chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Lip swelling, Menstrual disorder, Migraine, Swelling face
Clinical narrative: missed many days of work; Hormonal changes with cycles; lip swelling; migraine aggravated; Facial Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial Swelling), LIP SWELLING (lip swelling), MIGRAINE (migraine aggravated), MENSTRUAL DISORDER (Hormonal changes with cycles) and IMPAIRED WORK ABILITY (missed many days of work) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004MZ0A and 037K20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine (Flu Vaccine was given intramuscularly on left arm.) on 01-Dec-2020. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Drug allergy (Morphine), Drug allergy (Dilaudid), Drug allergy (Compazine) and Migraine (Since age 14). Concomitant products included VENLAFAXINE and HYDROXYZINE for Migraine.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced SWELLING FACE (Facial Swelling). On 28-Jan-2021, the patient experienced MIGRAINE (migraine aggravated). On 28-Jan-2021 at 9:30 AM, the patient experienced LIP SWELLING (lip swelling). On 28-Jan-2021 at 1:30 PM, the patient experienced MENSTRUAL DISORDER (Hormonal changes with cycles). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (missed many days of work). On 05-Feb-2021, LIP SWELLING (lip swelling) and MIGRAINE (migraine aggravated) had resolved. On 06-Mar-2021, MENSTRUAL DISORDER (Hormonal changes with cycles) had resolved with sequelae. At the time of the report, SWELLING FACE (Facial Swelling) had not resolved and IMPAIRED WORK ABILITY (missed many days of work) outcome was unknown.            The patient took antihistaminic 3 days prior to the second dose of the vaccine without specifying the names.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-021065 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received on 18-JUN-2021 contains non newinformation. On 26-Jul-2021: Follow up received on 26-Jul-2021, contains non significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Additional information is requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Carcinoembryonic antigen, Vaccination site pain, Vaccination site rash
Clinical narrative: COVID arm; a red rash underneath of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID arm) and VACCINATION SITE RASH (a red rash underneath of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Red rash, Vaccination site pain and Vaccination site rash.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (COVID arm) and VACCINATION SITE RASH (a red rash underneath of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (COVID arm) and VACCINATION SITE RASH (a red rash underneath of injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Carcinoembryonic antigen: other (Inconclusive) 3.7 ng/ML.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   This case was linked to MOD-2021-080891 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Email Response On 25-May-2021: No specific follow-up information recorded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: felt tingling in her lips for about 20 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (felt tingling in her lips for about 20 minutes.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 1991, Arthritic pains since 1991, Temporomandibular joint disorder since 1991, Neck pain since 1991 and Muscle pain since 1991.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (felt tingling in her lips for about 20 minutes.). On 22-Mar-2021, PARAESTHESIA ORAL (felt tingling in her lips for about 20 minutes.) had resolved.        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 reported.  The patient also reported that about 2-3 hours after receiving the vaccine, she felt relieved from her chronic pain. Her pain-free period lasted for about 36 hours after receiving the vaccine. Usually she is always in pain all day long and her muscles are usually tense and knotted. She has TNJ but after the vaccine, her muscles in her jaw which were always tight became more relaxed and did not hurt on the side when she talked. She usually barely sleeps though the night due to her muscle spasms and pain being unbearable but after the first dose, she slept through the entire first night pain free.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces hard, Flatulence, Pain in extremity
Clinical narrative: left arm severe pain; hard stool; gas pockets; liquid stool; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm severe pain), DIARRHOEA (liquid stool), FAECES HARD (hard stool) and FLATULENCE (gas pockets) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia in January 1992. Concurrent medical conditions included Myositis since 2002 and Drug allergy (Sporanox, Codeine, Morphine.). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), PREGABALIN (LYRICA) and CELECOXIB (CELEBREX) for Pain, ALLOPURINOL (ELAVIL [ALLOPURINOL]) for Sleep apnea, TRAZODONE, VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, VITAMIN D NOS and AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm severe pain), DIARRHOEA (liquid stool), FAECES HARD (hard stool) and FLATULENCE (gas pockets). At the time of the report, PAIN IN EXTREMITY (left arm severe pain), DIARRHOEA (liquid stool), FAECES HARD (hard stool) and FLATULENCE (gas pockets) outcome was unknown.            treatment details not reported.   This case was linked to MOD-2021-008723 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: NNI followup received on 24-May-21.
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pain in extremity, Renal disorder, Urinary incontinence
Clinical narrative: 15 min later had pain in left leg; Has slow blood flow"; "Kidneys feel lethargic"; "Felt like had to urinate and then very little would come out"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (15 min later had pain in left leg), HYPOTENSION (Has slow blood flow"), RENAL DISORDER ("Kidneys feel lethargic") and URINARY INCONTINENCE ("Felt like had to urinate and then very little would come out") 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 Stroke, Stent placement and Bypass surgery. Concurrent medical conditions included Cardiovascular disease, unspecified and Seizure.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (15 min later had pain in left leg), HYPOTENSION (Has slow blood flow"), RENAL DISORDER ("Kidneys feel lethargic") and URINARY INCONTINENCE ("Felt like had to urinate and then very little would come out"). At the time of the report, PAIN IN EXTREMITY (15 min later had pain in left leg), HYPOTENSION (Has slow blood flow"), RENAL DISORDER ("Kidneys feel lethargic") and URINARY INCONTINENCE ("Felt like had to urinate and then very little would come out") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.    Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Carcinoembryonic antigen, Chills, Pyrexia, Rash
Clinical narrative: a low grade fever of 99.2, 99.3; rash; got chills and went into shaking; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), CHILLS (got chills and went into shaking) and PYREXIA (a low grade fever of 99.2, 99.3) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient is a breast cancer survivor and has been "8 years out now".).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced RASH (rash) and CHILLS (got chills and went into shaking). On 10-Feb-2021, the patient experienced PYREXIA (a low grade fever of 99.2, 99.3). The patient was treated with PARACETAMOL (TYLENOL) on 08-Feb-2021 for Pyrexia, at an unspecified dose and frequency. On 09-Feb-2021, CHILLS (got chills and went into shaking) had resolved. At the time of the report, RASH (rash) and PYREXIA (a low grade fever of 99.2, 99.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.13 (High) Fever. On 09-Feb-2021, Body temperature: 99.2 (High) Low grade fever of 99.2. On 10-Feb-2021, Body temperature: 99.3 (High) Low grade fever of 99.3. On 09-Apr-2021, Carcinoembryonic antigen: 3.7 (High) CEA test is 3.7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported   This case was linked to MOD-2021-080882 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 073A21A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia, Arthritis, Temporomandibular joint dysfunction, Neck pain and Muscle pain.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 19-Apr-2021, the patient experienced PARAESTHESIA ORAL (In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes). At the time of the report, PARAESTHESIA ORAL (In both instances after receiving the vaccines she initially felt tingling in her lips for about 20 minutes) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at; injection site blue and purple; swollen Lymph nodes; injection site is swollen; headaches; nausea; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue), LYMPHADENOPATHY (swollen Lymph nodes) and PAIN IN EXTREMITY (left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at). At the time of the report, VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue), LYMPHADENOPATHY (swollen Lymph nodes) and PAIN IN EXTREMITY (left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medication provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site swelling
Clinical narrative: left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at; injection site blue and purple; swollen Lymph nodes; injection site is swollen; headaches; nausea; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue), LYMPHADENOPATHY (swollen Lymph nodes) and PAIN IN EXTREMITY (left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at). At the time of the report, VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue), LYMPHADENOPATHY (swollen Lymph nodes) and PAIN IN EXTREMITY (left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medication provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: arm felt sore and stiff, it was sensitive to touch; arm felt sore and stiff, it was sensitive to touch; arm felt sore and stiff, it was sensitive to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm felt sore and stiff, it was sensitive to touch), TENDERNESS (arm felt sore and stiff, it was sensitive to touch) and MUSCULOSKELETAL STIFFNESS (arm felt sore and stiff, it was sensitive to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm felt sore and stiff, it was sensitive to touch), TENDERNESS (arm felt sore and stiff, it was sensitive to touch) and MUSCULOSKELETAL STIFFNESS (arm felt sore and stiff, it was sensitive to touch). On 23-Mar-2021, PAIN IN EXTREMITY (arm felt sore and stiff, it was sensitive to touch), TENDERNESS (arm felt sore and stiff, it was sensitive to touch) and MUSCULOSKELETAL STIFFNESS (arm felt sore and stiff, it was sensitive to touch) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided   This case was linked to MOD-2021-080940 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Vaccination site pruritus
Clinical narrative: itching at the injection site; arm pain; body aches; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), PAIN IN EXTREMITY (arm pain), MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) 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) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), PAIN IN EXTREMITY (arm pain), MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache). On 17-Apr-2021, MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) and PAIN IN EXTREMITY (arm pain) outcome was unknown.            The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Her arm was red; Swollen at the injection site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her arm was red), VACCINATION SITE SWELLING (Swollen at the injection site) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury (3-years ago- Has short term memory), Shingles (Two episodes of shingles) and Oxygen therapy (On oxygen for 7yrs) since an unknown date. Previously administered products included for an unreported indication: HERPES SIMPLEX 2 VACCINE (1-year ago- still have knot on right arm from shot). Concurrent medical conditions included Immunocompromised, Asthma and Osteoporosis. Concomitant products included PREDNISONE for an unknown indication.    On 13-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 VACCINATION SITE ERYTHEMA (Her arm was red), VACCINATION SITE SWELLING (Swollen at the injection site) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE ERYTHEMA (Her arm was red) and VACCINATION SITE SWELLING (Swollen at the injection site) outcome was unknown and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient used cold packs and cold washcloth for the treatment.     This case was linked to MOD-2021-077748 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: malaise; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise) and PYREXIA (low grade fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, BPH, GERD and Allergy. Concomitant products included RABEPRAZOLE, FINASTERIDE, FAMOTIDINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and DOXAZOSIN for an unknown indication.   On 14-Jan-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise) and PYREXIA (low grade fever). At the time of the report, MALAISE (malaise) and PYREXIA (low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Impaired work ability, Oropharyngeal pain
Clinical narrative: Unable to work for 1.5 days; Fever; Headache; Extreme fatigue; Pain at injection site; Sore throat; Lack of appetite; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Lack of appetite), IMPAIRED WORK ABILITY (Unable to work for 1.5 days), PYREXIA (Fever) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Lack of appetite), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Extreme fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Unable to work for 1.5 days). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Lack of appetite), IMPAIRED WORK ABILITY (Unable to work for 1.5 days), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Extreme fatigue) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported by the reporter.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received on 26-May-2021 and does not contain any new information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Unable to work for 1.5 days; Fever; Headache; Extreme fatigue; Pain at injection site; Sore throat; Lack of appetite; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Lack of appetite), IMPAIRED WORK ABILITY (Unable to work for 1.5 days), PYREXIA (Fever) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Lack of appetite), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Extreme fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Unable to work for 1.5 days). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Lack of appetite), IMPAIRED WORK ABILITY (Unable to work for 1.5 days), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Extreme fatigue) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported by the reporter.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received on 26-May-2021 and does not contain any new information
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old son given vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son given vaccine) in a 16-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 reaction.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son given vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son given vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warm to the touch; Injection site redness; Very tender; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Very tender) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Very tender). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Very tender) 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 relevant concomitant medications were reported.   No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose outside of 42 day window; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose outside of 42 day window) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L21A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose outside of 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose outside of 42 day window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not provided.  Patient received First dose at 15-JAN-2021. Patient did not report pregnancy at that time. Se stated that she didn't know she was pregnant. Patient cancelled her second dose appointment due to confirmation of pregnancy. In March patient called the pharmacy to schedule her second dose because she had miscarriage(12-Mar-2021).   This case was linked to MOD-2021-047919 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Dry mouth, Dysphonia, Fatigue
Clinical narrative: Dryness and swelling of tongue and cheeks; Swelling of tongue and cheeks; Swelling of tongue and cheeks; Tongue is also "irritated" by certain foods; Diarrhea; Achiness; Nausea; Headaches; Fever; Fatigue; Hoarseness; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Achiness), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks) and SWELLING FACE (Swelling of tongue and cheeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial cancer, Uterine cancer, Ovarian cancer and Urinary incontinence. Concurrent medical conditions included Hypertension and Weight loss (Lost approximately 15 pounds since September 2020). Concomitant products included LISINOPRIL for Blood pressure high, LENVATINIB MESILATE (LENVIMA) from 19-Mar-2021 to an unknown date for an unknown indication.   On 06-Apr-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 07-Apr-2021, the patient experienced PAIN (Achiness), NAUSEA (Nausea), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue). On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and DYSPHONIA (Hoarseness). At the time of the report, DIARRHOEA (Diarrhea), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and NAUSEA (Nausea) had not resolved and PAIN (Achiness), DYSPHONIA (Hoarseness), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated but stable.         The patient was scheduled to receive their Keytruda vaccine on 09 Apr 2021 but rescheduled it to 19 Apr 2021.  The patient reported that they still had issues with their mouth and their blood pressure was still elevated but stable.  Patient's Relevant Medical history also included Keytruda infusions.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 as NNI-email without source document attached On 27-May-2021: Follow up received on 27-May-2021 as new events added
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Dryness and swelling of tongue and cheeks; Swelling of tongue and cheeks; Swelling of tongue and cheeks; Tongue is also "irritated" by certain foods; Diarrhea; Achiness; Nausea; Headaches; Fever; Fatigue; Hoarseness; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Achiness), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks) and SWELLING FACE (Swelling of tongue and cheeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial cancer, Uterine cancer, Ovarian cancer and Urinary incontinence. Concurrent medical conditions included Hypertension and Weight loss (Lost approximately 15 pounds since September 2020). Concomitant products included LISINOPRIL for Blood pressure high, LENVATINIB MESILATE (LENVIMA) from 19-Mar-2021 to an unknown date for an unknown indication.   On 06-Apr-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 07-Apr-2021, the patient experienced PAIN (Achiness), NAUSEA (Nausea), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue). On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and DYSPHONIA (Hoarseness). At the time of the report, DIARRHOEA (Diarrhea), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and NAUSEA (Nausea) had not resolved and PAIN (Achiness), DYSPHONIA (Hoarseness), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated but stable.         The patient was scheduled to receive their Keytruda vaccine on 09 Apr 2021 but rescheduled it to 19 Apr 2021.  The patient reported that they still had issues with their mouth and their blood pressure was still elevated but stable.  Patient's Relevant Medical history also included Keytruda infusions.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 as NNI-email without source document attached On 27-May-2021: Follow up received on 27-May-2021 as new events added
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Dryness and swelling of tongue and cheeks; Swelling of tongue and cheeks; Swelling of tongue and cheeks; Tongue is also "irritated" by certain foods; Diarrhea; Achiness; Nausea; Headaches; Fever; Fatigue; Hoarseness; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Achiness), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks) and SWELLING FACE (Swelling of tongue and cheeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial cancer, Uterine cancer, Ovarian cancer and Urinary incontinence. Concurrent medical conditions included Hypertension and Weight loss (Lost approximately 15 pounds since September 2020). Concomitant products included LISINOPRIL for Blood pressure high, LENVATINIB MESILATE (LENVIMA) from 19-Mar-2021 to an unknown date for an unknown indication.   On 06-Apr-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 07-Apr-2021, the patient experienced PAIN (Achiness), NAUSEA (Nausea), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue). On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and DYSPHONIA (Hoarseness). At the time of the report, DIARRHOEA (Diarrhea), DRY MOUTH (Dryness and swelling of tongue and cheeks), SWOLLEN TONGUE (Swelling of tongue and cheeks), SWELLING FACE (Swelling of tongue and cheeks), GLOSSITIS (Tongue is also "irritated" by certain foods) and NAUSEA (Nausea) had not resolved and PAIN (Achiness), DYSPHONIA (Hoarseness), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated but stable.         The patient was scheduled to receive their Keytruda vaccine on 09 Apr 2021 but rescheduled it to 19 Apr 2021.  The patient reported that they still had issues with their mouth and their blood pressure was still elevated but stable.  Patient's Relevant Medical history also included Keytruda infusions.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 as NNI-email without source document attached On 27-May-2021: Follow up received on 27-May-2021 as new events added
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arm down to elbow; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash on arm down to elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol, Thyroid disorder NOS and Ileostomy. Concomitant products included ibrutinib (irbutinib), alendronate sodium, allopurinol, amlodipine besylate, biotin, ezetimibe, folic acid, glucosamine chondroitin, levothyroxine sodium, magic mouthwash, magnesium, simvastatin, temazepam, allantoin, aloe vera, citrus aurantium, magnesium sulfate heptahydrate, silver colloidal, tocopheryl acetate, tramadol hydrochloride and multivitamin adults for an unknown indication.    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 RASH (Rash on arm down to elbow). At the time of the report, RASH (Rash on arm down to elbow) 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.
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: Severe IBS symptoms; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Severe IBS symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced IRRITABLE BOWEL SYNDROME (Severe IBS symptoms). At the time of the report, IRRITABLE BOWEL SYNDROME (Severe IBS symptoms) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: No new information reported.
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: severe IBS symptoms; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (severe IBS symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (severe IBS symptoms). At the time of the report, IRRITABLE BOWEL SYNDROME (severe IBS symptoms) outcome was unknown.            No concomitant product was reported.  No treatment information was reported.  Case was received via email with limited information.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-081083, MOD-2021-081083 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Feeling abnormal
Clinical narrative: Feel awful; Weak; extremely fatigue; chills; fever of 101; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills) and PYREXIA (fever of 101) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills), PYREXIA (fever of 101) and NAUSEA (Nauseous). At the time of the report, FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills), PYREXIA (fever of 101) and NAUSEA (Nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature increased: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-013041 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Feel awful; Weak; extremely fatigue; chills; fever of 101; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills) and PYREXIA (fever of 101) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills), PYREXIA (fever of 101) and NAUSEA (Nauseous). At the time of the report, FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills), PYREXIA (fever of 101) and NAUSEA (Nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature increased: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-013041 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling at injection site that is red and warm to touch; swelling at injection site that is red and warm to touch; swelling at injection site that is red and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swelling at injection site that is red and warm to touch), VACCINATION SITE SWELLING (swelling at injection site that is red and warm to touch) and VACCINATION SITE ERYTHEMA (swelling at injection site that is red and warm to touch) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE WARMTH (swelling at injection site that is red and warm to touch), VACCINATION SITE SWELLING (swelling at injection site that is red and warm to touch) and VACCINATION SITE ERYTHEMA (swelling at injection site that is red and warm to touch). At the time of the report, VACCINATION SITE WARMTH (swelling at injection site that is red and warm to touch), VACCINATION SITE SWELLING (swelling at injection site that is red and warm to touch) and VACCINATION SITE ERYTHEMA (swelling at injection site that is red and warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information provided about ay concomitant and treatment medications.   Reporter did not allow further contact