chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: patient received expired dose; patient received .5ml for booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 042B21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported   This case was linked to MOD-2021-402877 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: After the second shot, she also had a mild reaction; Low grade Fever 99.9F after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After the second shot, she also had a mild reaction) and PYREXIA (Low grade Fever 99.9F after 2nd shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Cataract operation (Summer 2021).Concurrent medical conditions included Diabetes and Hypothyroidism.Concomitant products included METFORMIN HYDROCHLORIDE for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS XR) for an unknown indication.On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (After the second shot, she also had a mild reaction) and PYREXIA (Low grade Fever 99.9F after 2nd shot). On 25-Feb-2021, VACCINATION COMPLICATION (After the second shot, she also had a mild reaction) and PYREXIA (Low grade Fever 99.9F after 2nd shot) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No treatment medications were reported. This case was linked to MOD-2021-404053, MOD-2021-403866 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: left arm hurt (1st dose); aches (1st dose) for a few days/pains (1st dose) for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (left arm hurt (1st dose)) and PAIN (aches (1st dose) for a few days/pains (1st dose) for a few days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Cataract. Previously administered products included for Drug use for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU. Concurrent medical conditions included Seasonal allergy, Muscle ache and Depression. Concomitant products included FISH OIL and ZINC for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (left arm hurt (1st dose)) and PAIN (aches (1st dose) for a few days/pains (1st dose) for a few days). At the time of the report, PAIN (left arm hurt (1st dose)) and PAIN (aches (1st dose) for a few days/pains (1st dose) for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.  concomitant drugs includes eye drops were used to treat cataract ,vitamins,fluid pill   This case was linked to MOD-2021-420631, MOD-2021-420632.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Reporter has said that the vial does not undergo any temperature excursions.   This case was linked to MOD-2021-429306 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site reaction
Clinical narrative: fluid build up at prior injection site; arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (fluid build up at prior injection site) and PAIN IN EXTREMITY (arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (fluid build up at prior injection site) and PAIN IN EXTREMITY (arm pain). At the time of the report, VACCINATION SITE REACTION (fluid build up at prior injection site) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Patient still taking physical therapy due to prior vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Freezing phenomenon
Clinical narrative: little weak overall; generalized body aches; felt like he was freezing; sweating of chest and neck area; too immobilized; probably had slight temperature; terribly weak; general muscle and joint pain; muscles and joints from neck down; significant chills/teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and MOBILITY DECREASED (too immobilized) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), ASTHENIA (terribly weak), ARTHRALGIA (general muscle and joint pain), MYALGIA (muscles and joints from neck down) and CHILLS (significant chills/teeth chattering). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) ongoing since an unknown date for Adverse event, at a dose of 325 mg every 4-5 hours. At the time of the report, ASTHENIA (little weak overall), PAIN (generalized body aches), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), ASTHENIA (terribly weak), ARTHRALGIA (general muscle and joint pain) and MYALGIA (muscles and joints from neck down) outcome was unknown and FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and CHILLS (significant chills/teeth chattering) had resolved.            No concomitant medications information was reported.   This case was linked to MOD-2021-402912 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mobility decreased, Myalgia, Pain
Clinical narrative: little weak overall; generalized body aches; felt like he was freezing; sweating of chest and neck area; too immobilized; probably had slight temperature; terribly weak; general muscle and joint pain; muscles and joints from neck down; significant chills/teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and MOBILITY DECREASED (too immobilized) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), ASTHENIA (terribly weak), ARTHRALGIA (general muscle and joint pain), MYALGIA (muscles and joints from neck down) and CHILLS (significant chills/teeth chattering). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) ongoing since an unknown date for Adverse event, at a dose of 325 mg every 4-5 hours. At the time of the report, ASTHENIA (little weak overall), PAIN (generalized body aches), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), ASTHENIA (terribly weak), ARTHRALGIA (general muscle and joint pain) and MYALGIA (muscles and joints from neck down) outcome was unknown and FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and CHILLS (significant chills/teeth chattering) had resolved.            No concomitant medications information was reported.   This case was linked to MOD-2021-402912 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Patient received expire dose; Patient received .5ml for booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expire dose) and ACCIDENTAL OVERDOSE (Patient received .5ml for booster) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 018B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expire dose) and ACCIDENTAL OVERDOSE (Patient received .5ml for booster). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expire dose) and ACCIDENTAL OVERDOSE (Patient received .5ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.Treatment information was not provided.   This case was linked to MOD-2021-402938, MOD-2021-403008, MOD-2021-403054 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Mental confusion the next morning; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Mental confusion the next morning) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 014M20A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021 at 9:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONFUSIONAL STATE (Mental confusion the next morning). At the time of the report, CONFUSIONAL STATE (Mental confusion the next morning) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-402971 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: The patient reported some soreness at the site of injection; he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (The patient reported some soreness at the site of injection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork). On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient reported some soreness at the site of injection). On 29-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he accidentally administered a first dose of the Moderna COVID-19 vaccine to a 17 year old patient after misreading the paperwork) had resolved. At the time of the report, VACCINATION SITE PAIN (The patient reported some soreness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm was sore; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that soreness in arm and headache resolved within a couple of days.   This case was linked to MOD-2021-403043 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: used it past the 12 hours, administered to 3 patients today 30-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today 30-Nov-2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 023M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today 30-Nov-2021). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today 30-Nov-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The pharmacy opened the Moderna vial for booster doses yesterday (29-Nov-2021) and they used it past the 12 hours.   This case was linked to MOD-2021-403032 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear inflammation, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Ear inflammation; 2nd- After 3-4 weeks had little rash; 2nd-tiredness; 2nd-little fever; 2nd-big headaches; 2nd-sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (2nd-sleepiness), EAR INFLAMMATION (Ear inflammation), RASH (2nd- After 3-4 weeks had little rash), FATIGUE (2nd-tiredness) and PYREXIA (2nd-little fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (2nd-sleepiness), FATIGUE (2nd-tiredness), PYREXIA (2nd-little fever) and HEADACHE (2nd-big headaches). In April 2021, the patient experienced RASH (2nd- After 3-4 weeks had little rash). In September 2021, the patient experienced EAR INFLAMMATION (Ear inflammation). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Ear inflammation, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (2nd-sleepiness), EAR INFLAMMATION (Ear inflammation), RASH (2nd- After 3-4 weeks had little rash), FATIGUE (2nd-tiredness), PYREXIA (2nd-little fever) and HEADACHE (2nd-big headaches) outcome was unknown.            It was reported that  3-4 weeks after Dose 2 she had little rash, but does not recall where on body. states Patient stated that she does not take any medications and so no concomitant medications were mentioned.   This case was linked to MOD-2021-403064, MOD-2021-403034 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Ear inflammation; 2nd- After 3-4 weeks had little rash; 2nd-tiredness; 2nd-little fever; 2nd-big headaches; 2nd-sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (2nd-sleepiness), EAR INFLAMMATION (Ear inflammation), RASH (2nd- After 3-4 weeks had little rash), FATIGUE (2nd-tiredness) and PYREXIA (2nd-little fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (2nd-sleepiness), FATIGUE (2nd-tiredness), PYREXIA (2nd-little fever) and HEADACHE (2nd-big headaches). In April 2021, the patient experienced RASH (2nd- After 3-4 weeks had little rash). In September 2021, the patient experienced EAR INFLAMMATION (Ear inflammation). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Ear inflammation, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (2nd-sleepiness), EAR INFLAMMATION (Ear inflammation), RASH (2nd- After 3-4 weeks had little rash), FATIGUE (2nd-tiredness), PYREXIA (2nd-little fever) and HEADACHE (2nd-big headaches) outcome was unknown.            It was reported that  3-4 weeks after Dose 2 she had little rash, but does not recall where on body. states Patient stated that she does not take any medications and so no concomitant medications were mentioned.   This case was linked to MOD-2021-403064, MOD-2021-403034 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pain
Clinical narrative: Pain; Joint pain; Fatigue; Fever for 1 day/Fever; Nausea; Vomiting; Chills; Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.), PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever for 1 day/Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.). On an unknown date, the patient experienced PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), PYREXIA (Fever for 1 day/Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.) had not resolved and PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), PYREXIA (Fever for 1 day/Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            Patient received 1st and 2nd dose of Pfizer COVID-19  vaccine. No relevant concomitant medications were reported..
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Pain; Joint pain; Fatigue; Fever for 1 day/Fever; Nausea; Vomiting; Chills; Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.), PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever for 1 day/Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.). On an unknown date, the patient experienced PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), PYREXIA (Fever for 1 day/Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.) had not resolved and PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), PYREXIA (Fever for 1 day/Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            Patient received 1st and 2nd dose of Pfizer COVID-19  vaccine. No relevant concomitant medications were reported..
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past published expiry; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. No adverse reactions reported. Dates moved from freezer to refrigerator were on dates of administration   This case was linked to MOD-2021-403046 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain in extremity
Clinical narrative: Ear has been in so much pain; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR PAIN (Ear has been in so much pain) and PAIN IN EXTREMITY (Sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EAR PAIN (Ear has been in so much pain) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN for Pain in ear, at a dose of 800 mg. At the time of the report, EAR PAIN (Ear has been in so much pain) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication is repported
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity
Clinical narrative: A sore arm; Just didn't feel well; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (A sore arm), MALAISE (Just didn't feel well) and HEADACHE (Headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Diagnosed twice.). Concurrent medical conditions included Asthma.    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 (A sore arm), MALAISE (Just didn't feel well) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (A sore arm), MALAISE (Just didn't feel well) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-403250 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: Mild sore arm after doses 1 and 2; Mild fatigue after doses 1 and 2; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild sore arm after doses 1 and 2) and FATIGUE (Mild fatigue after doses 1 and 2) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 008B21A and 052FZ119) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCORTISONE for Unspecified endocrine disorder.   On 25-Mar-1900, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Mild sore arm after doses 1 and 2) and FATIGUE (Mild fatigue after doses 1 and 2). The patient was treated with ZINC at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (Mild sore arm after doses 1 and 2) and FATIGUE (Mild fatigue after doses 1 and 2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID home test which came out negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that when Agent asked patient if she had a history of Myo/pericarditis she said NO, and she did not consult with her provider yet. Also, she did not have COVID in the past.   This case was linked to MOD-2021-403251 (Patient Link).
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Mild sore arm after first shot; Low fever after first shot; Tired after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild sore arm after first shot), PYREXIA (Low fever after first shot) and FATIGUE (Tired after first shot) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild sore arm after first shot), PYREXIA (Low fever after first shot) and FATIGUE (Tired after first shot). On 10-Jan-2021, VACCINATION SITE PAIN (Mild sore arm after first shot), PYREXIA (Low fever after first shot) and FATIGUE (Tired after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-403263, MOD-2021-403257 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fatigue; Mild fever after those; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Mild fever after those) and INJECTION SITE PAIN (Pain at the injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 010A21A and 039F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Cold sores, SERTRALINE and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Mild fever after those) and INJECTION SITE PAIN (Pain at the injection site). At the time of the report, FATIGUE (Fatigue) and PYREXIA (Mild fever after those) outcome was unknown and INJECTION SITE PAIN (Pain at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   He did not have any cutaneous reactions to this dose. No treatment details were reported for the particular dose events.   This case was linked to MOD-2021-403273, MOD-2021-402965, MOD-2021-402691 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gastrooesophageal reflux disease, Pain in extremity, Pyrexia
Clinical narrative: arm started hurting; said that I do have acids reflux but not this severe; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), GASTROOESOPHAGEAL REFLUX DISEASE (said that I do have acids reflux but not this severe) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011520A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Gas in stomach and Anxiety. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm started hurting), GASTROOESOPHAGEAL REFLUX DISEASE (said that I do have acids reflux but not this severe) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (arm started hurting), GASTROOESOPHAGEAL REFLUX DISEASE (said that I do have acids reflux but not this severe) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 degree fahrenheit (High) not more than 100 degree fahrenheit.         This case was linked to MOD-2021-403246, MOD-2021-407450 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021 at 4:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 09-Sep-2021 at 4:30 PM, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was 02-Sep-2021. Date and time the vial was first punctured was 08-Sep-2021 at 11:43 am. The vial was stored in fridge post puncture. The vial has not undergone any temperature excursions. The total amount of time the vial was exposed to room temperature range was 35 minutes. No concomitant medications were reported. No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Booster dose was administered in deltoid muscle. No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-400510 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swelling in wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in wrist) in a 65-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling in wrist). At the time of the report, JOINT SWELLING (swelling in wrist) outcome was unknown.            Concomitant medications were not provided.  Treatment information included unknown medication for swelling of wrist.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Laziness, Limb discomfort, Pain in extremity
Clinical narrative: still has arm discomfort from second shot.; Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.; felt lazy; she felt down the next day; did not want to do much; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (still has arm discomfort from second shot.), PAIN IN EXTREMITY (Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.), LAZINESS (felt lazy), FALL (she felt down the next day) and FATIGUE (did not want to do much) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LANSOPRAZOLE (PREVACID), SIMVASTATIN and TROSPIUM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced LAZINESS (felt lazy), FALL (she felt down the next day) and FATIGUE (did not want to do much). On an unknown date, the patient experienced LIMB DISCOMFORT (still has arm discomfort from second shot.) and PAIN IN EXTREMITY (Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.). At the time of the report, LIMB DISCOMFORT (still has arm discomfort from second shot.) and PAIN IN EXTREMITY (Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.) had not resolved and LAZINESS (felt lazy), FALL (she felt down the next day) and FATIGUE (did not want to do much) outcome was unknown.            Concomitant medication included Digestive probiotic.  Treatment information was not provided.   This case was linked to MOD-2021-403707 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine). At the time of the report, MALAISE (Patient reports that he does not know of anyone who received the Moderna Covid-19 vaccine who did not complain of malaise.I know a Medical Doctor who reported malaise after  the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: she has a bump, which is red and hot on her right arm at the injection site.; she has a bump, which is red and hot on her right arm at the injection site; she has a bump, which is red and hot on her right arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (she has a bump, which is red and hot on her right arm at the injection site.), VACCINATION SITE WARMTH (she has a bump, which is red and hot on her right arm at the injection site) and VACCINATION SITE ERYTHEMA (she has a bump, which is red and hot on her right arm at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 609F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received third 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (she has a bump, which is red and hot on her right arm at the injection site.), VACCINATION SITE WARMTH (she has a bump, which is red and hot on her right arm at the injection site) and VACCINATION SITE ERYTHEMA (she has a bump, which is red and hot on her right arm at the injection site). At the time of the report, VACCINATION SITE MASS (she has a bump, which is red and hot on her right arm at the injection site.), VACCINATION SITE WARMTH (she has a bump, which is red and hot on her right arm at the injection site) and VACCINATION SITE ERYTHEMA (she has a bump, which is red and hot on her right arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported.