chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nasal congestion, Pain, Pain in extremity
Clinical narrative: Congestion; Not feeling great; Fatigue; feel achy; Arm soreness about 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness about 2-3 days), NASAL CONGESTION (Congestion), MALAISE (Not feeling great), FATIGUE (Fatigue) and PAIN (feel achy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness about 2-3 days). On 10-Mar-2021, the patient experienced NASAL CONGESTION (Congestion), MALAISE (Not feeling great), FATIGUE (Fatigue) and PAIN (feel achy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm soreness about 2-3 days), NASAL CONGESTION (Congestion), MALAISE (Not feeling great), FATIGUE (Fatigue) and PAIN (feel achy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Advil
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema
Clinical narrative: red in the arm of the injection; red went up his shoulder and neck; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (red in the arm of the injection) and ERYTHEMA (red went up his shoulder and neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red in the arm of the injection) and ERYTHEMA (red went up his shoulder and neck). At the time of the report, VACCINATION SITE ERYTHEMA (red in the arm of the injection) and ERYTHEMA (red went up his shoulder and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mass
Clinical narrative: Red giant nod; Felt somewhat tired; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Red giant nod) and FATIGUE (Felt somewhat tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MASS (Red giant nod) and FATIGUE (Felt somewhat tired). At the time of the report, MASS (Red giant nod) and FATIGUE (Felt somewhat tired) outcome was unknown.            Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: People were complaining about vertigo days after the shot; 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 VERTIGO (People were complaining about vertigo days after the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (People were complaining about vertigo days after the shot). At the time of the report, VERTIGO (People were complaining about vertigo days after the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter treatment information n was not provided. This patient was reading a form on the internet where people were complaining about vertigo days after the shot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vaccination complication
Clinical narrative: severe nausea; She felt horrible/ felt like she was dragging; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She felt horrible/ felt like she was dragging), PYREXIA (Fever) and NAUSEA (severe nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A2A and 031M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOPROLOL and CLOPIDOGREL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (She felt horrible/ felt like she was dragging) and PYREXIA (Fever). On 11-Mar-2021 at 5:30 AM, the patient experienced NAUSEA (severe nausea). The patient was treated with PARACETAMOL (TYLENOL) on 10-Mar-2021 for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (She felt horrible/ felt like she was dragging), PYREXIA (Fever) and NAUSEA (severe nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.6 (High) degrees Fahrenheit @ 23:30. On 11-Mar-2021, Body temperature: 100.6 (High) degrees Fahrenheit @ 05:30.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Covid Arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Covid Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 HYPERSENSITIVITY (Covid Arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Covid Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-042732 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042732:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: small area that it hurts to touch and that somedays just hurts by itself; real sore shoulder but is still hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (small area that it hurts to touch and that somedays just hurts by itself) and MYALGIA (real sore shoulder but is still hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 303M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (small area that it hurts to touch and that somedays just hurts by itself) and MYALGIA (real sore shoulder but is still hurting). At the time of the report, PAIN (small area that it hurts to touch and that somedays just hurts by itself) and MYALGIA (real sore shoulder but is still hurting) 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
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itch; rash; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), RASH (rash) and URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRURITUS (itch), RASH (rash) and URTICARIA (hives). At the time of the report, PRURITUS (itch), RASH (rash) and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided include allergy medicine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK dosage form. At the time of the report, HEADACHE (persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; Aches and pains in joints; Sore Arm 2nd vaccine dose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore Arm 2nd vaccine dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Aches and pains in joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm 2nd vaccine dose) and ARTHRALGIA (Aches and pains in joints). On 11-Mar-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 11-Mar-2021, PAIN IN EXTREMITY (Sore Arm 2nd vaccine dose) and ARTHRALGIA (Aches and pains in joints) had resolved. At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-061491.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Pain in shoulder; Pain in top of arm; Pain going up to neck; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder), PAIN IN EXTREMITY (Pain in top of arm) and PAIN (Pain going up to neck) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METFORMIN, BACLOFEN, FOLIC ACID and ROSUVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (Pain in shoulder), PAIN IN EXTREMITY (Pain in top of arm) and PAIN (Pain going up to neck). At the time of the report, ARTHRALGIA (Pain in shoulder), PAIN IN EXTREMITY (Pain in top of arm) and PAIN (Pain going up to neck) outcome was unknown.            Treatment information was not provided. The reporter mentioned that the patient was undergoing a heart catheterization at the time of the report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Rash
Clinical narrative: feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest; rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest) and RASH (rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHEST DISCOMFORT (feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest) and RASH (rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back). The patient was treated with PREDNISONE for Chest discomfort, at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest) and RASH (rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified birth control pills.   Treatment medications also included antihistaminic.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Toothache
Clinical narrative: severe toothache; my toothache is better now but my face is swollen up a bit; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (severe toothache) and SWELLING FACE (my toothache is better now but my face is swollen up a bit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TOOTHACHE (severe toothache) and SWELLING FACE (my toothache is better now but my face is swollen up a bit). At the time of the report, TOOTHACHE (severe toothache) and SWELLING FACE (my toothache is better now but my face is swollen up a bit) outcome was unknown.            No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Sore arm; Redness around the Injection site; Swollen axillary lymph nodes; Joint pain; Chills; Fatigue and Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the Injection site), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the Injection site), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue and Tiredness) and HEADACHE (Headache). On 10-Mar-2021, VACCINATION SITE ERYTHEMA (Redness around the Injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue and Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: Sore arm; Redness around the Injection site; Swollen axillary lymph nodes; Joint pain; Chills; Fatigue and Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the Injection site), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the Injection site), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue and Tiredness) and HEADACHE (Headache). On 10-Mar-2021, VACCINATION SITE ERYTHEMA (Redness around the Injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue and Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration
Clinical narrative: Dehydration; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and DEHYDRATION (Dehydration) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 ASTHENIA (Weakness) and DEHYDRATION (Dehydration). At the time of the report, ASTHENIA (Weakness) and DEHYDRATION (Dehydration) outcome was unknown.            No treatment medicines were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vertigo
Clinical narrative: Vertigo; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Corneal transplant in October 2018. Concurrent medical conditions included Gluten intolerance, Lactose intolerance, Vertigo (Benign positional vertigo episodic), Paresthesia, Coronary artery disease, Tinnitus, Constipation (Chronic idiopathic constipation), Osteoarthritis (Osteoarthritis in hands), Osteopenia, Osteoporosis, Hypothyroidism, Anxiety and Lichen sclerosis atrophicus (Lichen Sclerosis vaginal labia area). Concomitant products included LUBIPROSTONE (AMITIZA), LEVOTHYROXINE, ROSUVASTATIN from 20-Nov-2020 to an unknown date, CLOPIDOGREL from 15-Aug-2020 to an unknown date, ESTRADIOL and DIFLUPREDNATE (DUREZOL) for an unknown indication, LOTEPREDNOL ETABONATE (LOTEMAX).    On 12-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 VERTIGO (Vertigo) and FATIGUE (Fatigue). At the time of the report, VERTIGO (Vertigo) had not resolved and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.   This case was linked to MOD-2021-104658 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow received  as updated outcome of the event
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a few days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Steroid dependant.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a few days). On 06-Mar-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-090324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090324:2st dose
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (upper body pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and MYALGIA (upper body pain). At the time of the report, HEADACHE (headaches) and MYALGIA (upper body pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to MOD-2021-039887 (E2B Linked Report).; Sender's Comments:  MOD-2021-039887:Same reporter
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema, Inflammation, Pruritus, Rash
Clinical narrative: small rash on right inner forearm; Tiny blisters on index finger; redness and skin peeled on index finger; inflammation on left wrist; itching on left wrist; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation on left wrist), PRURITUS (itching on left wrist), BLISTER (Tiny blisters on index finger), ERYTHEMA (redness and skin peeled on index finger) and RASH (small rash on right inner forearm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), FUROSEMIDE and POTASSIUM CHLORIDE (KLOR CON) 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 INFLAMMATION (inflammation on left wrist), PRURITUS (itching on left wrist) and VACCINATION SITE PAIN (soreness at injection site). On 03-Mar-2021, the patient experienced BLISTER (Tiny blisters on index finger) and ERYTHEMA (redness and skin peeled on index finger). On 06-Mar-2021, the patient experienced RASH (small rash on right inner forearm). On 03-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, INFLAMMATION (inflammation on left wrist), PRURITUS (itching on left wrist), BLISTER (Tiny blisters on index finger), ERYTHEMA (redness and skin peeled on index finger) and RASH (small rash on right inner forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes skin cream and diphenhydramine.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: small rash on right inner forearm; Tiny blisters on index finger; redness and skin peeled on index finger; inflammation on left wrist; itching on left wrist; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation on left wrist), PRURITUS (itching on left wrist), BLISTER (Tiny blisters on index finger), ERYTHEMA (redness and skin peeled on index finger) and RASH (small rash on right inner forearm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), FUROSEMIDE and POTASSIUM CHLORIDE (KLOR CON) 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 INFLAMMATION (inflammation on left wrist), PRURITUS (itching on left wrist) and VACCINATION SITE PAIN (soreness at injection site). On 03-Mar-2021, the patient experienced BLISTER (Tiny blisters on index finger) and ERYTHEMA (redness and skin peeled on index finger). On 06-Mar-2021, the patient experienced RASH (small rash on right inner forearm). On 03-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, INFLAMMATION (inflammation on left wrist), PRURITUS (itching on left wrist), BLISTER (Tiny blisters on index finger), ERYTHEMA (redness and skin peeled on index finger) and RASH (small rash on right inner forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes skin cream and diphenhydramine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PARAESTHESIA (tickling on the same arm of the injection). At the time of the report, VACCINATION SITE PARAESTHESIA (tickling on the same arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment for the event was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Swelling, Vaccination site erythema
Clinical narrative: going down the arm from shoulder to elbow; warm to touch and swollen; warm to touch and swollen; arm was red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (going down the arm from shoulder to elbow), FEELING HOT (warm to touch and swollen), SWELLING (warm to touch and swollen) and VACCINATION SITE ERYTHEMA (arm was red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZIA) for COVID-19 vaccination.     The patient's past medical history included Diabetes (diabetes). Concurrent medical conditions included Food allergy (bananas), Allergy to antibiotic (Clindamycin), Egg allergy, Fruit allergy (watermelon) and Food allergy (Cantaloupe). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), DESVENLAFAXINE SUCCINATE (PRISTIQ), GABAPENTIN, LAMOTRIGINE, FENOFIBRATE, ATORVASTATIN and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING HOT (warm to touch and swollen), SWELLING (warm to touch and swollen) and VACCINATION SITE ERYTHEMA (arm was red). On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (going down the arm from shoulder to elbow). At the time of the report, PAIN IN EXTREMITY (going down the arm from shoulder to elbow), FEELING HOT (warm to touch and swollen) and SWELLING (warm to touch and swollen) had not resolved and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. Other concomitant medicines include Amphipoda   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-Up Information Received on 16-JUN-2021 contains Non Significant Information
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pyrexia, Rash, Swelling face
Clinical narrative: swollen face; face redness; Urticaria; Rash; Fatigue; Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), ERYTHEMA (face redness), URTICARIA (Urticaria), RASH (Rash) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Itchy hives) and COVID-19 in November 2020.    On 02-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 FATIGUE (Fatigue) and PYREXIA (Pyrexia). On 03-Mar-2021, the patient experienced URTICARIA (Urticaria) and RASH (Rash). On an unknown date, the patient experienced SWELLING FACE (swollen face) and ERYTHEMA (face redness). At the time of the report, SWELLING FACE (swollen face), ERYTHEMA (face redness), URTICARIA (Urticaria), RASH (Rash), FATIGUE (Fatigue) and PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Concomitant medications were not provided.; 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: swollen face; face redness; Urticaria; Rash; Fatigue; Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), ERYTHEMA (face redness), URTICARIA (Urticaria), RASH (Rash) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Itchy hives) and COVID-19 in November 2020.    On 02-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 FATIGUE (Fatigue) and PYREXIA (Pyrexia). On 03-Mar-2021, the patient experienced URTICARIA (Urticaria) and RASH (Rash). On an unknown date, the patient experienced SWELLING FACE (swollen face) and ERYTHEMA (face redness). At the time of the report, SWELLING FACE (swollen face), ERYTHEMA (face redness), URTICARIA (Urticaria), RASH (Rash), FATIGUE (Fatigue) and PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pain in extremity, Peripheral swelling
Clinical narrative: peripheral swelling; Pain in extremity; Chest pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (peripheral swelling), PAIN IN EXTREMITY (Pain in extremity), CHEST PAIN (Chest pain) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient stated she was diagnosed with cancer 1.5 years age and is under treatment now). Concomitant products included LENALIDOMIDE (REVLIMID) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (peripheral swelling), PAIN IN EXTREMITY (Pain in extremity), CHEST PAIN (Chest pain) and CHILLS (Chills). At the time of the report, PERIPHERAL SWELLING (peripheral swelling), PAIN IN EXTREMITY (Pain in extremity), CHEST PAIN (Chest pain) and CHILLS (Chills) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was reported.  Patient advised the events had resolved and "were minor". She noted the chest pain lasted 10-15 minutes, then completely went away. She did not seek medical treatment for any of the events.  Patient advised she has a history of cancer and is in treatment. She stated she was diagnosed 1.5 years ago and perhaps this is what made her experience the listed events.   This case was linked to MOD-2021-210562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Event verbatim  has been changed  and outcome of event changed(from  unknown to recovered) and medical history was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Ended up getting the second shot for vaccine 48 days late; A spontaneous report was received from a consumer concerning a 74 year old-male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported Inappropriate schedule of vaccine administered.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 20 Jan 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 032120A) on left arm for prophylaxis of COVID-19 infection.  On 09 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch unknown) on left arm for prophylaxis of COVID-19 infection.  The patient ended up getting the 2nd dose of vaccine 48 days after the first dose (Inappropriate schedule of vaccine administered).  No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the event was considered as recovered at the time of the report.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Micturition urgency, Pollakiuria
Clinical narrative: sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021; felt like she was going to explode; she was up six times to use the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION URGENCY (sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021), FEELING ABNORMAL (felt like she was going to explode) and POLLAKIURIA (she was up six times to use the bathroom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     Concurrent medical conditions included Varices esophageal (can only drink water, no juice, no caffeine, no coffee).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MICTURITION URGENCY (sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021), FEELING ABNORMAL (felt like she was going to explode) and POLLAKIURIA (she was up six times to use the bathroom). At the time of the report, MICTURITION URGENCY (sudden urge to pee-all day long felt intense pressure of having to pee that continues on 10mar2021), FEELING ABNORMAL (felt like she was going to explode) and POLLAKIURIA (she was up six times to use the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment information was provided. The patient did not have water on her drive to the vaccination site 35 miles away, nor any water after the vaccine. The patient made it home and all day long felt intense pressure of having to pee that continued on 10 Mar 2021. .
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: bumps on inside of arms, back of legs and on stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bumps on inside of arms, back of legs and on stomach) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (bumps on inside of arms, back of legs and on stomach). At the time of the report, RASH (bumps on inside of arms, back of legs and on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin mass, Vaccination site swelling
Clinical narrative: very bad itching; hard lump; Initially swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very bad itching), SKIN MASS (hard lump) and VACCINATION SITE SWELLING (Initially swelling at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very bad itching), SKIN MASS (hard lump) and VACCINATION SITE SWELLING (Initially swelling at injection site). At the time of the report, PRURITUS (very bad itching), SKIN MASS (hard lump) and VACCINATION SITE SWELLING (Initially swelling at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: hard; very itchy; swollen; a large red circle (2.5x3 inch) formed at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (a large red circle (2.5x3 inch) formed at the injection site) in a 70-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 09-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (a large red circle (2.5x3 inch) formed at the injection site). At the time of the report, VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (a large red circle (2.5x3 inch) formed at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Malaise
Clinical narrative: body aches in entre body; joint pain in entire body; chills; extreme headache; dizziness; Arm pain; did not feel like herself; mild fever; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (Arm pain), MALAISE (did not feel like herself), PYREXIA (mild fever) and NAUSEA (nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (Arm pain), MALAISE (did not feel like herself), PYREXIA (mild fever), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (extreme headache). On an unknown date, the patient experienced MYALGIA (body aches in entre body) and ARTHRALGIA (joint pain in entire body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FEXOFENADINE at a dose of 1 mg. On 11-Feb-2021, DIZZINESS (dizziness), MALAISE (did not feel like herself), PYREXIA (mild fever), NAUSEA (nauseous) and CHILLS (chills) had resolved, HEADACHE (extreme headache) outcome was unknown. On 14-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MYALGIA (body aches in entre body) and ARTHRALGIA (joint pain in entire body) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-207513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Initial additional
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: body aches in entre body; joint pain in entire body; chills; extreme headache; dizziness; Arm pain; did not feel like herself; mild fever; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (Arm pain), MALAISE (did not feel like herself), PYREXIA (mild fever) and NAUSEA (nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (Arm pain), MALAISE (did not feel like herself), PYREXIA (mild fever), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (extreme headache). On an unknown date, the patient experienced MYALGIA (body aches in entre body) and ARTHRALGIA (joint pain in entire body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FEXOFENADINE at a dose of 1 mg. On 11-Feb-2021, DIZZINESS (dizziness), MALAISE (did not feel like herself), PYREXIA (mild fever), NAUSEA (nauseous) and CHILLS (chills) had resolved, HEADACHE (extreme headache) outcome was unknown. On 14-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MYALGIA (body aches in entre body) and ARTHRALGIA (joint pain in entire body) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-207513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Initial additional