chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Long hauler, Long haul symptoms and about killed him; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long hauler, Long haul symptoms and about killed him) in a 65-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long hauler, Long haul symptoms and about killed him). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long hauler, Long haul symptoms and about killed him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Neck pain, Nervousness, Odynophagia, Oropharyngeal blistering
Clinical narrative: became nervous and went to the emergency room on Sunday in which they sent her home; Has blisters in back of throat; Neck is "so sore and swollen"; Neck is swollen; Throat is so sore it hurts to swallow; Throat is so sore it hurts to swallow; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Has blisters in back of throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced OROPHARYNGEAL BLISTERING (Has blisters in back of throat) (seriousness criterion medically significant), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow) and ODYNOPHAGIA (Throat is so sore it hurts to swallow). On 01-Aug-2021, the patient experienced NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL BLISTERING (Has blisters in back of throat), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow), ODYNOPHAGIA (Throat is so sore it hurts to swallow) and NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional treatment included a salt water gargle.    Concomitant medication use included prescribed medications and supplements for which details were not provided.  On 01-Aug-2021, the patient went to the emergency room and took a Strep throat test which came negative and patient was sent home.  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-2021-273688 (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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swelling
Clinical narrative: became nervous and went to the emergency room on Sunday in which they sent her home; Has blisters in back of throat; Neck is "so sore and swollen"; Neck is swollen; Throat is so sore it hurts to swallow; Throat is so sore it hurts to swallow; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Has blisters in back of throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced OROPHARYNGEAL BLISTERING (Has blisters in back of throat) (seriousness criterion medically significant), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow) and ODYNOPHAGIA (Throat is so sore it hurts to swallow). On 01-Aug-2021, the patient experienced NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL BLISTERING (Has blisters in back of throat), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow), ODYNOPHAGIA (Throat is so sore it hurts to swallow) and NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional treatment included a salt water gargle.    Concomitant medication use included prescribed medications and supplements for which details were not provided.  On 01-Aug-2021, the patient went to the emergency room and took a Strep throat test which came negative and patient was sent home.  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-2021-273688 (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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Vaccine administered to patient; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error). On 01-Aug-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported.  Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2 degree Fahrenheit) beyond 12 hours. The vial was first punctured at 01:01 PM on 31-Jul-2021 and that was when it was first moved to the room temperature.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: significant follow up received on 12-Aug-2021 included updated patient's race information.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Deafness
Clinical narrative: He became deaf a month after receiving 2nd dose.; She saw him shivering and he couldn't hear anything.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (He became deaf a month after receiving 2nd dose.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dementia.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced DEAFNESS (He became deaf a month after receiving 2nd dose.) (seriousness criterion medically significant) and CHILLS (She saw him shivering and he couldn't hear anything.). At the time of the report, DEAFNESS (He became deaf a month after receiving 2nd dose.) and CHILLS (She saw him shivering and he couldn't hear anything.) outcome was unknown.            One of the patient's concomitant medications is a dementia medication.  No treatment was given for symptoms.  Company comment: 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. However, elderly age and underlying condition of dementia could be risk factors for the event of deafness.   This case was linked to MOD-2021-273358 (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 event, a causal relationship cannot be excluded. However, elderly age and underlying condition of dementia could be risk factors for the event of deafness.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Hypoxia, SARS-CoV-2 test
Clinical narrative: COVID-19; Dyspnoea; Hypoxia; This case was received via regulatory Authority (Reference number: 1490338) on 03-Aug-2021 and was forwarded to the company on 03-Aug-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Dyspnoea) and HYPOXIA (Hypoxia) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization) and HYPOXIA (Hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jul-2021 due to DYSPNOEA and HYPOXIA. At the time of the report, COVID-19 (COVID-19), DYSPNOEA (Dyspnoea) and HYPOXIA (Hypoxia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  The patient tested positive for COVID on 15-07-2021 after being exposed to family member(s) that were also positive. Patient went to the hospital on 19-07-2021 with symptoms of shortness of breath, hypoxia, and dyspnea.  Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable Company Comment  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events dyspnoea and hypoxia, a causal relationship cannot be excluded.  However, COVID-19 could be a contributory factor these events.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events dyspnoea and hypoxia, a causal relationship cannot be excluded.  However, COVID-19 could be a contributory factor these events.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Pain in extremity, Thrombosis
Clinical narrative: Guillain-Barre syndrome; Two blood clots; Pain was bad in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), THROMBOSIS (Two blood clots) and PAIN IN EXTREMITY (Pain was bad in legs and feet) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), RIVAROXABAN (XARELTO) and EZETIMIBE (ZETIA) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Pain was bad in legs and feet) (seriousness criterion hospitalization). On 23-Jul-2021, the patient experienced THROMBOSIS (Two blood clots) (seriousness criterion hospitalization). On 27-Jul-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criteria hospitalization and medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), THROMBOSIS (Two blood clots) and PAIN IN EXTREMITY (Pain was bad in legs and feet) outcome was unknown.            The patient was treated with IV immunoglobulin. The patient has been in the hospital for a week now.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received with no new information; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Cardiac flutter, Dyspnoea
Clinical narrative: heart was fluttering/heart problems; heart was only pumping 29% of the blood/heart wasn't pumping enough blood; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart was fluttering/heart problems), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) and DYSPNOEA (short of breath) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013M20A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included AMLODIPINE and ATORVASTATIN for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (heart was fluttering/heart problems) (seriousness criteria medically significant and life threatening), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) (seriousness criteria medically significant and life threatening) and DYSPNOEA (short of breath) (seriousness criterion life threatening). At the time of the report, CARDIAC FLUTTER (heart was fluttering/heart problems), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) and DYSPNOEA (short of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Cardiac stress test: abnormal (abnormal) Heart was pumping only 29% of blood. Heart was beating erratically..         Treatment  information was not reported.    Patient was not aware whether she experienced the symptoms after first dose of vaccine or second dose of vaccine. Patient was on Life Vest to keep herself from sudden death.  Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.  Company comment: Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.; Sender's Comments: Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) in a 41-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included steroids and an eye cream.  Concomitant medications were not provided.  Patient thought she got first vaccine on 30-JUN-2021 or during the 1st week of July 2021. On 15-JUL-2021, she thought she was having a stroke, went to the emergency room and was diagnosed with Bell's Palsy on the left side of her face. Her left eye was not closing all the way and would not blink at same pace as the right eye. She told that it had gotten better but it was not back to 100 percent.  Company comment: 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: 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Intracardiac thrombus
Clinical narrative: blood clot at the top/tip of his heart; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (patient had heart attack at age 40.), Bypass surgery in 1993 and Defibrillator/pacemaker insertion in 2006. Concurrent medical conditions included Heart disease aggravated. Concomitant products included METOPROLOL TARTRATE (METOPROLOL CT), HYDROCHLOROTHIAZIDE, PANTOPRAZOLE, ESCITALOPRAM, RANOLAZINE (RANEXA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CLOPIDOGREL, SIMVASTATIN (SIMVASTATIN AL), TAMSULOSIN HYDROCHLORIDE, TOLTERODINE L-TARTRATE (TAMSULIN T), TRAZODONE HYDROCHLORIDE (TRAZODONE FOCUS), FINASTERIDE and LOSARTAN POTASSIUM (LOSARTAN "AGP") for an unknown indication, ISOSORBIDE MONONITRATE (ISOSORBIDE AN).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) (seriousness criterion medically significant). The patient was treated with WARFARIN ongoing from 30-Jul-2021 for Adverse event, at a dose of 5 mg once a day. At the time of the report, INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Echocardiogram: abnormal (abnormal) 29Jul2021, husband received a call from his cardiologist, who said that a blood clot at the top/tip of his heart.         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. However, the medical history/ occurrence of Heart attack , Bypass surgery  and Defibrillator/pacemaker insertion, Heart disease aggravated could be a contributory factor.   This case was linked to MOD-2021-280866 (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. However, the medical history/ occurrence of Heart attack , Bypass surgery  and Defibrillator/pacemaker insertion, Heart disease aggravated could be a contributory factor.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy at injection site; Developed a hard red knot at the injection site; Left arm was really sore at the injection site; Did not have any energy (Felt drained); Developed a hard red knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C212A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site). On 02-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site) had not resolved and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non-significant follow-up received.
Sex: U
Vaccine: COVID19
Symptoms: Recurrent cancer
Clinical narrative: After getting vaccine the cancer got reactivated.; This spontaneous case was reported by a consumer and describes the occurrence of RECURRENT CANCER (After getting vaccine the cancer got reactivated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included 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 RECURRENT CANCER (After getting vaccine the cancer got reactivated.) (seriousness criterion medically significant). At the time of the report, RECURRENT CANCER (After getting vaccine the cancer got reactivated.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter The was provided updated  contact information since his  wife  passed away and also  stated that  a  friend of his next-door neighbor's who had  cancer  and  was considered  as cured few years ago, after getting vaccine the cancer got reactivated. Lab data was not provided Treatment product was not provided by the reporter  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Possible heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Possible heart inflammation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Possible heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Possible heart inflammation) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter.  No treatment details were added.  Company comment: Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow- up received : contains No new information
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Product dose omission issue
Clinical narrative: Had complications not related to the vaccine; First COVID vaccine in March, wasn't able to get the second dose until now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now). The patient was treated with Surgery for Adverse event. At the time of the report, ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ADVERSE EVENT (Had complications not related to the vaccine) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now).    No concomitant medications were provided.  Treatment for the events were not provided.  Patient got first COVID vaccine in March and had surgery later and had complications not related to the vaccine and wasn't able to get the second dose until now.  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 is not expected.   Reporter did not allow further contact; 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 is not expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: took ill and was in hospitalized; had their first dose of the Moderna vaccine on 08Jan2021 and has not gotten the second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (took ill and was in hospitalized) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ILLNESS (took ill and was in hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had their first dose of the Moderna vaccine on 08Jan2021 and has not gotten the second dose yet.). At the time of the report, ILLNESS (took ill and was in hospitalized) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had their first dose of the Moderna vaccine on 08Jan2021 and has not gotten the second dose yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator. No treatment medications provided by the reporter. Patient has not received the second dose yet.  Company comment: Causality for the event Product dose omission issue is not applicable. The event illness appears temporally dissociated with the product use; however, a causal relationship cannot be excluded.; Sender's Comments: Causality for the event Product dose omission issue is not applicable. The event illness appears temporally dissociated with the product use; however, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pulmonary mass, Wheezing
Clinical narrative: Wheezing; Coughing; Mass in her lungs; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), COUGH (Coughing) and PULMONARY MASS (Mass in her lungs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing), COUGH (Coughing) and PULMONARY MASS (Mass in her lungs). At the time of the report, WHEEZING (Wheezing), COUGH (Coughing) and PULMONARY MASS (Mass in her lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anaphylactic reaction
Clinical narrative: had an allergic reaction to the first dose of the Moderna vaccine; anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) and ANAPHYLACTIC REACTION (anaphylaxis) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) (seriousness criterion hospitalization) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) and ANAPHYLACTIC REACTION (anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported.  It was reported that, because of this anaphylaxis, the patient has been disqualified from taking the second dose of the vaccine. The patient's HCP recommended that patient receive the Pfizer vaccine for a second dose. The patient went to a vaccination clinic where they refused to give a dose of the Pfizer vaccine. The patient is concerned because she needs documentation showing 2 doses of vaccine to participate in school.  The patient does not want this reaction to prevent her from attending school. The patient has also followed up with her HCP after being declined by the vaccination provider who was steadfast in their recommendation to receive the second dose of the vaccine.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received which included updated narrative, seriousness criteria and treatment information.; Sender's Comments: 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Anxiety, Burning sensation, Chills, Condition aggravated
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus (second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin) and AMENORRHOEA (Lost of menstruation cycle) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety). On 26-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety) outcome was unknown.            Treatment drugs included steroids for symptoms after second dose. Patient has an appointment scheduled on 04-AUG-2021.   This case was linked to MOD-2021-275318 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Muscle atrophy, Muscle twitching, Neuropathy peripheral
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus (second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin) and AMENORRHOEA (Lost of menstruation cycle) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety). On 26-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety) outcome was unknown.            Treatment drugs included steroids for symptoms after second dose. Patient has an appointment scheduled on 04-AUG-2021.   This case was linked to MOD-2021-275318 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Tinnitus, Tremor, Weight decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus (second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin) and AMENORRHOEA (Lost of menstruation cycle) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety). On 26-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety) outcome was unknown.            Treatment drugs included steroids for symptoms after second dose. Patient has an appointment scheduled on 04-AUG-2021.   This case was linked to MOD-2021-275318 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid 19) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (diagnosed with covid 19). At the time of the report, COVID-19 (diagnosed with covid 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medication was reported.  No treatment medication was provided.   This case was linked to MOD-2021-013204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up information received contains NNI.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Haemorrhagic stroke, Myalgia
Clinical narrative: Patients father passed away; sore arm; Hemorrhagic stroke; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patients father passed away) and HAEMORRHAGIC STROKE (Hemorrhagic stroke) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes and Heart disorder (Heart rhythm was not normal).   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhagic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced DEATH (Patients father passed away) (seriousness criteria death and medically significant) and MYALGIA (sore arm). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGIC STROKE (Hemorrhagic stroke) and MYALGIA (sore arm) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter.  Company comment: Very limited information regarding  these  events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding  these  events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.