chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site papule, Vaccination site pruritus
Clinical narrative: Warm to touch; Injection site turned into a bump; Arm itching; Extremely swollen; Red circle; Arm started to get sore; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE PAIN (Arm started to get sore) and VACCINATION SITE SWELLING (Extremely swollen) in a 49-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.     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) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced HEADACHE (Headache). On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm started to get sore). On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE SWELLING (Extremely swollen) and VACCINATION SITE ERYTHEMA (Red circle). On 01-Jan-2021, VACCINATION SITE PAIN (Arm started to get sore) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE SWELLING (Extremely swollen) and VACCINATION SITE ERYTHEMA (Red circle) 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. Treatment medications included Paracetamol and Ibuprofen for headache which helped. She took Diphenhydramine and Cetirizine and put some ice for swelling and itching. She was not sure if this helped.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch; Injection site turned into a bump; Arm itching; Extremely swollen; Red circle; Arm started to get sore; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE PAIN (Arm started to get sore) and VACCINATION SITE SWELLING (Extremely swollen) in a 49-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.     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) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced HEADACHE (Headache). On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm started to get sore). On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE SWELLING (Extremely swollen) and VACCINATION SITE ERYTHEMA (Red circle). On 01-Jan-2021, VACCINATION SITE PAIN (Arm started to get sore) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE SWELLING (Extremely swollen) and VACCINATION SITE ERYTHEMA (Red circle) 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. Treatment medications included Paracetamol and Ibuprofen for headache which helped. She took Diphenhydramine and Cetirizine and put some ice for swelling and itching. She was not sure if this helped.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity, Rash, Vaccination site erythema
Clinical narrative: Warmness at the injection site; Itchiness at the injection site; Redness at the injection site; Raised borders at the injection site; rash that is increasing; Sharp worsened pain under her arm pit; Lymph nodes under clavicle were enlarged; Couldn't raise left arm; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MOBILITY DECREASED (Couldn't raise left arm), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and AXILLARY PAIN (Sharp worsened pain under her arm pit) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 06-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't raise left arm). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under clavicle were enlarged). On 08-Jan-2021, the patient experienced AXILLARY PAIN (Sharp worsened pain under her arm pit). On 09-Jan-2021, the patient experienced RASH (rash that is increasing). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Raised borders at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness), MOBILITY DECREASED (Couldn't raise left arm), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), AXILLARY PAIN (Sharp worsened pain under her arm pit), LYMPHADENOPATHY (Lymph nodes under clavicle were enlarged), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Raised borders at the injection site) and RASH (rash that is increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmness at the injection site; Itchiness at the injection site; Redness at the injection site; Raised borders at the injection site; rash that is increasing; Sharp worsened pain under her arm pit; Lymph nodes under clavicle were enlarged; Couldn't raise left arm; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MOBILITY DECREASED (Couldn't raise left arm), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and AXILLARY PAIN (Sharp worsened pain under her arm pit) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 06-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't raise left arm). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under clavicle were enlarged). On 08-Jan-2021, the patient experienced AXILLARY PAIN (Sharp worsened pain under her arm pit). On 09-Jan-2021, the patient experienced RASH (rash that is increasing). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Raised borders at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness), MOBILITY DECREASED (Couldn't raise left arm), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), AXILLARY PAIN (Sharp worsened pain under her arm pit), LYMPHADENOPATHY (Lymph nodes under clavicle were enlarged), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Raised borders at the injection site) and RASH (rash that is increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; Fever of 102 degree; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever of 102 degree) and FATIGUE (Fatigue) in a 67-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 (the patient was tested positive for covid-19 on 01-12-2020.) on 01-Dec-2020.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2020, the patient experienced PAIN (Body aches), PYREXIA (Fever of 102 degree) and FATIGUE (Fatigue). On 28-Dec-2020, PAIN (Body aches), PYREXIA (Fever of 102 degree) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Paracetamol and Ibuprofen.   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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site is a little tender; very red; itching; hot to the touch; cellulitis; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), LIMB DISCOMFORT (arm was a little sore), VACCINATION SITE PAIN (injection site is a little tender), VACCINATION SITE ERYTHEMA (very red) and VACCINATION SITE PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema, Heart disease, unspecified, Chronic obstructive pulmonary disease, Diabetes, Allergy to antibiotic, Allergy to antibiotic and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, METFORMIN, OMEPRAZOLE, DILTIAZEM, DULOXETINE and MONTELUKAST.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (cellulitis), VACCINATION SITE PAIN (injection site is a little tender), VACCINATION SITE ERYTHEMA (very red), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (hot to the touch). On an unknown date, the patient experienced LIMB DISCOMFORT (arm was a little sore). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis), VACCINATION SITE PAIN (injection site is a little tender), VACCINATION SITE ERYTHEMA (very red), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (hot to the touch) outcome was unknown and LIMB DISCOMFORT (arm was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included sulfamethoxazole/trimethoprim, an antibiotic.; 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: Vaccination site warmth
Clinical narrative: injection site is a little tender; very red; itching; hot to the touch; cellulitis; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), LIMB DISCOMFORT (arm was a little sore), VACCINATION SITE PAIN (injection site is a little tender), VACCINATION SITE ERYTHEMA (very red) and VACCINATION SITE PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema, Heart disease, unspecified, Chronic obstructive pulmonary disease, Diabetes, Allergy to antibiotic, Allergy to antibiotic and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, METFORMIN, OMEPRAZOLE, DILTIAZEM, DULOXETINE and MONTELUKAST.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (cellulitis), VACCINATION SITE PAIN (injection site is a little tender), VACCINATION SITE ERYTHEMA (very red), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (hot to the touch). On an unknown date, the patient experienced LIMB DISCOMFORT (arm was a little sore). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis), VACCINATION SITE PAIN (injection site is a little tender), VACCINATION SITE ERYTHEMA (very red), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (hot to the touch) outcome was unknown and LIMB DISCOMFORT (arm was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included sulfamethoxazole/trimethoprim, an antibiotic.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Grade 2 injection site pain; Grade 1 injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Grade 2 injection site pain) and VACCINATION SITE SWELLING (Grade 1 injection site swelling) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Grade 2 injection site pain) and VACCINATION SITE SWELLING (Grade 1 injection site swelling). On 09-Jan-2021, VACCINATION SITE PAIN (Grade 2 injection site pain) and VACCINATION SITE SWELLING (Grade 1 injection site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment details was not reported 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: Vaccination site erythema, Vaccination site warmth
Clinical narrative: injection site has remained red and warm to the touch; injection site has remained red and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site has remained red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site has remained red and warm to the touch) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE WARMTH (injection site has remained red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site has remained red and warm to the touch). At the time of the report, VACCINATION SITE WARMTH (injection site has remained red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site has remained red and warm to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0125L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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 Concomitant medications were provided by the reporter. No treatment information provided.. Company Comment  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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: grade 2 injection site pain; grade1 injection site swelling; grade 1 fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (grade 2 injection site pain), VACCINATION SITE SWELLING (grade1 injection site swelling) and FATIGUE (grade 1 fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-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 PAIN (grade 2 injection site pain), VACCINATION SITE SWELLING (grade1 injection site swelling) and FATIGUE (grade 1 fatigue). On 10-Jan-2021, VACCINATION SITE PAIN (grade 2 injection site pain), VACCINATION SITE SWELLING (grade1 injection site swelling) and FATIGUE (grade 1 fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  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 dates of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medication were provided by reporter. No treatment was 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 event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever/Because after take vaccine, my body at 39.8 temperature; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever/Because after take vaccine, my body at 39.8 temperature), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 55-year-old female 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) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (Fever/Because after take vaccine, my body at 39.8 temperature), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). On 12-Jan-2021, PYREXIA (Fever/Because after take vaccine, my body at 39.8 temperature), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39.8 (High) My body at 39.8 temperature..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   The patient did not receive any treatment.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Outcome of the events were updated (reaction only lasted 1 day); declined further follow-up On 21-Jul-2021: Lab data added.; 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: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medication were provided by reporter. No treatment was 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 event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Little welts or hives in the site where she received vaccine; Area towards my shoulder blade began to get sore again; Site where she received vaccine was a localized pinkish raised area; Some soreness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (Little welts or hives in the site where she received vaccine), PAIN (Some soreness), ARTHRALGIA (Area towards my shoulder blade began to get sore again) and VACCINATION SITE SWELLING (Site where she received vaccine was a localized pinkish raised area) in a 67-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.    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 (Some soreness). On 10-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Little welts or hives in the site where she received vaccine), ARTHRALGIA (Area towards my shoulder blade began to get sore again) and VACCINATION SITE SWELLING (Site where she received vaccine was a localized pinkish raised area). At the time of the report, VACCINATION SITE URTICARIA (Little welts or hives in the site where she received vaccine), PAIN (Some soreness), ARTHRALGIA (Area towards my shoulder blade began to get sore again) and VACCINATION SITE SWELLING (Site where she received vaccine was a localized pinkish raised area) 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. Patient had tried using witch hazel and cold water on the effected area without improvement.; 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: Lymph node pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site was warm to the touch; Itchiness at the injection site; Developed a 2.5 inches in diameter of redness around the injection site; Pain in lymph nodes under the same arm received injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Developed a 2.5 inches in diameter of redness around the injection site) and LYMPH NODE PAIN (Pain in lymph nodes under the same arm received injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy to antibiotic (allergy to cefine). Concomitant products included LEVOTHYROXINE, ESTROGENS CONJUGATED (PREMARIN), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VALSARTAN (DIOVAN) and DILTIAZEM for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Developed a 2.5 inches in diameter of redness around the injection site) and LYMPH NODE PAIN (Pain in lymph nodes under the same arm received injection). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Developed a 2.5 inches in diameter of redness around the injection site) and LYMPH NODE PAIN (Pain in lymph nodes under the same arm received injection) outcome was unknown.            Patient was allergic to Iodine dye. Treatment medication included Advil and a antihistamine/cold tablet and kept ice on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: F/U-1 : VAERS received on 19-JUN-2021 : Medical history and allergy was updated. Patient details :  Height, Weight, Race, Ethnic group was updated. Dose 2 information was updated. Route of administration , anatomical site, batch no. was updated. Action taken , De-challenge and Re-challenge were 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Ear discomfort, Head discomfort, Headache, Hypoacusis
Clinical narrative: Involuntary eye twitching; Pressure in ear left side; Pressure inside the head; Terrible headache; Arm soreness injection site; Nausea; Runny nose; Loss audition; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition), BLEPHAROSPASM (Involuntary eye twitching), EAR DISCOMFORT (Pressure in ear left side) and HEAD DISCOMFORT (Pressure inside the head) in a 67-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 Stroke (Four strokes.). Concurrent medical conditions included Cancer (Four times cancer patient.).    On 08-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 PAIN (Arm soreness injection site). On 10-Jan-2021, the patient experienced HEADACHE (Terrible headache). On 11-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure inside the head). On 12-Jan-2021, the patient experienced BLEPHAROSPASM (Involuntary eye twitching) and EAR DISCOMFORT (Pressure in ear left side). In January 2021, the patient experienced RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition) and NAUSEA (Nausea). On 12-Jan-2021, HEADACHE (Terrible headache) had resolved. At the time of the report, RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition), BLEPHAROSPASM (Involuntary eye twitching), EAR DISCOMFORT (Pressure in ear left side), HEAD DISCOMFORT (Pressure inside the head), VACCINATION SITE PAIN (Arm soreness injection site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: follow up received on 19-Jan-2021 included patient history and Events; Sender's Comments: Based on the current available information and  temporal / possible temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This case concerns a 67 year old female subject who experienced the unexpected non-serious events of head discomfort, ear discomfort, hypoacusis, and pain in extremity, and expected non-serious event of headache.  The events of head discomfort, ear discomfort, hypoacusis, pain in extremity and headache occurred 3, 4, 10, 1 and 3 days respectively after the first dose of the study medication.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea, Vaccination site pain
Clinical narrative: Involuntary eye twitching; Pressure in ear left side; Pressure inside the head; Terrible headache; Arm soreness injection site; Nausea; Runny nose; Loss audition; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition), BLEPHAROSPASM (Involuntary eye twitching), EAR DISCOMFORT (Pressure in ear left side) and HEAD DISCOMFORT (Pressure inside the head) in a 67-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 Stroke (Four strokes.). Concurrent medical conditions included Cancer (Four times cancer patient.).    On 08-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 PAIN (Arm soreness injection site). On 10-Jan-2021, the patient experienced HEADACHE (Terrible headache). On 11-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure inside the head). On 12-Jan-2021, the patient experienced BLEPHAROSPASM (Involuntary eye twitching) and EAR DISCOMFORT (Pressure in ear left side). In January 2021, the patient experienced RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition) and NAUSEA (Nausea). On 12-Jan-2021, HEADACHE (Terrible headache) had resolved. At the time of the report, RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition), BLEPHAROSPASM (Involuntary eye twitching), EAR DISCOMFORT (Pressure in ear left side), HEAD DISCOMFORT (Pressure inside the head), VACCINATION SITE PAIN (Arm soreness injection site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: follow up received on 19-Jan-2021 included patient history and Events; Sender's Comments: Based on the current available information and  temporal / possible temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This case concerns a 67 year old female subject who experienced the unexpected non-serious events of head discomfort, ear discomfort, hypoacusis, and pain in extremity, and expected non-serious event of headache.  The events of head discomfort, ear discomfort, hypoacusis, pain in extremity and headache occurred 3, 4, 10, 1 and 3 days respectively after the first dose of the study medication.  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, Nausea, Neck pain, Vaccination site pain
Clinical narrative: neck pain; Headache; pain on injection site; fatigue; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), HEADACHE (Headache), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and NAUSEA (nauseous) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced NECK PAIN (neck pain), HEADACHE (Headache), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and NAUSEA (nauseous). At the time of the report, NECK PAIN (neck pain), HEADACHE (Headache), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and NAUSEA (nauseous) outcome was 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Hardness at injection site; Redness at injection site; A spontaneous report was received from a female consumer (age not provided) who developed hardness/Induration and redness/Erythema at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided.  On 03-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) (injection site not provided) for prophylaxis of Covid-19 infection.  On 11-Jan-2021, the patient developed a hardness and some redness at the injection site. On 12-Jan-2021, the redness is larger and the hardness was gone. The patient denied any pain. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event, Hardness outcome was considered resolved. The event Redness outcome was considered 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.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid after receiving the vaccine; A spontaneous report was received from a physician concerning five patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID after receiving the vaccine.   The patients' medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the event, the patients received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the physician called in stating he knew of 5 other people that tested positive after receiving the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, tested positive for COVID after receiving the vaccine, was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of a Covid-19 positive test after vaccination, this event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site was hot; Firm to palpation; Injection site was swollen; Injection site skin is red; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE INDURATION (Firm to palpation), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site skin is red) 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 VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE INDURATION (Firm to palpation), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site skin is red). At the time of the report, VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE INDURATION (Firm to palpation), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site skin is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Diphenhydramine.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Unpleasant symptoms; Serious Aches; High fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unpleasant symptoms), PAIN (Serious Aches), PYREXIA (High fever) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 FEELING ABNORMAL (Unpleasant symptoms), PAIN (Serious Aches), PYREXIA (High fever) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Unpleasant symptoms) had not resolved and PAIN (Serious Aches), PYREXIA (High fever) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relavent concomitant medications and treatmen information provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: event added; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hyperhidrosis, Lymph node pain, Pain in extremity
Clinical narrative: Almost passed out; Very very hot and sweating; Increased resting heart rate; Fatigue; Whole arm area sore; Axillary lymph nodes were sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Whole arm area sore), PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Very very hot and sweating), HEART RATE INCREASED (Increased resting heart rate) and LYMPH NODE PAIN (Axillary lymph nodes were sore) in a 36-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 reported.    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 PAIN IN EXTREMITY (Whole arm area sore) and LYMPH NODE PAIN (Axillary lymph nodes were sore). On 08-Jan-2021, the patient experienced PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Very very hot and sweating), HEART RATE INCREASED (Increased resting heart rate) and FATIGUE (Fatigue). On 11-Jan-2021, HEART RATE INCREASED (Increased resting heart rate) and FATIGUE (Fatigue) had resolved. On 12-Jan-2021, PAIN IN EXTREMITY (Whole arm area sore), PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Very very hot and sweating) and LYMPH NODE PAIN (Axillary lymph nodes were sore) 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 relevant concomitant medications were reported.   Treatment for the events is Ibuprofen.; Sender's Comments: This case concerns a 36-year-old female who experienced NS unexpected event/s of Presyncope, heart rate increased, pain in extremity, hyperhidrosis, and NS expected events of lymph node pain, fatigue.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Almost passed out; Very very hot and sweating; Increased resting heart rate; Fatigue; Whole arm area sore; Axillary lymph nodes were sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Whole arm area sore), PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Very very hot and sweating), HEART RATE INCREASED (Increased resting heart rate) and LYMPH NODE PAIN (Axillary lymph nodes were sore) in a 36-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 reported.    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 PAIN IN EXTREMITY (Whole arm area sore) and LYMPH NODE PAIN (Axillary lymph nodes were sore). On 08-Jan-2021, the patient experienced PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Very very hot and sweating), HEART RATE INCREASED (Increased resting heart rate) and FATIGUE (Fatigue). On 11-Jan-2021, HEART RATE INCREASED (Increased resting heart rate) and FATIGUE (Fatigue) had resolved. On 12-Jan-2021, PAIN IN EXTREMITY (Whole arm area sore), PRESYNCOPE (Almost passed out), HYPERHIDROSIS (Very very hot and sweating) and LYMPH NODE PAIN (Axillary lymph nodes were sore) 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 relevant concomitant medications were reported.   Treatment for the events is Ibuprofen.; Sender's Comments: This case concerns a 36-year-old female who experienced NS unexpected event/s of Presyncope, heart rate increased, pain in extremity, hyperhidrosis, and NS expected events of lymph node pain, fatigue.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on 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.