chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: got COVID after the booster / tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID after the booster / tested positive) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced COVID-19 (got COVID after the booster / tested positive). At the time of the report, COVID-19 (got COVID after the booster / tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.         Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter. Patient got COVID after the booster on an unknown date, may be few months ago and had minimal symptoms. Patient tested on 30 Dec 2021 and the positive result came on 31 Dec 2021.  Company Comment: This is a spontaneous case concerning a 63-year-old, male patient with no relevant history, who experienced the unexpected, non-serious, AESI event of COVID-19 on 31-Dec-21. SARS-CoV-2 antibody test was positive. The event occurred unknown duration after the third/booster dose of mRNA-1273 vaccine given for COVID-19 immunisation on an unknown date. At the time of report outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case is assessed as non-serious as per report.; Sender's Comments: This is a spontaneous case concerning a 63-year-old, male patient with no relevant history, who experienced the unexpected, non-serious, AESI event of COVID-19 on 31-Dec-21. SARS-CoV-2 antibody test was positive. The event occurred unknown duration after the third/booster dose of mRNA-1273 vaccine given for COVID-19 immunisation on an unknown date. At the time of report outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case is assessed as non-serious as per report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with the Delta Variant after having the Moderna 2 shots; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots) 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. On 16-Dec-2021, the patient experienced COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots). At the time of the report, COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive, diagnosed with the Delta Variant.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that patient went to the hospital and had an antibody infusion on 16-Dec-2021.  Company comment: This Spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 vaccine. It was reported that the patient tested positive for the Delta variant and he received antibody infusion at the hospital on the same day of the diagnosis, however it is not clear if he was admitted or not. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-452033 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This Spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 vaccine. It was reported that the patient tested positive for the Delta variant and he received antibody infusion at the hospital on the same day of the diagnosis, however it is not clear if he was admitted or not. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: vaccine killed my mother; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (vaccine killed my mother) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The reporter was really upset and stated that the Moderna COVID-19 vacine killed his mother. The caller was demanding to talk to the scientists behind the Moderna COVID-19 vaccine and also wanted information about why ingredients like graphene, mercury are inside the vaccine. He also stated that the vaccine is causing the variants and that the people taking the poison it's genocide and that he observed the ingredients under a high power microscope.  Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced serious unexpected event of DEATH in an unknown timeframe after the unspecified dose of mRNA-1273 vaccine. The information regarding autopsy and cause of death was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Non significant follow up received.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced serious unexpected event of DEATH in an unknown timeframe after the unspecified dose of mRNA-1273 vaccine. The information regarding autopsy and cause of death was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Haemolysis, Pyrexia
Clinical narrative: Hemolysis; feeling miserable; Back pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Hemolysis) 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.    Co-suspect product included non-company product RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) for Paroxysmal nocturnal haemoglobinuria.    Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (Hemolysis) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), BACK PAIN (Back pain) and PYREXIA (Fever). At the time of the report, HAEMOLYSIS (Hemolysis), FEELING ABNORMAL (feeling miserable), BACK PAIN (Back pain) and PYREXIA (Fever) had resolved. Not Provided          No concomitant medications information was reported. No treatment medications were provided. It was reported that  patient  resolved with all the symptoms after his infusion in nov 2021.Also it was reported that the patient would be following up with physician in JAN 2022.  Company comment: This is a spontaneous case concerning a male patient of unknown age, with reported medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab) and previous hemolysis after the second dose of mRNA-1273 vaccine, who experienced the serious (medically significant) unexpected event of Hemolysis. The event occurred on an unknown date after the administration of the third dose of mRNA-1273 vaccine.  At the time of the report, the outcome of the event was Recovered/Resolved. The reported medical history of Paroxysmal nocturnal hemoglobinuria remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-451867 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow-up received contains no new information.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with reported medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab) and previous hemolysis after the second dose of mRNA-1273 vaccine, who experienced the serious (medically significant) unexpected event of Hemolysis. The event occurred on an unknown date after the administration of the third dose of mRNA-1273 vaccine.  At the time of the report, the outcome of the event was Recovered/Resolved. The reported medical history of Paroxysmal nocturnal hemoglobinuria remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with the Delta Variant after having the Moderna 2 shots; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jan-2022 and was forwarded to Moderna on 16-Jan-2022.    This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots) 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 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 16-Dec-2021, the patient experienced COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots). At the time of the report, COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a  female patient of an unknown age with no reported medical history, who experienced the non-serious event of special interest COVID-19. The events occurred on an unknown lapse of time after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications were reported. Patient went to hospital and took antibody infusion on 16-DEC-2021.   This case was linked to MOD-2022-451756 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a  female patient of an unknown age with no reported medical history, who experienced the non-serious event of special interest COVID-19. The events occurred on an unknown lapse of time after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack from  booster; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (heart attack from  booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack from  booster) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack from  booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDIAL INFARCTION (heart attack from  booster) to be related.    Concomitant medication and treatment details were not reported. Reporters daughter does not want get  booster dose because her father-in-law just had a heart attack from  it and she fears that  she may get.  Company comment:  This spontaneous case concerns a male patient with no medical history reported, who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the booster dose of the mRNA-1273. No further details were provided. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient with no medical history reported, who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the booster dose of the mRNA-1273. No further details were provided. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Splenic rupture
Clinical narrative: Ruptured spleen; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC RUPTURE (Ruptured spleen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced SPLENIC RUPTURE (Ruptured spleen) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Nov-2021 due to SPLENIC RUPTURE. At the time of the report, SPLENIC RUPTURE (Ruptured spleen) was resolving.            No concomitant medication provided. No treatment medication reported.  Patient went into the ER on 06-Nov-2021 and after that they spent 3 days in ICU.  Company comment: This case concerns a 70-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization and medically significant) event of splenic rupture. The event occurred approximately 4 days after the booster dose of mRNA-1273. One day after vaccine administration the patient experienced malaise; the next day the patient experienced pain. The patient went to the emergency department where she was diagnosed with splenic rupture and had to be admitted to the ICU. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 70-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization and medically significant) event of splenic rupture. The event occurred approximately 4 days after the booster dose of mRNA-1273. One day after vaccine administration the patient experienced malaise; the next day the patient experienced pain. The patient went to the emergency department where she was diagnosed with splenic rupture and had to be admitted to the ICU. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Became immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNODEFICIENCY (Became immunocompromised) 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. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 IMMUNODEFICIENCY (Became immunocompromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Became immunocompromised) outcome 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.  The reporter was inquiring about a patient who became immunocompromised and was confused whether the patient was eligible for fourth dose. Reporter was unsure if it was diagnosed before or after receiving the Moderna COVID-19 vaccination. The patient got two doses and the booster. HCP was concerned about the vaccination regarding the out of order (booster before 3rd dose).  Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected events of immunodeficiency. The event occurred after second or third dose of mRNA-1273. As reported, the patient became immunocompromised but it was unclear if it was diagnosed before or after receiving the Moderna COVID-19 vaccination. The patient got two doses and the booster, as reported. No information regarding any diagnostic findings was provided. Reportedly,  HCP was concerned about the vaccination which was out of order (booster before 3rd dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected events of immunodeficiency. The event occurred after second or third dose of mRNA-1273. As reported, the patient became immunocompromised but it was unclear if it was diagnosed before or after receiving the Moderna COVID-19 vaccination. The patient got two doses and the booster, as reported. No information regarding any diagnostic findings was provided. Reportedly,  HCP was concerned about the vaccination which was out of order (booster before 3rd dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for Covid-19) 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. In January 2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported. No treatment medications were reported. It was reported that patient had tested positive for COVID 19 in the past week of January 2022.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for Covid 19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid 19). At the time of the report, COVID-19 (tested positive for Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious event of special interest COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious event of special interest COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Newly diagnosed multiple sclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) in a 41-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) to be related.    No concomitant and treatment medications were reported.   This case was linked to MOD-2022-453474 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature-non-study case concerning a 41-year-old male patient with no reported medical history, who experienced the serious unexpected event of newly diagnosed multiple sclerosis. The event occurred on the unknown day after the unknown dose of mRNA-1273 vaccine administration. The event was conservatively assessed as related with the product administration since the temporal association cannot be assessed at this time. The rechallenge was not applicable since the dose number was not disclosed.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Newly diagnosed multiple sclerosis; This literature-non-study case was reported, (Newly diagnosed multiple sclerosis) in a 46-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) to be related.    Concomitant medication were not provided.  Reported Newly diagnosed Multiple sclerosis (MS) following recent exposure to mRNA COVID-19 vaccines. Latency from vaccination to initial presentation varied. Neurological manifestations and clinical course appeared to be typical for MS including response to high dose steroids in 4 cases and additional need for plasmapheresis in one case; Sender's Comments: This is a literature-non-study case concerning a 46-year-old female patient with no reported medical history, who experienced the serious unexpected event of newly diagnosed multiple sclerosis. The event occurred on the unknown day after the unknown dose of mRNA-1273 vaccine administration. The event was conservatively assessed as related with the product administration since the temporal association cannot be assessed at this time. The rechallenge was not applicable since the dose number was not disclosed.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     The patient's past medical history included Heart fluttering (Had even before she got the Pfizer vaccines whenever she was anxious). Previously administered products included for Product used for unknown indication: Pfizer (1st dose - EW0164) on 22-Apr-2021 and Pfizer (2nd dose - EW0173) on 13-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced CARDIAC FLUTTER (Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Fluttering of the heart/ it became a little more frequent/ It is on and off and goes away on its own) had not resolved.            No concomitant medications were provided. The patient said that she was nervous about getting the vaccine that was probably why she was experiencing it more often than her usual. No treatment medications were reported.  Company Comment - This regulatory authority case concerns a 43 year old female patient with medical history of cardiac flutter, who experienced the serious (medically significant) unexpected event of cardiac flutter. The event occurred 2 days after the third dose of mRNA-1273 vaccine. Patient's medical history of cardiac flutter remains a confounder. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 43 year old female patient with medical history of cardiac flutter, who experienced the serious (medically significant) unexpected event of cardiac flutter. The event occurred 2 days after the third dose of mRNA-1273 vaccine. Patient's medical history of cardiac flutter remains a confounder. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination complication
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (side effects) and SUSPECTED COVID-19 (wondering if it could be Covid) 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects) and SUSPECTED COVID-19 (wondering if it could be Covid). At the time of the report, VACCINATION COMPLICATION (side effects) and SUSPECTED COVID-19 (wondering if it could be Covid) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Sender's Comments: This case concerns a patient (demographics not provided) with no relevant medical history, who experienced the unexpected Non-serious AESI event of suspected COVID-19 and vaccination complication (side effects). The events occurred at unspecified interval after the booster dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after a booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: COVID19; Felt bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Felt bad). On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID19) and FEELING ABNORMAL (Felt bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Following vaccination patient started to feel bad, 3 days after vaccination he tested positive for COVID19 and was hospitalized. He was told not to get the vaccine after 90 days and after that patient lost his vaccination card.  No treatment information was provided.  Company comment: This is a spontaneous case concerning a 53-year-old male patient with no reported medical history, who experienced the serious event of special interest COVID-19, that lead to hospitalization. Patient get covid-19 3 days after receiving the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 53-year-old male patient with no reported medical history, who experienced the serious event of special interest COVID-19, that lead to hospitalization. Patient get covid-19 3 days after receiving the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: leukemia; This spontaneous case was reported by a pharmacist and describes the occurrence of LEUKAEMIA (leukemia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Mar-2021, the patient experienced LEUKAEMIA (leukemia) (seriousness criterion medically significant). The patient was treated with Transplant (Bone marrow transplant) for Leukaemia. At the time of the report, LEUKAEMIA (leukemia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  On 24-Mar-2021, the patient was diagnosed with leukemia.  On 02-Aug-2021, the patient underwent bone marrow transplant and hospitalization was required for the same.  On 20-Dec-2021, the patient took third dose, lot number 067H21A.; Sender's Comments: This case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Leukemia. The event occurred approximately 2 months after a reported second dose of mRNA-1273 (Moderna covid-19 vaccine); though it's unclear if it was the second or third dose. The rechallenge was not applicable as event occurred after second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Product storage error, Vaccination site discomfort
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in their injection arms), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) and PRODUCT STORAGE ERROR (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) 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. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) and PRODUCT STORAGE ERROR (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients). In January 2022, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in their injection arms) and HEADACHE (headache). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) and PRODUCT STORAGE ERROR (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in their injection arms) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vaccine was stored in the fridge (4.7 C) since 03-Dec-2022. All three patients stated discomfort in their injection arms and had no fever or no chills. The patient had headache the next day. No concomitant medication information was provided. No treatment medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Follow-up received: Reporter details, patient age and events updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Headache and Tremor of hands (Patient mentioned that had the hand tremors for a long time.). Concomitant products included CAFFEINE, PARACETAMOL (ACETAMINOPHEN AND CAFFEINE) for Headache, METOPROLOL, DILTIAZEM HYDROCHLORIDE (CARTIA XT), LOSARTAN, DIGOXIN, POTASSIUM CHLORIDE, WARFARIN, LEFLUNOMIDE, ATORVASTATIN and CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM; COLECALCIFEROL]) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AGEUSIA (loss of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah".). At the time of the report, AGEUSIA (loss of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") outcome was unknown. No treatment medications were reported. Patient stated that since receiving the Moderna vaccine had been experiencing a loss of taste and also stated that did not remember exactly when the loss of taste started, it had started sometime in Feb-2021 or Mar-2021, and had lingered on. Company Comment: This case concerns a 77-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Ageusia (of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") unspecified days after receiving mRNA-1273 Vaccine. The patient received the 1st dose of on 13FEB2021, her 2nd dose on 14MAR2021. Loss of taste started sometime in FEB2021 or MAR2021, and has lingered on. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 77-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Ageusia (of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") unspecified days after receiving mRNA-1273 Vaccine. The patient received the 1st dose of on 13FEB2021, her 2nd dose on 14MAR2021. Loss of taste started sometime in FEB2021 or MAR2021, and has lingered on. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Side effects after booster) 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after booster). At the time of the report, VACCINATION COMPLICATION (Side effects after booster) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: received 0.25 ml instead of 0.5 ml; First dose on 13-NOV-2021 and second dose on 18-Jan-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml instead of 0.5 ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-NOV-2021 and second dose on 18-Jan-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-NOV-2021 and second dose on 18-Jan-2022). On 18-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml instead of 0.5 ml). On 13-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-NOV-2021 and second dose on 18-Jan-2022) had resolved. On 18-Jan-2022, ACCIDENTAL UNDERDOSE (received 0.25 ml instead of 0.5 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: had body aches.; had a 102 Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (had body aches.) and PYREXIA (had a 102 Fever) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event following immunisation (Experienced side effects with the original immunization shots).    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022, the patient experienced PYREXIA (had a 102 Fever). On 17-Jan-2022, the patient experienced MYALGIA (had body aches.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 15-Jan-2022 at an unspecified dose and frequency. In January 2022, PYREXIA (had a 102 Fever) had resolved. At the time of the report, MYALGIA (had body aches.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-Jan-2022, Body temperature: 102 (High) 102 degree Fahrenheit.         It was reported that the patient had experienced side effects with the original immunization shots, so had preventatively taken some Advil on that evening after vaccination.  No concomitant medications were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness, Infection, Vaccination complication
Clinical narrative: Had more issues than ever before; Had more infections than ever before; Ill for 3 days; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Had more issues than ever before), INFECTION (Had more infections than ever before) and ILLNESS (Ill for 3 days) 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 Thyroidectomy in 2000. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    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 (Had more issues than ever before), INFECTION (Had more infections than ever before) and ILLNESS (Ill for 3 days). At the time of the report, VACCINATION COMPLICATION (Had more issues than ever before) and INFECTION (Had more infections than ever before) outcome was unknown and ILLNESS (Ill for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient stated that they worked with COVID-19 patients for 1 year before taking the vaccine and did not get COVID-19.   This case was linked to MOD-2022-455745 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bacterial rhinitis, Illness, Impaired work ability, Infection, Upper respiratory tract infection
Clinical narrative: Had more issues than ever before; Had more infections than ever before; Ill for 3 days; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Had more issues than ever before), INFECTION (Had more infections than ever before) and ILLNESS (Ill for 3 days) 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 Thyroidectomy in 2000. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    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 (Had more issues than ever before), INFECTION (Had more infections than ever before) and ILLNESS (Ill for 3 days). At the time of the report, VACCINATION COMPLICATION (Had more issues than ever before) and INFECTION (Had more infections than ever before) outcome was unknown and ILLNESS (Ill for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient stated that they worked with COVID-19 patients for 1 year before taking the vaccine and did not get COVID-19.   This case was linked to MOD-2022-455745 (Patient Link).