chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain where the vaccine was given) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain where the vaccine was given). At the time of the report, VACCINATION SITE PAIN (pain where the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified drugs for high blood pressure and cholesterol.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081697 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081697:for 2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Muscle aches; Nausea; Mild fever; vaccination site pain; Headache started 24 hours later after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MYALGIA (Muscle aches), HEADACHE (Headache started 24 hours later after second shot), NAUSEA (Nausea) and PYREXIA (Mild fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included DULOXETINE, BUPROPION, EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL and EXENATIDE (BYDUREON) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache started 24 hours later after second shot). On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 02-Apr-2021, the patient experienced MYALGIA (Muscle aches), NAUSEA (Nausea) and PYREXIA (Mild fever). On 02-Mar-2021, HEADACHE (Headache started 24 hours later after second shot) had resolved. On 01-Apr-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. On 03-Apr-2021, NAUSEA (Nausea) and PYREXIA (Mild fever) had resolved. On 04-Apr-2021, MYALGIA (Muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol to help side effects after the second dose.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: warm; Red; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 044B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLIPIZIDE, LISINOPRIL, PRAVASTATIN SODIUM (PRAVACHOL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (pain). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (pain) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-081706 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081706:2nd dose of vaccine
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and MYALGIA (Body Aches) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 PYREXIA (fever), CHILLS (chills) and MYALGIA (Body Aches). At the time of the report, PYREXIA (fever), CHILLS (chills) and MYALGIA (Body Aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Ear pain, Fatigue
Clinical narrative: Violent Chills; Violent Nausea; no energy; feels like she has laryngitis; horrible tinnitus; Heart Pain for 48 hours; slight earache; weakness; muscle ache for 48 hours; Sore arm for 48 hours; fever for 48 hours; nausea for 48 hours; Violent Chills for 48 hours; Severe muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache) and ASTHENIA (weakness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache), ASTHENIA (weakness), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours), CHILLS (Violent Chills for 48 hours), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy). At the time of the report, LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), EAR PAIN (slight earache), ASTHENIA (weakness), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy) outcome was unknown and CHEST PAIN (Heart Pain for 48 hours), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours) and CHILLS (Violent Chills for 48 hours) 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Laryngitis, Myalgia, Nausea, Pyrexia
Clinical narrative: Violent Chills; Violent Nausea; no energy; feels like she has laryngitis; horrible tinnitus; Heart Pain for 48 hours; slight earache; weakness; muscle ache for 48 hours; Sore arm for 48 hours; fever for 48 hours; nausea for 48 hours; Violent Chills for 48 hours; Severe muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache) and ASTHENIA (weakness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache), ASTHENIA (weakness), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours), CHILLS (Violent Chills for 48 hours), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy). At the time of the report, LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), EAR PAIN (slight earache), ASTHENIA (weakness), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy) outcome was unknown and CHEST PAIN (Heart Pain for 48 hours), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours) and CHILLS (Violent Chills for 48 hours) 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Violent Chills; Violent Nausea; no energy; feels like she has laryngitis; horrible tinnitus; Heart Pain for 48 hours; slight earache; weakness; muscle ache for 48 hours; Sore arm for 48 hours; fever for 48 hours; nausea for 48 hours; Violent Chills for 48 hours; Severe muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache) and ASTHENIA (weakness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache), ASTHENIA (weakness), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours), CHILLS (Violent Chills for 48 hours), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy). At the time of the report, LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), EAR PAIN (slight earache), ASTHENIA (weakness), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy) outcome was unknown and CHEST PAIN (Heart Pain for 48 hours), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours) and CHILLS (Violent Chills for 48 hours) 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm for first shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm for first shot) in a 57-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm for first shot). At the time of the report, INJECTION SITE PAIN (sore arm for first shot) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081725 (E2B Linked Report). This case was linked to MOD-2021-052313 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081725:Cross linked; Dose 1
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain where the vaccine was given) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-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 VACCINATION SITE PAIN (pain where the vaccine was given). At the time of the report, VACCINATION SITE PAIN (pain where the vaccine was given) outcome was unknown. Caregiver is not sure. Maybe husband took Tylenol          The other relevant concomitant medication were reported as high blood pressure medication and cholesterol medication.  No treatment was taken but reporter said maybe he took Tylenol.    Reporter did not allow further contact; Sender's Comments:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Mobility decreased
Clinical narrative: dizzy on the left side/dizzy; can't get up; could hardly walk/having trouble walking; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy on the left side/dizzy), MOBILITY DECREASED (can't get up) and GAIT DISTURBANCE (could hardly walk/having trouble walking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (dizzy on the left side/dizzy), MOBILITY DECREASED (can't get up) and GAIT DISTURBANCE (could hardly walk/having trouble walking). At the time of the report, DIZZINESS (dizzy on the left side/dizzy), MOBILITY DECREASED (can't get up) and GAIT DISTURBANCE (could hardly walk/having trouble walking) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 16-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 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant list. There is no product complaint associated with this case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Erythema, Nausea
Clinical narrative: red; dizziness; Chills; nausea; fever (100.2°f highest); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLIPIZIDE, LISINOPRIL, PRAVASTATIN SODIUM (PRAVACHOL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-081685 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR added - address updated, event outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081685:1st dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: red; dizziness; Chills; nausea; fever (100.2°f highest); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLIPIZIDE, LISINOPRIL, PRAVASTATIN SODIUM (PRAVACHOL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (nausea) and PYREXIA (fever (100.2°f highest)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-081685 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR added - address updated, event outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081685:1st dose of vaccine
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Confusional state, Dyspnoea, Fatigue
Clinical narrative: been very confused; found myself having difficulty in remembering anything; low blood pressure is due to aneurysm; difficulty with breathing; difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back; don't have strength to lift anything; mouth is full of bumps; sore tongue; stomach is involved in the way that it is not getting enough oxygen supply; i am still stuck; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing) and RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue). At the time of the report, CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue) 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 concomitant and treatment medications were reported.   This case was linked to MOD-2021-081681 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: The follow up received does not contain any new information.; Sender's Comments:  MOD-2021-081681:Second dose
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Glossodynia, Hypotension, Memory impairment, Oral pain
Clinical narrative: been very confused; found myself having difficulty in remembering anything; low blood pressure is due to aneurysm; difficulty with breathing; difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back; don't have strength to lift anything; mouth is full of bumps; sore tongue; stomach is involved in the way that it is not getting enough oxygen supply; i am still stuck; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing) and RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue). At the time of the report, CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue) 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 concomitant and treatment medications were reported.   This case was linked to MOD-2021-081681 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: The follow up received does not contain any new information.; Sender's Comments:  MOD-2021-081681:Second dose
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: been very confused; found myself having difficulty in remembering anything; low blood pressure is due to aneurysm; difficulty with breathing; difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back; don't have strength to lift anything; mouth is full of bumps; sore tongue; stomach is involved in the way that it is not getting enough oxygen supply; i am still stuck; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing) and RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue). At the time of the report, CONFUSIONAL STATE (been very confused), MEMORY IMPAIRMENT (found myself having difficulty in remembering anything), HYPOTENSION (low blood pressure is due to aneurysm), DYSPNOEA (difficulty with breathing), RESPIRATION ABNORMAL (difficulty with my entire respiratory system/can't even do breathing exercises to bring my breath back), ASTHENIA (don't have strength to lift anything), ORAL PAIN (mouth is full of bumps), GLOSSODYNIA (sore tongue), ABDOMINAL DISCOMFORT (stomach is involved in the way that it is not getting enough oxygen supply), FEELING ABNORMAL (i am still stuck) and FATIGUE (fatigue) 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 concomitant and treatment medications were reported.   This case was linked to MOD-2021-081681 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: The follow up received does not contain any new information.; Sender's Comments:  MOD-2021-081681:Second dose
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Given Pfizer as second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given Pfizer as second dose) in a 62-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) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Given Pfizer as second dose). At the time of the report, WRONG PRODUCT ADMINISTERED (Given Pfizer as second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Minimal pain on the injection Site After First Shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Stent placement (Patient has a heart stent.).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot). On 12-Feb-2021, INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081727:For second dose
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: stomach was a little jumpy; lost her apatite; Chills; mild fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was a little jumpy), DECREASED APPETITE (lost her apatite), CHILLS (Chills), PYREXIA (mild fever) and FATIGUE (tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0362A1A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 ABDOMINAL DISCOMFORT (stomach was a little jumpy), DECREASED APPETITE (lost her apatite), CHILLS (Chills), PYREXIA (mild fever) and FATIGUE (tired). At the time of the report, ABDOMINAL DISCOMFORT (stomach was a little jumpy), DECREASED APPETITE (lost her apatite), CHILLS (Chills), PYREXIA (mild fever) and FATIGUE (tired) 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.   This case was linked to MOD21-078787, US-MODERNATX, INC.-MOD-2021-081655 (Linked Report).; Sender's Comments:  MOD21-078787: US-MODERNATX, INC.-MOD-2021-081655:2nd dose events
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: second shot sore arm; second shot sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (second shot sore arm) and MYALGIA (second shot sore muscles) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (second shot sore arm) and MYALGIA (second shot sore muscles). At the time of the report, VACCINATION SITE PAIN (second shot sore arm) and MYALGIA (second shot sore muscles) outcome was unknown.            No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081696 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081696:Cross linked; Dose 1
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission in error
Clinical narrative: beyond 36 days for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (beyond 36 days for second dose) in an 85-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 PRODUCT DOSE OMISSION IN ERROR (beyond 36 days for second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (beyond 36 days for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Minimal pain on the injection Site After First Shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Stent placement (Heart stent).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot). In March 2021, INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot) had resolved. Not Provided          No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081717 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081717:For first dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Covid arm; Itchy; Welps; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Welps) and VACCINATION SITE ERYTHEMA (Red rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Welps) and VACCINATION SITE ERYTHEMA (Red rash). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Welps) and VACCINATION SITE ERYTHEMA (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Tinnitus, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), DIZZINESS (dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (bbrain fog like when people get COVID-19) 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 (tinnitus), DIZZINESS (dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (bbrain fog like when people get COVID-19). At the time of the report, TINNITUS (tinnitus), DIZZINESS (dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (bbrain fog like when people get COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD21-078918, MOD21-078917, MOD21-078863, MOD21-078916, MOD21-058947, MOD21-078425 (E2B Linked Report).; Sender's Comments:  MOD21-078918: MOD21-078917: MOD21-078863: MOD21-078916: MOD21-058947: MOD21-078425:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is hurting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm is hurting). At the time of the report, VACCINATION SITE PAIN (arm is hurting) had resolved. Not Provided. Patient was reported to be taking medication for blood pressure (not specified). No treatment medications were reported. Patient received the 2nd vaccine-Patient reported that  she did not experience any Adverse Event from the 2nd dose of vaccine. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow-up received- Patient's age added ,added second dose and Outcome was updated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: fever; chills; a bump from her neck to her shoulder; she feels pressure/chest oppression; it hurts; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (a bump from her neck to her shoulder), CHEST DISCOMFORT (she feels pressure/chest oppression), VACCINATION SITE PAIN, PYREXIA and CHILLS in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced SWELLING (a bump from her neck to her shoulder), CHEST DISCOMFORT (she feels pressure/chest oppression) and VACCINATION SITE PAIN. On an unknown date, the patient experienced PYREXIA and CHILLS. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (a bump from her neck to her shoulder), CHEST DISCOMFORT (she feels pressure/chest oppression), VACCINATION SITE PAIN, PYREXIA, and CHILLS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test abnormal
Clinical narrative: unusual results following antibody testing after administration of Moderna COVID19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST ABNORMAL (unusual results following antibody testing after administration of Moderna COVID19 vaccine) 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 ANTIBODY TEST ABNORMAL (unusual results following antibody testing after administration of Moderna COVID19 vaccine). At the time of the report, ANTIBODY TEST ABNORMAL (unusual results following antibody testing after administration of Moderna COVID19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Pain.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain in the arm). At the time of the report, VACCINATION SITE PAIN (pain in the arm) had not resolved.            Patient takes medication for pain and high blood pressure. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-079220 (E2B Linked Report). This case was linked to MOD-2021-081671 (Patient Link).; Sender's Comments:  MOD21-079220:wife
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is under authorized age range; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under authorized age range) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under authorized age range). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under authorized age range) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided.  Treatment information was not provided.