chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: not feeling well; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and HEADACHE (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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and HEADACHE (headache). At the time of the report, MALAISE (not feeling well) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.  Upon internal review on 21-May-2021, the age was corrected to unknown.   This case was linked to MOD21-085138, MOD21-085156, MOD21-14927, MOD21-041180, MOD21-041987 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Patient denied to give contact information and consent to follow up was not given.; Sender's Comments:  MOD21-085138:follow up - contact information updated MOD21-085156:cross linked id MOD21-14927:cross linked id MOD21-041180:cross linked id MOD21-041987:cross linked id
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 27-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 on an unknown date and the estimated date of delivery was 24-May-2021. On 27-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Pain all over her body; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over her body) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN (Pain all over her body) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain all over her body) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Feeling abnormal, Feeling cold
Clinical narrative: She didn't have appetite; She felt disgusted; Vomiting; Chills; Little bit Dizzy; My hands and feet were freezing; My body was hot; Body was shaking; My body was cold; I had "heats"; Did not sleep well during the night; I did not feel well; My arm hurt; My feet were freezing; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold) and FEELING HOT (I had "heats") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOVASTATIN, LOSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID] and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING HOT (I had "heats"), PAIN IN EXTREMITY (My arm hurt) and PERIPHERAL COLDNESS (My feet were freezing). On 03-Mar-2021, the patient experienced TREMOR (Body was shaking), FEELING COLD (My body was cold), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), DIZZINESS (Little bit Dizzy) and CHILLS (Chills). On an unknown date, the patient experienced DECREASED APPETITE (She didn't have appetite), FEELING ABNORMAL (She felt disgusted) and VOMITING (Vomiting). At the time of the report, TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold), FEELING HOT (I had "heats"), DECREASED APPETITE (She didn't have appetite), PAIN IN EXTREMITY (My arm hurt), PERIPHERAL COLDNESS (My feet were freezing), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), FEELING ABNORMAL (She felt disgusted), DIZZINESS (Little bit Dizzy), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Mar-2021, after the first shot administered, the blood pressure reading was taken with altered results. The nurse also suggested the patient to not to take Tylenol or Ibuprofen for 1 week.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia, Malaise, Pain in extremity, Peripheral coldness
Clinical narrative: She didn't have appetite; She felt disgusted; Vomiting; Chills; Little bit Dizzy; My hands and feet were freezing; My body was hot; Body was shaking; My body was cold; I had "heats"; Did not sleep well during the night; I did not feel well; My arm hurt; My feet were freezing; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold) and FEELING HOT (I had "heats") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOVASTATIN, LOSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID] and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING HOT (I had "heats"), PAIN IN EXTREMITY (My arm hurt) and PERIPHERAL COLDNESS (My feet were freezing). On 03-Mar-2021, the patient experienced TREMOR (Body was shaking), FEELING COLD (My body was cold), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), DIZZINESS (Little bit Dizzy) and CHILLS (Chills). On an unknown date, the patient experienced DECREASED APPETITE (She didn't have appetite), FEELING ABNORMAL (She felt disgusted) and VOMITING (Vomiting). At the time of the report, TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold), FEELING HOT (I had "heats"), DECREASED APPETITE (She didn't have appetite), PAIN IN EXTREMITY (My arm hurt), PERIPHERAL COLDNESS (My feet were freezing), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), FEELING ABNORMAL (She felt disgusted), DIZZINESS (Little bit Dizzy), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Mar-2021, after the first shot administered, the blood pressure reading was taken with altered results. The nurse also suggested the patient to not to take Tylenol or Ibuprofen for 1 week.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: She didn't have appetite; She felt disgusted; Vomiting; Chills; Little bit Dizzy; My hands and feet were freezing; My body was hot; Body was shaking; My body was cold; I had "heats"; Did not sleep well during the night; I did not feel well; My arm hurt; My feet were freezing; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold) and FEELING HOT (I had "heats") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOVASTATIN, LOSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID] and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING HOT (I had "heats"), PAIN IN EXTREMITY (My arm hurt) and PERIPHERAL COLDNESS (My feet were freezing). On 03-Mar-2021, the patient experienced TREMOR (Body was shaking), FEELING COLD (My body was cold), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), DIZZINESS (Little bit Dizzy) and CHILLS (Chills). On an unknown date, the patient experienced DECREASED APPETITE (She didn't have appetite), FEELING ABNORMAL (She felt disgusted) and VOMITING (Vomiting). At the time of the report, TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold), FEELING HOT (I had "heats"), DECREASED APPETITE (She didn't have appetite), PAIN IN EXTREMITY (My arm hurt), PERIPHERAL COLDNESS (My feet were freezing), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), FEELING ABNORMAL (She felt disgusted), DIZZINESS (Little bit Dizzy), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Mar-2021, after the first shot administered, the blood pressure reading was taken with altered results. The nurse also suggested the patient to not to take Tylenol or Ibuprofen for 1 week.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Neck pain, Pain in extremity
Clinical narrative: Hasn't been feeling well; Fever; Had aches in her back of her neck; Arm was a little sore; Aches in her shoulder; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event (No recorded medical history).   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In February 2021, the patient experienced NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder), PYREXIA (Fever) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder), PYREXIA (Fever) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications reported by investigator
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hasn't been feeling well; Fever; Had aches in her back of her neck; Arm was a little sore; Aches in her shoulder; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event (No recorded medical history).   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In February 2021, the patient experienced NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder), PYREXIA (Fever) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Had aches in her back of her neck), PAIN IN EXTREMITY (Arm was a little sore), MALAISE (Hasn't been feeling well), ARTHRALGIA (Aches in her shoulder), PYREXIA (Fever) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications reported by investigator
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Heart rate, Myalgia
Clinical narrative: Feeling "funny" like his breathing was heavier; Weakness; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Lactose intolerance and Drug allergy (Simvastatin). Concomitant products included ATORVASTATIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, METFORMIN, LEVOTHYROXINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 08-Feb-2021, RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Heart rate: fast (High) Fast.     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.   Treatment information was not provided. Concomitant medication included Vitamins   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR - Consent for FU declined
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: Feeling "funny" like his breathing was heavier; Weakness; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Lactose intolerance and Drug allergy (Simvastatin). Concomitant products included ATORVASTATIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, METFORMIN, LEVOTHYROXINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 08-Feb-2021, RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Heart rate: fast (High) Fast.     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.   Treatment information was not provided. Concomitant medication included Vitamins   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR - Consent for FU declined
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: feeling "hit by a truck; lack of energy; lack of appetite; lethargy; fatigue; hot flashes; chills; mild soreness at the site of injection; sleeplessness; feeling "lousy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness at the site of injection), INSOMNIA (sleeplessness), FEELING ABNORMAL (feeling "lousy), MALAISE (feeling "hit by a truck) and ASTHENIA (lack of energy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at the site of injection), INSOMNIA (sleeplessness) and FEELING ABNORMAL (feeling "lousy). On 01-Mar-2021, the patient experienced MALAISE (feeling "hit by a truck), ASTHENIA (lack of energy), DECREASED APPETITE (lack of appetite), LETHARGY (lethargy), FATIGUE (fatigue), HOT FLUSH (hot flashes) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (mild soreness at the site of injection), INSOMNIA (sleeplessness), FEELING ABNORMAL (feeling "lousy), MALAISE (feeling "hit by a truck), ASTHENIA (lack of energy), DECREASED APPETITE (lack of appetite), LETHARGY (lethargy), FATIGUE (fatigue), HOT FLUSH (hot flashes) and CHILLS (chills) 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 reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Insomnia, Lethargy, Malaise, Vaccination site pain
Clinical narrative: feeling "hit by a truck; lack of energy; lack of appetite; lethargy; fatigue; hot flashes; chills; mild soreness at the site of injection; sleeplessness; feeling "lousy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness at the site of injection), INSOMNIA (sleeplessness), FEELING ABNORMAL (feeling "lousy), MALAISE (feeling "hit by a truck) and ASTHENIA (lack of energy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at the site of injection), INSOMNIA (sleeplessness) and FEELING ABNORMAL (feeling "lousy). On 01-Mar-2021, the patient experienced MALAISE (feeling "hit by a truck), ASTHENIA (lack of energy), DECREASED APPETITE (lack of appetite), LETHARGY (lethargy), FATIGUE (fatigue), HOT FLUSH (hot flashes) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (mild soreness at the site of injection), INSOMNIA (sleeplessness), FEELING ABNORMAL (feeling "lousy), MALAISE (feeling "hit by a truck), ASTHENIA (lack of energy), DECREASED APPETITE (lack of appetite), LETHARGY (lethargy), FATIGUE (fatigue), HOT FLUSH (hot flashes) and CHILLS (chills) 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 reported
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: high blood pressure; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and HEADACHE (headache) 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 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 HYPERTENSION (high blood pressure) and HEADACHE (headache). The patient was treated with LISINOPRIL at a dose of 40 milligram two  times a day. At the time of the report, HYPERTENSION (high blood pressure) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site coldness
Clinical narrative: red spot on the injection site; cold sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (cold sensation) and RASH MACULAR (red spot on the injection site) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE COLDNESS (cold sensation). On 11-Feb-2021, the patient experienced RASH MACULAR (red spot on the injection site). On 11-Feb-2021, VACCINATION SITE COLDNESS (cold sensation) had resolved. At the time of the report, RASH MACULAR (red spot on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: redness is rectangular 1/4 by 2 inches in size; Swelling; Achiness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PAIN (Achiness), TENDERNESS (Tenderness) and ERYTHEMA (redness is rectangular 1/4 by 2 inches in size) in a 92-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 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 SWELLING (Swelling), PAIN (Achiness) and TENDERNESS (Tenderness). On 12-Feb-2021, the patient experienced ERYTHEMA (redness is rectangular 1/4 by 2 inches in size). On 11-Feb-2021, PAIN (Achiness) had resolved. At the time of the report, SWELLING (Swelling), TENDERNESS (Tenderness) and ERYTHEMA (redness is rectangular 1/4 by 2 inches in size) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Severe pain; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain), HEADACHE (Headache) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Severe pain), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Treatment details were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Red ring has gotten worse; left sore arm; red ring around injection site; left sore arm; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (left sore arm), VACCINATION SITE ERYTHEMA (red ring around injection site), VACCINATION SITE REACTION (Red ring has gotten worse) and the second episode of PAIN IN EXTREMITY (left sore arm) in a 71-year-old female 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Jan-2021, the patient experienced the first episode of PAIN IN EXTREMITY (left sore arm). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red ring around injection site) and the second episode of PAIN IN EXTREMITY (left sore arm). On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Red ring has gotten worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red ring around injection site), VACCINATION SITE REACTION (Red ring has gotten worse) and the last episode of PAIN IN EXTREMITY (left sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided/unknown. Treatment medication included Benadryl.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Redness of injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE RASH (Rash at injection site) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient used Benadryl cream as a Treatment medication
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: allergy in the arm 7 days after the shot; 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 REACTION (allergy in the arm 7 days after the shot) 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 medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (allergy in the arm 7 days after the shot). At the time of the report, VACCINATION SITE REACTION (allergy in the arm 7 days after the shot) outcome was unknown.            Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Night sweats
Clinical narrative: Chills; Diarrhea; Fever; General body pain; Joint pain; Night sweats; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Fever (100.6-104)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever (100.6-104)) and PAIN (Achy Body). On 25-Jan-2021, the patient experienced NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, CHILLS (Chills), PYREXIA (Fever (100.6-104)) and PAIN (Achy Body) had resolved. At the time of the report, NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and ARTHRALGIA (Joint Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 100.6 - 104 (Inconclusive) 100.6 - 104.     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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Chills; Diarrhea; Fever; General body pain; Joint pain; Night sweats; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Fever (100.6-104)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever (100.6-104)) and PAIN (Achy Body). On 25-Jan-2021, the patient experienced NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, CHILLS (Chills), PYREXIA (Fever (100.6-104)) and PAIN (Achy Body) had resolved. At the time of the report, NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and ARTHRALGIA (Joint Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 100.6 - 104 (Inconclusive) 100.6 - 104.     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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a headache going towards down her neck.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a headache going towards down her neck.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (a headache going towards down her neck.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (a headache going towards down her neck.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Finger deformity, Pain, Pruritus, Skin disorder
Clinical narrative: Broke out in my scalp and underneath my ring finger; Broke out in my scalp and underneath my ring finger; It was red; Itchy; it hurt; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Broke out in my scalp and underneath my ring finger), FINGER DEFORMITY (Broke out in my scalp and underneath my ring finger), ERYTHEMA (It was red), PRURITUS (Itchy) and PAIN (it hurt) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cardiac disorder. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, DULAGLUTIDE (TRULICITY), CLOPIDOGREL BISULFATE (PLAVIX), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), PANTOPRAZOLE, GABAPENTIN and PRAVASTATIN for an unknown indication.    On 25-Feb-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 SKIN DISORDER (Broke out in my scalp and underneath my ring finger), FINGER DEFORMITY (Broke out in my scalp and underneath my ring finger), ERYTHEMA (It was red), PRURITUS (Itchy) and PAIN (it hurt). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN TOPICAL) for Skin discolouration, at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (Broke out in my scalp and underneath my ring finger), FINGER DEFORMITY (Broke out in my scalp and underneath my ring finger), ERYTHEMA (It was red), PRURITUS (Itchy) and PAIN (it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She wanted to know if there was sulfa in it Regular med: Four medications where not clear to agent. Consent given   This case was linked to MOD21-043773, MOD21-043774, MOD21-043775, MOD21-043777, MOD21-043827 (E2B Linked Report).; Sender's Comments:  MOD21-043773:Crosslink Guillory, Jacqueline MOD21-043774:Crosslink Guillory, Jacqueline MOD21-043775:Crosslink Guillory, Jacqueline MOD21-043777:Crosslink Guillory, Jacqueline MOD21-043827:Crosslink Guillory, Jacqueline
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), SWELLING (Swelling), PRURITUS (Itches) and PYREXIA (Fever) in a 30-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (Body Aches), SWELLING (Swelling), PRURITUS (Itches) and PYREXIA (Fever). At the time of the report, PAIN (Body Aches), SWELLING (Swelling), PRURITUS (Itches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach cramps; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131720A) 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) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given. No lab details were provided. No treatment information was given. Patient experienced stomach cramps during the night and woke up with diarrhea.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue) 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 (Medical history was not reported).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (Fatigue). On 12-Feb-2021, FATIGUE (Fatigue) 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.   Concomitant information were not provided. No treatment information was provided
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, Full-term  birth) on 23-May-2019, Pregnancy (Live, Full-term  birth) on 23-Aug-2015 and Pregnancy (Live, Full-term  birth) on 24-Feb-2013. Concomitant products included NITROFURANTOIN for UTI.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Estimated date of conception reported as 10-OCT-2020. Mother is surrogate. Previous pregnancies included three live full-term birth without complications on 24-Feb-2013, 23-Aug-2015 and 23-May-2019 respectively. Fetal anatomy scan performed on 10-Feb-2021 was normal.  No treatment medication details was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives down shoulder blades and left arm; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives down shoulder blades and left arm) and PRURITUS (itching) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives down shoulder blades and left arm) and PRURITUS (itching). At the time of the report, URTICARIA (hives down shoulder blades and left arm) and PRURITUS (itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, Paraesthesia, Vaccination site warmth
Clinical narrative: Warm in chest and arms; Tingling and warm in chest and arms; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (Tingling and warm in chest and arms) and VACCINATION SITE WARMTH (Warm in chest and arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (Tingling and warm in chest and arms). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm in chest and arms). At the time of the report, PARAESTHESIA (Tingling and warm in chest and arms) and VACCINATION SITE WARMTH (Warm in chest and arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 133/95 mmHg (normal) 133/95 mm HG, 145/95 mmHg (Inconclusive) 145/95 mm HG, 144/84 mmHg (Inconclusive) 144/84 mmHG and 147/89 mmHg (Inconclusive) 147/89 mm HG. On 12-Feb-2021, Heart rate: 96 96, 95 95, 82 82 and 76 76. On 12-Feb-2021, Oxygen saturation: 98 98, 97 97, 98 98 and 97 97. On an unknown date, Blood pressure measurement: 144/88 mmHg (Inconclusive) 144/88 mm HG. On an unknown date, Heart rate: 77 77. On an unknown date, Oxygen saturation: 97 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications used were not reported. No treatment information reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast/hard heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast/hard heartbeat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, METOPROLOL, ALLOPURINOL and OMEPRAZOLE for an unknown indication.    On 13-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 (fast/hard heartbeat). On 13-Feb-2021, HEART RATE INCREASED (fast/hard heartbeat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Reporter did not allow further contact