chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Retching, Vomiting
Clinical narrative: headache; vomiting; dry heaved; stomach still kind of hurts; chills; fever; sweating profusely; sickest he has felt for as long as he can remember; A spontaneous report was received from a consumer, a 21 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced headache, chills, fever, sweating profusely, vomiting, dry heaved, sickest he has felt for as long as he can remember, and stomach still kind of hurts.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch 011L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.   That evening, the patient started getting a headache and chills. He stated that the chills got worse and he started running a fever, but he didn't measure his temperature at that time. The patient reported that he was sweating profusely at night.   On 13 Jan 2021, the patient woke up around 1:00 am and vomited. He reported that he fell back asleep and woke up with a pounding headache, where his entire head was throbbing. The patient stated that he vomited, then dry heaved for about an hour, and was not able to keep anything down. He reported that his temperature that morning was 100.1 Fahrenheit. The patient stated that was the sickest he felt for as long as he could remember. He reported that he was finally able to keep liquids down and he was a little better. The patient stated that his stomach still kind of hurt. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, vomiting, sickest he has felt for as long as he can remember, and stomach still kind of hurts, was considered resolving. The outcome of the events, chills, fever, sweating profusely, and dry heaved, was considered resolved on 13 Jan 2021.; 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch at injection site; Left arm itching; Left arm got red; Left arm got swollen; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at injection site), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE PRURITUS (Left arm itching), VACCINATION SITE ERYTHEMA (Left arm got red) and VACCINATION SITE SWELLING (Left arm got swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE PRURITUS (Left arm itching), VACCINATION SITE ERYTHEMA (Left arm got red) and VACCINATION SITE SWELLING (Left arm got swollen). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE PRURITUS (Left arm itching), VACCINATION SITE ERYTHEMA (Left arm got red) and VACCINATION SITE SWELLING (Left arm got swollen) 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 and treatment medications were provided. Patient was 28 weeks pregnant at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: Additional initial document attached.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test positive, Vaccination site erythema
Clinical narrative: COVID-19; Cough; Itching at injection site; Fatigue; Red skin at injection site; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), COUGH (Cough), VACCINATION SITE PRURITUS (Itching at injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red skin at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COUGH (Cough), VACCINATION SITE PRURITUS (Itching at injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red skin at injection site). On 03-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), COUGH (Cough), VACCINATION SITE PRURITUS (Itching at injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red skin at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Follow-up information received  and does not contain any new information.; Sender's Comments: Based on the current available information and  temporal association between the use of the product and start date of the events, a causal relationship cannot be excluded. However, the event of COVID -19 POSITIVE  is Unlikely related to mRNA-1273. Further information has been requested
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: COVID-19; Cough; Itching at injection site; Fatigue; Red skin at injection site; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), COUGH (Cough), VACCINATION SITE PRURITUS (Itching at injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red skin at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COUGH (Cough), VACCINATION SITE PRURITUS (Itching at injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red skin at injection site). On 03-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), COUGH (Cough), VACCINATION SITE PRURITUS (Itching at injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red skin at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Follow-up information received  and does not contain any new information.; Sender's Comments: Based on the current available information and  temporal association between the use of the product and start date of the events, a causal relationship cannot be excluded. However, the event of COVID -19 POSITIVE  is Unlikely related to mRNA-1273. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a 46 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced migraine.   The patient's medical history was not provided. The patient denied any history of previous adverse reactions to vaccines.  No relevant concomitant medications were reported.   On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 025L20A) via unknown route in right deltoid muscle for prophylaxis of COVID-19 infection. Follow up response to treatment was good, the patient was discharged and was stable to go home and to be followed up with primary care physician.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event migraine was unknown.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: enlarged quite a bit; real red, 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (real red, 3 inches in diameter) and INJECTION SITE SWELLING (enlarged quite a bit) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (real red, 3 inches in diameter). On 15-Jan-2021, the patient experienced INJECTION SITE SWELLING (enlarged quite a bit). At the time of the report, INJECTION SITE ERYTHEMA (real red, 3 inches in diameter) and INJECTION SITE SWELLING (enlarged quite a bit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been 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.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Diagnosis of Covid-19 two weeks after administration of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Diagnosis of Covid-19 two weeks after administration of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 SARS-COV-2 TEST POSITIVE (Diagnosis of Covid-19 two weeks after administration of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Diagnosis of Covid-19 two weeks after administration of the vaccine) 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. Treatment medications were not provided.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Chills, Headache, Pain in extremity
Clinical narrative: Stomach hurt; covid symptoms; Head hurt; arm is swollen and sore and the size of a golf ball; Severe pain in arm; shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt), PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball), COVID-19 (covid symptoms), PAIN IN EXTREMITY (Severe pain in arm) and CHILLS (shivering) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm) and CHILLS (shivering). On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt), COVID-19 (covid symptoms) and HEADACHE (Head hurt). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt), PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball), COVID-19 (covid symptoms), PAIN IN EXTREMITY (Severe pain in arm), CHILLS (shivering) and HEADACHE (Head hurt) 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 medication was reported. No treatment details were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Stomach hurt; covid symptoms; Head hurt; arm is swollen and sore and the size of a golf ball; Severe pain in arm; shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt), PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball), COVID-19 (covid symptoms), PAIN IN EXTREMITY (Severe pain in arm) and CHILLS (shivering) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm) and CHILLS (shivering). On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt), COVID-19 (covid symptoms) and HEADACHE (Head hurt). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt), PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball), COVID-19 (covid symptoms), PAIN IN EXTREMITY (Severe pain in arm), CHILLS (shivering) and HEADACHE (Head hurt) 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 medication was reported. No treatment details were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use in August 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 06-Jan-2021 at 11:30 AM, 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-Jul-2020 and the estimated date of delivery was 26-Apr-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided.  No treatment information provided.  Lad data reported was ultrasound on 21 Sep 2020 with no result. Patient had glucose test scheduled on 18 Jan 2021. Estimated date of conception was 03 Aug 2020.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm red and warm to the touch 8 days after the shot; Arm red and warm to the touch 8 days after the shot; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Arm red and warm to the touch 8 days after the shot) and VACCINATION SITE ERYTHEMA (Arm red and warm to the touch 8 days after the shot) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm red and warm to the touch 8 days after the shot) and VACCINATION SITE ERYTHEMA (Arm red and warm to the touch 8 days after the shot). At the time of the report, VACCINATION SITE WARMTH (Arm red and warm to the touch 8 days after the shot) and VACCINATION SITE ERYTHEMA (Arm red and warm to the touch 8 days after the shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were provided as birth control pills Treatment information provided as topical steroids and icing the area; 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: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Low grade temp at about 100.3 degrees; Vomiting; Fatigue; Slowed down; Sore arm; Warmth and pain near the injection; pain near the injection; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Slowed down), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warmth and pain near the injection), PYREXIA (Low grade temp at about 100.3 degrees) and VOMITING (Vomiting) in a 44-year-old male 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 information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warmth and pain near the injection) and VACCINATION SITE PAIN (pain near the injection). On 12-Jan-2021, the patient experienced ASTHENIA (Slowed down), PYREXIA (Low grade temp at about 100.3 degrees), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Slowed down), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warmth and pain near the injection), PYREXIA (Low grade temp at about 100.3 degrees), VOMITING (Vomiting), FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain near the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.3 (Inconclusive) 100.3.     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 reported.   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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: Low grade temp at about 100.3 degrees; Vomiting; Fatigue; Slowed down; Sore arm; Warmth and pain near the injection; pain near the injection; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Slowed down), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warmth and pain near the injection), PYREXIA (Low grade temp at about 100.3 degrees) and VOMITING (Vomiting) in a 44-year-old male 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 information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warmth and pain near the injection) and VACCINATION SITE PAIN (pain near the injection). On 12-Jan-2021, the patient experienced ASTHENIA (Slowed down), PYREXIA (Low grade temp at about 100.3 degrees), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Slowed down), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warmth and pain near the injection), PYREXIA (Low grade temp at about 100.3 degrees), VOMITING (Vomiting), FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain near the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.3 (Inconclusive) 100.3.     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 reported.   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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Generalized headache; Fatigue; Body Aches; Chills; Warm at the injection site; Red rash; Red rash; Arm was sore the day of injection; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE PAIN (Arm was sore the day of injection), INJECTION SITE ERYTHEMA (Red rash), INJECTION SITE RASH (Red rash) and HEADACHE (Generalized headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Arm was sore the day of injection). On 06-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE ERYTHEMA (Red rash) and INJECTION SITE RASH (Red rash). On 09-Jan-2021, the patient experienced HEADACHE (Generalized headache), FATIGUE (Fatigue), MYALGIA (Body Aches) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE PAIN (Arm was sore the day of injection), HEADACHE (Generalized headache), FATIGUE (Fatigue), MYALGIA (Body Aches) and CHILLS (Chills) outcome was unknown and INJECTION SITE ERYTHEMA (Red rash) and INJECTION SITE RASH (Red rash) was resolving.        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 the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Myalgia
Clinical narrative: Generalized headache; Fatigue; Body Aches; Chills; Warm at the injection site; Red rash; Red rash; Arm was sore the day of injection; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE PAIN (Arm was sore the day of injection), INJECTION SITE ERYTHEMA (Red rash), INJECTION SITE RASH (Red rash) and HEADACHE (Generalized headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Arm was sore the day of injection). On 06-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE ERYTHEMA (Red rash) and INJECTION SITE RASH (Red rash). On 09-Jan-2021, the patient experienced HEADACHE (Generalized headache), FATIGUE (Fatigue), MYALGIA (Body Aches) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE PAIN (Arm was sore the day of injection), HEADACHE (Generalized headache), FATIGUE (Fatigue), MYALGIA (Body Aches) and CHILLS (Chills) outcome was unknown and INJECTION SITE ERYTHEMA (Red rash) and INJECTION SITE RASH (Red rash) was resolving.        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 the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site calcification, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy at the injection site; injection site was hard; Injection site pink; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CALCIFICATION (injection site was hard), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Injection site pink) and VACCINATION SITE SWELLING (Injection site swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J02A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site pink) and VACCINATION SITE SWELLING (Injection site swelling). On 07-Jan-2021, the patient experienced VACCINATION SITE CALCIFICATION (injection site was hard). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the injection site). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CALCIFICATION (injection site was hard), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Injection site pink) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included warm compress.; 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    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 VACCINATION SITE PAIN (Sore). At the time of the report, VACCINATION SITE PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported..; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste on her mouth immediately after the shoot; A spontaneous report was received from a consumer, concerning herself, a 51-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced metallic taste on her mouth immediately after the shot.  The patient's medical history reported included autoimmune disorder. Concomitant medication reported included levothyroxine.  On 29-Dec-2020, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced metallic taste in her mouth immediately after the vaccine shot, which had lasted for 18hrs. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, metallic taste on her mouth immediately after the shoot was resolved on 30-Dec-2020.; Reporter's Comments: This case concerns a 51 year-old, female patient, who experienced events of metallic taste on her mouth immediately after the shot. The event occurred immediately after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pyrexia, Vomiting
Clinical narrative: stiff neck; very very severe vomiting; body aches; fever of 102.7; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (very very severe vomiting), PAIN (body aches), PYREXIA (fever of 102.7), HEADACHE (severe headache) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 21-year-old female 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) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VOMITING (very very severe vomiting), PAIN (body aches), PYREXIA (fever of 102.7), HEADACHE (severe headache) and MUSCULOSKELETAL STIFFNESS (stiff neck). At the time of the report, VOMITING (very very severe vomiting), PAIN (body aches), PYREXIA (fever of 102.7), HEADACHE (severe headache) and MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of VOMITING (vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 VOMITING (vomiting). On 10-Jan-2021, VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not receive any treatment for the reported event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: I saw the hives; Curvy streak beyond where the muscle ends; Very red in that area; a reaction under the site where the shot was given. Probably like 2 inches wide; rash (like hive) on the area where the vaccine was administered; It was itching; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (a reaction under the site where the shot was given. Probably like 2 inches wide), VACCINATION SITE URTICARIA (I saw the hives), VACCINATION SITE ERYTHEMA (Curvy streak beyond where the muscle ends), VACCINATION SITE PRURITUS (It was itching) and VACCINATION SITE ERYTHEMA (Very red in that area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It was itching) and VACCINATION SITE RASH (rash (like hive) on the area where the vaccine was administered). On 11-Jan-2021, the patient experienced VACCINATION SITE REACTION (a reaction under the site where the shot was given. Probably like 2 inches wide). On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Very red in that area). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (I saw the hives) and VACCINATION SITE ERYTHEMA (Curvy streak beyond where the muscle ends). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form. On 12-Jan-2021, VACCINATION SITE URTICARIA (I saw the hives) had resolved. At the time of the report, VACCINATION SITE REACTION (a reaction under the site where the shot was given. Probably like 2 inches wide), VACCINATION SITE ERYTHEMA (Curvy streak beyond where the muscle ends), VACCINATION SITE PRURITUS (It was itching), VACCINATION SITE ERYTHEMA (Very red in that area) and VACCINATION SITE RASH (rash (like hive) on the area where the vaccine was administered) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site warm to the touch; rash at the injection site that is about 4 inches; injection site a little sore; little swollen on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the injection site that is about 4 inches), VACCINATION SITE PAIN (injection site a little sore) and VACCINATION SITE SWELLING (little swollen on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the injection site that is about 4 inches), VACCINATION SITE PAIN (injection site a little sore) and VACCINATION SITE SWELLING (little swollen on her arm). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the injection site that is about 4 inches), VACCINATION SITE PAIN (injection site a little sore) and VACCINATION SITE SWELLING (little swollen on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Throat irritation
Clinical narrative: Tested positive for Covid; Scratchy throat; Was exposed to the virus; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Was exposed to the virus), THROAT IRRITATION (Scratchy throat) and COVID-19 (Tested positive for Covid) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Was exposed to the virus). On 05-Jan-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On 10-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, EXPOSURE TO SARS-COV-2 (Was exposed to the virus), THROAT IRRITATION (Scratchy throat) and COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient was exposed to the virus on Monday 04Jan2021 or Tuesday 05Jan2021 of last week after the vaccine. The patient did not receive treatment.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her right arm is sore/soreness on her right arm/arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her right arm is sore/soreness on her right arm/arm is sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (her right arm is sore/soreness on her right arm/arm is sore). At the time of the report, VACCINATION SITE PAIN (her right arm is sore/soreness on her right arm/arm is sore) outcome was unknown. 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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Mental disorder (mental health) on 01-Jan-2015, Depression since an unknown date, Anxiety since an unknown date and Allergy since an unknown date. Concomitant products included CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY) from 01-Jul-2018 to an unknown date for Allergy, CLONIDINE from 01-Jul-2018 to an unknown date for Anxiety, BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 01-Jul-2018 to an unknown date and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from 01-Jul-2018 to an unknown date for Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jul-2020 to an unknown date for an unknown indication.    On 20-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 04-Jul-2020 and the estimated date of delivery was 10-Apr-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, Pregnancy test: positive (Positive) Pregnancy test positive..     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.   on 20jan2021, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy.   No treatment information was provided Internal review on 22jul2021 resulted in updates to pregnancy information   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Internal review on 22jul2021 resulted in updates to pregnancy information; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.