chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Thinking abnormal, Tremor
Clinical narrative: allergic reaction; feeling sick; Feels lousy; can't breathe; arm has been painful, tender; arm swollen; dizzy; weakness; shaking; didn't get of bed for 2 days and she just can't function; can't even think; feeling  hot and  cold; hands and feet are cold and just can't get warm; sweaty; heartbeat is racing; lethargic; fever; redness; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe) and PAIN IN EXTREMITY (arm has been painful, tender) in a 68-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.     The patient's past medical history included No adverse event.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided   Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-053149 (E2B Linked Report).; Sender's Comments:  MOD-2021-053149:First dose
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Chills, Fatigue, Headache, Lip swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). On 07-Apr-2021, the patient experienced CHEILITIS (sore lip) and LIP SWELLING (swelling lip). At the time of the report, FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and LIP SWELLING (swelling lip) had resolved and CHEILITIS (sore lip) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment for the events included dermal fillers.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). On 07-Apr-2021, the patient experienced CHEILITIS (sore lip) and LIP SWELLING (swelling lip). At the time of the report, FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and LIP SWELLING (swelling lip) had resolved and CHEILITIS (sore lip) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment for the events included dermal fillers.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of drug administration; Extreme diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea). At the time of the report, DIARRHOEA (Extreme diarrhea) had not resolved. Not Provided          Treatment Medication for Diarrhea    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No specific follow-up information recorded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: body ache; Diarrhea for over 4 days; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), DIARRHOEA (Diarrhea for over 4 days), HEADACHE (headache) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (body ache), DIARRHOEA (Diarrhea for over 4 days), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, PAIN (body ache), DIARRHOEA (Diarrhea for over 4 days), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on an known medication for blood pressure.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: arm swollen; soreness at the injection site; red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), INJECTION SITE PAIN (soreness at the injection site) and INJECTION SITE ERYTHEMA (red spot at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swollen), INJECTION SITE PAIN (soreness at the injection site) and INJECTION SITE ERYTHEMA (red spot at the injection site). At the time of the report, PERIPHERAL SWELLING (arm swollen), INJECTION SITE PAIN (soreness at the injection site) and INJECTION SITE ERYTHEMA (red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Did not make antibodies; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Did not make antibodies) 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 Lung transplant and Chemotherapy. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Did not make antibodies). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Did not make antibodies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: "developing a spotted red rash on (her) skin, on (her) face. This happens when she goes for a walk, or if she is out in the "heat of the day" or "skin is exposed to the sun and the heat; fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS ("developing a spotted red rash on (her) skin, on (her) face. This happens when she goes for a walk, or if she is out in the "heat of the day" or "skin is exposed to the sun and the heat) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and #030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Feb-2021, the patient experienced RASH ERYTHEMATOUS ("developing a spotted red rash on (her) skin, on (her) face. This happens when she goes for a walk, or if she is out in the "heat of the day" or "skin is exposed to the sun and the heat) and PYREXIA (fever). On 28-Feb-2021, RASH ERYTHEMATOUS ("developing a spotted red rash on (her) skin, on (her) face. This happens when she goes for a walk, or if she is out in the "heat of the day" or "skin is exposed to the sun and the heat) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment included Minimizes heat and sunlight exposure.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-072932 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072932:second dose
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Rhinorrhoea
Clinical narrative: Runny nose; Throat is white from back; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and PHARYNGITIS (Throat is white from back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, EZETIMIBE (ZETIA), POTASSIUM CHLORIDE (KLOR-CON), HYDROCHLOROTHIAZIDE, OMEPRAZOLE (OMEPRAZOLE ABBOTT), LABETALOL and GABAPENTIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Runny nose) and PHARYNGITIS (Throat is white from back). At the time of the report, RHINORRHOEA (Runny nose) and PHARYNGITIS (Throat is white from back) had not resolved.        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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: stiffness; Headache; Nausea; Fatigue; aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, HEADACHE, NAUSEA, FATIGUE, and MYALGIA in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included GABAPENTIN, PROPRANOLOL and LOSARTAN for an unknown indication.    On 08-Apr-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 MUSCULOSKELETAL STIFFNESS, HEADACHE, NAUSEA, FATIGUE, and MYALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS, HEADACHE, NAUSEA, FATIGUE and MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medications also included sleeping pills at night.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Felt tired) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMIN [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) 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 PYREXIA (Low grade fever) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (Low grade fever) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-072933 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072933:Second dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Fatigue, Nasal congestion
Clinical narrative: nasal congestion; diarrhea; fever of 100.5; chills; fatigue; quite a few symptoms, but not severe; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (quite a few symptoms, but not severe), NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 02-Apr-2021, the patient experienced COVID-19 (quite a few symptoms, but not severe). On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, COVID-19 (quite a few symptoms, but not severe), NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Covid-19 test positive.     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 information were provided.  No treatment medication information were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received does not contain any significant information.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: nasal congestion; diarrhea; fever of 100.5; chills; fatigue; quite a few symptoms, but not severe; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (quite a few symptoms, but not severe), NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 02-Apr-2021, the patient experienced COVID-19 (quite a few symptoms, but not severe). On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, COVID-19 (quite a few symptoms, but not severe), NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Covid-19 test positive.     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 information were provided.  No treatment medication information were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received does not contain any significant information.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Device connection issue, Underdose
Clinical narrative: Syringe Connection Issue; Vaccine underdose; Accidental overdose; 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 DEVICE CONNECTION ISSUE (Syringe Connection Issue), UNDERDOSE (Vaccine underdose) and ACCIDENTAL OVERDOSE (Accidental overdose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Syringe Connection Issue), UNDERDOSE (Vaccine underdose) and ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe Connection Issue), UNDERDOSE (Vaccine underdose) and ACCIDENTAL OVERDOSE (Accidental overdose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Feeling hot, Headache, Inappropriate schedule of product administration
Clinical narrative: Hot to touch; Throat felt closed/glands swollen; Headache; 2nd dose given after 35 days; Lips feel different; Low grade fever; Nauseated; sore arm; Body is red/pinkish; Throat felt closed/glands swollen; Vomited; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch) and ASTHENIA (Weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weakness). On 07-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt closed/glands swollen), ORAL DISCOMFORT (Lips feel different), VOMITING (Vomited), NAUSEA (Nauseated) and LYMPHADENOPATHY (Throat felt closed/glands swollen). On 08-Apr-2021, the patient experienced FEELING HOT (Hot to touch), ERYTHEMA (Body is red/pinkish) and PYREXIA (Low grade fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days) had resolved and PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch), ASTHENIA (Weakness), ORAL DISCOMFORT (Lips feel different), ERYTHEMA (Body is red/pinkish), HEADACHE (Headache), VOMITING (Vomited), NAUSEA (Nauseated), LYMPHADENOPATHY (Throat felt closed/glands swollen) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-072924 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 contains non-significant information: updated reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072924:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Oral discomfort, Pain in extremity, Pharyngeal swelling
Clinical narrative: Hot to touch; Throat felt closed/glands swollen; Headache; 2nd dose given after 35 days; Lips feel different; Low grade fever; Nauseated; sore arm; Body is red/pinkish; Throat felt closed/glands swollen; Vomited; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch) and ASTHENIA (Weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weakness). On 07-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt closed/glands swollen), ORAL DISCOMFORT (Lips feel different), VOMITING (Vomited), NAUSEA (Nauseated) and LYMPHADENOPATHY (Throat felt closed/glands swollen). On 08-Apr-2021, the patient experienced FEELING HOT (Hot to touch), ERYTHEMA (Body is red/pinkish) and PYREXIA (Low grade fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days) had resolved and PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch), ASTHENIA (Weakness), ORAL DISCOMFORT (Lips feel different), ERYTHEMA (Body is red/pinkish), HEADACHE (Headache), VOMITING (Vomited), NAUSEA (Nauseated), LYMPHADENOPATHY (Throat felt closed/glands swollen) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-072924 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 contains non-significant information: updated reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072924:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Hot to touch; Throat felt closed/glands swollen; Headache; 2nd dose given after 35 days; Lips feel different; Low grade fever; Nauseated; sore arm; Body is red/pinkish; Throat felt closed/glands swollen; Vomited; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch) and ASTHENIA (Weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weakness). On 07-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt closed/glands swollen), ORAL DISCOMFORT (Lips feel different), VOMITING (Vomited), NAUSEA (Nauseated) and LYMPHADENOPATHY (Throat felt closed/glands swollen). On 08-Apr-2021, the patient experienced FEELING HOT (Hot to touch), ERYTHEMA (Body is red/pinkish) and PYREXIA (Low grade fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given after 35 days) had resolved and PHARYNGEAL SWELLING (Throat felt closed/glands swollen), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot to touch), ASTHENIA (Weakness), ORAL DISCOMFORT (Lips feel different), ERYTHEMA (Body is red/pinkish), HEADACHE (Headache), VOMITING (Vomited), NAUSEA (Nauseated), LYMPHADENOPATHY (Throat felt closed/glands swollen) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-072924 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 contains non-significant information: updated reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072924:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Nodule, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand) and VACCINATION SITE HAEMORRHAGE (Bleed a little after injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) 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 PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMINS [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) 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 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High) Unknown.         Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-072928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072928:first dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site haemorrhage, Vaccination site pain, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand) and VACCINATION SITE HAEMORRHAGE (Bleed a little after injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) 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 PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMINS [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) 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 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High) Unknown.         Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-072928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072928:first dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand) and VACCINATION SITE HAEMORRHAGE (Bleed a little after injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) 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 PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMINS [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) 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 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High) Unknown.         Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-072928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072928:first dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness at the COVID arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the COVID arm (left arm)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 INJECTION SITE ERYTHEMA (Redness at the COVID arm (left arm)). At the time of the report, INJECTION SITE ERYTHEMA (Redness at the COVID arm (left arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10-MAY-2021 and contains No New Information
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Pain on right leg; Soreness on lower right back and hip/ soreness above his waist; Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), BACK PAIN (Soreness on lower right back and hip/ soreness above his waist) and PAIN IN EXTREMITY (Pain on right leg) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness). On 07-Apr-2021, the patient experienced BACK PAIN (Soreness on lower right back and hip/ soreness above his waist). On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain on right leg). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 07-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 08-Apr-2021, BACK PAIN (Soreness on lower right back and hip/ soreness above his waist) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on right leg) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications  were provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received and updated the outcome of the event (pain on right leg) from unknown to recovering.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: both of his arms right at the biceps are hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of his arms right at the biceps are hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dislocated shoulder (30 years ago.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (both of his arms right at the biceps are hurting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (both of his arms right at the biceps are hurting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient stated that the pain was intermittent from 2 to 10 out of 10 and the pain was different everyday.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Over the next week the spots that itch; Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face) and RASH PRURITIC (Over the next week the spots that itch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH MACULAR (Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face). On an unknown date, the patient experienced RASH PRURITIC (Over the next week the spots that itch). At the time of the report, RASH MACULAR (Little red spots on her legs, torso, and arms/ Over the next week the small spots got much larger, bright red and were all over body and face) and RASH PRURITIC (Over the next week the spots that itch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information provided included, seen a few doctors over Telehealth and was given a prescription for prednisolone which she completed with no change.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise, Myalgia, Pain
Clinical narrative: Pain; Flu like symptoms; Further described as malaise; A really sore arm at the injection site; A general feeling of fatigue; Also achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site) and FATIGUE (A general feeling of fatigue) in a 44-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.     Concurrent medical conditions included Multiple sclerosis relapse (Relapsing Remitting Multiple Sclerosis).    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site), FATIGUE (A general feeling of fatigue) and MYALGIA (Also achiness). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site), FATIGUE (A general feeling of fatigue) and MYALGIA (Also achiness) had resolved. Probable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain; Flu like symptoms; Further described as malaise; A really sore arm at the injection site; A general feeling of fatigue; Also achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site) and FATIGUE (A general feeling of fatigue) in a 44-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.     Concurrent medical conditions included Multiple sclerosis relapse (Relapsing Remitting Multiple Sclerosis).    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site), FATIGUE (A general feeling of fatigue) and MYALGIA (Also achiness). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site), FATIGUE (A general feeling of fatigue) and MYALGIA (Also achiness) had resolved. Probable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.