chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Chills, Dehydration, Dizziness, Electrocardiogram
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy), DEHYDRATION (Found to be dehydrated), PALPITATIONS (Heart was racing/heart was pounding), BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down) and FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation and Heart rate increased.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced PALPITATIONS (Heart was racing/heart was pounding). 03-Dec-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down) and FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up). 03-Dec-2021, the patient experienced CHILLS (Experienced chills). On 04-Dec-2021, the patient experienced MALAISE (Feeling sick). On 05-Dec-2021, the patient experienced DIZZINESS (Extremely dizzy). 05-Dec-2021, the patient experienced DEHYDRATION (Found to be dehydrated). On 05-Dec-2021, DIZZINESS (Extremely dizzy), DEHYDRATION (Found to be dehydrated), PALPITATIONS (Heart was racing/heart was pounding), BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down), FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up), MALAISE (Feeling sick) and CHILLS (Experienced chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2021, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported feeling sick after the booster dose. The patient received her Moderna Booster Dose on 2DEC2021 lot number 027H21B expiration date was not provided. The patient received the booster dose in her left arm shoulder deltoid muscle. 24 hours after the booster dose the patient experienced chills, heart was racing and pounding, blood pressure went up and down. The patient was blood pressure went up and down. The patient went to the emergency room on 5DEC2021 for because she got extremely dizzy. Upon presentation to the Emergency Room the patient was found to be dehydrated. The patient reports a feeling of fogginess for 2 days. The fogginess cleared up around 5DEC2021. The patient was found to be dehydrated and received IV Fluids.    This case was linked to MOD-2022-447895, MOD-2022-447964 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy), DEHYDRATION (Found to be dehydrated), PALPITATIONS (Heart was racing/heart was pounding), BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down) and FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation and Heart rate increased.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced PALPITATIONS (Heart was racing/heart was pounding). 03-Dec-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down) and FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up). 03-Dec-2021, the patient experienced CHILLS (Experienced chills). On 04-Dec-2021, the patient experienced MALAISE (Feeling sick). On 05-Dec-2021, the patient experienced DIZZINESS (Extremely dizzy). 05-Dec-2021, the patient experienced DEHYDRATION (Found to be dehydrated). On 05-Dec-2021, DIZZINESS (Extremely dizzy), DEHYDRATION (Found to be dehydrated), PALPITATIONS (Heart was racing/heart was pounding), BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down), FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up), MALAISE (Feeling sick) and CHILLS (Experienced chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2021, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported feeling sick after the booster dose. The patient received her Moderna Booster Dose on 2DEC2021 lot number 027H21B expiration date was not provided. The patient received the booster dose in her left arm shoulder deltoid muscle. 24 hours after the booster dose the patient experienced chills, heart was racing and pounding, blood pressure went up and down. The patient was blood pressure went up and down. The patient went to the emergency room on 5DEC2021 for because she got extremely dizzy. Upon presentation to the Emergency Room the patient was found to be dehydrated. The patient reports a feeling of fogginess for 2 days. The fogginess cleared up around 5DEC2021. The patient was found to be dehydrated and received IV Fluids.    This case was linked to MOD-2022-447895, MOD-2022-447964 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Device related infection
Clinical narrative: after receiving a dose of the Moderna vaccine (not booster), her implants became infected; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE RELATED INFECTION (after receiving a dose of the Moderna vaccine (not booster), her implants became infected) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast implant user (had breast implants).    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 DEVICE RELATED INFECTION (after receiving a dose of the Moderna vaccine (not booster), her implants became infected) (seriousness criterion medically significant). The patient was treated with Surgery (One implant need to be removed) for Device related infection. At the time of the report, DEVICE RELATED INFECTION (after receiving a dose of the Moderna vaccine (not booster), her implants became infected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.  Company comment:  This case concerns a female patient with no relevant medical history who experienced serious unexpected event of device related infection, reported as breast implant infection, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no relevant medical history who experienced serious unexpected event of device related infection, reported as breast implant infection, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse event,side effects that I had; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event,side effects that I had) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event,side effects that I had). At the time of the report, VACCINATION COMPLICATION (adverse event,side effects that I had) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: later died.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (later died.) in a 7-decade-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Caller reported that she heard from her friends about their two aunts in their 70's that received the second Moderna COVID-19 dose and they each later died. No additional information known or provided.  No concomitant medication provided.  No treatment information mentioned   This case was linked to MOD-2022-445279, MOD-2022-445768, MOD-2022-445950.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 7decade-old female patient with no reported medical history, who experienced the serious  unexpected event Death, on an unknown date after receiving  the second dose of mRNA-1273.  The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Platelet count
Clinical narrative: very dizzy; massive stroke; cascade of blood disorders and blood issues; cascade of organ issues; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), CEREBROVASCULAR ACCIDENT (massive stroke), BLOOD DISORDER (cascade of blood disorders and blood issues) and MULTI-ORGAN DISORDER (cascade of organ issues) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 DIZZINESS (very dizzy) (seriousness criterion hospitalization), CEREBROVASCULAR ACCIDENT (massive stroke) (seriousness criteria hospitalization and medically significant), BLOOD DISORDER (cascade of blood disorders and blood issues) (seriousness criterion hospitalization) and MULTI-ORGAN DISORDER (cascade of organ issues) (seriousness criteria hospitalization and medically significant). At the time of the report, DIZZINESS (very dizzy), CEREBROVASCULAR ACCIDENT (massive stroke), BLOOD DISORDER (cascade of blood disorders and blood issues) and MULTI-ORGAN DISORDER (cascade of organ issues) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: decreased (Low) Decreased. On an unknown date, Oxygen saturation: decreased (Low) Decreased. On an unknown date, Platelet count: decreased (Low) decreased.         No concomitant medications were provided As reported, four days after after the second Moderna COVID-19 dose, he became very dizzy and had a massive stroke. He was in the ICU for 3 weeks. He had a cascade of blood disorders and blood issues and organ issues. His platelets, oxygen and hemoglobin were down. He received 2 transfusions to replace his red blood cells.  Company comment: This is a spontaneous case concerning a 73-year-old male patient with no medical history reported, who experienced the unexpected serious events of Dizziness, Cerebrovascular accident, Blood disorder and Multi-organ disorder four days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445768, MOD-2022-445279, MOD-2022-447065 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no medical history reported, who experienced the unexpected serious events of Dizziness, Cerebrovascular accident, Blood disorder and Multi-organ disorder four days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Device related infection
Clinical narrative: She has been informed of similar adverse effects with other implant recipients (implants became infected); This spontaneous case was reported by a consumer and describes the occurrence of DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Breast prosthesis implantation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) (seriousness criterion medically significant). At the time of the report, DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) outcome was unknown.        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.  Company comment:  This case concerns a  female patient with no reported medical history who experienced serious unexpected event of device related infection, reported as breast implant became infected, that occurred after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a  female patient with no reported medical history who experienced serious unexpected event of device related infection, reported as breast implant became infected, that occurred after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Investigation, Product dose omission issue
Clinical narrative: Greater than 35 days between Moderna Covid-19; Patient went to a health screening on and was told there were health issues with his blood; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD DISORDER (Patient went to a health screening on and was told there were health issues with his blood) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced BLOOD DISORDER (Patient went to a health screening on and was told there were health issues with his blood). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19). At the time of the report, BLOOD DISORDER (Patient went to a health screening on and was told there were health issues with his blood) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2022, Investigation: abnormal (abnormal) health issues with his blood.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: later died.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (later died.) in an 8-decade-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Company comment: This is a spontaneous case concerning a 8-decade-old female patient with no reported medical history, who experienced the serious  unexpected event Death, on an unknown date after receiving  the second dose of mRNA-1273.  The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reported that she heard from her friends about their two aunts in their 70s that received the second Moderna COVID-19 dose and they each later died.  No additional information known or provided.  Consent not given for Safety follow-up.  Caller wished to remain anonymous.  No concomitant medication provided.   No treatment information mentioned.   This case was linked to MOD-2022-445768, MOD-2022-445950, MOD-2022-447065.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 8-decade-old female patient with no reported medical history, who experienced the serious  unexpected event Death, on an unknown date after receiving  the second dose of mRNA-1273.  The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Diabetes mellitus
Clinical narrative: After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of DIABETES MELLITUS (After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (After take the vaccines now blood work shows i am a diabetic, was not before take the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) no blood work shows i am a diabetic. On an unknown date, Blood test: abnormal (abnormal) Blood work shows as  diabetic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment:  This case concerns a patient with no reported medical history who experienced serious unexpected event of diabetes mellitus, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. Reportedly, the patient denied having any sings or symptoms of diabetes prior to vaccination . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced serious unexpected event of diabetes mellitus, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. Reportedly, the patient denied having any sings or symptoms of diabetes prior to vaccination . The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: I have been feeling extremely out of breath; my energy level is low as well; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (I have been feeling extremely out of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced DYSPNOEA (I have been feeling extremely out of breath) (seriousness criterion medically significant) and ASTHENIA (my energy level is low as well). At the time of the report, DYSPNOEA (I have been feeling extremely out of breath) and ASTHENIA (my energy level is low as well) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected, serious event of Dyspnoea and unexpected, non-serious event of Asthenia on an unspecified date after the third dose of mRNA-1273 vaccine. The events had not resolved. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected, serious event of Dyspnoea and unexpected, non-serious event of Asthenia on an unspecified date after the third dose of mRNA-1273 vaccine. The events had not resolved. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster, Shock, Visual impairment
Clinical narrative: Got an adverse reaction which placed patient body into shock; Optic shingles; Lost part of my vision; This spontaneous case was reported by a consumer and describes the occurrence of SHOCK (Got an adverse reaction which placed patient body into shock) and OPHTHALMIC HERPES ZOSTER (Optic shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SHOCK (Got an adverse reaction which placed patient body into shock) (seriousness criterion medically significant), OPHTHALMIC HERPES ZOSTER (Optic shingles) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Lost part of my vision). At the time of the report, SHOCK (Got an adverse reaction which placed patient body into shock) had resolved and OPHTHALMIC HERPES ZOSTER (Optic shingles) and VISUAL IMPAIRMENT (Lost part of my vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient received the first shot in March and got an adverse reaction which placed patient body into shock and gave patient optic shingles and patient lost part of vision.   After 8 months of treatment, patient was cleared by a doctor to receive pfizer second shot tomorrow under anti virals.  Company comment: This case concerns a female patient with no medical history reported, who experienced the unexpected events of shock and ophthalmic herpes zoster and non serious event of visual impairment. The events occurred after the first dose of mRNA-1273. As reported, the patient received the first shot in March and got an adverse reaction which placed patient body into shock and gave patient optic shingles and patient lost part of vision. After 8 months of treatment, patient was cleared by a doctor to receive pfizer second shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no medical history reported, who experienced the unexpected events of shock and ophthalmic herpes zoster and non serious event of visual impairment. The events occurred after the first dose of mRNA-1273. As reported, the patient received the first shot in March and got an adverse reaction which placed patient body into shock and gave patient optic shingles and patient lost part of vision. After 8 months of treatment, patient was cleared by a doctor to receive pfizer second shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got very sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got very sick) 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 ILLNESS (Got very sick). At the time of the report, ILLNESS (Got very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having some weird side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (having some weird side effects) 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 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (having some weird side effects). At the time of the report, VACCINATION COMPLICATION (having some weird side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (experienced soreness) in a 62-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (experienced soreness). At the time of the report, MYALGIA (experienced soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included Vitamins.  No treatment was given.   This case was linked to MOD-2022-452101, MOD-2022-452106 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 15-Jul-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown.            No Treatment was received. The patient stated that he received both the doses on the exact recommended time frame.   This case was linked to MOD-2022-452074, MOD-2022-452106 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive PCR test 7 months after 2nd dose; Positive PCR test 7 months after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive PCR test 7 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR test 7 months after 2nd dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 006221A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced COVID-19 (Positive PCR test 7 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR test 7 months after 2nd dose). At the time of the report, COVID-19 (Positive PCR test 7 months after 2nd dose) had not resolved and DRUG INEFFECTIVE (Positive PCR test 7 months after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.         Concomitant and treatment medication were not reported. The patient had a positive PCR test today (06-Jan-2022).  This is a case of Lack of efficacy that concerns a 40-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19. The event occurred approximately 7 months after receiving the second dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a case of Lack of efficacy that concerns a 40-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19. The event occurred approximately 7 months after receiving the second dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Suddenly died from a heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Suddenly died from a heart attack) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jun-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 04-Jan-2022, the patient experienced MYOCARDIAL INFARCTION (Suddenly died from a heart attack) (seriousness criteria death and medically significant). The patient died on 04-Jan-2022. The reported cause of death was suddenly died from a heart attack. It is unknown if an autopsy was performed.            No concomitant medication details was provided. The patient was  died from unexplained experimental mRNA technology which was seen result in massive wave  of youth illness and death. No treatment medication details was provided. Company comment:This case concerns 13-years-old, male patient with no reported medical history, who experienced the unexpected Fatal AESI event of Myocardial infarction event (seriousness criteria death and medically significant). The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine. At the time of report, very limited information has been provided about the patient and about the event leading to the fatal outcome. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns 13-years-old, male patient with no reported medical history, who experienced the unexpected Fatal AESI event of Myocardial infarction event (seriousness criteria death and medically significant). The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine. At the time of report, very limited information has been provided about the patient and about the event leading to the fatal outcome. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Suddenly died from a heart attack
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Mild COVID-19 disease with a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild COVID-19 disease with a little fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (Mild COVID-19 disease with a little fatigue). At the time of the report, COVID-19 (Mild COVID-19 disease with a little fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient had mild COVID-19 Disease on  SEP2021 with a little Fatigue only. Patient received Monoclonal Antibody on 17-Sep-2021.  Company comment: This case concerns a 74-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of COVID-19. The event occurred 6 months after the second dose of mRNA 1273 COVID-19 vaccine. Patient had mild COVID-19, and felt a little fatigue only. She received monoclonal antibody as treatment. The patient's age may have increased her risk of getting infected with COVID-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of COVID-19. The event occurred 6 months after the second dose of mRNA 1273 COVID-19 vaccine. Patient had mild COVID-19, and felt a little fatigue only. She received monoclonal antibody as treatment. The patient's age may have increased her risk of getting infected with COVID-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: problem/ bout put me in the hospital; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (problem/ bout put me in the hospital) 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 VACCINATION COMPLICATION (problem/ bout put me in the hospital) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (problem/ bout put me in the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious event of Vaccination complication that resulted in hospitalisation after mRNA-1273 vaccine. The reporter stated a "problem/ bout put me in the hospital". The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Follow-up received is Non Significant. Reporter's qualification is updated.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious event of Vaccination complication that resulted in hospitalisation after mRNA-1273 vaccine. The reporter stated a "problem/ bout put me in the hospital". The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: We both have the Omicron virus right now; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (We both have the Omicron virus right now) 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 COVID-19 (We both have the Omicron virus right now). At the time of the report, COVID-19 (We both have the Omicron virus right now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Omicron virus confirmed by a home test..     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.   Booster shot was planned on January 18th but was confirmed with Omicron virus by a home test. No concomitant medication were given. No treatment information were given.  This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19. The event occurred on an unknown interval after receiving an unspecified dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19. The event occurred on an unknown interval after receiving an unspecified dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after receiving a booster, died the next day; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after receiving a booster, died the next day) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant and treatment details were provided.  The reporter stated that,  'a relative of his died after receiving a booster, died the next day.'  Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of death. The event occurred 1 day after the third dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. As reported, patient died after receiving a booster, died the next day. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-445190, US-MODERNATX, INC.-MOD-2022-445179, US-MODERNATX, INC.-MOD-2021-127441, US-MODERNATX, INC.-MOD-2022-445363, US-MODERNATX, INC.-MOD-2021-420943, US-MODERNATX, INC.-MOD-2021-385861 (E2B Linked Report).; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of death. The event occurred 1 day after the third dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. As reported, patient died after receiving a booster, died the next day. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-445190:Mothers case US-MODERNATX, INC.-MOD-2022-445179: US-MODERNATX, INC.-MOD-2021-127441: US-MODERNATX, INC.-MOD-2022-445363: US-MODERNATX, INC.-MOD-2021-420943: US-MODERNATX, INC.-MOD-2021-385861:; Reported Cause(s) of Death: died after receiving a booster, died the next day
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Based on case narrative, the patient was just asking when is the ideal date of booster dose after a Covid-19 infection. Patient did not state that he tested positive after Moderna vaccination. Hence, this case needs to be invalidated.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Friend that died and that was fully  vaccinated with the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Friend that died and that was fully  vaccinated with the Moderna) 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 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            It was reported that patient died and that was fully vaccinated with the Moderna covid19 vaccine, but reporter could not provide any more details about patient.  Company comment:  This case concerns a patient with no reported medical history who experienced serious unexpected event of death, that occurred day after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose and fatal event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced serious unexpected event of death, that occurred day after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose and fatal event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) 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 31-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. She was not hospitalized, she stayed at home. She was fully vaccinated and did not know manufacturer.  Company Comment: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected  event of SARS-CoV-2 test positive. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected  event of SARS-CoV-2 test positive. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.