INJECTION SITE BRUISING (eel where the injection was at as it feels like a little bruise) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (A little dizzy) and INJECTION SITE BRUISING (eel where the injection was at as it feels like a little bruise). At the time of the report, DIZZINESS (A little dizzy) and INJECTION SITE BRUISING (eel where the injection was at as it feels like a little bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Small hive lower than injection site; Itchy hive that got larger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Small hive lower than injection site) and VACCINATION SITE PRURITUS (Itchy hive that got larger) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0LIMZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 15-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 VACCINATION SITE URTICARIA (Small hive lower than injection site) and VACCINATION SITE PRURITUS (Itchy hive that got larger). On 15-Feb-2021, VACCINATION SITE URTICARIA (Small hive lower than injection site) and VACCINATION SITE PRURITUS (Itchy hive that got larger) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used were not reported.  No treatment information were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache
Clinical narrative: Temperature more than 100°F; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature more than 100°F), CHILLS (Chills) and HEADACHE (Headaches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature more than 100°F), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, BODY TEMPERATURE INCREASED (Temperature more than 100°F), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N concomitant medications reported. no treatment details provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal discomfort
Clinical narrative: Muscle cramps; Arm cramps; She felt like someone hit me on top of my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps), MUSCLE SPASMS (Arm cramps) and MUSCULOSKELETAL DISCOMFORT (She felt like someone hit me on top of my shoulder) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle cramps), MUSCLE SPASMS (Arm cramps) and MUSCULOSKELETAL DISCOMFORT (She felt like someone hit me on top of my shoulder). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Muscle cramps), MUSCLE SPASMS (Arm cramps) and MUSCULOSKELETAL DISCOMFORT (She felt like someone hit me on top of my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant treatment included hemp rub.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: CONTINOUS GRADE 3 FEVER OF 102 TO 103; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (CONTINOUS GRADE 3 FEVER OF 102 TO 103) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (CONTINOUS GRADE 3 FEVER OF 102 TO 103). At the time of the report, PYREXIA (CONTINOUS GRADE 3 FEVER OF 102 TO 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown (High) 102 TO 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain while I was shaking out towels; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain while I was shaking out towels) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain while I was shaking out towels). On 28-Feb-2021, PAIN IN EXTREMITY (arm pain while I was shaking out towels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Tiny bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Tiny bit of soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for Macular degeneration, APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL), METOPROLOL, TORSEMIDE, POTASSIUM CHLORIDE, BUPROPION, LEVOCETIRIZINE, FLUTICASONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), SALBUTAMOL (ALBUTEROL HFA), MULTIVITAMINS [VITAMINS NOS] and L-ARGININE [ARGININE] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (Tiny bit of soreness). At the time of the report, PAIN (Tiny bit of soreness) outcome was unknown.            Concomitant medication included l-glulisine. No treatment information was provided.   This case was linked to MOD-2021-035078, MOD-2021-035078 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mouth swelling, Nausea, Pain in extremity
Clinical narrative: Had like angioedema; Arm is like two or three times its size; Arm just hurts a lot; Having chills; Felt nauseous right away after getting the vaccine; Very tired; A spontaneous report was received from a consumer concerning a 59-years-old female patient who experienced having "like angioedema" (swollen mouth), arm is like two or three times its size (vaccination site swelling), arm just hurts a lot (pain in extremity), very tired (fatigue), having chills (chills), and felt nauseous right away after getting the vaccine (nausea).  The patient's medical history was not provided. Concomitant product use was unknown.   On 03 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient felt nauseous right away after getting the vaccine, and she went to bed because she was very tired.     On 04 Mar 2021, the patient had her arm "like two or three times its size" and the arm just hurt a lot. When the patient woke up and looked inside her mouth, she had "like angioedema". She also stated that she was having chills. She was not so concerned at that moment.  Treatment details included pain medication, allergy medication, and stomach/nausea medication.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events of having like angioedema (swollen mouth), arm is like two or three times its size (vaccination site swelling), arm just hurts a lot (vaccination site pain), very tired (fatigue), having chills (chills), and felt nauseous right away after getting the vaccine (nausea), was unknown.  Consent for HCP safety follow up denied.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Had like angioedema; Arm is like two or three times its size; Arm just hurts a lot; Having chills; Felt nauseous right away after getting the vaccine; Very tired; A spontaneous report was received from a consumer concerning a 59-years-old female patient who experienced having "like angioedema" (swollen mouth), arm is like two or three times its size (vaccination site swelling), arm just hurts a lot (pain in extremity), very tired (fatigue), having chills (chills), and felt nauseous right away after getting the vaccine (nausea).  The patient's medical history was not provided. Concomitant product use was unknown.   On 03 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient felt nauseous right away after getting the vaccine, and she went to bed because she was very tired.     On 04 Mar 2021, the patient had her arm "like two or three times its size" and the arm just hurt a lot. When the patient woke up and looked inside her mouth, she had "like angioedema". She also stated that she was having chills. She was not so concerned at that moment.  Treatment details included pain medication, allergy medication, and stomach/nausea medication.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events of having like angioedema (swollen mouth), arm is like two or three times its size (vaccination site swelling), arm just hurts a lot (vaccination site pain), very tired (fatigue), having chills (chills), and felt nauseous right away after getting the vaccine (nausea), was unknown.  Consent for HCP safety follow up denied.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Swelling
Clinical narrative: discomfort in arm pit; swollen; hard lump; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in arm pit), PERIPHERAL SWELLING (swollen) and SWELLING (hard lump) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21a) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm pit), PERIPHERAL SWELLING (swollen) and SWELLING (hard lump). At the time of the report, LIMB DISCOMFORT (discomfort in arm pit), PERIPHERAL SWELLING (swollen) and SWELLING (hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: worst flu like symptoms, felt terrible; felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (worst flu like symptoms, felt terrible) and FEELING ABNORMAL (felt terrible) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 215M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (worst flu like symptoms, felt terrible) and FEELING ABNORMAL (felt terrible). On 15-Feb-2021, INFLUENZA LIKE ILLNESS (worst flu like symptoms, felt terrible) and FEELING ABNORMAL (felt terrible) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysmenorrhoea, Pain, Pain in extremity
Clinical narrative: arm was hurting; couldn't straighten arm because her back was hurting; abdominal/lower menstrual cramps; pain was a 9; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), BACK PAIN (couldn't straighten arm because her back was hurting), DYSMENORRHOEA (abdominal/lower menstrual cramps) and PAIN (pain was a 9) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting), BACK PAIN (couldn't straighten arm because her back was hurting), DYSMENORRHOEA (abdominal/lower menstrual cramps) and PAIN (pain was a 9). At the time of the report, PAIN IN EXTREMITY (arm was hurting), BACK PAIN (couldn't straighten arm because her back was hurting), DYSMENORRHOEA (abdominal/lower menstrual cramps) and PAIN (pain was a 9) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the event included paracetamol and ibuprofen.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: Numbness on left side of this body/numbness on left arm and leg/numbness on left side of face; lost feeling on left side of body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (lost feeling on left side of body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII in 2003.    On 22-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 FEELING ABNORMAL (lost feeling on left side of body). On 25-Feb-2021, FEELING ABNORMAL (lost feeling on left side of body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at injection site; Itchy at injection site; Red at injection site; Swollen at injection site 5.5 X 5.5 inches in diameter; Very red at site of injection; Very swollen at site of injection 2.5 X 2.5 inches in diameter; Very hot at site of injection; Very itchy at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE WARMTH (Very hot at site of injection), VACCINATION SITE PRURITUS (Very itchy at site of injection), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Very red at site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant concomitant medications reported. .     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot at site of injection), VACCINATION SITE PRURITUS (Very itchy at site of injection), VACCINATION SITE ERYTHEMA (Very red at site of injection) and VACCINATION SITE SWELLING (Very swollen at site of injection 2.5 X 2.5 inches in diameter). On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site 5.5 X 5.5 inches in diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 21-Feb-2021, VACCINATION SITE WARMTH (Very hot at site of injection), VACCINATION SITE PRURITUS (Very itchy at site of injection), VACCINATION SITE ERYTHEMA (Very red at site of injection) and VACCINATION SITE SWELLING (Very swollen at site of injection 2.5 X 2.5 inches in diameter) had resolved. On 03-Mar-2021, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site 5.5 X 5.5 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant treatment included Ice packs, prescription steroid cream. No relevant concomitant medications reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Musculoskeletal stiffness, Neck pain, Vaccination site pain
Clinical narrative: Neck pain both sides; Stiffness arm injected site; Soreness arm injected site; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain both sides), MUSCULOSKELETAL STIFFNESS (Stiffness arm injected site), VACCINATION SITE PAIN (Soreness arm injected site), CHILLS (Chills) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Kidney disorder, Diabetes, Acid reflux (esophageal) and Constipation.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced NECK PAIN (Neck pain both sides), MUSCULOSKELETAL STIFFNESS (Stiffness arm injected site), VACCINATION SITE PAIN (Soreness arm injected site), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NECK PAIN (Neck pain both sides), MUSCULOSKELETAL STIFFNESS (Stiffness arm injected site), VACCINATION SITE PAIN (Soreness arm injected site), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: Left hand swelled up; Left arm was a little tender; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Drug allergy (Codeine Allergy), Drug allergy (Sulfa allergy), Iodine allergy and Sun sensitivity (Allergic to sun (causes eczema)).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included Vitamins. Treatment medications were unknown.    This case was linked to MOD-2021-035104 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received first vaccine at 17; A regulatory report () was received from a consumer concerning a 17-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  while the product was found to be administered at an inappropriate age.   The patient's medical history were not provided. Concomitant were not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  It was observed that the patient received first dose of vaccine at 17 (product administered to patient of inappropriate age).  Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was considered to be resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: very sore arm; Lightheadedness; Dizziness; feeling not right; Cold sweats; Aches; Upset stomach; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right) and HYPERHIDROSIS (Cold sweats) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    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 PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right), HYPERHIDROSIS (Cold sweats), PAIN (Aches), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills) and PYREXIA (Fever). On 02-Mar-2021, PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right), HYPERHIDROSIS (Cold sweats), PAIN (Aches), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: very sore arm; Lightheadedness; Dizziness; feeling not right; Cold sweats; Aches; Upset stomach; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right) and HYPERHIDROSIS (Cold sweats) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    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 PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right), HYPERHIDROSIS (Cold sweats), PAIN (Aches), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills) and PYREXIA (Fever). On 02-Mar-2021, PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right), HYPERHIDROSIS (Cold sweats), PAIN (Aches), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm - left arm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm - left arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-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) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm - left arm). At the time of the report, VACCINATION SITE PAIN (sore arm - left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.