chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Oropharyngeal pain, Product dose omission issue
Clinical narrative: missed 2 dose of moderna vaccine scheduled on 9 May; Sore throat; Sleepy; Arm pain; Tiredness; I had chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (Sleepy) and MYALGIA (Arm pain) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever), SOMNOLENCE (Sleepy), MYALGIA (Arm pain), FATIGUE (Tiredness) and CHILLS (I had chills). On 08-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (Fever), SOMNOLENCE (Sleepy), MYALGIA (Arm pain), FATIGUE (Tiredness) and CHILLS (I had chills) had resolved. On 11-May-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: missed 2 dose of moderna vaccine scheduled on 9 May; Sore throat; Sleepy; Arm pain; Tiredness; I had chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (Sleepy) and MYALGIA (Arm pain) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever), SOMNOLENCE (Sleepy), MYALGIA (Arm pain), FATIGUE (Tiredness) and CHILLS (I had chills). On 08-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (Fever), SOMNOLENCE (Sleepy), MYALGIA (Arm pain), FATIGUE (Tiredness) and CHILLS (I had chills) had resolved. On 11-May-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Can not sleep without noise masking device; Tinnitus started with right ear and was in both ears the following day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus started with right ear and was in both ears the following day) and INSOMNIA (Can not sleep without noise masking device) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21Q) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy.    On 15-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021 at 4:00 PM, the patient experienced TINNITUS (Tinnitus started with right ear and was in both ears the following day). On an unknown date, the patient experienced INSOMNIA (Can not sleep without noise masking device). The patient was treated with PREDNISONE for Tinnitus, at an unspecified dose and frequency and Physical therapy for Tinnitus. At the time of the report, TINNITUS (Tinnitus started with right ear and was in both ears the following day) had not resolved and INSOMNIA (Can not sleep without noise masking device) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient was given hearing aids to create background noise as corrective. Patient underwent hearing tests, however the findings were not reported. Patient reported that as per the specialist the tinnitus was probably permanent.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received information contains Patient's demographic details, medical history, vaccine start date and new event insomnia was added. Treatment medication specified.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose 57 days ago; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 57 days ago) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 57 days ago). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 57 days ago) 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.   No concomitant medication taken by the patient. No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Feeling weak; Lightheadedness; Queasy; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Feeling weak), DIZZINESS (Lightheadedness) and NAUSEA (Queasy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feeling weak), DIZZINESS (Lightheadedness) and NAUSEA (Queasy). At the time of the report, ASTHENIA (Feeling weak), DIZZINESS (Lightheadedness) and NAUSEA (Queasy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Dizziness
Clinical narrative: lost smell; Loss of taste; Felt exhausted; Chills; Nausea; Cough; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DIZZINESS (Dizziness), ANOSMIA (lost smell), AGEUSIA (Loss of taste) and FATIGUE (Felt exhausted) in a 52-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.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced COUGH (Cough), DIZZINESS (Dizziness), FATIGUE (Felt exhausted), CHILLS (Chills) and NAUSEA (Nausea). On 10-May-2021, the patient experienced ANOSMIA (lost smell) and AGEUSIA (Loss of taste). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DIZZINESS (Dizziness), ANOSMIA (lost smell), AGEUSIA (Loss of taste), FATIGUE (Felt exhausted), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: lost smell; Loss of taste; Felt exhausted; Chills; Nausea; Cough; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DIZZINESS (Dizziness), ANOSMIA (lost smell), AGEUSIA (Loss of taste) and FATIGUE (Felt exhausted) in a 52-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.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced COUGH (Cough), DIZZINESS (Dizziness), FATIGUE (Felt exhausted), CHILLS (Chills) and NAUSEA (Nausea). On 10-May-2021, the patient experienced ANOSMIA (lost smell) and AGEUSIA (Loss of taste). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DIZZINESS (Dizziness), ANOSMIA (lost smell), AGEUSIA (Loss of taste), FATIGUE (Felt exhausted), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Product administered at inappropriate site, Vaccination site erythema
Clinical narrative: A little bit warm; it was red ( at the injection site), It was about 3-inch-wide and 2 inches high; I felt the vaccinator gave me the injection   way on the top of the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (I felt the vaccinator gave me the injection   way on the top of the shoulder), FEELING HOT (A little bit warm) and VACCINATION SITE ERYTHEMA (it was red ( at the injection site), It was about 3-inch-wide and 2 inches high) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O37B21A and COAC21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (I felt the vaccinator gave me the injection   way on the top of the shoulder). On 11-May-2021, the patient experienced FEELING HOT (A little bit warm) and VACCINATION SITE ERYTHEMA (it was red ( at the injection site), It was about 3-inch-wide and 2 inches high). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 10-May-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (I felt the vaccinator gave me the injection   way on the top of the shoulder) had resolved. At the time of the report, FEELING HOT (A little bit warm) and VACCINATION SITE ERYTHEMA (it was red ( at the injection site), It was about 3-inch-wide and 2 inches high) outcome was unknown.            No Concomitant medication administered.  Action taken with mRNA-1273 Moderna vaccine was not applicable
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Decreased appetite, Fatigue, Feeling of body temperature change
Clinical narrative: hasn't eaten anything in two days; no taste for nothing either; unable to work due to so much pain; aching better; so much pain moving it she was scared to move it (arm); head hurting like crazy; woke up that day with a headache; joint pain; really tired; started feeling under the weather; felt like the flu; runny eyes; sneezing; getting hot and cold all night; sweating to death; pain started with the arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing) and FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00SC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced VACCINATION SITE PAIN (pain started with the arm). On 10-May-2021, the patient experienced MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain) and FATIGUE (really tired). On an unknown date, the patient experienced DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)) and HEADACHE (head hurting like crazy). The patient was treated with LIDOCAINE ongoing since an unknown date at an unspecified dose and frequency. On 11-May-2021, VACCINATION SITE PAIN (pain started with the arm) outcome was unknown. At the time of the report, MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain), FATIGUE (really tired) and HEADACHE (head hurting like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes unspecified blood pressure pill. Treatment information included were heat and cold packs, lidocaine patch, daytime cold and flu medication.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Lacrimation increased, Malaise
Clinical narrative: hasn't eaten anything in two days; no taste for nothing either; unable to work due to so much pain; aching better; so much pain moving it she was scared to move it (arm); head hurting like crazy; woke up that day with a headache; joint pain; really tired; started feeling under the weather; felt like the flu; runny eyes; sneezing; getting hot and cold all night; sweating to death; pain started with the arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing) and FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00SC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced VACCINATION SITE PAIN (pain started with the arm). On 10-May-2021, the patient experienced MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain) and FATIGUE (really tired). On an unknown date, the patient experienced DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)) and HEADACHE (head hurting like crazy). The patient was treated with LIDOCAINE ongoing since an unknown date at an unspecified dose and frequency. On 11-May-2021, VACCINATION SITE PAIN (pain started with the arm) outcome was unknown. At the time of the report, MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain), FATIGUE (really tired) and HEADACHE (head hurting like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes unspecified blood pressure pill. Treatment information included were heat and cold packs, lidocaine patch, daytime cold and flu medication.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Sneezing, Vaccination site pain
Clinical narrative: hasn't eaten anything in two days; no taste for nothing either; unable to work due to so much pain; aching better; so much pain moving it she was scared to move it (arm); head hurting like crazy; woke up that day with a headache; joint pain; really tired; started feeling under the weather; felt like the flu; runny eyes; sneezing; getting hot and cold all night; sweating to death; pain started with the arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing) and FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00SC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced VACCINATION SITE PAIN (pain started with the arm). On 10-May-2021, the patient experienced MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain) and FATIGUE (really tired). On an unknown date, the patient experienced DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)) and HEADACHE (head hurting like crazy). The patient was treated with LIDOCAINE ongoing since an unknown date at an unspecified dose and frequency. On 11-May-2021, VACCINATION SITE PAIN (pain started with the arm) outcome was unknown. At the time of the report, MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain), FATIGUE (really tired) and HEADACHE (head hurting like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes unspecified blood pressure pill. Treatment information included were heat and cold packs, lidocaine patch, daytime cold and flu medication.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: positive for covid-19/ Had covid like symptoms; sore throat for 3 days; Was extremely tired/  Still feeling tired; severe headache; Arm hurt 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for covid-19/ Had covid like symptoms), OROPHARYNGEAL PAIN (sore throat for 3 days), FATIGUE (Was extremely tired/  Still feeling tired), HEADACHE (severe headache) and MYALGIA (Arm hurt 2 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (Arm hurt 2 days). On 20-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat for 3 days), FATIGUE (Was extremely tired/  Still feeling tired) and HEADACHE (severe headache). On 24-Apr-2021, the patient experienced COVID-19 (positive for covid-19/ Had covid like symptoms). On 19-Apr-2021, MYALGIA (Arm hurt 2 days) had resolved. On 24-Apr-2021, OROPHARYNGEAL PAIN (sore throat for 3 days) had resolved. At the time of the report, COVID-19 (positive for covid-19/ Had covid like symptoms), FATIGUE (Was extremely tired/  Still feeling tired) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: other (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: positive for covid-19/ Had covid like symptoms; sore throat for 3 days; Was extremely tired/  Still feeling tired; severe headache; Arm hurt 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for covid-19/ Had covid like symptoms), OROPHARYNGEAL PAIN (sore throat for 3 days), FATIGUE (Was extremely tired/  Still feeling tired), HEADACHE (severe headache) and MYALGIA (Arm hurt 2 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (Arm hurt 2 days). On 20-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat for 3 days), FATIGUE (Was extremely tired/  Still feeling tired) and HEADACHE (severe headache). On 24-Apr-2021, the patient experienced COVID-19 (positive for covid-19/ Had covid like symptoms). On 19-Apr-2021, MYALGIA (Arm hurt 2 days) had resolved. On 24-Apr-2021, OROPHARYNGEAL PAIN (sore throat for 3 days) had resolved. At the time of the report, COVID-19 (positive for covid-19/ Had covid like symptoms), FATIGUE (Was extremely tired/  Still feeling tired) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: other (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot to the touch; rash on the injection site; redness that is the size of a softball; sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness that is the size of a softball) and VACCINATION SITE PAIN (sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness that is the size of a softball) and VACCINATION SITE PAIN (sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness that is the size of a softball) and VACCINATION SITE PAIN (sore arm) 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.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Feeling unwell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) and PYREXIA (Fever) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Dyspnoea, Fatigue
Clinical narrative: condition worsened; Flu like symptoms; Shortness Of Breath; In Bed For 1 Week (After Second Shot),tired; Headache; Arthralgia; Myalgia; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ) and VOMITING (Vomiting ). 05-Apr-2021, the patient experienced NAUSEA (Nausea). On 12-Apr-2021, FATIGUE (In Bed For 1 Week (After Second Shot),tired) had resolved. On 14-Apr-2021, CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ), NAUSEA (Nausea) and VOMITING (Vomiting ) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-058172 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pyrexia
Clinical narrative: condition worsened; Flu like symptoms; Shortness Of Breath; In Bed For 1 Week (After Second Shot),tired; Headache; Arthralgia; Myalgia; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ) and VOMITING (Vomiting ). 05-Apr-2021, the patient experienced NAUSEA (Nausea). On 12-Apr-2021, FATIGUE (In Bed For 1 Week (After Second Shot),tired) had resolved. On 14-Apr-2021, CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ), NAUSEA (Nausea) and VOMITING (Vomiting ) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-058172 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: condition worsened; Flu like symptoms; Shortness Of Breath; In Bed For 1 Week (After Second Shot),tired; Headache; Arthralgia; Myalgia; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ) and VOMITING (Vomiting ). 05-Apr-2021, the patient experienced NAUSEA (Nausea). On 12-Apr-2021, FATIGUE (In Bed For 1 Week (After Second Shot),tired) had resolved. On 14-Apr-2021, CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ), NAUSEA (Nausea) and VOMITING (Vomiting ) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-058172 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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.   It was reported that patient had received first dose more than 42 days ago. No decision about second dose yet. No more information available, pharmacist was in rash with line.  No treatment medication was reported. No concomitant medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-017714 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-017714:dose 1
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breathe) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DYSPNOEA (Shortness of breathe). At the time of the report, DYSPNOEA (Shortness of breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. It was reported that patient experienced all the expected symptoms that is listed on the sheet.  Follow-up received 08-MAY-2021 date included no new information   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow-up received and does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Palpitations
Clinical narrative: Heart racing; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PALPITATIONS (Heart racing), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PALPITATIONS (Heart racing) had not resolved and MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Cough, Fatigue
Clinical narrative: Loss of taste; Cough; Loss of smell; congestion; Muscle aches; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion) and MYALGIA (Muscle aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced AGEUSIA (Loss of taste), COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion), MYALGIA (Muscle aches), PYREXIA (fever) and FATIGUE (tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 11-May-2021, COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion), MYALGIA (Muscle aches), PYREXIA (fever) and FATIGUE (tired) had resolved. At the time of the report, AGEUSIA (Loss of taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Body temperature: 103 (High) 103F. On 04-May-2021, Body temperature: 101 (High) 101F. On 05-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that he tested positive six days after first dose. On 02-May-2021 patient experienced symptoms. He experienced COVID-19 symptoms like fever, lost taste, cough, congestion, tired. Patient did not seek medical care for the events. Patient rested at home to recover. Patient stated that possibly he caught COVID-19 at clinic while being vaccinated and no other place he could have got it. Patient recovered on 11-May-2021 and still had lost of taste as of 19-Jun-2021.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Additional information received on 19-Jun-2021: Patient demographics were updated; Lab data was updated; second dose details added and additional events of fever and congestion were added.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Loss of taste; Cough; Loss of smell; congestion; Muscle aches; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion) and MYALGIA (Muscle aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 038c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced AGEUSIA (Loss of taste), COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion), MYALGIA (Muscle aches), PYREXIA (fever) and FATIGUE (tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 11-May-2021, COUGH (Cough), ANOSMIA (Loss of smell), NASAL CONGESTION (congestion), MYALGIA (Muscle aches), PYREXIA (fever) and FATIGUE (tired) had resolved. At the time of the report, AGEUSIA (Loss of taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Body temperature: 103 (High) 103F. On 04-May-2021, Body temperature: 101 (High) 101F. On 05-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that he tested positive six days after first dose. On 02-May-2021 patient experienced symptoms. He experienced COVID-19 symptoms like fever, lost taste, cough, congestion, tired. Patient did not seek medical care for the events. Patient rested at home to recover. Patient stated that possibly he caught COVID-19 at clinic while being vaccinated and no other place he could have got it. Patient recovered on 11-May-2021 and still had lost of taste as of 19-Jun-2021.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Additional information received on 19-Jun-2021: Patient demographics were updated; Lab data was updated; second dose details added and additional events of fever and congestion were added.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Bigger and itchier rash come back again; Unexplained episode of diarrhea after the 1st dose; Black and blue marks under the skin in the injection site left arm after the 1st dose; Itchy left arm after 1st dose; Red left arm after 1st dose; Swollen left arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose). On 11-May-2021, the patient experienced VACCINATION SITE RASH (Bigger and itchier rash come back again). On 09-May-2021, DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose) had not resolved and VACCINATION SITE RASH (Bigger and itchier rash come back again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Bigger and itchier rash come back again; Unexplained episode of diarrhea after the 1st dose; Black and blue marks under the skin in the injection site left arm after the 1st dose; Itchy left arm after 1st dose; Red left arm after 1st dose; Swollen left arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose). On 11-May-2021, the patient experienced VACCINATION SITE RASH (Bigger and itchier rash come back again). On 09-May-2021, DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose) had not resolved and VACCINATION SITE RASH (Bigger and itchier rash come back again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.