chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm got very hot; red; Swollen; Itchy; The circumference is about 2-3 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 03-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 VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches). At the time of the report, VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 03-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 VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches). At the time of the report, VACCINATION SITE WARMTH (Left arm got very hot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and INJECTION SITE RASH (The circumference is about 2-3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: stomach discomfort; dizziness; fever; chills; nausea; sore arm (site of injection); This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach discomfort), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 52-year-old female 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.     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 06-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach discomfort), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm (site of injection)). On 08-Feb-2021, ABDOMINAL DISCOMFORT (stomach discomfort), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm (site of injection)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included. The patient's medical history was not provided. Relevant concomitant products usage were not reported by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: stomach discomfort; dizziness; fever; chills; nausea; sore arm (site of injection); This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach discomfort), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 52-year-old female 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.     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 06-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach discomfort), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm (site of injection)). On 08-Feb-2021, ABDOMINAL DISCOMFORT (stomach discomfort), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm (site of injection)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included. The patient's medical history was not provided. Relevant concomitant products usage were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 616M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia, Pain in extremity
Clinical narrative: shortness of breath/ Problems breathing; forearm aching; body was aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/ Problems breathing), PAIN IN EXTREMITY (forearm aching) and MYALGIA (body was aching) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 DYSPNOEA (shortness of breath/ Problems breathing), PAIN IN EXTREMITY (forearm aching) and MYALGIA (body was aching). At the time of the report, DYSPNOEA (shortness of breath/ Problems breathing), PAIN IN EXTREMITY (forearm aching) and MYALGIA (body was aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: sweating; fast heartbeat; chills; complete exhaustion; headache; nausea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), HEART RATE INCREASED (fast heartbeat), CHILLS (chills), FATIGUE (complete exhaustion) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE, CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 08-Feb-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 08-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), HEART RATE INCREASED (fast heartbeat), CHILLS (chills), FATIGUE (complete exhaustion), HEADACHE (headache) and NAUSEA (nausea). 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, HYPERHIDROSIS (sweating), HEART RATE INCREASED (fast heartbeat), CHILLS (chills), FATIGUE (complete exhaustion), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  Concomitant medications reported were High Blood Pressure Medication
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: sweating; fast heartbeat; chills; complete exhaustion; headache; nausea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), HEART RATE INCREASED (fast heartbeat), CHILLS (chills), FATIGUE (complete exhaustion) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE, CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 08-Feb-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 08-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), HEART RATE INCREASED (fast heartbeat), CHILLS (chills), FATIGUE (complete exhaustion), HEADACHE (headache) and NAUSEA (nausea). 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, HYPERHIDROSIS (sweating), HEART RATE INCREASED (fast heartbeat), CHILLS (chills), FATIGUE (complete exhaustion), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  Concomitant medications reported were High Blood Pressure Medication
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: warm to touch on the injection site; Soreness at the injection site; Redness that is spreading; joint and bone pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch on the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness that is spreading) and ARTHRALGIA (joint and bone pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Controlled by medicines) since 2008, Cholesterol (Controlled by medicines) since 2008 and Acid reflux (oesophageal) (Controlled by medicines) since 2008. Concomitant products included FLUOXETINE HYDROCHLORIDE, PANTOPRAZOLE, ATORVASTATIN, METOPROLOL and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    On 03-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (joint and bone pain). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to touch on the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is spreading). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 06-Mar-2021, ARTHRALGIA (joint and bone pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch on the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is spreading) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient has undergone blood workup as a normal checkup and everything look good including calcium and vitamin D. He took a Bone density scan which shows significant osteoporosis. Patient was referred to Osteoporosis clinic, where he was recommended Reclast infusion which he took.   This case was linked to MOD-2021-263858 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow-up:- medical history, second dose info and concomitants are updated. On 22-Jul-2021: NNI- No New Information
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year receiving moderna vaccine; A spontaneous report was received from a consumer concerning a 17-year-old patient, who received the vaccine/product administered to patient of inappropriate age.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the 17-year-old patient received the vaccine.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome event, product administered to patient of inappropriate age, was considered recovered.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dry mouth, Nausea, Pyrexia
Clinical narrative: Extreme dry mouth; Weakness; Nausea; 103.9 Fever; A spontaneous report (United States) was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 103.9 fever, nausea, extreme dry mouth and weakness.  The patient's medical history included Covid 19 prior to vaccination. He tested negative prior to receiving vaccination. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not Provided) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event- 103.9 fever, nausea, extreme dry mouth and weakness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- 103.9 fever, nausea,  extreme dry mouth and weakness was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash
Clinical narrative: Serious adverse reaction; Stining sensation; Rash; Chills; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Serious adverse reaction), PAIN (Stining sensation), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) 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.     Concurrent medical conditions included Drug allergy (Allergy to macrolides).    On 11-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 VACCINATION COMPLICATION (Serious adverse reaction), PAIN (Stining sensation), RASH (Rash), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, VACCINATION COMPLICATION (Serious adverse reaction), PAIN (Stining sensation), RASH (Rash), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment details included cream and pain Killer.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Serious adverse reaction; Stining sensation; Rash; Chills; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Serious adverse reaction), PAIN (Stining sensation), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) 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.     Concurrent medical conditions included Drug allergy (Allergy to macrolides).    On 11-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 VACCINATION COMPLICATION (Serious adverse reaction), PAIN (Stining sensation), RASH (Rash), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, VACCINATION COMPLICATION (Serious adverse reaction), PAIN (Stining sensation), RASH (Rash), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment details included cream and pain Killer.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: cant seem to stay awake; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (cant seem to stay awake) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL, ATORVASTATIN, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ANTACIDS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (cant seem to stay awake). At the time of the report, SOMNOLENCE (cant seem to stay awake) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Vaginal discharge
Clinical narrative: Vaginal discharge; Sore sort of like a yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (Vaginal discharge) and FUNGAL INFECTION (Sore sort of like a yeast infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Celiac disease and Graves' disease.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VAGINAL DISCHARGE (Vaginal discharge) and FUNGAL INFECTION (Sore sort of like a yeast infection). At the time of the report, VAGINAL DISCHARGE (Vaginal discharge) and FUNGAL INFECTION (Sore sort of like a yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site itchy; injection site redness/outside of arm, just above elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site redness/outside of arm, just above elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Hypertension and Leg edema. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, FUROSEMIDE and SPIRONOLACTONE for an unknown indication.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site redness/outside of arm, just above elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site redness/outside of arm, just above elbow) outcome was unknown.            Patient used an ice pack and took Tylenol before she went to bed. Action taken with mRNA-1273 in response to events was not applicable.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Neck pain, Pain in extremity, X-ray
Clinical narrative: Patient started experiencing pain in muscle and bones in left arm; Patient started experiencing pain in muscle and bones in left arm; Neck pain (with radiation); Patient reported sore arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient reported sore arm after receiving 1st dose), BONE PAIN (Patient started experiencing pain in muscle and bones in left arm), NECK PAIN (Neck pain (with radiation)) and MYALGIA (Patient started experiencing pain in muscle and bones in left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE and LOVASTATIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Patient reported sore arm after receiving 1st dose). On 22-Feb-2021, the patient experienced NECK PAIN (Neck pain (with radiation)). On 02-Mar-2021, the patient experienced BONE PAIN (Patient started experiencing pain in muscle and bones in left arm) and MYALGIA (Patient started experiencing pain in muscle and bones in left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Patient reported sore arm after receiving 1st dose), BONE PAIN (Patient started experiencing pain in muscle and bones in left arm), NECK PAIN (Neck pain (with radiation)) and MYALGIA (Patient started experiencing pain in muscle and bones in left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, X-ray: normal (normal) MD did x-ray and couldn't find anything.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Pain
Clinical narrative: washed out feeling; Felt worse; Headache; Felt terrible; Achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), PAIN (Achy), MALAISE (Felt worse), HEADACHE (Headache) and FATIGUE (washed out feeling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 0131L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FEELING ABNORMAL (Felt terrible), PAIN (Achy) and HEADACHE (Headache). On 27-Feb-2021, the patient experienced MALAISE (Felt worse). On 02-Mar-2021, the patient experienced FATIGUE (washed out feeling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt terrible), PAIN (Achy), MALAISE (Felt worse), HEADACHE (Headache) and FATIGUE (washed out feeling) outcome was unknown.            Patient  reported that she took two Tylenol. On 27 Feb 2021, she stated that she "felt worse" and took two additional Tylenol.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Muscle spasticity, Myalgia
Clinical narrative: Lower left side abdominal pain; Acute abdominal pain; stiff arm; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Acute abdominal pain), ABDOMINAL PAIN (Lower left side abdominal pain), MUSCLE SPASTICITY (stiff arm), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 26-Feb-2021, the patient experienced MUSCLE SPASTICITY (stiff arm), FATIGUE (fatigue) and MYALGIA (muscle pain). On 27-Feb-2021, the patient experienced ABDOMINAL PAIN (Acute abdominal pain). On 02-Mar-2021, the patient experienced ABDOMINAL PAIN (Lower left side abdominal pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Acute abdominal pain) outcome was unknown, ABDOMINAL PAIN (Lower left side abdominal pain) had not resolved and MUSCLE SPASTICITY (stiff arm), FATIGUE (fatigue) and MYALGIA (muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were none.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient vomited for 3 times; really bad watery diarrhea; diarrhea got worse 4 days later; Patient started getting diarrhea 2 days after receving 2nd dose of vaccine; Patient started getting chills; nausea on same night of receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Patient started getting diarrhea 2 days after receving 2nd dose of vaccine), DIARRHOEA (really bad watery diarrhea), DIARRHOEA (diarrhea got worse 4 days later), CHILLS (Patient started getting chills) and VOMITING (Patient vomited for 3 times) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), ASENAPINE MALEATE (SAPHRIS), CLONAZEPAM (KLONOPIN) and TRAZODONE for an unknown indication.   On 19-Feb-2021 at 10:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (Patient started getting chills) and NAUSEA (nausea on same night of receiving 2nd dose). On 21-Feb-2021, the patient experienced DIARRHOEA (Patient started getting diarrhea 2 days after receving 2nd dose of vaccine). On 25-Feb-2021, the patient experienced DIARRHOEA (diarrhea got worse 4 days later). On 26-Feb-2021, the patient experienced DIARRHOEA (really bad watery diarrhea). On 28-Feb-2021, the patient experienced VOMITING (Patient vomited for 3 times). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Patient started getting diarrhea 2 days after receving 2nd dose of vaccine), DIARRHOEA (really bad watery diarrhea), DIARRHOEA (diarrhea got worse 4 days later), CHILLS (Patient started getting chills), VOMITING (Patient vomited for 3 times) and NAUSEA (nausea on same night of receiving 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Lower left side abdominal pain; Acute abdominal pain; stiff arm; Muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Acute abdominal pain), ABDOMINAL PAIN (Lower left side abdominal pain), MUSCULOSKELETAL STIFFNESS (stiff arm), MYALGIA (Muscle pain) and FATIGUE (fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff arm), MYALGIA (Muscle pain) and FATIGUE (fatigue). On 27-Feb-2021, the patient experienced ABDOMINAL PAIN (Acute abdominal pain). On 02-Mar-2021, the patient experienced ABDOMINAL PAIN (Lower left side abdominal pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Acute abdominal pain) and ABDOMINAL PAIN (Lower left side abdominal pain) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiff arm), MYALGIA (Muscle pain) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were none.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash at the injection site and arm; Rash in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site and arm) and RASH (Rash in arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site and arm) and RASH (Rash in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash at the injection site and arm) and RASH (Rash in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: Achy; Exhausted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy), FATIGUE (Exhausted) and CHILLS (Chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and NABUMETONE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MYALGIA (Achy), FATIGUE (Exhausted) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Achy), FATIGUE (Exhausted) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) he had Covid 6 months ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR Received. Significant FU- AE Outcomes updated
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenia, Fatigue, Malaise, Myalgia
Clinical narrative: reaction after three days; wasn't feeling well; too weak to get ready to go; getting fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (reaction after three days), MALAISE (wasn't feeling well), ASTHENIA (too weak to get ready to go), FATIGUE (getting fatigue) and MYALGIA (muscle pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 014M20A) 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) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ADVERSE REACTION (reaction after three days), MALAISE (wasn't feeling well), ASTHENIA (too weak to get ready to go), FATIGUE (getting fatigue) and MYALGIA (muscle pain). At the time of the report, ADVERSE REACTION (reaction after three days), MALAISE (wasn't feeling well), ASTHENIA (too weak to get ready to go), FATIGUE (getting fatigue) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that I just got my first dose of Moderna vaccine last Friday on 26feb2021 and I was fine until now. Today I started getting fatigue and muscle pain. I had doctor's appointment but I wasn't feeling well so I couldn't go. I was too weak to get ready to go. Is it okay to get the reaction after three days?
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast swelling, Swelling, Tenderness
Clinical narrative: Breast swollen like a water balloon; Whole side from shoulder to feet is swollen; Armpit hurting; Swollen area tender; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast swollen like a water balloon), SWELLING (Whole side from shoulder to feet is swollen), AXILLARY PAIN (Armpit hurting) and TENDERNESS (Swollen area tender) in an 80-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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced BREAST SWELLING (Breast swollen like a water balloon), SWELLING (Whole side from shoulder to feet is swollen), AXILLARY PAIN (Armpit hurting) and TENDERNESS (Swollen area tender). At the time of the report, BREAST SWELLING (Breast swollen like a water balloon), SWELLING (Whole side from shoulder to feet is swollen), AXILLARY PAIN (Armpit hurting) and TENDERNESS (Swollen area tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment medication was provided.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Exceeded dosing interval; Fatigue; A spontaneous report was received from a consumer for a 78 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue. It was known the patient had exceeded dosing interval.  The patient's medical history included chronic obstructive pulmonary disease. Concomitant medication included inhaler.  On 29-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. It was known the patient had exceeded the dosing interval. On 29-Jan-2021, an unspecified interval after receiving the vaccine the patient experienced fatigue.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, exceeded dosing interval was not applicable and for the event fatigue was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot 012L20A with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the fatigue, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Redness; itchy; tender; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021 Contains Age of the patient was added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Pain at the injection site; Itchiness at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 73-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.            No treatment information provided, no concomitant medications reported. Patient called to report her adverse events Pain, Itchiness and Rash at the injection site, following her second shot of MODERNA COVID 19 Vaccine intramuscularly on the left arm, last Friday, 26FEB2021. Consumer confirmed using ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021:
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Nausea, Peripheral coldness
Clinical narrative: thumb not straight; fatigue; nausea; cold extremities; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue) and NAUSEA (nausea) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information was reported.     On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 30-Jan-2021, the patient experienced MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue), NAUSEA (nausea) and PERIPHERAL COLDNESS (cold extremities). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 30-Jan-2021, CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight) and NAUSEA (nausea) had resolved. On 31-Jan-2021, FATIGUE (fatigue) and PERIPHERAL COLDNESS (cold extremities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue) and NAUSEA (nausea) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information was reported.     On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 30-Jan-2021, the patient experienced MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue), NAUSEA (nausea) and PERIPHERAL COLDNESS (cold extremities). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 30-Jan-2021, CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight) and NAUSEA (nausea) had resolved. On 31-Jan-2021, FATIGUE (fatigue) and PERIPHERAL COLDNESS (cold extremities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: thumb not straight; fatigue; nausea; cold extremities; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue) and NAUSEA (nausea) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information was reported.     On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 30-Jan-2021, the patient experienced MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue), NAUSEA (nausea) and PERIPHERAL COLDNESS (cold extremities). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 30-Jan-2021, CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight) and NAUSEA (nausea) had resolved. On 31-Jan-2021, FATIGUE (fatigue) and PERIPHERAL COLDNESS (cold extremities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue) and NAUSEA (nausea) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information was reported.     On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 30-Jan-2021, the patient experienced MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue), NAUSEA (nausea) and PERIPHERAL COLDNESS (cold extremities). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 30-Jan-2021, CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight) and NAUSEA (nausea) had resolved. On 31-Jan-2021, FATIGUE (fatigue) and PERIPHERAL COLDNESS (cold extremities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.