chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Musculoskeletal discomfort, Pain, Rotator cuff syndrome
Clinical narrative: burning sensation in my deltoid, sensation goes down to the elbow; pain got really intense; Rotator cuff tendinitis; Could not move shoulder for 3 days; Soreness in the left arm; limited range of motion; injection site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and PAIN (pain got really intense) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Penicillin allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), PAIN (pain got really intense) and VACCINATION SITE PAIN (injection site pain). On 15-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and ARTHRALGIA (Soreness in the left arm). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), PAIN (pain got really intense) and VACCINATION SITE PAIN (injection site pain) had not resolved and BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and ARTHRALGIA (Soreness in the left arm) outcome was unknown.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant products were not provided by the reporter.  This case was linked to MOD21-09517 (E2B Linked Report).  Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient demographics, vaccination facility details, second dose information and event outcome were updated.  Sender's Comments: MOD21-09517:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: burning sensation in my deltoid, sensation goes down to the elbow; pain got really intense; Rotator cuff tendinitis; Could not move shoulder for 3 days; Soreness in the left arm; limited range of motion; injection site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and PAIN (pain got really intense) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Penicillin allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), PAIN (pain got really intense) and VACCINATION SITE PAIN (injection site pain). On 15-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and ARTHRALGIA (Soreness in the left arm). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Could not move shoulder for 3 days), VACCINATION SITE MOVEMENT IMPAIRMENT (limited range of motion), PAIN (pain got really intense) and VACCINATION SITE PAIN (injection site pain) had not resolved and BURNING SENSATION (burning sensation in my deltoid,sensation goes down to the elbow), ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) and ARTHRALGIA (Soreness in the left arm) outcome was unknown.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant products were not provided by the reporter.  This case was linked to MOD21-09517 (E2B Linked Report).  Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient demographics, vaccination facility details, second dose information and event outcome were updated.  Sender's Comments: MOD21-09517:
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, SARS-CoV-2 test positive, Ultrasound foetal
Clinical narrative: Vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) in an adult female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Chronic migraine in 2007. Previously administered products included for an unreported indication: ALCOHOL (1 glass of wine per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 28-Jan-2021 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 13-Feb-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2020, Pregnancy test: positive (Positive) Positive. In October 2020, SARS-CoV-2 test positive: positive (Positive) Patient tested positive Covid-19. In December 2020, Glucose tolerance test: normal (normal) Normal. In 2021, Ultrasound foetal: normal (normal) Normal.     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.   Estimated date of conception was reported as 23 May 2020.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received with no new information and patient not interested in follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Electrocardiogram, Fatigue, Feeling jittery
Clinical narrative: Heart Palpitations-heart racing on and off; Felt uncomfortable; Felt quite alert and jittery at the same time; Shortening of breath; She wakes up at night; Fatigued; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Heart Palpitations-heart racing on and off), DISCOMFORT (Felt uncomfortable), FEELING JITTERY (Felt quite alert and jittery at the same time), DYSPNOEA (Shortening of breath) and POOR QUALITY SLEEP (She wakes up at night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PALPITATIONS (Heart Palpitations-heart racing on and off), DISCOMFORT (Felt uncomfortable), FEELING JITTERY (Felt quite alert and jittery at the same time), DYSPNOEA (Shortening of breath), POOR QUALITY SLEEP (She wakes up at night) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart Palpitations-heart racing on and off), DISCOMFORT (Felt uncomfortable), FEELING JITTERY (Felt quite alert and jittery at the same time), DYSPNOEA (Shortening of breath), POOR QUALITY SLEEP (She wakes up at night) and FATIGUE (Fatigued) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were not provided.  Treatment information was provided included 325mg Tylenol and lots of water.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Poor quality sleep
Clinical narrative: Heart Palpitations-heart racing on and off; Felt uncomfortable; Felt quite alert and jittery at the same time; Shortening of breath; She wakes up at night; Fatigued; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Heart Palpitations-heart racing on and off), DISCOMFORT (Felt uncomfortable), FEELING JITTERY (Felt quite alert and jittery at the same time), DYSPNOEA (Shortening of breath) and POOR QUALITY SLEEP (She wakes up at night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PALPITATIONS (Heart Palpitations-heart racing on and off), DISCOMFORT (Felt uncomfortable), FEELING JITTERY (Felt quite alert and jittery at the same time), DYSPNOEA (Shortening of breath), POOR QUALITY SLEEP (She wakes up at night) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart Palpitations-heart racing on and off), DISCOMFORT (Felt uncomfortable), FEELING JITTERY (Felt quite alert and jittery at the same time), DYSPNOEA (Shortening of breath), POOR QUALITY SLEEP (She wakes up at night) and FATIGUE (Fatigued) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were not provided.  Treatment information was provided included 325mg Tylenol and lots of water.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Got vaccine while Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Sep-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) 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.   Treatment medication was not reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical histroy).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-May-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received prenatal and heartburn treatment medicine during her pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain on and off which is mild; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain on and off which is mild) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Guillain-Barre syndrome (24 years ago).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced NECK PAIN (Neck pain on and off which is mild). The patient was treated with Manual therapy (Heating pad) for Neck pain. At the time of the report, NECK PAIN (Neck pain on and off which is mild) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional information received from the patient was processed with initial report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration), INFLUENZA LIKE ILLNESS (She felt like she had the flu), INJECTION SITE ERYTHEMA (She had redness at the injection site) and INJECTION SITE SWELLING (swelling at 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. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bariatric surgery. Concurrent medical conditions included Hypertension, Obesity, Diabetes and Drug allergy (clinoril). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), LABETALOL, MELOXICAM (MOBIC) and OMEPRAZOLE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (She had redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). On 16-Jan-2021, the patient experienced PAIN (body ache), INFLUENZA LIKE ILLNESS (She felt like she had the flu), HEADACHE (bad headache) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body ache), BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration), INFLUENZA LIKE ILLNESS (She felt like she had the flu), INJECTION SITE ERYTHEMA (She had redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE PAIN (pain at the injection site), HEADACHE (bad headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: No new information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration), INFLUENZA LIKE ILLNESS (She felt like she had the flu), INJECTION SITE ERYTHEMA (She had redness at the injection site) and INJECTION SITE SWELLING (swelling at 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. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bariatric surgery. Concurrent medical conditions included Hypertension, Obesity, Diabetes and Drug allergy (clinoril). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), LABETALOL, MELOXICAM (MOBIC) and OMEPRAZOLE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (She had redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). On 16-Jan-2021, the patient experienced PAIN (body ache), INFLUENZA LIKE ILLNESS (She felt like she had the flu), HEADACHE (bad headache) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body ache), BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration), INFLUENZA LIKE ILLNESS (She felt like she had the flu), INJECTION SITE ERYTHEMA (She had redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE PAIN (pain at the injection site), HEADACHE (bad headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cough, Dizziness, Headache, Nausea
Clinical narrative: dizziness; Headache; nausea; cough; swelling above her eyelid and some underneath the eye; elevated blood pressure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough) and PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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 DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough), PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) and BLOOD PRESSURE INCREASED (elevated blood pressure). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough), PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) and BLOOD PRESSURE INCREASED (elevated blood pressure) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment: SoluMedrol, Tylenol, Benadryl, Pepcid   This case was linked to US-MODERNATX, INC.-MOD-2021-010122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-010122:Second patient as per SD
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: dizziness; Headache; nausea; cough; swelling above her eyelid and some underneath the eye; elevated blood pressure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough) and PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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 DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough), PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) and BLOOD PRESSURE INCREASED (elevated blood pressure). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough), PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) and BLOOD PRESSURE INCREASED (elevated blood pressure) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment: SoluMedrol, Tylenol, Benadryl, Pepcid   This case was linked to US-MODERNATX, INC.-MOD-2021-010122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-010122:Second patient as per SD
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: Rash All Over His Body; Soreness in the Injection Site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Soreness in the Injection Site) and RASH (Rash All Over His Body) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness in the Injection Site). On 20-Jan-2021, the patient experienced RASH (Rash All Over His Body). On 15-Jan-2021, INJECTION SITE PAIN (Soreness in the Injection Site) had resolved. At the time of the report, RASH (Rash All Over His Body) 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness and pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.    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 PAIN (soreness and pain). At the time of the report, PAIN (soreness and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: numb from the waist down; can't sleep; can't push up on her arm; Been sick as a dog; arm is killing her; freezing to death; Case reference number MOD-2021-010474 is a spontaneous case report sent by a Other on 20-JAN-2021 00:00:00 , which refers to a Female aged 71 Years .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed numbness. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed chills,pain in arm,insomnia,weakness arm,Been sick as a dog. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Malaise . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between numb from the waist down and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .  Update 1: 21-JAN-2021 00:00:00 .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Other,  Age- 71 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: numb from the waist down; can't sleep; can't push up on her arm; Been sick as a dog; arm is killing her; freezing to death; Case reference number MOD-2021-010474 is a spontaneous case report sent by a Other on 20-JAN-2021 00:00:00 , which refers to a Female aged 71 Years .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed numbness. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed chills,pain in arm,insomnia,weakness arm,Been sick as a dog. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Malaise . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between numb from the waist down and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .  Update 1: 21-JAN-2021 00:00:00 .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Other,  Age- 71 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Pain in extremity
Clinical narrative: coughing; chills; exhaustion; SORENESS; pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), PAIN IN EXTREMITY (pain in arm), FATIGUE (exhaustion), ARTHRALGIA (SORENESS) and COUGH (coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PAIN IN EXTREMITY (pain in arm), FATIGUE (exhaustion) and ARTHRALGIA (SORENESS). On 20-Jan-2021, the patient experienced COUGH (coughing). On 20-Jan-2021, PAIN IN EXTREMITY (pain in arm) and ARTHRALGIA (SORENESS) had resolved. At the time of the report, CHILLS (chills) had resolved and FATIGUE (exhaustion) and COUGH (coughing) 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 medication was not reported. Treatment medication was not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received both vaccines and is pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received both vaccines and is pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.  No Medical History information was reported.  On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 14-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 19-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received both vaccines and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 19-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received both vaccines and is pregnant) had resolved.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site has been itchy for a couple of days; there is a red bump size of a half dollar at the injection site; a bit of a heat at the injection site; A spontaneous report  was received from a consumer concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site itchiness, a red bump (size of a half dollar) at the injection site and a bit of heat at the injection site.    The patient's medical history, as provided by the reporter, included thyroid and reflex. Concomitant medications reported includedthyroid and reflex medications.     On 12 Jan 2021, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 20 Dec 2021, the patient reported that the injection site was itching for a couple of days. On  the morning of 20 Jan 2021 she noticed a red bump size of a half dollar and felt a little heat there. Treatment for the eventswere not  included.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome for the events, injection site itchiness, a red bump (size of a half dollar) and a bit of heat at the injection site were 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report was received from a female consumer concerning a 81-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea.  The patient's medical history was not provided. The patient current condition included collagenous colitis. No relevant concomitant medications were reported.  On 30 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 2 Feb 2021, the patient experienced diarrhea. Treatment for the event included pepto bismol.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event diarrhea was unknown.; Reporter's Comments: This case concerns a 81-year-old female patient, with a relevant underlying condition of collagenous colitis, who experienced a non-serious unexpected event of diarrhea. The event occurred approximately 3 days after first dose of mRNA-1273, lot unknown. The event of herpes simplex occurred 2 days after first dose of mRNA-1273, lot # 013L20A. Treatment for the event included pepto bismol. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Patient's underlying collagenous colitis is considered a significant confounder.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: a very severe delayed site reaction; it was a reaction where towards the arm was swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (a very severe delayed site reaction) and VACCINATION SITE SWELLING (it was a reaction where towards the arm was swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (a very severe delayed site reaction) and VACCINATION SITE SWELLING (it was a reaction where towards the arm was swollen). At the time of the report, VACCINATION SITE REACTION (a very severe delayed site reaction) and VACCINATION SITE SWELLING (it was a reaction where towards the arm was swollen) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This report concerns one of 7 patients, who experienced the same reactions.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Vaccination site pain
Clinical narrative: Shortness of breath; Pain; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Pain) and CHILLS (Extreme chills) in a 77-year-old female patient 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 DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Pain) and CHILLS (Extreme chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Pain) and CHILLS (Extreme chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: little tired the day (after the shot); red spot; swollen at spot; warm spot; sore arm; temperature elevated; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot) and INJECTION SITE PAIN (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot), INJECTION SITE PAIN (sore arm) and BODY TEMPERATURE INCREASED (temperature elevated). At the time of the report, FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot), INJECTION SITE PAIN (sore arm) and BODY TEMPERATURE INCREASED (temperature elevated) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications are not reported.   Treatment: Ice.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: little tired the day (after the shot); red spot; swollen at spot; warm spot; sore arm; temperature elevated; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot) and INJECTION SITE PAIN (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot), INJECTION SITE PAIN (sore arm) and BODY TEMPERATURE INCREASED (temperature elevated). At the time of the report, FATIGUE (little tired the day (after the shot)), INJECTION SITE ERYTHEMA (red spot), INJECTION SITE SWELLING (swollen at spot), INJECTION SITE WARMTH (warm spot), INJECTION SITE PAIN (sore arm) and BODY TEMPERATURE INCREASED (temperature elevated) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications are not reported.   Treatment: Ice.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy; Swollen; Red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Swollen), INJECTION SITE PAIN (Sore) and INJECTION SITE ERYTHEMA (Red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included WARFARIN, PRAVASTATIN and METOPROLOL for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore). On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red). On 13-Jan-2021, INJECTION SITE PAIN (Sore) had resolved. On 21-Jan-2021, INJECTION SITE PRURITUS (Itchy) had resolved. At the time of the report, INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No new information.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Pain
Clinical narrative: he can barely lift his arm; soreness; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), INJECTED LIMB MOBILITY DECREASED (he can barely lift his arm) and ARTHRALGIA (soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (pain) and ARTHRALGIA (soreness). On 21-Jan-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (he can barely lift his arm). At the time of the report, PAIN (pain), INJECTED LIMB MOBILITY DECREASED (he can barely lift his arm) and ARTHRALGIA (soreness) 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.   Other medicines: he takes medication for his blood pressure, cholesterol and diabetes.  Treatment: None.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Night sweats, Tremor
Clinical narrative: chills; sore arm; night sweats; headaches; shakings; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), INJECTION SITE PAIN (sore arm), NIGHT SWEATS (night sweats), HEADACHE (headaches) and TREMOR (shakings) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (sore arm), NIGHT SWEATS (night sweats), HEADACHE (headaches) and TREMOR (shakings). At the time of the report, CHILLS (chills), INJECTION SITE PAIN (sore arm), NIGHT SWEATS (night sweats), HEADACHE (headaches) and TREMOR (shakings) was resolving.      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 medications were not provided.   Treatment information not provided.