chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine past its expiration date administered to 11 patients; 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 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 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medication were reported.   This case was linked to MOD-2021-371236 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Illness, Insomnia
Clinical narrative: Illness; Insomnia; Diarrhoea; Chills; Nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Illness), INSOMNIA (Insomnia), DIARRHOEA (Diarrhoea), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ILLNESS (Illness), INSOMNIA (Insomnia), DIARRHOEA (Diarrhoea), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ILLNESS (Illness), INSOMNIA (Insomnia), DIARRHOEA (Diarrhoea), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Reporter's sister in law experienced similar events after the second dose .   This case was linked to MOD-2021-370198 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Illness; Insomnia; Diarrhoea; Chills; Nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Illness), INSOMNIA (Insomnia), DIARRHOEA (Diarrhoea), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ILLNESS (Illness), INSOMNIA (Insomnia), DIARRHOEA (Diarrhoea), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ILLNESS (Illness), INSOMNIA (Insomnia), DIARRHOEA (Diarrhoea), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Reporter's sister in law experienced similar events after the second dose .   This case was linked to MOD-2021-370198 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Chills, Eye irritation, Feeling cold
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, BACK PAIN, EYE IRRITATION, BALANCE DISORDER, and NECK PAIN in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06AE21N, 012120A, and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced BALANCE DISORDER, FEELING COLD, and CHILLS. On 28-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS, BACK PAIN, EYE IRRITATION, and HEADACHE. On 31-Oct-2021, the patient experienced NECK PAIN. On 29-Oct-2021, FEELING COLD, and CHILLS had resolved. On 30-Oct-2021, MUSCULOSKELETAL STIFFNESS, BACK PAIN, and HEADACHE had resolved. On 31-Oct-2021, NECK PAIN had resolved. On 01-Nov-2021, EYE IRRITATION and BALANCE DISORDER had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drugs were reported.  Treatment reported were Eye wash/drops.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, BACK PAIN, EYE IRRITATION, BALANCE DISORDER, and NECK PAIN in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06AE21N, 012120A, and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced BALANCE DISORDER, FEELING COLD, and CHILLS. On 28-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS, BACK PAIN, EYE IRRITATION, and HEADACHE. On 31-Oct-2021, the patient experienced NECK PAIN. On 29-Oct-2021, FEELING COLD, and CHILLS had resolved. On 30-Oct-2021, MUSCULOSKELETAL STIFFNESS, BACK PAIN, and HEADACHE had resolved. On 31-Oct-2021, NECK PAIN had resolved. On 01-Nov-2021, EYE IRRITATION and BALANCE DISORDER had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drugs were reported.  Treatment reported were Eye wash/drops.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia
Clinical narrative: he was sick for a day; chills; body aches all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over). At the time of the report, ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-371356, MOD-2021-369390.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site was warm; Sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH and VACCINATION SITE PAIN in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE WARMTH and VACCINATION SITE PAIN outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-371373, MOD-2021-369457 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site right arm warm to the touch; sore injection site; had a low grade fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site right arm warm to the touch), VACCINATION SITE PAIN (sore injection site), PYREXIA (had a low grade fever) and NAUSEA (nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MWA and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site right arm warm to the touch), VACCINATION SITE PAIN (sore injection site), PYREXIA (had a low grade fever) and NAUSEA (nausea). At the time of the report, VACCINATION SITE WARMTH (injection site right arm warm to the touch), VACCINATION SITE PAIN (sore injection site), PYREXIA (had a low grade fever) and NAUSEA (nausea) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-371357, MOD-2021-369457.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-369478.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: acute hypoxic respiratory failure; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Characteristics and outcomes of adverse events after COVID-19 vaccination. J2021;2:e12565     The patient's past medical history included Atrial fibrillation and Chronic kidney disease. Concurrent medical conditions included Hypertension and Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) to be possibly related.    Concomitant medications were not reported Treatment medications were not reported  This fatal literature-study case concerns a 90-year-old, female patient with medical history of Atrial fibrillation, Chronic kidney disease, Hypertension and Congestive heart failure who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371541, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received 03-Nov-2021 included an Email with FTA received from the team and  contains significant information.; Sender's Comments: This fatal literature-study case concerns a 90-year-old, female patient with medical history of Atrial fibrillation, Chronic kidney disease, Hypertension and Congestive heart failure who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: acute hypoxic respiratory failure; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension and Lung cancer.    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 ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) to be possibly related.    Treatment medications were not reported Concomitant medications were not reported  Company Comment: This case concerns a 81-year-old, male patient, with medical history of hypertension and lung cancer, who experienced the fatal event of Acute respiratory failure. The event occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. The medical history of hypertension and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with a regulatory authority and  contains significant information.; Sender's Comments: This case concerns a 81-year-old, male patient, with medical history of hypertension and lung cancer, who experienced the fatal event of Acute respiratory failure. The event occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. The medical history of hypertension and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: acute hypoxic respiratory failure; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Hypertension, Congestive heart failure, Atrial fibrillation and Lung cancer.    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 ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) to be possibly related.    Treatment medications were not reported Concomitant medications were not reported  Company Comment: This fatal regulatory case concerns a 66-year-old, male patient with medical history of Hypertension, Congestive heart failure, Atrial fibrillation and Lung cancer who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The medical history and concurrent conditions remain as confounders. The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371541, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from SARA team and  contains significant information.; Sender's Comments: This fatal regulatory case concerns a 66-year-old, male patient with medical history of Hypertension, Congestive heart failure, Atrial fibrillation and Lung cancer who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The medical history and concurrent conditions remain as confounders. The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock
Clinical narrative: Cardiogenic shock; This literature-study case was reported in a literature article and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension, Congestive heart failure, Atrial fibrillation, Chronic kidney disease, Chronic obstructive lung disease and Type 2 diabetes mellitus.    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 CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Cardiogenic shock. It is unknown if an autopsy was performed.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CARDIOGENIC SHOCK (Cardiogenic shock) to be possibly related.    Concomitant product and treatment medication use was not provided by the reporter.  Company Comment: This case concerns an 82-year-old female patient, with medical history of hypertension, congestive heart failure and atrial fibrillation, who experienced the fatal event of CARDIOGENIC SHOCK. The event occurred on an unknown date after receiving a dose of unknown number of the Moderna COVID 19 vaccine. Date of death was not reported, and it is unknown if an autopsy was performed. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, congestive heart failure and atrial fibrillation remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371541, MOD-2021-371542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from SARA team and  contains significant information. Added correspondence contact in general tab; medical relevant history in patient tab.; Sender's Comments: This case concerns an 82-year-old female patient, with medical history of hypertension, congestive heart failure and atrial fibrillation, who experienced the fatal event of CARDIOGENIC SHOCK. The event occurred on an unknown date after receiving a dose of unknown number of the Moderna COVID 19 vaccine. Date of death was not reported, and it is unknown if an autopsy was performed. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, congestive heart failure and atrial fibrillation remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Reported Cause(s) of Death: Cardiogenic shock
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: headache; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 31-Oct-2021, the patient experienced HEADACHE (headache). On 30-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.            Patient received Johnson & Johnson as her first dose. No concomitant medications was reported. no treatment was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Chest pain, Colonoscopy, Dyspnoea, Fatigue
Clinical narrative: swollen lymph node; shortness of breath; upper chest pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia (cholesterol) and Gastrooesophageal reflux disease (Acid reflux).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue). The patient was treated with IRON (intravenous) in May 2021 for Iron low, at an unspecified dose and frequency; IRON (intravenous) on 30-Oct-2021 for Iron low, at an unspecified dose and frequency and IRON (intravenous) on 05-Nov-2021 for Iron low, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood iron: 7 (Low) iron level went down to 7. In May 2021, Colonoscopy: negative (Negative) negative with no polyp. In May 2021, Haemoglobin (13-17): 9 (Low) blood level was 9 when normal level is 13~17.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken medications for cholesterol and acid reflux Patient had had colonoscopy on upper and lower GI on Monday to see bleeding, and it showed negative with no polyp It was reported that the Patient cannot do a lot of strenuous stuffs due to his symptoms
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Lymphadenopathy
Clinical narrative: swollen lymph node; shortness of breath; upper chest pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia (cholesterol) and Gastrooesophageal reflux disease (Acid reflux).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue). The patient was treated with IRON (intravenous) in May 2021 for Iron low, at an unspecified dose and frequency; IRON (intravenous) on 30-Oct-2021 for Iron low, at an unspecified dose and frequency and IRON (intravenous) on 05-Nov-2021 for Iron low, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood iron: 7 (Low) iron level went down to 7. In May 2021, Colonoscopy: negative (Negative) negative with no polyp. In May 2021, Haemoglobin (13-17): 9 (Low) blood level was 9 when normal level is 13~17.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken medications for cholesterol and acid reflux Patient had had colonoscopy on upper and lower GI on Monday to see bleeding, and it showed negative with no polyp It was reported that the Patient cannot do a lot of strenuous stuffs due to his symptoms
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Blood pressure high, Diabetes, Blood cholesterol abnormal, Sleep disorder, Thyroid disorder and Arthritis. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure, LOVASTATIN for Cholesterol, INSULIN ASPART (NOVOLOG) for Diabetes, TRAMADOL and GABAPENTIN for Fibromyalgia, LORNOXICAM for Pain, TEMAZEPAM for Sleep disorder, LEVOTHYROXINE for Thyroid disorder, UBIDECARENONE (COQ 10), MULTIVITAMINS;MINERALS, CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            This case was linked to MOD-2021-371792, MOD-2021-371898.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Patient age and current conditions were updated, route of administration and anatomical location added for suspect vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This is a case of Expired Product Administered concerning a 73-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.; Sender's Comments: This is a case of Expired Product Administered concerning a 73-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging heart: abnormal (abnormal) cardiac MRI Findings typical of myocarditis of other causes. In 2021, Troponin: 6.8 plus minus 4.1 ng/ml mean peak troponin I, 6.8 plus minus 4.1 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant information were reported. Treatment information was not provided.  These 5 patients were all males with age ranging from 16 to 19 years (mean, 17.2+/-1.0 years) who presented within 4 days of the second dose of COVID-19 mRNA vaccine. All 5 patients had a favorable hospital course and were discharged in stable condition with improved or resolved symptoms after mean hospitalization length of 4.8 days  This case concerns a 19-year-old, male patient with no relevant medical history reported, who experienced the expected serious AESI event of Myocarditis. The event occurred approximately at an unknown day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 04-Nov-2021 included an Email and does not contain any new information. Only reporter details are updated.Updated lab test in patient tab and Hospitalized info event tab from initial report.; Sender's Comments: This case concerns a 19-year-old, male patient with no relevant medical history reported, who experienced the expected serious AESI event of Myocarditis. The event occurred approximately at an unknown day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, and VACCINATION SITE ERYTHEMA in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. In October 2021, the patient experienced VACCINATION SITE WARMTH, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, and VACCINATION SITE ERYTHEMA. On 29-Oct-2021, the patient experienced PAIN IN EXTREMITY and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE WARMTH, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE PAIN outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The reaction started a little bit on later on 29 Oct 2021. The patient got the flu shot at the same time at the same arm.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, and VACCINATION SITE ERYTHEMA in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. In October 2021, the patient experienced VACCINATION SITE WARMTH, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, and VACCINATION SITE ERYTHEMA. On 29-Oct-2021, the patient experienced PAIN IN EXTREMITY and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE WARMTH, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE PAIN outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The reaction started a little bit on later on 29 Oct 2021. The patient got the flu shot at the same time at the same arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication of Janssen vaccine (first dose and the lot number was 1805022) on 15-Mar-2021 and Flu vaccine on 01-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine and Janssen vaccine.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood thyroid stimulating hormone, Paraesthesia, Thyroiditis, Thyroxine free
Clinical narrative: Painless thyroiditis; Paresthesia; Join pains; This literature-non-study case was reported in a literature article and describes the occurrence of THYROIDITIS (Painless thyroiditis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       Concurrent medical conditions included Autoimmune thyroid disorder. Concomitant products included LEVOTHYROXINE for Autoimmune thyroid disorder.    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 THYROIDITIS (Painless thyroiditis) (seriousness criterion medically significant), PARAESTHESIA (Paresthesia) and ARTHRALGIA (Join pains). At the time of the report, THYROIDITIS (Painless thyroiditis), PARAESTHESIA (Paresthesia) and ARTHRALGIA (Join pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: 0.1 liu/ml 0.1 lIU/mL and normal TSH rose to 21 which returned to normal limits after progressive increase in dose of levothyroxine.. On an unknown date, Thyroxine free: 1.6 ng/dl 1.6 ng/dL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THYROIDITIS (Painless thyroiditis), PARAESTHESIA (Paresthesia) and ARTHRALGIA (Join pains) to be possibly related.    Treatment information was not provided.  Patient presented with left thyroid lobe painless swelling, paresthesia and join pains 2 weeks after her first dose of moderna vaccine.  This is a literature-non-study case concerning a 47-year-old female patient with history of Autoimmune thyroid disorder, previously euthyroid on levothyroxine, who experienced the serious  unexpected event Thyroiditis. The events occurred approximately two weeks after  the first  dose of mRNA-1273 Moderna vaccine, on an unknown date.  The medical history of autoimmune thyroid disorder remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-372388 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a 47-year-old female patient with history of Autoimmune thyroid disorder, previously euthyroid on levothyroxine, who experienced the serious  unexpected event Thyroiditis. The events occurred approximately two weeks after  the first  dose of mRNA-1273 Moderna vaccine, on an unknown date.  The medical history of autoimmune thyroid disorder remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS. At the time of the report, ILLNESS had resolved. Not Provided          No concomitant medication provided. No treatment medication provided.  Patient's age reported by the reporter was around late 20s or early 30s   This case was linked to MOD-2021-372525 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, PRAVASTATIN and GABAPENTIN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third 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 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.