chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Mar-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with RIVAROXABAN (XARELTO) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency; ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency; TAMSULOSIN at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Eye discomfort, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke) 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.   Patient stated they were not taking any medications at the time of the first dose. Second dose was administered on 01Sept2021, lot#062E21A. Patient inquires if they should get the booster in a month.  Company comment: This is a spontaneous case concerning a 74-year-old male patient with no medical history reported, who experienced the unexpected serious AESI of Cerebrovascular accident 15 days after the first dose of mRNA-1273 vaccine. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445531 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 74-year-old male patient with no medical history reported, who experienced the unexpected serious AESI of Cerebrovascular accident 15 days after the first dose of mRNA-1273 vaccine. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Lip swelling, Mechanical urticaria, Night sweats, Pruritus
Clinical narrative: broke out into hives everywhere; hives extremely itchy; lip swelling; night sweats; dermatographia; skin swells up; angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema), URTICARIA (broke out into hives everywhere), PRURITUS (hives extremely itchy), LIP SWELLING (lip swelling) and NIGHT SWEATS (night sweats) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced URTICARIA (broke out into hives everywhere) and PRURITUS (hives extremely itchy). In December 2021, the patient experienced ANGIOEDEMA (angioedema), LIP SWELLING (lip swelling), NIGHT SWEATS (night sweats), MECHANICAL URTICARIA (dermatographia) and SKIN SWELLING (skin swells up). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (angioedema), URTICARIA (broke out into hives everywhere), PRURITUS (hives extremely itchy), LIP SWELLING (lip swelling), NIGHT SWEATS (night sweats), MECHANICAL URTICARIA (dermatographia) and SKIN SWELLING (skin swells up) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Zyrtec at least every 2 days or else the hives came back like clockwork. Patient reported she thought she was not pregnant because she had an IUD.   This case was linked to MOD-2022-445506 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Urticaria
Clinical narrative: broke out into hives everywhere; hives extremely itchy; lip swelling; night sweats; dermatographia; skin swells up; angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema), URTICARIA (broke out into hives everywhere), PRURITUS (hives extremely itchy), LIP SWELLING (lip swelling) and NIGHT SWEATS (night sweats) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced URTICARIA (broke out into hives everywhere) and PRURITUS (hives extremely itchy). In December 2021, the patient experienced ANGIOEDEMA (angioedema), LIP SWELLING (lip swelling), NIGHT SWEATS (night sweats), MECHANICAL URTICARIA (dermatographia) and SKIN SWELLING (skin swells up). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (angioedema), URTICARIA (broke out into hives everywhere), PRURITUS (hives extremely itchy), LIP SWELLING (lip swelling), NIGHT SWEATS (night sweats), MECHANICAL URTICARIA (dermatographia) and SKIN SWELLING (skin swells up) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Zyrtec at least every 2 days or else the hives came back like clockwork. Patient reported she thought she was not pregnant because she had an IUD.   This case was linked to MOD-2022-445506 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Exposure to COVID-19; Lack of drug effect; Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 011J20A and 028L20A) 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) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, COVID-19 (Tested positive for COVID) had not resolved and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Patient was 100 percentage asymptomatic. Patient tested for covid-19 on 06 Jan 2022 and results came back positive later on the day. Patient decided to get tested because she was exposure. HCP was not taking any medications at the time of report.; Sender's Comments: This spontaneous case concerns a female patient with unknown  age , healthcare worker, with no medical history reported ,  who experienced non-serious unexpected, AESI event of Covid 19 which occurred 2 months 13 days post vaccination with the 3rd dose of mRNA-1273 vaccine  ( Moderna Covid 19 Vaccine ) . This was accompanied by other non-serious , unexpected events of Drug ineffective and Exposure to SARS COV-2 . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID after receiving all three Moderna vaccines) in a 55-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 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 03-Jan-2022, the patient experienced COVID-19 (Patient tested positive for COVID after receiving all three Moderna vaccines). At the time of the report, COVID-19 (Patient tested positive for COVID after receiving all three Moderna vaccines) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medication was reported. No treatment medications were reported. Company comment: This is a spontaneous case concerning a 55-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the third dose of mRNA-1273 vaccine. The exact details regarding the either of the doses were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-445636, MOD-2022-444983 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the third dose of mRNA-1273 vaccine. The exact details regarding the either of the doses were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID after vaccination). At the time of the report, COVID-19 (contracted COVID after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Contracted COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was a lady, She is staying home and was not hospitalized and was quarantined for 10 days.  Reporter was not sure about which manufacturer patient got the vaccine from and reported that it might be Pfizer due to patient being from over seas.  Concomitant and treatment medication was not reported.  This is a spontaneous case concerning  a female patient of unknown age,  with no relevant medical history, who experienced the unexpected non-serious events of Covid-19. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed.  The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age,  with no relevant medical history, who experienced the unexpected non-serious events of Covid-19. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed.  The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Massive heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Bypass surgery.    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 MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Massive heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  The patient had quadruple bypass surgery 2 weeks after taking the vaccine.  The side effects and deaths are being underreported. Some doctors have said they have tried to report the side effects from the COVID shots online and were Blocked.  Company comment: This case concerns a patient of an unknown age and gender with relevant history of bypass surgery, who experienced serious unexpected MYOCARDIAL INFARCTION in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). Treatment information was not provided and outcome is unknown. The patient's medical history of bypass surgery remains a major confounding factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445808, MOD-2022-445817 (Patient Link).; Sender's Comments: This case concerns a patient of an unknown age and gender with relevant history of bypass surgery, who experienced serious unexpected MYOCARDIAL INFARCTION in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). Treatment information was not provided and outcome is unknown. The patient's medical history of bypass surgery remains a major confounding factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Neck pain, SARS-CoV-2 test
Clinical narrative: Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice; Lower back pain moved up to his neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her patient with regular normal voice) and NECK PAIN (Lower back pain moved up to his neck) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (JNJ 78436735). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 (JNJ 78436735). Concurrent medical conditions included Low back pain (treated with painkiller).    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice) and NECK PAIN (Lower back pain moved up to his neck). At the time of the report, HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice) had resolved and NECK PAIN (Lower back pain moved up to his neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NECK PAIN (Lower back pain moved up to his neck) to be related. No further causality assessment was provided for HYPOACUSIS (Lost his hearing in a 90% for almost 5 hours/I couldn't hear anything/he hear himself with a squeaky voice, but patient wife mention could her Patient with regular normal voice).    No concomitant product was provided. No treatment information was provided. The patient could hear himself with a squeaky voice, but patient wife mention she could hear the Patient with his regular normal voice. No expiration date available on vaccination card.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 18-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-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.   No concomitant medications were reported. No treatment information was provided.  The patient reported that the patient had taken the first doses of the vaccine and asked for how long do the patient have to wait to get the booster dose of the vaccine.  Company comment: This case concerns a female patient with no reported medical history who experienced non-serious unexpected  of SARS-CoV-2 test positive, that occurred unspecified time after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced non-serious unexpectedof SARS-CoV-2 test positive, that occurred unspecified time after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I also got COVID 25 days ago/ got COVID after 2 doses; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I also got COVID 25 days ago/ got COVID after 2 doses) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (I also got COVID 25 days ago/ got COVID after 2 doses). At the time of the report, COVID-19 (I also got COVID 25 days ago/ got COVID after 2 doses) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected non-serious of COVID-19 approximately 10 months after the second dose of mRNA-1273 vaccine. The exact details regarding the first and the second dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected non-serious of COVID-19 approximately 10 months after the second dose of mRNA-1273 vaccine. The exact details regarding the first and the second dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted 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, 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 COVID-19 (Contracted COVID). At the time of the report, COVID-19 (Contracted COVID) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Patient received Moderna shots and a Moderna booster but contracted COVID, with mild cold-like symptoms.   Company comment; This case concerns a patient of unknown age, with no medical history reported, who experienced the unexpected non serious event COVID 19. The event occurred after the third dose of mRNA-1273. As reported patient received Moderna shots and a Moderna booster but contracted COVID, with mild cold-like symptoms. 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, with no medical history reported, who experienced the unexpected non serious event COVID 19. The event occurred after the third dose of mRNA-1273. As reported patient received Moderna shots and a Moderna booster but contracted COVID, with mild cold-like symptoms. 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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19; have been vaccinated with two shots; 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-19; have been vaccinated with two 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, 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 SARS-COV-2 TEST POSITIVE (tested positive for covid-19; have been vaccinated with two shots). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19; have been vaccinated with two shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided. The patient recently tested positive for covid-19. The patient had been vaccinated with two shots, but have yet to get a booster.  Company comment:  This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of SARS-CoV-2 test positive , that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of SARS-CoV-2 test positive , that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Chills, Dementia, Dementia Alzheimer's type
Clinical narrative: dementia; Alzheimer; Loss of memory; Loss of energy; chills; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), DEMENTIA ALZHEIMER'S TYPE (Alzheimer) (seriousness criterion medically significant), AMNESIA (Loss of memory), ASTHENIA (Loss of energy) and CHILLS (chills). At the time of the report, DEMENTIA (dementia), DEMENTIA ALZHEIMER'S TYPE (Alzheimer), AMNESIA (Loss of memory), ASTHENIA (Loss of energy) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  As reported, the patient was healthy, extremely active, a professor (still teaching), he was biking. Almost overnight, he went into dementia/Alzheimer's with loss of memory, loss of energy, chills. The symptoms had not gone away.  Company comment: This is a spontaneous case concerning an elderly male patient with no medical history reported, who experienced the unexpected serious events of Dementia/ Dementia Alzheimer's type with unexpected non-serious events of Amnesia and Asthenia and expected non-serious event of Chills after the unspecified dose number of mRNA-1273 vaccine. There were no diagnostic findings to support the reported events. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-449363 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly male patient with no medical history reported, who experienced the unexpected serious events of Dementia/ Dementia Alzheimer's type with unexpected non-serious events of Amnesia and Asthenia and expected non-serious event of Chills after the unspecified dose number of mRNA-1273 vaccine. There were no diagnostic findings to support the reported events. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis
Clinical narrative: antineutrophilic cytoplasmic antibody vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) (seriousness criterion medically significant). The patient was treated with Immunotherapy for Anti-neutrophil cytoplasmic antibody positive vasculitis. At the time of the report, ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) to be related.    No concomitant was reported.  The patient developed the event one day after the first dose of the mRNA-1273 vaccine. Patient improved with supportive care and immunosuppressive therapies.  Company comment: This case concerns a 60-year-old female patient with no medical history provided, who experienced serious unexpected event of Anti-neutrophilic cytoplasmic antibody positive vasculitis which presented as granulomatous pulmonary nodules. As per currently available information, the event occurred the day after the patient had received the first dose of the mRNA-1273 vaccine. The patient was treated with supportive care and immunosuppressive therapies and her condition improved. No further details were available at the moment. The reporter assessed the event as related to the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60-year-old female patient with no medical history provided, who experienced serious unexpected event of Anti-neutrophilic cytoplasmic antibody positive vasculitis which presented as granulomatous pulmonary nodules. As per currently available information, the event occurred the day after the patient had received the first dose of the mRNA-1273 vaccine. The patient was treated with supportive care and immunosuppressive therapies and her condition improved. No further details were available at the moment. The reporter assessed the event as related to the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis flare; This literature-study case was reported in a literature article and describes the occurrence of PSORIASIS (psoriasis flare) in a 52-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previous COVID-19: Yes). Concurrent medical conditions included Psoriasis.    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (psoriasis flare) (seriousness criterion medically significant). The patient was treated with RISANKIZUMAB for Psoriasis flare-up, at an unspecified dose and frequency; CLOBETASOL for Psoriasis flare-up, at an unspecified dose and frequency; MOMETASONE for Psoriasis flare-up, at an unspecified dose and frequency and TRIAMCINOLONE for Psoriasis flare-up, at an unspecified dose and frequency. At the time of the report, PSORIASIS (psoriasis flare) was resolving.        For mRNA-1273 (MODERNA COVID-19 Vaccine) (Unknown), the reporter considered PSORIASIS (psoriasis flare) to be related.    No concomitant medication information provided. Physical Examination : Scalp, face, trunk, arms 30% BSA (body surface area).  Company comment: This literature-study case concerns a 52-year-old female patient with relevant medical history of psoriasis, who experienced serious unexpected event of psoriasis flare, that occurred 7 days after the 1st dose of the mRNA-1273 and 7 days after the 2nd dose.  The rechallenge was positive due to reoccurrence after both doses. Patient's relevant medical history is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-447246, MOD-2022-447206, MOD-2022-447248, MOD-2022-447249, MOD-2022-447250, MOD-2022-448166 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Follow-up received by safety on 11-Jan-2022 included an Email with FTA received from team does not contain any new information.; Sender's Comments: This literature-study case concerns a 52-year-old female patient with relevant medical history of psoriasis, who experienced serious unexpected event of psoriasis flare, that occurred 7 days after the 1st dose of the mRNA-1273 and 7 days after the 2nd dose.  The rechallenge was positive due to reoccurrence after both doses. Patient's relevant medical history is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Paraparesis, Product administered to patient of inappropriate age
Clinical narrative: Partial paralysis in legs and face; Partial paralysis in legs and face; 11 year old girl who got your vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARAPARESIS (Partial paralysis in legs and face) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PARAPARESIS (Partial paralysis in legs and face) (seriousness criterion medically significant), FACIAL PARESIS (Partial paralysis in legs and face) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 year old girl who got your vaccine). At the time of the report, PARAPARESIS (Partial paralysis in legs and face) and FACIAL PARESIS (Partial paralysis in legs and face) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 year old girl who got your vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No Treatment medication was provided. It was reported that the 11 year old girl who got vaccine that now has partial paralysis in her legs and face.  Company comment:  This case of product administered to patient of inappropriate age concerns a 11-year-old female patient with no reported medical history who experienced serious unexpected event of paraparesis, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to  unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-447283, MOD-2022-447298, MOD-2022-447300 (Patient Link).; Sender's Comments: This case of product administered to patient of inappropriate age concerns a 11-year-old female patient with no reported medical history who experienced serious unexpected event of paraparesis, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to  unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had 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.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COVID-19 (Had COVID). The patient was treated with MONOCLONAL ANTIBODY 17-1A (intravenous) for COVID-19, at a dose of UNK infusion. At the time of the report, COVID-19 (Had COVID) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient had Covid in October, 1 week before boosters approved.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 approximately nine months after the second dose of mRNA-1273 vaccine. The details regarding the first dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 approximately nine months after the second dose of mRNA-1273 vaccine. The details regarding the first dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid positive after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive after vaccination) 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.  Company comment:  This case concerns a female patient with no reported medical history who experienced non serious unexpected AESI of SARS COV2 test positive, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to nature of the event and unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced non serious unexpected AESI of SARS COV2 test positive, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to nature of the event and unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Expired product administered, Feeling abnormal, Hot flush
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching) and HYPERHIDROSIS (Sweating) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 011L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever), CHILLS (Chills) and EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long) had resolved. On 16-Dec-2021, SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever) and CHILLS (Chills) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received the booster dose of the vaccine at 2:00 AM and by 4:30 AM she felt really sick, very dizzy, like she was going to faint, and she had a little fever.  She took ibuprofen for symptoms and they resolved within 24 hours.  Also after receiving the booster dose of the vaccine, she was told that the vaccine had been stored improperly prior to administration. She believed that the vaccine had expired or was left out of the refrigerator for longer than it was supposed to.   This case was linked to MOD-2022-448411 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Pain, Product storage error, Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching) and HYPERHIDROSIS (Sweating) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 011L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever), CHILLS (Chills) and EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long) had resolved. On 16-Dec-2021, SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever) and CHILLS (Chills) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received the booster dose of the vaccine at 2:00 AM and by 4:30 AM she felt really sick, very dizzy, like she was going to faint, and she had a little fever.  She took ibuprofen for symptoms and they resolved within 24 hours.  Also after receiving the booster dose of the vaccine, she was told that the vaccine had been stored improperly prior to administration. She believed that the vaccine had expired or was left out of the refrigerator for longer than it was supposed to.   This case was linked to MOD-2022-448411 (Patient Link).