chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Sensitive skin
Clinical narrative: severe arm pain; Skin sensitivity at the injection site area; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain), SENSITIVE SKIN (Skin sensitivity at the injection site area) and FATIGUE (Exhaustion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROXYZINE, PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain), SENSITIVE SKIN (Skin sensitivity at the injection site area) and FATIGUE (Exhaustion). On 13-Mar-2021, PAIN IN EXTREMITY (severe arm pain), SENSITIVE SKIN (Skin sensitivity at the injection site area) and FATIGUE (Exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications    This case was linked to -MODERNATX, INC.-MOD-2021-070028 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-070028:Second dose case
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Temporomandibular joint syndrome, Vaccination site pain
Clinical narrative: Flare up of his TMJ pain; Chills; Body aches; Pain in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of TEMPOROMANDIBULAR JOINT SYNDROME (Flare up of his TMJ pain), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain in the right arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Temporomandibular joint syndrome. Concomitant products included PREDNISONE from 03-Apr-2021 to an unknown date for Temporomandibular joint syndrome.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 06-Apr-2021, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (Flare up of his TMJ pain), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain in the right arm). At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (Flare up of his TMJ pain), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain in the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received 1st dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 1st dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 1st dose of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 1st dose of vaccine) outcome was unknown. Not Provided      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.   Concomitant product use was not provided. No treatment was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient >42 days since first dose on 20Feb2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient >42 days since first dose on 20Feb2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient >42 days since first dose on 20Feb2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient >42 days since first dose on 20Feb2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: Had arm pain; Malaise; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had arm pain), MALAISE (Malaise) and FATIGUE (Fatigue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergic to scallops and mollusks) and Hashimoto's thyroiditis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Had arm pain), MALAISE (Malaise) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Had arm pain), MALAISE (Malaise) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.  On 02 Apr 2021, the patient received second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  As the patient received both scheduled doses of vaccine action taken with the drug in response to the event was not applicable.    Treatment details was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-070029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070029:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: painful infection in her left molar that was beginning to abscess; painful infection in her left molar that was beginning to abscess; her face was swollen; eye was twitching; she had intense pain at night due to the molar infection.; fever; chills; tiredness; achiness; painful infection in her left molar that was beginning to; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (painful infection in her left molar that was beginning to abscess), TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess), SWELLING FACE (her face was swollen), THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to) and BLEPHAROSPASM (eye was twitching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental abscess. Concomitant products included BENZOCAINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (achiness). On an unknown date, the patient experienced TOOTH INFECTION (painful infection in her left molar that was beginning to abscess), TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess), SWELLING FACE (her face was swollen), BLEPHAROSPASM (eye was twitching) and TOOTHACHE (she had intense pain at night due to the molar infection.). On 13-Mar-2021, TOOTH INFECTION (painful infection in her left molar that was beginning to abscess) had resolved, TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess) outcome was unknown. On 15-Mar-2021, PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (achiness) had resolved. At the time of the report, SWELLING FACE (her face was swollen), THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to), BLEPHAROSPASM (eye was twitching) and TOOTHACHE (she had intense pain at night due to the molar infection.) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-069996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069996:case for first dose
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Therapeutic response unexpected, Tooth abscess, Tooth infection, Toothache
Clinical narrative: painful infection in her left molar that was beginning to abscess; painful infection in her left molar that was beginning to abscess; her face was swollen; eye was twitching; she had intense pain at night due to the molar infection.; fever; chills; tiredness; achiness; painful infection in her left molar that was beginning to; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (painful infection in her left molar that was beginning to abscess), TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess), SWELLING FACE (her face was swollen), THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to) and BLEPHAROSPASM (eye was twitching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental abscess. Concomitant products included BENZOCAINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (achiness). On an unknown date, the patient experienced TOOTH INFECTION (painful infection in her left molar that was beginning to abscess), TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess), SWELLING FACE (her face was swollen), BLEPHAROSPASM (eye was twitching) and TOOTHACHE (she had intense pain at night due to the molar infection.). On 13-Mar-2021, TOOTH INFECTION (painful infection in her left molar that was beginning to abscess) had resolved, TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess) outcome was unknown. On 15-Mar-2021, PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (achiness) had resolved. At the time of the report, SWELLING FACE (her face was swollen), THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to), BLEPHAROSPASM (eye was twitching) and TOOTHACHE (she had intense pain at night due to the molar infection.) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-069996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069996:case for first dose
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache; Fatigue; muscle aches and severe body aches; massive migraine; felt like she had COVID19; extreme chills/freezing; fever; tenderness at injection site/same site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection site/same site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia in November 2020. Concurrent medical conditions included Drug allergy (Zithromax.), Breathing difficult (Only needed inhalers once in a while. Patient use them much more often.), Asthma and Heart disorder. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, QUINAPRIL for Blood pressure management, ROSUVASTATIN and METOPROLOL for Heart disease, unspecified, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection site/same site pain). On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (muscle aches and severe body aches). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency and IBUPROFEN for Migraine, at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE PAIN (tenderness at injection site/same site pain) and HEADACHE (Headache) had resolved. At the time of the report, MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever), FATIGUE (Fatigue) and MYALGIA (muscle aches and severe body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 102 (High) went up quickly and ran 102-104 for the next 48 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Current condition also included blood pressure NOS.  The patient stated that she felt up to starting work in about 4 days but was totally wiped out.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: The patient information, events, event outcomes and concomitant medications were updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Fatigue; muscle aches and severe body aches; massive migraine; felt like she had COVID19; extreme chills/freezing; fever; tenderness at injection site/same site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection site/same site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia in November 2020. Concurrent medical conditions included Drug allergy (Zithromax.), Breathing difficult (Only needed inhalers once in a while. Patient use them much more often.), Asthma and Heart disorder. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, QUINAPRIL for Blood pressure management, ROSUVASTATIN and METOPROLOL for Heart disease, unspecified, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection site/same site pain). On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (muscle aches and severe body aches). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency and IBUPROFEN for Migraine, at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE PAIN (tenderness at injection site/same site pain) and HEADACHE (Headache) had resolved. At the time of the report, MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever), FATIGUE (Fatigue) and MYALGIA (muscle aches and severe body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 102 (High) went up quickly and ran 102-104 for the next 48 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Current condition also included blood pressure NOS.  The patient stated that she felt up to starting work in about 4 days but was totally wiped out.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: The patient information, events, event outcomes and concomitant medications were updated.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bed rest, Body temperature, Body temperature increased, Erythema
Clinical narrative: Soreness in shoulder; In bed for a while; Swelling; Redness; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038KZ0A and 00ZBZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, FLECAINIDE, HYDROCHLOROTHIAZIDE, METHIMAZOLE, OMEPRAZOLE, RIVAROXABAN (XARELTO) and ATORVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness). At the time of the report, ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness) outcome was unknown. Not Provided          Treatment information included ice. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Soreness in shoulder; In bed for a while; Swelling; Redness; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038KZ0A and 00ZBZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, FLECAINIDE, HYDROCHLOROTHIAZIDE, METHIMAZOLE, OMEPRAZOLE, RIVAROXABAN (XARELTO) and ATORVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness). At the time of the report, ARTHRALGIA (Soreness in shoulder), BED REST (In bed for a while), BODY TEMPERATURE INCREASED (Temperature), SWELLING (Swelling) and ERYTHEMA (Redness) outcome was unknown. Not Provided          Treatment information included ice. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Soreness in arm; Headache; Muscle pain; chills; joint pain; fatigue and tiredness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included ESCITALOPRAM, ROSUVASTATIN, INSULIN, VITAMINS NOS and AMLODIPINE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills), ARTHRALGIA (joint pain), FATIGUE (fatigue and tiredness) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills), ARTHRALGIA (joint pain), FATIGUE (fatigue and tiredness) and FATIGUE (Tiredness) outcome was unknown.      Treatment information included Tylenol.  Action taken with the drug in response to events was not applicable.  It was reported that the patient does not want to receive any paperwork or provide consent for further follow up.   This case was linked to MOD-2021-069902 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up was received on 17-may-2021. The patient denied the Email ID and said he was doing fine. On 19-May-2021: Follow up was received on 19-May-2021 and does not contain any significant information. The patient denied further follow-up.; Sender's Comments:  MOD-2021-069902:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; Headache; Muscle pain; chills; joint pain; fatigue and tiredness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included ESCITALOPRAM, ROSUVASTATIN, INSULIN, VITAMINS NOS and AMLODIPINE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills), ARTHRALGIA (joint pain), FATIGUE (fatigue and tiredness) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Soreness in arm), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (chills), ARTHRALGIA (joint pain), FATIGUE (fatigue and tiredness) and FATIGUE (Tiredness) outcome was unknown.      Treatment information included Tylenol.  Action taken with the drug in response to events was not applicable.  It was reported that the patient does not want to receive any paperwork or provide consent for further follow up.   This case was linked to MOD-2021-069902 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up was received on 17-may-2021. The patient denied the Email ID and said he was doing fine. On 19-May-2021: Follow up was received on 19-May-2021 and does not contain any significant information. The patient denied further follow-up.; Sender's Comments:  MOD-2021-069902:
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (tenderness at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Taking medication for arthritis).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2011, the patient experienced INJECTION SITE PAIN (tenderness at the injection site). On 11-Mar-2021, INJECTION SITE PAIN (tenderness at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: did not receive the entire .5mL dose; syringe was leaking by the needles; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (did not receive the entire .5mL dose) and DEVICE CONNECTION ISSUE (syringe was leaking by the needles) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced UNDERDOSE (did not receive the entire .5mL dose) and DEVICE CONNECTION ISSUE (syringe was leaking by the needles). On 07-Apr-2021, UNDERDOSE (did not receive the entire .5mL dose) and DEVICE CONNECTION ISSUE (syringe was leaking by the needles) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received her second dose and it was discovered that the syringe was leaking by the needle tip. It was reported that the patient did not receive the entire 0.5mL dose.  No treatment medication provided  No concomitant medication list provided.  This report refers to a case of Underdose and Device connection issue for mRNA-1273, lot # unreported with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No New information; Sender's Comments: This report refers to a case of Underdose and Device connection issue for mRNA-1273, lot # unreported with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Skin induration
Clinical narrative: arm has been itchy for the last 3 days; but today, it's driving her crazy; Big hard disc; It's driving me crazy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm has been itchy for the last 3 days; but today, it's driving her crazy), FEELING ABNORMAL (It's driving me crazy) and SKIN INDURATION (Big hard disc) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (It's driving me crazy). On an unknown date, the patient experienced PRURITUS (arm has been itchy for the last 3 days; but today, it's driving her crazy) and SKIN INDURATION (Big hard disc). At the time of the report, PRURITUS (arm has been itchy for the last 3 days; but today, it's driving her crazy), FEELING ABNORMAL (It's driving me crazy) and SKIN INDURATION (Big hard disc) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Dyspnoea, Fatigue, Irritability
Clinical narrative: She experienced difficulty breathing on an unspecified date.; She became anxious.; She became irritable.; She became depressed.; She became shaky.; She was tired.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She experienced difficulty breathing on an unspecified date.), ANXIETY (She became anxious.), IRRITABILITY (She became irritable.), DEPRESSION (She became depressed.) and TREMOR (She became shaky.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant past medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and CALCIUM for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (She was tired.). On 29-Mar-2021, the patient experienced ANXIETY (She became anxious.), IRRITABILITY (She became irritable.), DEPRESSION (She became depressed.) and TREMOR (She became shaky.). On 06-Apr-2021, the patient experienced DYSPNOEA (She experienced difficulty breathing on an unspecified date.). At the time of the report, DYSPNOEA (She experienced difficulty breathing on an unspecified date.), ANXIETY (She became anxious.), IRRITABILITY (She became irritable.), DEPRESSION (She became depressed.), TREMOR (She became shaky.) and FATIGUE (She was tired.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included buspirone. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and CALCIUM for an unknown indication   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Telephone contact report- patient not willing to provide mail id or fax number
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: She experienced difficulty breathing on an unspecified date.; She became anxious.; She became irritable.; She became depressed.; She became shaky.; She was tired.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She experienced difficulty breathing on an unspecified date.), ANXIETY (She became anxious.), IRRITABILITY (She became irritable.), DEPRESSION (She became depressed.) and TREMOR (She became shaky.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant past medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and CALCIUM for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (She was tired.). On 29-Mar-2021, the patient experienced ANXIETY (She became anxious.), IRRITABILITY (She became irritable.), DEPRESSION (She became depressed.) and TREMOR (She became shaky.). On 06-Apr-2021, the patient experienced DYSPNOEA (She experienced difficulty breathing on an unspecified date.). At the time of the report, DYSPNOEA (She experienced difficulty breathing on an unspecified date.), ANXIETY (She became anxious.), IRRITABILITY (She became irritable.), DEPRESSION (She became depressed.), TREMOR (She became shaky.) and FATIGUE (She was tired.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included buspirone. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and CALCIUM for an unknown indication   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Telephone contact report- patient not willing to provide mail id or fax number
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Couldn't move arm correctly/Hurts; Inflammation under the armpit; Warm; Pain; joint pain; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Fatigue), ARTHRALGIA (joint pain), PYREXIA (Fever) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEUCOVORIN CALCIUM for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-Apr-2021, the patient experienced PAIN (Pain), ARTHRALGIA (joint pain), PYREXIA (Fever) and CHILLS (Chills). On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Couldn't move arm correctly/Hurts), VACCINATION SITE INFLAMMATION (Inflammation under the armpit) and VACCINATION SITE WARMTH (Warm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), FATIGUE (Fatigue), ARTHRALGIA (joint pain), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PAIN (Couldn't move arm correctly/Hurts), VACCINATION SITE INFLAMMATION (Inflammation under the armpit) and VACCINATION SITE WARMTH (Warm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
Clinical narrative: Couldn't move arm correctly/Hurts; Inflammation under the armpit; Warm; Pain; joint pain; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Fatigue), ARTHRALGIA (joint pain), PYREXIA (Fever) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEUCOVORIN CALCIUM for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-Apr-2021, the patient experienced PAIN (Pain), ARTHRALGIA (joint pain), PYREXIA (Fever) and CHILLS (Chills). On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Couldn't move arm correctly/Hurts), VACCINATION SITE INFLAMMATION (Inflammation under the armpit) and VACCINATION SITE WARMTH (Warm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), FATIGUE (Fatigue), ARTHRALGIA (joint pain), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PAIN (Couldn't move arm correctly/Hurts), VACCINATION SITE INFLAMMATION (Inflammation under the armpit) and VACCINATION SITE WARMTH (Warm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia, Rash, Skin exfoliation
Clinical narrative: rash all over her body that is starting to peel; rash all over her body that is starting to peel; chills; fever; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN EXFOLIATION (rash all over her body that is starting to peel), RASH (rash all over her body that is starting to peel), CHILLS (chills) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 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) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever). On 09-Mar-2021, the patient experienced SKIN EXFOLIATION (rash all over her body that is starting to peel) and RASH (rash all over her body that is starting to peel). The patient was treated with PREDNISONE at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 19-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, SKIN EXFOLIATION (rash all over her body that is starting to peel) and RASH (rash all over her body that is starting to peel) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bed rest, Erythema, Pyrexia, Swelling
Clinical narrative: redness in arm is still ongoing; swelling; soreness became worse.; In bed for a while.; had temperature; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in arm is still ongoing), SWELLING (swelling), ARTHRALGIA (soreness became worse.), BED REST (In bed for a while.) and PYREXIA (had temperature) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00ZBZ1A) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (redness in arm is still ongoing), SWELLING (swelling), ARTHRALGIA (soreness became worse.), BED REST (In bed for a while.) and PYREXIA (had temperature). At the time of the report, ERYTHEMA (redness in arm is still ongoing), SWELLING (swelling), ARTHRALGIA (soreness became worse.), BED REST (In bed for a while.) and PYREXIA (had temperature) had not resolved. Not Provided            Patient received treatment with ice.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Secretion discharge, Wheezing
Clinical narrative: She feels that she is having covid like symptoms; This week she started with heavy mucus; She started with slight wheezing a week later; She had a sore arm for 1 week after receiving 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm for 1 week after receiving 1st dose), WHEEZING (She started with slight wheezing a week later), SECRETION DISCHARGE (This week she started with heavy mucus) and COVID-19 (She feels that she is having covid like symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FENOFIBRATE, IRBESARTAN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm for 1 week after receiving 1st dose). On 25-Mar-2021, the patient experienced WHEEZING (She started with slight wheezing a week later). On 05-Apr-2021, the patient experienced SECRETION DISCHARGE (This week she started with heavy mucus). On 07-Apr-2021, the patient experienced COVID-19 (She feels that she is having covid like symptoms). The patient was treated with ALBUTEROL SULFATE at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (She had a sore arm for 1 week after receiving 1st dose), WHEEZING (She started with slight wheezing a week later), SECRETION DISCHARGE (This week she started with heavy mucus) and COVID-19 (She feels that she is having covid like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 08-JUL-2021 contains Non-Significant information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium decreased, Chills, Cough, Diarrhoea, Epistaxis
Clinical narrative: sores radiating to throat on the injection side (left side) of the body; Coughing; Calcium level Dropped; nose bleeding while blowing nose; body aches; Chills; Diarrhea; Nausea; fever (103); tired; unable to get out of bed; Mouth Sores radiating to the throat on the body side of injection; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed) and ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TOPIRAMATE (TOPAMAX), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed), ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection), MYALGIA (body aches), CHILLS (Chills), DIARRHOEA (Diarrhea) and EPISTAXIS (nose bleeding while blowing nose). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sores radiating to throat on the injection side (left side) of the body), COUGH (Coughing) and BLOOD CALCIUM DECREASED (Calcium level Dropped). At the time of the report, NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed), ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection), OROPHARYNGEAL PAIN (sores radiating to throat on the injection side (left side) of the body), MYALGIA (body aches), CHILLS (Chills), DIARRHOEA (Diarrhea), COUGH (Coughing), EPISTAXIS (nose bleeding while blowing nose) and BLOOD CALCIUM DECREASED (Calcium level Dropped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Topamax 50mg BID, Wellbutrin 100mg daily, Vitamin D 2000mg. Treatment products included Benadryl.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Oral pain, Oropharyngeal pain
Clinical narrative: sores radiating to throat on the injection side (left side) of the body; Coughing; Calcium level Dropped; nose bleeding while blowing nose; body aches; Chills; Diarrhea; Nausea; fever (103); tired; unable to get out of bed; Mouth Sores radiating to the throat on the body side of injection; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed) and ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TOPIRAMATE (TOPAMAX), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed), ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection), MYALGIA (body aches), CHILLS (Chills), DIARRHOEA (Diarrhea) and EPISTAXIS (nose bleeding while blowing nose). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sores radiating to throat on the injection side (left side) of the body), COUGH (Coughing) and BLOOD CALCIUM DECREASED (Calcium level Dropped). At the time of the report, NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed), ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection), OROPHARYNGEAL PAIN (sores radiating to throat on the injection side (left side) of the body), MYALGIA (body aches), CHILLS (Chills), DIARRHOEA (Diarrhea), COUGH (Coughing), EPISTAXIS (nose bleeding while blowing nose) and BLOOD CALCIUM DECREASED (Calcium level Dropped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Topamax 50mg BID, Wellbutrin 100mg daily, Vitamin D 2000mg. Treatment products included Benadryl.   Reporter did not allow further contact