chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vomiting
Clinical narrative: started itching; 3" X 1" rash over the injection site; still feels sore; exhausted, and stayed in bed; started feeling nauseous; vomiting; feeling weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling weird), VACCINATION SITE PRURITUS (started itching), NAUSEA (started feeling nauseous), VOMITING (vomiting) and VACCINATION SITE RASH (3" X 1" rash over the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced FEELING ABNORMAL (feeling weird), NAUSEA (started feeling nauseous) and VOMITING (vomiting). On 06-Mar-2021, the patient experienced FATIGUE (exhausted, and stayed in bed). On 07-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (started itching), VACCINATION SITE RASH (3" X 1" rash over the injection site) and VACCINATION SITE PAIN (still feels sore). On 05-Mar-2021, NAUSEA (started feeling nauseous) and VOMITING (vomiting) had resolved. On 07-Mar-2021, FATIGUE (exhausted, and stayed in bed) had resolved. At the time of the report, FEELING ABNORMAL (feeling weird), VACCINATION SITE PRURITUS (started itching) and VACCINATION SITE RASH (3" X 1" rash over the injection site) outcome was unknown and VACCINATION SITE PAIN (still feels sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication details were provided. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: dizziness; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). The patient was treated with RIZATRIPTAN BENZOATE (MAXALT) at a dose of 1 dosage form; MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) at a dose of 1 dosage form; MECLIZINE [MECLOZINE] at a dose of 1 dosage form and BENZYL BENZOATE at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter declined consent for further follow up
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: I'm a little concerned that it was given subcutaneously; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I'm a little concerned that it was given subcutaneously) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I'm a little concerned that it was given subcutaneously). On 18-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I'm a little concerned that it was given subcutaneously) had resolved. 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.   No relevant concomitant medications are provided. No treatment information was provided.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, with no associated AEs.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Lip dry, Paraesthesia, Vaccination site pain
Clinical narrative: dry lips; Intense pain on injection site; Elevated temperature (100.5F); Wriggling sensation on face; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (dry lips), VACCINATION SITE PAIN (Intense pain on injection site), BODY TEMPERATURE INCREASED (Elevated temperature (100.5F)) and PARAESTHESIA (Wriggling sensation on face) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030MZ0ALLD073121 and 036ALIN) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 31-Mar-2021, the patient experienced LIP DRY (dry lips), BODY TEMPERATURE INCREASED (Elevated temperature (100.5F)) and PARAESTHESIA (Wriggling sensation on face). 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Intense pain on injection site). At the time of the report, LIP DRY (dry lips), VACCINATION SITE PAIN (Intense pain on injection site), BODY TEMPERATURE INCREASED (Elevated temperature (100.5F)) and PARAESTHESIA (Wriggling sensation on face) outcome was unknown. Not Provided
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 3 x 3 inch circular, raised rash; 3 x 3 inch circular, raised, red rash; 3 x 3 inch circular, raised, itchy rash; 3 x 3 inch circular, raised, hot rash; Headache after receiving first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PAPULAR (3 x 3 inch circular, raised rash), RASH ERYTHEMATOUS (3 x 3 inch circular, raised, red rash), RASH PRURITIC (3 x 3 inch circular, raised, itchy rash), RASH (3 x 3 inch circular, raised, hot rash) and HEADACHE (Headache after receiving first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013N20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 1985. Concomitant products included CARVEDILOL, ATORVASTATIN, LISINOPRIL, FAMOTIDINE and TAMSULOSIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache after receiving first dose). On 17-Mar-2021, the patient experienced RASH PAPULAR (3 x 3 inch circular, raised rash), RASH ERYTHEMATOUS (3 x 3 inch circular, raised, red rash), RASH PRURITIC (3 x 3 inch circular, raised, itchy rash) and RASH (3 x 3 inch circular, raised, hot rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Mar-2021, HEADACHE (Headache after receiving first dose) had resolved. On 26-Mar-2021, RASH PAPULAR (3 x 3 inch circular, raised rash), RASH ERYTHEMATOUS (3 x 3 inch circular, raised, red rash), RASH PRURITIC (3 x 3 inch circular, raised, itchy rash) and RASH (3 x 3 inch circular, raised, hot rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient visited doctor's office/urgent care visit due to the events Patient stated that the events were most likely caused by mRNA-1273. There were no other potential causes for the events. Patient had not experienced similar events in the past.   This case was linked to MOD-2021-064565 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up report included updates on patient demographics, race, concomitant medications, historical condition and outcome of events.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Gingival pain, Lymphadenopathy
Clinical narrative: pain in gums/teeth right side only; right side ear aches; Swollen glands in right side of neck; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (pain in gums/teeth right side only), EAR PAIN (right side ear aches) and LYMPHADENOPATHY (Swollen glands in right side of neck) in a 75-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 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced GINGIVAL PAIN (pain in gums/teeth right side only), EAR PAIN (right side ear aches) and LYMPHADENOPATHY (Swollen glands in right side of neck). At the time of the report, GINGIVAL PAIN (pain in gums/teeth right side only), EAR PAIN (right side ear aches) and LYMPHADENOPATHY (Swollen glands in right side of neck) outcome was unknown.            No concomitant products and treatment medication were provided by reporter.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Neck pain, Pain, Pyrexia
Clinical narrative: neck hurt in the side of the injection (left) to the top of the head, on her ea; still on a lot pain / Achy; run a low grade fever; Saturday afternoon started just feeling bad; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NECK PAIN (neck hurt in the side of the injection (left) to the top of the head, on her ea), FEELING ABNORMAL (Saturday afternoon started just feeling bad), PAIN (still on a lot pain / Achy) and PYREXIA (run a low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (Saturday afternoon started just feeling bad). On 28-Mar-2021, the patient experienced NECK PAIN (neck hurt in the side of the injection (left) to the top of the head, on her ea), PAIN (still on a lot pain / Achy) and PYREXIA (run a low grade fever). At the time of the report, NECK PAIN (neck hurt in the side of the injection (left) to the top of the head, on her ea), FEELING ABNORMAL (Saturday afternoon started just feeling bad), PAIN (still on a lot pain / Achy) and PYREXIA (run a low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications:- 1 pill a day for diabetes
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Nausea, Vomiting
Clinical narrative: Deathly sick; Diarrhea; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Deathly sick), DIARRHEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ILLNESS (Deathly sick), DIARRHEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, ILLNESS (Deathly sick), DIARRHEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment were 7-Up, water, iced tea and applesauce.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-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 an unknown date, the patient experienced RASH (rash on the arm). The patient was treated with CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (rash on the arm) outcome was unknown. Not Provided          No concomitant  medications were provided   This case was linked to INC.-MOD-2021-015612 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: INC.-MOD-2021-015612:First dose vaccination
Sex: M
Vaccine: COVID19
Symptoms: Animal bite, Tetanus immunisation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANIMAL BITE (dog bite) and TETANUS IMMUNISATION (tetanus shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ANIMAL BITE (dog bite) and TETANUS IMMUNISATION (tetanus shot). At the time of the report, ANIMAL BITE (dog bite) and TETANUS IMMUNISATION (tetanus shot) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication details were provided. No treatment medication details were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: PREGNANT; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (PREGNANT) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VALACICLOVIR HYDROCHLORIDE (VALTREX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jul-2020 and the estimated date of delivery was 14-Apr-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (PREGNANT). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-eighth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (PREGNANT) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Allergy shots are listed in concomitant drugs.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MYALGIA, FATIGUE, and HEADACHE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA, FATIGUE, and HEADACHE. At the time of the report, MYALGIA, FATIGUE, and HEADACHE outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he might get tested for COVID19. No concomitant and treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (head cold) and illness (sickness) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 19, 2021, patient experienced nasopharyngitis (head cold) and illness (sickness). At the time of the report, nasopharyngitis (head cold) and illness (sickness) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient was sick with a head cold for the last 8 days. Treatment information unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Pregnant at time of vaccine administration; Soreness in the injection arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at time of vaccine administration) and VACCINATION SITE PAIN (Soreness in the injection arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Nov-2020 and the estimated date of delivery was 21-Aug-2021. On 26-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at time of vaccine administration) and VACCINATION SITE PAIN (Soreness in the injection arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at time of vaccine administration) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast swelling, Dry throat, Fatigue, Lymphadenopathy
Clinical narrative: Swelling under left arm pit and breast area; Swelling under left arm pit and breast area; Slight Fever (Low grade); Tiredness; Dry throat; Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips; Skin warm; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), BREAST SWELLING (Swelling under left arm pit and breast area) and PYREXIA (Slight Fever (Low grade)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herpes NOS.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), PYREXIA (Slight Fever (Low grade)) and FATIGUE (Tiredness). On an unknown date, the patient experienced BREAST SWELLING (Swelling under left arm pit and breast area) and LYMPHADENOPATHY (Swelling under left arm pit and breast area). On 30-Mar-2021, DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), PYREXIA (Slight Fever (Low grade)) and FATIGUE (Tiredness) had resolved. At the time of the report, BREAST SWELLING (Swelling under left arm pit and breast area) and LYMPHADENOPATHY (Swelling under left arm pit and breast area) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: low grade fever (High) low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY 2021 contain new events(Lymphadenopathy) and (Breast swelling). Out come of all the events has been updated to recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, Skin warm
Clinical narrative: Swelling under left arm pit and breast area; Swelling under left arm pit and breast area; Slight Fever (Low grade); Tiredness; Dry throat; Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips; Skin warm; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), BREAST SWELLING (Swelling under left arm pit and breast area) and PYREXIA (Slight Fever (Low grade)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herpes NOS.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), PYREXIA (Slight Fever (Low grade)) and FATIGUE (Tiredness). On an unknown date, the patient experienced BREAST SWELLING (Swelling under left arm pit and breast area) and LYMPHADENOPATHY (Swelling under left arm pit and breast area). On 30-Mar-2021, DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), PYREXIA (Slight Fever (Low grade)) and FATIGUE (Tiredness) had resolved. At the time of the report, BREAST SWELLING (Swelling under left arm pit and breast area) and LYMPHADENOPATHY (Swelling under left arm pit and breast area) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: low grade fever (High) low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY 2021 contain new events(Lymphadenopathy) and (Breast swelling). Out come of all the events has been updated to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia
Clinical narrative: numbness on her left side of her face on and off.; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on her left side of her face on and off.), HEADACHE (Headache) and CHILLS (Chills) 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 27-Mar-2021, 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) and CHILLS (Chills). On 30-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on her left side of her face on and off.). At the time of the report, HYPOAESTHESIA (numbness on her left side of her face on and off.) outcome was unknown and HEADACHE (Headache) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy.   No concomitant medication was reported.  Treatment information was unknown.  she was 26 weeks and 6 days pregnant when she received the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Oral herpes
Clinical narrative: Cold sores; Lips were swollen/Swelling lips; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of ORAL HERPES (Cold sores) and LIP SWELLING (Lips were swollen/Swelling lips) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Cold sores) and LIP SWELLING (Lips were swollen/Swelling lips). The patient was treated with PREDNISONE for Swelling lips, at a dose of Unknown. At the time of the report, ORAL HERPES (Cold sores) and LIP SWELLING (Lips were swollen/Swelling lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Prednisone shot was given by allergist.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow-up was received and contains no new information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Rash, Stomatitis
Clinical narrative: Sore on the roof of mouth after 1st dose; No energy after 1st dose; Rash on the top of mouth after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Sore on the roof of mouth after 1st dose), ASTHENIA (No energy after 1st dose) and RASH (Rash on the top of mouth after 1st dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] 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 STOMATITIS (Sore on the roof of mouth after 1st dose), ASTHENIA (No energy after 1st dose) and RASH (Rash on the top of mouth after 1st dose). At the time of the report, STOMATITIS (Sore on the roof of mouth after 1st dose), ASTHENIA (No energy after 1st dose) and RASH (Rash on the top of mouth after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.   Patient noticed a sore on the roof of her mouth. She said she could feel it with her tongue. She says that now she can see it and it looks like a rash on the top of her mouth. She says it is a darker red color. She says it is sore and feels like when you burn the roof of your mouth. She also says that she still doesn't have any energy.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills). On 05-Mar-2021, the patient experienced HEADACHE (Headache). On 22-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip), CHILLS (Chills) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-067006.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills). On 05-Mar-2021, the patient experienced HEADACHE (Headache). On 22-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip), CHILLS (Chills) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-067006.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash, Rash macular
Clinical narrative: injection site blotches; injection site rash; injection site itch; injection site redness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (injection site blotches), RASH (injection site rash), PRURITUS (injection site itch), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH MACULAR (injection site blotches), RASH (injection site rash), PRURITUS (injection site itch), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site pain). On 29-Mar-2021, RASH MACULAR (injection site blotches) outcome was unknown and RASH (injection site rash), PRURITUS (injection site itch), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) 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 (No medical history reported).    On 14-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 HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) 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. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-064545 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. MOD-2021-064545:Son
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site rash
Clinical narrative: pain; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-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 RASH (injection site rash). On an unknown date, the patient experienced PAIN (pain). At the time of the report, VACCINATION SITE RASH (injection site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Received.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Dizziness, Fatigue
Clinical narrative: weak; unable to stand upright; dizzy; sweaty from the process of vomiting; nauseous; vomited; low-grade fever; headache; chills; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (tiredness), CHILLS (chills) and PYREXIA (fever). On 27-Mar-2021, the patient experienced ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting), NAUSEA (nauseous), VOMITING (vomited), PYREXIA (low-grade fever) and HEADACHE (headache). On 27-Mar-2021, ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting), FATIGUE (tiredness), NAUSEA (nauseous), VOMITING (vomited), CHILLS (chills), PYREXIA (fever), PYREXIA (low-grade fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was taken. no treatment medication was taken.   This case was linked to US-MODERNATX, INC.-MOD-2021-132333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132333:Dose 1
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia, Vomiting
Clinical narrative: weak; unable to stand upright; dizzy; sweaty from the process of vomiting; nauseous; vomited; low-grade fever; headache; chills; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (tiredness), CHILLS (chills) and PYREXIA (fever). On 27-Mar-2021, the patient experienced ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting), NAUSEA (nauseous), VOMITING (vomited), PYREXIA (low-grade fever) and HEADACHE (headache). On 27-Mar-2021, ASTHENIA (weak), BALANCE DISORDER (unable to stand upright), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty from the process of vomiting), FATIGUE (tiredness), NAUSEA (nauseous), VOMITING (vomited), CHILLS (chills), PYREXIA (fever), PYREXIA (low-grade fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was taken. no treatment medication was taken.   This case was linked to US-MODERNATX, INC.-MOD-2021-132333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132333:Dose 1
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Burning sensation, Chest discomfort, Decreased appetite
Clinical narrative: Hardness at arm of injection; Blood pressure went high again; Warm at arm of injection and feels the heat goes though her body; No appetite; Body burning, like heat inside body; Turned black my knuckles in my hand; Unpleasant feeling in chest area; Doctor says it is anxiety; Fatigue, couldn't get out of couch; Pain at injection site; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite) and BURNING SENSATION (Body burning, like heat inside body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Controlled).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite), BURNING SENSATION (Body burning, like heat inside body), KNUCKLE PADS (Turned black my knuckles in my hand), CHEST DISCOMFORT (Unpleasant feeling in chest area), ANXIETY (Doctor says it is anxiety), FATIGUE (Fatigue, couldn't get out of couch), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache). The patient was treated with LOSARTAN for Blood pressure high, at a dose of 25 mg, 2 pills at night; METOPROLOL SUCCINATE for Blood pressure high, at a dose of 25 mg once a day; ESCITALOPRAM OXALATE (LEXAPRO) at a dose of 10 UNK and SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression and Anxiety, at an unspecified dose and frequency. At the time of the report, INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite), BURNING SENSATION (Body burning, like heat inside body), KNUCKLE PADS (Turned black my knuckles in my hand), CHEST DISCOMFORT (Unpleasant feeling in chest area), ANXIETY (Doctor says it is anxiety), FATIGUE (Fatigue, couldn't get out of couch), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Induration, Knuckle pads, Vaccination site pain
Clinical narrative: Hardness at arm of injection; Blood pressure went high again; Warm at arm of injection and feels the heat goes though her body; No appetite; Body burning, like heat inside body; Turned black my knuckles in my hand; Unpleasant feeling in chest area; Doctor says it is anxiety; Fatigue, couldn't get out of couch; Pain at injection site; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite) and BURNING SENSATION (Body burning, like heat inside body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Controlled).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite), BURNING SENSATION (Body burning, like heat inside body), KNUCKLE PADS (Turned black my knuckles in my hand), CHEST DISCOMFORT (Unpleasant feeling in chest area), ANXIETY (Doctor says it is anxiety), FATIGUE (Fatigue, couldn't get out of couch), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache). The patient was treated with LOSARTAN for Blood pressure high, at a dose of 25 mg, 2 pills at night; METOPROLOL SUCCINATE for Blood pressure high, at a dose of 25 mg once a day; ESCITALOPRAM OXALATE (LEXAPRO) at a dose of 10 UNK and SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression and Anxiety, at an unspecified dose and frequency. At the time of the report, INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite), BURNING SENSATION (Body burning, like heat inside body), KNUCKLE PADS (Turned black my knuckles in my hand), CHEST DISCOMFORT (Unpleasant feeling in chest area), ANXIETY (Doctor says it is anxiety), FATIGUE (Fatigue, couldn't get out of couch), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.