chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: vaccination site warmth; vaccination site etching; vaccination site pain; vaccination site redness; vaccination site prickly-looking rash; a swollen knot the size of the palm of her hand at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. 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 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site). On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site prickly-looking rash). The patient was treated with MELOXICAM for Pain, at an unspecified dose and frequency. On 10-Apr-2021, VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site) had resolved. At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site prickly-looking rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: vaccination site warmth; vaccination site etching; vaccination site pain; vaccination site redness; vaccination site prickly-looking rash; a swollen knot the size of the palm of her hand at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. 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 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site). On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site prickly-looking rash). The patient was treated with MELOXICAM for Pain, at an unspecified dose and frequency. On 10-Apr-2021, VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site) had resolved. At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site prickly-looking rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Hypokinesia
Clinical narrative: right hand drying up like a prune when it touches water; barely being able to move his right hand; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (right hand drying up like a prune when it touches water) and HYPOKINESIA (barely being able to move his right hand) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DRY SKIN (right hand drying up like a prune when it touches water) and HYPOKINESIA (barely being able to move his right hand). At the time of the report, DRY SKIN (right hand drying up like a prune when it touches water) and HYPOKINESIA (barely being able to move his right hand) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea post chemotherapy, PEMBROLIZUMAB (KEYTRUDA), LEVOTHYROXINE, BIOTIN, CALCIUM, OMEPRAZOLE, MAGNESIUM, IRON, TOPIRAMATE, ESCITALOPRAM, ZOLPIDEM, NARATRIPTAN and NAPROXEN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-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 DIARRHOEA (diarrhoea). The patient was treated with PREDNISONE at a dose of 40 mg. At the time of the report, DIARRHOEA (diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078198 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078198:first dose case
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown. Not Provided      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.   Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: mild body aches; fatigue; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mild body aches), FATIGUE (fatigue) and HEADACHE (mild headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 014MZ0A) 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) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MYALGIA (mild body aches), FATIGUE (fatigue) and HEADACHE (mild headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (mild body aches), FATIGUE (fatigue) and HEADACHE (mild headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. The action taken with the drug was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-077752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-077752:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyskinesia, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: left leg had big jerk; numbness in the left foot; tingling in the left foot; numbness in the right hand; tingling in the right hand; right hand fingers were tingling and numb too; right hand fingers were tingling and numb too; wrong with her left leg; left leg toes those were tingling and numb; left leg toes those were tingling and numb; lower back pain very badly; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain very badly), LIMB DISCOMFORT (wrong with her left leg), PARAESTHESIA (left leg toes those were tingling and numb), HYPOAESTHESIA (left leg toes those were tingling and numb) and PARAESTHESIA (right hand fingers were tingling and numb too) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cold extremities.    On 25-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 BACK PAIN (lower back pain very badly). On 04-Apr-2021, the patient experienced LIMB DISCOMFORT (wrong with her left leg), PARAESTHESIA (left leg toes those were tingling and numb) and HYPOAESTHESIA (left leg toes those were tingling and numb). On 05-Apr-2021, the patient experienced PARAESTHESIA (right hand fingers were tingling and numb too) and HYPOAESTHESIA (right hand fingers were tingling and numb too). On an unknown date, the patient experienced DYSKINESIA (left leg had big jerk), HYPOAESTHESIA (numbness in the left foot), PARAESTHESIA (tingling in the left foot), HYPOAESTHESIA (numbness in the right hand) and PARAESTHESIA (tingling in the right hand). At the time of the report, BACK PAIN (lower back pain very badly), LIMB DISCOMFORT (wrong with her left leg), PARAESTHESIA (left leg toes those were tingling and numb), HYPOAESTHESIA (left leg toes those were tingling and numb), PARAESTHESIA (right hand fingers were tingling and numb too), HYPOAESTHESIA (right hand fingers were tingling and numb too), DYSKINESIA (left leg had big jerk), HYPOAESTHESIA (numbness in the left foot), PARAESTHESIA (tingling in the left foot), HYPOAESTHESIA (numbness in the right hand) and PARAESTHESIA (tingling in the right hand) outcome was unknown. Not Provided      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 treatment information was provided.  Concomitant medication included menopause depression medication of very low dose on regular basis.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Nurse reported other adverse events and patient's current condition.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm in injection site; Swelling of lymph nodes; redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm in injection site), LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE ERYTHEMA (redness in injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included THYROID and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm in injection site), LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE ERYTHEMA (redness in injection site). On 29-Mar-2021, VACCINATION SITE WARMTH (Warm in injection site), LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE ERYTHEMA (redness in injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: dolor de las cervicales / neck pain; dolor intenso de cabeza / intense headache; fiebre /fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (dolor de las cervicales / neck pain), PYREXIA (fiebre /fever) and HEADACHE (dolor intenso de cabeza / intense headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 036A211A) for COVID-19 vaccination.     The patient's past medical history included Varicose veins, Vascular disorder NOS and Operation NOS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fiebre /fever). On 12-Apr-2021, the patient experienced NECK PAIN (dolor de las cervicales / neck pain) and HEADACHE (dolor intenso de cabeza / intense headache). On 12-Apr-2021, PYREXIA (fiebre /fever) had resolved. At the time of the report, NECK PAIN (dolor de las cervicales / neck pain) and HEADACHE (dolor intenso de cabeza / intense headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided Action taken with mRNA-1273 in response to the events were Not Applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: little bit of rash at injection site; little bit of swelling at injection site; Injection site red; larger rash at injection site; larger swelling at injection site; Injection site warm; Injection site itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Injection site warm), PRURITUS (Injection site itchy), INJECTION SITE RASH (little bit of rash at injection site), INJECTION SITE SWELLING (little bit of swelling at injection site) and INJECTION SITE ERYTHEMA (Injection site red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm), PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE RASH (larger rash at injection site) and INJECTION SITE SWELLING (larger swelling at injection site). On an unknown date, the patient experienced INJECTION SITE RASH (little bit of rash at injection site) and INJECTION SITE SWELLING (little bit of swelling at injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Injection site warm), PRURITUS (Injection site itchy), INJECTION SITE RASH (little bit of rash at injection site), INJECTION SITE SWELLING (little bit of swelling at injection site), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE RASH (larger rash at injection site) and INJECTION SITE SWELLING (larger swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-078223 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078223:cross linked to Dose 2
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the left injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the left injection arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure management, CALCIUM for Calcium supplementation, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness of the left injection arm). On 18-Mar-2021, VACCINATION SITE PAIN (soreness of the left injection arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not reported. In concomitant medications iron pills was also reported.   This case was linked to MOD-2021-078137 (E2B Linked Report). This case was linked to MOD-2021-078137 (Patient Link).; Sender's Comments:  MOD-2021-078137:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Headache
Clinical narrative: chest pain; drowsy; sore arm; headache; chills; joint pain; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), PYREXIA (fever) and FATIGUE (tired). On 19-Apr-2021, CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), PYREXIA (fever) and FATIGUE (tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.Treatment information was not provided.   This case was linked to MOD-2021-151144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Completed ADR. (Wrong ARGUS number on form)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: chest pain; drowsy; sore arm; headache; chills; joint pain; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), PYREXIA (fever) and FATIGUE (tired). On 19-Apr-2021, CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), PYREXIA (fever) and FATIGUE (tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.Treatment information was not provided.   This case was linked to MOD-2021-151144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Completed ADR. (Wrong ARGUS number on form)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PEMBROLIZUMAB (KEYTRUDA), LEVOTHYROXINE, BIOTIN, CALCIUM, OMEPRAZOLE, CYANOCOBALAMIN (VITAMIN B-12), MAGNESIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IRON, ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY + C), TOPIRAMATE, ESCITALOPRAM, ZOLPIDEM, NARATRIPTAN, NAPROXEN and ONDANSETRON (ZOFRAN MELT) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhoea). The patient was treated with PREDNISONE at a dose of 40 mg. At the time of the report, DIARRHOEA (diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078150 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078150:second dose case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: red spot on the left arm; feverish spot on the left arm; red spot on the left arm; feverish spot on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of RASH MACULAR (red spot on the left arm), the second episode of RASH MACULAR (red spot on the left arm), the first episode of PYREXIA (feverish spot on the left arm) and the second episode of PYREXIA (feverish spot on the left arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced the first episode of RASH MACULAR (red spot on the left arm) and the first episode of PYREXIA (feverish spot on the left arm). On 14-Apr-2021, the patient experienced the second episode of RASH MACULAR (red spot on the left arm) and the second episode of PYREXIA (feverish spot on the left arm). At the time of the report, last episode of RASH MACULAR (red spot on the left arm) and the last episode of PYREXIA (feverish spot on the left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue, SARS-CoV-2 test
Clinical narrative: Patient's doctor has advised him to wait 90 days; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) and INTENTIONAL PRODUCT USE ISSUE (Patient's doctor has advised him to wait 90 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Contracted COVID). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient's doctor has advised him to wait 90 days). At the time of the report, COVID-19 (Contracted COVID) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Patient's doctor has advised him to wait 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: other (Positive) Tested COVID-19 positive. On 12-Apr-2021, SARS-CoV-2 test: other (Positive) Tested positive COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-077772 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rashes after the second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rashes after the second shot). At the time of the report, RASH (rashes after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Ear pain, Facial pain, Hypoaesthesia
Clinical narrative: patient's face is swollen; stomach is nauseated; joint pain in the collarbone and neck; Neck hurt; mother's collarbone neck area began hurting; left ear/side of face felt it numb and hurting; left ear/side of face felt it numb and hurting; left ear pain; she couldn't sleep last night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck hurt), BONE PAIN (mother's collarbone neck area began hurting), HYPOAESTHESIA (left ear/side of face felt it numb and hurting), FACIAL PAIN (left ear/side of face felt it numb and hurting) and EAR PAIN (left ear pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, VENLAFAXINE, ACETYLSALICYLIC ACID (ECOTRIN), PANTOPRAZOLE, HYDROCHLOROTHIAZIDE, LISINOPRIL and FAMOTIDINE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced NECK PAIN (Neck hurt), BONE PAIN (mother's collarbone neck area began hurting), HYPOAESTHESIA (left ear/side of face felt it numb and hurting), FACIAL PAIN (left ear/side of face felt it numb and hurting), EAR PAIN (left ear pain), INSOMNIA (she couldn't sleep last night) and ARTHRALGIA (joint pain in the collarbone and neck). On 15-Apr-2021, the patient experienced SWELLING FACE (patient's face is swollen) and NAUSEA (stomach is nauseated). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck hurt), BONE PAIN (mother's collarbone neck area began hurting), HYPOAESTHESIA (left ear/side of face felt it numb and hurting), FACIAL PAIN (left ear/side of face felt it numb and hurting), EAR PAIN (left ear pain), INSOMNIA (she couldn't sleep last night), SWELLING FACE (patient's face is swollen), ARTHRALGIA (joint pain in the collarbone and neck) and NAUSEA (stomach is nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Cough medications
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Neck pain, Swelling face
Clinical narrative: patient's face is swollen; stomach is nauseated; joint pain in the collarbone and neck; Neck hurt; mother's collarbone neck area began hurting; left ear/side of face felt it numb and hurting; left ear/side of face felt it numb and hurting; left ear pain; she couldn't sleep last night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck hurt), BONE PAIN (mother's collarbone neck area began hurting), HYPOAESTHESIA (left ear/side of face felt it numb and hurting), FACIAL PAIN (left ear/side of face felt it numb and hurting) and EAR PAIN (left ear pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, VENLAFAXINE, ACETYLSALICYLIC ACID (ECOTRIN), PANTOPRAZOLE, HYDROCHLOROTHIAZIDE, LISINOPRIL and FAMOTIDINE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced NECK PAIN (Neck hurt), BONE PAIN (mother's collarbone neck area began hurting), HYPOAESTHESIA (left ear/side of face felt it numb and hurting), FACIAL PAIN (left ear/side of face felt it numb and hurting), EAR PAIN (left ear pain), INSOMNIA (she couldn't sleep last night) and ARTHRALGIA (joint pain in the collarbone and neck). On 15-Apr-2021, the patient experienced SWELLING FACE (patient's face is swollen) and NAUSEA (stomach is nauseated). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck hurt), BONE PAIN (mother's collarbone neck area began hurting), HYPOAESTHESIA (left ear/side of face felt it numb and hurting), FACIAL PAIN (left ear/side of face felt it numb and hurting), EAR PAIN (left ear pain), INSOMNIA (she couldn't sleep last night), SWELLING FACE (patient's face is swollen), ARTHRALGIA (joint pain in the collarbone and neck) and NAUSEA (stomach is nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Cough medications
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Erythema, Vaccination site bruising, Vaccination site erythema
Clinical narrative: Injection site bruised after 2nd dose; Red spots on opposite arm after 2nd dose; Bruises on opposite arm after 2nd dose; Burning feeling in arm after 2nd dose; Injection site red after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site bruised after 2nd dose), ERYTHEMA (Red spots on opposite arm after 2nd dose), CONTUSION (Bruises on opposite arm after 2nd dose), BURNING SENSATION (Burning feeling in arm after 2nd dose) and VACCINATION SITE ERYTHEMA (Injection site red after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 VACCINATION SITE BRUISING (Injection site bruised after 2nd dose), ERYTHEMA (Red spots on opposite arm after 2nd dose), CONTUSION (Bruises on opposite arm after 2nd dose), BURNING SENSATION (Burning feeling in arm after 2nd dose) and VACCINATION SITE ERYTHEMA (Injection site red after 2nd dose). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Injection site bruised after 2nd dose), ERYTHEMA (Red spots on opposite arm after 2nd dose), CONTUSION (Bruises on opposite arm after 2nd dose), BURNING SENSATION (Burning feeling in arm after 2nd dose) and VACCINATION SITE ERYTHEMA (Injection site red after 2nd dose) outcome was unknown.            This case was linked to MODERNATX, INC.-MOD-2021-078182 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-078182:cross linked to Dose 1
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Vomiting
Clinical narrative: have this very bad cough since one year and suddenly it is just gone; Threw up little bit because of ciprofloxacin; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (have this very bad cough since one year and suddenly it is just gone) and VOMITING (Threw up little bit because of ciprofloxacin) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder infection. Concomitant products included CIPROFLOXACIN for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced COUGH (have this very bad cough since one year and suddenly it is just gone) and VOMITING (Threw up little bit because of ciprofloxacin). At the time of the report, COUGH (have this very bad cough since one year and suddenly it is just gone) and VOMITING (Threw up little bit because of ciprofloxacin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: very dizzy; clammy; blood pressure drop; "face turned white"; "ready to vomit; nausea; headache; need to lie on the floor; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white") and VOMITING ("ready to vomit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 serology test negative. Concurrent medical conditions included Food allergy, Drug allergy and Drug allergy.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white"), VOMITING ("ready to vomit), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (need to lie on the floor). On 15-Apr-2021, DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white"), VOMITING ("ready to vomit), NAUSEA (nausea) and FATIGUE (need to lie on the floor) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Treatment information includes Ice packs (to face and neck), Feet propped, BP monitoring.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Skin discolouration, Vomiting
Clinical narrative: very dizzy; clammy; blood pressure drop; "face turned white"; "ready to vomit; nausea; headache; need to lie on the floor; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white") and VOMITING ("ready to vomit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 serology test negative. Concurrent medical conditions included Food allergy, Drug allergy and Drug allergy.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white"), VOMITING ("ready to vomit), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (need to lie on the floor). On 15-Apr-2021, DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white"), VOMITING ("ready to vomit), NAUSEA (nausea) and FATIGUE (need to lie on the floor) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Treatment information includes Ice packs (to face and neck), Feet propped, BP monitoring.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: invalid doses given after 12 hours from first puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (invalid doses given after 12 hours from first puncture) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Diabetes in 2015 and Hypertension in 2013. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CARBAMAZEPINE for Back pain, INSULIN GLARGINE (LANTUS XR) and METFORMIN for Diabetes mellitus, ARMODAFINIL for Sleep disorder NOS, LEVOTHYROXINE for Thyroid disorder NOS, GABAPENTIN and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (invalid doses given after 12 hours from first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (invalid doses given after 12 hours from first puncture) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non-significant follow-up On 24-May-2021: Followup- patient information update
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B214 and 001A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Joint Pain; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain), MYALGIA (Achy) and FATIGUE (Tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ARTHRALGIA (Joint Pain), MYALGIA (Achy) and FATIGUE (Tired). At the time of the report, ARTHRALGIA (Joint Pain), MYALGIA (Achy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included paracetamol.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in her arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in her arm). At the time of the report, PAIN IN EXTREMITY (little soreness in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-078301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078301:second dose case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: L arm sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (L arm sore for a couple of days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (L arm sore for a couple of days). At the time of the report, PAIN IN EXTREMITY (L arm sore for a couple of days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2021-078282 (E2B Linked Report). This case was linked to MOD-2021-078282 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078282:cross linked to Dose 2