chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Biopsy breast abnormal, Breast cancer, Lymphadenopathy, Mammogram
Clinical narrative: malignancy/cancerous/three tumors/lump in my left breast; Pain and soreness in left arm; swelling of the arm; biopsy breast abnormal; three lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-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 BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain and soreness in left arm), PERIPHERAL SWELLING (swelling of the arm), BIOPSY BREAST ABNORMAL (biopsy breast abnormal) and LYMPHADENOPATHY (three lymph nodes). At the time of the report, BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) had not resolved and PAIN IN EXTREMITY (Pain and soreness in left arm), PERIPHERAL SWELLING (swelling of the arm), BIOPSY BREAST ABNORMAL (biopsy breast abnormal) and LYMPHADENOPATHY (three lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Mammogram: abnormal (abnormal) three tumors and three lymph nodes. On 11-Mar-2021, Ultrasound scan: cancerous (abnormal) cancerous. On 24-Mar-2021, Biopsy breast: confirmed malignancy (abnormal) confirmed malignancy.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information includes on 09 Apr2021 started chemotherapy for breast cancer NOS, continuing since then.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-276971 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: malignancy/cancerous/three tumors/lump in my left breast; Pain and soreness in left arm; swelling of the arm; biopsy breast abnormal; three lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-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 BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain and soreness in left arm), PERIPHERAL SWELLING (swelling of the arm), BIOPSY BREAST ABNORMAL (biopsy breast abnormal) and LYMPHADENOPATHY (three lymph nodes). At the time of the report, BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) had not resolved and PAIN IN EXTREMITY (Pain and soreness in left arm), PERIPHERAL SWELLING (swelling of the arm), BIOPSY BREAST ABNORMAL (biopsy breast abnormal) and LYMPHADENOPATHY (three lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Mammogram: abnormal (abnormal) three tumors and three lymph nodes. On 11-Mar-2021, Ultrasound scan: cancerous (abnormal) cancerous. On 24-Mar-2021, Biopsy breast: confirmed malignancy (abnormal) confirmed malignancy.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information includes on 09 Apr2021 started chemotherapy for breast cancer NOS, continuing since then.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-276971 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Electrocardiogram, Feeling abnormal, Heart rate increased
Clinical narrative: blood pressure was high all week; Chest heaviness; Palpitation; feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was high all week) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chest X-ray (bronchitis two times) in December 2019. Concurrent medical conditions included Diabetes and Hypercholesterolemia. Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced FEELING ABNORMAL (feeling funny). On an unknown date, the patient experienced HYPERTENSION (blood pressure was high all week) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest heaviness) and PALPITATIONS (Palpitation). The patient was treated with LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Blood pressure measurement, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (blood pressure was high all week) and CHEST DISCOMFORT (Chest heaviness) outcome was unknown and PALPITATIONS (Palpitation) and FEELING ABNORMAL (feeling funny) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Blood pressure measurement: high (High) blood pressure was at 200. On 29-Jun-2021, Electrocardiogram: inconclusive (Inconclusive) an abnormal left atrial enlargement and possible pulmonary nodules on lungs.. On 29-Jun-2021, Heart rate increased: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient laid down in the emergency room for a few hours until blood pressure went down.  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.   This case was linked to MOD-2021-277031 (Patient Link).; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: blood pressure was high all week; Chest heaviness; Palpitation; feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was high all week) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chest X-ray (bronchitis two times) in December 2019. Concurrent medical conditions included Diabetes and Hypercholesterolemia. Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced FEELING ABNORMAL (feeling funny). On an unknown date, the patient experienced HYPERTENSION (blood pressure was high all week) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest heaviness) and PALPITATIONS (Palpitation). The patient was treated with LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Blood pressure measurement, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (blood pressure was high all week) and CHEST DISCOMFORT (Chest heaviness) outcome was unknown and PALPITATIONS (Palpitation) and FEELING ABNORMAL (feeling funny) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Blood pressure measurement: high (High) blood pressure was at 200. On 29-Jun-2021, Electrocardiogram: inconclusive (Inconclusive) an abnormal left atrial enlargement and possible pulmonary nodules on lungs.. On 29-Jun-2021, Heart rate increased: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient laid down in the emergency room for a few hours until blood pressure went down.  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.   This case was linked to MOD-2021-277031 (Patient Link).; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest X-ray, Electrocardiogram, Heart rate, Left atrial enlargement
Clinical narrative: An abnormal left atrial enlargement; Possible pulmonary nodules on her lungs; This spontaneous case was reported by a consumer and describes the occurrence of LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) and PULMONARY MASS (Possible pulmonary nodules on her lungs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 053C21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (had it two times in a row) in December 2019. Concurrent medical conditions included Diabetes, Hypercholesterolemia and Non-smoker (Does not partake in cigarettes or liquor). Concomitant products included LOSARTAN for Blood pressure.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced PULMONARY MASS (Possible pulmonary nodules on her lungs) (seriousness criterion medically significant). On 30-Jul-2021, the patient experienced LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) (seriousness criterion medically significant). At the time of the report, LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) and PULMONARY MASS (Possible pulmonary nodules on her lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Chest X-ray: abnormal (abnormal) showed an abnormal left atrial enlargement and possible pulmonary nodules on patient's lungs. On 30-Jul-2021, Electrocardiogram: abnormal (abnormal) showed an abnormal left atrial enlargement and possible pulmonary nodules on patient's lungs. On an unknown date, Blood pressure measurement: low (Low) Blood pressure was down. On an unknown date, Heart rate: high (High) High.         No relevant concomitant medications were reported. It was reported that prior to second dose on Monday 19JUL2021, patient stopped taking losartan that Sunday and Monday. The patient also had an upcoming CT scan and echocardiogram with a cardiologist. Treatment information was not provided.  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.   This case was linked to MOD-2021-277027 (Patient Link).; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: An abnormal left atrial enlargement; Possible pulmonary nodules on her lungs; This spontaneous case was reported by a consumer and describes the occurrence of LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) and PULMONARY MASS (Possible pulmonary nodules on her lungs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 053C21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (had it two times in a row) in December 2019. Concurrent medical conditions included Diabetes, Hypercholesterolemia and Non-smoker (Does not partake in cigarettes or liquor). Concomitant products included LOSARTAN for Blood pressure.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced PULMONARY MASS (Possible pulmonary nodules on her lungs) (seriousness criterion medically significant). On 30-Jul-2021, the patient experienced LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) (seriousness criterion medically significant). At the time of the report, LEFT ATRIAL ENLARGEMENT (An abnormal left atrial enlargement) and PULMONARY MASS (Possible pulmonary nodules on her lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Chest X-ray: abnormal (abnormal) showed an abnormal left atrial enlargement and possible pulmonary nodules on patient's lungs. On 30-Jul-2021, Electrocardiogram: abnormal (abnormal) showed an abnormal left atrial enlargement and possible pulmonary nodules on patient's lungs. On an unknown date, Blood pressure measurement: low (Low) Blood pressure was down. On an unknown date, Heart rate: high (High) High.         No relevant concomitant medications were reported. It was reported that prior to second dose on Monday 19JUL2021, patient stopped taking losartan that Sunday and Monday. The patient also had an upcoming CT scan and echocardiogram with a cardiologist. Treatment information was not provided.  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.   This case was linked to MOD-2021-277027 (Patient Link).; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Blood test after second dose, result came back as negative- no antibody count; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Blood test after second dose, result came back as negative- no antibody count) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression, Hypercholesterolemia and Sleep disorder. Concurrent medical conditions included Rheumatoid arthritis since 1985, Supraventricular tachycardia since 1985, Allergy to antibiotic (Doxycycline), Allergy to antibiotic (Tetracycline) and Allergy to antibiotic (Minocin). Concomitant products included BUPROPION from 01-Sep-1997 to an unknown date for Depression, SIMVASTATIN from 19-Oct-2000 to an unknown date for Hypercholesterolaemia, HYDROXYCHLOROQUINE from 10-Jan-2002 to an unknown date for Rheumatoid arthritis, TRAZODONE from 07-Jun-2019 to an unknown date for Sleep disorder, ATENOLOL from 10-Jan-2002 to an unknown date for Supraventricular tachycardia.   On 04-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 3:06 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Blood test after second dose, result came back as negative- no antibody count). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Blood test after second dose, result came back as negative- no antibody count) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-022851 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received 03-Aug-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Product dose omission issue, Vision blurred
Clinical narrative: dizziness; blurred vision; never received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VISION BLURRED (blurred vision) and PRODUCT DOSE OMISSION ISSUE (never received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), VISION BLURRED (blurred vision) and PRODUCT DOSE OMISSION ISSUE (never received the second dose). At the time of the report, DIZZINESS (dizziness), VISION BLURRED (blurred vision) and PRODUCT DOSE OMISSION ISSUE (never received the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) 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 APPENDICITIS (Appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No Further information is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No Further information is expected at this time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose\did not receive the 2nd dose in recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose\did not receive the 2nd dose in recommended time frame) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 08-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 (Missed 2nd dose\did not receive the 2nd dose in recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose\did not receive the 2nd dose in recommended time frame) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking Birth control pills as concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: follow up document received on 11-AUG-2021 contains start date of the suspect updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: "milder" right arm rash/COVID Rash (arm); This spontaneous case was reported by a physician and describes the occurrence of RASH ("milder" right arm rash/COVID Rash (arm)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer and Thyroidectomy (10 years ago). Concurrent medical conditions included High cholesterol and Blood pressure high (Patient reported high blood pressure). Concomitant products included AMLODIPINE, VALSARTAN, CALCIUM, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], SIMVASTATIN, LEVOTHYROXINE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH ("milder" right arm rash/COVID Rash (arm)). On 08-Apr-2021, RASH ("milder" right arm rash/COVID Rash (arm)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported.   This case was linked to MOD-2021-053984, MOD-2021-053984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received and contain Non-significant information. On 11-Aug-2021: Non-Significant follow-up. Contact updated. On 13-Aug-2021: Non-Significant follow-up. Reporter type was updated to physician. Consent to follow-up given through email.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: possible effects of vaccines could be autoimmune problems.; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (possible effects of vaccines could be autoimmune problems.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (possible effects of vaccines could be autoimmune problems.) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (possible effects of vaccines could be autoimmune problems.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) 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.   Concomitant product use not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up: Event term updated. On 11-Aug-2021: Follow up received on 11-AUG-2021 contains non-significant information.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) in a 36-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) , while the parent received the product for COVID-19 vaccination.     No medical history was provided.    On 03-Jul-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021 at 4:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021,  after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the adult was diagnosed with EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was punctured on 30-JUL-21 at 4.45pm, it was used and then put back into the refrigerator on that day. Then on 31-JUL-2021, it was used again at 10:45AM and it was left out of the refrigerator, the last dose was given at 3:45PM was noted. No concomitant medications are provided by reporter. No treatment medications are provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Updated  reporter contact information. Ethnicity and race info are updated from unknown to Not Hispanic or Latino and other respectively.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: wife passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (wife passed away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 19-May-2021 The patient died on 19-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected; 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 (Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) 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 EXPIRED PRODUCT ADMINISTERED (Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected) 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 was provided by the reporter. No treatmentt medications was provided by the reporter.  Vaccines were first frozen on 03-Jul-2021, were taken out to refrigerator at 6.30AM on 03Jun2021, on 03Jul2021 they should have been discarded, but they have been administered ever since. The lot number was 040B21A, it was one box with multiple vials, 40 patients approximate were involved. The update on the excursion was that the 9 vials in question were used on patients through July 29. The update on patients for the AE were that  43 patients were affected.  Fifteen were given 1st doses and 28 were give 2nd doses  between 4 and 26 days past the use by date.   This case was linked to MOD-2021-286864, MOD-2021-286796, MOD-2021-287108, MOD-2021-286869 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant information received on 06 Aug 2021:  Event term updated to Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Cerebrovascular accident, Hemiplegia
Clinical narrative: Stroke; Paralyzed on one side of the body; Urinating Blood; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), HEMIPLEGIA (Paralyzed on one side of the body) and BLOOD URINE PRESENT (Urinating Blood) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced BLOOD URINE PRESENT (Urinating Blood) (seriousness criterion hospitalization). On 03-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and HEMIPLEGIA (Paralyzed on one side of the body) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), HEMIPLEGIA (Paralyzed on one side of the body) and BLOOD URINE PRESENT (Urinating Blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  It was reported within 45 minutes after the first vaccine, patient was urinating blood.  The next day after vaccination he had a stroke and became paralyzed on one side of his body. Patient Doctor's say it was not related to the vaccine.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago/Neither of them received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/Neither of them received the second dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/Neither of them received the second dose). On 09-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/Neither of them received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported. No treatment information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Headache, Impaired work ability, Myalgia
Clinical narrative: muscle pain; headache; dizziness; He is sick; stay in bed; constantly miss work; Body pain for 3 months now; Mild body pain (legs, arm); This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headache) and DIZZINESS (dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2006, Cholesterol since 2006 and Diabetes since 2006.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild body pain (legs, arm)). On 10-May-2021, the patient experienced MYALGIA (muscle pain) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION COMPLICATION (He is sick), BEDRIDDEN (stay in bed), IMPAIRED WORK ABILITY (constantly miss work) and MYALGIA (Body pain for 3 months now). The patient was hospitalized on sometime in July 2021 due to DIZZINESS, HEADACHE and MYALGIA. At the time of the report, MYALGIA (muscle pain), HEADACHE (headache), DIZZINESS (dizziness), PAIN IN EXTREMITY (Mild body pain (legs, arm)), VACCINATION COMPLICATION (He is sick) and MYALGIA (Body pain for 3 months now) had not resolved and BEDRIDDEN (stay in bed) and IMPAIRED WORK ABILITY (constantly miss work) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Patient lab data reported as MRI and blood work with no diagnosis. No concomitant medication were reported. Patient has taken a lot of painkillers as treatment drug and stayed in the bed.  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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Followup appended with newevents, current conditions were added.; 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: muscle pain; headache; dizziness; He is sick; stay in bed; constantly miss work; Body pain for 3 months now; Mild body pain (legs, arm); This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headache) and DIZZINESS (dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2006, Cholesterol since 2006 and Diabetes since 2006.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild body pain (legs, arm)). On 10-May-2021, the patient experienced MYALGIA (muscle pain) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION COMPLICATION (He is sick), BEDRIDDEN (stay in bed), IMPAIRED WORK ABILITY (constantly miss work) and MYALGIA (Body pain for 3 months now). The patient was hospitalized on sometime in July 2021 due to DIZZINESS, HEADACHE and MYALGIA. At the time of the report, MYALGIA (muscle pain), HEADACHE (headache), DIZZINESS (dizziness), PAIN IN EXTREMITY (Mild body pain (legs, arm)), VACCINATION COMPLICATION (He is sick) and MYALGIA (Body pain for 3 months now) had not resolved and BEDRIDDEN (stay in bed) and IMPAIRED WORK ABILITY (constantly miss work) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Patient lab data reported as MRI and blood work with no diagnosis. No concomitant medication were reported. Patient has taken a lot of painkillers as treatment drug and stayed in the bed.  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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Followup appended with newevents, current conditions were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia, Paraesthesia, Paresis
Clinical narrative: Flet like she was going paralyzed; could barely even walk; legs were feeling a little bit numb/numbness in her face/numbness in her lips; tingling down her spine/awkward tingling in the spinal column area; tingling in the upper area of her spine and then in her legs and face; This spontaneous case was reported by a consumer and describes the occurrence of PARESIS (Flet like she was going paralyzed), PARAESTHESIA (tingling in the upper area of her spine and then in her legs and face), GAIT INABILITY (could barely even walk), HYPOAESTHESIA (legs were feeling a little bit numb/numbness in her face/numbness in her lips) and PARAESTHESIA (tingling down her spine/awkward tingling in the spinal column area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C2117) for COVID-19 vaccination.     Concurrent medical conditions included Neurological disorder NOS (under control) and Brain lesion (under control).    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced PARAESTHESIA (tingling in the upper area of her spine and then in her legs and face). On 10-Jul-2021, the patient experienced PARESIS (Flet like she was going paralyzed), GAIT INABILITY (could barely even walk), HYPOAESTHESIA (legs were feeling a little bit numb/numbness in her face/numbness in her lips) and PARAESTHESIA (tingling down her spine/awkward tingling in the spinal column area). In July 2021, PARESIS (Flet like she was going paralyzed), PARAESTHESIA (tingling in the upper area of her spine and then in her legs and face), GAIT INABILITY (could barely even walk), HYPOAESTHESIA (legs were feeling a little bit numb/numbness in her face/numbness in her lips) and PARAESTHESIA (tingling down her spine/awkward tingling in the spinal column area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient reported that she is scheduled for an MRI on 17Aug2021 to check neurological issues and brain lesions. Patient reported that she is scheduled for the second dose on 06Aug2021.  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. Patients concurrent medical conditions of Neurological disorder and Brain Lesions may be a confounding factor to the events.; 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. Patients concurrent medical conditions of Neurological disorder and Brain Lesions may be a confounding factor to the events.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Nausea, Pyrexia, Thrombosis
Clinical narrative: "may have had blood clots" but this may not have been about her"; chest pain; "nausea"; "105 fever"; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS ("may have had blood clots" but this may not have been about her") 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, 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 THROMBOSIS ("may have had blood clots" but this may not have been about her") (seriousness criterion medically significant), CHEST PAIN (chest pain), NAUSEA ("nausea") and PYREXIA ("105 fever"). At the time of the report, THROMBOSIS ("may have had blood clots" but this may not have been about her"), CHEST PAIN (chest pain), NAUSEA ("nausea") and PYREXIA ("105 fever") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 105 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medication has been reported.  Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-278420 (Patient Link).   Reporter did not allow further contact.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Great amount of confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Great amount of confusion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 CONFUSIONAL STATE (Great amount of confusion) (seriousness criterion hospitalization). At the time of the report, CONFUSIONAL STATE (Great amount of confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported ending up in the medical hospital due to confusion state and that the same happened to his aunt.  Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.