chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
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 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 medication was reported.  The treatment information was not given.   This case was linked to MOD-2021-008744 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature Excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: swollen; itchy; Huge rash on right hip almost down to the knee and spreading to the other leg; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PRURITUS (itchy) and RASH (Huge rash on right hip almost down to the knee and spreading to the other leg) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen), PRURITUS (itchy) and RASH (Huge rash on right hip almost down to the knee and spreading to the other leg). At the time of the report, SWELLING (swollen), PRURITUS (itchy) and RASH (Huge rash on right hip almost down to the knee and spreading to the other leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (feels lightheaded when she gets up) and headache in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 11, 2021, patient experienced dizziness (feels lightheaded when she gets up) and headache. Patient treated with ibuprofen on Jun 13, 2021 for adverse event, at a dose of 1 tablet. At the time of the report, dizziness (feels lightheaded when she gets up) and headache outcome: unknown. Birth control pills taken as concomitant medication.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure went up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Rheumatoid arthritis and Tingling (tingling pain in the leg). Concomitant products included HYDRALAZINE (HYDRALAZINE APS), LOSARTAN POTASSIUM (LOSARTAN "AGP"), FUROSEMIDE, METOPROLOL SUCCINATE (METOPROLOL SUCC CT) and POTASSIUM CHLORIDE (K TAB) for Blood pressure, METHOTREXATE for Rheumatoid arthritis, GABAPENTIN for Tingling, FOLIC ACID for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood pressure measurement: increased (High) blood pressure went up.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.   This case was linked to MOD-2021-221122 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy red spot on arm; itchy rash spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy red spot on arm) and RASH PRURITIC (itchy rash spot on arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. not provided and not provided) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (itchy rash spot on arm). On 03-Mar-2021, the patient experienced RASH PRURITIC (itchy red spot on arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy red spot on arm) and RASH PRURITIC (itchy rash spot on arm) outcome was unknown.            No concomitant medications provided  Treatment medicine include Benadryl  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: sore throat; little bit of a cold; This spontaneous case was reported by a health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (little bit of a cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-20A) 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 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (little bit of a cold). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (little bit of a cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient also experienced events don't feel sick and symptoms started 2 days ago. No relevant concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Patient went off period at 53 years of age and period has returned now she is 58 years old; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Patient went off period at 53 years of age and period has returned now she is 58 years old) in a 58-year-old female patient 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 an unknown date, the patient experienced MENSTRUAL DISORDER (Patient went off period at 53 years of age and period has returned now she is 58 years old). At the time of the report, MENSTRUAL DISORDER (Patient went off period at 53 years of age and period has returned now she is 58 years old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.  Patient states her period went off when she was 53 years old and after receiving injection it has returned.
Sex: F
Vaccine: COVID19
Symptoms: Lip dry
Clinical narrative: Dry lips worsened; 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 LIP DRY (Dry lips worsened) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's syndrome.    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 LIP DRY (Dry lips worsened). At the time of the report, LIP DRY (Dry lips worsened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.   This case was linked to MOD-2021-221124 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Iris discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: right eye jumps; Iris turned blue; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of IRIS DISCOLOURATION (Iris turned blue), EYE MOVEMENT DISORDER (right eye jumps), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-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. On 19-May-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). On 14-Jun-2021, the patient experienced IRIS DISCOLOURATION (Iris turned blue). On an unknown date, the patient experienced EYE MOVEMENT DISORDER (right eye jumps). On 22-May-2021, VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) had resolved. At the time of the report, IRIS DISCOLOURATION (Iris turned blue) had not resolved and EYE MOVEMENT DISORDER (right eye jumps) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information included  Reporter information, Patient information and significant event information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash
Clinical narrative: Injection site hard; Rash around the injection site; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (Crab allergy) and Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include blood pressure pills. Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Fatigue, Hypotension, Myalgia
Clinical narrative: Reduced the blood pressure; Blood pressure gradually reduced/Reduced the blood pressure; Blood pressure were fluctuated; Edema in the leg which got worst; Arm sored; Tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (Edema in the leg which got worst), BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated), BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure), HYPOTENSION (Reduced the blood pressure) and MYALGIA (Arm sored) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation, Rheumatoid arthritis and Tingling (Pain in the leg). Concomitant products included HYDRALAZINE, LOSARTAN, FUROSEMIDE, METOPROLOL SUCCINATE and POTASSIUM CHLORIDE (K-TAB) for Blood pressure management, METHOTREXATE for Rheumatoid arthritis, GABAPENTIN for Tingling, FOLIC ACID for an unknown indication.   On 10-Mar-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 10-Mar-2021, the patient experienced OEDEMA PERIPHERAL (Edema in the leg which got worst). 10-Mar-2021, the patient experienced MYALGIA (Arm sored) and FATIGUE (Tired). On 01-Apr-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated). On 01-May-2021, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure). On 01-Jun-2021, the patient experienced HYPOTENSION (Reduced the blood pressure). At the time of the report, OEDEMA PERIPHERAL (Edema in the leg which got worst), HYPOTENSION (Reduced the blood pressure), MYALGIA (Arm sored) and FATIGUE (Tired) outcome was unknown and BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated) and BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported in the month of June physician give medication which help her to reduce blood pressure to140/66 and 123/58.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-221114 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Reduced the blood pressure; Blood pressure gradually reduced/Reduced the blood pressure; Blood pressure were fluctuated; Edema in the leg which got worst; Arm sored; Tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (Edema in the leg which got worst), BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated), BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure), HYPOTENSION (Reduced the blood pressure) and MYALGIA (Arm sored) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation, Rheumatoid arthritis and Tingling (Pain in the leg). Concomitant products included HYDRALAZINE, LOSARTAN, FUROSEMIDE, METOPROLOL SUCCINATE and POTASSIUM CHLORIDE (K-TAB) for Blood pressure management, METHOTREXATE for Rheumatoid arthritis, GABAPENTIN for Tingling, FOLIC ACID for an unknown indication.   On 10-Mar-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 10-Mar-2021, the patient experienced OEDEMA PERIPHERAL (Edema in the leg which got worst). 10-Mar-2021, the patient experienced MYALGIA (Arm sored) and FATIGUE (Tired). On 01-Apr-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated). On 01-May-2021, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure). On 01-Jun-2021, the patient experienced HYPOTENSION (Reduced the blood pressure). At the time of the report, OEDEMA PERIPHERAL (Edema in the leg which got worst), HYPOTENSION (Reduced the blood pressure), MYALGIA (Arm sored) and FATIGUE (Tired) outcome was unknown and BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated) and BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported in the month of June physician give medication which help her to reduce blood pressure to140/66 and 123/58.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-221114 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: more tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 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 FATIGUE (more tired). At the time of the report, FATIGUE (more tired) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported   This case was linked to MOD-2021-035175, MOD-2021-221118 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash reaction; This spontaneous case was reported by a physician and describes the occurrence of RASH (2 or 3 other people, women, patients of their doctor had this rash reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (2 or 3 other people, women, patients of their doctor had this rash reaction). At the time of the report, RASH (2 or 3 other people, women, patients of their doctor had this rash reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was not reported if any treatment was administered in response to the events.   This case was linked to MOD-2021-030985 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse events between 8 to 12 days after receiving the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (Adverse events between 8 to 12 days after receiving the first dose) 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) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ADVERSE EVENT (Adverse events between 8 to 12 days after receiving the first dose). At the time of the report, ADVERSE EVENT (Adverse events between 8 to 12 days after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Sleep deficit
Clinical narrative: Felt terrible; Very little sleep; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), SLEEP DEFICIT (Very little sleep) and DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 FEELING ABNORMAL (Felt terrible), SLEEP DEFICIT (Very little sleep) and DIZZINESS (Dizziness). At the time of the report, FEELING ABNORMAL (Felt terrible), SLEEP DEFICIT (Very little sleep) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; 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 PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Hypertension, Hypotension, Vaccination complication
Clinical narrative: High blood pressure; Low blood pressure reading sometime; When i got the second shot i had after reactions to it; Erractic heart beat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (When i got the second shot i had after reactions to it), HEART RATE IRREGULAR (Erractic heart beat), HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The patient's past medical history included Parathyroid gland excision (Removed it 5 years back.). Concurrent medical conditions included Drug allergy (Statins Hmg Coa Reductase inhibitors), Drug allergy (Doxycycline), Drug allergy (Levothyroxine (Synthroid)), Drug allergy (Ibuprofen) and Hypercholesterolemia (Patient was told this was genetic by the endocrinologist.) since 1985. Concomitant products included FISH OIL for High cholesterol, MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CALCIUM for an unknown indication.   On 28-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2012 at 6:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE IRREGULAR (Erractic heart beat). On 29-May-2019, the patient experienced VACCINATION COMPLICATION (When I got the second shot I had after reactions to it). On 29-May-2021 at 6:00 AM, the patient experienced HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime). At the time of the report, VACCINATION COMPLICATION (When i got the second shot i had after reactions to it), HEART RATE IRREGULAR (Erractic heart beat), HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Heart rate: low (Low) Low.         Treatment information was not provided.   This case was linked to MOD-2021-122775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Patient demographics updated, medical history added, and dose 2 information updated. Dose 2 events added. On 08-Jul-2021: Follow up received contains No new information. On 06-Aug-2021: Follow up received contains no new information.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Illness, Macule
Clinical narrative: got really sick; red dot on left arm; shakes; sweating; injection site itchy; injection site is the size of a baseball,injection site is growing; injection site painful; shaking; fever; muscle aches; exhaustion; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating) and VACCINATION SITE PRURITUS (injection site itchy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included FINASTERIDE (PROPECIA), CITALOPRAM and PROPRANOLOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache). At the time of the report, ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was provided.   This case was linked to MOD-2021-245590 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: The follow-up document added on 02-jun-2021. Two new events were added, concomitants were added and Batch no for 2nd dose was also added.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor, Vaccination site pain, Vaccination site pruritus
Clinical narrative: got really sick; red dot on left arm; shakes; sweating; injection site itchy; injection site is the size of a baseball,injection site is growing; injection site painful; shaking; fever; muscle aches; exhaustion; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating) and VACCINATION SITE PRURITUS (injection site itchy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included FINASTERIDE (PROPECIA), CITALOPRAM and PROPRANOLOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache). At the time of the report, ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was provided.   This case was linked to MOD-2021-245590 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: The follow-up document added on 02-jun-2021. Two new events were added, concomitants were added and Batch no for 2nd dose was also added.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: got really sick; red dot on left arm; shakes; sweating; injection site itchy; injection site is the size of a baseball,injection site is growing; injection site painful; shaking; fever; muscle aches; exhaustion; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating) and VACCINATION SITE PRURITUS (injection site itchy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included FINASTERIDE (PROPECIA), CITALOPRAM and PROPRANOLOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache). At the time of the report, ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was provided.   This case was linked to MOD-2021-245590 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: The follow-up document added on 02-jun-2021. Two new events were added, concomitants were added and Batch no for 2nd dose was also added.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Product dose omission issue, Urticaria
Clinical narrative: Missed his/her 2nd dose, more than 42 days; I broke out in hives after the 1st dose; I was fatigued after the 1st dose; Chills after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days), URTICARIA (I broke out in hives after the 1st dose), FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose). On 01-May-2021, the patient experienced URTICARIA (I broke out in hives after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days), URTICARIA (I broke out in hives after the 1st dose), FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LYMPHADENOPATHY (swollen lymph node). At the time of the report, LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Injection site reaction; Tenderness of the skin 2-3 inches from the injection site; Swelling of the skin 2-3 inches from the injection site; Redness in her skin; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin) 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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin). On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include birth control pills. No treatment information provided.   This case was linked to MOD-2021-004542 (Patient Link).   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm felt really bad for a couple of days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm felt really bad for a couple of days). At the time of the report, pain in extremity (arm felt really bad for a couple of days) resolved. No concomitant medication use or treatment of events provided. This case linked to MOD-2021-132115 (patient link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnitus; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A421A and 038A421A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Pollen allergy. Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced TINNITUS (Tinnitus) and HEADACHE (headache). At the time of the report, TINNITUS (Tinnitus) and HEADACHE (headache) outcome was unknown.            Concomitant medication also included unspecified spray for nose. Treatment medication was not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Chest pain, Confusional state
Clinical narrative: Shortness of breath; Confused; Tightness in chest; Chest pain; Blood pressure high; Blood pressure increased from 106/72 mmhg to 140/90 mmHg; Headache; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain) and HYPERTENSION (Blood pressure high) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL and GABAPENTIN for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain), HYPERTENSION (Blood pressure high) and HEADACHE (Headache). 27-May-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased from 106/72 mmhg to 140/90 mmHg). On 27-May-2021, DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain), HYPERTENSION (Blood pressure high), BLOOD PRESSURE INCREASED (Blood pressure increased from 106/72 mmhg to 140/90 mmHg) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Blood pressure measurement: 140/90 mmHg (abnormal) following the first shot of vaccine BP  was 140/90. On 27-May-2021, Electrocardiogram: normal (normal) normal. On an unknown date, Blood pressure measurement: 106/72 mmHg (normal) her normal blood pressure was 106/72.     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.   The patient reported 20 minutes after vaccination shot she experienced the reported adverse events for 30 seconds. The patient was transported to the ER and was discharged within 2 hrs.  The treatment medications relevant to events were not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.