chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: Sick on the stomach; Heart was racing at times; Sweating a little; Bad headaches; Feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick on the stomach), HEART RATE INCREASED (Heart was racing at times), HYPERHIDROSIS (Sweating a little), HEADACHE (Bad headaches) and NAUSEA (Feeling nauseous) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-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 ABDOMINAL DISCOMFORT (Sick on the stomach), HEART RATE INCREASED (Heart was racing at times), HYPERHIDROSIS (Sweating a little), HEADACHE (Bad headaches) and NAUSEA (Feeling nauseous). At the time of the report, ABDOMINAL DISCOMFORT (Sick on the stomach), HEART RATE INCREASED (Heart was racing at times), HYPERHIDROSIS (Sweating a little), HEADACHE (Bad headaches) and NAUSEA (Feeling nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) 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 11-Mar-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 HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Sinusitis
Clinical narrative: stuffy nose; sinuses; headaches; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), SINUSITIS (sinuses) and HEADACHE (headaches) 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 COVID-19.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (stuffy nose), SINUSITIS (sinuses) and HEADACHE (headaches). At the time of the report, NASAL CONGESTION (stuffy nose), SINUSITIS (sinuses) and HEADACHE (headaches) had resolved.            No concomitant product information was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060910 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Adverse event outcome changed from Unknown to Recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060910:1st Dose
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus
Clinical narrative: Generalized itching all over her body; itching comes and goes after 3-4 days post vaccine; fatigue/tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalized itching all over her body), PRURITUS (itching comes and goes after 3-4 days post vaccine), FATIGUE (fatigue/tired) and PAIN IN EXTREMITY (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for an unknown indication.     Concurrent medical conditions included Drug allergy (Allergy to drugs: Avelox, Amoxicillin, Erythromycin, Ceftin, Omnicef, Voltrex).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PRURITUS (Generalized itching all over her body), PRURITUS (itching comes and goes after 3-4 days post vaccine), FATIGUE (fatigue/tired) and PAIN IN EXTREMITY (sore arm). At the time of the report, PRURITUS (Generalized itching all over her body), PRURITUS (itching comes and goes after 3-4 days post vaccine), FATIGUE (fatigue/tired) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Dizziness; Body aches.; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body aches.), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (Dizziness), PAIN (Body aches.), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), PAIN (Body aches.), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medications treatment information was not reported by reporter For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Second dose details was added
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: got numbness and tingling all around my mouth and lower parts of my face; got numbness and tingling all around my mouth and lower parts of my face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (got numbness and tingling all around my mouth and lower parts of my face) and PARAESTHESIA ORAL (got numbness and tingling all around my mouth and lower parts of my face) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement in 2019. Concomitant products included LISINOPRIL, ROSUVASTATIN, METOPROLOL and ALLOPURINOL for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced HYPOAESTHESIA (got numbness and tingling all around my mouth and lower parts of my face) and PARAESTHESIA ORAL (got numbness and tingling all around my mouth and lower parts of my face). At the time of the report, HYPOAESTHESIA (got numbness and tingling all around my mouth and lower parts of my face) and PARAESTHESIA ORAL (got numbness and tingling all around my mouth and lower parts of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Pain Left Arm (Left Shoulder to elbow); could not raise her left arm; Stiff Left Arm; Left Hand Swollen; Left leg weak; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm), MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen) and MUSCULAR WEAKNESS (Left leg weak) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm), MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen), MUSCULAR WEAKNESS (Left leg weak) and GAIT DISTURBANCE (could not walk). On 28-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen) and GAIT DISTURBANCE (could not walk) had resolved. On 29-Mar-2021, MUSCULAR WEAKNESS (Left leg weak) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)) and VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up received on 12-MAY-2021, no new information
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: Pain Left Arm (Left Shoulder to elbow); could not raise her left arm; Stiff Left Arm; Left Hand Swollen; Left leg weak; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm), MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen) and MUSCULAR WEAKNESS (Left leg weak) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm), MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen), MUSCULAR WEAKNESS (Left leg weak) and GAIT DISTURBANCE (could not walk). On 28-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen) and GAIT DISTURBANCE (could not walk) had resolved. On 29-Mar-2021, MUSCULAR WEAKNESS (Left leg weak) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)) and VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up received on 12-MAY-2021, no new information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; Fatigue; slight fever; chills; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (chills), the second episode of CHILLS (chills), FATIGUE (fatigue), PYREXIA (fever) and PYREXIA (slight fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced the first episode of CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever). On 26-Mar-2021, the patient experienced PYREXIA (slight fever). On 28-Mar-2021, the patient experienced the second episode of CHILLS (chills) and FATIGUE (Fatigue). On 07-Mar-2021, FATIGUE (fatigue) and PYREXIA (fever) had resolved. On 26-Mar-2021, PYREXIA (slight fever) had resolved. On 28-Mar-2021, last episode of CHILLS (chills) and FATIGUE (Fatigue) 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Feb-2021 and the estimated date of delivery was 26-Nov-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pregnancy test
Clinical narrative: has not gotten her menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (has not gotten her menstrual cycle) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history.). Concomitant products included TAMOXIFEN.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 MENSTRUATION IRREGULAR (has not gotten her menstrual cycle). At the time of the report, MENSTRUATION IRREGULAR (has not gotten her menstrual cycle) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative NEGATIVE.         No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigued; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and NAUSEA (nauseous) 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 26-Mar-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 FATIGUE (fatigued) and NAUSEA (nauseous). At the time of the report, FATIGUE (fatigued) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: half of her face was numb; half of her face was tingling; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (half of her face was numb) and PARAESTHESIA (half of her face was tingling) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (half of her face was numb) and PARAESTHESIA (half of her face was tingling). At the time of the report, HYPOAESTHESIA (half of her face was numb) and PARAESTHESIA (half of her face was tingling) was resolving.        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.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-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 PAIN IN EXTREMITY (Mild sore arm). At the time of the report, PAIN IN EXTREMITY (Mild sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Injection site rash
Clinical narrative: Eczema; Injection site rash; This spontaneous case was reported by a health care professional and describes the occurrence of ECZEMA (Eczema) and INJECTION SITE RASH (Injection site rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, LOSARTAN, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE and DOXYCYCLINE for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema) and INJECTION SITE RASH (Injection site rash). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, ECZEMA (Eczema) and INJECTION SITE RASH (Injection site rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Fatigue, Injection site pain
Clinical narrative: Chest pain; Low oxygen saturation; Sore throat; Fatigue which initialy started on 28Apr2021 and continued after COVID test was positive; Cough; woke up at 4:30 am with deltoid muscle pain; unable to move arm; fever of 101.17 degree; chills; body ache; Injection site pain; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree F) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 30-Mar-2021, the patient experienced MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache). At the time of the report, INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) are included.  Patient was treated with two tablets of Tylenol 500 mg at 4:30 am.  For events with onset date 28Apr2021, i.e., sore throat and cough, patient took Zinc lozenges as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: events updated
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chest pain; Low oxygen saturation; Sore throat; Fatigue which initialy started on 28Apr2021 and continued after COVID test was positive; Cough; woke up at 4:30 am with deltoid muscle pain; unable to move arm; fever of 101.17 degree; chills; body ache; Injection site pain; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree F) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 30-Mar-2021, the patient experienced MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache). At the time of the report, INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) are included.  Patient was treated with two tablets of Tylenol 500 mg at 4:30 am.  For events with onset date 28Apr2021, i.e., sore throat and cough, patient took Zinc lozenges as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: events updated
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: Chest pain; Low oxygen saturation; Sore throat; Fatigue which initialy started on 28Apr2021 and continued after COVID test was positive; Cough; woke up at 4:30 am with deltoid muscle pain; unable to move arm; fever of 101.17 degree; chills; body ache; Injection site pain; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree F) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 30-Mar-2021, the patient experienced MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache). At the time of the report, INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) are included.  Patient was treated with two tablets of Tylenol 500 mg at 4:30 am.  For events with onset date 28Apr2021, i.e., sore throat and cough, patient took Zinc lozenges as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: events updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Limb discomfort, Swelling face
Clinical narrative: high blood pressure (200/110) after vaccination; facial swelling; couldn't lift arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure (200/110) after vaccination), SWELLING FACE (facial swelling), LIMB DISCOMFORT (couldn't lift arm) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 31M20A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 20-Jan-2021.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HYPERTENSION (high blood pressure (200/110) after vaccination), SWELLING FACE (facial swelling), LIMB DISCOMFORT (couldn't lift arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Mar-2021, SWELLING FACE (facial swelling) had resolved. At the time of the report, HYPERTENSION (high blood pressure (200/110) after vaccination) and LIMB DISCOMFORT (couldn't lift arm) outcome was unknown and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  The  concomitant medications on use were not provided. No laboratory data was provided.   This case was linked to MOD-2021-049768 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Headache, Hyperhidrosis
Clinical narrative: Up all night; Sweating; body Aches; Coughing; Fever; Chills; Joint pain; Headache; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HYPERHIDROSIS (Sweating), PAIN (body Aches), POOR QUALITY SLEEP (Up all night) and PYREXIA (Fever) in a male patient of 45-year-old who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISDEXAMFETAMINE MESILATE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 26-Mar-2021, the patient experienced COUGH (Coughing), PAIN (body Aches), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced POOR QUALITY SLEEP (Up all night). At the time of the report, COUGH (Coughing), PAIN (body Aches), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had not resolved and HYPERHIDROSIS (Sweating), POOR QUALITY SLEEP (Up all night) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included acetaminophen
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: Up all night; Sweating; body Aches; Coughing; Fever; Chills; Joint pain; Headache; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HYPERHIDROSIS (Sweating), PAIN (body Aches), POOR QUALITY SLEEP (Up all night) and PYREXIA (Fever) in a male patient of 45-year-old who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISDEXAMFETAMINE MESILATE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 26-Mar-2021, the patient experienced COUGH (Coughing), PAIN (body Aches), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced POOR QUALITY SLEEP (Up all night). At the time of the report, COUGH (Coughing), PAIN (body Aches), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had not resolved and HYPERHIDROSIS (Sweating), POOR QUALITY SLEEP (Up all night) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included acetaminophen
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Erythema, Fatigue, Headache
Clinical narrative: Back pain; Neck ache; Arm swollen; Arm red; Arm hot to touch; Chills; Tired; Headache; nausea; Golf ball size lymph node; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen) and ERYTHEMA (Arm red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), SKIN WARM (Arm hot to touch), CHILLS (Chills), FATIGUE (Tired), HEADACHE (Headache), NAUSEA (nausea) and LYMPHADENOPATHY (Golf ball size lymph node). On 29-Mar-2021, PAIN IN EXTREMITY (Sore arm), BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), SKIN WARM (Arm hot to touch), CHILLS (Chills), FATIGUE (Tired), HEADACHE (Headache), NAUSEA (nausea) and LYMPHADENOPATHY (Golf ball size lymph node) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included Tylenol.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Back pain; Neck ache; Arm swollen; Arm red; Arm hot to touch; Chills; Tired; Headache; nausea; Golf ball size lymph node; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen) and ERYTHEMA (Arm red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), SKIN WARM (Arm hot to touch), CHILLS (Chills), FATIGUE (Tired), HEADACHE (Headache), NAUSEA (nausea) and LYMPHADENOPATHY (Golf ball size lymph node). On 29-Mar-2021, PAIN IN EXTREMITY (Sore arm), BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), SKIN WARM (Arm hot to touch), CHILLS (Chills), FATIGUE (Tired), HEADACHE (Headache), NAUSEA (nausea) and LYMPHADENOPATHY (Golf ball size lymph node) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included Tylenol.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Back pain; Neck ache; Arm swollen; Arm red; Arm hot to touch; Chills; Tired; Headache; nausea; Golf ball size lymph node; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen) and ERYTHEMA (Arm red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), SKIN WARM (Arm hot to touch), CHILLS (Chills), FATIGUE (Tired), HEADACHE (Headache), NAUSEA (nausea) and LYMPHADENOPATHY (Golf ball size lymph node). On 29-Mar-2021, PAIN IN EXTREMITY (Sore arm), BACK PAIN (Back pain), NECK PAIN (Neck ache), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), SKIN WARM (Arm hot to touch), CHILLS (Chills), FATIGUE (Tired), HEADACHE (Headache), NAUSEA (nausea) and LYMPHADENOPATHY (Golf ball size lymph node) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included Tylenol.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Lymphadenopathy, Swelling
Clinical narrative: dizziness; lightheadedness; left arm is swollen; lymph nodes are swollen; severe pain in armpit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIZZINESS (lightheadedness), SWELLING (left arm is swollen), LYMPHADENOPATHY (lymph nodes are swollen) and AXILLARY PAIN (severe pain in armpit) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (dizziness), DIZZINESS (lightheadedness), SWELLING (left arm is swollen), LYMPHADENOPATHY (lymph nodes are swollen) and AXILLARY PAIN (severe pain in armpit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), DIZZINESS (lightheadedness), SWELLING (left arm is swollen), LYMPHADENOPATHY (lymph nodes are swollen) and AXILLARY PAIN (severe pain in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication include birth control  medication.    Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: TCR Updated
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) 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 Injury (She Injured to her lower back.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The patient had a injury in her lower back before  taking the first dose. She received her first dose and had not taken any pain medication since because she did not think she was allowed to. The patient's back was in a lot of pain from the prior injury and wants to know whether she can take OTC pain medication or not.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Fatigue, Photophobia, Pyrexia, Vaccination complication
Clinical narrative: Double vision; Sensitivity to light/ had to wear sunglass siting inside; has not been able to work; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), PHOTOPHOBIA (Sensitivity to light/ had to wear sunglass siting inside), VACCINATION COMPLICATION (has not been able to work), FATIGUE (Fatigue) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DIPLOPIA (Double vision), PHOTOPHOBIA (Sensitivity to light/ had to wear sunglass siting inside), VACCINATION COMPLICATION (has not been able to work), FATIGUE (Fatigue) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Double vision), PHOTOPHOBIA (Sensitivity to light/ had to wear sunglass siting inside), VACCINATION COMPLICATION (has not been able to work), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-062372, -MODERNATX, INC.-MOD-2021-062392, -MODERNATX, INC.-MOD-2021-062392 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-062372:Cross linked with first dose -MODERNATX, INC.-MOD-2021-062392:wife case -MODERNATX, INC.-MOD-2021-062392:Cross linked with Husband case
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: whole body turned bright red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (whole body turned bright red) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 02B21A) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (whole body turned bright red). At the time of the report, ERYTHEMA (whole body turned bright red) outcome was unknown.            No concomitant medications reported by investigator No treatment medications provided by the reporter.   Patient had an appointment with doctor right after being vaccinated. While the patient was examined by his Doctor, he reports that his whole body turned bright red.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: significant follow up appended contains, first and second dose lot number were added and updated action taken
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Chills, Dizziness
Clinical narrative: Dizziness; Stomach discomfort; Swollen glands in the neck (front and back); Sore arm; Chills; Headaches; Stomach pain; Neck pain; Sore shoulder and collar bone; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), LYMPHADENOPATHY (Swollen glands in the neck (front and back)) and PAIN IN EXTREMITY (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History.  The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included EZETIMIBE 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 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), NECK PAIN (Neck pain), ARTHRALGIA (Sore shoulder and collar bone) and HEADACHE (Headaches). On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), LYMPHADENOPATHY (Swollen glands in the neck (front and back)), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), LYMPHADENOPATHY (Swollen glands in the neck (front and back)), NECK PAIN (Neck pain), ARTHRALGIA (Sore shoulder and collar bone), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.