chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, Somnolence
Clinical narrative: Sore throat; Nasal congestion; Runny nose; Feel as if I had the virus, I experience the symptoms of a heavy flu; Shortness of breath; Coughing with great effort; Thorax pain due to coughing; Weakness; Sleepiness; Tiredness; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort) and CHEST PAIN (Thorax pain due to coughing) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 12-Jan-2021, the patient experienced ASTHENIA (Weakness), SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing) and INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Runny nose). On 12-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion), INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu), RHINORRHOEA (Runny nose) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore throat; Nasal congestion; Runny nose; Feel as if I had the virus, I experience the symptoms of a heavy flu; Shortness of breath; Coughing with great effort; Thorax pain due to coughing; Weakness; Sleepiness; Tiredness; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort) and CHEST PAIN (Thorax pain due to coughing) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 12-Jan-2021, the patient experienced ASTHENIA (Weakness), SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing) and INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Runny nose). On 12-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion), INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu), RHINORRHOEA (Runny nose) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Night sweats, Pain in extremity
Clinical narrative: Shooting pain on the arm; Stomach cramping; Night sweats; Headache; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Shooting pain on the arm), ABDOMINAL PAIN UPPER (Stomach cramping) and NIGHT SWEATS (Night sweats) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Hypertension. Concomitant products included CARVEDILOL and HYDROCHLOROTHIAZIDE for an unknown indication.    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 FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Shooting pain on the arm), ABDOMINAL PAIN UPPER (Stomach cramping) and NIGHT SWEATS (Night sweats). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 14-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue), PAIN IN EXTREMITY (Shooting pain on the arm), ABDOMINAL PAIN UPPER (Stomach cramping) and NIGHT SWEATS (Night sweats) 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.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Slightly swollen; It is red/pink; Tenderness at the injection site; Soreness on the left arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness on the left arm), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Slightly swollen), VACCINATION SITE ERYTHEMA (It is red/pink) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS 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 PAIN IN EXTREMITY (Soreness on the left arm). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Slightly swollen), VACCINATION SITE ERYTHEMA (It is red/pink) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, PAIN IN EXTREMITY (Soreness on the left arm), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Slightly swollen), VACCINATION SITE ERYTHEMA (It is red/pink) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product include lood pressure medication.  Treatment for the event included none.; 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: Headache, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Lump at injection site; Red and Itchy rash at injection site; Red and Itchy rash at injection site; Red and Itchy rash at injection site; Slight Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Red and Itchy rash at injection site), HEADACHE (Slight Headache), VACCINATION SITE ERYTHEMA (Red and Itchy rash at injection site) and VACCINATION SITE RASH (Red and Itchy rash at injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 HEADACHE (Slight Headache). On 14-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Red and Itchy rash at injection site), VACCINATION SITE ERYTHEMA (Red and Itchy rash at injection site) and VACCINATION SITE RASH (Red and Itchy rash at injection site). On 06-Jan-2021, HEADACHE (Slight Headache) had resolved. At the time of the report, VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Red and Itchy rash at injection site), VACCINATION SITE ERYTHEMA (Red and Itchy rash at injection site) and VACCINATION SITE RASH (Red and Itchy rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Ibuprofen  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: Received the Moderna vaccine and she is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the Moderna vaccine and she is pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-3 glasses per week) on 15-Aug-2020. Concurrent medical conditions included Allergy to antibiotic. Concomitant products included FOLIC ACID, IRON (PRENATAL [FOLIC ACID;IRON]) and DOCOSAHEXAENOIC ACID (DHA) for Pregnancy, VITAMIN C [ASCORBIC ACID] for Routine health maintenance, ALCOHOL from an unknown date to 15-Aug-2020 for an unknown indication.    On 22-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the Moderna vaccine and she is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Received the Moderna vaccine and she is pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) Positive. In October 2020, Ultrasound scan: results not reported (Inconclusive) Results not reported. In November 2020, Ultrasound scan: results not reported (Inconclusive) Results not reported. In January 2021, Glucose tolerance test: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Myalgia
Clinical narrative: Redness; Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt; Swelling; Lump under the skin; Dizzy; Joint pains; Muscle pain down in legs; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt), SKIN MASS (Lump under the skin) and DIZZINESS (Dizzy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Skin disorder NOS.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SWELLING (Swelling) and PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt). On 08-Jan-2021, the patient experienced ERYTHEMA (Redness). In January 2021, the patient experienced SKIN MASS (Lump under the skin), DIZZINESS (Dizzy), ARTHRALGIA (Joint pains), MYALGIA (Muscle pain down in legs) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling), PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt), SKIN MASS (Lump under the skin), DIZZINESS (Dizzy), ARTHRALGIA (Joint pains), MYALGIA (Muscle pain down in legs) and CHILLS (Chills) outcome was unknown and ERYTHEMA (Redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin mass, Swelling
Clinical narrative: Redness; Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt; Swelling; Lump under the skin; Dizzy; Joint pains; Muscle pain down in legs; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt), SKIN MASS (Lump under the skin) and DIZZINESS (Dizzy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Skin disorder NOS.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SWELLING (Swelling) and PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt). On 08-Jan-2021, the patient experienced ERYTHEMA (Redness). In January 2021, the patient experienced SKIN MASS (Lump under the skin), DIZZINESS (Dizzy), ARTHRALGIA (Joint pains), MYALGIA (Muscle pain down in legs) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling), PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt), SKIN MASS (Lump under the skin), DIZZINESS (Dizzy), ARTHRALGIA (Joint pains), MYALGIA (Muscle pain down in legs) and CHILLS (Chills) outcome was unknown and ERYTHEMA (Redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of vaccination site erythema (big red circle around the injection site) and vaccination site pruritus (itchy around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On Dec 30, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 12, 2021, patient experienced vaccination site erythema (big red circle around the injection site) and vaccination site erythema (big red circle around the injection site) and vaccination site pruritus (itchy around the injection site). The patient  treated with Benadryl (diphenhydramine hydrochloride) for adverse event, unknown dosage form. At the time of the report, vaccination site erythema (big red circle around the injection site) and vaccination site pruritus (itchy around the injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication not reported. Treatment medication included topical steroids. 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Persistent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Persistent diarrhea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (Persistent diarrhea). On 13-Jan-2021, DIARRHOEA (Persistent diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Reporter'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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Severe vertigo; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of VERTIGO (Severe vertigo) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Severe vertigo) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency.   At the time of the report, VERTIGO (Severe vertigo) and HEADACHE (Headache) 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 product use was not 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Some swelling in her thumb; her thumb  was reddish in color and index is more reddish in color; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Some swelling in her thumb) and ERYTHEMA (her thumb  was reddish in color and index is more reddish in color) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 05-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 PERIPHERAL SWELLING (Some swelling in her thumb) and ERYTHEMA (her thumb  was reddish in color and index is more reddish in color). At the time of the report, PERIPHERAL SWELLING (Some swelling in her thumb) and ERYTHEMA (her thumb  was reddish in color and index is more reddish in color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter'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 erythema, Vaccination site pain
Clinical narrative: redness is 2 inches wide and 4 inches long; soreness in the arm, redness is 2 inches wide and 4 inches long; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness is 2 inches wide and 4 inches long) and VACCINATION SITE PAIN (soreness in the arm, redness is 2 inches wide and 4 inches long) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in the arm, redness is 2 inches wide and 4 inches long). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness is 2 inches wide and 4 inches long). At the time of the report, VACCINATION SITE ERYTHEMA (redness is 2 inches wide and 4 inches long) and VACCINATION SITE PAIN (soreness in the arm, redness is 2 inches wide and 4 inches long) 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.   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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Large area raised rash at injection site; Injection site swelling; Tenderness around the injection site; Redness all around injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness all around injection site) in a 48-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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness all around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness all around injection site) 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.   No relevant concomitant medications were reported. 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
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site dysaesthesia, Vaccination site inflammation, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Inflammation on injection site; Skin Sensitivity on injcetion site; Swelling on injection site; Itching at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation on injection site), VACCINATION SITE DYSAESTHESIA (Skin Sensitivity on injcetion site), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE PRURITUS (Itching at injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation on injection site), VACCINATION SITE DYSAESTHESIA (Skin Sensitivity on injcetion site), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE INFLAMMATION (Inflammation on injection site), VACCINATION SITE DYSAESTHESIA (Skin Sensitivity on injcetion site), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the event included aleve.  This case is under data review.; Sender's Comments: This case is under data review
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Flushing, Hypertension, Tachycardia
Clinical narrative: Face flushing; Tachycardia; Hypertensive; This spontaneous case was reported by a physician and describes the occurrence of FLUSHING (Face flushing), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertensive) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Palpitation. Concurrent medical conditions included Drug allergy (Lidocaine, Cephalexin).    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FLUSHING (Face flushing), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertensive). At the time of the report, FLUSHING (Face flushing), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertensive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 160/110 160/110.     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 reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, Vaccination site swelling
Clinical narrative: Cough; Fever; mild swelling at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Cough), VACCINATION SITE SWELLING (mild swelling at the injection site) and PYREXIA (Fever) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (mild swelling at the injection site). On 14-Jan-2021, the patient experienced COUGH (Cough) and PYREXIA (Fever). At the time of the report, COUGH (Cough), VACCINATION SITE SWELLING (mild swelling at the injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, COVID-19 (positive-negative): positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Injection site flared up; Injection site is knotty; injection site is warm; redness has tripled in size at her deltoid; injection site is very itchy; sore arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (redness has tripled in size at her deltoid) in a 44-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness has tripled in size at her deltoid). At the time of the report, INJECTION SITE ERYTHEMA (redness has tripled in size at her deltoid) 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.   On an unknown date, She had a tuberculosis test done before the swelling happened. On 12-JAN-2021, she got a purified protein derivative test on the same arm but at her forearm. Concomitant medications were not provided. Treatment medication included anti-allergy medication.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Injection site flared up; Injection site is knotty; injection site is warm; redness has tripled in size at her deltoid; injection site is very itchy; sore arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (redness has tripled in size at her deltoid) in a 44-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness has tripled in size at her deltoid). At the time of the report, INJECTION SITE ERYTHEMA (redness has tripled in size at her deltoid) 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.   On an unknown date, She had a tuberculosis test done before the swelling happened. On 12-JAN-2021, she got a purified protein derivative test on the same arm but at her forearm. Concomitant medications were not provided. Treatment medication included anti-allergy medication.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; 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 PAIN (Soreness at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 13-Jan-2021, VACCINATION SITE PAIN (Soreness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: pain; aches in body/muscle pain; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), MYALGIA (aches in body/muscle pain) and HEADACHE (Slight Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    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 PAIN (pain), MYALGIA (aches in body/muscle pain) and HEADACHE (Slight Headache). At the time of the report, PAIN (pain), MYALGIA (aches in body/muscle pain) and HEADACHE (Slight Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site erythema, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Warm to touch; Feels like vaccine has been dissipated; Feel heavy; Redmark appears on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE REACTION (Feels like vaccine has been dissipated), DISCOMFORT (Feel heavy) and VACCINATION SITE ERYTHEMA (Redmark appears on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE REACTION (Feels like vaccine has been dissipated), DISCOMFORT (Feel heavy) and VACCINATION SITE ERYTHEMA (Redmark appears on the left arm). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE REACTION (Feels like vaccine has been dissipated), DISCOMFORT (Feel heavy) and VACCINATION SITE ERYTHEMA (Redmark appears on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear discomfort, Lymph node pain, Neck pain, Oropharyngeal pain
Clinical narrative: Neck is sore; jaw is sore; ear is sore; injection site is itchy; injection site is warm; lymph nodes are sore; shoulder is sore; injection site is red; throat is sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), OROPHARYNGEAL PAIN (throat is sore) and VACCINATION SITE PRURITUS (injection site is itchy) in a 59-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 medical history found).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE WARMTH (injection site is warm), LYMPH NODE PAIN (lymph nodes are sore), ARTHRALGIA (shoulder is sore) and VACCINATION SITE ERYTHEMA (injection site is red). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat is sore). At the time of the report, NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE WARMTH (injection site is warm), LYMPH NODE PAIN (lymph nodes are sore), ARTHRALGIA (shoulder is sore) and VACCINATION SITE ERYTHEMA (injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment provided no concomitant medication given
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Neck is sore; jaw is sore; ear is sore; injection site is itchy; injection site is warm; lymph nodes are sore; shoulder is sore; injection site is red; throat is sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), OROPHARYNGEAL PAIN (throat is sore) and VACCINATION SITE PRURITUS (injection site is itchy) in a 59-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 medical history found).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE WARMTH (injection site is warm), LYMPH NODE PAIN (lymph nodes are sore), ARTHRALGIA (shoulder is sore) and VACCINATION SITE ERYTHEMA (injection site is red). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat is sore). At the time of the report, NECK PAIN (Neck is sore), PAIN IN JAW (jaw is sore), EAR DISCOMFORT (ear is sore), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE WARMTH (injection site is warm), LYMPH NODE PAIN (lymph nodes are sore), ARTHRALGIA (shoulder is sore) and VACCINATION SITE ERYTHEMA (injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment provided no concomitant medication given
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Foggy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Foggy). On 30-Dec-2020, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Foggy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills; severe fatigue; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (severe fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     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 an unknown date, the patient experienced MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (severe fatigue). At the time of the report, MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (severe fatigue) 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.   Laboratory details were not reported. Treatment information was 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: Papule, Skin irritation
Clinical narrative: Minor skin irritation; Tiny dot/bump; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Minor skin irritation) and PAPULE (Tiny dot/bump) 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 SKIN IRRITATION (Minor skin irritation) and PAPULE (Tiny dot/bump). At the time of the report, SKIN IRRITATION (Minor skin irritation) and PAPULE (Tiny dot/bump) outcome was unknown. Not Provided      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.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Rare case of severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Rare case of severe diarrhea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included GABAPENTIN for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DIARRHOEA (Rare case of severe diarrhea). At the time of the report, DIARRHOEA (Rare case of severe diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Blood pressure medications and diabetes medication. Treatment details was not reported by the reporter.; 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.