chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Urticaria
Clinical narrative: broke out into hives on left side of face, neck and ears; neck stiffness; swollen glands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out into hives on left side of face, neck and ears), MUSCULOSKELETAL STIFFNESS (neck stiffness) and LYMPHADENOPATHY (swollen glands) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Allergic dermatitis, Allergic conjunctivitis and Bell's palsy (Weakness on right side of face) on 28-Nov-2016. Previously administered products included for Product used for unknown indication: Cymbalta. Past adverse reactions to the above products included Allergy with Cymbalta. Family history included Stroke and TIA. Concurrent medical conditions included Hypertension since 2000, Diabetes since 2005, Fibromyalgia since 2008, Latex allergy, Shellfish allergy and Allergy to molds. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 24-Mar-2020 to an unknown date for Allergy, SALBUTAMOL SULFATE (VENTOLIN HFA) from 24-Mar-2020 to an unknown date for Cough, METFORMIN for Diabetes, GABAPENTIN for Fibromyalgia, LEVOCETIRIZINE DIHYDROCHLORIDE from 24-Apr-2020 to an unknown date and FLUTICASONE PROPIONATE from 24-Apr-2020 to an unknown date for Hypersensitivity, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) and METOPROLOL TARTRATE for Hypertension, NAPROXEN from 17-Jan-2019 to an unknown date for Pain, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and IBUPROFEN from 20-Jan-2018 to an unknown date for an unknown indication.    On 04-Jan-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced URTICARIA (broke out into hives on left side of face, neck and ears), MUSCULOSKELETAL STIFFNESS (neck stiffness) and LYMPHADENOPATHY (swollen glands). The patient was treated with METHYLPREDNISOLONE ACETATE at a dose of 40 milligram; CETIRIZINE HYDROCHLORIDE at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. On 05-Feb-2021, URTICARIA (broke out into hives on left side of face, neck and ears), MUSCULOSKELETAL STIFFNESS (neck stiffness) and LYMPHADENOPATHY (swollen glands) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Reporter Last name changed.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chills.    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, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Wheezing
Clinical narrative: lungs feel like they're closing; Shortness of breath; wheezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (lungs feel like they're closing), DYSPNOEA (Shortness of breath), WHEEZING (wheezing) and COUGH (coughing) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included TESTOSTERONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced CHEST DISCOMFORT (lungs feel like they're closing), DYSPNOEA (Shortness of breath), WHEEZING (wheezing) and COUGH (coughing). At the time of the report, CHEST DISCOMFORT (lungs feel like they're closing), DYSPNOEA (Shortness of breath), WHEEZING (wheezing) and COUGH (coughing) outcome was unknown.            Treatment of the events were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body temperature, Erythema, Pyrexia
Clinical narrative: blisters; Redness/erythema; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of BLISTER (blisters), ERYTHEMA (Redness/erythema) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in 2017. Concurrent medical conditions included Hypertension (no medication report were provided) since 2010 and High cholesterol since 2015. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), PRAVASTATIN and EZETIMIBE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced BLISTER (blisters), ERYTHEMA (Redness/erythema) and PYREXIA (Fever). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) on 12-Mar-2021 for Antihistamine therapy, at a dose of 500 mg twice a day. On 05-Apr-2021, BLISTER (blisters), ERYTHEMA (Redness/erythema) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) fever  101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073502 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 contain significant information including patient demographic information, suspect product information, concomitant medication, treatment medication, events outcome unknown to resolved.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive the second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Erythema, Injection site pain, Malaise
Clinical narrative: Redness/erythema; fever blister; Pain in arm; Malaise; Injection site pain; chills; Fever; Blisters; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (fever blister), BLISTER (Blisters), ERYTHEMA (Redness/erythema), PAIN IN EXTREMITY (Pain in arm) and MALAISE (Malaise) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since March 2010, High cholesterol since 2015 and Shingles in 2017. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), PRAVASTATIN and EZETIMIBE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BLISTER (Blisters). 12-Mar-2021, the patient experienced PYREXIA (Fever). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). 02-Apr-2021, the patient experienced MALAISE (Malaise) and CHILLS (chills). 02-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 05-Apr-2021, the patient experienced ORAL HERPES (fever blister). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Fever blister, at a dose of 500 mg twice a day. On 04-Apr-2021, PAIN IN EXTREMITY (Pain in arm), MALAISE (Malaise), INJECTION SITE PAIN (Injection site pain), CHILLS (chills) and PYREXIA (Fever) had resolved. At the time of the report, ORAL HERPES (fever blister) had not resolved, BLISTER (Blisters) outcome was unknown and ERYTHEMA (Redness/erythema) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Fever blister on lip developed after each dose of the COVID vaccine, each lasting about 10 days.First fever blister treated with Valtrex 500mg X 2 tablets once. With second dose, treated with Valtrex 500mg X 2 daily for 7 days with little impact on resolving fever blister.   This case was linked to MOD-2021-073494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow up appended for AE Event/Contact update
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: Redness/erythema; fever blister; Pain in arm; Malaise; Injection site pain; chills; Fever; Blisters; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (fever blister), BLISTER (Blisters), ERYTHEMA (Redness/erythema), PAIN IN EXTREMITY (Pain in arm) and MALAISE (Malaise) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since March 2010, High cholesterol since 2015 and Shingles in 2017. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), PRAVASTATIN and EZETIMIBE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BLISTER (Blisters). 12-Mar-2021, the patient experienced PYREXIA (Fever). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). 02-Apr-2021, the patient experienced MALAISE (Malaise) and CHILLS (chills). 02-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 05-Apr-2021, the patient experienced ORAL HERPES (fever blister). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Fever blister, at a dose of 500 mg twice a day. On 04-Apr-2021, PAIN IN EXTREMITY (Pain in arm), MALAISE (Malaise), INJECTION SITE PAIN (Injection site pain), CHILLS (chills) and PYREXIA (Fever) had resolved. At the time of the report, ORAL HERPES (fever blister) had not resolved, BLISTER (Blisters) outcome was unknown and ERYTHEMA (Redness/erythema) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Fever blister on lip developed after each dose of the COVID vaccine, each lasting about 10 days.First fever blister treated with Valtrex 500mg X 2 tablets once. With second dose, treated with Valtrex 500mg X 2 daily for 7 days with little impact on resolving fever blister.   This case was linked to MOD-2021-073494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow up appended for AE Event/Contact update
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: stuffy head; nose running; began to sneeze; Arthralgia aggravated; Myalgia aggravated; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy head), RHINORRHOEA (nose running), SNEEZING (began to sneeze), ARTHRALGIA (Arthralgia aggravated) and MYALGIA (Myalgia aggravated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy. Previously administered products included for Joint pain: Meloxicam. Concurrent medical conditions included Secondary pulmonary arterial hypertension, Myalgia, Arthralgia and Rheumatoid arthritis. Concomitant products included TREPROSTINIL SODIUM (TYVASO) for Secondary pulmonary arterial hypertension, SILDENAFIL CITRATE and AMLODIPINE for an unknown indication.    On 29-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 NASAL CONGESTION (stuffy head), RHINORRHOEA (nose running), SNEEZING (began to sneeze), ARTHRALGIA (Arthralgia aggravated) and MYALGIA (Myalgia aggravated). At the time of the report, NASAL CONGESTION (stuffy head), RHINORRHOEA (nose running) and SNEEZING (began to sneeze) outcome was unknown and ARTHRALGIA (Arthralgia aggravated) and MYALGIA (Myalgia aggravated) was resolving.             Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine given too early) and PAIN IN EXTREMITY (arm soreness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 23-Feb-2021 at 2:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine given too early). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine given too early) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided. No concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (injection site tenderness) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included tetanus vaccine (for an unreported indication). On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (injection site tenderness). At the time of the report, vaccination site pain (injection site tenderness) resolved. No concomitant product use or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Part of the vaccine splashed on face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (Part of the vaccine splashed on face) 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 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Part of the vaccine splashed on face). At the time of the report, ACCIDENTAL UNDERDOSE (Part of the vaccine splashed on face) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: After the needle was withdrawn, a few drops dripped out and flowed down my arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (After the needle was withdrawn, a few drops dripped out and flowed down my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (After the needle was withdrawn, a few drops dripped out and flowed down my arm). At the time of the report, UNDERDOSE (After the needle was withdrawn, a few drops dripped out and flowed down my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Tension headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced TENSION HEADACHE (Tension headache). At the time of the report, TENSION HEADACHE (Tension headache) had not resolved.            No treatment information was not provided by the reporter.  No concomitant medications were available.  Patient reported of having migraines a couple times a year in a specific area, like the right eye. These are symmetrical headaches at both temples.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-068659 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: added details of the events in the supplement,; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068659:
Sex: U
Vaccine: COVID19
Symptoms: Vestibular neuronitis
Clinical narrative: vestibular neuritis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VESTIBULAR NEURONITIS (vestibular neuritis) 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 03-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 VESTIBULAR NEURONITIS (vestibular neuritis). At the time of the report, VESTIBULAR NEURONITIS (vestibular neuritis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient experienced symptoms two days following the vaccination. The symptoms included vertigo, dizziness, migraines, nausea and insomnia.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: follow up received and contains non significant information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Neck mass, Pain in extremity
Clinical narrative: neck lump; Left arm pain; swollen lips; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING, NECK MASS, and PAIN IN EXTREMITY in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ankylosing spondylitis, Drug allergy (Dicyclomine), Latex allergy and Drug allergy (metformin).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LIP SWELLING. On 09-Jan-2021, the patient experienced NECK MASS and PAIN IN EXTREMITY. On 28-Jan-2021, LIP SWELLING, NECK MASS, and PAIN IN EXTREMITY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LIP SWELLING, NECK MASS, and PAIN IN EXTREMITY to be related.    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. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Urticaria
Clinical narrative: Hives; Blisters and lesions on both hands(knuckles) and both elbows; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and BLISTER (Blisters and lesions on both hands(knuckles) and both elbows) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced URTICARIA (Hives) and BLISTER (Blisters and lesions on both hands(knuckles) and both elbows). At the time of the report, URTICARIA (Hives) and BLISTER (Blisters and lesions on both hands(knuckles) and both elbows) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications provided were steroids/antihistamines.   This case was linked to MOD-2021-073526 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching in knuckles; Reddening of knuckles; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in knuckles) and ERYTHEMA (Reddening of knuckles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching in knuckles) and ERYTHEMA (Reddening of knuckles). At the time of the report, PRURITUS (Itching in knuckles) and ERYTHEMA (Reddening of knuckles) outcome was unknown.            No concomitant medications were provided.  Treatment medications include antihistamines.   This case was linked to MOD-2021-073525 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Previously administered products included for an unreported indication: COVID-19 VACCINE (PFIZER-BIONTECH COVID-19 VACCINE).    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, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.            This case was linked to MOD-2021-073533 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity
Clinical narrative: severe allergic reaction; very fast heartbeat", like she was going to have a heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (very fast heartbeat", like she was going to have a heart attack) and HYPERSENSITIVITY (severe allergic reaction) in a 63-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEART RATE INCREASED (very fast heartbeat", like she was going to have a heart attack). On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction). At the time of the report, HEART RATE INCREASED (very fast heartbeat", like she was going to have a heart attack) and HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pruritus
Clinical narrative: itchiness in her upper back and her scalp; nauseas; extremely tired; just a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness in her upper back and her scalp), NAUSEA (nauseas), FATIGUE (extremely tired) and PAIN (just a little sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for Heart disease pulmonary.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced PRURITUS (itchiness in her upper back and her scalp), NAUSEA (nauseas), FATIGUE (extremely tired) and PAIN (just a little sore). At the time of the report, PRURITUS (itchiness in her upper back and her scalp) had resolved and NAUSEA (nauseas), FATIGUE (extremely tired) and PAIN (just a little sore) outcome was unknown.            Concomitants medication included 1/2 low doses of METOPROLOL SUCC 25 mg 1 table every day for heart.  No laboratory details were  provided.  Treatment medications included Benadryl and Zyrtec.   This case was linked to MOD-2021-046314 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeding disorder, Feeling abnormal, Hyperhidrosis
Clinical narrative: didn't feel well; felt like hell broke loose; couldn't eat; burning up, felt like he was on fire; hurting; chills; muscle pain; Fever; nauseated; broke out in sweat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (broke out in sweat) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced PAIN (hurting), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire). On 11-Apr-2021, the patient experienced MALAISE (didn't feel well). At the time of the report, HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat), SKIN BURNING SENSATION (burning up, felt like he was on fire), MALAISE (didn't feel well), NAUSEA (nauseated), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.9 (High) 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant information On 19-Jul-2021: Follow up  document contains No New Information
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: didn't feel well; felt like hell broke loose; couldn't eat; burning up, felt like he was on fire; hurting; chills; muscle pain; Fever; nauseated; broke out in sweat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (broke out in sweat) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced PAIN (hurting), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire). On 11-Apr-2021, the patient experienced MALAISE (didn't feel well). At the time of the report, HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat), SKIN BURNING SENSATION (burning up, felt like he was on fire), MALAISE (didn't feel well), NAUSEA (nauseated), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.9 (High) 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant information On 19-Jul-2021: Follow up  document contains No New Information
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: didn't feel well; felt like hell broke loose; couldn't eat; burning up, felt like he was on fire; hurting; chills; muscle pain; Fever; nauseated; broke out in sweat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (broke out in sweat) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced PAIN (hurting), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire). On 11-Apr-2021, the patient experienced MALAISE (didn't feel well). At the time of the report, HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat), SKIN BURNING SENSATION (burning up, felt like he was on fire), MALAISE (didn't feel well), NAUSEA (nauseated), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.9 (High) 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant information On 19-Jul-2021: Follow up  document contains No New Information
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: longer fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (longer fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (longer fatigue). At the time of the report, FATIGUE (longer fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-073528 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 04-Apr-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: pain on one side of his head/headache; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (pain on one side of his head/headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 06-Apr-2021, the patient experienced HEADACHE (pain on one side of his head/headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (pain on one side of his head/headache) had not resolved.            No treatment information was provided.  No concomitant medication was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pain on one side of his head/headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pain on one side of his head/headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Pain on one side of his head/headache). At the time of the report, HEADACHE (Pain on one side of his head/headache) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-073535 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073535:Original Case : MOD-2021-073535 (First dose case)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a Pediatric Patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a Pediatric Patient) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a Pediatric Patient). On 18-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a Pediatric Patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Followup received includes reporter details, Patient details and second dose details were updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchy lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy lump at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 003A21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy lump at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy lump at injection site) outcome was unknown.            Treatment information included ice pack.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eye irritation, Headache, Myalgia
Clinical narrative: burning to left eye; blurry vision to left eye; jaw pain to the left side of her mouth; lower back pain; chills; headaches; muscle aches; fever; This spontaneous case was reported by a nurse and describes the occurrence of EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and PYREXIA (fever). At the time of the report, EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Vision blurred
Clinical narrative: burning to left eye; blurry vision to left eye; jaw pain to the left side of her mouth; lower back pain; chills; headaches; muscle aches; fever; This spontaneous case was reported by a nurse and describes the occurrence of EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and PYREXIA (fever). At the time of the report, EYE IRRITATION (burning to left eye), VISION BLURRED (blurry vision to left eye), PAIN IN JAW (jaw pain to the left side of her mouth), BACK PAIN (lower back pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.