chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Pain in extremity, Pyrexia
Clinical narrative: Arm hurt so bad it went all the way up an around back of my neck; Migraines; Fever; Chills; Real fatigued; Throwing up; lost weight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever) and VOMITING (Throwing up) in a patient of an unknown age and gender 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 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 PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever), VOMITING (Throwing up), CHILLS (Chills) and FATIGUE (Real fatigued). At the time of the report, PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever), VOMITING (Throwing up), CHILLS (Chills) and FATIGUE (Real fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter.  Patient mentioned that all events went on for a week.  No treatment medication provided by reporter.   This case was linked to MOD-2021-220819, MOD-2021-220819 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Arm hurt so bad it went all the way up an around back of my neck; Migraines; Fever; Chills; Real fatigued; Throwing up; lost weight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever) and VOMITING (Throwing up) in a patient of an unknown age and gender 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 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 PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever), VOMITING (Throwing up), CHILLS (Chills) and FATIGUE (Real fatigued). At the time of the report, PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever), VOMITING (Throwing up), CHILLS (Chills) and FATIGUE (Real fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter.  Patient mentioned that all events went on for a week.  No treatment medication provided by reporter.   This case was linked to MOD-2021-220819, MOD-2021-220819 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Myalgia
Clinical narrative: patient only reported sore arm with no additional side effects; Accidental 3rd dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidental 3rd dose of Moderna vaccine) and MYALGIA (patient only reported sore arm with no additional side effects) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidental 3rd dose of Moderna vaccine). On 25-May-2021, the patient experienced MYALGIA (patient only reported sore arm with no additional side effects). On 24-May-2021, EXTRA DOSE ADMINISTERED (Accidental 3rd dose of Moderna vaccine) had resolved. At the time of the report, MYALGIA (patient only reported sore arm with no additional side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant Follow up Appended - New reporter and event added
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long do the side effects of 2nd shot last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long do the side effects of 2nd shot last) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do the side effects of 2nd shot last). At the time of the report, VACCINATION COMPLICATION (How long do the side effects of 2nd shot last) outcome was unknown.            No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine Injected to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine Injected to patient) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine Injected to patient). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine Injected to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment drugs were reported  The reporter stated the patient was vaccinated with a dose from a punctured vial of Moderna COVID-19 Vaccine that had been sitting at room temperature since 11-May-2021.   This case was linked to MOD-2021-220907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received and contains no new information
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: enlarged lymph nodes over the right side of the body and not painful; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Sore arm) and LYMPHADENOPATHY (enlarged lymph nodes over the right side of the body and not painful) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Breast cancer left side).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Sore arm). On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes over the right side of the body and not painful). At the time of the report, FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown and LYMPHADENOPATHY (enlarged lymph nodes over the right side of the body and not painful) had not resolved.            Concomitant product use was not provided. Patient had visited the health care physician who recommended patient to do ultrasound of the neck. Treatment information was not provided   This case was linked to MOD-2021-220848 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination site bruising
Clinical narrative: shot area bruised again; sleepy; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (shot area bruised again), SOMNOLENCE (sleepy) and FATIGUE (very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE BRUISING (shot area bruised again), SOMNOLENCE (sleepy) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (shot area bruised again), SOMNOLENCE (sleepy) and FATIGUE (very tired) outcome was unknown.            concomitant medication included a hormone for unknown indication.   This case was linked to MOD-2021-220809 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: right arm has a lump on it; went to visit our healthcare provider and they took a MRI and said it seems to be an abscess; right arm is swollen; The right arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (right arm has a lump on it), ABSCESS (went to visit our healthcare provider and they took a MRI and said it seems to be an abscess), VACCINATION SITE SWELLING (right arm is swollen) and VACCINATION SITE PAIN (The right arm got sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (right arm has a lump on it), ABSCESS (went to visit our healthcare provider and they took a MRI and said it seems to be an abscess), VACCINATION SITE SWELLING (right arm is swollen) and VACCINATION SITE PAIN (The right arm got sore). At the time of the report, VACCINATION SITE MASS (right arm has a lump on it), ABSCESS (went to visit our healthcare provider and they took a MRI and said it seems to be an abscess), VACCINATION SITE SWELLING (right arm is swollen) and VACCINATION SITE PAIN (The right arm got sore) 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 and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Generalized aches; persistent nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aches) and NAUSEA (persistent nausea) 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 PAIN (Generalized aches) and NAUSEA (persistent nausea). At the time of the report, PAIN (Generalized aches) and NAUSEA (persistent nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Heart rate
Clinical narrative: Been dizzy; heart issues; 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 DIZZINESS (Been dizzy) and CARDIAC DISORDER (heart issues) 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 DIZZINESS (Been dizzy) and CARDIAC DISORDER (heart issues). At the time of the report, DIZZINESS (Been dizzy) and CARDIAC DISORDER (heart issues) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 200 bpm (abnormal) Go under 200 Beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Autoimmune disorder.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported that she experienced unspecified side affects after receiving the first dose of vaccine.   Concomitant product details was not reported.  Treatment details was not reported .   This case was linked to MOD-2021-220837 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having some side effects listed but 23 days after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having some side effects listed but 23 days after receiving vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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 (Having some side effects listed but 23 days after receiving vaccine). At the time of the report, VACCINATION COMPLICATION (Having some side effects listed but 23 days after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Retching
Clinical narrative: felt gagged; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (felt gagged) and NAUSEA (felt nauseated) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included METOPROLOL, CHLORTALIDONE (THALITONE), ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RETCHING (felt gagged) and NAUSEA (felt nauseated). At the time of the report, RETCHING (felt gagged) and NAUSEA (felt nauseated) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not Applicable Treatment information wa snot provided.   This case was linked to MOD2021-221040 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence, Tachycardia
Clinical narrative: Rapid Heart beats; Dizzy; Wanted to sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid Heart beats), DIZZINESS (Dizzy) and SOMNOLENCE (Wanted to sleep a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Rapid Heart beats), DIZZINESS (Dizzy) and SOMNOLENCE (Wanted to sleep a lot). At the time of the report, TACHYCARDIA (Rapid Heart beats), DIZZINESS (Dizzy) and SOMNOLENCE (Wanted to sleep a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heart rate has been anywhere from 105 Heart Rate to 136; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Heart rate has been anywhere from 105 Heart Rate to 136) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate has been anywhere from 105 Heart Rate to 136). At the time of the report, HEART RATE INCREASED (Heart rate has been anywhere from 105 Heart Rate to 136) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 136 (High) Increased from 105 to 136.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information request declined.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects of the moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects of the moderna covid vaccine) 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 VACCINATION COMPLICATION (side effects of the moderna covid vaccine). At the time of the report, VACCINATION COMPLICATION (side effects of the moderna covid vaccine) 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 provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: A patient exceeded her second dose beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient exceeded her second dose beyond 42 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-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 (A patient exceeded her second dose beyond 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient exceeded her second dose beyond 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Pyrexia, Vomiting
Clinical narrative: Still sick; Very weak; Vomitting; High fever; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ILLNESS (Still sick), ASTHENIA (Very weak), VOMITING (Vomitting) and PYREXIA (High fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomitting) and PYREXIA (High fever). On 14-Jun-2021, the patient experienced ILLNESS (Still sick) and ASTHENIA (Very weak). At the time of the report, DIARRHOEA (Diarrhea), ILLNESS (Still sick), ASTHENIA (Very weak), VOMITING (Vomitting) and PYREXIA (High fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received and contains no new information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated the vaccine vial was punctured at 10:00am on 13 Jun 2021 and should have been discarded at 10:00pm that evening. However, the patient was vaccinated at 1:00pm with the expired vaccine.  Concomitant medications were not reported.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Bronchitis, Dyspnoea
Clinical narrative: Shortness of breath/breathing problems/can't talk for too long; could be bad bronchitis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNEA (Shortness of breath/breathing problems/can't talk for too long) and BRONCHITIS (could be bad bronchitis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, RAMIPRIL, OMEPRAZOLE, METHYLPHENIDATE HYDROCHLORIDE (BIPHENTIN) and IRON for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced DYSPNEA (Shortness of breath/breathing problems/can't talk for too long) and BRONCHITIS (could be bad bronchitis). The patient was treated with AMOXICILLIN ongoing since an unknown date for Shortness of breath and Bronchitis, at an unspecified dose and frequency. At the time of the report, DYSPNEA (Shortness of breath/breathing problems/can't talk for too long) and BRONCHITIS (could be bad bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2021, Blood test: normal (normal) normal.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site warmth, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site was really hot for few days), VACCINATION COMPLICATION (other general side effects), CHILLS (Chills) and PYREXIA (Fever) 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 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site was really hot for few days), VACCINATION COMPLICATION (other general side effects), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INJECTION SITE WARMTH (Injection site was really hot for few days), VACCINATION COMPLICATION (other general side effects), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's concomitant medication was not reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Swelling
Clinical narrative: Left shoulder is swallowing up; Pain getting worse; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Left shoulder is swallowing up) and ARTHRALGIA (Pain getting worse) 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 SWELLING (Left shoulder is swallowing up) and ARTHRALGIA (Pain getting worse). At the time of the report, SWELLING (Left shoulder is swallowing up) and ARTHRALGIA (Pain getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bowel movement irregularity, Decreased appetite, Hallucination, Parosmia
Clinical narrative: Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it; hallucinations; appetite was off; bowel movements were off; feeling weak; strong sense of smell; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002BNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Hypertension, FAMOTIDINE and EZETIMIBE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinations) had resolved and DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak), PAROSMIA (strong sense of smell) and PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient's second dose was scheduled at 4Jun2021 but still its pending  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it; hallucinations; appetite was off; bowel movements were off; feeling weak; strong sense of smell; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002BNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Hypertension, FAMOTIDINE and EZETIMIBE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinations) had resolved and DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak), PAROSMIA (strong sense of smell) and PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient's second dose was scheduled at 4Jun2021 but still its pending  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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Been 72 days since he received the first dose but not the second dose; Got diagnosed with Corona disease; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Been 72 days since he received the first dose but not the second dose) and COVID-19 (Got diagnosed with Corona disease) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COVID-19 (Got diagnosed with Corona disease). On 14-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Been 72 days since he received the first dose but not the second dose). On 14-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Been 72 days since he received the first dose but not the second dose) had resolved. At the time of the report, COVID-19 (Got diagnosed with Corona disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine Injected to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine Injected to patient) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine Injected to patient). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine Injected to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  The reporter stated the patient was vaccinated with a dose from a punctured vial of Moderna COVID-19 Vaccine that had been sitting at room temperature since 11-May-2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up information contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination complication
Clinical narrative: bad cold; bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (bad cold) 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 08-Jun-2021, the patient experienced VACCINATION COMPLICATION (bad reaction). On 14-Jun-2021, the patient experienced NASOPHARYNGITIS (bad cold). At the time of the report, VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (bad cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  On Tuesday, the patient had a bad reaction.  The patient's treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 2 days after its expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 2 days after its expiration date) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine given 2 days after its expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 2 days after its expiration date) 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 medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: shot administered after the vial being punctured for over 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (shot administered after the vial being punctured for over 12 hours) 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 June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (shot administered after the vial being punctured for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (shot administered after the vial being punctured for over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I cannot eat without throwing it up all back; 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 VOMITING (I cannot eat without throwing it up all back) 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 04-Jun-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 VOMITING (I cannot eat without throwing it up all back). At the time of the report, VOMITING (I cannot eat without throwing it up all back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Depression; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSION (Depression) 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 DEPRESSION (Depression). At the time of the report, DEPRESSION (Depression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. The patient's treatment medication was not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash pruritic
Clinical narrative: arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days; arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) and RASH PRURITIC (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) and RASH PRURITIC (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days). On 03-Mar-2021, PERIPHERAL SWELLING (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) and RASH PRURITIC (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 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.   Concomitant drug also included LUTEIN for the prevention of Macular degeneration  No treatment drugs were reported   This case was linked to MOD-2021-051262 (Patient Link).