chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site pain, Lymphadenopathy
Clinical narrative: cough; lump or lymph node; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), INJECTION SITE PAIN (pain at injection site) and LYMPHADENOPATHY (lump or lymph node) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Tumor is in left side). Concurrent medical conditions included Drug allergy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (lump or lymph node). On 18-Jan-2021, the patient experienced COUGH (cough). On 15-Jan-2021, INJECTION SITE PAIN (pain at injection site) had resolved. At the time of the report, COUGH (cough) and LYMPHADENOPATHY (lump or lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Erythema, Hot flush, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: swelling in the arm; red; hot; hard; swollen; I think it is a drug interaction between the vaccine and Methotrexate; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm), ERYTHEMA (red), HOT FLUSH (hot), MUSCULOSKELETAL STIFFNESS (hard) and PERIPHERAL SWELLING (swollen) in a 65-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.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in the arm), ERYTHEMA (red), HOT FLUSH (hot), MUSCULOSKELETAL STIFFNESS (hard), PERIPHERAL SWELLING (swollen) and DRUG INTERACTION (I think it is a drug interaction between the vaccine and Methotrexate). On 19-Jan-2021, PERIPHERAL SWELLING (swelling in the arm), ERYTHEMA (red), HOT FLUSH (hot), MUSCULOSKELETAL STIFFNESS (hard), PERIPHERAL SWELLING (swollen) and DRUG INTERACTION (I think it is a drug interaction between the vaccine and Methotrexate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache
Clinical narrative: Elevated BP; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated BP) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Elevated BP) and HEADACHE (Headache). At the time of the report, BLOOD PRESSURE INCREASED (Elevated BP) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Valid information received
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria, Vaccination site urticaria
Clinical narrative: left axillary lymph neck lymph nodes swollen.; hive on neck; Huge hive on arm lower than injection site; Hives on neck and face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on neck and face), LYMPHADENOPATHY (left axillary lymph neck lymph nodes swollen.), VACCINATION SITE URTICARIA (hive on neck) and VACCINATION SITE URTICARIA (Huge hive on arm lower than injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced URTICARIA (Hives on neck and face). On 16-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Huge hive on arm lower than injection site). On 19-Jan-2021, the patient experienced LYMPHADENOPATHY (left axillary lymph neck lymph nodes swollen.) and VACCINATION SITE URTICARIA (hive on neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on neck and face), LYMPHADENOPATHY (left axillary lymph neck lymph nodes swollen.), VACCINATION SITE URTICARIA (hive on neck) and VACCINATION SITE URTICARIA (Huge hive on arm lower than injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in my ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in my ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in my ears). At the time of the report, TINNITUS (ringing in my ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.  Very limited information regarding the event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event has been provided at this time.  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: F
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a female 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 (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) 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 18-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 18-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). On 18-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) 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: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a physician assistant and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included PYRIDOXINE HYDROCHLORIDE (VITAMINE).    On 27-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 20-Jun-2020 and the estimated date of delivery was 28-Mar-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2020, Pregnancy test: positive (Positive) Positive.         Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: reddish rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PITYRIASIS ROSEA (reddish rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 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 PITYRIASIS ROSEA (reddish rash). At the time of the report, PITYRIASIS ROSEA (reddish rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: warm to the touch; had a smooth red rash the size of a quarter (or maybe two quarters); is a smooth red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch), INJECTION SITE RASH (had a smooth red rash the size of a quarter (or maybe two quarters)) and INJECTION SITE ERYTHEMA (is a smooth red) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520/2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN and TAMSULOSIN for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch), INJECTION SITE RASH (had a smooth red rash the size of a quarter (or maybe two quarters)) and INJECTION SITE ERYTHEMA (is a smooth red). At the time of the report, INJECTION SITE WARMTH (warm to the touch), INJECTION SITE RASH (had a smooth red rash the size of a quarter (or maybe two quarters)) and INJECTION SITE ERYTHEMA (is a smooth red) 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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; A spontaneous report was received from a 86-year-old female patient, who received  Moderna's covid 19 vaccine (mRNA-1273) and experienced sore at injection site.  The patient's medical history include back pain from which she was scheduled to receive radiation. No relevant concomitant medications were reported.    On 15-Jan-2021, prior to the onset of event, the patient received first dose of mRNA-1273 (Lot: not provided) intramuscular injection for prophylaxis of COVID-19 infection.  On 15-Jan-2021, the patient experienced sore at injection site.   No treatment information provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  Outcome of the event, sore at injection site is resolved.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Vaccination site pain
Clinical narrative: Had flu-like feeling the next day; Was Achy; Pain in her arm (injection site); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu-like feeling the next day), VACCINATION SITE PAIN (Pain in her arm (injection site)) and MYALGIA (Was Achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu-like feeling the next day), VACCINATION SITE PAIN (Pain in her arm (injection site)) and MYALGIA (Was Achy). At the time of the report, INFLUENZA LIKE ILLNESS (Had flu-like feeling the next day), VACCINATION SITE PAIN (Pain in her arm (injection site)) and MYALGIA (Was Achy) 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: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives; Swelling in the facial area; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives) and SWELLING FACE (Swelling in the facial area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and SWELLING FACE (Swelling in the facial area). At the time of the report, URTICARIA (Hives) and SWELLING FACE (Swelling in the facial area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 28-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 in December 2020 and the estimated date of delivery was on an unknown date. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Expected due date was reported as Sep-2021.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria reaction; This spontaneous case was reported by a dentist (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 COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lethargy
Clinical narrative: Really bad lower back pain; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Couldn't get out of bed) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LETHARGY (Couldn't get out of bed). At the time of the report, LETHARGY (Couldn't get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Advil and Heating pad used as a Treatment medication    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up information included reporter details; 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Lightheaded and dizzy; arm was burning and sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded and dizzy) and VACCINATION SITE PAIN (arm was burning and sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheaded and dizzy) and VACCINATION SITE PAIN (arm was burning and sore). On 15-Jan-2021, DIZZINESS (Lightheaded and dizzy) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was burning and sore) had not 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia
Clinical narrative: tested positive for COVID; body ache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID) and MYALGIA (body ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID) and MYALGIA (body ache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; AZITHROMYCIN (ZITHROMAX Z-PAK) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID) and MYALGIA (body ache) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: arm started to swell that got to about 4 inches by 4 inches; arm itched; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dizziness, Vaccination site pain
Clinical narrative: Dizziness; the pt started to experience that her brain is swelling; arm was sore; A spontaneous report was received from a consumer concerning a 61 years old female patient who experienced dizziness/dizziness, brain is swelling/adverse reaction following immunization and sore in the arm/Vaccination site pain.  The patient's medical history was not provided. The relevant concomitant medications were also not provided by the reporter.  On 12-Jan-2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (batch number:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After receiving the shot the patient felt dizziness and sore in her arm and three days after (15- jan-2021) the patient started to experience brain fog.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event dizziness and brain swelling was unknown. The event sore in the arm was recovered on 15-Jan-2021.  Additional information received on 19 Jan 2021 include patients date of birth, gender and also the events such as brain fog and sore in the arms.; 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 of dizziness and vaccination site pain, a causal relationship cannot be excluded.  Very limited information has been provided for the event of adverse reaction after immunization. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: come down with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (come down with COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 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 COVID-19 (come down with COVID). At the time of the report, COVID-19 (come down with COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Big red circle around injection site; Itchy injection site; Warm to touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: High fever; Dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (High fever) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-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 PYREXIA (High fever) and DIZZINESS (Dizziness). At the time of the report, PYREXIA (High fever) and DIZZINESS (Dizziness) 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: little lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little lightheaded) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIZZINESS (little lightheaded). On 11-Jan-2021, DIZZINESS (little lightheaded) had resolved. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up was received on 2-JUL-2021: Email was added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Lip dry, Paraesthesia oral, Rash pruritic, Stomatitis
Clinical narrative: Rash is all over his body looks like poison ivy and it's itchy; his lips are very dry; Feels dehydrated; mouth feels very werid his tongue and the inside of his mouth feels; mouth feels very werid his tongue and the inside of his mouth feels; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is all over his body looks like poison ivy and it's itchy), LIP DRY (his lips are very dry), DEHYDRATION (Feels dehydrated), PARAESTHESIA ORAL (mouth feels very werid his tongue and the inside of his mouth feels) and STOMATITIS (mouth feels very werid his tongue and the inside of his mouth feels) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-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 RASH PRURITIC (Rash is all over his body looks like poison ivy and it's itchy), LIP DRY (his lips are very dry), DEHYDRATION (Feels dehydrated), PARAESTHESIA ORAL (mouth feels very werid his tongue and the inside of his mouth feels) and STOMATITIS (mouth feels very werid his tongue and the inside of his mouth feels). At the time of the report, RASH PRURITIC (Rash is all over his body looks like poison ivy and it's itchy), LIP DRY (his lips are very dry), DEHYDRATION (Feels dehydrated), PARAESTHESIA ORAL (mouth feels very werid his tongue and the inside of his mouth feels) and STOMATITIS (mouth feels very werid his tongue and the inside of his mouth feels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: It was red, wealty, rasied, feverish and very sore.; I had a spot that was the size of a silver dollar.  It felt and looked like a bruise; I had a spot that was the size of a silver dollar. It was sore.; It was red, wealty, rasied, feverish and very sore.; It was red, wealty, rasied, feverish and very sore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It was red, wealty, rasied, feverish and very sore.), VACCINATION SITE BRUISING (I had a spot that was the size of a silver dollar.  It felt and looked like a bruise), VACCINATION SITE PAIN (I had a spot that was the size of a silver dollar. It was sore.), VACCINATION SITE ERYTHEMA (It was red, wealty, rasied, feverish and very sore.) and VACCINATION SITE URTICARIA (It was red, wealty, rasied, feverish and very sore.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-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 VACCINATION SITE WARMTH (It was red, wealty, rasied, feverish and very sore.), VACCINATION SITE BRUISING (I had a spot that was the size of a silver dollar.  It felt and looked like a bruise), VACCINATION SITE PAIN (I had a spot that was the size of a silver dollar. It was sore.), VACCINATION SITE ERYTHEMA (It was red, wealty, rasied, feverish and very sore.) and VACCINATION SITE URTICARIA (It was red, wealty, rasied, feverish and very sore.). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (It was red, wealty, rasied, feverish and very sore.), VACCINATION SITE BRUISING (I had a spot that was the size of a silver dollar.  It felt and looked like a bruise), VACCINATION SITE PAIN (I had a spot that was the size of a silver dollar. It was sore.), VACCINATION SITE ERYTHEMA (It was red, wealty, rasied, feverish and very sore.) and VACCINATION SITE URTICARIA (It was red, wealty, rasied, feverish and very sore.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information have been request.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). an unknown date, the patient experienced RASH (Rash). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and RASH (Rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Adverse event rash added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Pain in extremity, Pruritus
Clinical narrative: felt like she had a cold; itchy ankles; joint pain around her ankle; small red bumps; injection site started to itch; red raised bump "quarter size"; injection site feels warm; swollen in the arm pit; large lymph nodes; sore arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (felt like she had a cold), PRURITUS (itchy ankles), VACCINATION SITE MASS (red raised bump "quarter size") and ARTHRALGIA (joint pain around her ankle) in a 32-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.    Co-suspect product included non-company product IBUPROFEN (IBU) for an unknown indication.    No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (IBU) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced FATIGUE (mild fatigue). On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (large lymph nodes). On 18-Jan-2021, the patient experienced VACCINATION SITE MASS (red raised bump "quarter size"), VACCINATION SITE WARMTH (injection site feels warm) and VACCINATION SITE PRURITUS (injection site started to itch). On 19-Jan-2021, the patient experienced MALAISE (felt like she had a cold), PRURITUS (itchy ankles), ARTHRALGIA (joint pain around her ankle) and VACCINATION SITE RASH (small red bumps). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (felt like she had a cold), PRURITUS (itchy ankles), VACCINATION SITE MASS (red raised bump "quarter size"), ARTHRALGIA (joint pain around her ankle), VACCINATION SITE LYMPHADENOPATHY (large lymph nodes), VACCINATION SITE WARMTH (injection site feels warm), VACCINATION SITE RASH (small red bumps), VACCINATION SITE PRURITUS (injection site started to itch) and FATIGUE (mild fatigue) outcome was unknown. Not Provided      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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site lymphadenopathy, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: felt like she had a cold; itchy ankles; joint pain around her ankle; small red bumps; injection site started to itch; red raised bump "quarter size"; injection site feels warm; swollen in the arm pit; large lymph nodes; sore arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (felt like she had a cold), PRURITUS (itchy ankles), VACCINATION SITE MASS (red raised bump "quarter size") and ARTHRALGIA (joint pain around her ankle) in a 32-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.    Co-suspect product included non-company product IBUPROFEN (IBU) for an unknown indication.    No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (IBU) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced FATIGUE (mild fatigue). On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (large lymph nodes). On 18-Jan-2021, the patient experienced VACCINATION SITE MASS (red raised bump "quarter size"), VACCINATION SITE WARMTH (injection site feels warm) and VACCINATION SITE PRURITUS (injection site started to itch). On 19-Jan-2021, the patient experienced MALAISE (felt like she had a cold), PRURITUS (itchy ankles), ARTHRALGIA (joint pain around her ankle) and VACCINATION SITE RASH (small red bumps). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (felt like she had a cold), PRURITUS (itchy ankles), VACCINATION SITE MASS (red raised bump "quarter size"), ARTHRALGIA (joint pain around her ankle), VACCINATION SITE LYMPHADENOPATHY (large lymph nodes), VACCINATION SITE WARMTH (injection site feels warm), VACCINATION SITE RASH (small red bumps), VACCINATION SITE PRURITUS (injection site started to itch) and FATIGUE (mild fatigue) outcome was unknown. Not Provided      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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: felt like she had a cold; itchy ankles; joint pain around her ankle; small red bumps; injection site started to itch; red raised bump "quarter size"; injection site feels warm; swollen in the arm pit; large lymph nodes; sore arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (felt like she had a cold), PRURITUS (itchy ankles), VACCINATION SITE MASS (red raised bump "quarter size") and ARTHRALGIA (joint pain around her ankle) in a 32-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.    Co-suspect product included non-company product IBUPROFEN (IBU) for an unknown indication.    No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (IBU) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced FATIGUE (mild fatigue). On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (large lymph nodes). On 18-Jan-2021, the patient experienced VACCINATION SITE MASS (red raised bump "quarter size"), VACCINATION SITE WARMTH (injection site feels warm) and VACCINATION SITE PRURITUS (injection site started to itch). On 19-Jan-2021, the patient experienced MALAISE (felt like she had a cold), PRURITUS (itchy ankles), ARTHRALGIA (joint pain around her ankle) and VACCINATION SITE RASH (small red bumps). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (felt like she had a cold), PRURITUS (itchy ankles), VACCINATION SITE MASS (red raised bump "quarter size"), ARTHRALGIA (joint pain around her ankle), VACCINATION SITE LYMPHADENOPATHY (large lymph nodes), VACCINATION SITE WARMTH (injection site feels warm), VACCINATION SITE RASH (small red bumps), VACCINATION SITE PRURITUS (injection site started to itch) and FATIGUE (mild fatigue) outcome was unknown. Not Provided      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.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain behind left ear/left side neck down to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-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 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site inflammation
Clinical narrative: vaccination site inflammation; vaccination site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (vaccination site redness) 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 10-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 INJECTION SITE ERYTHEMA (vaccination site redness). At the time of the report, INJECTION SITE ERYTHEMA (vaccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact