chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Arm has liquid on it; Arm is hot; Arm is swollen, puffy, swelling is getting bigger; Arm is tender; Rash in my chest; Metal taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in mouth), VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), RASH (Rash in my chest) and VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) in a 44-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 Depression and Attention deficit hyperactivity disorder.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) and VACCINATION SITE PAIN (Arm is tender). In January 2021, the patient experienced DYSGEUSIA (Metal taste in mouth) and RASH (Rash in my chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In January 2021, DYSGEUSIA (Metal taste in mouth) and RASH (Rash in my chest) had resolved. At the time of the report, VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) and VACCINATION SITE PAIN (Arm is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking medications for depression and ADHT.; Reporter's Comments: This case concerns a 44-year-old female with a nonserious unexpected event of dysgeusia, vaccination site warmth, vaccination site discharge, and expected rash, vaccination site swelling, and vaccination site pain. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness of arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness of arm) in a 57-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 reported medical history).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness of arm). At the time of the report, VACCINATION SITE PAIN (Soreness of arm) 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.   Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Diarrhea; Headache; Fatigue; Temperature of 99.2; Chills; Nausea; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Temperature of 99.2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Temperature of 99.2), CHILLS (Chills) and NAUSEA (Nausea). On 07-Jan-2021, PYREXIA (Temperature of 99.2) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication includes: Tylenol and Mylanta.  Company Comment: 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Diarrhea; Headache; Fatigue; Temperature of 99.2; Chills; Nausea; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Temperature of 99.2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Temperature of 99.2), CHILLS (Chills) and NAUSEA (Nausea). On 07-Jan-2021, PYREXIA (Temperature of 99.2) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication includes: Tylenol and Mylanta.  Company Comment: 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Fatigue; Headache; Chills; Arm where got the vaccine is still red; Arm where got the vaccine has a little bit of swelling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Arm where got the vaccine is still red) and VACCINATION SITE SWELLING (Arm where got the vaccine has a little bit of swelling). In January 2021, PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Arm where got the vaccine is still red) and VACCINATION SITE SWELLING (Arm where got the vaccine has a little bit of swelling) had resolved. At the time of the report, NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol.; 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Fever; Nausea; Fatigue; Headache; Chills; Arm where got the vaccine is still red; Arm where got the vaccine has a little bit of swelling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Arm where got the vaccine is still red) and VACCINATION SITE SWELLING (Arm where got the vaccine has a little bit of swelling). In January 2021, PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Arm where got the vaccine is still red) and VACCINATION SITE SWELLING (Arm where got the vaccine has a little bit of swelling) had resolved. At the time of the report, NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site pruritus
Clinical narrative: Chills; Itchy arm; Sore arm; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm) and PAIN IN EXTREMITY (Sore arm). On 10-Jan-2021, the patient experienced CHILLS (Chills). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) 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 relevant concomitant medications were provided.   No treatment was 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm; 2 inch circle around the injection site in red-bluish color; swollen arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE DISCOLOURATION (2 inch circle around the injection site in red-bluish color) and PERIPHERAL SWELLING (swollen arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy NOS. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy NOS, SILODOSIN for BPH, HYDROCHLOROTHIAZIDE for Diuretic therapy, IRBESARTAN for Hypertension, VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ZINC for Immune enhancement therapy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE DISCOLOURATION (2 inch circle around the injection site in red-bluish color) and PERIPHERAL SWELLING (swollen arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and INJECTION SITE DISCOLOURATION (2 inch circle around the injection site in red-bluish color) and PERIPHERAL SWELLING (swollen arm) 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 information also provided as aloe vera.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 13 Apr 2021 included adverse event, treatment 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm was swollen; arm was sored; big bump at injection site; injection site was hot; injection site was itchy; injection site hurt a little; injection site was red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot) and VACCINATION SITE PRURITUS (injection site was itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Patient reported as taking high blood pressure medication) and Hyperlipidemia (Patient reported as taking high cholesterol medications).    On 30-Dec-2020, 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 SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE PAIN (injection site hurt a little) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE PAIN (injection site hurt a little) and VACCINATION SITE ERYTHEMA (injection site was red) outcome was unknown.        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.; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm was swollen; arm was sored; big bump at injection site; injection site was hot; injection site was itchy; injection site hurt a little; injection site was red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot) and VACCINATION SITE PRURITUS (injection site was itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Patient reported as taking high blood pressure medication) and Hyperlipidemia (Patient reported as taking high cholesterol medications).    On 30-Dec-2020, 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 SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE PAIN (injection site hurt a little) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE PAIN (injection site hurt a little) and VACCINATION SITE ERYTHEMA (injection site was red) outcome was unknown.        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.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash, Vaccination site rash
Clinical narrative: Eczema; Rash spreading all over the body; Rash on the left arm site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), RASH (Rash spreading all over the body) and VACCINATION SITE RASH (Rash on the left arm site of injection) in a 61-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 was reported.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash on the left arm site of injection). On 08-Jan-2021, the patient experienced RASH (Rash spreading all over the body). On an unknown date, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) outcome was unknown and RASH (Rash spreading all over the body) and VACCINATION SITE RASH (Rash on the left arm site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included the Cortisone for treatment of Eczema.  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'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.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Injection site swelling
Clinical narrative: felt all side effect; Blister on the tongue and back of her mouth; felt like she was hit by a truck; throat swelling up; Red, hot, and hurt on arm; Throw Up Three Times; arm was swollen; Fever; Chills; Her head feels like it'll explode off her neck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was hit by a truck), ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth), VACCINATION COMPLICATION (felt all side effect), PHARYNGEAL SWELLING (throat swelling up) and INJECTION SITE WARMTH (Red, hot, and hurt on arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to venom (Bug bite.).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (felt like she was hit by a truck), PHARYNGEAL SWELLING (throat swelling up), INJECTION SITE WARMTH (Red, hot, and hurt on arm), VOMITING (Throw Up Three Times), INJECTION SITE SWELLING (arm was swollen), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Her head feels like it'll explode off her neck). On 10-Jan-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt all side effect). On 09-Jan-2021, FEELING ABNORMAL (felt like she was hit by a truck), PHARYNGEAL SWELLING (throat swelling up), VOMITING (Throw Up Three Times), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Her head feels like it'll explode off her neck) had resolved. On 21-Jan-2021, INJECTION SITE WARMTH (Red, hot, and hurt on arm) and INJECTION SITE SWELLING (arm was swollen) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth) and VACCINATION COMPLICATION (felt all side effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 (High) 102F. On 07-Jan-2021, Oxygen consumption decreased: 89 (Low) 89.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included for nausea medicine, Advil, Oxygen   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: significant follow up On 09-Jun-2021: No new information; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Oral mucosal blistering, Oxygen consumption decreased, Pharyngeal swelling, Pyrexia
Clinical narrative: felt all side effect; Blister on the tongue and back of her mouth; felt like she was hit by a truck; throat swelling up; Red, hot, and hurt on arm; Throw Up Three Times; arm was swollen; Fever; Chills; Her head feels like it'll explode off her neck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was hit by a truck), ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth), VACCINATION COMPLICATION (felt all side effect), PHARYNGEAL SWELLING (throat swelling up) and INJECTION SITE WARMTH (Red, hot, and hurt on arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to venom (Bug bite.).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (felt like she was hit by a truck), PHARYNGEAL SWELLING (throat swelling up), INJECTION SITE WARMTH (Red, hot, and hurt on arm), VOMITING (Throw Up Three Times), INJECTION SITE SWELLING (arm was swollen), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Her head feels like it'll explode off her neck). On 10-Jan-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt all side effect). On 09-Jan-2021, FEELING ABNORMAL (felt like she was hit by a truck), PHARYNGEAL SWELLING (throat swelling up), VOMITING (Throw Up Three Times), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Her head feels like it'll explode off her neck) had resolved. On 21-Jan-2021, INJECTION SITE WARMTH (Red, hot, and hurt on arm) and INJECTION SITE SWELLING (arm was swollen) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth) and VACCINATION COMPLICATION (felt all side effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 (High) 102F. On 07-Jan-2021, Oxygen consumption decreased: 89 (Low) 89.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included for nausea medicine, Advil, Oxygen   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: significant follow up On 09-Jun-2021: No new information; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: felt all side effect; Blister on the tongue and back of her mouth; felt like she was hit by a truck; throat swelling up; Red, hot, and hurt on arm; Throw Up Three Times; arm was swollen; Fever; Chills; Her head feels like it'll explode off her neck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was hit by a truck), ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth), VACCINATION COMPLICATION (felt all side effect), PHARYNGEAL SWELLING (throat swelling up) and INJECTION SITE WARMTH (Red, hot, and hurt on arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to venom (Bug bite.).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (felt like she was hit by a truck), PHARYNGEAL SWELLING (throat swelling up), INJECTION SITE WARMTH (Red, hot, and hurt on arm), VOMITING (Throw Up Three Times), INJECTION SITE SWELLING (arm was swollen), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Her head feels like it'll explode off her neck). On 10-Jan-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt all side effect). On 09-Jan-2021, FEELING ABNORMAL (felt like she was hit by a truck), PHARYNGEAL SWELLING (throat swelling up), VOMITING (Throw Up Three Times), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Her head feels like it'll explode off her neck) had resolved. On 21-Jan-2021, INJECTION SITE WARMTH (Red, hot, and hurt on arm) and INJECTION SITE SWELLING (arm was swollen) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blister on the tongue and back of her mouth) and VACCINATION COMPLICATION (felt all side effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 (High) 102F. On 07-Jan-2021, Oxygen consumption decreased: 89 (Low) 89.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included for nausea medicine, Advil, Oxygen   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: significant follow up On 09-Jun-2021: No new information; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: his glucose reading was at 166 mg/dl.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (his glucose reading was at 166 mg/dl.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-ZA) for COVID-19 vaccination.     The patient's past medical history included Triple vessel bypass graft and Stent placement since an unknown date. Concurrent medical conditions included Diabetes (Patient reported triple bypass and has heart stents.). Concomitant products included METFORMIN for Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (his glucose reading was at 166 mg/dl.). At the time of the report, BLOOD GLUCOSE INCREASED (his glucose reading was at 166 mg/dl.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 166 mg/dl (High) blood glucose normally runs about 120 mg/dl. On an unknown date, Blood glucose: 120 mg/dl (Inconclusive) blood glucose normally runs about 120 mg/dl. On an unknown date, Glycosylated haemoglobin: 5.7 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 79-year-old male with a nonserious unexpected event of blood glucose increased. Event onset 4 days after first dose mRNA-1273. Event outcome unknown. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin disorder, Vaccination site pruritus
Clinical narrative: got itchy; bumps; redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (got itchy), SKIN DISORDER (bumps) and ERYTHEMA (redness) in a 66-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 effect (No medical history provided). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (got itchy), SKIN DISORDER (bumps) and ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (got itchy), SKIN DISORDER (bumps) and ERYTHEMA (redness) 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 information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome was updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Ear discomfort, Headache
Clinical narrative: Has not had a desire to eat; Couldn't touch behind her right side of her ear; Experienced joint pain; Developed a mild headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Has not had a desire to eat), EAR DISCOMFORT (Couldn't touch behind her right side of her ear), HEADACHE (Developed a mild headache) and ARTHRALGIA (Experienced joint pain) in a 68-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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced HEADACHE (Developed a mild headache). On 01-Jan-2021, the patient experienced ARTHRALGIA (Experienced joint pain). On 02-Jan-2021, the patient experienced DECREASED APPETITE (Has not had a desire to eat) and EAR DISCOMFORT (Couldn't touch behind her right side of her ear). On 02-Jan-2021, ARTHRALGIA (Experienced joint pain) had resolved. At the time of the report, DECREASED APPETITE (Has not had a desire to eat), EAR DISCOMFORT (Couldn't touch behind her right side of her ear) and HEADACHE (Developed a mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included paracetamol, sinade, neck stretcher, epson salt bath, steroid prednisolone and erythromycin.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at injection site; swelling at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        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.   No concomitant medications were reported. No treatment related information has been reported.; Reporter'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: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and the temporal association between the use of ht eproduct and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; A spontaneous report was received from a consumer concerning a female patient of an unspecified age who received Moderna (mRNA-1273) vaccine and felt nauseous (NAUSEA).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 6 Jan 2021, approximately four days prior to the onset of the symptoms, the patient received their doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.    On 10 Jan 2021, about 4 days after receiving the vaccine, the patient felt nauseous and was still nauseous.No concomitant drugs listed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the event, felt nauseous was not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive COVID test; body aches; low grade fever/felt feverish; A spontaneous report was received from a male, physician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a positive COVID test, body aches, low grade fever/ felt feverish.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient received the vaccine and also had an antibody test and nasal swab the same day. On 04 Jan 2021, the patient had minor symptoms of body aches and low grade fever. He stated he felt feverish which was not normal for him. On 05 Jan 2021, his antibody test, IgG, was non-reactive and he tested positive for COVID.  Treatment included being quarantined when he tested positive.  Action taken with mRNA-1273 in response to the events was not reported.  The events, positive COVID test, body aches, low grade fever/felt feverish, was not resolved at the time of this report.; Sender's Comments: This case concerns a male of unknown age with a non serious unexpected events of SARS-CoV-2 test positive and pain along with expected pyrexia. Event onset 8 days after first dose mRNA-1273. Events ongoing. 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both side of belly and it looks like heat rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both side of belly and it looks like heat rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-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 RASH (Rash on both side of belly and it looks like heat rash). The patient was treated with CALAMINE at an unspecified dose and frequency. At the time of the report, RASH (Rash on both side of belly and it looks like heat rash) outcome was unknown. Not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Body aches; Arm sore; A fever of about 100.3, temperature was up every 3 hours; Swollen lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Body aches), VACCINATION SITE PAIN (Arm sore), PYREXIA (A fever of about 100.3, temperature was up every 3 hours) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Arm sore), PYREXIA (A fever of about 100.3, temperature was up every 3 hours) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN (Body aches), PYREXIA (A fever of about 100.3, temperature was up every 3 hours) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown and VACCINATION SITE PAIN (Arm sore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test negative: negative (Negative) negative (prior to receiving the vaccine).     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 for event included Tylenol and Advil.  Concomitant information not provided.  Company comment: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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever; threw up a couple of times; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VOMITING (threw up a couple of times) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112L0A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (Fever). February 2021, the patient experienced VOMITING (threw up a couple of times). At the time of the report, PYREXIA (Fever) and VOMITING (threw up a couple of times) had resolved.            No concomitant medications were provided by the reporter.   Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-004683 (E2B Linked Report). This case was linked to MOD-2021-205686 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3 JUN 2021 contain information include:New adverse event- Vomiting was added, the outcome of other events were updated and information about second dose of vaccine was added.; 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. US-MODERNATX, INC.-MOD-2021-004683:Crosslinked (MOD21-03428)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112L0A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.  No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-004679 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter said that her husband is doing fine. Updated outcomes to recovered/resolved. Additional FU declined; 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. US-MODERNATX, INC.-MOD-2021-004679:Crosslinked (MOD21-03428)