chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site induration, Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: Arm is very painful; Arm is swollen; The knot is about the size of a peach; The knot  is very warm; has been vomiting non stop; Was very disoriented; Could not make out a complete sentence; Had been feeling pretty sick; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had been feeling pretty sick), DISCOMFORT (very uncomfortable), VOMITING (has been vomiting non stop), DISORIENTATION (Was very disoriented) and SPEECH DISORDER (Could not make out a complete sentence) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless legs syndrome (Reported by patient that she takes medication for restless legs syndrome) and Insulin-dependent diabetes mellitus (Reported that patient is an insulin dependent diabetic and has an insulin pump). Concomitant products included AMITRIPTYLINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION COMPLICATION (Had been feeling pretty sick) and DISCOMFORT (very uncomfortable). On 16-Jan-2021, the patient experienced VOMITING (has been vomiting non stop), DISORIENTATION (Was very disoriented) and SPEECH DISORDER (Could not make out a complete sentence). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is very painful), VACCINATION SITE SWELLING (Arm is swollen), VACCINATION SITE INDURATION (The knot is about the size of a peach) and VACCINATION SITE WARMTH (The knot  is very warm). On 16-Jan-2021, VACCINATION COMPLICATION (Had been feeling pretty sick) and DISCOMFORT (very uncomfortable) had resolved. On 18-Jan-2021, VOMITING (has been vomiting non stop), DISORIENTATION (Was very disoriented) and SPEECH DISORDER (Could not make out a complete sentence) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is very painful), VACCINATION SITE SWELLING (Arm is swollen), VACCINATION SITE INDURATION (The knot is about the size of a peach) and VACCINATION SITE WARMTH (The knot  is very warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Blood glucose: 146 or 156 mg/dl (High) blood sugar was 146 or 156 in the morning( the patient couldn't remember) ) and started dropping .. On 19-Jan-2021, Blood glucose: 88 mg/dl morning -88mg/dl.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included acetaminophen.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vomiting
Clinical narrative: chills; tiredness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (tiredness) and VOMITING (vomiting) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery and Pacemaker insertion (cardiac) since an unknown date.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CHILLS (chills), FATIGUE (tiredness) and VOMITING (vomiting). At the time of the report, CHILLS (chills), FATIGUE (tiredness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Myalgia
Clinical narrative: Sick to her stomach; Having diarrhea; Severe muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Having diarrhea) and MYALGIA (Severe muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Having diarrhea) and MYALGIA (Severe muscle pain). At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Having diarrhea) and MYALGIA (Severe muscle pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and HEADACHE (HEADACHE) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.  No Medical History information was reported.   On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (CHILLS) and HEADACHE (HEADACHE). At the time of the report, CHILLS (CHILLS) and HEADACHE (HEADACHE) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.  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: Adverse reaction
Clinical narrative: Took the vaccine and had a reaction to it; A spontaneous report was received from a consumer, regarding a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction.  The patient medical history was not reported. Concomitant medications were not provided.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in unknown for prophylaxis of COVID-19 infection.  On 19-Jan-2021, after vaccine administration, the patient experienced reactio.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events took the vaccine and had a reaction to it was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Had some bruising; warm to the touch; intense itching; it was swell; Very red; very tender; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell) and VACCINATION SITE ERYTHEMA (Very red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VALSARTAN and ATORVASTATIN for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE PAIN (very tender). At the time of the report, VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE PAIN (very tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl and ibuprofen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Had some bruising; warm to the touch; intense itching; it was swell; Very red; very tender; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell) and VACCINATION SITE ERYTHEMA (Very red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VALSARTAN and ATORVASTATIN for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE PAIN (very tender). At the time of the report, VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE PAIN (very tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl and ibuprofen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness
Clinical narrative: flu-like symptoms; weakness; A spontaneous report  was received from a consumer concerning a 60-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced influenza-like illness and asthenia.  The patient has a history of hypertension. No relevant concomitant medications were reported. Other medications included HCTZ, Prevacid, Adderall, Cerezyme.  The patient received their first of two planned doses of mRNA-1273 on 24-Dec-2020. On 18-Jan-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 02620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 24-Dec-2020, the patient experienced influenza-like illness and asthenia.  Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (influenza-like illness and asthenia) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: I called sick for 2 days; complete loss of appetite; Fever 101.7F; Headache; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (I called sick for 2 days), DECREASED APPETITE (complete loss of appetite), PYREXIA (Fever 101.7F), HEADACHE (Headache) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination.     The patient's past medical history included No adverse event.    On 06-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 COMPLICATION (I called sick for 2 days), DECREASED APPETITE (complete loss of appetite), PYREXIA (Fever 101.7F), HEADACHE (Headache) and MYALGIA (body ache). On 08-Jan-2021, VACCINATION COMPLICATION (I called sick for 2 days), DECREASED APPETITE (complete loss of appetite), PYREXIA (Fever 101.7F), HEADACHE (Headache) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 101.7 (Inconclusive) Body temperature-101.7.     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 medication were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I called sick for 2 days; complete loss of appetite; Fever 101.7F; Headache; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (I called sick for 2 days), DECREASED APPETITE (complete loss of appetite), PYREXIA (Fever 101.7F), HEADACHE (Headache) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination.     The patient's past medical history included No adverse event.    On 06-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 COMPLICATION (I called sick for 2 days), DECREASED APPETITE (complete loss of appetite), PYREXIA (Fever 101.7F), HEADACHE (Headache) and MYALGIA (body ache). On 08-Jan-2021, VACCINATION COMPLICATION (I called sick for 2 days), DECREASED APPETITE (complete loss of appetite), PYREXIA (Fever 101.7F), HEADACHE (Headache) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 101.7 (Inconclusive) Body temperature-101.7.     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 medication were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Strong headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Strong headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced HEADACHE (Strong headache). At the time of the report, HEADACHE (Strong headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment included 800 mg of Tylenol.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: sore arm; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) and PYREXIA (a little fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm) and PYREXIA (a little fever). At the time of the report, INJECTION SITE PAIN (sore arm) and PYREXIA (a little fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   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.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Vaccination site rash
Clinical narrative: cramps; nauseous; rash; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), NAUSEA (nauseous) and VACCINATION SITE RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced MUSCLE SPASMS (cramps), NAUSEA (nauseous) and VACCINATION SITE RASH (rash). At the time of the report, MUSCLE SPASMS (cramps), NAUSEA (nauseous) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Hypersensitivity, Lymphadenopathy
Clinical narrative: her arm blew up with edema (moderate); Hives; likely experienced an allergic reaction; arm itching; arm redness; typical arm pain; arm  swelling; Chills; Fatigue; a swollen lymph node on same side of injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives), HYPERSENSITIVITY (likely experienced an allergic reaction), PRURITUS (arm itching) and ERYTHEMA (arm redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic urticaria (18 years ago). Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, VALACYCLOVIR [VALACICLOVIR], ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (typical arm pain), VACCINATION SITE SWELLING (arm  swelling), CHILLS (Chills), FATIGUE (Fatigue) and LYMPHADENOPATHY (a swollen lymph node on same side of injection site). On 14-Jan-2021, the patient experienced OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives), HYPERSENSITIVITY (likely experienced an allergic reaction), PRURITUS (arm itching) and ERYTHEMA (arm redness). On 09-Jan-2021, VACCINATION SITE PAIN (typical arm pain), VACCINATION SITE SWELLING (arm  swelling), CHILLS (Chills), FATIGUE (Fatigue) and LYMPHADENOPATHY (a swollen lymph node on same side of injection site) had resolved. At the time of the report, OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives) and HYPERSENSITIVITY (likely experienced an allergic reaction) outcome was unknown and PRURITUS (arm itching) and ERYTHEMA (arm redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl and Tylenol. Primary health care professional suggested diphenhydramine hydrochloride and paracetamol as treatment. The doctor stated that is likely an allergic reaction. It was reported that the events began to improve; but was still experiencing a red, itchy arm that is painful, but the events are "going down".   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Email address updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pruritus, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: her arm blew up with edema (moderate); Hives; likely experienced an allergic reaction; arm itching; arm redness; typical arm pain; arm  swelling; Chills; Fatigue; a swollen lymph node on same side of injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives), HYPERSENSITIVITY (likely experienced an allergic reaction), PRURITUS (arm itching) and ERYTHEMA (arm redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic urticaria (18 years ago). Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, VALACYCLOVIR [VALACICLOVIR], ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (typical arm pain), VACCINATION SITE SWELLING (arm  swelling), CHILLS (Chills), FATIGUE (Fatigue) and LYMPHADENOPATHY (a swollen lymph node on same side of injection site). On 14-Jan-2021, the patient experienced OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives), HYPERSENSITIVITY (likely experienced an allergic reaction), PRURITUS (arm itching) and ERYTHEMA (arm redness). On 09-Jan-2021, VACCINATION SITE PAIN (typical arm pain), VACCINATION SITE SWELLING (arm  swelling), CHILLS (Chills), FATIGUE (Fatigue) and LYMPHADENOPATHY (a swollen lymph node on same side of injection site) had resolved. At the time of the report, OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives) and HYPERSENSITIVITY (likely experienced an allergic reaction) outcome was unknown and PRURITUS (arm itching) and ERYTHEMA (arm redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl and Tylenol. Primary health care professional suggested diphenhydramine hydrochloride and paracetamol as treatment. The doctor stated that is likely an allergic reaction. It was reported that the events began to improve; but was still experiencing a red, itchy arm that is painful, but the events are "going down".   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Email address updated
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (contracted COVID-19 after receiving the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    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 (contracted COVID-19 after receiving the first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (contracted COVID-19 after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oxygen saturation decreased, Vaccination site swelling
Clinical narrative: Flu-like symptoms; Her oxygen level dropped to 80mm Hg because she is asthmatic; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), OXYGEN SATURATION DECREASED (Her oxygen level dropped to 80mm Hg because she is asthmatic) and VACCINATION SITE SWELLING (Swelling at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthmatic (Reported but start date and stop date not provided).    On 07-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 INFLUENZA LIKE ILLNESS (Flu-like symptoms), OXYGEN SATURATION DECREASED (Her oxygen level dropped to 80mm Hg because she is asthmatic) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), OXYGEN SATURATION DECREASED (Her oxygen level dropped to 80mm Hg because she is asthmatic) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details were not reported by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: patient voluntarily enrolled in pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (patient voluntarily enrolled in pregnancy registry) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (a couple drinks a week maximum) and UTI (During this pregnancy resolved with antibiotic). Concurrent medical conditions included Drug hypersensitivity (Sulfa), Seasonal allergy and Asthma (Patient was without treatment for ~15 years) since 1994. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC), FISH OIL and PLANTAGO OVATA (METAMUCIL FIBER) for an unknown indication.    On 27-Jan-2021 at 12:25 PM, 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 17-Mar-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (patient voluntarily enrolled in pregnancy registry). On 27-Jan-2021, EXPOSURE DURING PREGNANCY (patient voluntarily enrolled in pregnancy registry) 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.   At 20 weeks of this pregnancy, low line placenta started and resolve at 30 weeks. On unknown data diagnostic results for glucose test, ultrasound and genetic test were normal. The patient called to enroll herself in pregnancy registry.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Internal review on 21-Jul-2021 resulted in the update of birth type, fetal outcome and narrative.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Face being red and hot; Stiff neck; Dizziness; Weakness; Hardly able to move; Loss of appetite; Diarrhea; Couldn't think right; Severe headache; Fatigue; Chills; Body aches and muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness) and MOBILITY DECREASED (Hardly able to move) in an 80-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 Pacemaker insertion (cardiac) since an unknown date.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness), MOBILITY DECREASED (Hardly able to move), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), THINKING ABNORMAL (Couldn't think right), HEADACHE (Severe headache), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Body aches and muscle aches). On 18-Jan-2021, FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness), MOBILITY DECREASED (Hardly able to move), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), THINKING ABNORMAL (Couldn't think right), HEADACHE (Severe headache), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Body aches and muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment of the events included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up report received on 13APR2021 included the patient's second dose information for the suspect drug.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Face being red and hot; Stiff neck; Dizziness; Weakness; Hardly able to move; Loss of appetite; Diarrhea; Couldn't think right; Severe headache; Fatigue; Chills; Body aches and muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness) and MOBILITY DECREASED (Hardly able to move) in an 80-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 Pacemaker insertion (cardiac) since an unknown date.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness), MOBILITY DECREASED (Hardly able to move), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), THINKING ABNORMAL (Couldn't think right), HEADACHE (Severe headache), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Body aches and muscle aches). On 18-Jan-2021, FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness), MOBILITY DECREASED (Hardly able to move), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), THINKING ABNORMAL (Couldn't think right), HEADACHE (Severe headache), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Body aches and muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment of the events included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up report received on 13APR2021 included the patient's second dose information for the suspect drug.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Thinking abnormal
Clinical narrative: Face being red and hot; Stiff neck; Dizziness; Weakness; Hardly able to move; Loss of appetite; Diarrhea; Couldn't think right; Severe headache; Fatigue; Chills; Body aches and muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness) and MOBILITY DECREASED (Hardly able to move) in an 80-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 Pacemaker insertion (cardiac) since an unknown date.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness), MOBILITY DECREASED (Hardly able to move), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), THINKING ABNORMAL (Couldn't think right), HEADACHE (Severe headache), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Body aches and muscle aches). On 18-Jan-2021, FLUSHING (Face being red and hot), MUSCULOSKELETAL STIFFNESS (Stiff neck), DIZZINESS (Dizziness), ASTHENIA (Weakness), MOBILITY DECREASED (Hardly able to move), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), THINKING ABNORMAL (Couldn't think right), HEADACHE (Severe headache), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Body aches and muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment of the events included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up report received on 13APR2021 included the patient's second dose information for the suspect drug.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: warm, red welt at the injection site; Red welt at the injection site of the size of golf ball with indefinite margin; warm, red welt at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warm, red welt at the injection site), VACCINATION SITE URTICARIA (Red welt at the injection site of the size of golf ball with indefinite margin) and VACCINATION SITE ERYTHEMA (warm, red welt at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm, red welt at the injection site), VACCINATION SITE URTICARIA (Red welt at the injection site of the size of golf ball with indefinite margin) and VACCINATION SITE ERYTHEMA (warm, red welt at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm, red welt at the injection site) had not resolved and VACCINATION SITE URTICARIA (Red welt at the injection site of the size of golf ball with indefinite margin) and VACCINATION SITE ERYTHEMA (warm, red welt at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included Benadryl oral and Benadryl topical cream.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle soreness in her arm (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (muscle soreness in her arm (injection site)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle soreness in her arm (injection site)). At the time of the report, VACCINATION SITE PAIN (muscle soreness in her arm (injection site)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: arm soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm soreness) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (arm soreness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: a bit of a rash, like an allergy but not really bad; The injection site got itchy; The injection site got red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The injection site got itchy), VACCINATION SITE ERYTHEMA (The injection site got red) and VACCINATION SITE RASH (a bit of a rash, like an allergy but not really bad) 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 reported.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (The injection site got itchy) and VACCINATION SITE ERYTHEMA (The injection site got red). On an unknown date, the patient experienced VACCINATION SITE RASH (a bit of a rash, like an allergy but not really bad). At the time of the report, VACCINATION SITE PRURITUS (The injection site got itchy), VACCINATION SITE ERYTHEMA (The injection site got red) and VACCINATION SITE RASH (a bit of a rash, like an allergy but not really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment included Claritin.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash around the area of the vaccine; This spontaneous case was reported by an attorney and describes the occurrence of VACCINATION SITE RASH (Rash around the area of the vaccine) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash around the area of the vaccine). At the time of the report, VACCINATION SITE RASH (Rash around the area of the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site is warm; Injection site is red; Injection site is raised; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is raised) 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 reported.).    On 11-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 VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is raised). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details were not provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment medication details was not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Epidural injection (in order to mitigate back aches.). Concurrent medical conditions included Back ache.    On 06-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included back injections to treat back-aches.  Treatment information was not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Visual impairment, Vomiting
Clinical narrative: severe headaches; Face was hot; vision issues; a screen/wire appears over eyes; Vomiting, difficulty to keep food down; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face was hot), VISUAL IMPAIRMENT (vision issues; a screen/wire appears over eyes), VOMITING (Vomiting, difficulty to keep food down) and HEADACHE (severe headaches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced FLUSHING (Face was hot), VISUAL IMPAIRMENT (vision issues; a screen/wire appears over eyes), VOMITING (Vomiting, difficulty to keep food down) and HEADACHE (severe headaches). At the time of the report, FLUSHING (Face was hot), VISUAL IMPAIRMENT (vision issues; a screen/wire appears over eyes), VOMITING (Vomiting, difficulty to keep food down) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were blood thinner, thyroid medication and baby aspirin. Treatment details included Tylenol and Ondansetron HCL 4 mg tablets.