chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Eye swelling, Headache
Clinical narrative: Tightness of the chest; Tightness of throat; headache; red bump and itching; rash in the right arm; Joint pain; Nausea; allergic reaction of the face; painful arm; Difficulty breathing; top lip swollen; Eye swelling; Swelling in the left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face) and CHEST DISCOMFORT (Tightness of the chest) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Shellfish allergy, Seafood allergy, Penicillin allergy, Drug allergy (codeine, aspirin) and Diabetes. Concomitant products included GLIMEPIRIDE, ATORVASTATIN and DULOXETINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face), HYPERSENSITIVITY (allergic reaction of the face) and PAIN IN EXTREMITY (painful arm). On 18-Apr-2021, the patient experienced RASH PRURITIC (red bump and itching), RASH (rash in the right arm), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 19-Apr-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced CHEST DISCOMFORT (Tightness of the chest) and THROAT TIGHTNESS (Tightness of throat). At the time of the report, DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face), CHEST DISCOMFORT (Tightness of the chest), THROAT TIGHTNESS (Tightness of throat), HYPERSENSITIVITY (allergic reaction of the face), PAIN IN EXTREMITY (painful arm), RASH PRURITIC (red bump and itching), RASH (rash in the right arm), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol and Benadryl.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Nausea, Pain in extremity, Rash
Clinical narrative: Tightness of the chest; Tightness of throat; headache; red bump and itching; rash in the right arm; Joint pain; Nausea; allergic reaction of the face; painful arm; Difficulty breathing; top lip swollen; Eye swelling; Swelling in the left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face) and CHEST DISCOMFORT (Tightness of the chest) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Shellfish allergy, Seafood allergy, Penicillin allergy, Drug allergy (codeine, aspirin) and Diabetes. Concomitant products included GLIMEPIRIDE, ATORVASTATIN and DULOXETINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face), HYPERSENSITIVITY (allergic reaction of the face) and PAIN IN EXTREMITY (painful arm). On 18-Apr-2021, the patient experienced RASH PRURITIC (red bump and itching), RASH (rash in the right arm), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 19-Apr-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced CHEST DISCOMFORT (Tightness of the chest) and THROAT TIGHTNESS (Tightness of throat). At the time of the report, DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face), CHEST DISCOMFORT (Tightness of the chest), THROAT TIGHTNESS (Tightness of throat), HYPERSENSITIVITY (allergic reaction of the face), PAIN IN EXTREMITY (painful arm), RASH PRURITIC (red bump and itching), RASH (rash in the right arm), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol and Benadryl.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling face, Throat tightness
Clinical narrative: Tightness of the chest; Tightness of throat; headache; red bump and itching; rash in the right arm; Joint pain; Nausea; allergic reaction of the face; painful arm; Difficulty breathing; top lip swollen; Eye swelling; Swelling in the left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face) and CHEST DISCOMFORT (Tightness of the chest) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Shellfish allergy, Seafood allergy, Penicillin allergy, Drug allergy (codeine, aspirin) and Diabetes. Concomitant products included GLIMEPIRIDE, ATORVASTATIN and DULOXETINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face), HYPERSENSITIVITY (allergic reaction of the face) and PAIN IN EXTREMITY (painful arm). On 18-Apr-2021, the patient experienced RASH PRURITIC (red bump and itching), RASH (rash in the right arm), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 19-Apr-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced CHEST DISCOMFORT (Tightness of the chest) and THROAT TIGHTNESS (Tightness of throat). At the time of the report, DYSPNOEA (Difficulty breathing), LIP SWELLING (top lip swollen), SWELLING (Swelling in the left eye), SWELLING FACE (Swelling in the left side of the face), CHEST DISCOMFORT (Tightness of the chest), THROAT TIGHTNESS (Tightness of throat), HYPERSENSITIVITY (allergic reaction of the face), PAIN IN EXTREMITY (painful arm), RASH PRURITIC (red bump and itching), RASH (rash in the right arm), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol and Benadryl.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dehydration, Migraine
Clinical narrative: experienced migraines for 14 days straight; blood pressure also went up for about 5 days; really dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (experienced migraines for 14 days straight), BLOOD PRESSURE INCREASED (blood pressure also went up for about 5 days) and DEHYDRATION (really dehydrated) in a 50-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product exposures included HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 27-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with MIGRAINE (experienced migraines for 14 days straight), BLOOD PRESSURE INCREASED (blood pressure also went up for about 5 days) and DEHYDRATION (really dehydrated). The adult was treated with LISINOPRIL for Hypertension, at an unspecified dose and frequency. At the time of the report, MIGRAINE (experienced migraines for 14 days straight), BLOOD PRESSURE INCREASED (blood pressure also went up for about 5 days) and DEHYDRATION (really dehydrated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lisinopril dose was increased from 10 mg to 40 mg.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site rash
Clinical narrative: Slight numbness of her arms, legs, face and hands; Injection site itchy; Injection site rash; Injection site red; Injection site swollen; Injection site painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site swollen) in a 51-year-old female 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 No adverse event (Historical condition not reported.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site painful). At the time of the report, HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported Treatment drugs were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-080174 (E2B Linked Report).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Slight numbness of her arms, legs, face and hands; Injection site itchy; Injection site rash; Injection site red; Injection site swollen; Injection site painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site swollen) in a 51-year-old female 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 No adverse event (Historical condition not reported.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site painful). At the time of the report, HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported Treatment drugs were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-080174 (E2B Linked Report).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Red rash on the back, chest, elbow, and forearm; temperature of 101,3°F; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash on the back, chest, elbow, and forearm) and PYREXIA (temperature of 101,3°F) in a 45-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.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on the back, chest, elbow, and forearm) and PYREXIA (temperature of 101,3°F). On 17-Apr-2021, PYREXIA (temperature of 101,3°F) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red rash on the back, chest, elbow, and forearm) had resolved. 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Panel-reactive antibody
Clinical narrative: Autoimmune panel came back as positive; Chronic headache (daily head pressure and pain); This spontaneous case was reported by a consumer and describes the occurrence of PANEL-REACTIVE ANTIBODY (Autoimmune panel came back as positive) and HEADACHE (Chronic headache (daily head pressure and pain)) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANEL-REACTIVE ANTIBODY (Autoimmune panel came back as positive) and HEADACHE (Chronic headache (daily head pressure and pain)). At the time of the report, PANEL-REACTIVE ANTIBODY (Autoimmune panel came back as positive) and HEADACHE (Chronic headache (daily head pressure and pain)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.   This case was linked to MOD21-078107, MOD-2021-015967, INC.-MOD-2021-080106 (E2B Linked Report).; Sender's Comments:  MOD21-078107: MOD-2021-015967:MOD21-033662INC.-MOD-2021-080106:MOD21-078196
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Nausea, Rash
Clinical narrative: Broke out holiday weekend; Rash; Nauseated for about 1-2 days after 1st shot/Nauseated holiday weekend; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Broke out holiday weekend), RASH (Rash) and NAUSEA (Nauseated for about 1-2 days after 1st shot/Nauseated holiday weekend) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus-like syndrome.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Broke out holiday weekend), RASH (Rash) and NAUSEA (Nauseated for about 1-2 days after 1st shot/Nauseated holiday weekend). At the time of the report, ADVERSE DRUG REACTION (Broke out holiday weekend), RASH (Rash) and NAUSEA (Nauseated for about 1-2 days after 1st shot/Nauseated holiday weekend) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Reporter details were reported On 20-Jul-2021: Follow-up received on 21-JUL-2021 and contains non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080222:FIRST DOSE CASE
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: big knot on arm at the injection site; hot to the touch; hard knot; bumpy red rash; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (big knot on arm at the injection site), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE INDURATION (hard knot), VACCINATION SITE RASH (bumpy red rash) and VACCINATION SITE SWELLING (swollen) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE MASS (big knot on arm at the injection site), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE INDURATION (hard knot), VACCINATION SITE RASH (bumpy red rash) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE MASS (big knot on arm at the injection site), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE INDURATION (hard knot), VACCINATION SITE RASH (bumpy red rash) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided. Patient treated symptoms with ice pack.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: soreness spread to wrist and across back to other arm; "muscle in leg is real sore"; soreness spread to wrist and across back to other arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA ("muscle in leg is real sore"), ARTHRALGIA (soreness spread to wrist and across back to other arm) and BACK PAIN (soreness spread to wrist and across back to other arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID (CHEMO C) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (soreness spread to wrist and across back to other arm). On 19-Apr-2021, the patient experienced MYALGIA ("muscle in leg is real sore"). On an unknown date, the patient experienced BACK PAIN (soreness spread to wrist and across back to other arm). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA ("muscle in leg is real sore"), ARTHRALGIA (soreness spread to wrist and across back to other arm) and BACK PAIN (soreness spread to wrist and across back to other arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Hydrocodone 7.5mg as treatment medication for other pains.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Hypoaesthesia, Nausea
Clinical narrative: numbness of the hand; side effects; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness of the hand), ADVERSE REACTION (side effects) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness of the hand), ADVERSE REACTION (side effects) and NAUSEA (nausea). At the time of the report, HYPOAESTHESIA (numbness of the hand), ADVERSE REACTION (side effects) and NAUSEA (nausea) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nasopharyngitis
Clinical narrative: cold; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, NASOPHARYNGITIS (cold), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            no concomitant medications reported. no treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-080289 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080289:second dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Cough, Headache, Lacrimation increased
Clinical narrative: a lot of tears in her eyes and couldn't see well; a lot of coughing, an uncontrollable cough; breast starts to hurt a lot; a little pain in the front of the body from the shoulder down; pain in the top / back of the head; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well), COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot) and CHEST PAIN (a little pain in the front of the body from the shoulder down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (Patient received the flu vaccine one month before Moderna's). Concurrent medical conditions included Allergy to topical drugs, Drug allergy and Drug allergy. Concomitant products included VITAMIN D NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 08-Apr-2021, the patient experienced LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well). In April 2021, the patient experienced COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot), CHEST PAIN (a little pain in the front of the body from the shoulder down) and HEADACHE (pain in the top / back of the head). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well), COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot), CHEST PAIN (a little pain in the front of the body from the shoulder down) and HEADACHE (pain in the top / back of the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included high blood pressure medication and cholesterol medication.  No treatment information provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: a lot of tears in her eyes and couldn't see well; a lot of coughing, an uncontrollable cough; breast starts to hurt a lot; a little pain in the front of the body from the shoulder down; pain in the top / back of the head; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well), COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot) and CHEST PAIN (a little pain in the front of the body from the shoulder down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (Patient received the flu vaccine one month before Moderna's). Concurrent medical conditions included Allergy to topical drugs, Drug allergy and Drug allergy. Concomitant products included VITAMIN D NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 08-Apr-2021, the patient experienced LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well). In April 2021, the patient experienced COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot), CHEST PAIN (a little pain in the front of the body from the shoulder down) and HEADACHE (pain in the top / back of the head). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well), COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot), CHEST PAIN (a little pain in the front of the body from the shoulder down) and HEADACHE (pain in the top / back of the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included high blood pressure medication and cholesterol medication.  No treatment information provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeding disorder, Myalgia, Nausea, Pain in extremity
Clinical narrative: cant eat anything; Aching in legs; Lack of appetite; Nauseous; intermittent achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching in legs), DECREASED APPETITE (Lack of appetite), FEEDING DISORDER (cant eat anything), MYALGIA (intermittent achy) and NAUSEA (Nauseous) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (intermittent achy). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Aching in legs), DECREASED APPETITE (Lack of appetite) and NAUSEA (Nauseous). On an unknown date, the patient experienced FEEDING DISORDER (cant eat anything). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Aching in legs), DECREASED APPETITE (Lack of appetite), FEEDING DISORDER (cant eat anything), MYALGIA (intermittent achy) and NAUSEA (Nauseous) had not resolved.            The consumer is taking Tylenol, ibuprofen, OTC cold and flu to try to alleviate the symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-080199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080199:1st dose events
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: tons of muscle aches/tons of body aches; achy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), NAUSEA (nauseous) and MYALGIA (tons of muscle aches/tons of body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Apr-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 16-Apr-2021, the patient experienced MYALGIA (achy) and NAUSEA (nauseous). On 19-Apr-2021, the patient experienced MYALGIA (tons of muscle aches/tons of body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 16-Apr-2021, MYALGIA (achy) had resolved, NAUSEA (nauseous) outcome was unknown. At the time of the report, MYALGIA (tons of muscle aches/tons of body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Palpitations, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of pyrexia (fever), palpitation(s), fatigue, influenza-like illness (flu-like symptoms) and chills in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 02UA21A) for COVID-19 immunization. The occurrence of additional events detailed below. Co-suspect product included Tylenol (paracetamol) for an unknown indication. The patient's past medical history included no adverse event. On Mar 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form and Tylenol (paracetamol), unknown route; 1 dosage form. On Mar 26, 2021, patient experienced pyrexia (fever), palpitation(s), fatigue (feeling tired), influenza-like illness (flu-like symptoms) and chills. At the time of the report, pyrexia (fever), palpitation(s), fatigue (feeling tired), influenza-like illness (flu-like symptoms) and chills outcome: unknown/not provided. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 46 days later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 46 days later) 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 04-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 46 days later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 46 days later) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details was not reported by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red rash at injection site; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-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 ERYTHEMA (Red rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full rash from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full rash from head to toe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus systemic.   On 13-Apr-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 an unknown date, the patient experienced RASH (Full rash from head to toe). At the time of the report, RASH (Full rash from head to toe) outcome was unknown. Not Provided          Rash started after the first dose and developed full rash from head to toe after the second dose  Action taken with mRNA1273 Moderna vaccine was Not Applicable    This case was linked to MOD-2021-080207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080207:FIRST DOSE CASE
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria, Vaccination complication
Clinical narrative: red bumps on both legs and on ear; itchy; welts; felt a little bit sickly like he was fighting a bug; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red bumps on both legs and on ear), PRURITUS (itchy), VACCINATION COMPLICATION (felt a little bit sickly like he was fighting a bug) and URTICARIA (welts) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red bumps on both legs and on ear), PRURITUS (itchy), VACCINATION COMPLICATION (felt a little bit sickly like he was fighting a bug) and URTICARIA (welts). At the time of the report, RASH ERYTHEMATOUS (red bumps on both legs and on ear), PRURITUS (itchy), VACCINATION COMPLICATION (felt a little bit sickly like he was fighting a bug) and URTICARIA (welts) had resolved. Not Provided          No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant FU: New events added and outcome updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021)) 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 10-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 PRODUCT DOSE OMISSION ISSUE (1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021)) outcome was unknown. Not Provided      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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) had resolved. Not Provided Event Stop date: ??-???-2021      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported. patient doesn't want to go for second shot ,he wants to know how effective is a single dose of moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: 2nd dose was out of the temperature requirements; asked her to come again for the dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2nd dose was out of the temperature requirements) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (asked her to come again for the 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 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2nd dose was out of the temperature requirements) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (asked her to come again for the dose). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (2nd dose was out of the temperature requirements) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (asked her to come again for the dose) had resolved.            No concomitant drugs and treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Tenderness, Vaccination site erythema, Vaccination site induration
Clinical narrative: swollen arm; red; hot; hard; tenderness; sore; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and TENDERNESS (tenderness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), TENDERNESS (tenderness), VACCINATION SITE PAIN (sore) and HEADACHE (headaches). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), TENDERNESS (tenderness), VACCINATION SITE PAIN (sore) and HEADACHE (headaches) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: swollen arm; red; hot; hard; tenderness; sore; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and TENDERNESS (tenderness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), TENDERNESS (tenderness), VACCINATION SITE PAIN (sore) and HEADACHE (headaches). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), TENDERNESS (tenderness), VACCINATION SITE PAIN (sore) and HEADACHE (headaches) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs used. Patient will refer to HCP to find out whether she can take aspirin or tylenol after the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, Rhinorrhoea, SARS-CoV-2 antibody test
Clinical narrative: Running Nose; Cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running Nose), COUGH (Cough) and PAIN (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) 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. On an unknown date, the patient experienced RHINORRHOEA (Running Nose), COUGH (Cough) and PAIN (Body aches). At the time of the report, RHINORRHOEA (Running Nose), COUGH (Cough) and PAIN (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pain in extremity, Swelling
Clinical narrative: patient is feeling like someone punched her arm; feels like its a big bruise; 3x2inch patch of deep red skin; little bump underneath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient is feeling like someone punched her arm), CONTUSION (feels like its a big bruise), ERYTHEMA (3x2inch patch of deep red skin) and SWELLING (little bump underneath) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC (TRESIBA), GLIMEPIRIDE, BUMETANIDE, VENLAFAXINE, MONTELUKAST, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), CARVEDILOL, LEVOTHYROXINE, LORATADINE, FAMOTIDINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (patient is feeling like someone punched her arm), CONTUSION (feels like its a big bruise), ERYTHEMA (3x2inch patch of deep red skin) and SWELLING (little bump underneath). At the time of the report, PAIN IN EXTREMITY (patient is feeling like someone punched her arm), CONTUSION (feels like its a big bruise), ERYTHEMA (3x2inch patch of deep red skin) and SWELLING (little bump underneath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that it doesn't seem like they gave it to her in the upper should (deltoid) they gave it in the middle of her arm near the elbow. No treatment medications were provided.