chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2022-437373 (Patient Link).; Sender's Comments: This case concerns a patient, with medical history (not reported), who experienced the serious unexpected event(s) of Influenza like illness. The event(s) started occurring approximately within 1 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2022-437373 (Patient Link).; Sender's Comments: This case concerns a patient, with medical history (not reported), who experienced the serious unexpected event(s) of Influenza like illness. The event(s) started occurring approximately within 1 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: blacked out which she described as conscious but no memory of what happened; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out which she described as conscious but no memory of what happened) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy and Hives (for three months) since 2021.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (blacked out which she described as conscious but no memory of what happened) (seriousness criterion medically significant). In September 2021, LOSS OF CONSCIOUSNESS (blacked out which she described as conscious but no memory of what happened) had resolved.            No concomitant and treatment medications were provided.  Patient consulted a dermatologist and allergist as the medications that she has been on, did not seem to work. Patient mentioned that she would not have the booster dose.  This is a spontaneous case concerning a 52-year-old female patient with medical history of Egg allergy and Hives, who experienced the unexpected serious (medically significant) event of loss of consciousness . The rechallenge was not applicable, as the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to MOD-2022-437368 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient with medical history of Egg allergy and Hives, who experienced the unexpected serious (medically significant) event of loss of consciousness . The rechallenge was not applicable, as the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: blacked out which she described as conscious but no memory of what happened; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out which she described as conscious but no memory of what happened) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy and Hives (for three months) since 2021.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (blacked out which she described as conscious but no memory of what happened) (seriousness criterion medically significant). In September 2021, LOSS OF CONSCIOUSNESS (blacked out which she described as conscious but no memory of what happened) had resolved.            No concomitant and treatment medications were provided.  Patient consulted a dermatologist and allergist as the medications that she has been on, did not seem to work. Patient mentioned that she would not have the booster dose.  This is a spontaneous case concerning a 52-year-old female patient with medical history of Egg allergy and Hives, who experienced the unexpected serious (medically significant) event of loss of consciousness . The rechallenge was not applicable, as the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to MOD-2022-437368 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient with medical history of Egg allergy and Hives, who experienced the unexpected serious (medically significant) event of loss of consciousness . The rechallenge was not applicable, as the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Renal cancer
Clinical narrative: diagnosed with Kidney cancer; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (diagnosed with Kidney cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 010M(or N)20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced RENAL CANCER (diagnosed with Kidney cancer) (seriousness criterion medically significant). At the time of the report, RENAL CANCER (diagnosed with Kidney cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Angiogram: result not reported she had an MRA on her back.         Concomitant medication use was not provided. Treatment information was not provided.  It was reported that the cancer might be an slow-grown  and she is under more documentation to get a fully diagnose. She was told that she might have had the cancer for almost 10 years. She stated at the end of the call that she had an MRA on her back in October 2020, and believes that from that study she was diagnosed with Kidney cancer after eight months.  Company Comment: This case concerns a 74-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Renal cancer. The event was diagnosed 4 months after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). It was reported that the patient was told that she might have had the cancer for almost 10 years. She stated that she had an MRA on her back in October 2020, and believes that from that study she was diagnosed with Kidney cancer after eight months. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and on 04-Mar-2021, received second dose of mRNA-1273. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Renal cancer. The event was diagnosed 4 months after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). It was reported that the patient was told that she might have had the cancer for almost 10 years. She stated that she had an MRA on her back in October 2020, and believes that from that study she was diagnosed with Kidney cancer after eight months. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and on 04-Mar-2021, received second dose of mRNA-1273. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Vaccination complication
Clinical narrative: I lost consciousness; I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I lost consciousness) and VACCINATION COMPLICATION (I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced LOSS OF CONSCIOUSNESS (I lost consciousness) (seriousness criteria hospitalization, disability and medically significant) and VACCINATION COMPLICATION (I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (I lost consciousness) and VACCINATION COMPLICATION (I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Company comment:This is a spontaneous case concerning a female patient of an unknown age with no medical history provided, who experienced the serious unexpected events of Loss of consciousness and Vaccination complication(seriousness criterion hospitalization). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). On 03-Jan-2022, the patient experienced Loss of consciousness and Vaccination complication. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-437625, MOD-2022-437619 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history provided, who experienced the serious unexpected events of Loss of consciousness and Vaccination complication(seriousness criterion hospitalization). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). On 03-Jan-2022, the patient experienced Loss of consciousness and Vaccination complication. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nausea, SARS-CoV-1 test positive, Skin disorder
Clinical narrative: 5 days after first shot she tested positive for covid; small bumps in the hand; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (5 days after firs shoot she tested positive for covid), SKIN DISORDER (small bumps in the hand), HEADACHE (Headache) and NAUSEA (Nausea) 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 COVID-19 (5 days after firs shoot she tested positive for covid), SKIN DISORDER (small bumps in the hand), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, COVID-19 (5 days after firs shoot she tested positive for covid) had resolved and SKIN DISORDER (small bumps in the hand), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided. Company comment: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the non-serious unexpected, according CCDS, AESI of COVID-19 and the non-serious unexpected, according CCDS,  event of Skin disorder and the non-serious expected, according CCDS,  events of headache and nausea. . The event COVID-19 occurred approximately 5 days after the first dose of mRNA-1273 vaccine, no onset date was provided for other events. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-437661 (Patient Link).; Sender's Comments: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the non-serious unexpected, according CCDS, AESI of COVID-19 and the non-serious unexpected, according CCDS,  event of Skin disorder and the non-serious expected, according CCDS,  events of headache and nausea. . The event COVID-19 occurred approximately 5 days after the first dose of mRNA-1273 vaccine, no onset date was provided for other events. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: She had every adverse reaction; Slept for 15hs; Fever; Chills; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had every adverse reaction), HYPERSOMNIA (Slept for 15hs), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 91875) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 (She had every adverse reaction), HYPERSOMNIA (Slept for 15hs), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, VACCINATION COMPLICATION (She had every adverse reaction), HYPERSOMNIA (Slept for 15hs), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported. Company comment: This is a regulatory case concerning unknown age, female patient with no medical history reported, who experienced the non-serious unexpected, according Regulatory Authority of Hypersomnia. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.   This case was linked to MOD-2022-437646 (Patient Link).; Sender's Comments: This is a regulatory case concerning unknown age, female patient with no medical history reported, who experienced the non-serious unexpected, according Regulatory Authority Hypersomnia. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: yes, I had covid-19 in september. I was vaccinated in January and February 2020. Is it safe for me to get the booster?; This spontaneous case was reported by another health care professional and describes the occurrence of COVID-19 (yes, I had covid-19 in september. I was vaccinated in January and February 2020. Is it safe for me to get the 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.   In January 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2020, 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 (yes, I had covid-19 in september. I was vaccinated in January and February 2020. Is it safe for me to get the booster?). At the time of the report, COVID-19 (yes, I had covid-19 in september. I was vaccinated in January and February 2020. Is it safe for me to get the booster?) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI COVID-19. The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI COVID-19. The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago). At the time of the report, COVID-19 (Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) PCR positive.         No concomitant drug details were reported. No treatment details were reported.  Patient stated that he never lost sense of taste or smell. Patient had mild COVID symptoms such as cough and being lethergic Patient received the booster dose on 03-Jan-2022 i.e. 7 days after testing positive for COVID-19.  Company comment :This is a spontaneous case concerning a 75-year-old, male patient with no medical history reported who was diagnosed with COVID-19 7 months after receiving the second dose of mRNA1273. Patient refers having mild symptoms. He confirmed receiving the booster dose on 03JAN2022 without any associated AEs. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old, male patient with no medical history reported who was diagnosed with COVID-19 7 months after receiving the second dose of mRNA1273. Patient refers having mild symptoms. He confirmed receiving the booster dose on 03JAN2022 without any associated AEs. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 drug details were reported.  No treatment information was provided.  Patient just tested positive for COVID-19. Patient was scheduled to get the booster on Monday, 03Jan2022. Patient cancelled the appointment and wants to know when to get the booster.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Infection
Clinical narrative: breakthrough covid infection; covid infection after first 2 doses of moderna; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (breakthrough covid infection) and COVID-19 (covid infection after first 2 doses of moderna) 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, 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 INFECTION (breakthrough covid infection) and COVID-19 (covid infection after first 2 doses of moderna). At the time of the report, INFECTION (breakthrough covid infection) and COVID-19 (covid infection after first 2 doses of moderna) 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.  Company comment: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected non serious events of infection and COVID 19. The events occurred on an unknown date after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected non serious events of infection and COVID 19. The events occurred on an unknown date after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Myelitis transverse
Clinical narrative: Exhibiti ng signs of what has now been determined to be transvers myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Exhibiti ng signs of what has now been determined to be transvers myelitis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MYELITIS TRANSVERSE (Exhibiti ng signs of what has now been determined to be transvers myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Exhibiti ng signs of what has now been determined to be transvers myelitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: abnormal (abnormal) Diagnosed with transvers myelitis..         No concomitant medications were provided.  Within three weeks of the second shot the patient began exhibiting signs of what has now been determined to be transvers myelitis. The patient have gone through a battery of test and the symptom seem to lead to this conclusion by all of the neurologist. There appears to be a likely causation between the vaccine and transvers myelitis.  No treatment medications were reported.  Company Comment - This regulatory authority case concerns a male patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of myelitis transverse. The event occurred three weeks after the second dose of mRNA-1273 vaccine. 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.   Reporter did not allow further contact; Sender's Comments: This regulatory authority case concerns a male patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of myelitis transverse. The event occurred three weeks after the second dose of mRNA-1273 vaccine. 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: F
Vaccine: COVID19
Symptoms: Narcolepsy
Clinical narrative: After the booster dose caller cant stay awake, it's like narcolepsy.; This spontaneous case was reported by a nurse and describes the occurrence of NARCOLEPSY (After the booster dose caller cant stay awake, it's like narcolepsy.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 NARCOLEPSY (After the booster dose caller cant stay awake, it's like narcolepsy.) (seriousness criterion medically significant). At the time of the report, NARCOLEPSY (After the booster dose caller cant stay awake, it's like narcolepsy.) 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.  Company Comment - This regulatory authority case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of narcolepsy. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. 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.     This case was linked to MOD-2022-438428, MOD-2022-438418 (Patient Link).; Sender's Comments: This regulatory authority case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of narcolepsy. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. 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.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever caused man to convulse; is showing up ill; his arm is so sore he can barely move it; with chills; a sly fever/Fever reached 105.6F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jan-2022 and was forwarded to Moderna on 04-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of FEBRILE CONVULSION (Fever caused man to convulse), ILLNESS (is showing up ill), PAIN IN EXTREMITY (his arm is so sore he can barely move it), CHILLS (with chills) and PYREXIA (a sly fever/Fever reached 105.6F) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEBRILE CONVULSION (Fever caused man to convulse), ILLNESS (is showing up ill), PAIN IN EXTREMITY (his arm is so sore he can barely move it), CHILLS (with chills) and PYREXIA (a sly fever/Fever reached 105.6F). At the time of the report, FEBRILE CONVULSION (Fever caused man to convulse), ILLNESS (is showing up ill), PAIN IN EXTREMITY (his arm is so sore he can barely move it) and CHILLS (with chills) outcome was unknown and PYREXIA (a sly fever/Fever reached 105.6F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105.6 (High) Fever reached 105.6F before.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company Comment: This spontaneous case concerns an 88-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of febrile convulsion and other associated unexpected and expected, non-serious events after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event pyrexia had resolved at the time of the report. The outcomes of the other events were unknown at the time of the report. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 88-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of febrile convulsion and other associated unexpected and expected, non-serious events after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event pyrexia had resolved at the time of the report. The outcomes of the other events were unknown at the time of the report. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Hyperhidrosis, Syncope
Clinical narrative: patient fainted; shortness of breath when standing up; unable to stand up; excess of sweating; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (patient fainted), DYSPNOEA (shortness of breath when standing up), DYSSTASIA (unable to stand up) and HYPERHIDROSIS (excess of sweating) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 007B21A and 0391321A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced SYNCOPE (patient fainted), DYSPNOEA (shortness of breath when standing up), DYSSTASIA (unable to stand up) and HYPERHIDROSIS (excess of sweating). At the time of the report, SYNCOPE (patient fainted), DYSPNOEA (shortness of breath when standing up), DYSSTASIA (unable to stand up) and HYPERHIDROSIS (excess of sweating) had not resolved.      Concomitant medication was not provided.  Patient never tested positive for COVID and did not had any previous condition or any health problem before this.  Treatment information was not provided.  The patient received the booster dose around 3PM and symptoms started at 9 PM on the same day. At the time of reporting symptoms were ongoing and raising.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: this as happened to friend of mine around my age (21), menstrual spotting; this as happened to friend of mine around my age (21), period started unexpectedly.; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (this as happened to friend of mine around my age (21), menstrual spotting) and MENSTRUAL DISORDER (this as happened to friend of mine around my age (21), period started unexpectedly.) in an adult 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 INTERMENSTRUAL BLEEDING (this as happened to friend of mine around my age (21), menstrual spotting) and MENSTRUAL DISORDER (this as happened to friend of mine around my age (21), period started unexpectedly.). At the time of the report, INTERMENSTRUAL BLEEDING (this as happened to friend of mine around my age (21), menstrual spotting) and MENSTRUAL DISORDER (this as happened to friend of mine around my age (21), period started unexpectedly.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2022-443324 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3005243) 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) (Intramuscular) .25 ml. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) had resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. grav in hebd 12+0   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Translation received on 11-Jan-2022, Contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: Stayed in bed all day long; Appetite /no appetite; Headache; Nausea; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Stayed in bed all day long), DECREASED APPETITE (Appetite /no appetite), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Slight fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 FEELING ABNORMAL (Stayed in bed all day long), DECREASED APPETITE (Appetite /no appetite), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Slight fever). At the time of the report, FEELING ABNORMAL (Stayed in bed all day long), DECREASED APPETITE (Appetite /no appetite), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Tgey said exactly injected 0.3 ml undiluted doze; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Tgey said exactly injected 0.3 ml undiluted doze) 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 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 08-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Tgey said exactly injected 0.3 ml undiluted doze). On 08-Jan-2022, ACCIDENTAL OVERDOSE (Tgey said exactly injected 0.3 ml undiluted doze) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given < 25 days from 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given < 25 days from 1st dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given < 25 days from 1st dose). On 30-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given < 25 days from 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: I recently got a second booster moderna  or 4th shot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (I recently got a second booster moderna  or 4th shot) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (I recently got a second booster moderna  or 4th shot). At the time of the report, EXTRA DOSE ADMINISTERED (I recently got a second booster moderna  or 4th shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dehydration, Pain in extremity, Retching, Vomiting
Clinical narrative: very sick to my stomach; retching/dry heaves; very sore arm; dehydration; vomiting/ like a kid that went out drinking and threwup alcohol; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (very sick to my stomach), RETCHING (retching/dry heaves), PAIN IN EXTREMITY (very sore arm), DEHYDRATION (dehydration) and VOMITING (vomiting/ like a kid that went out drinking and threwup alcohol) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Menopausal in January 2011 and Surgery. Concurrent medical conditions included Bone disorder and Joint disorder.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (very sick to my stomach), RETCHING (retching/dry heaves), PAIN IN EXTREMITY (very sore arm), DEHYDRATION (dehydration) and VOMITING (vomiting/ like a kid that went out drinking and threwup alcohol). At the time of the report, ABDOMINAL DISCOMFORT (very sick to my stomach), RETCHING (retching/dry heaves), PAIN IN EXTREMITY (very sore arm), DEHYDRATION (dehydration) and VOMITING (vomiting/ like a kid that went out drinking and threwup alcohol) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not take any medication to treat the side effects but thought about taking a rapid release Tylenol. the patient had comorbidities, a couple of surgeries, and bone issues, joint disorders and has been menopausal in Jan-2011. Patient was not currently on any medications.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-446928, MOD-2022-446932 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red bumps two weeks after receiving each of the Moderna shots; Itchy bumps two weeks after receiving each of the Moderna shots; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (Red bumps two weeks after receiving each of the Moderna shots) and RASH PRURITIC (Itchy bumps two weeks after receiving each of the Moderna shots) 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 RASH ERYTHEMATOUS (Red bumps two weeks after receiving each of the Moderna shots) and RASH PRURITIC (Itchy bumps two weeks after receiving each of the Moderna shots). At the time of the report, RASH ERYTHEMATOUS (Red bumps two weeks after receiving each of the Moderna shots) and RASH PRURITIC (Itchy bumps two weeks after receiving each of the Moderna shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-446935 (Patient Link).