chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Cough, Dizziness
Clinical narrative: feeling high; extremely dizzy; could barely stand up; congestion now in chest; massive congestion in her throat; when she coughs it burns; overwhelming nausea; could barely keep food down; chills; feels hot; severe stomach cramping; tried to rest but had to go back to work; threw up; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest) and OROPHARYNGEAL DISCOMFORT (massive congestion in her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 22-Apr-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 EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest), OROPHARYNGEAL DISCOMFORT (massive congestion in her throat), COUGH (when she coughs it burns), NAUSEA (overwhelming nausea), VOMITING (could barely keep food down), CHILLS (chills), FEELING HOT (feels hot), ABDOMINAL PAIN UPPER (severe stomach cramping), RESTLESSNESS (tried to rest but had to go back to work) and VOMITING (threw up). At the time of the report, EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest), OROPHARYNGEAL DISCOMFORT (massive congestion in her throat), COUGH (when she coughs it burns), NAUSEA (overwhelming nausea), VOMITING (could barely keep food down), CHILLS (chills), FEELING HOT (feels hot), ABDOMINAL PAIN UPPER (severe stomach cramping), RESTLESSNESS (tried to rest but had to go back to work) and VOMITING (threw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include Mucinex and tried to rest.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Euphoric mood, Feeling hot, Nausea, Oropharyngeal discomfort
Clinical narrative: feeling high; extremely dizzy; could barely stand up; congestion now in chest; massive congestion in her throat; when she coughs it burns; overwhelming nausea; could barely keep food down; chills; feels hot; severe stomach cramping; tried to rest but had to go back to work; threw up; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest) and OROPHARYNGEAL DISCOMFORT (massive congestion in her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 22-Apr-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 EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest), OROPHARYNGEAL DISCOMFORT (massive congestion in her throat), COUGH (when she coughs it burns), NAUSEA (overwhelming nausea), VOMITING (could barely keep food down), CHILLS (chills), FEELING HOT (feels hot), ABDOMINAL PAIN UPPER (severe stomach cramping), RESTLESSNESS (tried to rest but had to go back to work) and VOMITING (threw up). At the time of the report, EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest), OROPHARYNGEAL DISCOMFORT (massive congestion in her throat), COUGH (when she coughs it burns), NAUSEA (overwhelming nausea), VOMITING (could barely keep food down), CHILLS (chills), FEELING HOT (feels hot), ABDOMINAL PAIN UPPER (severe stomach cramping), RESTLESSNESS (tried to rest but had to go back to work) and VOMITING (threw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include Mucinex and tried to rest.
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Vomiting
Clinical narrative: feeling high; extremely dizzy; could barely stand up; congestion now in chest; massive congestion in her throat; when she coughs it burns; overwhelming nausea; could barely keep food down; chills; feels hot; severe stomach cramping; tried to rest but had to go back to work; threw up; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest) and OROPHARYNGEAL DISCOMFORT (massive congestion in her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 22-Apr-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 EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest), OROPHARYNGEAL DISCOMFORT (massive congestion in her throat), COUGH (when she coughs it burns), NAUSEA (overwhelming nausea), VOMITING (could barely keep food down), CHILLS (chills), FEELING HOT (feels hot), ABDOMINAL PAIN UPPER (severe stomach cramping), RESTLESSNESS (tried to rest but had to go back to work) and VOMITING (threw up). At the time of the report, EUPHORIC MOOD (feeling high), DIZZINESS (extremely dizzy), DYSSTASIA (could barely stand up), CHEST DISCOMFORT (congestion now in chest), OROPHARYNGEAL DISCOMFORT (massive congestion in her throat), COUGH (when she coughs it burns), NAUSEA (overwhelming nausea), VOMITING (could barely keep food down), CHILLS (chills), FEELING HOT (feels hot), ABDOMINAL PAIN UPPER (severe stomach cramping), RESTLESSNESS (tried to rest but had to go back to work) and VOMITING (threw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include Mucinex and tried to rest.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Received Pfizer vaccine 5 days after Moderna vaccine; Received Pfizer vaccine 5 days after Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine 5 days after Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer vaccine 5 days after Moderna vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine 5 days after Moderna vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer vaccine 5 days after Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine 5 days after Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer vaccine 5 days after Moderna vaccine) 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 provided No treatment medications were provided
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Sore arm; fatigue; 2nd dose received a week early, less than 26 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received a week early, less than 26 days from first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First dose Covid-19 vaccination.) on 05-Apr-2021.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received a week early, less than 26 days from first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received a week early, less than 26 days from first dose) had resolved. 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 relevant past medical history provided.  Treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: stomach is acting up; lost his appetite; feeling weird; feels like he is getting the flu; he is cold; Diarrhea; stiffness in arm; itching; sore; has the chills; feels "queasy"; tired; aching really bad; injection site itching; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu) and FEELING COLD (he is cold) in a 70-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.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First Covid-19 vaccination and type and date taken unknown.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Prophylaxis.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain). At the time of the report, ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            No relevant medical history provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-May-2021 via TCR. Events updated
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Influenza like illness, Injection site pain, Injection site pruritus
Clinical narrative: stomach is acting up; lost his appetite; feeling weird; feels like he is getting the flu; he is cold; Diarrhea; stiffness in arm; itching; sore; has the chills; feels "queasy"; tired; aching really bad; injection site itching; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu) and FEELING COLD (he is cold) in a 70-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.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First Covid-19 vaccination and type and date taken unknown.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Prophylaxis.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain). At the time of the report, ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            No relevant medical history provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-May-2021 via TCR. Events updated
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pruritus
Clinical narrative: stomach is acting up; lost his appetite; feeling weird; feels like he is getting the flu; he is cold; Diarrhea; stiffness in arm; itching; sore; has the chills; feels "queasy"; tired; aching really bad; injection site itching; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu) and FEELING COLD (he is cold) in a 70-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.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First Covid-19 vaccination and type and date taken unknown.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Prophylaxis.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain). At the time of the report, ABDOMINAL DISCOMFORT (stomach is acting up), DECREASED APPETITE (lost his appetite), FEELING ABNORMAL (feeling weird), INFLUENZA LIKE ILLNESS (feels like he is getting the flu), FEELING COLD (he is cold), DIARRHOEA (Diarrhea), MUSCULOSKELETAL STIFFNESS (stiffness in arm), PRURITUS (itching), PAIN (sore), CHILLS (has the chills), NAUSEA (feels "queasy"), FATIGUE (tired), MYALGIA (aching really bad), INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            No relevant medical history provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-May-2021 via TCR. Events updated
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose was due on 05Apr2021 but caller forgot to get the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was due on 05Apr2021 but caller forgot to get the vaccination) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was due on 05Apr2021 but caller forgot to get the vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was due on 05Apr2021 but caller forgot to get the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection pain; Swelling in arm; Ringing in ear; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection pain), VACCINATION SITE SWELLING (Swelling in arm) and TINNITUS (Ringing in ear) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0378B29) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO medical history reported).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (Injection pain), VACCINATION SITE SWELLING (Swelling in arm) and TINNITUS (Ringing in ear). At the time of the report, VACCINATION SITE PAIN (Injection pain) and VACCINATION SITE SWELLING (Swelling in arm) had resolved and TINNITUS (Ringing in ear) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and lab test were not reported   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Coordination abnormal, Dizziness, Fatigue, Headache
Clinical narrative: does not intend to get the second dose.; tired; head hurt for a long time; nauseous; dizzy; arm was sore (for a week); stomach hurt head hurt for a long time; lost control of his bodily functions; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (arm was sore (for a week)), ABDOMINAL PAIN UPPER (stomach hurt head hurt for a long time), COORDINATION ABNORMAL (lost control of his bodily functions) and TREATMENT NONCOMPLIANCE (does not intend to get the second dose.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (dizzy), PAIN IN EXTREMITY (arm was sore (for a week)), ABDOMINAL PAIN UPPER (stomach hurt head hurt for a long time), COORDINATION ABNORMAL (lost control of his bodily functions), FATIGUE (tired), HEADACHE (head hurt for a long time) and NAUSEA (nauseous). On an unknown date, the patient experienced TREATMENT NONCOMPLIANCE (does not intend to get the second dose.). On 11-Apr-2021, PAIN IN EXTREMITY (arm was sore (for a week)) had resolved. At the time of the report, DIZZINESS (dizzy), ABDOMINAL PAIN UPPER (stomach hurt head hurt for a long time), COORDINATION ABNORMAL (lost control of his bodily functions), TREATMENT NONCOMPLIANCE (does not intend to get the second dose.), FATIGUE (tired), HEADACHE (head hurt for a long time) and NAUSEA (nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Treatment noncompliance, Vaccination site pain
Clinical narrative: does not intend to get the second dose.; tired; head hurt for a long time; nauseous; dizzy; arm was sore (for a week); stomach hurt head hurt for a long time; lost control of his bodily functions; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (arm was sore (for a week)), ABDOMINAL PAIN UPPER (stomach hurt head hurt for a long time), COORDINATION ABNORMAL (lost control of his bodily functions) and TREATMENT NONCOMPLIANCE (does not intend to get the second dose.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (dizzy), PAIN IN EXTREMITY (arm was sore (for a week)), ABDOMINAL PAIN UPPER (stomach hurt head hurt for a long time), COORDINATION ABNORMAL (lost control of his bodily functions), FATIGUE (tired), HEADACHE (head hurt for a long time) and NAUSEA (nauseous). On an unknown date, the patient experienced TREATMENT NONCOMPLIANCE (does not intend to get the second dose.). On 11-Apr-2021, PAIN IN EXTREMITY (arm was sore (for a week)) had resolved. At the time of the report, DIZZINESS (dizzy), ABDOMINAL PAIN UPPER (stomach hurt head hurt for a long time), COORDINATION ABNORMAL (lost control of his bodily functions), TREATMENT NONCOMPLIANCE (does not intend to get the second dose.), FATIGUE (tired), HEADACHE (head hurt for a long time) and NAUSEA (nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Swollen left eye; Red eye; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Swollen left eye) and OCULAR HYPERAEMIA (Red eye) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced EYE SWELLING (Swollen left eye) and OCULAR HYPERAEMIA (Red eye). On 31-Mar-2021, EYE SWELLING (Swollen left eye) and OCULAR HYPERAEMIA (Red eye) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  EMS was called and Benadryl was given to the patient at the vaccination center
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: pain when moving right arm up and down or to the side; Right arm throbbing , started to give pain; fever; chills; a little" tiredness "; pain is in upside of elbow and now its going towards shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain when moving right arm up and down or to the side), PAIN (Right arm throbbing , started to give pain), PYREXIA (fever), CHILLS (chills) and FATIGUE (a little" tiredness ") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: CORTISONE (at right shoulder.) on 15-Feb-2021. Concurrent medical conditions included Drug allergy (Allergies to Augmentin.). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ANASTROZOLE (ANASTRAZOLE DENK) for Cancer, SIMVASTATIN for Cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE for Thyroid disorder.   On 03-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain when moving right arm up and down or to the side), PAIN (Right arm throbbing , started to give pain), PYREXIA (fever), CHILLS (chills), FATIGUE (a little" tiredness ") and ARTHRALGIA (pain is in upside of elbow and now its going towards shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (a little" tiredness ") had resolved. At the time of the report, PAIN IN EXTREMITY (pain when moving right arm up and down or to the side) and ARTHRALGIA (pain is in upside of elbow and now its going towards shoulder) had not resolved and PAIN (Right arm throbbing , started to give pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date blood work up was done and reports were normal.   This case was linked to MOD-2021-090316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Events added On 02-Jun-2021: follow-up received on 2 June 2021. reporter details updatedpatient height and weight updated.allergies updated.concomitant medications updated.vaccination facility details updated. On 28-Jul-2021: Followup received on 28 JUL 2021, Patient gave consent to contact HCP, Possible NNI,; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain when moving right arm up and down or to the side; Right arm throbbing , started to give pain; fever; chills; a little" tiredness "; pain is in upside of elbow and now its going towards shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain when moving right arm up and down or to the side), PAIN (Right arm throbbing , started to give pain), PYREXIA (fever), CHILLS (chills) and FATIGUE (a little" tiredness ") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: CORTISONE (at right shoulder.) on 15-Feb-2021. Concurrent medical conditions included Drug allergy (Allergies to Augmentin.). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ANASTROZOLE (ANASTRAZOLE DENK) for Cancer, SIMVASTATIN for Cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE for Thyroid disorder.   On 03-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain when moving right arm up and down or to the side), PAIN (Right arm throbbing , started to give pain), PYREXIA (fever), CHILLS (chills), FATIGUE (a little" tiredness ") and ARTHRALGIA (pain is in upside of elbow and now its going towards shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (a little" tiredness ") had resolved. At the time of the report, PAIN IN EXTREMITY (pain when moving right arm up and down or to the side) and ARTHRALGIA (pain is in upside of elbow and now its going towards shoulder) had not resolved and PAIN (Right arm throbbing , started to give pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date blood work up was done and reports were normal.   This case was linked to MOD-2021-090316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Events added On 02-Jun-2021: follow-up received on 2 June 2021. reporter details updatedpatient height and weight updated.allergies updated.concomitant medications updated.vaccination facility details updated. On 28-Jul-2021: Followup received on 28 JUL 2021, Patient gave consent to contact HCP, Possible NNI,; 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: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Feeling different--not feeling good; Sore arm--m Sensation on her left arm around the breas; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling different--not feeling good), PAIN IN EXTREMITY (Sore arm--m Sensation on her left arm around the breas), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included OLMESARTAN MEDOXOMIL, MOMETASONE FUROATE (NASONEX), VITAMIN D3 and PROBIOTICS NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling different--not feeling good) and PAIN IN EXTREMITY (Sore arm--m Sensation on her left arm around the breas). In April 2021, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (Feeling different--not feeling good), PAIN IN EXTREMITY (Sore arm--m Sensation on her left arm around the breas), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient also uses Neti pot flush, Premarin vaginal cream and high blood pressure pills.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Does something physically he has pain in his arm at night; Pain in his arm periodically; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm periodically) and PAIN (Does something physically he has pain in his arm at night) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm periodically). On an unknown date, the patient experienced PAIN (Does something physically he has pain in his arm at night). At the time of the report, PAIN IN EXTREMITY (Pain in his arm periodically) and PAIN (Does something physically he has pain in his arm at night) outcome was unknown.            no treatment and concomitant medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Feeling abnormal, Flatulence, Headache, Pharyngeal swelling
Clinical narrative: Throat sweling; Had to clear throat constantly; Throat was extremely dry; He said it just didn't feel right.; a lot of mucus.; extremely thirsty; stomach gas; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly), DRY THROAT (Throat was extremely dry), FEELING ABNORMAL (He said it just didn't feel right.) and SECRETION DISCHARGE (a lot of mucus.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy (History of allergies, no further specification).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly), DRY THROAT (Throat was extremely dry), FEELING ABNORMAL (He said it just didn't feel right.), SECRETION DISCHARGE (a lot of mucus.), THIRST (extremely thirsty), FLATULENCE (stomach gas) and HEADACHE (headache). At the time of the report, PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly) and DRY THROAT (Throat was extremely dry) outcome was unknown and FEELING ABNORMAL (He said it just didn't feel right.), SECRETION DISCHARGE (a lot of mucus.), THIRST (extremely thirsty), FLATULENCE (stomach gas) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Vital signs measurement: normal (normal) Vitals were normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use includes unspecified herbal supplements.   The patient was evaluated in the Emergency Room approximately 6-7 hours after vaccine administration/symptom onset, he was not admitted and discharged home. No other treatment information was reported.  On 26-APR-2021, patient was improving and feeling well.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: adverse events added (dry throat, pharyngeal swelling, throat clearing). Patient was not intending to get his second vaccine dose next week. On 02-Aug-2021: Non-significant follow up received- Further consent denied; 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Secretion discharge, Thirst, Throat clearing, Vital signs measurement
Clinical narrative: Throat sweling; Had to clear throat constantly; Throat was extremely dry; He said it just didn't feel right.; a lot of mucus.; extremely thirsty; stomach gas; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly), DRY THROAT (Throat was extremely dry), FEELING ABNORMAL (He said it just didn't feel right.) and SECRETION DISCHARGE (a lot of mucus.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy (History of allergies, no further specification).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly), DRY THROAT (Throat was extremely dry), FEELING ABNORMAL (He said it just didn't feel right.), SECRETION DISCHARGE (a lot of mucus.), THIRST (extremely thirsty), FLATULENCE (stomach gas) and HEADACHE (headache). At the time of the report, PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly) and DRY THROAT (Throat was extremely dry) outcome was unknown and FEELING ABNORMAL (He said it just didn't feel right.), SECRETION DISCHARGE (a lot of mucus.), THIRST (extremely thirsty), FLATULENCE (stomach gas) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Vital signs measurement: normal (normal) Vitals were normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use includes unspecified herbal supplements.   The patient was evaluated in the Emergency Room approximately 6-7 hours after vaccine administration/symptom onset, he was not admitted and discharged home. No other treatment information was reported.  On 26-APR-2021, patient was improving and feeling well.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: adverse events added (dry throat, pharyngeal swelling, throat clearing). Patient was not intending to get his second vaccine dose next week. On 02-Aug-2021: Non-significant follow up received- Further consent denied; 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain in extremity, Palpitations, Urticaria
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chest pain, dyspnea (shortness of breath), palpitations, urticaria (hives all over the body) and pain in extremity (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031A21A) for COVID-19 immunization. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 22, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 24, 2021, patient experienced chest pain, dyspnea (shortness of breath), palpitations), urticaria (hives all over the body) and pain in extremity (sore arm). The patient treated with paracetamol; 1 dosage form. At the time of the report, chest pain, dyspnea (shortness of breath), palpitations, urticaria (hives all over the body) and pain in extremity (sore arm): not resolved. Concomitant product use not provided by the reporter. Action taken with mRNA-1273 in response to the event: not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC.-MOD-2021-090242 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090242:Crosslinked case
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling miserable). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling miserable) had not resolved. 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.   The concomitants include  Blood pressure medication  and Diabetic medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-090387, US-MODERNATX, INC.-MOD-2021-090392 (E2B Linked Report). This case was linked to MOD-2021-090279 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090392:Husband dose 1 case US-MODERNATX, INC.-MOD-2021-090387:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Nausea, Night sweats, Rash
Clinical narrative: Lethargic; night sweats; Rash on arm; swollen lymph node under arm; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), NIGHT SWEATS (night sweats), RASH (Rash on arm), LYMPHADENOPATHY (swollen lymph node under arm) and NAUSEA (nauseous) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Allergy. Concomitant products included CITALOPRAM, CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) and LEVONORGESTREL for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced LETHARGY (Lethargic), NIGHT SWEATS (night sweats), RASH (Rash on arm), LYMPHADENOPATHY (swollen lymph node under arm) and NAUSEA (nauseous). At the time of the report, LETHARGY (Lethargic), NIGHT SWEATS (night sweats), RASH (Rash on arm), LYMPHADENOPATHY (swollen lymph node under arm) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Steroid cream and benedryl
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Feeling abnormal, Palpitations, Paraesthesia, Presyncope
Clinical narrative: Felt like drugged; not feeling myself; palpitations; Felt like pass out; Pins and needles in arms and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations), PRESYNCOPE (Felt like pass out), PARAESTHESIA (Pins and needles in arms and feet), EUPHORIC MOOD (Felt like drugged) and FEELING ABNORMAL (not feeling myself) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PALPITATIONS (palpitations), PRESYNCOPE (Felt like pass out) and PARAESTHESIA (Pins and needles in arms and feet). On 18-Apr-2021, the patient experienced EUPHORIC MOOD (Felt like drugged) and FEELING ABNORMAL (not feeling myself). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (palpitations), PRESYNCOPE (Felt like pass out), PARAESTHESIA (Pins and needles in arms and feet), EUPHORIC MOOD (Felt like drugged) and FEELING ABNORMAL (not feeling myself) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that felt like took 10 muscle relaxers and better now but still has some symptoms. No medical history, lab data, are provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up document does not contain any new information