chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: Dizziness; Headache; Tired; Pain at the site of injection; A spontaneous report , was received from a consumer (patient), a 58 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, headache, tired (fatigue), and pain at the site of injection (injection site pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 23 Dec 2020, after the first shot, the patient experienced headache, dizziness (like confused), tired and pain in site of injection. No treatment medication information was available.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, dizziness, headache, tired, and pain at the site of injection was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of headache, dizziness, headache, fatigue, and injection site pain,  a causal relationship cannot be excluded.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach pain/cramps; diarrhea; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain/cramps) and DIARRHOEA (diarrhea) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain/cramps) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain/cramps) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itchy; red area the size of my palm, down from needle mark; warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red area the size of my palm, down from needle mark), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PRURITUS (itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, TELMISARTAN, ROSUVASTATIN and ESCITALOPRAM for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red area the size of my palm, down from needle mark) and VACCINATION SITE WARMTH (warm to the touch). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE ERYTHEMA (red area the size of my palm, down from needle mark), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills and nausea in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 010M20A) for COVID-19 immunization. The patient's past medical history included. No adverse event. On Jan 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), chills and nausea. At the time of the report, pyrexia (fever), chills and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant information or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain
Clinical narrative: cough; achy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (cough) and PAIN (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and PAIN (achy). At the time of the report, COUGH (cough) and PAIN (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Rash
Clinical narrative: rash; pain at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), INJECTION SITE PAIN (pain at injection site) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Tylenol                                                        Twice a day for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection site) and FATIGUE (fatigue). On 29-Jan-2021, the patient experienced RASH (rash). On 28-Jan-2021, INJECTION SITE PAIN (pain at injection site) and FATIGUE (fatigue) had resolved. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Self Administered: Tylenol QD for pain in addition to daily medication   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: still itches a bit; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (still itches a bit) and VACCINATION SITE RASH (rash at the site of the injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the site of the injection). On an unknown date, the patient experienced PRURITUS (still itches a bit). On 30-Jan-2021, VACCINATION SITE RASH (rash at the site of the injection) had resolved. At the time of the report, PRURITUS (still itches a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Myalgia, Nausea, Pain
Clinical narrative: Arm was in pain; Achy; Muscle pain; Chills; Fever; Nausea; Vomiting; Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain) and CHILLS (Chills) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment For the symptoms: Tylenol.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Arm was in pain; Achy; Muscle pain; Chills; Fever; Nausea; Vomiting; Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain) and CHILLS (Chills) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment For the symptoms: Tylenol.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (Nausea) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   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. Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (HR higher than normal) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. Concomitant products included Eliquis (apixaban) and carvedilol for an unknown indication. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient experienced increased heart rate (HR higher than normal). At the time of the report, increased heart rate (HR higher than normal) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Oropharyngeal pain
Clinical narrative: sore throat; temperature as high as 101.5; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), BODY TEMPERATURE INCREASED (temperature as high as 101.5), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 25-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 OROPHARYNGEAL PAIN (sore throat), BODY TEMPERATURE INCREASED (temperature as high as 101.5), CHILLS (chills) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), BODY TEMPERATURE INCREASED (temperature as high as 101.5), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site discomfort, Nausea, Pruritus
Clinical narrative: Can feel where they injection was; Red, itchy spot; Headache; Nausea; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (Can feel where they injection was), PRURITUS (Red, itchy spot), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 16-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 DIARRHOEA (Diarrhea) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Can feel where they injection was), PRURITUS (Red, itchy spot) and HEADACHE (Headache). At the time of the report, INJECTION SITE DISCOMFORT (Can feel where they injection was), PRURITUS (Red, itchy spot), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant and had vaccine administered; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and had vaccine administered) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  The patient's past medical history included Gallbladder removal. Concurrent medical conditions included Constipation. Concomitant products included DOCUSATE SODIUM (COLACE) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and had vaccine administered). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and had vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information was  provided.  The patient's estimated date of conception was 4-Sep-2020.  On an unknown date, patient's genetic testing was negative.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Fever for 36 hours; Ache for 36 hours; Chills for 36 hours; Swollen Lymph nodes; Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up), PYREXIA (Fever for 36 hours), PAIN (Ache for 36 hours), CHILLS (Chills for 36 hours) and LYMPHADENOPATHY (Swollen Lymph nodes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up) and LYMPHADENOPATHY (Swollen Lymph nodes). On 27-Jan-2021, the patient experienced PYREXIA (Fever for 36 hours), PAIN (Ache for 36 hours) and CHILLS (Chills for 36 hours). On 29-Jan-2021, PYREXIA (Fever for 36 hours), PAIN (Ache for 36 hours) and CHILLS (Chills for 36 hours) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up) and LYMPHADENOPATHY (Swollen Lymph nodes) outcome was unknown.            No concomitant medications were provided No treatment information provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: threw up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VOMITING (threw up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 30-Jan-2021, the patient experienced VOMITING (threw up). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Influenza, Malaise, Muscle tightness, Pain in extremity
Clinical narrative: Arm muscle is hard; arm muscle is hot; Very sick along with flu- like symptoms; Had to stay in bed at all; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Very sick along with flu- like symptoms), MALAISE (Had to stay in bed at all), MUSCLE TIGHTNESS (Arm muscle is hard), FEELING HOT (arm muscle is hot) and PAIN IN EXTREMITY (Arm sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .  Concomitant products included AMLODIPINE, DIPHENHYDRAMINE HYDROCHLORIDE (NYTOL 1-A-NIGHT), EZETIMIBE, ESOMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COLECALCIFEROL (VIT D [COLECALCIFEROL]), PROBIOTIC 10 and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 28-Jan-2021, the patient experienced INFLUENZA (Very sick along with flu- like symptoms) and MALAISE (Had to stay in bed at all). On 29-Jan-2021, the patient experienced MUSCLE TIGHTNESS (Arm muscle is hard) and FEELING HOT (arm muscle is hot). At the time of the report, INFLUENZA (Very sick along with flu- like symptoms), MALAISE (Had to stay in bed at all), MUSCLE TIGHTNESS (Arm muscle is hard), FEELING HOT (arm muscle is hot) and PAIN IN EXTREMITY (Arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: I had a reaction to the covid vaccine.; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No relevant medical history).    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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.   No concomitant medications were provided No treatment information provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness and swelling at the injection site; Itchiness and swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness and swelling at the injection site) and VACCINATION SITE SWELLING (Itchiness and swelling at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) and ATORVASTATIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness and swelling at the injection site) and VACCINATION SITE SWELLING (Itchiness and swelling at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness and swelling at the injection site) and VACCINATION SITE SWELLING (Itchiness and swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included dabbed alcohol swab to ease itching.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Peripheral swelling, Pruritus, Skin burning sensation
Clinical narrative: a secondary inflammatory incident starting on day 9 after the moderna covid vaccine; Swollen arm; itching; Burning; red; A spontaneous report was received from a Consumer concerning of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen arm, red, itching, burning and a secondary inflammatory incident starting on day 9 after the moderna covid vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced swollen arm, red, itching, burning and a secondary inflammatory incident that started on day 9 after the moderna covid vaccine.  Treatment details included Ice, Advil  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events-  swollen arm, red, itching, burning, a secondary inflammatory incident that started on day 9 after the moderna covid vaccine- was considered to be unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Breast tenderness, Fatigue, Hangover, Headache
Clinical narrative: Her breasts doubled in size and became very tender; Her breasts doubled in size and became very tender; Sty in her eye; Gums became inflamed; Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling; Headache; She related the experience to feeling hungover; She began feeling tired; Achy; This spontaneous case was reported by a nurse and describes the occurrence of HANGOVER (She related the experience to feeling hungover), BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye) and NONINFECTIVE GINGIVITIS (Gums became inflamed) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HANGOVER (She related the experience to feeling hungover), FATIGUE (She began feeling tired), PAIN (Achy) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye), NONINFECTIVE GINGIVITIS (Gums became inflamed) and LYMPHADENOPATHY (Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, HANGOVER (She related the experience to feeling hungover), FATIGUE (She began feeling tired), PAIN (Achy) and HEADACHE (Headache) had resolved. At the time of the report, BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye), NONINFECTIVE GINGIVITIS (Gums became inflamed) and LYMPHADENOPATHY (Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication provided; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Lymphadenopathy, Noninfective gingivitis, Pain
Clinical narrative: Her breasts doubled in size and became very tender; Her breasts doubled in size and became very tender; Sty in her eye; Gums became inflamed; Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling; Headache; She related the experience to feeling hungover; She began feeling tired; Achy; This spontaneous case was reported by a nurse and describes the occurrence of HANGOVER (She related the experience to feeling hungover), BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye) and NONINFECTIVE GINGIVITIS (Gums became inflamed) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HANGOVER (She related the experience to feeling hungover), FATIGUE (She began feeling tired), PAIN (Achy) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye), NONINFECTIVE GINGIVITIS (Gums became inflamed) and LYMPHADENOPATHY (Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, HANGOVER (She related the experience to feeling hungover), FATIGUE (She began feeling tired), PAIN (Achy) and HEADACHE (Headache) had resolved. At the time of the report, BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye), NONINFECTIVE GINGIVITIS (Gums became inflamed) and LYMPHADENOPATHY (Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication provided; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Skin reaction, Vaccination site inflammation
Clinical narrative: dull headache; arm pain; It traveled from the injection site up to the shoulder and down towards the elbow; delayed response; It was inflammation, swelling, rash, almost in the shape of a square; It was inflammation, swelling, rash, almost in the shape of a square; It was inflammation, swelling, rash, almost in the shape of a square; aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), PAIN (aching), SKIN REACTION (delayed response) and VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis and Immune system disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), SKIN REACTION (delayed response), VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE SWELLING (It was inflammation, swelling, rash, almost in the shape of a square) and VACCINATION SITE RASH (It was inflammation, swelling, rash, almost in the shape of a square). On an unknown date, the patient experienced PAIN (aching) and HEADACHE (dull headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), PAIN (aching), SKIN REACTION (delayed response), VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE SWELLING (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE RASH (It was inflammation, swelling, rash, almost in the shape of a square) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: dull headache; arm pain; It traveled from the injection site up to the shoulder and down towards the elbow; delayed response; It was inflammation, swelling, rash, almost in the shape of a square; It was inflammation, swelling, rash, almost in the shape of a square; It was inflammation, swelling, rash, almost in the shape of a square; aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), PAIN (aching), SKIN REACTION (delayed response) and VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis and Immune system disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), SKIN REACTION (delayed response), VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE SWELLING (It was inflammation, swelling, rash, almost in the shape of a square) and VACCINATION SITE RASH (It was inflammation, swelling, rash, almost in the shape of a square). On an unknown date, the patient experienced PAIN (aching) and HEADACHE (dull headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE REACTION (It traveled from the injection site up to the shoulder and down towards the elbow), PAIN (aching), SKIN REACTION (delayed response), VACCINATION SITE INFLAMMATION (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE SWELLING (It was inflammation, swelling, rash, almost in the shape of a square), VACCINATION SITE RASH (It was inflammation, swelling, rash, almost in the shape of a square) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (arm aches), vaccination site pain (arm pain near injection site) and fatigue in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, (batch# unknown) for COVID-19 immunization. No medical history reported. On Feb 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 11, 2021, patient experienced pain (arm aches), vaccination site pain (arm pain near injection site) and fatigue. The patient treated with Tylenol (paracetamol) at an unspecified dose and frequency; and ibuprofen  at an unspecified dose and frequency. On Feb 14, 2021, pain (arm aches), vaccination site pain (arm pain near injection site) and fatigue resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Coldness below knee-both lower extremities; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Coldness below knee-both lower extremities) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20?- either 4 or a 9) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Coldness below knee-both lower extremities). At the time of the report, PERIPHERAL COLDNESS (Coldness below knee-both lower extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a 60-year-old female of unknown age with NS unexpected event of coldness below knee in both lower extremities (Peripheral coldness).  Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. 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: Chills, Fatigue, Feeling hot, Headache, Nausea
Clinical narrative: felt her whole body was on fire; nausea; 100.3°F fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills) and HEADACHE (headache) 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 COVID-19 in August 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). On 18-Jan-2021, FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt her whole body was on fire; nausea; 100.3°F fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills) and HEADACHE (headache) 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 COVID-19 in August 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). On 18-Jan-2021, FEELING HOT (felt her whole body was on fire), NAUSEA (nausea), PYREXIA (100.3°F fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching at the injection site; Redness at the injection site; Bump at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CLOPIDOGREL and CARVEDILOL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CLOPIDOGREL and CARVEDILOL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.