chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination site erythema, Vaccination site pain
Clinical narrative: dizziness; weakness; pain in injection site; redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE PAIN (pain in injection site) and VACCINATION SITE ERYTHEMA (redness in injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620-4) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE PAIN (pain in injection site) and VACCINATION SITE ERYTHEMA (redness in injection site). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE PAIN (pain in injection site) and VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Got the vaccine and was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got the vaccine and was pregnant) in a 33-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included HELLP syndrome (Live, full term birth) on 13-Sep-2019 and Pre-eclampsia (Live, full term birth) on 13-Sep-2019. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Shortness of breath, ASA and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 12-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Aug-2020 and the estimated date of delivery was 13-Jun-2021. On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got the vaccine and was pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The cesarean delivery occurred on 02-Jun-2021, which was reported as Premature. For neonate 1, the birth weight was 2700 grams (5lbs 15oz) with an APGAR score of 8 at 1 minute. The outcome was reported as Pre-Term Birth NOS. pregnancy during problem was happen placental abruption, gestational thrombocytopenia, preeclampsia. fetus/infant detail-week gestation was 38 and weight was 2.7kg and length was 48cm and Agar score at 1minutes was8 and Agar score at 5minute was 9. On 12-Jan-2021, EXPOSURE DURING PREGNANCY (Got the vaccine and was pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2020, Pregnancy test: positive positive (Positive) positive.         The patient tested positive for pregnancy on 28-Sep-2020. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Internal review on 21-JUL-2021 resulted in updated of Number of fetus and para gravida. and lab data also updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Low grade fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and VOMITING (Vomiting) in a male 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 PYREXIA (Low grade fever) and VOMITING (Vomiting). At the time of the report, PYREXIA (Low grade fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  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.   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 onset date of the reported events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1-2/week prior to pregnancy) on 25-Jun-2020, Miscarriage (At 11 weeks gestational age Spontaneous abortion) on 18-May-2018 and Delivery (Live, full term birth) on 06-Nov-2019. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Dec-2020 to an unknown date for Pregnancy.   On 08-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Pregnancy test: Positive. On 18-Feb-2021, Ultrasound foetal: normal normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported estimated date of conception as 06-JAN-2021. Patient had 2 prior pregnancies.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Pregnancy form received with additional information regarding LMP, previous pregtnancies, physician contact, medical history., and 2nd vaccine dosage.; 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: injection site seemed to be like a mosquito bite; itching at the injection site; swelling that is a bit raised at the injection site; redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE VESICLES (injection site seemed to be like a mosquito bite), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE VESICLES (injection site seemed to be like a mosquito bite), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE VESICLES (injection site seemed to be like a mosquito bite), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Chills, Lymphadenopathy, Myalgia
Clinical narrative: Body ache; Chest pain when breathing; Inflammation below underarm; Vaccination site inflammation; Vaccination site hardness; Fever; Chills; Axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHEST PAIN (Chest pain when breathing), LYMPHADENOPATHY (Inflammation below underarm), VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and VACCINATION SITE INDURATION (Vaccination site hardness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 08-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 MYALGIA (Body ache), CHEST PAIN (Chest pain when breathing), LYMPHADENOPATHY (Inflammation below underarm), VACCINATION SITE INFLAMMATION (Vaccination site inflammation), VACCINATION SITE INDURATION (Vaccination site hardness), PYREXIA (Fever), CHILLS (Chills) and AXILLARY PAIN (Axillary pain). On 11-Jan-2021, MYALGIA (Body ache), CHEST PAIN (Chest pain when breathing), LYMPHADENOPATHY (Inflammation below underarm), VACCINATION SITE INFLAMMATION (Vaccination site inflammation), VACCINATION SITE INDURATION (Vaccination site hardness), PYREXIA (Fever), CHILLS (Chills) and AXILLARY PAIN (Axillary pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment details was provided .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration, Vaccination site inflammation
Clinical narrative: Body ache; Chest pain when breathing; Inflammation below underarm; Vaccination site inflammation; Vaccination site hardness; Fever; Chills; Axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHEST PAIN (Chest pain when breathing), LYMPHADENOPATHY (Inflammation below underarm), VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and VACCINATION SITE INDURATION (Vaccination site hardness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 08-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 MYALGIA (Body ache), CHEST PAIN (Chest pain when breathing), LYMPHADENOPATHY (Inflammation below underarm), VACCINATION SITE INFLAMMATION (Vaccination site inflammation), VACCINATION SITE INDURATION (Vaccination site hardness), PYREXIA (Fever), CHILLS (Chills) and AXILLARY PAIN (Axillary pain). On 11-Jan-2021, MYALGIA (Body ache), CHEST PAIN (Chest pain when breathing), LYMPHADENOPATHY (Inflammation below underarm), VACCINATION SITE INFLAMMATION (Vaccination site inflammation), VACCINATION SITE INDURATION (Vaccination site hardness), PYREXIA (Fever), CHILLS (Chills) and AXILLARY PAIN (Axillary pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment details was provided .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination complication
Clinical narrative: feels dizzy; feels very weak; feels very sick; having an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels dizzy), ASTHENIA (feels very weak), VACCINATION COMPLICATION (feels very sick) and VACCINATION COMPLICATION (having an allergic reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included OLOPATADINE HYDROCHLORIDE (PATANOL) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (feels dizzy), ASTHENIA (feels very weak), VACCINATION COMPLICATION (feels very sick) and VACCINATION COMPLICATION (having an allergic reaction). At the time of the report, DIZZINESS (feels dizzy), ASTHENIA (feels very weak), VACCINATION COMPLICATION (feels very sick) and VACCINATION COMPLICATION (having an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication also included medication for allergies at an unknown dose and frequency via an unknown route.  No treatment medication information provided. Laboratory details was not provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   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 these events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Her arm around the injection site was warm to the touch; Her arm around the injection site was red; Her arm around the injection site was swollen; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Her arm around the injection site was warm to the touch), INJECTION SITE ERYTHEMA (Her arm around the injection site was red) and INJECTION SITE SWELLING (Her arm around the injection site was swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE WARMTH (Her arm around the injection site was warm to the touch), INJECTION SITE ERYTHEMA (Her arm around the injection site was red) and INJECTION SITE SWELLING (Her arm around the injection site was swollen). At the time of the report, INJECTION SITE WARMTH (Her arm around the injection site was warm to the touch), INJECTION SITE ERYTHEMA (Her arm around the injection site was red) and INJECTION SITE SWELLING (Her arm around the injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. Treatment medication include steroid shot. The Physician told her the second shot could elicit a stronger response and the patient should pre medicate with Tylenol and plan to do no activities for 2 days post second injection.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Pyrexia
Clinical narrative: Light headed; Woke up tired; fever of 100 Fehrenheit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), FATIGUE (Woke up tired) and PYREXIA (fever of 100 Fehrenheit) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), FATIGUE (Woke up tired) and PYREXIA (fever of 100 Fehrenheit). At the time of the report, DIZZINESS (Light headed), FATIGUE (Woke up tired) and PYREXIA (fever of 100 Fehrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100 fahrenheit (Borderline) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       While waiting to be vaccinated, the patient was exposed to a person with a positive COVID-19 test. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: Red hardness on her arm which "was hot"; Red hardness on her arm which "was hot"; Bad headaches; fatigue (she couldn't leave the bed); Red hardness on her arm which "was hot"; High fever (102°); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), VACCINATION SITE INDURATION (Red hardness on her arm which "was hot"), PYREXIA (High fever (102°)), HEADACHE (Bad headaches) and FATIGUE (fatigue (she couldn't leave the bed)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Asthma.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (High fever (102°)). On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), VACCINATION SITE INDURATION (Red hardness on her arm which "was hot"), HEADACHE (Bad headaches), FATIGUE (fatigue (she couldn't leave the bed)) and VACCINATION SITE ERYTHEMA (Red hardness on her arm which "was hot"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Jan-2021, VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), PYREXIA (High fever (102°)), HEADACHE (Bad headaches) and FATIGUE (fatigue (she couldn't leave the bed)) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red hardness on her arm which "was hot") and VACCINATION SITE ERYTHEMA (Red hardness on her arm which "was hot") 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red hardness on her arm which "was hot"; Red hardness on her arm which "was hot"; Bad headaches; fatigue (she couldn't leave the bed); Red hardness on her arm which "was hot"; High fever (102°); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), VACCINATION SITE INDURATION (Red hardness on her arm which "was hot"), PYREXIA (High fever (102°)), HEADACHE (Bad headaches) and FATIGUE (fatigue (she couldn't leave the bed)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Asthma.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (High fever (102°)). On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), VACCINATION SITE INDURATION (Red hardness on her arm which "was hot"), HEADACHE (Bad headaches), FATIGUE (fatigue (she couldn't leave the bed)) and VACCINATION SITE ERYTHEMA (Red hardness on her arm which "was hot"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Jan-2021, VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), PYREXIA (High fever (102°)), HEADACHE (Bad headaches) and FATIGUE (fatigue (she couldn't leave the bed)) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red hardness on her arm which "was hot") and VACCINATION SITE ERYTHEMA (Red hardness on her arm which "was hot") 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site looks red; A kind of tenderness; Injection site hurt; Injection site itchy; Injection site was kind of swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site was kind of swollen), VACCINATION SITE PAIN (Injection site hurt), VACCINATION SITE ERYTHEMA (Injection site looks red), VACCINATION SITE PAIN (A kind of tenderness) and VACCINATION SITE PRURITUS (injection site itchy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No medical history reported). Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2020, the patient experienced VACCINATION SITE ERYTHEMA (Injection site looks red). On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Injection site was kind of swollen) and VACCINATION SITE PAIN (Injection site hurt). On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (A kind of tenderness) and VACCINATION SITE PRURITUS (injection site itchy). On 30-Dec-2020, VACCINATION SITE PAIN (Injection site hurt) had resolved. At the time of the report, VACCINATION SITE SWELLING (Injection site was kind of swollen), VACCINATION SITE ERYTHEMA (Injection site looks red) and VACCINATION SITE PRURITUS (injection site itchy) had not resolved and VACCINATION SITE PAIN (A kind of tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: 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: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vomiting
Clinical narrative: Not feeling well; Slight fever; Throwing up; Chills; A spontaneous report was received from a consumer concerning himself, a 67-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight fever/pyrexia, throwing up/vomiting, chills and not feeling well/malaise.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011L20A) intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced slight fever, throwing up, chilling and not feeling well. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown    The outcome of the events, slight fever, throwing up, chilling and not feeling well, were considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: round itchy, somewhat red injection site; Swelling at the injection site; round itchy, somewhat red injection site; Sore arms; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arms), VACCINATION SITE PRURITUS (round itchy, somewhat red injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (round itchy, somewhat red injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arms). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (round itchy, somewhat red injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (round itchy, somewhat red injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Sore arms) had resolved. At the time of the report, VACCINATION SITE PRURITUS (round itchy, somewhat red injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (round itchy, somewhat red injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Rash erythematous
Clinical narrative: Bumps; Red rash started near the wrist and went all the way up both of her arms; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (Bumps) and RASH ERYTHEMATOUS (Red rash started near the wrist and went all the way up both of her arms) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash started near the wrist and went all the way up both of her arms). On 12-Jan-2021, the patient experienced PAPULE (Bumps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash erythematous and Papule, at an unspecified dose and frequency. At the time of the report, PAPULE (Bumps) had not resolved and RASH ERYTHEMATOUS (Red rash started near the wrist and went all the way up both of her arms) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: itchiness all over her body, including arms, back, legs, shoulder, and scalp; The itchiness is not just in the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J200/025JZ00) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, 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.   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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature fluctuation, Flushing, Headache, Malaise
Clinical narrative: face being really red with intense pruritis on the side of her face; rash; temperature 99.4-102.5F/had a 101.5F temperature; could not get out of bed; headache; Flushing; waves of malaise; A spontaneous report was received from physician concerning a 68 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed.  No medical history was reported.  No concomitant medication was reported.  On 30-Dec-2020, prior to the onset of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route in lefty arm for prophylaxis of COVID-19 infection.  On 30-Dec-2020, the patient experienced flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and on an unknown date experienced could not get out of bed.  Laboratory details were not provided.  Treatment medication included Benadryl at a dose of 50 milligram at an unknown frequency via an unknown route and Tylenol at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed was not provided.  The outcome of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed was not provided.  The reporter did not provide the assessment of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed to study drug.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: face being really red with intense pruritis on the side of her face; rash; temperature 99.4-102.5F/had a 101.5F temperature; could not get out of bed; headache; Flushing; waves of malaise; A spontaneous report was received from physician concerning a 68 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed.  No medical history was reported.  No concomitant medication was reported.  On 30-Dec-2020, prior to the onset of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route in lefty arm for prophylaxis of COVID-19 infection.  On 30-Dec-2020, the patient experienced flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and on an unknown date experienced could not get out of bed.  Laboratory details were not provided.  Treatment medication included Benadryl at a dose of 50 milligram at an unknown frequency via an unknown route and Tylenol at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed was not provided.  The outcome of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed was not provided.  The reporter did not provide the assessment of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed to study drug.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Neck pain
Clinical narrative: Necklace pain; Knees inflamed; Pain getting worse; Pain in his knees; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Necklace pain), ARTHRITIS (Knees inflamed), ARTHRALGIA (Pain getting worse) and ARTHRALGIA (Pain in his knees) in an 18-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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced NECK PAIN (Necklace pain), ARTHRITIS (Knees inflamed), ARTHRALGIA (Pain getting worse) and ARTHRALGIA (Pain in his knees). At the time of the report, NECK PAIN (Necklace pain), ARTHRITIS (Knees inflamed), ARTHRALGIA (Pain getting worse) and ARTHRALGIA (Pain in his knees) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment for the events was given as pills for pain.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) 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 event, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 26-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Latex allergy, Polycystic ovarian syndrome, Pregnancy on 2014 and Pregnancy (Live, full term birth) on 2018. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Sep-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 21-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported.  Previous pregnancies included first pregnancy ended on 2014 with no outcome details and second pregnancy was ended on 2018 with full-term live birth as outcome without any complications.; 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) had not resolved and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included was acetaminophen.  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.; 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: Headache, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: small area that is more firm than the rest of the arm; injection site is red and warm; injection site is red and warm; The site is tender and soreness that weekend following injection; the site became itchy; headache; she felt feverish and reported a fever of 102.2; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm), VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE PRURITUS (the site became itchy), VACCINATION SITE ERYTHEMA (injection site is red and warm) and HEADACHE (headache) in a female patient of an unknown age 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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm). On 08-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (she felt feverish and reported a fever of 102.2). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (the site became itchy). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE ERYTHEMA (injection site is red and warm) and VACCINATION SITE PAIN (The site is tender and soreness that weekend following injection). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. On 08-Jan-2021, PYREXIA (she felt feverish and reported a fever of 102.2) had resolved. At the time of the report, VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm), VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE PRURITUS (the site became itchy) and VACCINATION SITE ERYTHEMA (injection site is red and warm) had not resolved and HEADACHE (headache) and VACCINATION SITE PAIN (The site is tender and soreness that weekend following injection) 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 medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.