chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity
Clinical narrative: here were 6 hours that she was feeling bad; neck ache; temperature of 100.7F; severe chills for 2 hours; severe aches in her legs; severe aches on her hips; headache; nausea; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (here were 6 hours that she was feeling bad), NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (temperature of 100.7F), CHILLS (severe chills for 2 hours) and PAIN IN EXTREMITY (severe aches in her legs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (here were 6 hours that she was feeling bad), NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (temperature of 100.7F), CHILLS (severe chills for 2 hours), PAIN IN EXTREMITY (severe aches in her legs), ARTHRALGIA (severe aches on her hips), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (here were 6 hours that she was feeling bad), NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (temperature of 100.7F), CHILLS (severe chills for 2 hours), PAIN IN EXTREMITY (severe aches in her legs), ARTHRALGIA (severe aches on her hips), HEADACHE (headache) and NAUSEA (nausea) 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.   patient treatment medication include Tylenol.  No concomitant mediction is reported.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pruritus, Rash, Rash papular, Urticaria
Clinical narrative: Itchy; Weakness; Rash is raised; Looks like hives; Rash all over her back, forearm and on her face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ASTHENIA (Weakness), RASH PAPULAR (Rash is raised), URTICARIA (Looks like hives) and RASH (Rash all over her back, forearm and on her face) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (Itchy), ASTHENIA (Weakness), RASH PAPULAR (Rash is raised), URTICARIA (Looks like hives) and RASH (Rash all over her back, forearm and on her face). At the time of the report, PRURITUS (Itchy), ASTHENIA (Weakness), RASH PAPULAR (Rash is raised), URTICARIA (Looks like hives) and RASH (Rash all over her back, forearm and on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itching; big red circle; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching) and ERYTHEMA (big red circle) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itching) and ERYTHEMA (big red circle). At the time of the report, PRURITUS (itching) and ERYTHEMA (big red circle) outcome was unknown. Possible      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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Joint pain; Unable to open my hand/to roll over in bed; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Joint pain) and MOBILITY DECREASED (Unable to open my hand/to roll over in bed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (Joint pain) and MOBILITY DECREASED (Unable to open my hand/to roll over in bed). On 24-Feb-2021, ARTHRALGIA (Joint pain) and MOBILITY DECREASED (Unable to open my hand/to roll over in bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was reported as steroid pack. Action taken with mRNA-1273 in response to the events was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: From the elbow up to injection site feels warm; From the elbow up to injection site is red; From the elbow up to injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (From the elbow up to injection site feels warm), VACCINATION SITE ERYTHEMA (From the elbow up to injection site is red) and VACCINATION SITE PRURITUS (From the elbow up to injection site is itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (From the elbow up to injection site feels warm), VACCINATION SITE ERYTHEMA (From the elbow up to injection site is red) and VACCINATION SITE PRURITUS (From the elbow up to injection site is itchy). At the time of the report, VACCINATION SITE WARMTH (From the elbow up to injection site feels warm), VACCINATION SITE ERYTHEMA (From the elbow up to injection site is red) and VACCINATION SITE PRURITUS (From the elbow up to injection site is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: Numbness in the arm/ hand; Cannot lift the arm after a certain point because it hurts; Arm hurts in the area of the shot; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness in the arm/ hand), PAIN IN EXTREMITY (Cannot lift the arm after a certain point because it hurts), VACCINATION SITE PAIN (Arm hurts in the area of the shot) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in the arm/ hand), PAIN IN EXTREMITY (Cannot lift the arm after a certain point because it hurts), VACCINATION SITE PAIN (Arm hurts in the area of the shot) and CHILLS (Chills). The patient was treated with PREDNISONE at a dose of unknown. At the time of the report, HYPOAESTHESIA (Numbness in the arm/ hand), PAIN IN EXTREMITY (Cannot lift the arm after a certain point because it hurts), VACCINATION SITE PAIN (Arm hurts in the area of the shot) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient uses unspecified medication for high blood pressure as concomitants.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Illness, Tachycardia
Clinical narrative: Heart rate is around 100 bpm / increased to 125 bpm; Got very sick  /  like "5 Mack trucks ran over her"; Didn't have any energy; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate is around 100 bpm / increased to 125 bpm), ILLNESS (Got very sick  /  like "5 Mack trucks ran over her") and ASTHENIA (Didn't have any energy) in a 28-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced TACHYCARDIA (Heart rate is around 100 bpm / increased to 125 bpm), ILLNESS (Got very sick  /  like "5 Mack trucks ran over her") and ASTHENIA (Didn't have any energy). At the time of the report, TACHYCARDIA (Heart rate is around 100 bpm / increased to 125 bpm), ILLNESS (Got very sick  /  like "5 Mack trucks ran over her") and ASTHENIA (Didn't have any energy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Heart rate: 125 (High) Her heart rate was around 100 bpm and had increased to 125 bpm at one point..
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Influenza like illness, Pruritus
Clinical narrative: flu-like symptoms; itchy; rash; very hot to touch; injection site was very red; injection site to the elbow is very red; arm was sore at the inject site; headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch) and VACCINATION SITE ERYTHEMA (injection site was very red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, TAMSULOSIN, LEVOTHYROXINE, FINASTERIDE, ATORVASTATIN and DOXYCYCLINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch), VACCINATION SITE ERYTHEMA (injection site was very red), ERYTHEMA (injection site to the elbow is very red), VACCINATION SITE SWELLING (arm was sore at the inject site) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch), VACCINATION SITE ERYTHEMA (injection site was very red), ERYTHEMA (injection site to the elbow is very red), VACCINATION SITE SWELLING (arm was sore at the inject site) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-029591 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: flu-like symptoms; itchy; rash; very hot to touch; injection site was very red; injection site to the elbow is very red; arm was sore at the inject site; headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch) and VACCINATION SITE ERYTHEMA (injection site was very red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, TAMSULOSIN, LEVOTHYROXINE, FINASTERIDE, ATORVASTATIN and DOXYCYCLINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch), VACCINATION SITE ERYTHEMA (injection site was very red), ERYTHEMA (injection site to the elbow is very red), VACCINATION SITE SWELLING (arm was sore at the inject site) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch), VACCINATION SITE ERYTHEMA (injection site was very red), ERYTHEMA (injection site to the elbow is very red), VACCINATION SITE SWELLING (arm was sore at the inject site) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-029591 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling abnormal, Nausea, Oropharyngeal pain
Clinical narrative: my throat hurt; Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.; arm was sore/my arm hurt worse; Felt terrible; Pressure in the sinus area; Felt tired; I felt nauseated (I almost threw up); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (my throat hurt), EYE PAIN (Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.), PAIN IN EXTREMITY (arm was sore/my arm hurt worse), FEELING ABNORMAL (Felt terrible) and PARANASAL SINUS DISCOMFORT (Pressure in the sinus area) in a 72-year-old male 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (my throat hurt), EYE PAIN (Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.), PAIN IN EXTREMITY (arm was sore/my arm hurt worse), FEELING ABNORMAL (Felt terrible), PARANASAL SINUS DISCOMFORT (Pressure in the sinus area), FATIGUE (Felt tired) and NAUSEA (I felt nauseated (I almost threw up)). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC EYE) for Eye pain, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL PAIN (my throat hurt), EYE PAIN (Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.), PAIN IN EXTREMITY (arm was sore/my arm hurt worse), FEELING ABNORMAL (Felt terrible), PARANASAL SINUS DISCOMFORT (Pressure in the sinus area), FATIGUE (Felt tired) and NAUSEA (I felt nauseated (I almost threw up)) outcome was unknown.            Concomitant medications were not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paranasal sinus discomfort
Clinical narrative: my throat hurt; Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.; arm was sore/my arm hurt worse; Felt terrible; Pressure in the sinus area; Felt tired; I felt nauseated (I almost threw up); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (my throat hurt), EYE PAIN (Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.), PAIN IN EXTREMITY (arm was sore/my arm hurt worse), FEELING ABNORMAL (Felt terrible) and PARANASAL SINUS DISCOMFORT (Pressure in the sinus area) in a 72-year-old male 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (my throat hurt), EYE PAIN (Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.), PAIN IN EXTREMITY (arm was sore/my arm hurt worse), FEELING ABNORMAL (Felt terrible), PARANASAL SINUS DISCOMFORT (Pressure in the sinus area), FATIGUE (Felt tired) and NAUSEA (I felt nauseated (I almost threw up)). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC EYE) for Eye pain, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL PAIN (my throat hurt), EYE PAIN (Then both of my eyes begun to hurt, like underneath and on the sides, it was a pressure in the sinus area.), PAIN IN EXTREMITY (arm was sore/my arm hurt worse), FEELING ABNORMAL (Felt terrible), PARANASAL SINUS DISCOMFORT (Pressure in the sinus area), FATIGUE (Felt tired) and NAUSEA (I felt nauseated (I almost threw up)) outcome was unknown.            Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site pain). At the time of the report, INJECTION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 01-Mar-2021, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine administered below the deltoid; A spontaneous report was received from  a consumer (patient's husband) concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had vaccine administered below the deltoid.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly below deltoid for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the husband of the patient reported that his wife (the patient) did not receive her shot in the deltoid, but below the deltoid area. No further information was provided.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the events is not applicable.  The event vaccine administered below the deltoid, was considered resolved.  The reporter did not provide an assessment for the event vaccine administered below the deltoid.; Reporter's Comments: This case concerns a female patient of unknown  age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered at inappropriate site without any associated adverse events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash around the vaccine injection site 3 inches X 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the vaccine injection site 3 inches X 3 inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 VACCINATION SITE RASH (Rash around the vaccine injection site 3 inches X 3 inches). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash around the vaccine injection site 3 inches X 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: warm; big red mark at the injection site; very itchy; swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), INJECTION SITE ERYTHEMA (big red mark at the injection site), INJECTION SITE PRURITUS (very itchy) and INJECTION SITE SWELLING (swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm), INJECTION SITE ERYTHEMA (big red mark at the injection site), INJECTION SITE PRURITUS (very itchy) and INJECTION SITE SWELLING (swollen). On 12-Feb-2021, INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (very itchy) and INJECTION SITE SWELLING (swollen) had resolved. On 14-Feb-2021, INJECTION SITE ERYTHEMA (big red mark at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       No concomitant medication history reported. Treatment information is not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A12A) for COVID-19 vaccination.     No medical history was provided.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: her arm has got a huge red splotch on it, down from the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (her arm has got a huge red splotch on it, down from the injection site.) 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 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE RASH (her arm has got a huge red splotch on it, down from the injection site.). At the time of the report, VACCINATION SITE RASH (her arm has got a huge red splotch on it, down from the injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching around the injection site turning red right afterward and when she scratched it, the; red around the injection site; little tender at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around the injection site turning red right afterward and when she scratched it, the), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE ERYTHEMA (red around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (little tender at the injection site). On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the injection site turning red right afterward and when she scratched it, the) and VACCINATION SITE ERYTHEMA (red around the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching around the injection site turning red right afterward and when she scratched it, the), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE ERYTHEMA (red around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Organic vinegar, alcohol. First put organic vinegar on it and then started using alcohol to try to alleviate the itching.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain when raising arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain when raising arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain when raising arm). At the time of the report, PAIN IN EXTREMITY (Pain when raising arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia
Clinical narrative: Redness both arms; tingling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness both arms) and PARAESTHESIA (tingling) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ERYTHEMA (Redness both arms) and PARAESTHESIA (tingling). At the time of the report, ERYTHEMA (Redness both arms) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Neck pain, Pain in extremity
Clinical narrative: Back ache; ache arm and legs; Ache neck; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), PAIN IN EXTREMITY (ache arm and legs), NECK PAIN (Ache neck) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 09-Feb-2021, the patient experienced BACK PAIN (Back ache), PAIN IN EXTREMITY (ache arm and legs), NECK PAIN (Ache neck) and FATIGUE (Fatigue).   At the time of the report, BACK PAIN (Back ache), PAIN IN EXTREMITY (ache arm and legs), NECK PAIN (Ache neck) and FATIGUE (Fatigue) outcome was unknown.      Treatment details included warming pad. Concomitant product use was not provided by the reporter.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN CHILDREN) for Fever, at an unspecified dose and frequency. On 14-Jan-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse affection; A spontaneous report was received from a consumer concerning a female patient with an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events adverse affection/Vaccination complication.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event adverse affection.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, adverse affection was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 022A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 23-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved.            Concomitant information use was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: extremely warm at the injection site; sore arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (extremely warm at the injection site), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (extremely warm at the injection site), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (extremely warm at the injection site), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Peripheral swelling
Clinical narrative: Chest Pain; Sore Arm; Inflamed Arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), PAIN IN EXTREMITY (Sore Arm) and PERIPHERAL SWELLING (Inflamed Arm) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST PAIN (Chest Pain), PAIN IN EXTREMITY (Sore Arm) and PERIPHERAL SWELLING (Inflamed Arm). At the time of the report, CHEST PAIN (Chest Pain), PAIN IN EXTREMITY (Sore Arm) and PERIPHERAL SWELLING (Inflamed Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Confirmed case of covid in between doses; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Confirmed case of covid in between doses) in a 38-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Feb-2021, the adult was diagnosed with COVID-19 (Confirmed case of covid in between doses). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, COVID-19 (Confirmed case of covid in between doses) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: positive Positive.     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 medication were reported. No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyskinesia, Lymphadenopathy, Pain
Clinical narrative: Felt achy all over; All joints hurt; Left node underneath chin was puffed out - like swelling of left lymph node; Couldn't lift her arm up; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Couldn't lift her arm up), PAIN (Felt achy all over), ARTHRALGIA (All joints hurt) and LYMPHADENOPATHY (Left node underneath chin was puffed out - like swelling of left lymph node) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DYSKINESIA (Couldn't lift her arm up). On 22-Feb-2021, the patient experienced LYMPHADENOPATHY (Left node underneath chin was puffed out - like swelling of left lymph node). On an unknown date, the patient experienced PAIN (Felt achy all over) and ARTHRALGIA (All joints hurt). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 25-Feb-2021, LYMPHADENOPATHY (Left node underneath chin was puffed out - like swelling of left lymph node) had resolved. At the time of the report, DYSKINESIA (Couldn't lift her arm up), PAIN (Felt achy all over) and ARTHRALGIA (All joints hurt) was resolving.            The patient administered Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information included updated patient demographics.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm is sore; Arm is tender if she touches or bumps it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) and TENDERNESS (Arm is tender if she touches or bumps it) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is sore) and TENDERNESS (Arm is tender if she touches or bumps it). At the time of the report, PAIN IN EXTREMITY (arm is sore) and TENDERNESS (Arm is tender if she touches or bumps it) outcome was unknown.            No treatment information was provided. No relevant concomitant medications reported
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19
Clinical narrative: Tested positive for COVID; Slightest back pain a little more intense; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and BACK PAIN (Slightest back pain a little more intense) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID) and BACK PAIN (Slightest back pain a little more intense). At the time of the report, COVID-19 (Tested positive for COVID) and BACK PAIN (Slightest back pain a little more intense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up was received on 03 June 2021 and it contains no new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration
Clinical narrative: redness from top of shoulder to elbow; injection site is hard as a rock; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness from top of shoulder to elbow) and INJECTION SITE INDURATION (injection site is hard as a rock) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness from top of shoulder to elbow) and INJECTION SITE INDURATION (injection site is hard as a rock). At the time of the report, ERYTHEMA (redness from top of shoulder to elbow) and INJECTION SITE INDURATION (injection site is hard as a rock) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment medications were not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: a big round red mark appeared on her arm; a little swollen; hot and a little sore; a little soreness on her arm /soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness on her arm /soreness on her arm), ERYTHEMA (a big round red mark appeared on her arm), PERIPHERAL SWELLING (a little swollen) and FEELING HOT (hot and a little sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (a little soreness on her arm /soreness on her arm). On 07-Feb-2021, the patient experienced ERYTHEMA (a big round red mark appeared on her arm), PERIPHERAL SWELLING (a little swollen) and FEELING HOT (hot and a little sore). On 28-Jan-2021, PAIN IN EXTREMITY (a little soreness on her arm /soreness on her arm) outcome was unknown. At the time of the report, ERYTHEMA (a big round red mark appeared on her arm), PERIPHERAL SWELLING (a little swollen) and FEELING HOT (hot and a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In addition to above mentioned patient also takes High blood pressure medication, antacid and over the counter medication for allergies. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Slept for two days; This spontaneous case was reported by an other caregiver and describes the occurrence of HYPERSOMNIA (Slept for two days) in a 101-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPERSOMNIA (Slept for two days). In February 2021, HYPERSOMNIA (Slept for two days) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Telephone contact report received on 29-APR-2021 contain no new information