chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient reported itching on her arm, face, and neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient reported itching on her arm, face, and neck) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRURITUS (Patient reported itching on her arm, face, and neck). At the time of the report, PRURITUS (Patient reported itching on her arm, face, and neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021, updated event outcome to recovered and the patient declined for a follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Arm got the injection in is stiff; Felt weak; Arm got the injection in is sore; A spontaneous report was received from a consumer concerning a 77 years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm got the injection in is sore, arm got the injection in is stiff, and felt weak.   The patient's medical history was not reported. Concomitant product use included unspecified blood thinner.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) on 26 Jan 2021.  On 23 Feb 2021, approximately one day prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 022M20A) in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the patient reported the arm which got the injection was sore & stiff and the patient felt weak the same morning. Patient reported forgetting to inform that patient was taking a blood thinner.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events arm got the injection in is sore, arm got the injection in is stiff, and felt weak is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
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. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 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) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-024017 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024017:crosslink
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant pt; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant pt) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (During current pregnancy, she had marginal cord insertion as a pregnancy complication.). 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], COLECALCIFEROL (D3 VITAMIIN) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 26-Apr-2021. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant pt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant pt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2020, Pregnancy test: positive positive (Positive) Pregnancy test was positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were added.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Palpitations, Vision blurred, Visual impairment
Clinical narrative: Problem with close-up vision; Blurred vision; Metallic taste in her mouth; Heart started racing; Mind felt foggy; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), DYSGEUSIA (Metallic taste in her mouth), PALPITATIONS (Heart started racing), FEELING ABNORMAL (Mind felt foggy) and VISUAL IMPAIRMENT (Problem with close-up vision) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VISION BLURRED (Blurred vision), DYSGEUSIA (Metallic taste in her mouth), PALPITATIONS (Heart started racing) and FEELING ABNORMAL (Mind felt foggy). On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Problem with close-up vision). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Feeling abnormal, Taste metallic and Visual impairment, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurred vision), DYSGEUSIA (Metallic taste in her mouth), PALPITATIONS (Heart started racing), FEELING ABNORMAL (Mind felt foggy) and VISUAL IMPAIRMENT (Problem with close-up vision) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Chills, Fatigue
Clinical narrative: Muscle pain; Back pain; Bad body odor; Tiredness; Severe chills; Joint pain; Fever; Headache; Nausea; Vomiting; Arm burned really bad during administration; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness) and CHILLS (Severe chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced BURNING SENSATION (Arm burned really bad during administration). On 23-Feb-2021, the patient experienced BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). On 24-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient took Advil (ibuprofen) and Tylenol (paracetamol).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Skin odour abnormal
Clinical narrative: Muscle pain; Back pain; Bad body odor; Tiredness; Severe chills; Joint pain; Fever; Headache; Nausea; Vomiting; Arm burned really bad during administration; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness) and CHILLS (Severe chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced BURNING SENSATION (Arm burned really bad during administration). On 23-Feb-2021, the patient experienced BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). On 24-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient took Advil (ibuprofen) and Tylenol (paracetamol).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Muscle pain; Back pain; Bad body odor; Tiredness; Severe chills; Joint pain; Fever; Headache; Nausea; Vomiting; Arm burned really bad during administration; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness) and CHILLS (Severe chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced BURNING SENSATION (Arm burned really bad during administration). On 23-Feb-2021, the patient experienced BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). On 24-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient took Advil (ibuprofen) and Tylenol (paracetamol).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Cough; labored breathing,Shortness of breath; Swelling of the left lymph node; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Cough), DYSPNOEA (labored breathing,Shortness of breath), VACCINATION SITE LYMPHADENOPATHY (Swelling of the left lymph node), CHILLS (Chills) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced COUGH (Cough), DYSPNOEA (labored breathing,Shortness of breath), VACCINATION SITE LYMPHADENOPATHY (Swelling of the left lymph node), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). On 15-Feb-2021, VACCINATION SITE LYMPHADENOPATHY (Swelling of the left lymph node), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, COUGH (Cough) and DYSPNOEA (labored breathing,Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Cough; labored breathing,Shortness of breath; Swelling of the left lymph node; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Cough), DYSPNOEA (labored breathing,Shortness of breath), VACCINATION SITE LYMPHADENOPATHY (Swelling of the left lymph node), CHILLS (Chills) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced COUGH (Cough), DYSPNOEA (labored breathing,Shortness of breath), VACCINATION SITE LYMPHADENOPATHY (Swelling of the left lymph node), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). On 15-Feb-2021, VACCINATION SITE LYMPHADENOPATHY (Swelling of the left lymph node), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, COUGH (Cough) and DYSPNOEA (labored breathing,Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Eye swelling, Fatigue, Flushing
Clinical narrative: Flushing Rash; eyes stared to swell; fatigued; light head; rash; Turned all red; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing Rash), EYE SWELLING (eyes stared to swell), FATIGUE (fatigued), DIZZINESS (light head) and RASH (rash) in a 55-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 No adverse event.    On 21-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 FLUSHING (Flushing Rash), EYE SWELLING (eyes stared to swell), FATIGUE (fatigued), DIZZINESS (light head), RASH (rash) and ERYTHEMA (Turned all red). At the time of the report, FLUSHING (Flushing Rash), EYE SWELLING (eyes stared to swell), FATIGUE (fatigued), DIZZINESS (light head), RASH (rash) and ERYTHEMA (Turned all red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Benadryl, Pepcid, Prednisone
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Flushing Rash; eyes stared to swell; fatigued; light head; rash; Turned all red; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing Rash), EYE SWELLING (eyes stared to swell), FATIGUE (fatigued), DIZZINESS (light head) and RASH (rash) in a 55-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 No adverse event.    On 21-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 FLUSHING (Flushing Rash), EYE SWELLING (eyes stared to swell), FATIGUE (fatigued), DIZZINESS (light head), RASH (rash) and ERYTHEMA (Turned all red). At the time of the report, FLUSHING (Flushing Rash), EYE SWELLING (eyes stared to swell), FATIGUE (fatigued), DIZZINESS (light head), RASH (rash) and ERYTHEMA (Turned all red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Benadryl, Pepcid, Prednisone
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Bed chilling; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Bed chilling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced CHILLS (Bed chilling). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Chills, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (Bed chilling) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment medication included Motrin and Tylenol.   This case was linked to MOD-2021-024573, MOD-2021-024583 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-024573:Same reporter MOD-2021-024583:Same reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) 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) (Intramuscular) 1 dosage form. On 04-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 VACCINATION SITE PAIN (Pain at injection site). On 05-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Tylenol BID
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling - Near Injection Site; Soreness - Near Injection Site; Fever - Temperature of 100.0F; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site), PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site), PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site), PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. no treatment details reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hypertension, Off label use
Clinical narrative: Off label dosing; Fatigue; Diarrhea; Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label dosing), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HYPERTENSION (Hypertension) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    The patient's past medical history included No adverse event.   On 01-Feb-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (Off label dosing), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HYPERTENSION (Hypertension). At the time of the report, OFF LABEL USE (Off label dosing), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HYPERTENSION (Hypertension) had not resolved.            No treatment information provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: COVID arm; The site of injection started itching; Site of injection has red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (The site of injection started itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (The site of injection started itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (The site of injection started itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Vaccination site pain
Clinical narrative: Heart rate of 140; Chills; Pain in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate of 140), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in arm at injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20n) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS) and LOVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate of 140), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in arm at injection site). At the time of the report, HEART RATE INCREASED (Heart rate of 140), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysuria, Heart rate increased, Micturition disorder
Clinical narrative: felt a discomfort in his groin area; kidney was hurting on his left side; Urinating less and less amounts until I couldn't urinate for 12 hours; Dizziness; faster heart rate; Chills; problems urinating; had the feeling of going to the bathroom even though nothing came out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (faster heart rate), CHILLS (Chills), MICTURITION DISORDER (problems urinating) and DYSURIA (had the feeling of going to the bathroom even though nothing came out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ATENOLOL, CLOPIDOGREL BISULFATE (lisinopril), UBIDECARENONE (COQ 10) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (faster heart rate), CHILLS (Chills), MICTURITION DISORDER (problems urinating), DYSURIA (had the feeling of going to the bathroom even though nothing came out) and OLIGURIA (Urinating less and less amounts until I couldn't urinate for 12 hours). On 21-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (felt a discomfort in his groin area) and RENAL PAIN (kidney was hurting on his left side). On 21-Feb-2021, MICTURITION DISORDER (problems urinating), DYSURIA (had the feeling of going to the bathroom even though nothing came out) and OLIGURIA (Urinating less and less amounts until I couldn't urinate for 12 hours) had resolved. On 23-Feb-2021, HEART RATE INCREASED (faster heart rate) and CHILLS (Chills) had resolved. On 24-Feb-2021, MUSCULOSKELETAL DISCOMFORT (felt a discomfort in his groin area) had resolved. At the time of the report, DIZZINESS (Dizziness) and RENAL PAIN (kidney was hurting on his left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Oliguria, Renal pain
Clinical narrative: felt a discomfort in his groin area; kidney was hurting on his left side; Urinating less and less amounts until I couldn't urinate for 12 hours; Dizziness; faster heart rate; Chills; problems urinating; had the feeling of going to the bathroom even though nothing came out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (faster heart rate), CHILLS (Chills), MICTURITION DISORDER (problems urinating) and DYSURIA (had the feeling of going to the bathroom even though nothing came out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ATENOLOL, CLOPIDOGREL BISULFATE (lisinopril), UBIDECARENONE (COQ 10) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (faster heart rate), CHILLS (Chills), MICTURITION DISORDER (problems urinating), DYSURIA (had the feeling of going to the bathroom even though nothing came out) and OLIGURIA (Urinating less and less amounts until I couldn't urinate for 12 hours). On 21-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (felt a discomfort in his groin area) and RENAL PAIN (kidney was hurting on his left side). On 21-Feb-2021, MICTURITION DISORDER (problems urinating), DYSURIA (had the feeling of going to the bathroom even though nothing came out) and OLIGURIA (Urinating less and less amounts until I couldn't urinate for 12 hours) had resolved. On 23-Feb-2021, HEART RATE INCREASED (faster heart rate) and CHILLS (Chills) had resolved. On 24-Feb-2021, MUSCULOSKELETAL DISCOMFORT (felt a discomfort in his groin area) had resolved. At the time of the report, DIZZINESS (Dizziness) and RENAL PAIN (kidney was hurting on his left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; Cough; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), COUGH (Cough) and FATIGUE (fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), COUGH (Cough) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath) and COUGH (Cough) outcome was unknown and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Nausea, Pain
Clinical narrative: Really sick; Nauseas; Couldn't get around the house for a couple of days; Felt real sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), NAUSEA (Nauseas), ASTHENIA (Couldn't get around the house for a couple of days) and PAIN (Felt real sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Kidney dysfunction, Diabetes and Blood pressure high.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ILLNESS (Really sick), NAUSEA (Nauseas), ASTHENIA (Couldn't get around the house for a couple of days) and PAIN (Felt real sore). At the time of the report, ILLNESS (Really sick), NAUSEA (Nauseas), ASTHENIA (Couldn't get around the house for a couple of days) and PAIN (Felt real sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Urinary tract infection
Clinical narrative: Cold; Mild UTI; Body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold), URINARY TRACT INFECTION (Mild UTI) and PAIN (Body ache) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 NASOPHARYNGITIS (Cold), URINARY TRACT INFECTION (Mild UTI) and PAIN (Body ache). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), URINARY TRACT INFECTION (Mild UTI) and PAIN (Body ache) outcome was unknown.            No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold), URINARY TRACT INFECTION (Mild UTI) and PAIN (Body ache) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 NASOPHARYNGITIS (Cold), URINARY TRACT INFECTION (Mild UTI) and PAIN (Body ache). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), URINARY TRACT INFECTION (Mild UTI) and PAIN (Body ache) outcome was unknown.            No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchiness; Rash on back and sides below rib cage; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and RASH (Rash on back and sides below rib cage) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PRURITUS (Itchiness) and RASH (Rash on back and sides below rib cage). On 26-Jan-2021, RASH (Rash on back and sides below rib cage) had resolved. On 31-Jan-2021, PRURITUS (Itchiness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included anti-itch lotions (calamine) and lotion for dry skin.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information was received on 22-Apr-2021.Treatment medication included.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: starting to experience some pain in the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (starting to experience some pain in the area) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (starting to experience some pain in the area). At the time of the report, VACCINATION SITE PAIN (starting to experience some pain in the area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (starting to experience some pain in the area) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (starting to experience some pain in the area). At the time of the report, VACCINATION SITE PAIN (starting to experience some pain in the area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pruritus, Vaccination site swelling
Clinical narrative: soreness; swelling; pain in neck; joint pain; muscle pain; itching; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness), VACCINATION SITE SWELLING (swelling), NECK PAIN (pain in neck), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (soreness), VACCINATION SITE SWELLING (swelling), NECK PAIN (pain in neck), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PRURITUS (itching). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness), VACCINATION SITE SWELLING (swelling), NECK PAIN (pain in neck), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness), VACCINATION SITE SWELLING (swelling), NECK PAIN (pain in neck), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (soreness), VACCINATION SITE SWELLING (swelling), NECK PAIN (pain in neck), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PRURITUS (itching). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness), VACCINATION SITE SWELLING (swelling), NECK PAIN (pain in neck), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Malaise, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Fell once; wobbly legs; felt like throwing up; Tenderness on left arm; Nausea; little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell once), MUSCULAR WEAKNESS (wobbly legs), MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm) and NAUSEA (Nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm), NAUSEA (Nausea) and PYREXIA (little fever). On 23-Feb-2021, the patient experienced FALL (Fell once) and MUSCULAR WEAKNESS (wobbly legs). On 22-Feb-2021, MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm), NAUSEA (Nausea) and PYREXIA (little fever) had resolved. At the time of the report, FALL (Fell once) and MUSCULAR WEAKNESS (wobbly legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-024626 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fell once; wobbly legs; felt like throwing up; Tenderness on left arm; Nausea; little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell once), MUSCULAR WEAKNESS (wobbly legs), MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm) and NAUSEA (Nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm), NAUSEA (Nausea) and PYREXIA (little fever). On 23-Feb-2021, the patient experienced FALL (Fell once) and MUSCULAR WEAKNESS (wobbly legs). On 22-Feb-2021, MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm), NAUSEA (Nausea) and PYREXIA (little fever) had resolved. At the time of the report, FALL (Fell once) and MUSCULAR WEAKNESS (wobbly legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-024626 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: was breathless; Increased Heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Increased Heart rate) and DYSPNOEA (was breathless) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Increased Heart rate). On an unknown date, the patient experienced DYSPNOEA (was breathless). At the time of the report, HEART RATE INCREASED (Increased Heart rate) and DYSPNOEA (was breathless) 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 Medications were not provided by the reporter.