chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site pain; Itches a lot; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Itches a lot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itches a lot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Itches a lot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Pruritus, Throat irritation
Clinical narrative: itchy skin; itchy throat; itchy lips; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy skin), THROAT IRRITATION (itchy throat) and LIP PRURITUS (itchy lips) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, the patient experienced PRURITUS (itchy skin), THROAT IRRITATION (itchy throat) and LIP PRURITUS (itchy lips). At the time of the report, PRURITUS (itchy skin), THROAT IRRITATION (itchy throat) and LIP PRURITUS (itchy lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensitive skin, Vaccination site discomfort, Vaccination site movement impairment
Clinical narrative: pain in arm; pain in arm ever since; sensitive to touch; Arm hurts to move; "causes discomfort"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm ever since), SENSITIVE SKIN (sensitive to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm hurts to move), VACCINATION SITE DISCOMFORT ("causes discomfort") and PAIN IN EXTREMITY (pain in arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm ever since), SENSITIVE SKIN (sensitive to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm hurts to move) and VACCINATION SITE DISCOMFORT ("causes discomfort"). On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm ever since), SENSITIVE SKIN (sensitive to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm hurts to move), VACCINATION SITE DISCOMFORT ("causes discomfort") and PAIN IN EXTREMITY (pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Rash
Clinical narrative: Hot sore on her arm; Pain in arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot sore on her arm), PAIN IN EXTREMITY (Pain in arm) and RASH (Rash) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FEELING HOT (Hot sore on her arm), PAIN IN EXTREMITY (Pain in arm) and RASH (Rash). At the time of the report, FEELING HOT (Hot sore on her arm), PAIN IN EXTREMITY (Pain in arm) and RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided. Treatment details were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in her left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in her left shoulder) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 ARTHRALGIA (Pain in her left shoulder). The patient was treated with IBUPROFEN ongoing since an unknown date for Arthralgia, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date for Arthralgia, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Pain in her left shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  Treatment details included Ibuprofen and Tylenol combined.   This case was linked to MOD-2021-066923 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional info received
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Joint pain; Fatigue; headache; Muscle pain; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was taking insulin. Patient treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Joint pain; Fatigue; headache; Muscle pain; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was taking insulin. Patient treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea
Clinical narrative: numbness, a weird taste on her mouth and her throat got really dry; tickle on her nose and headaches; nausea, headaches, chills and extreme weakness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness, a weird taste on her mouth and her throat got really dry), NAUSEA (nausea, headaches, chills and extreme weakness) and HEADACHE (tickle on her nose and headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027a21a and 019b21a) for COVID-19 vaccination.     Concomitant products included BUPROPION, SPIRONOLACTONE and VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Mar-2021, the patient experienced NAUSEA (nausea, headaches, chills and extreme weakness). On 13-Mar-2021, the patient experienced HEADACHE (tickle on her nose and headaches). On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness, a weird taste on her mouth and her throat got really dry). At the time of the report, HYPOAESTHESIA (numbness, a weird taste on her mouth and her throat got really dry), NAUSEA (nausea, headaches, chills and extreme weakness) and HEADACHE (tickle on her nose and headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to COVID-19 virus after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 virus after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 virus after vaccination). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 virus after vaccination) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    .
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: May not get the second dose on time (may be greater than 36 days) for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Tongue felt numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tongue felt numb) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Tongue felt numb). At the time of the report, HYPOAESTHESIA ORAL (Tongue felt numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: headache all day; pins and needles all over parts of the body randomly. sometimes feet, hands, chest, armpit, dental; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache all day) and PARAESTHESIA (pins and needles all over parts of the body randomly. sometimes feet, hands, chest, armpit, dental) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (headache all day) and PARAESTHESIA (pins and needles all over parts of the body randomly. sometimes feet, hands, chest, armpit, dental). At the time of the report, HEADACHE (headache all day) and PARAESTHESIA (pins and needles all over parts of the body randomly. sometimes feet, hands, chest, armpit, dental) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.   This case was linked to MOD21-066614 (E2B Linked Report).; Sender's Comments:  MOD21-066614:MOD-2021-064127 -2nd Dose of Vaccine
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (outcome unknown). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Feb-2021 and the estimated date of delivery was 02-Dec-2021. On 26-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 26-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: injection arm lump; injection arm itched like crazy; injection arm large red area with minor eruptions; injection arm swollen; injection arm rash from shoulder to elbow; extreme Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection arm lump), VACCINATION SITE PRURITUS (injection arm itched like crazy), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen) and VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 0115120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia since an unknown date.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE MASS (injection arm lump), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen), VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) and FATIGUE (extreme Fatigue). 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection arm itched like crazy). On 28-Mar-2021, VACCINATION SITE MASS (injection arm lump), VACCINATION SITE PRURITUS (injection arm itched like crazy), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen), VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) and FATIGUE (extreme Fatigue) had resolved.            Concomitant medications use was not provided.  Treatment information was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection arm lump; injection arm itched like crazy; injection arm large red area with minor eruptions; injection arm swollen; injection arm rash from shoulder to elbow; extreme Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection arm lump), VACCINATION SITE PRURITUS (injection arm itched like crazy), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen) and VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 0115120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia since an unknown date.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE MASS (injection arm lump), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen), VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) and FATIGUE (extreme Fatigue). 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection arm itched like crazy). On 28-Mar-2021, VACCINATION SITE MASS (injection arm lump), VACCINATION SITE PRURITUS (injection arm itched like crazy), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen), VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) and FATIGUE (extreme Fatigue) had resolved.            Concomitant medications use was not provided.  Treatment information was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: her left arm started getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (her left arm started getting red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma and High cholesterol.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (her left arm started getting red). At the time of the report, VACCINATION SITE ERYTHEMA (her left arm started getting red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: tinnitus; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) and FATIGUE (tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Ear drum perforation (ruptured eardrum).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (tiredness). On 20-Mar-2021, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Painful; looks like Covid Arm, hot to touch, and painful; Injection site is a bright red mark; had terrible Chills; Fever went 103 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful), VACCINATION SITE ERYTHEMA (Injection site is a bright red mark), VACCINATION SITE PAIN (Painful), CHILLS (had terrible Chills) and PYREXIA (Fever went 103 degrees Farenheight) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 27-Mar-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 27-Mar-2021, the patient experienced CHILLS (had terrible Chills) and PYREXIA (Fever went 103 degrees Farenheight). On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful) and VACCINATION SITE ERYTHEMA (Injection site is a bright red mark). On an unknown date, the patient experienced VACCINATION SITE PAIN (Painful). On 29-Mar-2021, PYREXIA (Fever went 103 degrees Farenheight) had resolved. At the time of the report, VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful), VACCINATION SITE ERYTHEMA (Injection site is a bright red mark), VACCINATION SITE PAIN (Painful) and CHILLS (had terrible Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 103 degrees farenheight (High) 103 degrees Farenheight.         Treatment for the events included Prednisone and Antibiotics.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-079925 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Painful; looks like Covid Arm, hot to touch, and painful; Injection site is a bright red mark; had terrible Chills; Fever went 103 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful), VACCINATION SITE ERYTHEMA (Injection site is a bright red mark), VACCINATION SITE PAIN (Painful), CHILLS (had terrible Chills) and PYREXIA (Fever went 103 degrees Farenheight) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 27-Mar-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 27-Mar-2021, the patient experienced CHILLS (had terrible Chills) and PYREXIA (Fever went 103 degrees Farenheight). On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful) and VACCINATION SITE ERYTHEMA (Injection site is a bright red mark). On an unknown date, the patient experienced VACCINATION SITE PAIN (Painful). On 29-Mar-2021, PYREXIA (Fever went 103 degrees Farenheight) had resolved. At the time of the report, VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful), VACCINATION SITE ERYTHEMA (Injection site is a bright red mark), VACCINATION SITE PAIN (Painful) and CHILLS (had terrible Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 103 degrees farenheight (High) 103 degrees Farenheight.         Treatment for the events included Prednisone and Antibiotics.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-079925 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm on his injection site arm), PYREXIA (Fever of 101.4 Degrees Farenheight), CHILLS (Chills) and MYALGIA (Muscle aches) in a 19-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 (Np medical history reported.). 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 VACCINATION SITE PAIN (Sore arm on his injection site arm), PYREXIA (Fever of 101.4 Degrees Farenheight), CHILLS (Chills) and MYALGIA (Muscle aches). At the time of the report, VACCINATION SITE PAIN (Sore arm on his injection site arm), PYREXIA (Fever of 101.4 Degrees Farenheight), CHILLS (Chills) and MYALGIA (Muscle aches) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on the right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the right leg) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, POTASSIUM, COLECALCIFEROL (VITAMIN D 3) and CHLORTHALIDONE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on the right leg). At the time of the report, PAIN IN EXTREMITY (pain on the right leg) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol and ibuprofen.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: leg pain; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (leg pain) and BACK PAIN (Back pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 27-Mar-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 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain) and BACK PAIN (Back pain). The patient was treated with TIZANIDINE at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (leg pain) and BACK PAIN (Back pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Many concomitant drugs were used which was not reported. Treatment for the event included prednisone which was substituted by Tizanidine.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in an 88-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.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown. Not Provided          This case was linked to MOD-2021-064163.; Sender's Comments:  MOD-2021-064163:first dose
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I haven't taken my 2nd dose yet because google and some websites and the facility where I got; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I haven't taken my 2nd dose yet because google and some websites and the facility where I got) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I haven't taken my 2nd dose yet because google and some websites and the facility where I got). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I haven't taken my 2nd dose yet because google and some websites and the facility where I got) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased
Clinical narrative: using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93; This spontaneous case was reported by a patient and describes the occurrence of OXYGEN SATURATION DECREASED (using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Arrhythmia and Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93). At the time of the report, OXYGEN SATURATION DECREASED (using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patients due date for second dose was on 02 apr 2021   This case was linked to US-MODERNATX, INC.-MOD-2021-063946 (E2B Linked Report).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (fever) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PYREXIA (fever) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided          Treatment details were not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: The amount was less than 1/2 of the administered dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (The amount was less than 1/2 of the administered dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (The amount was less than 1/2 of the administered dose). At the time of the report, ACCIDENTAL UNDERDOSE (The amount was less than 1/2 of the administered dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported  No treatment information was provided  Action taken with mRNA-1273 was not applicable
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minimal Pain at the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minimal Pain at the Injection Site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Minimal Pain at the Injection Site). On 17-Mar-2021, VACCINATION SITE PAIN (Minimal Pain at the Injection Site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site indentation
Clinical narrative: indentation at the injection site 3 inches long to a quarter inch deep; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDENTATION (indentation at the injection site 3 inches long to a quarter inch deep) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Melanoma in 2016 and Skin neoplasm excision (melanoma removal) in 2016. Concurrent medical conditions included Penicillin allergy, Sumac rash, Drug allergy and Allergy to antibiotic.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE INDENTATION (indentation at the injection site 3 inches long to a quarter inch deep). At the time of the report, INJECTION SITE INDENTATION (indentation at the injection site 3 inches long to a quarter inch deep) had not resolved.            No concomitant medications were reported. Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-MAY-2021 and Patient Race ,ethnic group ,Allergies were updated and  second dose was updated On 25-Jul-2021: Follow-up  received on 25-Jul-2021 and does not contain any new information. Patient reported no change.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Oropharyngeal pain
Clinical narrative: Pain in the bones; A sore throat; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in the bones) and OROPHARYNGEAL PAIN (A sore throat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BONE PAIN (Pain in the bones) and OROPHARYNGEAL PAIN (A sore throat). At the time of the report, BONE PAIN (Pain in the bones) and OROPHARYNGEAL PAIN (A sore throat) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.  The patient has already received both doses and wants to know if she can get the vaccine again in 6 months.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site discomfort
Clinical narrative: dizziness that comes and goes; Vaccination site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Vaccination site discomfort) and DIZZINESS (dizziness that comes and goes) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Vaccination site discomfort). On 25-Mar-2021, the patient experienced DIZZINESS (dizziness that comes and goes). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (Vaccination site discomfort) and DIZZINESS (dizziness that comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter  Treatment information was not provided
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat(Cannot swallow food); Dizziness (Has trouble staying awake); fever(Temperature 101F); nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat(Cannot swallow food)), DIZZINESS (Dizziness (Has trouble staying awake)), PYREXIA (fever(Temperature 101F)) and NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K21A and 047A21A) for COVID-19 vaccination.    Co-suspect product included non-company product HEPATITIS E VACCINE for an unknown indication.    No medical history was reported.  Concomitant products included CARVEDILOL, ROSUVASTATIN, HYDROCORTISONE, OXYCODONE, TIZANIDINE HYDROCHLORIDE (ZANAFLEX), DIAZEPAM (VALIUM), ZOLPIDEM TARTRATE (AMBIEN), CYANOCOBALAMIN (VITAMIN B12 AAA), VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient started HEPATITIS E VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat(Cannot swallow food)), DIZZINESS (Dizziness (Has trouble staying awake)), PYREXIA (fever(Temperature 101F)) and NAUSEA (nausea). At the time of the report, OROPHARYNGEAL PAIN (sore throat(Cannot swallow food)), DIZZINESS (Dizziness (Has trouble staying awake)), PYREXIA (fever(Temperature 101F)) and NAUSEA (nausea) outcome was unknown.            Treatment information was not provided.  On 30 MAR 2021 within 11 days of receiving the COVID-19 second dose). A few hours after receiving the hepatitis vaccine (patient does not know whether it was hepatitis B or Hepatitis A vaccine) experienced the events.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: Breast-Feeding; Pain in the arm of the injection; Shortness of breath; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm of the injection), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breast-Feeding) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breast-Feeding). At the time of the report, PAIN IN EXTREMITY (Pain in the arm of the injection) and DYSPNOEA (Shortness of breath) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (Breast-Feeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment details were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Pain, Pain in extremity, Pyrexia
Clinical narrative: 4 days later, she fell and hurt herself; she had a big bruise on right leg; She had open cut on her right leg; term 4 days later, she fell and hurt herself; She had a sore arm after receiving 2nd dose; She had little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg), PAIN (term 4 days later, she fell and hurt herself) and PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) and PYREXIA (She had little fever). On 14-Mar-2021, the patient experienced FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg) and PAIN (term 4 days later, she fell and hurt herself). At the time of the report, FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg), PAIN (term 4 days later, she fell and hurt herself), PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) and PYREXIA (She had little fever) outcome was unknown.            No concomitant medication reported   No treatment medication reported  Action taken with mRNA-1273 was not applicable