chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses given with punctured vial beyond 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given with punctured vial beyond 12 hours) 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-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given with punctured vial beyond 12 hours). On 04-May-2021, EXPIRED PRODUCT ADMINISTERED (Doses given with punctured vial beyond 12 hours) 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.   Concomitant medication was not reported by reporter  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: fallow up received on 10-jun-2021 contains No New Information
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: headache after the first vaccine; severe joint pain after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after the first vaccine) and ARTHRALGIA (severe joint pain after the first vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache after the first vaccine) and ARTHRALGIA (severe joint pain after the first vaccine). At the time of the report, HEADACHE (headache after the first vaccine) and ARTHRALGIA (severe joint pain after the first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114551:dose 2
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Taste disorder
Clinical narrative: awful taste in her mouth; pain in both arms; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (awful taste in her mouth) and PAIN IN EXTREMITY (pain in both arms) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced TASTE DISORDER (awful taste in her mouth) and PAIN IN EXTREMITY (pain in both arms). At the time of the report, TASTE DISORDER (awful taste in her mouth) and PAIN IN EXTREMITY (pain in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Sore arm at the injection site after first dose; Chills after first dose; Felt little tired after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site after first dose), CHILLS (Chills after first dose) and FATIGUE (Felt little tired after first dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site after first dose), CHILLS (Chills after first dose) and FATIGUE (Felt little tired after first dose). On 24-Mar-2021, VACCINATION SITE PAIN (Sore arm at the injection site after first dose), CHILLS (Chills after first dose) and FATIGUE (Felt little tired after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported.   This case was linked to MOD-2021-114616 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vomiting
Clinical narrative: picky about eating,; pain is going around stomach; pain is going around ribs; Pain is going around her torso, back, ribs, stomach, really painful;; she feels nauseated; pain is going around torso; if she moves too fast, feels like she is going to pass out; really bad indigestion; really severe muscle spasms around stomach to back,cycling muscle spasm; keeps feeling like going to throw up; Headache; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (if she moves too fast, feels like she is going to pass out), ABDOMINAL DISCOMFORT (upset stomach), DYSPEPSIA (really bad indigestion), DECREASED APPETITE (picky about eating,) and ABDOMINAL PAIN UPPER (pain is going around stomach) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tramadol) and Cancer. Concomitant products included ANASTROZOLE (ANASTRAZOLE DENK), METOPROLOL TARTRATE (METAPRO [METOPROLOL TARTRATE]), MENAQUINONE-7 (VITAMIN K 2) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (Headache). On 05-May-2021, the patient experienced DYSPEPSIA (really bad indigestion), MUSCLE SPASMS (really severe muscle spasms around stomach to back,cycling muscle spasm) and VOMITING (keeps feeling like going to throw up). On 06-May-2021, the patient experienced PRESYNCOPE (if she moves too fast, feels like she is going to pass out), ABDOMINAL PAIN UPPER (pain is going around stomach), MUSCULOSKELETAL CHEST PAIN (pain is going around ribs), BACK PAIN (Pain is going around her torso, back, ribs, stomach, really painful;), NAUSEA (she feels nauseated) and MYALGIA (pain is going around torso). On an unknown date, the patient experienced DECREASED APPETITE (picky about eating,). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (if she moves too fast, feels like she is going to pass out), ABDOMINAL DISCOMFORT (upset stomach), DYSPEPSIA (really bad indigestion), DECREASED APPETITE (picky about eating,), ABDOMINAL PAIN UPPER (pain is going around stomach), MUSCULOSKELETAL CHEST PAIN (pain is going around ribs), MUSCLE SPASMS (really severe muscle spasms around stomach to back,cycling muscle spasm), VOMITING (keeps feeling like going to throw up), BACK PAIN (Pain is going around her torso, back, ribs, stomach, really painful;), NAUSEA (she feels nauseated), MYALGIA (pain is going around torso) and HEADACHE (Headache) 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; head feeling little funny; tasting medication in the tongue; soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (head feeling little funny), DYSGEUSIA (tasting medication in the tongue) and VACCINATION SITE PAIN (soreness at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included BIOTIN, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for Supplementation therapy, VITAMIN B COMPLEX and ASCORBIC ACID, SODIUM ASCORBATE (VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]) for Vitamin supplementation.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (head feeling little funny), DYSGEUSIA (tasting medication in the tongue) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Apr-2021, FEELING ABNORMAL (head feeling little funny), DYSGEUSIA (tasting medication in the tongue) and VACCINATION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) 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.   Patient stated that still have some symptoms, seen a cardiologist- since wondered if developed a myocarditis and have an appointment for a cardiac echocardiogram, stress test and halter monitor on 25-JUN-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-231450 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information received and patient updated that still have symptoms. On 13-Jul-2021: New event sore arm was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-231450:MOD21-114592 (Cross-linked)
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: diarrhea; Nausea; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches) and FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches) and FATIGUE (fatigue). On 05-May-2021, DIARRHOEA (diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches) and FATIGUE (fatigue) had resolved.      No treatment information was provided. No relevant concomitant medications reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 after receiving both doses of the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after receiving both doses of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after receiving both doses of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after receiving both doses of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test positive: Positive.     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 Concomitant medications were provided by the reporter. No Treatment history was provided by the reporter   This case was linked to MOD-2021-114608 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: non significant follow up received on 10-MAY-2021 contains no new information
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: soreness; little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (little tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune haemolytic anaemia, Gaucher's disease type I, Kidney stones, Gallbladder removal, Arthrodesis and Shoulder replacement (both shoulders replaced). Concurrent medical conditions included Drug allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (soreness) and FATIGUE (little tired). At the time of the report, PAIN (soreness) and FATIGUE (little tired) 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 medication information was not reported. Treatment information as not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-114568 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114568:Dose 2
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Myalgia
Clinical narrative: soreness in her arm, Feeling a tiny bit achy; severe diarrhea; Feeling a tiny bit off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), MALAISE (Feeling a tiny bit off) and MYALGIA (soreness in her arm, Feeling a tiny bit achy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AZ21A) for COVID-19 vaccination.     The patient's past medical history included Hiatal hernia repair (underwent surgery for hiatal hernia) in February 2021. Concurrent medical conditions included Constipation (Since hiatal hernia surgery) since February 2021 and Diarrhea (Since hiatal hernia surgery) since February 2021. Concomitant products included CITALOPRAM, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and LEVOTHYROXINE for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea), MALAISE (Feeling a tiny bit off) and MYALGIA (soreness in her arm, Feeling a tiny bit achy). At the time of the report, DIARRHOEA (severe diarrhea), MALAISE (Feeling a tiny bit off) and MYALGIA (soreness in her arm, Feeling a tiny bit achy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment includes Tylenol on the second and third day and Imodium    This case was linked to US-MODERNATX, INC.-MOD-2021-114578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114578:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Rash
Clinical narrative: Patient states that the rash is very uncomfortable; Patient states that the rash is very uncomfortable and keeps him up at night; rash appears like measles and is located all over his arms, hips, chest, and back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (Patient states that the rash is very uncomfortable), INSOMNIA (Patient states that the rash is very uncomfortable and keeps him up at night) and RASH (rash appears like measles and is located all over his arms, hips, chest, and back) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 05-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 DISCOMFORT (Patient states that the rash is very uncomfortable), INSOMNIA (Patient states that the rash is very uncomfortable and keeps him up at night) and RASH (rash appears like measles and is located all over his arms, hips, chest, and back). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Patient states that the rash is very uncomfortable) and INSOMNIA (Patient states that the rash is very uncomfortable and keeps him up at night) outcome was unknown and RASH (rash appears like measles and is located all over his arms, hips, chest, and back) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication included 5-day course of steroids.   This case was linked to MOD-2021-114619.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eustachian tube dysfunction, Left ventricular hypertrophy, Myalgia, Right ventricular hypertrophy
Clinical narrative: Right ventricle is also enlarged; Left ventricle is has double the size; Eustachian tubes in left ear is flat and moved; Difficulty breathing; Pain all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RIGHT VENTRICULAR HYPERTROPHY (Right ventricle is also enlarged), LEFT VENTRICULAR HYPERTROPHY (Left ventricle is has double the size) and EUSTACHIAN TUBE DYSFUNCTION (Eustachian tubes in left ear is flat and moved) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Cerebral palsy. Concomitant products included MAGNESIUM and IBUPROFEN for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RIGHT VENTRICULAR HYPERTROPHY (Right ventricle is also enlarged) (seriousness criterion medically significant), LEFT VENTRICULAR HYPERTROPHY (Left ventricle is has double the size) (seriousness criterion medically significant), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tubes in left ear is flat and moved) (seriousness criterion medically significant) and MYALGIA (Pain all over the body). 05-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, RIGHT VENTRICULAR HYPERTROPHY (Right ventricle is also enlarged), LEFT VENTRICULAR HYPERTROPHY (Left ventricle is has double the size), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tubes in left ear is flat and moved), DYSPNOEA (Difficulty breathing) and MYALGIA (Pain all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his thigh after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his thigh after second dose) 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 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (pain in his thigh after second dose). At the time of the report, PAIN IN EXTREMITY (pain in his thigh after second dose) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (lot of pain her arm), ABDOMINAL PAIN (lot of pain in her belly) and ABDOMINAL PAIN UPPER (lot of pain in her stomach) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (lot of pain her arm), ABDOMINAL PAIN (lot of pain in her belly) and ABDOMINAL PAIN UPPER (lot of pain in her stomach). At the time of the report, PAIN IN EXTREMITY (lot of pain her arm), ABDOMINAL PAIN (lot of pain in her belly) and ABDOMINAL PAIN UPPER (lot of pain in her stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported. The patient wanted to know what medication to take.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysphonia, Injection site bruising, Paraesthesia, Paraesthesia oral, Peripheral swelling
Clinical narrative: Tingling tongue; Bruising injection site; Bruising on shin; facial paresthesia; dysphonia; runny nose; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site), PERIPHERAL SWELLING (Bruising on shin), DYSPHONIA (dysphonia) and RHINORRHOEA (runny nose) in a 45-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Crohn's disease.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 13-Apr-2021, the patient experienced PARAESTHESIA (facial paresthesia). In April 2021, the patient experienced DYSPHONIA (dysphonia) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site) and PERIPHERAL SWELLING (Bruising on shin). At the time of the report, PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site), PERIPHERAL SWELLING (Bruising on shin), DYSPHONIA (dysphonia), RHINORRHOEA (runny nose) and PARAESTHESIA (facial paresthesia) 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 and treatment medications were provided by reporter.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rhinorrhoea
Clinical narrative: Tingling tongue; Bruising injection site; Bruising on shin; facial paresthesia; dysphonia; runny nose; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site), PERIPHERAL SWELLING (Bruising on shin), DYSPHONIA (dysphonia) and RHINORRHOEA (runny nose) in a 45-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Crohn's disease.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 13-Apr-2021, the patient experienced PARAESTHESIA (facial paresthesia). In April 2021, the patient experienced DYSPHONIA (dysphonia) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site) and PERIPHERAL SWELLING (Bruising on shin). At the time of the report, PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site), PERIPHERAL SWELLING (Bruising on shin), DYSPHONIA (dysphonia), RHINORRHOEA (runny nose) and PARAESTHESIA (facial paresthesia) 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 and treatment medications were provided by reporter.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Influenza like illness, Lethargy, Myalgia
Clinical narrative: I got really really sick; I was feeling lethargic; terrible body aches; fever; I had chills; I had flu like symptoms for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I had flu like symptoms for 24 hours), ILLNESS (I got really really sick), LETHARGY (I was feeling lethargic), MYALGIA (terrible body aches) and PYREXIA (fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ETANERCEPT (ENBREL) for Psoriatic arthritis, VITAMIN D NOS and CALCIUM for an unknown indication.   On 09-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) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (I had flu like symptoms for 24 hours). On 16-Apr-2021, the patient experienced ILLNESS (I got really really sick), LETHARGY (I was feeling lethargic), MYALGIA (terrible body aches), PYREXIA (fever) and CHILLS (I had chills). On 10-Apr-2021, INFLUENZA LIKE ILLNESS (I had flu like symptoms for 24 hours) had resolved. At the time of the report, ILLNESS (I got really really sick), LETHARGY (I was feeling lethargic), MYALGIA (terrible body aches), PYREXIA (fever) and CHILLS (I had chills) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant treatment also included heart burn pill. No specific treatment information provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I got really really sick; I was feeling lethargic; terrible body aches; fever; I had chills; I had flu like symptoms for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I had flu like symptoms for 24 hours), ILLNESS (I got really really sick), LETHARGY (I was feeling lethargic), MYALGIA (terrible body aches) and PYREXIA (fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ETANERCEPT (ENBREL) for Psoriatic arthritis, VITAMIN D NOS and CALCIUM for an unknown indication.   On 09-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) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (I had flu like symptoms for 24 hours). On 16-Apr-2021, the patient experienced ILLNESS (I got really really sick), LETHARGY (I was feeling lethargic), MYALGIA (terrible body aches), PYREXIA (fever) and CHILLS (I had chills). On 10-Apr-2021, INFLUENZA LIKE ILLNESS (I had flu like symptoms for 24 hours) had resolved. At the time of the report, ILLNESS (I got really really sick), LETHARGY (I was feeling lethargic), MYALGIA (terrible body aches), PYREXIA (fever) and CHILLS (I had chills) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant treatment also included heart burn pill. No specific treatment information provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site rash
Clinical narrative: I got Covid arm; large circular rash around the injection site; lack of drug effect; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-May-2021. The most recent information was received on 07-May-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got Covid arm), VACCINATION SITE RASH (large circular rash around the injection site) and DRUG INEFFECTIVE (lack of drug effect) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rash (Read Rash).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (I got Covid arm), VACCINATION SITE RASH (large circular rash around the injection site) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with CLOBETASOL PROPIONATE ongoing since an unknown date for Steroid therapy, at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. On 04-Mar-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (I got Covid arm) and VACCINATION SITE RASH (large circular rash around the injection site) outcome was unknown.            Treatment medication was not provided.No concomitant medication was reported.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as unlikely related.  Based on the current available information and temporal association between the use of the product and the start date of the events of vaccination site rash and drug ineffective,  a causal relationship cannot be excluded   This case was linked to MOD-2021-114583 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Upon internal review on 16 Jul 2021, an event (lack of efficacy) was added at Moderna's request. On 07-Jun-2021: No specific follow-up information recorded.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as unlikely related. Based on the current available information and temporal association between the use of the product and the start date of the events of vaccination site rash and drug ineffective,  a causal relationship cannot be excluded
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cytokine test, Dyspnoea, Fibrin D dimer, Lymphocyte count
Clinical narrative: Dyspnea/tachypnea; Dyspnea/tachypnea; Diagnosed with coronavirus after receiving both doses of Moderna; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna), DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (BMI reported 30.4).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna). On 10-May-2021, the patient experienced DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea). The patient was treated with ALBUTEROL [SALBUTAMOL] (nasal) on 03-May-2021 for COVID-19, at a dose of 90 microgram 2 puffs q 4 hours. On 10-May-2021, DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea) had resolved. At the time of the report, COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) Nasal swab. On 10-May-2021, Cytokine test: 5.4 (Inconclusive) 5.4 K/mcl. On 10-May-2021, Fibrin D dimer: 513 ng/mL (Inconclusive) 513ng/ml DDU. On 10-May-2021, Lymphocyte count: 5.4 (Inconclusive) 5.4K/mcl. On 10-May-2021, Procalcitonin: 5.4 (Inconclusive) 5.4 K/mcl. On 10-May-2021, Red blood cell sedimentation rate: 5.4 (Inconclusive) 5.4K/mcl. On 10-May-2021, Serum ferritin: 16.2 (Inconclusive) 16.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  The patient experienced COVID-19 symptoms like cough, muscle aches, headache, loss of taste, loss of smell, Nasal congestion/runny nose.     Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received does not contain any significant information. On 07-Jun-2021: Follow-up information received updated lab data, treatment medication, new events (dyspnea and tachypnea) were added. On 28-Jun-2021: Follow-up received updated lab data and treatment information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Procalcitonin, Red blood cell sedimentation rate, SARS-CoV-2 test, Serum ferritin, Tachypnoea
Clinical narrative: Dyspnea/tachypnea; Dyspnea/tachypnea; Diagnosed with coronavirus after receiving both doses of Moderna; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna), DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (BMI reported 30.4).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna). On 10-May-2021, the patient experienced DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea). The patient was treated with ALBUTEROL [SALBUTAMOL] (nasal) on 03-May-2021 for COVID-19, at a dose of 90 microgram 2 puffs q 4 hours. On 10-May-2021, DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea) had resolved. At the time of the report, COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) Nasal swab. On 10-May-2021, Cytokine test: 5.4 (Inconclusive) 5.4 K/mcl. On 10-May-2021, Fibrin D dimer: 513 ng/mL (Inconclusive) 513ng/ml DDU. On 10-May-2021, Lymphocyte count: 5.4 (Inconclusive) 5.4K/mcl. On 10-May-2021, Procalcitonin: 5.4 (Inconclusive) 5.4 K/mcl. On 10-May-2021, Red blood cell sedimentation rate: 5.4 (Inconclusive) 5.4K/mcl. On 10-May-2021, Serum ferritin: 16.2 (Inconclusive) 16.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  The patient experienced COVID-19 symptoms like cough, muscle aches, headache, loss of taste, loss of smell, Nasal congestion/runny nose.     Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received does not contain any significant information. On 07-Jun-2021: Follow-up information received updated lab data, treatment medication, new events (dyspnea and tachypnea) were added. On 28-Jun-2021: Follow-up received updated lab data and treatment information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: "feels like someone is me with a fire poker"; rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle); sleepy; swollen feet and blood shot red hands; rash all over their body (shoulder, arms, down ankle); headache; swollen feet and blood shot red hands; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("feels like someone is me with a fire poker"), RASH ERYTHEMATOUS (rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle)), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (swollen feet and blood shot red hands) and RASH (rash all over their body (shoulder, arms, down ankle)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus-like syndrome, Rheumatoid arthritis, Celiac disease, Anxiety and Thyroid disorder. Concomitant products included TRAMADOL, CLONAZEPAM and LEVOTHYROXINE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL ("feels like someone is me with a fire poker"), RASH ERYTHEMATOUS (rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle)), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (swollen feet and blood shot red hands), RASH (rash all over their body (shoulder, arms, down ankle)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (swollen feet and blood shot red hands). At the time of the report, FEELING ABNORMAL ("feels like someone is me with a fire poker"), RASH ERYTHEMATOUS (rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle)), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (swollen feet and blood shot red hands), RASH (rash all over their body (shoulder, arms, down ankle)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (swollen feet and blood shot red hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site erythema
Clinical narrative: "feels like someone is me with a fire poker"; rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle); sleepy; swollen feet and blood shot red hands; rash all over their body (shoulder, arms, down ankle); headache; swollen feet and blood shot red hands; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("feels like someone is me with a fire poker"), RASH ERYTHEMATOUS (rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle)), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (swollen feet and blood shot red hands) and RASH (rash all over their body (shoulder, arms, down ankle)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus-like syndrome, Rheumatoid arthritis, Celiac disease, Anxiety and Thyroid disorder. Concomitant products included TRAMADOL, CLONAZEPAM and LEVOTHYROXINE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL ("feels like someone is me with a fire poker"), RASH ERYTHEMATOUS (rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle)), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (swollen feet and blood shot red hands), RASH (rash all over their body (shoulder, arms, down ankle)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (swollen feet and blood shot red hands). At the time of the report, FEELING ABNORMAL ("feels like someone is me with a fire poker"), RASH ERYTHEMATOUS (rash is red hot and swollen, they have never seen a rash like this before-rash all over their body (shoulder, arms, down ankle)), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (swollen feet and blood shot red hands), RASH (rash all over their body (shoulder, arms, down ankle)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (swollen feet and blood shot red hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: swollen lymph node in left side of collar bone and another one in right side inside groin; swollen lymph node in my left arm pit; little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever), LYMPHADENOPATHY (swollen lymph node in my left arm pit) and LYMPHADENOPATHY (swollen lymph node in left side of collar bone and another one in right side inside groin) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (little fever). On 06-May-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node in my left arm pit). On 07-May-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node in left side of collar bone and another one in right side inside groin). On 01-May-2021, PYREXIA (little fever) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph node in my left arm pit) and LYMPHADENOPATHY (swollen lymph node in left side of collar bone and another one in right side inside groin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction, Rash erythematous
Clinical narrative: Panicking; Rash all over/ red patch all over her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash all over/ red patch all over her chest) and PANIC REACTION (Panicking) 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 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced RASH ERYTHEMATOUS (Rash all over/ red patch all over her chest). On an unknown date, the patient experienced PANIC REACTION (Panicking). At the time of the report, RASH ERYTHEMATOUS (Rash all over/ red patch all over her chest) and PANIC REACTION (Panicking) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: "real nasty body aches"/ "kicking hard"; fever; making him "a little sick"; dizziness; being "sweaty"; "everything hurts"; heart beat a little elevated; chills; "everything but vomiting"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (making him "a little sick"), DIZZINESS (dizziness), HYPERHIDROSIS (being "sweaty"), PAIN ("everything hurts") and HEART RATE INCREASED (heart beat a little elevated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ILLNESS (making him "a little sick"), DIZZINESS (dizziness), HYPERHIDROSIS (being "sweaty"), PAIN ("everything hurts"), HEART RATE INCREASED (heart beat a little elevated), CHILLS (chills), VOMITING ("everything but vomiting") and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA ("real nasty body aches"/ "kicking hard"). At the time of the report, ILLNESS (making him "a little sick"), DIZZINESS (dizziness), HYPERHIDROSIS (being "sweaty"), PAIN ("everything hurts"), HEART RATE INCREASED (heart beat a little elevated), CHILLS (chills), VOMITING ("everything but vomiting"), MYALGIA ("real nasty body aches"/ "kicking hard") and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated (Inconclusive) heart beat a little elevated..