chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Fatigue, Nocturia
Clinical narrative: went for a walk and felt really tired; blood pressure goes from high to low; blood pressure goes from high to low; Nocturia; A spontaneous report was received from a consumer concerning a 92 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced going for a walk and feeling really tired, blood pressure going from high to low and waking up to go to the bathroom three times.  The patient's medical history was not provided. Concomitant product use was not provided.  On 11 Jan 2021, the patient received their dose of mRNA-1273 (Lot number 012120A) in his left arm for prophylaxis of COVID-19 infection.   The patient stated that the same day of the vaccination he went for a walk and felt really tired, which was something uncommon for him.  The next day he woke up and took his blood pressure and it was high.  After breakfast he took the pressure again and it was low.  He also mentioned that overnight he had to wake up three times to go to the bathroom.  There were no treatments for these events.    The events, going for a walk and feeling really tired, blood pressure going from high to low and waking up to go to the bathroom three times were still recovering as of this report.; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Injection site like a hive; Pain; Injection site swelling; Wheel like redness on the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (Injection site like a hive), PAIN (Pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Wheel like redness on the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided). Concomitant products included HYDROXYZINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 07-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Injection site like a hive), PAIN (Pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Wheel like redness on the injection site). At the time of the report, VACCINATION SITE URTICARIA (Injection site like a hive), PAIN (Pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Wheel like redness on the injection site) 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 treatment information was provided.; Sender's Comments: This case concerns a 39-year-old female with a nonserious unexpected event of vaccination site urticaria, and nonserious expected pain, vaccination site erythema, vaccination site swelling. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Chills, Feeling hot, Gait disturbance
Clinical narrative: Palpitation; Pinch near heart; Sore throat; phlegm; Stomach warmth; Body aches; Could not get up from bed; Increases in temperature; Headaches; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm) and FEELING HOT (Stomach warmth) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized twice due to COVID 19) in July 2020, Breathing difficult and Heart disease, unspecified (Long QC prolongation).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm), FEELING HOT (Stomach warmth), PAIN (Body aches), GAIT DISTURBANCE (Could not get up from bed), BODY TEMPERATURE INCREASED (Increases in temperature), HEADACHE (Headaches) and CHILLS (Shivers). At the time of the report, PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm), FEELING HOT (Stomach warmth), PAIN (Body aches), GAIT DISTURBANCE (Could not get up from bed), BODY TEMPERATURE INCREASED (Increases in temperature), HEADACHE (Headaches) and CHILLS (Shivers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 52-year-old female with a nonserious unexpected event of pain, chest pain, palpitations, productive cough, oropharyngeal pain, feeling hot, gait disturbance, and expected body temperature increased, chills, headache. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 52-year-old female with a nonserious unexpected event of pain, chest pain, palpitations, productive cough, oropharyngeal pain, feeling hot, gait disturbance, and expected body temperature increased, chills, headache. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Palpitations, Productive cough
Clinical narrative: Palpitation; Pinch near heart; Sore throat; phlegm; Stomach warmth; Body aches; Could not get up from bed; Increases in temperature; Headaches; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm) and FEELING HOT (Stomach warmth) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized twice due to COVID 19) in July 2020, Breathing difficult and Heart disease, unspecified (Long QC prolongation).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm), FEELING HOT (Stomach warmth), PAIN (Body aches), GAIT DISTURBANCE (Could not get up from bed), BODY TEMPERATURE INCREASED (Increases in temperature), HEADACHE (Headaches) and CHILLS (Shivers). At the time of the report, PALPITATIONS (Palpitation), CHEST PAIN (Pinch near heart), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (phlegm), FEELING HOT (Stomach warmth), PAIN (Body aches), GAIT DISTURBANCE (Could not get up from bed), BODY TEMPERATURE INCREASED (Increases in temperature), HEADACHE (Headaches) and CHILLS (Shivers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 52-year-old female with a nonserious unexpected event of pain, chest pain, palpitations, productive cough, oropharyngeal pain, feeling hot, gait disturbance, and expected body temperature increased, chills, headache. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 52-year-old female with a nonserious unexpected event of pain, chest pain, palpitations, productive cough, oropharyngeal pain, feeling hot, gait disturbance, and expected body temperature increased, chills, headache. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Breast cyst, Diarrhoea, Mammogram, Medication error
Clinical narrative: received second dose more than 35 days apart from the first; LT BREAST MASS/CYST; Diarrhea; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), BREAST CYST (LT BREAST MASS/CYST) and MEDICATION ERROR (received second dose more than 35 days apart from the first) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 03-Feb-2013 to an unknown date and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL) for Hypertension.   On 07-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 21-May-2021, the patient experienced BREAST CYST (LT BREAST MASS/CYST). On an unknown date, the patient experienced MEDICATION ERROR (received second dose more than 35 days apart from the first). On 07-Jan-2021, ABDOMINAL DISCOMFORT (Upset stomach) had resolved. On 11-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 06-Jun-2021, BREAST CYST (LT BREAST MASS/CYST) had resolved. At the time of the report, MEDICATION ERROR (received second dose more than 35 days apart from the first) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Mammogram: inconclusive (Inconclusive) Exam : 3D Mammogram screening Digital w/CAD [116]-Breast -B   Result : No other significant masses,calcification, or other findings are seen in either breast.. On 10-May-2021, Mammogram: inconclusive (Inconclusive) Exam : 3D Mammogram Diagnostic Unilateral Digital [115]-Breast -L Result : No other significant masses, calcification, or other findings are seen in either breast.. On 10-May-2021, Ultrasound scan: hypoechoic (abnormal) Exam : Breast Ultrasound -Limited Unilatera  [137] -Breast -L The 1.4 cm ova mass in the left breast is suspicious of malignancy..         The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-219845 (E2B Linked Report). This case was linked to MOD-2021-219845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up appended.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-219845:Dose 1
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: received second dose more than 35 days apart from the first; LT BREAST MASS/CYST; Diarrhea; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), BREAST CYST (LT BREAST MASS/CYST) and MEDICATION ERROR (received second dose more than 35 days apart from the first) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 03-Feb-2013 to an unknown date and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL) for Hypertension.   On 07-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 21-May-2021, the patient experienced BREAST CYST (LT BREAST MASS/CYST). On an unknown date, the patient experienced MEDICATION ERROR (received second dose more than 35 days apart from the first). On 07-Jan-2021, ABDOMINAL DISCOMFORT (Upset stomach) had resolved. On 11-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 06-Jun-2021, BREAST CYST (LT BREAST MASS/CYST) had resolved. At the time of the report, MEDICATION ERROR (received second dose more than 35 days apart from the first) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Mammogram: inconclusive (Inconclusive) Exam : 3D Mammogram screening Digital w/CAD [116]-Breast -B   Result : No other significant masses,calcification, or other findings are seen in either breast.. On 10-May-2021, Mammogram: inconclusive (Inconclusive) Exam : 3D Mammogram Diagnostic Unilateral Digital [115]-Breast -L Result : No other significant masses, calcification, or other findings are seen in either breast.. On 10-May-2021, Ultrasound scan: hypoechoic (abnormal) Exam : Breast Ultrasound -Limited Unilatera  [137] -Breast -L The 1.4 cm ova mass in the left breast is suspicious of malignancy..         The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-219845 (E2B Linked Report). This case was linked to MOD-2021-219845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up appended.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-219845:Dose 1
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine) in a 39-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.  The patient's past medical history included Asthma chronic since an unknown date. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].    On 16-Jan-2021 at 10:58 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 16-Sep-2020 and the estimated date of delivery was 23-Jun-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 16-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, Blood test: 10dec2020 (Negative) Down syndrome genetic. On 04-Dec-2020, Ultrasound scan: positive (Positive) Confirm pregnancy.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Intentional product use issue, Pruritus, Rash
Clinical narrative: He decided not to take the second shot; Allergic reaction; Small pimples throughout my body; Lot of itching; Rash throughout my body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (He decided not to take the second shot), HYPERSENSITIVITY (Allergic reaction), ACNE (Small pimples throughout my body), PRURITUS (Lot of itching) and RASH (Rash throughout my body) 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 09-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 INTENTIONAL PRODUCT USE ISSUE (He decided not to take the second shot), HYPERSENSITIVITY (Allergic reaction), ACNE (Small pimples throughout my body), PRURITUS (Lot of itching) and RASH (Rash throughout my body). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (He decided not to take the second shot), HYPERSENSITIVITY (Allergic reaction), ACNE (Small pimples throughout my body), PRURITUS (Lot of itching) and RASH (Rash throughout my body) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported.  Patient stated he applied a cream, which seemed to neither help or make the events worse.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received and contains significant information: new events allergic reaction and intentional deviation added, event outcome updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia, Renal pain
Clinical narrative: Fever over 101.9F; Severe headache; Body aches; Feel the kidneys heavy, and now has severe pain on the kidneys; Feeling very bad; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever over 101.9F), HEADACHE (Severe headache), MYALGIA (Body aches), RENAL PAIN (Feel the kidneys heavy, and now has severe pain on the kidneys) and FEELING ABNORMAL (Feeling very bad) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension. Concomitant products included INSULIN and METFORMIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (Fever over 101.9F), HEADACHE (Severe headache), MYALGIA (Body aches), RENAL PAIN (Feel the kidneys heavy, and now has severe pain on the kidneys) and FEELING ABNORMAL (Feeling very bad). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, PYREXIA (Fever over 101.9F), HEADACHE (Severe headache), MYALGIA (Body aches), RENAL PAIN (Feel the kidneys heavy, and now has severe pain on the kidneys) and FEELING ABNORMAL (Feeling very bad) 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.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Symptoms that she had when she had COVID19 in March; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Symptoms that she had when she had COVID19 in March) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19 in March 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Symptoms that she had when she had COVID19 in March). At the time of the report, SUSPECTED COVID-19 (Symptoms that she had when she had COVID19 in March) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Very limited information regarding the symptoms has been provided at this time. Further information has been requested.; Reporter's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Very limited information regarding the symptoms has been provided at this time. Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site extravasation, Pain in extremity
Clinical narrative: Vaccine leaked out of the arm; Sore arm; A spontaneous report was received from a pharmacist concerning a 73-year-old male patient who was participating in the mRNA-1273 Emergency Use Program and Vaccine leaked out of the arm and the patient experienced sore arm.  The patient's medical history was not provided. Concomitant medications were not reported.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 11 Jan 2021, the vaccine leaked out of his arm and the patient experienced a sore arm for a couple of days. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event incorrect dose administered was considered resolved on 11 Jan 2021. The outcome of the event sore arm was unknown on an unknown date.; Reporter's Comments: This case concerns a 73-year-old, male patient. The patient's medical history was not provided. The patient experienced a non serious event of vaccine leak and pain of arm. The event occurred the day the first dose of mRNA was administered. Based on the current available information and temporal association between the use of the product and the start date of the pain in arm, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Two people tested positive for COVID-19 after the administration of that first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Two people tested positive for COVID-19 after the administration of that first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Two people tested positive for COVID-19 after the administration of that first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Two people tested positive for COVID-19 after the administration of that first dose) outcome was unknown. Infection control nurse at hospital mentioned how she was giving the Moderna COVID-19 vaccine for about two weeks and two people tested positive for COVID-19 after the administration of that first dose. She was wondering if they can they take the second dose and when. She also mentioned that the CDC mentions that they should not administer that second dose if a patient had a previous or known allergic reaction to any of the ingredients in the Moderna COVID-19 vaccine. She stated that one of the doctors in the hospital wants to medicate a patient before and take all necessary precautions when vaccinating this person with the Moderna COVID-19 vaccine and if it is okay. She did not want to give me any information about the lack of efficacy in those two patients who tested positive for COVID-19 after taking the first dose of the Moderna COVID-19 vaccine but did give me the lot number. Consent for safety to follow-up with her- Yes YNS8Jan2021 Agent spoke from SRD: Contraindications And Warnings And Precautions I told her I cannot decide whether the doctor should do that or not but instead read her what Moderna says about it and gave her the CDC website.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: This case concerns a patient of unknown age and gender with a nonserious unexpected event of SARS-CoV-2 test positive. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness at injection site; Pain at injection site; Itching at injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No recorded medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Pain at injection site). On 09-Jan-2021, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and VACCINATION SITE SWELLING (Swelling at the injection site) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Paraesthesia oral
Clinical narrative: Thrush; Mouth was tingly; A Spontaneous report was received from a consumer concerning herself a 66 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mouth was tingly/paraesthesia oral and thrush/ candidia infection.  The patient's medical history was not provided. Concomitant medications included diclofenac, pravastatin,flaxseed oil, fish oil, ubidecarenone, Vitamin D3, Curcumin, Magnesium, vitamin B12 and oxymetazoline hydrochloride.  On 04 Jan 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 07 Jan 2021 the patient started exhibiting symptoms of thrush, her mouth was tingly initially. On Sunday, 10 JAN 2021, she realized it was thrush. On 11 JAN 2021 she feels a little uncomfortable. Her 2nd dose of the COVID-19 vaccine is scheduled for 1 FEB 2021.  On 18 Jan 2021 update received, She had to take another 150mg Fluconazole. Her doctor prescribed an oral nystatin to be taken for the next 7 days.  Treatment information included fluconazole and oral nystatin   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events, mouth was tingly and thrush were not resolved.  A follow up received on 18 Jan 2021 which included the treatment details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nasal discomfort, Oropharyngeal pain, Sinus disorder
Clinical narrative: Nose hurting; Sore throat; sinus issues; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Nose hurting), OROPHARYNGEAL PAIN (Sore throat), SINUS DISORDER (sinus issues) and LIMB DISCOMFORT (Sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced NASAL DISCOMFORT (Nose hurting), OROPHARYNGEAL PAIN (Sore throat), SINUS DISORDER (sinus issues) and LIMB DISCOMFORT (Sore arm). At the time of the report, NASAL DISCOMFORT (Nose hurting), OROPHARYNGEAL PAIN (Sore throat), SINUS DISORDER (sinus issues) and LIMB DISCOMFORT (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included paracetamol.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Erythema, Fatigue, Feeling hot
Clinical narrative: tested positive for COVID-19; lost sense of taste; red face; warm, hot, red face; flu-like symptoms; chills; achiness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red face), FEELING HOT (warm, hot, red face), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PAIN (achiness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced ERYTHEMA (red face). 31-Dec-2020, the patient experienced FEELING HOT (warm, hot, red face), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills), PAIN (achiness) and FATIGUE (fatigue). On 06-Jan-2021, the patient experienced AGEUSIA (lost sense of taste). On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). On 05-Jan-2021, ERYTHEMA (red face), FEELING HOT (warm, hot, red face), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills), PAIN (achiness) and FATIGUE (fatigue) had resolved. At the time of the report, AGEUSIA (lost sense of taste) and SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatments of these events are unknown.  Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine; Reporter's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; lost sense of taste; red face; warm, hot, red face; flu-like symptoms; chills; achiness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red face), FEELING HOT (warm, hot, red face), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PAIN (achiness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced ERYTHEMA (red face). 31-Dec-2020, the patient experienced FEELING HOT (warm, hot, red face), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills), PAIN (achiness) and FATIGUE (fatigue). On 06-Jan-2021, the patient experienced AGEUSIA (lost sense of taste). On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). On 05-Jan-2021, ERYTHEMA (red face), FEELING HOT (warm, hot, red face), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills), PAIN (achiness) and FATIGUE (fatigue) had resolved. At the time of the report, AGEUSIA (lost sense of taste) and SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatments of these events are unknown.  Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine; Reporter's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness at injection site; Itching at injection site; Injection site swelling; Small bumps on skin at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE MASS (Small bumps on skin at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, 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 ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE MASS (Small bumps on skin at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE MASS (Small bumps on skin at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-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 RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.; 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: Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Provided).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VERTIGO (Vertigo). 08-Jan-2021, the patient experienced NAUSEA (Nausea). On 09-Jan-2021, VERTIGO (Vertigo) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test positive
Clinical narrative: tested positive; lost all smell and taste; lost all smell and taste; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (lost all smell and taste), AGEUSIA (lost all smell and taste) and SARS-COV-2 TEST POSITIVE (tested positive) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced ANOSMIA (lost all smell and taste) and AGEUSIA (lost all smell and taste). On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive). At the time of the report, ANOSMIA (lost all smell and taste), AGEUSIA (lost all smell and taste) and SARS-COV-2 TEST POSITIVE (tested positive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.      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 by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: Her arm was swollen, red, bumpy and itchy and about a size of orange; Her arm was swollen, red, bumpy and itchy and about a size of orange; neck pain; arm pain; Her arm was swollen, red, bumpy and itchy and about a size of orange; she got an allergic reaction at site; Her arm was swollen, red, bumpy and itchy and about a size of orange; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain) and INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain), INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE HYPERSENSITIVITY (she got an allergic reaction at site) and INJECTION SITE PAPULE (Her arm was swollen, red, bumpy and itchy and about a size of orange). At the time of the report, INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain), INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE HYPERSENSITIVITY (she got an allergic reaction at site) and INJECTION SITE PAPULE (Her arm was swollen, red, bumpy and itchy and about a size of orange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol, Antihistamines and Hydrocortisone cream.; Sender's Comments: This case concerns a 32-year-old female with a nonserious unexpected event of injection site hypersensitivity, injection site papule, pain in extremity, neck pain and expected injection site pruritus, injection site erythema, injection site swelling. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.