chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Vaccination site pain
Clinical narrative: tiredness at injection site; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness at injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included IBRUTINIB (IMBRUVICA) and GAMMA GLOBULIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 FATIGUE (tiredness at injection site) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, FATIGUE (tiredness at injection site) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) doctor reported did not have antibodies.         Treatment information not reported.   This case was linked to MOD-2021-308895 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypopnoea, Nausea, Pharyngeal swelling, Rhinorrhoea, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat is swelling a bit), HYPOPNEA (shallow breathing), SOMNOLENCE (unusually very sleepy), RHINORRHEA (nose was clogged a few minutes ago and now he feels some nasal drip) and NAUSEA (Slightly nauseated) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062D21A) for COVID-19 vaccination. The patient's past medical history included Stroke in 2015 and Atrial fibrillation. Concomitant products included BUSPIRONE, ATORVASTATIN, METOPROLOL and APIXABAN for an unknown indication. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PHARYNGEAL SWELLING (throat is swelling a bit), HYPOPNEA (shallow breathing), SOMNOLENCE (unusually very sleepy), RHINORRHEA (nose was clogged a few minutes ago and now he feels some nasal drip) and NAUSEA (Slightly nauseated). At the time of the report, PHARYNGEAL SWELLING (throat is swelling a bit), HYPOPNEA (shallow breathing), SOMNOLENCE (unusually very sleepy), RHINORRHEA (nose was clogged a few minutes ago and now he feels some nasal drip) and NAUSEA (Slightly nauseated) was resolving. 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 treatment medication use was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling in right arm 8 inch by 5 inch patch around bicep; Swelling from armpit to occipital bone with lymph node swelling; Fatigue and headache took three days to go away; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep), LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling), FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep), LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling), FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache). In August 2021, FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep) and LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-309088 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain
Clinical narrative: congestion; dry cough; sore throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Sep-2021 and was forwarded to Moderna on 06-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), COUGH (dry cough) and OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), COUGH (dry cough) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, NASAL CONGESTION (congestion), COUGH (dry cough) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported No treatment Drug was reported
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cough, Drug ineffective, Headache
Clinical narrative: back and joints pain; cough; headache; back and joints pain; lack of efficacy; Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back and joints pain), COUGH (cough), DRUG INEFFECTIVE (lack of efficacy), SARS-COV-2 TEST POSITIVE (Positive for Covid) and HEADACHE (headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced DRUG INEFFECTIVE (lack of efficacy) and SARS-COV-2 TEST POSITIVE (Positive for Covid). On an unknown date, the patient experienced BACK PAIN (back and joints pain), COUGH (cough), HEADACHE (headache) and ARTHRALGIA (back and joints pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (back and joints pain), COUGH (cough), DRUG INEFFECTIVE (lack of efficacy), SARS-COV-2 TEST POSITIVE (Positive for Covid), HEADACHE (headache) and ARTHRALGIA (back and joints pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Result : Patient  tested positive for Covid 19 via rapid test.         No Concomitant medications were reported.; Sender's Comments: Covid infection following vaccination has a causality assessment of "not applicable" by convention.  Other events captured are likely symptoms of the Covid infection but a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: back and joints pain; cough; headache; back and joints pain; lack of efficacy; Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back and joints pain), COUGH (cough), DRUG INEFFECTIVE (lack of efficacy), SARS-COV-2 TEST POSITIVE (Positive for Covid) and HEADACHE (headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced DRUG INEFFECTIVE (lack of efficacy) and SARS-COV-2 TEST POSITIVE (Positive for Covid). On an unknown date, the patient experienced BACK PAIN (back and joints pain), COUGH (cough), HEADACHE (headache) and ARTHRALGIA (back and joints pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (back and joints pain), COUGH (cough), DRUG INEFFECTIVE (lack of efficacy), SARS-COV-2 TEST POSITIVE (Positive for Covid), HEADACHE (headache) and ARTHRALGIA (back and joints pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Result : Patient  tested positive for Covid 19 via rapid test.         No Concomitant medications were reported.; Sender's Comments: Covid infection following vaccination has a causality assessment of "not applicable" by convention.  Other events captured are likely symptoms of the Covid infection but a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days before I can receive the second dose of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 26-Jul-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 SARS-COV-2 TEST POSITIVE (Tested positive for Covid 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days before I can receive the second dose of Moderna). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 10 days after 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days before I can receive the second dose of Moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  patient received antibody infusion  on 5-Aug-2021 and the patient was under the targeted treatment for cancer.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at armpit on the same injection site; This spontaneous case was reported by a consumer and describes the occurrence of APPLICATION SITE PAIN (Pain at armpit on the same injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, the patient experienced APPLICATION SITE PAIN (Pain at armpit on the same injection site). At the time of the report, APPLICATION SITE PAIN (Pain at armpit on the same injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.   Treatment information was not  provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Horrible heartburn) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Horrible heartburn). At the time of the report, DYSPEPSIA (Horrible heartburn) outcome was unknown. Relevant concomitant medications were not provided. Treatment information was not provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Gout, Hyperhidrosis, Illness
Clinical narrative: Missed two days of work; Pain; Slight fever of 100°F; Right foot had a gout attack; Felt sick; Right foot hurts really bad/Right foot hurts like crazy; Could not sleep; Sweat like crazy; Messed them up; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Right foot had a gout attack), ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep) and HYPERHIDROSIS (Sweat like crazy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout (Gout once 6 years ago and since then the patient had to modify his diet.) in 2015.    On 02-Sep-2021 at 1:26 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Messed them up). On 03-Sep-2021, the patient experienced GOUT (Right foot had a gout attack), ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweat like crazy) and PYREXIA (Slight fever of 100°F). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed two days of work) and PAIN (Pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, HYPERHIDROSIS (Sweat like crazy) and PYREXIA (Slight fever of 100°F) had resolved. At the time of the report, GOUT (Right foot had a gout attack) was resolving and ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed two days of work), FEELING ABNORMAL (Messed them up) and PAIN (Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 100 (High) Had a slight fever of 100 degree Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Additional information received included patient demographic details, suspect vaccine details, reported adverse event outcome and causality.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity, Pyrexia
Clinical narrative: Missed two days of work; Pain; Slight fever of 100°F; Right foot had a gout attack; Felt sick; Right foot hurts really bad/Right foot hurts like crazy; Could not sleep; Sweat like crazy; Messed them up; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Right foot had a gout attack), ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep) and HYPERHIDROSIS (Sweat like crazy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout (Gout once 6 years ago and since then the patient had to modify his diet.) in 2015.    On 02-Sep-2021 at 1:26 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Messed them up). On 03-Sep-2021, the patient experienced GOUT (Right foot had a gout attack), ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweat like crazy) and PYREXIA (Slight fever of 100°F). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed two days of work) and PAIN (Pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, HYPERHIDROSIS (Sweat like crazy) and PYREXIA (Slight fever of 100°F) had resolved. At the time of the report, GOUT (Right foot had a gout attack) was resolving and ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed two days of work), FEELING ABNORMAL (Messed them up) and PAIN (Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 100 (High) Had a slight fever of 100 degree Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Additional information received included patient demographic details, suspect vaccine details, reported adverse event outcome and causality.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness of the site of the injection; a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.; fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness of the site of the injection), VACCINATION SITE SWELLING (a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.) and PYREXIA (fever for 48 hours) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included IBUPROFEN for Rheumatoid arthritis.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PYREXIA (fever for 48 hours). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness of the site of the injection) and VACCINATION SITE SWELLING (a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 1 dosage form and ACETAMINOPHEN for Fever, at a dose of 1 dosage form. On 05-Sep-2021, PYREXIA (fever for 48 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness of the site of the injection) and VACCINATION SITE SWELLING (a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.) outcome was unknown.            Patient report no side effects after the first dose.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Area around the injection site started to get itchy, red & hot to the touch; Area around the injection site started to get itchy, red & hot to the touch; Area around the injection site started to get itchy, red & hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area around the injection site started to get itchy, red & hot to the touch), VACCINATION SITE PRURITUS (Area around the injection site started to get itchy, red & hot to the touch) and VACCINATION SITE ERYTHEMA (Area around the injection site started to get itchy, red & hot to the touch) 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 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 VACCINATION SITE WARMTH (Area around the injection site started to get itchy, red & hot to the touch), VACCINATION SITE PRURITUS (Area around the injection site started to get itchy, red & hot to the touch) and VACCINATION SITE ERYTHEMA (Area around the injection site started to get itchy, red & hot to the touch). At the time of the report, VACCINATION SITE WARMTH (Area around the injection site started to get itchy, red & hot to the touch), VACCINATION SITE PRURITUS (Area around the injection site started to get itchy, red & hot to the touch) and VACCINATION SITE ERYTHEMA (Area around the injection site started to get itchy, red & hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment product information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Experience body ache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Experience body ache), NAUSEA (Nausea) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included THYROID (ARMOUR THYROID), CIMETIDINE, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), OXYBUTYNIN, PHENTERMINE, TOPIRAMATE, HYDROXYZINE, PREDNISONE, SPIRONOLACTONE, ESZOPICLONE (LUNESTA), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE and METHENAMINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Experience body ache), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (Experience body ache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-309664 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Vaginal haemorrhage
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of DYSMENORRHOEA (It occurred within a week of getting the vaccine, vaginal bleeding and cramping) and VAGINAL HAEMORRHAGE (She got vaginal bleeding after both doses, It stopped on its own lasting no more than 3 days of heavy period then spotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (It occurred within a week of getting the vaccine, vaginal bleeding and cramping) and VAGINAL HAEMORRHAGE (She got vaginal bleeding after both doses, It stopped on its own lasting no more than 3 days of heavy period then spotting). At the time of the report, DYSMENORRHOEA (It occurred within a week of getting the vaccine, vaginal bleeding and cramping) outcome was unknown and VAGINAL HAEMORRHAGE (She got vaginal bleeding after both doses, It stopped on its own lasting no more than 3 days of heavy period then spotting) had resolved. 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 provided Treatment information was not reported It was reported that the symptoms included cramping and vaginal bleeding were more severe after the first dose than the second dose. The bleeding stopped on its own, lasting no more than 3 days
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired 2nd dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose of the Moderna vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose of the Moderna vaccine). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.  Expired doses of the Moderna vaccine were administered to three patients.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine). On 28-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not  provided.  The pharmacist wanted to know if the patient can receive a second dose of the Moderna COVID-19 vaccine or if they need to restart the series.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Bleeding heavier than normal during period; This spontaneous case was reported by a pharmacist and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Bleeding heavier than normal during period) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding heavier than normal during period). At the time of the report, HEAVY MENSTRUAL BLEEDING (Bleeding heavier than normal during period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment history was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Very painful that he cannot sleep comfortably; Fever; Chills; Headache; Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe), INSOMNIA (Very painful that he cannot sleep comfortably), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0056021A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 03-Sep-2021, the patient experienced INSOMNIA (Very painful that he cannot sleep comfortably). At the time of the report, PAIN IN EXTREMITY (Pain on the left arm,After that, he will still have intermittent moderate to severe arm pain. the arm pain started to be severe), INSOMNIA (Very painful that he cannot sleep comfortably), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) 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 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 HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided.  Patient had no side effects from the first dose.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Fever; Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-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 05-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 07-Feb-2021, HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm) had resolved.            No relevant concomitant medications reported.   This case was linked to MOD-2021-309111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up received contains additional Include no new significant information.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Tired; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), PYREXIA (Slight fever) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (25 years ago).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), PYREXIA (Slight fever) and HEADACHE (Headache). On 28-Aug-2021, FATIGUE (Tired), PYREXIA (Slight fever) and HEADACHE (Headache) had resolved.            No concomitant medications reported.  No treatment information was reported by reporter.   This case was linked to MOD-2021-265490, MOD-2021-265483 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Had a red spot where didn't get the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 06-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Had a red spot where didn't get the shot) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Had a red spot where didn't get the shot). At the time of the report, ERYTHEMA (Had a red spot where didn't get the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Myalgia
Clinical narrative: Shortness of breath; Tightness in chest; Soreness in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and MYALGIA (Soreness in arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 031A21A and 939902) for COVID-19 vaccination.     Concomitant products included FINASTERIDE, ALFUZOSIN and ALLOPURINOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and MYALGIA (Soreness in arm). At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and MYALGIA (Soreness in arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: haven't felt good all day; I woke up this morning chilling; have a fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (haven't felt good all day), CHILLS (I woke up this morning chilling) and PYREXIA (have a fever of 101) 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 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 MALAISE (haven't felt good all day), CHILLS (I woke up this morning chilling) and PYREXIA (have a fever of 101). At the time of the report, MALAISE (haven't felt good all day), CHILLS (I woke up this morning chilling) and PYREXIA (have a fever of 101) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Mild L arm edema; L axillary tenderness; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Mild L arm edema) and AXILLARY PAIN (L axillary tenderness) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OEDEMA PERIPHERAL (Mild L arm edema) and AXILLARY PAIN (L axillary tenderness). At the time of the report, OEDEMA PERIPHERAL (Mild L arm edema) and AXILLARY PAIN (L axillary tenderness) had resolved. Not Provided          No Concomitant medication details were provided. No Treatment medication details were provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: My husband has Covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My husband has Covid right now) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COVID-19 (My husband has Covid right now). At the time of the report, COVID-19 (My husband has Covid right now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were not reported by reporter. Treatment information was not reported by reporter.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Balance disorder, Dizziness, Hypoaesthesia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot) and ARTHRITIS (Inflammation in the elbow) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot), ARTHRITIS (Inflammation in the elbow), PAIN IN EXTREMITY (pain in the left hand  is increasing), ARTHRALGIA (left shoulder blade hurts) and MYALGIA (body aches). At the time of the report, INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot), ARTHRITIS (Inflammation in the elbow), PAIN IN EXTREMITY (pain in the left hand  is increasing), ARTHRALGIA (left shoulder blade hurts) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. On an unknown date, the patient underwent some laboratory tests like blood test, urine test and x-rays and revealed to be normal, except that they had a little blood in urine. HCP prescribed treatment medication. This case was linked to MOD-2021-309675 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: significant follow up appended. Translation document updated the events. Which includes Inflammation, Dizziness, balance disorder, hypoaesthesia, arthritis, pain in extremity, arthralgia, myalgia.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot) and ARTHRITIS (Inflammation in the elbow) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot), ARTHRITIS (Inflammation in the elbow), PAIN IN EXTREMITY (pain in the left hand  is increasing), ARTHRALGIA (left shoulder blade hurts) and MYALGIA (body aches). At the time of the report, INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot), ARTHRITIS (Inflammation in the elbow), PAIN IN EXTREMITY (pain in the left hand  is increasing), ARTHRALGIA (left shoulder blade hurts) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. On an unknown date, the patient underwent some laboratory tests like blood test, urine test and x-rays and revealed to be normal, except that they had a little blood in urine. HCP prescribed treatment medication. This case was linked to MOD-2021-309675 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: significant follow up appended. Translation document updated the events. Which includes Inflammation, Dizziness, balance disorder, hypoaesthesia, arthritis, pain in extremity, arthralgia, myalgia.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Panic attack, Vaccination site pain
Clinical narrative: Extremely vivid dreams about killing herself; Panic attacks; Extreme pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Extremely vivid dreams about killing herself) and PANIC ATTACK (Panic attacks) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Prozac).   On 07-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ABNORMAL DREAMS (Extremely vivid dreams about killing herself) (seriousness criterion life threatening), PANIC ATTACK (Panic attacks) (seriousness criterion life threatening) and VACCINATION SITE PAIN (Extreme pain on injection site). At the time of the report, ABNORMAL DREAMS (Extremely vivid dreams about killing herself), PANIC ATTACK (Panic attacks) and VACCINATION SITE PAIN (Extreme pain on injection site) outcome was unknown.            Concomitant products were not provided. Treatment information was not reported.  Company Comment:  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Myalgia
Clinical narrative: muscle spasms; feeling fatigue; recurring headaches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms), FATIGUE (feeling fatigue), HEADACHE (recurring headaches) and MYALGIA (sore arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03421A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for Hypercholesteraemia, LOSARTAN for Hypertension.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms), FATIGUE (feeling fatigue), HEADACHE (recurring headaches) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (muscle spasms), FATIGUE (feeling fatigue), HEADACHE (recurring headaches) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.