chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects after a week of getting vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after a week of getting vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after a week of getting vaccinated). At the time of the report, VACCINATION COMPLICATION (Side effects after a week of getting vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medications were reported. No information on treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Swelling
Clinical narrative: Swelling; Redness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: cystitis; 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 CYSTITIS (cystitis) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CYSTITIS (cystitis). At the time of the report, CYSTITIS (cystitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: has been putting up with eye troubles; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (has been putting up with eye troubles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Diabetes and Blood pressure high.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced EYE DISORDER (has been putting up with eye troubles). At the time of the report, EYE DISORDER (has been putting up with eye troubles) outcome was unknown.            concomitant medication were reported include High cholesterol-Diabetes-High blood pressure medication.  Treatment information not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain
Clinical narrative: afib; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criteria hospitalization and medically significant). On 22-Jul-2021, the patient experienced CHEST PAIN (Chest pain). The patient was hospitalized from 20-May-2021 to 20-May-2021 due to ATRIAL FIBRILLATION. On 20-May-2021, ATRIAL FIBRILLATION (afib) had resolved. On 22-Jul-2021, CHEST PAIN (Chest pain) had resolved.            Patient  Never had any heart issues until after vaccine,Now on prescribed meds and awaiting treatment and testing by cardiologist. he is not claiming his heart issue was caused by vaccine, but thought it should be reported for records.  Company Comment  Very limited information regarding this events has been provided at this time. 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.   This case was linked to MOD-2021-259218 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. 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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Heart rate, Myocarditis, Troponin
Clinical narrative: Myocarditis; chest pain; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and CHEST PAIN (chest pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Heart rate: high (High) high rate beat. On 07-Aug-2021, Troponin: eelvated (High) Elevated troponin level. On an unknown date, Echocardiogram: normal (normal) normal echocardiogram. Diagnosis: Myocarditis.     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.  Company comment: Based on the current available information and temporal association between the use of second dose of the product mRNA-1273 and the start date of the serious expected event of Myocarditis, a causal relationship cannot be excluded. Non-serious event of Chest pain was more consistent with the manifestation of Myocarditis.; Sender's Comments: Based on the current available information and temporal association between the use of second dose of the product mRNA-1273 and the start date of the serious expected event of Myocarditis, a causal relationship cannot be excluded. Non-serious event of Chest pain was more consistent with the manifestation of Myocarditis.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dizziness, Fatigue, Influenza
Clinical narrative: Dizziness, Can't stop falling; sleepiness; Weakness; Migraines; Insomnia; Shaking and tremors; Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction; Backache; Crappy like if you were sick like  the flu; total fatigue; Muscle and body aches:; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease, Fibromyalgia and Normal pressure hydrocephalus.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction), BACK PAIN (Backache), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:). At the time of the report, DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction) and BACK PAIN (Backache) had not resolved and ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:) outcome was unknown.            No information concomitant medications were reported. No information on  treatment medications were reported. Patient felt like a bomb went off in my body as one of the event.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Myalgia, Pruritus, Somnolence
Clinical narrative: Dizziness, Can't stop falling; sleepiness; Weakness; Migraines; Insomnia; Shaking and tremors; Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction; Backache; Crappy like if you were sick like  the flu; total fatigue; Muscle and body aches:; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease, Fibromyalgia and Normal pressure hydrocephalus.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction), BACK PAIN (Backache), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:). At the time of the report, DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction) and BACK PAIN (Backache) had not resolved and ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:) outcome was unknown.            No information concomitant medications were reported. No information on  treatment medications were reported. Patient felt like a bomb went off in my body as one of the event.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Dizziness, Can't stop falling; sleepiness; Weakness; Migraines; Insomnia; Shaking and tremors; Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction; Backache; Crappy like if you were sick like  the flu; total fatigue; Muscle and body aches:; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease, Fibromyalgia and Normal pressure hydrocephalus.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction), BACK PAIN (Backache), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:). At the time of the report, DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction) and BACK PAIN (Backache) had not resolved and ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:) outcome was unknown.            No information concomitant medications were reported. No information on  treatment medications were reported. Patient felt like a bomb went off in my body as one of the event.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Pruritus, Pyrexia
Clinical narrative: arm itchy; arm hot; redness has spread to her entire upper area and is red, it hurts  and is hot/arm red; it hurts; fever; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy), FEELING HOT (arm hot), SOMNOLENCE (slept all day), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts  and is hot/arm red) and MYALGIA (it hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart block second degree and Pacemaker insertion (cardiac). Concurrent medical conditions included Congestive heart failure and Allergy multiple. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and LOSARTAN for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced SOMNOLENCE (slept all day) and PYREXIA (fever). On an unknown date, the patient experienced PRURITUS (arm itchy), FEELING HOT (arm hot), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts  and is hot/arm red) and MYALGIA (it hurts). On 09-Aug-2021, SOMNOLENCE (slept all day) and PYREXIA (fever) had resolved. At the time of the report, PRURITUS (arm itchy), FEELING HOT (arm hot), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts  and is hot/arm red) and MYALGIA (it hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant product  included for patient Multiple Vitamin as needed  for an unknown indication. Patient second vaccine due date on  04-SEP-2021.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: arm itchy; arm hot; redness has spread to her entire upper area and is red, it hurts  and is hot/arm red; it hurts; fever; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy), FEELING HOT (arm hot), SOMNOLENCE (slept all day), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts  and is hot/arm red) and MYALGIA (it hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart block second degree and Pacemaker insertion (cardiac). Concurrent medical conditions included Congestive heart failure and Allergy multiple. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and LOSARTAN for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced SOMNOLENCE (slept all day) and PYREXIA (fever). On an unknown date, the patient experienced PRURITUS (arm itchy), FEELING HOT (arm hot), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts  and is hot/arm red) and MYALGIA (it hurts). On 09-Aug-2021, SOMNOLENCE (slept all day) and PYREXIA (fever) had resolved. At the time of the report, PRURITUS (arm itchy), FEELING HOT (arm hot), ERYTHEMA (redness has spread to her entire upper area and is red, it hurts  and is hot/arm red) and MYALGIA (it hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant product  included for patient Multiple Vitamin as needed  for an unknown indication. Patient second vaccine due date on  04-SEP-2021.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: tongue feels as if it is swollen; tongue feels as if it is sprained; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained) 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 SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained). At the time of the report, SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 (only received one dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment medication were reported.  Patient received his first dose of the Moderna vaccine back in late Apr 2021 or early May2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue
Clinical narrative: She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away; Covid-19 after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19 after the 1st dose) and INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (Covid-19 after the 1st dose). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away). The patient was treated with Manual therapy (monoclonal antibodies on 29-Mar-2021) for COVID-19. At the time of the report, COVID-19 (Covid-19 after the 1st dose) and INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away) 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.   No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient hasn't received 2nd dose past 36 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose past 36 days) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose past 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient hasn't received 2nd dose past 36 days) had 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 relevant concomitant medications were reported.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: Face is really flushed; Started running a fever; she's totally spent; She feels very weak, her whole body feels weak,; Is in extreme pain all through her stomach area; Face is really hot; Getting chills real bad; Lot of pain in the injection site, all the time since yesterday, severe pain; This spontaneous case was reported by a non-health professional and describes the occurrence of FLUSHING (Face is really flushed), ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot) and CHILLS (Getting chills real bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (2 heart attacks) and Stent placement. Concurrent medical conditions included Blood pressure high.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot), CHILLS (Getting chills real bad), VACCINATION SITE PAIN (Lot of pain in the injection site, all the time since yesterday, severe pain) and FATIGUE (she's totally spent). On 09-Aug-2021 at 10:00 PM, the patient experienced PYREXIA (Started running a fever). On 10-Aug-2021, the patient experienced FLUSHING (Face is really flushed). The patient was treated with Manual therapy (Cold compresses  in face, neck and arm to try to bring the fever down) for Pyrexia. At the time of the report, FLUSHING (Face is really flushed), ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot), VACCINATION SITE PAIN (Lot of pain in the injection site, all the time since yesterday, severe pain), PYREXIA (Started running a fever) and FATIGUE (she's totally spent) had not resolved and CHILLS (Getting chills real bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, Body temperature: 101.5 (High) At 10 pm-101.5 Degree Celsius. On 10-Aug-2021, Body temperature: 101.1 (High) 101.1 Degree Celsius.         Concomitant medication includes high blood pressure medication.  The patient had no adverse events after first dose of vaccine.  No treatment medications were reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Pyrexia, Vaccination site pain
Clinical narrative: Face is really flushed; Started running a fever; she's totally spent; She feels very weak, her whole body feels weak,; Is in extreme pain all through her stomach area; Face is really hot; Getting chills real bad; Lot of pain in the injection site, all the time since yesterday, severe pain; This spontaneous case was reported by a non-health professional and describes the occurrence of FLUSHING (Face is really flushed), ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot) and CHILLS (Getting chills real bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (2 heart attacks) and Stent placement. Concurrent medical conditions included Blood pressure high.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot), CHILLS (Getting chills real bad), VACCINATION SITE PAIN (Lot of pain in the injection site, all the time since yesterday, severe pain) and FATIGUE (she's totally spent). On 09-Aug-2021 at 10:00 PM, the patient experienced PYREXIA (Started running a fever). On 10-Aug-2021, the patient experienced FLUSHING (Face is really flushed). The patient was treated with Manual therapy (Cold compresses  in face, neck and arm to try to bring the fever down) for Pyrexia. At the time of the report, FLUSHING (Face is really flushed), ASTHENIA (She feels very weak, her whole body feels weak,), ABDOMINAL PAIN UPPER (Is in extreme pain all through her stomach area), FEELING HOT (Face is really hot), VACCINATION SITE PAIN (Lot of pain in the injection site, all the time since yesterday, severe pain), PYREXIA (Started running a fever) and FATIGUE (she's totally spent) had not resolved and CHILLS (Getting chills real bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, Body temperature: 101.5 (High) At 10 pm-101.5 Degree Celsius. On 10-Aug-2021, Body temperature: 101.1 (High) 101.1 Degree Celsius.         Concomitant medication includes high blood pressure medication.  The patient had no adverse events after first dose of vaccine.  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Developed a sore throat; Runny nosr three days ago; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Developed a sore throat) and RHINORRHOEA (Runny nosr three days ago) 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.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Developed a sore throat) and RHINORRHOEA (Runny nosr three days ago). At the time of the report, OROPHARYNGEAL PAIN (Developed a sore throat) and RHINORRHOEA (Runny nosr three days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Body temperature: high (High) with a 1degree elevation in temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick) 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 ILLNESS (got very sick). At the time of the report, ILLNESS (got very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-282508 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Heart rate
Clinical narrative: Had heart pain; Chest was hurting; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Had heart pain) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced ANGINA PECTORIS (Had heart pain) (seriousness criterion medically significant) and CHEST PAIN (Chest was hurting). At the time of the report, ANGINA PECTORIS (Had heart pain) and CHEST PAIN (Chest was hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2022, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Patient felt as if he was going to have a heart attack and it happened while lying down at bedtime. The symptoms would disappear whenever he got up & walked around.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Illness, Lethargy, Loss of consciousness, Malaise
Clinical narrative: coma for a day / doesn't remember getting out of bed; not feeling well; sick; lethargic; Sleep excessive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed) (seriousness criterion medically significant), MALAISE (not feeling well), ILLNESS (sick), LETHARGY (lethargic) and HYPERSOMNIA (Sleep excessive). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (coma for a day / doesn't remember getting out of bed), MALAISE (not feeling well), ILLNESS (sick) and LETHARGY (lethargic) was resolving and HYPERSOMNIA (Sleep excessive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Lab data was not provided. Treatment product was not provided by the reporter.  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 and therefore, causality for the events is assessed as possibly related. No further information will be requested. Patient niece was a doctor, and told him that the batch may have been exposed to high humidity.; 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 and therefore, causality for the events is assessed as possibly related. No further information will be requested.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Asymptomatic COVID-19
Clinical narrative: In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic) 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.   In August 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2020, the patient experienced ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: abnormal (abnormal) have no antibodies.         No concomitant medications were reported.  No reactions to shot. In January the study was unblinded and She was given the second shot. She got tested two times in 2021 and have no antibodies  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change
Clinical narrative: a hot cold for 4/5 hours; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (a hot cold for 4/5 hours) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (a hot cold for 4/5 hours) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (a hot cold for 4/5 hours) and CHILLS (Chills) 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. No treatment medication were provided.   This case was linked to MOD-2021-279823 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna covid vaccine found to be out of date after administration on 8/4/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/4/21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Brain operation, Diplopia, Headache, Malaise
Clinical narrative: Ageusia; Brain operation; Diplopia; Headache; Malaise; Sensory loss; Vision blurred; This case was received via  FDA VAERS (Reference number: 1505378) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AGEUSIA (Ageusia), BRAIN OPERATION (Brain operation), DIPLOPIA (Diplopia), HEADACHE (Headache), MALAISE (Malaise), SENSORY LOSS (Sensory loss) and VISION BLURRED (Vision blurred) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Operation NOS on 16-Jul-2021.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced AGEUSIA (Ageusia) (seriousness criteria hospitalization and disability), DIPLOPIA (Diplopia) (seriousness criteria hospitalization and disability), HEADACHE (Headache) (seriousness criteria hospitalization and disability), MALAISE (Malaise) (seriousness criteria hospitalization and disability), SENSORY LOSS (Sensory loss) (seriousness criteria hospitalization and disability) and VISION BLURRED (Vision blurred) (seriousness criteria hospitalization and disability). 27-Jul-2021, the patient experienced BRAIN OPERATION (Brain operation) (seriousness criteria hospitalization and disability). At the time of the report, AGEUSIA (Ageusia), BRAIN OPERATION (Brain operation), DIPLOPIA (Diplopia), HEADACHE (Headache), MALAISE (Malaise), SENSORY LOSS (Sensory loss) and VISION BLURRED (Vision blurred) 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 medication was reported.  Patient received 1st Moderna Vaccine shot and was very sick first two weeks, on 3rd week she started getting headaches, blurry vision that was little to double vision and lost all taste and feeling in hand. They could only do a brain surgery to relieve pressure. It was reported that the original problem was in too dangerous of a spot to remove. Patient was sent back home a week ago.  Treatment medication was not provided by the reporter.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss, Vision blurred
Clinical narrative: Ageusia; Brain operation; Diplopia; Headache; Malaise; Sensory loss; Vision blurred; This case was received via  FDA VAERS (Reference number: 1505378) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AGEUSIA (Ageusia), BRAIN OPERATION (Brain operation), DIPLOPIA (Diplopia), HEADACHE (Headache), MALAISE (Malaise), SENSORY LOSS (Sensory loss) and VISION BLURRED (Vision blurred) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Operation NOS on 16-Jul-2021.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced AGEUSIA (Ageusia) (seriousness criteria hospitalization and disability), DIPLOPIA (Diplopia) (seriousness criteria hospitalization and disability), HEADACHE (Headache) (seriousness criteria hospitalization and disability), MALAISE (Malaise) (seriousness criteria hospitalization and disability), SENSORY LOSS (Sensory loss) (seriousness criteria hospitalization and disability) and VISION BLURRED (Vision blurred) (seriousness criteria hospitalization and disability). 27-Jul-2021, the patient experienced BRAIN OPERATION (Brain operation) (seriousness criteria hospitalization and disability). At the time of the report, AGEUSIA (Ageusia), BRAIN OPERATION (Brain operation), DIPLOPIA (Diplopia), HEADACHE (Headache), MALAISE (Malaise), SENSORY LOSS (Sensory loss) and VISION BLURRED (Vision blurred) 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 medication was reported.  Patient received 1st Moderna Vaccine shot and was very sick first two weeks, on 3rd week she started getting headaches, blurry vision that was little to double vision and lost all taste and feeling in hand. They could only do a brain surgery to relieve pressure. It was reported that the original problem was in too dangerous of a spot to remove. Patient was sent back home a week ago.  Treatment medication was not provided by the reporter.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Nausea, Tremor, Vaccination site pain
Clinical narrative: makes my head feel really high; shaking; kinda feel weak; makes my stomach nauseous; shot site was itchy and a little painful; shot site is itchy, was a little painful; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and NAUSEA (makes my stomach nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Halidol.). Concomitant products included AMITRIPTYLINE, CITALOPRAM, FOLIC ACID, ADALIMUMAB (HUMIRA), HYDROXYCHLOROQUINE, CALCIUM FOLINATE (LEUCOVORINE), LEVOTHYROXINE, LOSARTAN and METHOTREXATE for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and VACCINATION SITE PAIN (shot site was itchy and a little painful). On 09-Aug-2021, the patient experienced HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak) and NAUSEA (makes my stomach nauseous). At the time of the report, HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful), NAUSEA (makes my stomach nauseous) and VACCINATION SITE PAIN (shot site was itchy and a little painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported that the patient was having the same as the effects when she took Erythromycin.  No treatment information was provided.