chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (Little fatigue). At the time of the report, FATIGUE (Little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included acetaminophen. No concomitant medications reported.   This case was linked to MOD-2021-100450 (E2B Linked Report).; Sender's Comments:  MOD-2021-100450:Second Dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Excruciating neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Excruciating neck pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, TOPIRAMATE (TOPAMAX) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NECK PAIN (Excruciating neck pain). At the time of the report, NECK PAIN (Excruciating neck pain) outcome was unknown. Not Provided          Treatment information included steroid injection.   This case was linked to US-MODERNATX, INC.-MOD-2021-102933, US-MODERNATX, INC.-MOD-2021-103601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102933:2 dose case US-MODERNATX, INC.-MOD-2021-103601:Same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Generalised Body aches/a little soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Generalised Body aches/a little soreness in the left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, PRAVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Generalised Body aches/a little soreness in the left arm). The patient was treated with FAMCICLOVIR (FAMCLOVIR) for Herpes infection, at a dose of 250mg 2/day. At the time of the report, MYALGIA (Generalised Body aches/a little soreness in the left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-250562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received; Vaccine information updated, concomitant medications updated.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receive the second dose 100 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receive the second dose 100 days after first dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DCB0H) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receive the second dose 100 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receive the second dose 100 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient would like to know if he can receive his second dose on 03-May-2021.  No treatment information was provided.    This case was linked to MOD21-085872 (E2B Linked Report). This case was linked to MOD-2021-110397 (Patient Link).; Sender's Comments:  MOD21-085872:Crosslinked case
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got their second shots today (7 days early); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got their second shots today (7 days early)) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got their second shots today (7 days early)). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got their second shots today (7 days early)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-102768 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102768:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate increased
Clinical narrative: tightness in chest; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest) and HEART RATE INCREASED (fast heart beat) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced CHEST DISCOMFORT (tightness in chest) and HEART RATE INCREASED (fast heart beat). The patient was treated with IBUPROFEN for Heart rate high, at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (tightness in chest) and HEART RATE INCREASED (fast heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Illness, Lymphadenopathy, Mobility decreased, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), MOBILITY DECREASED (she could barely lift her arm), ILLNESS (She got sick), ORAL HERPES (developed a herpes bump on her lip) and ABSCESS (she thought it could have been an abcess or due to the vaccination) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pollen allergy and Sensitivity to weather change. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), MOBILITY DECREASED (she could barely lift her arm), ILLNESS (She got sick), ORAL HERPES (developed a herpes bump on her lip), LYMPHADENOPATHY (lymph nodes are still swollen) and MYALGIA (Pain under arm). On an unknown date, the patient experienced ABSCESS (she thought it could have been an abcess or due to the vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Apr-2021, MOBILITY DECREASED (she could barely lift her arm) had resolved. On 27-Apr-2021, ILLNESS (She got sick) and ORAL HERPES (developed a herpes bump on her lip) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), ABSCESS (she thought it could have been an abcess or due to the vaccination) and LYMPHADENOPATHY (lymph nodes are still swollen) outcome was unknown and MYALGIA (Pain under arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), MOBILITY DECREASED (she could barely lift her arm), ILLNESS (She got sick), ORAL HERPES (developed a herpes bump on her lip) and ABSCESS (she thought it could have been an abcess or due to the vaccination) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pollen allergy and Sensitivity to weather change. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), MOBILITY DECREASED (she could barely lift her arm), ILLNESS (She got sick), ORAL HERPES (developed a herpes bump on her lip), LYMPHADENOPATHY (lymph nodes are still swollen) and MYALGIA (Pain under arm). On an unknown date, the patient experienced ABSCESS (she thought it could have been an abcess or due to the vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Apr-2021, MOBILITY DECREASED (she could barely lift her arm) had resolved. On 27-Apr-2021, ILLNESS (She got sick) and ORAL HERPES (developed a herpes bump on her lip) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), ABSCESS (she thought it could have been an abcess or due to the vaccination) and LYMPHADENOPATHY (lymph nodes are still swollen) outcome was unknown and MYALGIA (Pain under arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Headache, Peripheral swelling
Clinical narrative: Hot body/ hot arm; Red arm; Really Swollen arm; really bad headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot body/ hot arm), ERYTHEMA (Red arm), PERIPHERAL SWELLING (Really Swollen arm), HEADACHE (really bad headache) and CHILLS (chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL (ASTHMA-SPRAY) and EPINEPHRINE (EPIPEN) for an unknown indication.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FEELING HOT (Hot body/ hot arm), ERYTHEMA (Red arm), PERIPHERAL SWELLING (Really Swollen arm), HEADACHE (really bad headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Hot body/ hot arm), ERYTHEMA (Red arm), PERIPHERAL SWELLING (Really Swollen arm), HEADACHE (really bad headache) and CHILLS (chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: He started to get chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (He started to get chills) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 048B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.  Concomitant products included FISH OIL, AMLODIPINE, POTASSIUM, METOPROLOL, HYDROCORTISONE and OMEPRAZOLE for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (He started to get chills) and PYREXIA (Fever). At the time of the report, CHILLS (He started to get chills) and PYREXIA (Fever) outcome was unknown.            Treatment details included Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in his ears). At the time of the report, TINNITUS (ringing in his ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: excruciating hip pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (excruciating hip pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, TOPIRAMATE (TOPAMAX) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (excruciating hip pain). The patient was treated with Physical therapy for Arthralgia. At the time of the report, ARTHRALGIA (excruciating hip pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.       This case was linked to US-MODERNATX, INC.-MOD-2021-103601 (E2B Linked Report). This case was linked to MOD-2021-102896 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103601:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose administered 29Mar2021. Patient has not received second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose administered 29Mar2021. Patient has not received second dose) 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 29-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 (First dose administered 29Mar2021. Patient has not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose administered 29Mar2021. Patient has not received second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04-Jun-2021, contain no new information.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Product administered at inappropriate site
Clinical narrative: Could not move her arm for 2 weeks,Loss of range of motion; received vaccine in her sub deltoid bursa instead of her upper deltoid; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move her arm for 2 weeks,Loss of range of motion) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received vaccine in her sub deltoid bursa instead of her upper deltoid) 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Could not move her arm for 2 weeks,Loss of range of motion) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received vaccine in her sub deltoid bursa instead of her upper deltoid). At the time of the report, HYPOKINESIA (Could not move her arm for 2 weeks,Loss of range of motion) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received vaccine in her sub deltoid bursa instead of her upper deltoid) outcome was unknown. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It as reported that patient had a MRI scan, nerve study and receiving physical therapy.  No Concomitant medication was reported. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-Up was received on 22-Jun-2021 contain Non-Significant information (Reporter contact conformation was updated)
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: we were tested positive for Corona; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (we were tested positive for Corona) in a 38-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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (we were tested positive for Corona). At the time of the report, SARS-COV-2 TEST POSITIVE (we were tested positive for Corona) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       04-May-2021, the result came negative for Covid-19 infection.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-102840 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102840:Wife Case
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Tremor
Clinical narrative: Shakes; fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PYREXIA (fever), CHILLS (Chills) and MYALGIA (Body aches) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PYREXIA (fever), CHILLS (Chills) and MYALGIA (Body aches). On 04-May-2021, the patient experienced TREMOR (Shakes). On 03-May-2021, PYREXIA (fever) and MYALGIA (Body aches) had resolved. At the time of the report, TREMOR (Shakes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash extending from elbow to hand; Itchy sensation on left arm; Rash on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash extending from elbow to hand), VACCINATION SITE PRURITUS (Itchy sensation on left arm) and VACCINATION SITE RASH (Rash on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced RASH (Rash extending from elbow to hand), VACCINATION SITE PRURITUS (Itchy sensation on left arm) and VACCINATION SITE RASH (Rash on the left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash extending from elbow to hand), VACCINATION SITE PRURITUS (Itchy sensation on left arm) and VACCINATION SITE RASH (Rash on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received the 2nd dose,Missed dose/ Patient missed the dosing window of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose,Missed dose/ Patient missed the dosing window of the second dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LEVOTHYROXINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose,Missed dose/ Patient missed the dosing window of the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose,Missed dose/ Patient missed the dosing window of the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information Provided   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional document received on 4-MAY-2021. Added information included change in  start date of the event
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nausea, Stress
Clinical narrative: Sickness; stressed before 2 dose; Flu like symptoms; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), STRESS (stressed before 2 dose), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 01-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 ILLNESS (Sickness), STRESS (stressed before 2 dose), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea). At the time of the report, ILLNESS (Sickness), STRESS (stressed before 2 dose), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea) outcome was unknown. Not Provided      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.   Concomitant informations were not provided.  Treatment informations were not provided   This case was linked to MOD-2021-103017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow-up appended On 07-Jul-2021: Follow-up received on 7-July-2021 and contain no new information On 28-Jul-2021: Follow up received included updated action taken of suspect product
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in lip and jaw; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in lip and jaw) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in lip and jaw). At the time of the report, HYPOAESTHESIA (numbness in lip and jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) 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.   Relevant concomitant medications were not reported.  The treatment information was  not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-100553 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100553:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Headache, Rhinorrhoea
Clinical narrative: nose running; shortness of breath; hot / cold chills; hot / cold chills; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose running), DYSPNOEA (shortness of breath), FEELING HOT (hot / cold chills), CHILLS (hot / cold chills) and HEADACHE (bad headaches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced RHINORRHOEA (nose running), DYSPNOEA (shortness of breath), FEELING HOT (hot / cold chills), CHILLS (hot / cold chills) and HEADACHE (bad headaches). At the time of the report, RHINORRHOEA (nose running), DYSPNOEA (shortness of breath), FEELING HOT (hot / cold chills), CHILLS (hot / cold chills) and HEADACHE (bad headaches) 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 relevant concomitant medications was reported.  Treatment information included cold tablets.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Poor quality sleep, Swelling
Clinical narrative: pain is "swimming" and it feels like its on the bone or nerve; cannot sleep well; Swelling; Pain of the left arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021. The most recent information was received on 22-Jul-2021 and was forwarded to Moderna on 22-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (pain is "swimming" and it feels like its on the bone or nerve), POOR QUALITY SLEEP (cannot sleep well), SWELLING (Swelling) and PAIN IN EXTREMITY (Pain of the left arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NEURALGIA (pain is "swimming" and it feels like its on the bone or nerve), POOR QUALITY SLEEP (cannot sleep well), SWELLING (Swelling) and PAIN IN EXTREMITY (Pain of the left arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, NEURALGIA (pain is "swimming" and it feels like its on the bone or nerve), POOR QUALITY SLEEP (cannot sleep well), SWELLING (Swelling) and PAIN IN EXTREMITY (Pain of the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received-Event Outcome  Updated. Denied Followup.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: Blood pressure increased to 199; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure increased to 199) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased to 199) and HEADACHE (Headache). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure increased to 199) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 199 (Inconclusive) 199.         Concomitant product use was not provided by the reporter.  After receiving second dose the patient had no side effects.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-229995 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03-May-2021, contains no new information.; Sender's Comments:  MOD-2021-229995:Son case
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. Treatment medication not reported. This case was linked to US-MODERNATX, INC.-MOD-2021-103058 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103058:Case for husband.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Had red rash on the lower part of the right arm/Had red rash on right beast) and PRURITUS (Had itchiness on the lower part of the right arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Had red rash on the lower part of the right arm/Had red rash on right beast) and PRURITUS (Had itchiness on the lower part of the right arm). At the time of the report, RASH ERYTHEMATOUS (Had red rash on the lower part of the right arm/Had red rash on right beast) and PRURITUS (Had itchiness on the lower part of the right arm) 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. The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: TCR: Gave HCP follow Up consent. No email address/fax number to send ADR.Received new document, No New Information
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: covered their throats, they lose their breath; dizzy; feeling bad; nauseous; he has a fever (104-103 ° F), a lot of fever; headache; body aches ( body hurts a lot); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous) and PYREXIA (he has a fever (104-103 ° F), a lot of fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014cz14) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous), PYREXIA (he has a fever (104-103 ° F), a lot of fever), HEADACHE (headache) and MYALGIA (body aches ( body hurts a lot)). At the time of the report, DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous), PYREXIA (he has a fever (104-103 ° F), a lot of fever), HEADACHE (headache) and MYALGIA (body aches ( body hurts a lot)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 104-103 f (High) 104-103 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-103344 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: covered their throats, they lose their breath; dizzy; feeling bad; nauseous; he has a fever (104-103 ° F), a lot of fever; headache; body aches ( body hurts a lot); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous) and PYREXIA (he has a fever (104-103 ° F), a lot of fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014cz14) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous), PYREXIA (he has a fever (104-103 ° F), a lot of fever), HEADACHE (headache) and MYALGIA (body aches ( body hurts a lot)). At the time of the report, DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous), PYREXIA (he has a fever (104-103 ° F), a lot of fever), HEADACHE (headache) and MYALGIA (body aches ( body hurts a lot)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 104-103 f (High) 104-103 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-103344 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: allergic reaction; swelling of her hands and feet; swelliing of feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (swelling of her hands and feet), PERIPHERAL SWELLING (swelliing of feet) and HYPERSENSITIVITY (allergic reaction) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL], AMLODIPINE, ATORVASTATIN, EMPAGLIFLOZIN (JARDIANCE), FAMOTIDINE (PEPCID AC), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), GABAPENTIN, INSULIN, METFORMIN, NAPROXEN, MULTIVITAMIN & MINERAL and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) 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 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling of her hands and feet) and PERIPHERAL SWELLING (swelliing of feet). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). On 12-Apr-2021, PERIPHERAL SWELLING (swelling of her hands and feet) and PERIPHERAL SWELLING (swelliing of feet) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction) 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.   The patient took Benadryl to treat the swelling.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: arm started hurting; arm and hand trembling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting) and TREMOR (arm and hand trembling) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm started hurting) and TREMOR (arm and hand trembling). At the time of the report, PAIN IN EXTREMITY (arm started hurting) and TREMOR (arm and hand trembling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes blood pressure pills and cholesterol medication.  No Treatment medications was provided by the reporter.   This case was linked to MOD-2021-103051 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Headache, Myalgia, Tenderness
Clinical narrative: dizziness; Tenderness; Warm body temperature; Headache; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TENDERNESS (Tenderness), BODY TEMPERATURE INCREASED (Warm body temperature), HEADACHE (Headache) and MYALGIA (Muscle Aches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 DIZZINESS (dizziness), TENDERNESS (Tenderness), BODY TEMPERATURE INCREASED (Warm body temperature), HEADACHE (Headache) and MYALGIA (Muscle Aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), TENDERNESS (Tenderness), BODY TEMPERATURE INCREASED (Warm body temperature), HEADACHE (Headache) and MYALGIA (Muscle Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching here and there form first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching here and there form first vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-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 PRURITUS (itching here and there form first vaccine). At the time of the report, PRURITUS (itching here and there form first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-103063 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: perfect red circle 2 x 2 inch, not bumpy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (perfect red circle 2 x 2 inch, not bumpy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (perfect red circle 2 x 2 inch, not bumpy). At the time of the report, VACCINATION SITE ERYTHEMA (perfect red circle 2 x 2 inch, not bumpy) outcome was unknown.  Action taken with mRNA-1273 in response to the events was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor, Vaccination site erythema
Clinical narrative: upper part of the arm constantly hurting; arm still trembling; 2x4 inch area around bandage and injection site was really red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper part of the arm constantly hurting), TREMOR (arm still trembling) and VACCINATION SITE ERYTHEMA (2x4 inch area around bandage and injection site was really red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure and Cholesterol.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (upper part of the arm constantly hurting), TREMOR (arm still trembling) and VACCINATION SITE ERYTHEMA (2x4 inch area around bandage and injection site was really red). The patient was treated with CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) for Trembling, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (upper part of the arm constantly hurting), TREMOR (arm still trembling) and VACCINATION SITE ERYTHEMA (2x4 inch area around bandage and injection site was really red) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included blood pressure pills and cholesterol medications   This case was linked to MOD-2021-103033 (Patient Link).