chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Vaccination complication
Clinical narrative: Headache that comes and goes; Didn't feel right; Nauseous; Achy; Injection site warm; A bump appeared at the injection site; Injection site itchy; injection site got red; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Didn't feel right), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site got red) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Adrenal insufficiency. Concomitant products included HYDROCORTISONE and FLUDROCORTISONE ACETATE (FLORINEF) for an unknown indication.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site got red) and CHILLS (Chills). On 10-Jan-2021, the patient experienced NAUSEA (Nauseous) and MYALGIA (Achy). On 11-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel right). On 12-Jan-2021, the patient experienced HEADACHE (Headache that comes and goes). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site got red) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Didn't feel right), NAUSEA (Nauseous), MYALGIA (Achy) and HEADACHE (Headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that redness was as big as a half dollar. She mentioned that she does not have adrenal glands so she takes steroids daily to supplement her body with the ones that would be missing.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Headache that comes and goes; Didn't feel right; Nauseous; Achy; Injection site warm; A bump appeared at the injection site; Injection site itchy; injection site got red; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Didn't feel right), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site got red) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Adrenal insufficiency. Concomitant products included HYDROCORTISONE and FLUDROCORTISONE ACETATE (FLORINEF) for an unknown indication.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site got red) and CHILLS (Chills). On 10-Jan-2021, the patient experienced NAUSEA (Nauseous) and MYALGIA (Achy). On 11-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel right). On 12-Jan-2021, the patient experienced HEADACHE (Headache that comes and goes). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site got red) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Didn't feel right), NAUSEA (Nauseous), MYALGIA (Achy) and HEADACHE (Headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that redness was as big as a half dollar. She mentioned that she does not have adrenal glands so she takes steroids daily to supplement her body with the ones that would be missing.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling towards her elbow.; upper arm swelling at the injection site; Red circle; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling towards her elbow.), VACCINATION SITE SWELLING (upper arm swelling at the injection site) and VACCINATION SITE ERYTHEMA (Red circle) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (upper arm swelling at the injection site) and VACCINATION SITE ERYTHEMA (Red circle). On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling towards her elbow.). On 09-Jan-2021, VACCINATION SITE SWELLING (upper arm swelling at the injection site) and VACCINATION SITE ERYTHEMA (Red circle) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling towards her elbow.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 06 jan 2021, patient experienced upper arm swelling at the injection site and red circle for 72 hours after the vaccine. On 13 jan 2021,afternoon the symptoms came back,a red circle and swelling towards her elbow. No Treatment for the event was given; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness that can't be touched without hurting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness that can't be touched without hurting) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness that can't be touched without hurting). At the time of the report, INJECTION SITE PAIN (soreness that can't be touched without hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Vomiting
Clinical narrative: Migraine; Severe piercing headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), HEADACHE (Severe piercing headache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Takes regular medications for thyroid). Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAVASTATIN and VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced MIGRAINE (Migraine), HEADACHE (Severe piercing headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, MIGRAINE (Migraine), HEADACHE (Severe piercing headache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included trimethoprim/sulfamethoxazole (had left overs from prior prescription) and took something for migraine.  After treatments symptoms lasted roughly24 hours and not feeling them anymore.   the patient took concomitant medication levothyroxine, pravastatin something for sleep and vitamins and her treatment was sulfrim for nausea 2 pills she had over from prior prescription and took something for the migraine drug is unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm showed soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. On Dec 29, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Dec 29, 2020, patient experienced of vaccination site pain (arm showed soreness). At the time of the report, of vaccination site pain (arm showed soreness) resolved. Reporter did not allow further contact. No concomitant medications or treatment information reported. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient received the first dose of moderna covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna covid-19 vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-May-2020 and the estimated date of delivery was 26-Feb-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna covid-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna covid-19 vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2020, Pregnancy test: positive (Positive) 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 relevant treatment medications and concomitant medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Feeling super anxious; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANXIETY (Feeling super anxious) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (On medication for extreme anxiety.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced ANXIETY (Feeling super anxious). At the time of the report, ANXIETY (Feeling super anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment for the event included risperidone to help her calm down.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine. Concomitant products included RIZATRIPTAN for Migraine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Respiratory symptoms; Sinus symptoms; Cough; experiencing phlegm and green mucous; Typical fatigue; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms), COUGH (Cough), PRODUCTIVE COUGH (experiencing phlegm and green mucous) and FATIGUE (Typical fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis (Sensitive sinuses and prone to getting cold.) and Common cold. Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) and BIOTIN (HAIR, SKIN & NAILS [BIOTIN]) for an unknown indication.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Typical fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 06-Jan-2021, the patient experienced PRODUCTIVE COUGH (experiencing phlegm and green mucous). On 10-Jan-2021, the patient experienced RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms) and COUGH (Cough). On 04-Jan-2021, FATIGUE (Typical fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms), COUGH (Cough) and PRODUCTIVE COUGH (experiencing phlegm and green mucous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She received a covid test for her symptoms which was negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: no information was provided On 22-Jul-2021: Contact information updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Respiratory symptom, SARS-CoV-2 test, Sinus disorder
Clinical narrative: Respiratory symptoms; Sinus symptoms; Cough; experiencing phlegm and green mucous; Typical fatigue; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms), COUGH (Cough), PRODUCTIVE COUGH (experiencing phlegm and green mucous) and FATIGUE (Typical fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis (Sensitive sinuses and prone to getting cold.) and Common cold. Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) and BIOTIN (HAIR, SKIN & NAILS [BIOTIN]) for an unknown indication.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Typical fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 06-Jan-2021, the patient experienced PRODUCTIVE COUGH (experiencing phlegm and green mucous). On 10-Jan-2021, the patient experienced RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms) and COUGH (Cough). On 04-Jan-2021, FATIGUE (Typical fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms), COUGH (Cough) and PRODUCTIVE COUGH (experiencing phlegm and green mucous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She received a covid test for her symptoms which was negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: no information was provided On 22-Jul-2021: Contact information updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Injection site pain; Running nose; Sinus; Just like flu; Feeling exhaustion; Chills; Headache; bump on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE SWELLING (bump on the injection site) 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 (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE SWELLING (bump on the injection site). On 12-Jan-2021, the patient experienced RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), FATIGUE (Feeling exhaustion), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), INJECTION SITE SWELLING (bump on the injection site), FATIGUE (Feeling exhaustion), CHILLS (Chills) and HEADACHE (Headache) had not resolved and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Rhinorrhoea, Sinus disorder
Clinical narrative: Injection site pain; Running nose; Sinus; Just like flu; Feeling exhaustion; Chills; Headache; bump on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE SWELLING (bump on the injection site) 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 (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE SWELLING (bump on the injection site). On 12-Jan-2021, the patient experienced RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), FATIGUE (Feeling exhaustion), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), INJECTION SITE SWELLING (bump on the injection site), FATIGUE (Feeling exhaustion), CHILLS (Chills) and HEADACHE (Headache) had not resolved and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis, Pyrexia, Vaccination site pain
Clinical narrative: Unbearably cold; fever 100.8F; Headache; Pain in the injection site; swelling at the injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and FATIGUE (Tired). At the time of the report, NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Unbearably cold; fever 100.8F; Headache; Pain in the injection site; swelling at the injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and FATIGUE (Tired). At the time of the report, NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O27L2O1) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-006688 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-006688:Crosslinked with MOD21-05193 (Husband case)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Intraocular pressure increased, Vision blurred
Clinical narrative: Vision was currently blurry in her left eye; ocular pressure is slightly high; Dry eye; Eyeballs got a throbbing pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE PAIN (Eyeballs got a throbbing pain), DRY EYE (Dry eye), VISION BLURRED (Vision was currently blurry in her left eye) and INTRAOCULAR PRESSURE INCREASED (ocular pressure is slightly high) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-Jan-2021, the patient experienced EYE PAIN (Eyeballs got a throbbing pain).   On 11-Jan-2021, the patient experienced DRY EYE (Dry eye). On an unknown date, the patient experienced VISION BLURRED (Vision was currently blurry in her left eye) and INTRAOCULAR PRESSURE INCREASED (ocular pressure is slightly high). The patient was treated with DEXTRAN (MOISTURE EYES [DEXTRAN]) at an unspecified dose and frequency.   On 03-Jan-2021, EYE PAIN (Eyeballs got a throbbing pain) had resolved. At the time of the report, DRY EYE (Dry eye), VISION BLURRED (Vision was currently blurry in her left eye) and INTRAOCULAR PRESSURE INCREASED (ocular pressure is slightly high) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is using moisture drops in mostly the left eye.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: menstrual cycle flow has increased; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (menstrual cycle flow has increased) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (menstrual cycle flow has increased). At the time of the report, HEAVY MENSTRUAL BLEEDING (menstrual cycle flow has increased) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking vitamins.; Sender's Comments: Very limited information regarding this event/s has been provided at this time Critical  Further information has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm in the injection site is feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm in the injection site is feeling sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm in the injection site is feeling sore). At the time of the report, VACCINATION SITE PAIN (Arm in the injection site is feeling sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: slight swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slight swelling at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (slight swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (slight swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria, Vaccination site erythema
Clinical narrative: Injection site was red a firm; Red welt in the arm; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Red welt in the arm), PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE ERYTHEMA (Injection site was red a firm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced URTICARIA (Red welt in the arm) and PAIN IN EXTREMITY (Pain in the arm). On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red a firm). At the time of the report, URTICARIA (Red welt in the arm), PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE ERYTHEMA (Injection site was red a firm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced welt calmed down. After a week symptom reappeared and the injection site was red a firm. Then the redness was expanded.  patient take Antiallergic for treatment   Concomitant product use was not provided by the reporter.  Treatment for the event included antiallergic.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the known safety profile of the vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Headache, Vision blurred
Clinical narrative: Affects his vision see as blurry; Bone pain; Bad headache behind his eyes; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Affects his vision see as blurry), BONE PAIN (Bone pain), HEADACHE (Bad headache behind his eyes) and ARTHRALGIA (Joint pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Neuropathic pain.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VISION BLURRED (Affects his vision see as blurry), BONE PAIN (Bone pain), HEADACHE (Bad headache behind his eyes) and ARTHRALGIA (Joint pain). At the time of the report, VISION BLURRED (Affects his vision see as blurry), BONE PAIN (Bone pain), HEADACHE (Bad headache behind his eyes) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified heart and neuropathic medication. No treatment was received.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache and arthralgia are consistent with the known safety profile of the vaccine.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: Diarrhea; weakness; Fever; Redness; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness) and HEADACHE (Mild headache) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness) and HEADACHE (Mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Reddish; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Reddish) and FEELING HOT (Warm to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ERYTHEMA (Reddish) and FEELING HOT (Warm to touch). The patient was treated with PARACETAMOL (TYLENOL) on 29-Dec-2020 at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Reddish) and FEELING HOT (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Injection site is warm to touch; Injection site rash; A spontaneous report was received from a consumer concerning a 56 years old, female patient who experienced injection site rash/vaccination site rash and injection site warm to touch/ vaccination site warmth.   The patient's medical history included allergy.  Products known to have been used by the patient, within two weeks prior to the event, included fexofenadine hydrochloride, fluticasone propionate, vitamins c &d, montelukast sodium and omeprazole magnesium.  On 05 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient experienced injection site rash and injection site was warm to touch.  Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events injection site rash and injection site was warm to touch were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Big rash at the injection site; Warm to touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Big rash at the injection site) and VACCINATION SITE WARMTH (Warm to touch 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Big rash at the injection site) and VACCINATION SITE WARMTH (Warm to touch at the injection site). At the time of the report, VACCINATION SITE RASH (Big rash at the injection site) and VACCINATION SITE WARMTH (Warm to touch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient developed a big rash warm to touch at the injection site 8 days post injection. No treatment details were provided.    Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with COVID-19; This spontaneous case was reported by a paramedic (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). On 11-Jan-2021, COVID-19 (Diagnosed with COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test positive: positive 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.   Concomitant medications were not provided  Treatment information was not provided.; Sender's Comments: Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Left arm is swollen; left arm is red; left arm is little hard; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Left arm is swollen), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE INDURATION (left arm is little hard) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Left arm is swollen), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE INDURATION (left arm is little hard). At the time of the report, VACCINATION SITE SWELLING (Left arm is swollen), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE INDURATION (left arm is little hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided.