chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: pain intensified from itchy to a "persistent twingy pain" that ranges rom mild to moderate; Breast pain; Twingy; "itchy odd sensation" on the left side (side of injection) of the "armpit" that radiates to the breast area that began a week after injection; Armpit pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (pain intensified from itchy to a "persistent twingy pain" that ranges rom mild to moderate), BREAST PAIN (Breast pain), MALAISE (Twingy), PRURITUS ("itchy odd sensation" on the left side (side of injection) of the "armpit" that radiates to the breast area that began a week after injection) and AXILLARY PAIN (Armpit pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiovascular disease, unspecified.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN (pain intensified from itchy to a "persistent twingy pain" that ranges rom mild to moderate), BREAST PAIN (Breast pain), MALAISE (Twingy), PRURITUS ("itchy odd sensation" on the left side (side of injection) of the "armpit" that radiates to the breast area that began a week after injection) and AXILLARY PAIN (Armpit pain). At the time of the report, PAIN (pain intensified from itchy to a "persistent twingy pain" that ranges rom mild to moderate), BREAST PAIN (Breast pain), MALAISE (Twingy), PRURITUS ("itchy odd sensation" on the left side (side of injection) of the "armpit" that radiates to the breast area that began a week after injection) and AXILLARY PAIN (Armpit pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) No abnormalities were found.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked toMOD-2021-123400 (E2B Linked Report).; Sender's Comments:  MOD-2021-123400:dose 2
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: throat started to close up/felt kind of like a burning slightly going up side of her neck; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat started to close up/felt kind of like a burning slightly going up side of her neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM, LEVOTHYROXINE and ESTRADIOL for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced THROAT IRRITATION (throat started to close up/felt kind of like a burning slightly going up side of her neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat irritation, at an unspecified dose and frequency. On 19-Apr-2021, THROAT IRRITATION (throat started to close up/felt kind of like a burning slightly going up side of her neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other treatment medications included an unspecified medicine taken in emergency room and patient was released once she was able to breath easier.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Memory impairment, Pain in extremity
Clinical narrative: more confused this times and confusion at times; forgets more and stops in the middle of her sentence when she is saying something; soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (more confused this times and confusion at times), MEMORY IMPAIRMENT (forgets more and stops in the middle of her sentence when she is saying something) and PAIN IN EXTREMITY (soreness in right arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced CONFUSIONAL STATE (more confused this times and confusion at times), MEMORY IMPAIRMENT (forgets more and stops in the middle of her sentence when she is saying something) and PAIN IN EXTREMITY (soreness in right arm). On 13-Apr-2021, CONFUSIONAL STATE (more confused this times and confusion at times), MEMORY IMPAIRMENT (forgets more and stops in the middle of her sentence when she is saying something) and PAIN IN EXTREMITY (soreness in right arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-123226 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Rash, Throat tightness
Clinical narrative: Throat started to close; could not breathe; Rash broke out on back and arms; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Throat started to close), DYSPNOEA (could not breathe) and RASH (Rash broke out on back and arms) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020AB21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced THROAT TIGHTNESS (Throat started to close). 05-Apr-2021, the patient experienced DYSPNOEA (could not breathe) and RASH (Rash broke out on back and arms). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Throat started to close), DYSPNOEA (could not breathe) and RASH (Rash broke out on back and arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Blood pressure measurement: high (High) went up. On 05-Apr-2021, Heart rate: high (High) High.         Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-123438 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: Fever; Chills; Joint pains; Headaches; Injection site pain; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-May-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient reported using ice for treating the events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Chills; Joint pains; Headaches; Injection site pain; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-May-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient reported using ice for treating the events.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: missed second dose /it is now49 days since patient received the 1st dose; Pain at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose /it is now49 days since patient received the 1st dose) and VACCINATION SITE PAIN (Pain at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Blood pressure. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST, ALBUTEROL [SALBUTAMOL] and SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, AMLODIPINE and LISINOPRIL for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID] and VIT D [VITAMIN D NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose /it is now49 days since patient received the 1st dose) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose /it is now49 days since patient received the 1st dose) and VACCINATION SITE PAIN (Pain at injection site) 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 treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Event added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Myalgia, Nasopharyngitis
Clinical narrative: cold; soreness in arm; ache; whole body ache; Tiredness; loss appetite; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss appetite), ASTHENIA (Weakness), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (soreness in arm) and PAIN (ache) in a 71-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 was reported.  Concomitant products included FISH OIL, MULTIVITAMIN [VITAMINS NOS] and GLUCOSAMINE & CHONDORITIN for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DECREASED APPETITE (loss appetite), ASTHENIA (Weakness), PAIN IN EXTREMITY (soreness in arm), PAIN (ache), MYALGIA (whole body ache) and FATIGUE (Tiredness). On 26-Apr-2021, the patient experienced NASOPHARYNGITIS (cold). On 21-Apr-2021, DECREASED APPETITE (loss appetite), ASTHENIA (Weakness), PAIN IN EXTREMITY (soreness in arm), PAIN (ache), MYALGIA (whole body ache) and FATIGUE (Tiredness) had resolved. On 03-May-2021, NASOPHARYNGITIS (cold) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-122864, US-MODERNATX, INC.-MOD-2021-122966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122864:Crosslink US-MODERNATX, INC.-MOD-2021-122966:Case for husband
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: cold; soreness in arm; ache; whole body ache; Tiredness; loss appetite; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss appetite), ASTHENIA (Weakness), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (soreness in arm) and PAIN (ache) in a 71-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 was reported.  Concomitant products included FISH OIL, MULTIVITAMIN [VITAMINS NOS] and GLUCOSAMINE & CHONDORITIN for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DECREASED APPETITE (loss appetite), ASTHENIA (Weakness), PAIN IN EXTREMITY (soreness in arm), PAIN (ache), MYALGIA (whole body ache) and FATIGUE (Tiredness). On 26-Apr-2021, the patient experienced NASOPHARYNGITIS (cold). On 21-Apr-2021, DECREASED APPETITE (loss appetite), ASTHENIA (Weakness), PAIN IN EXTREMITY (soreness in arm), PAIN (ache), MYALGIA (whole body ache) and FATIGUE (Tiredness) had resolved. On 03-May-2021, NASOPHARYNGITIS (cold) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-122864, US-MODERNATX, INC.-MOD-2021-122966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122864:Crosslink US-MODERNATX, INC.-MOD-2021-122966:Case for husband
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Asthenopia, Fatigue, Headache
Clinical narrative: Swollen arm; Could not tolerate the smell of food; Lost sense of taste; could not keep my eyes open; Fatigue; Sore arm for 5 days; Nagging headache; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PERIPHERAL SWELLING (Swollen arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost sense of taste) and ASTHENOPIA (could not keep my eyes open) in a 61-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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PERIPHERAL SWELLING (Swollen arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost sense of taste), ASTHENOPIA (could not keep my eyes open), FATIGUE (Fatigue), MYALGIA (Sore arm for 5 days) and HEADACHE (Nagging headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form every six hours. At the time of the report, ASTHENIA (Weakness), PERIPHERAL SWELLING (Swollen arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost sense of taste), ASTHENOPIA (could not keep my eyes open), FATIGUE (Fatigue), MYALGIA (Sore arm for 5 days) and HEADACHE (Nagging headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-123540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123540:Husband's case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Parosmia, Peripheral swelling
Clinical narrative: Swollen arm; Could not tolerate the smell of food; Lost sense of taste; could not keep my eyes open; Fatigue; Sore arm for 5 days; Nagging headache; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PERIPHERAL SWELLING (Swollen arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost sense of taste) and ASTHENOPIA (could not keep my eyes open) in a 61-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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PERIPHERAL SWELLING (Swollen arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost sense of taste), ASTHENOPIA (could not keep my eyes open), FATIGUE (Fatigue), MYALGIA (Sore arm for 5 days) and HEADACHE (Nagging headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form every six hours. At the time of the report, ASTHENIA (Weakness), PERIPHERAL SWELLING (Swollen arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost sense of taste), ASTHENOPIA (could not keep my eyes open), FATIGUE (Fatigue), MYALGIA (Sore arm for 5 days) and HEADACHE (Nagging headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-123540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123540:Husband's case
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Felt confused; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Felt confused) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Felt confused). At the time of the report, CONFUSIONAL STATE (Felt confused) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-123936 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123936:crosslinked
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; Nausea; Soreness of Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Arm), PYREXIA (Fever) and NAUSEA (Nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Arm). On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Soreness of Arm), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 101 degree fahrenheit (High) 101 Degree Fahrenheit.         Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (felt warm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (felt warm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (felt warm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No relevant concomitant medications were reported. The patient visited her daughter the weekend before the second vaccination and found out on Friday 07May2021 the day after vaccination that her daughter was positive for COVID-19. This case was linked to MOD21-089454, US-MODERNATX, INC.-MOD-2021-123426, MOD21-089473 (E2B Linked Report).; Sender's Comments: MOD21-089454: US-MODERNATX, INC.-MOD-2021-123426:Mother. MOD21-089473:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to patient <18 yrs old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient <18 yrs old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient <18 yrs old). On 14-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient <18 yrs old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had rashes on my upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Had rashes on my upper body) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) 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) at an unspecified dose. On 22-Apr-2021, the patient experienced RASH (Had rashes on my upper body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 24-Apr-2021, RASH (Had rashes on my upper body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: pyrexia; Shortness of Breath; oxygen saturation went down of 86%; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), OXYGEN SATURATION DECREASED (oxygen saturation went down of 86%) and PYREXIA (pyrexia) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Hypertension. Concomitant products included OXYGEN for COPD, AMLODIPINE and LISINOPRIL for Hypertension arterial.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Shortness of Breath) and OXYGEN SATURATION DECREASED (oxygen saturation went down of 86%). On an unknown date, the patient experienced PYREXIA (pyrexia). The patient was treated with OXYGEN on 17-Apr-2021 for Oxygen saturation decreased, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of Breath), OXYGEN SATURATION DECREASED (oxygen saturation went down of 86%) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Oxygen saturation: 86% (Low) 86%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to-MOD-2021-122565 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Followup received included date of birth and pyrexia as event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-122565:Wife case
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia
Clinical narrative: Heavy sound sleep and need more sleep; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Heavy sound sleep and need more sleep), HEADACHE (Headache) and FATIGUE (Fatigue) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HYPERSOMNIA (Heavy sound sleep and need more sleep), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HYPERSOMNIA (Heavy sound sleep and need more sleep) had not resolved and HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.            No concomitant and treatment medication information was reported. Patient stated that she generally have intolerances to pharmaceuticals and avoid them and she does not eat meat and have a heathy diet and that she is overweight and exercises regularly.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow-up received: updated event outcomes headache to resolved and hypersomnia to not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Skin discolouration, Vaccination complication
Clinical narrative: Something set into pinky and fingers; Whole hand on right side affected; Feet and toes hurt/almost crippled; Hard and painful to get out of bed; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Something set into pinky and fingers), LIMB DISCOMFORT (Whole hand on right side affected), PAIN IN EXTREMITY (Feet and toes hurt/almost crippled) and VACCINATION COMPLICATION (Hard and painful to get out of bed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042821A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (seasonal allergies). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Seasonal allergy.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Apr-2021, the patient experienced SKIN DISCOLOURATION (Something set into pinky and fingers), LIMB DISCOMFORT (Whole hand on right side affected), PAIN IN EXTREMITY (Feet and toes hurt/almost crippled) and VACCINATION COMPLICATION (Hard and painful to get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Something set into pinky and fingers), LIMB DISCOMFORT (Whole hand on right side affected), PAIN IN EXTREMITY (Feet and toes hurt/almost crippled) and VACCINATION COMPLICATION (Hard and painful to get out of bed) 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Felt like regurgitating; Injection 'really burned' in left arm; Left arm  was sore; Feeling really nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Felt like regurgitating), PAIN IN EXTREMITY (Left arm  was sore), NAUSEA (Feeling really nauseous) and INJECTION SITE PAIN (Injection 'really burned' in left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection 'really burned' in left arm). In January 2021, the patient experienced PAIN IN EXTREMITY (Left arm  was sore) and NAUSEA (Feeling really nauseous). On 03-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like regurgitating). At the time of the report, FEELING ABNORMAL (Felt like regurgitating), PAIN IN EXTREMITY (Left arm  was sore), NAUSEA (Feeling really nauseous) and INJECTION SITE PAIN (Injection 'really burned' in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer reported that she received the first dose of Moderna COVID-19 vaccine in left upper arm on 06-Jan-2021. Expiration Date: Unknown. Consumer reports the injection 'really burned' in left arm. Consumer reports on the second day, feeling really nauseous, felt like regurgitating, was not too tired and left arm was sore, after first dose. Concomitant medications included: Cholesterol pills. No information provided regarding treatment. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 2-JUN-2021 has no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) 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 medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-089564, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089653, MOD21-089655, MOD21-089658, MOD21-089660 (E2B Linked Report).; Sender's Comments:  MOD21-089564:same reporter MOD21-089636:same reporter MOD21-089642:same reporter MOD21-089644:same reporter MOD21-089646:same reporter MOD21-089653:same reporter MOD21-089655:same reporter MOD21-089658:same reporter MOD21-089660:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of an adverse reaction (severe reactions), vaccination site pain (tenderness at the injection site) and pyrexia (fever of 102.7 degrees) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 7 , 2021, patient experienced an adverse reaction (severe reactions), vaccination site pain (tenderness at the injection site) and pyrexia (fever of 102.7 degrees). At the time of the report, adverse reaction (severe reactions) resolved; vaccination site pain (tenderness at the injection site): not resolved; and pyrexia (fever of 102.7 degrees) outcome: unknown. Diagnostic results: On May 7, 2021, body temperature: Fever of 102.7 degrees (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: Diarrhea; Fever; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03922) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhea, at an unspecified dose and frequency. On 17-Apr-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: fever of 99.5 degrees Farenheight; flu symptoms; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.5 degrees Farenheight), INFLUENZA LIKE ILLNESS (flu symptoms) and MYALGIA (muscle aches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (fever of 99.5 degrees Farenheight), INFLUENZA LIKE ILLNESS (flu symptoms) and MYALGIA (muscle aches). At the time of the report, PYREXIA (fever of 99.5 degrees Farenheight), INFLUENZA LIKE ILLNESS (flu symptoms) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 99.5 fever of 99.5 degrees Farenheight.         no concomitant medications are provided. treatment to the events not  provided. Action taken with mRNA-1273 in response to the event was not applicable
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Axillary pain, Breast pain, Pain, Pruritus
Clinical narrative: Itchy; Odd sensation; Breast pain; Twingy; Armpit pain; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain), PAIN (Twingy) and AXILLARY PAIN (Armpit pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiovascular disorder.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain) and PAIN (Twingy). 07-Feb-2021, the patient experienced AXILLARY PAIN (Armpit pain). At the time of the report, PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain), PAIN (Twingy) and AXILLARY PAIN (Armpit pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (normal) No abnormalities found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Patient experienced the same symptoms as of the first dose," itchy odd sensation" under her right armpit and the right side of her breast. Nurse reports symptoms are still present as of 12 May 2021 and that the pain "comes and goes". She reported that the pain was worse on the left side than the right side.   This case was linked to INC.-MOD-2021-123238 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-123238:dose 1
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Itchy; Odd sensation; Breast pain; Twingy; Armpit pain; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain), PAIN (Twingy) and AXILLARY PAIN (Armpit pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiovascular disorder.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain) and PAIN (Twingy). 07-Feb-2021, the patient experienced AXILLARY PAIN (Armpit pain). At the time of the report, PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain), PAIN (Twingy) and AXILLARY PAIN (Armpit pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (normal) No abnormalities found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Patient experienced the same symptoms as of the first dose," itchy odd sensation" under her right armpit and the right side of her breast. Nurse reports symptoms are still present as of 12 May 2021 and that the pain "comes and goes". She reported that the pain was worse on the left side than the right side.   This case was linked to INC.-MOD-2021-123238 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-123238:dose 1
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Heart rate irregular, Influenza like illness
Clinical narrative: temperature of 99.6; soreness in the arm; sleepy; felt like crap/feels so crappy right now; weakness; fast heartbeat which fluctuates; feels like she is was having a flu; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FEELING ABNORMAL (felt like crap/feels so crappy right now), ASTHENIA (weakness), HEART RATE IRREGULAR (fast heartbeat which fluctuates) and INFLUENZA LIKE ILLNESS (feels like she is was having a flu) in a 63-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.     The patient's past medical history included Stent placement (5years ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN, ATORVASTATIN and ISOSORBIDE MONONITRATE for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced SOMNOLENCE (sleepy), FEELING ABNORMAL (felt like crap/feels so crappy right now), ASTHENIA (weakness), HEART RATE IRREGULAR (fast heartbeat which fluctuates), INFLUENZA LIKE ILLNESS (feels like she is was having a flu) and MYALGIA (soreness in the arm). On 12-May-2021, the patient experienced PYREXIA (temperature of 99.6). At the time of the report, SOMNOLENCE (sleepy), FEELING ABNORMAL (felt like crap/feels so crappy right now), ASTHENIA (weakness), HEART RATE IRREGULAR (fast heartbeat which fluctuates), INFLUENZA LIKE ILLNESS (feels like she is was having a flu), PYREXIA (temperature of 99.6) and MYALGIA (soreness in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (High) 99.6F.         This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non significant follow up received on 11-JUN-2021, no new information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Somnolence
Clinical narrative: temperature of 99.6; soreness in the arm; sleepy; felt like crap/feels so crappy right now; weakness; fast heartbeat which fluctuates; feels like she is was having a flu; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FEELING ABNORMAL (felt like crap/feels so crappy right now), ASTHENIA (weakness), HEART RATE IRREGULAR (fast heartbeat which fluctuates) and INFLUENZA LIKE ILLNESS (feels like she is was having a flu) in a 63-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.     The patient's past medical history included Stent placement (5years ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN, ATORVASTATIN and ISOSORBIDE MONONITRATE for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced SOMNOLENCE (sleepy), FEELING ABNORMAL (felt like crap/feels so crappy right now), ASTHENIA (weakness), HEART RATE IRREGULAR (fast heartbeat which fluctuates), INFLUENZA LIKE ILLNESS (feels like she is was having a flu) and MYALGIA (soreness in the arm). On 12-May-2021, the patient experienced PYREXIA (temperature of 99.6). At the time of the report, SOMNOLENCE (sleepy), FEELING ABNORMAL (felt like crap/feels so crappy right now), ASTHENIA (weakness), HEART RATE IRREGULAR (fast heartbeat which fluctuates), INFLUENZA LIKE ILLNESS (feels like she is was having a flu), PYREXIA (temperature of 99.6) and MYALGIA (soreness in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (High) 99.6F.         This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non significant follow up received on 11-JUN-2021, no new information