chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Vaccination complication
Clinical narrative: had strong reactions causing arthritis flares after the second shot; had strong reactions causing arthritis flares after the second shot; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRITIS (had strong reactions causing arthritis flares after the second shot) and VACCINATION COMPLICATION (had strong reactions causing arthritis flares after the second shot) 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 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 ARTHRITIS (had strong reactions causing arthritis flares after the second shot) and VACCINATION COMPLICATION (had strong reactions causing arthritis flares after the second shot). At the time of the report, ARTHRITIS (had strong reactions causing arthritis flares after the second shot) and VACCINATION COMPLICATION (had strong reactions causing arthritis flares after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.  This case concerns an adult female patient with no medical history, who experienced the unexpected serious adverse event of special interest, Arthritis. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the other dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  The patient have had strong reactions to the vaccine causing arthritis flare.   This case was linked to MOD-2021-428572 (Patient Link).; Sender's Comments: This case concerns an adult female patient with no medical history, who experienced the unexpected serious adverse event of special interest, Arthritis. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the other dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received half-volume of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received half-volume of Moderna COVID-19 vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received half-volume of Moderna COVID-19 vaccine). On 26-Dec-2021, ACCIDENTAL UNDERDOSE (Patient received half-volume of Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died in December 2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            No concomitant medication reported.   No treatment Medication reported.  It was mentioned that the patient was editor at a local newspaper who died of heart attack less than one day later booster dose. It was stated that the media lied as a local newspaper reported only death while (unlisted country) news reported death due to shot.  Company comment: This case concerns a  49-year-old male patient, with no reported medical history, who experienced the serious, unexpected events myocardial infarction one day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient died and reported cause of death was heart attack. It is unknown if an autopsy was performed. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Added information in I-narrative supplement.; Sender's Comments: This case concerns a  49-year-old male patient, with no reported medical history, who experienced the serious, unexpected events myocardial infarction one day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient died and reported cause of death was heart attack. It is unknown if an autopsy was performed. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Heart attack
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia on the right lung; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia on the right lung) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMONIA (Pneumonia on the right lung) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized for 6 days due to PNEUMONIA. On 22-Dec-2021, PNEUMONIA (Pneumonia on the right lung) had resolved.            Concomitant medication of the patient was not reported.   After the first dose, the patient did not have any side effects.  Company Comment This case concerns an 87-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of pneumonia. The event occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Wife of the patient called rescue. The patient was hospitalized for 5 nights/6 days.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-428485.; Sender's Comments: Company Comment This case concerns an 87-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of pneumonia. The event occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia on the right lung after booster shot) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 024M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMONIA (Pneumonia on the right lung after booster shot) (seriousness criteria hospitalization and medically significant). On 13-Dec-2021, PNEUMONIA (Pneumonia on the right lung after booster shot) had resolved.            No concomitant and treatment medication was reported by patient. It was reported that after booster vaccine at 12 midnight patient had the same symptoms that happened after the second shot. Patient was hospitalized again and had Pneumonia in the right lung again. The pulmonologist told patient to call Moderna and report it.  Company Comment: This case concerns an 87-year-old, male patient, with no relevant medical history reported, who experienced the unexpected event of pneumonia. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-428474 (Patient Link).; Sender's Comments: This case concerns an 87-year-old, male patient, with no relevant medical history reported, who experienced the unexpected event of pneumonia. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test positive
Clinical narrative: Covid-19 Virus Test Postive; I don't have smell; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA and SARS-COV-2 TEST POSITIVE 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 23-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced ANOSMIA. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE. At the time of the report, ANOSMIA and SARS-COV-2 TEST POSITIVE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) in December 2021, SARS-CoV-2 test positive SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non serious event of anosmia and  Covid-19 Virus Test Positive as an added event. The events occurred approximately 3 days after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: lupus after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS 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 SYSTEMIC LUPUS ERYTHEMATOSUS. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Caller read that COVID vaccines (no particular manufacturer) can give symptomatic lupus. Patient is not identificable.   This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of Systemic lupus erythematous after mRNA- vaccine. Identifiable patient and brand of vaccine needs to be confirmed. Very limited information is available at this moment. Systemic lupus erythematosus was automatically upgraded as serious as per list. However, due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. However, there is insufficient evidence to exclude it as serious. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-429358 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were administered past the 30-day beyond use date in the refrigerator; Doses were administered past the 30-day beyond use date in the refrigerator; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR 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) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR. At the time of the report, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The reporter stated that for lot number 062E21A, the date vaccine moved to refrigerator on 8/18/21 and last Date Administered was 12/21/21 and for lot number 040C21A, the date vaccine moved to refrigerator on 8/24/21 and last Date Administered was 12/14/21.  The reporter stated that Moderna Lot analysis, regarding dose(s) administered on and after November 11, 2021 from lot number 062E21A; and doses administered on and after October 11, 2021 from lot number 040C21A: Moderna cannot guarantee patients received full protection against the COVID-19 Virus.  No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes on 04-Jan-2022 Follow up received included Updated information in narrative supplement and also updated outcome of the event product storage error.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood iron, Blood magnesium, Cerebrovascular accident
Clinical narrative: stroke; so weak/so weak, which has never happened; did not feel safe/pretty bad state/felt bad every single day; shaky; arm was really really sore; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 038B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (arm was really really sore). On 24-Dec-2021, the patient experienced TREMOR (shaky). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), ASTHENIA (so weak/so weak, which has never happened) and FEELING ABNORMAL (did not feel safe/pretty bad state/felt bad every single day). The patient was hospitalized on 26-Dec-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), ASTHENIA (so weak/so weak, which has never happened), FEELING ABNORMAL (did not feel safe/pretty bad state/felt bad every single day), PAIN IN EXTREMITY (arm was really really sore) and TREMOR (shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 507 (High) 507. On an unknown date, Blood iron: depleted (Low) depleted. On an unknown date, Blood magnesium: depleted (Low) depleted.         Concomitant medications were not reported. Treatment medications were not reported. Company Comment This case concerns a 64-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Tremor
Clinical narrative: stroke; so weak/so weak, which has never happened; did not feel safe/pretty bad state/felt bad every single day; shaky; arm was really really sore; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 038B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (arm was really really sore). On 24-Dec-2021, the patient experienced TREMOR (shaky). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), ASTHENIA (so weak/so weak, which has never happened) and FEELING ABNORMAL (did not feel safe/pretty bad state/felt bad every single day). The patient was hospitalized on 26-Dec-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), ASTHENIA (so weak/so weak, which has never happened), FEELING ABNORMAL (did not feel safe/pretty bad state/felt bad every single day), PAIN IN EXTREMITY (arm was really really sore) and TREMOR (shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 507 (High) 507. On an unknown date, Blood iron: depleted (Low) depleted. On an unknown date, Blood magnesium: depleted (Low) depleted.         Concomitant medications were not reported. Treatment medications were not reported. Company Comment This case concerns a 64-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Therapeutic response unexpected
Clinical narrative: Atrial fibrillation; heart converted to regular sinus rhythm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE UNEXPECTED (heart converted to regular sinus rhythm). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and THERAPEUTIC RESPONSE UNEXPECTED (heart converted to regular sinus rhythm) outcome was unknown.            It was reported that patient  experienced events after 20 years of having atrial fibrillation.  No concomitant medication information was reported.  No treatment medication information was reported  This case concerns a male patient of an unknown age with relevant medical history of Atrial Fibrillation, who experienced the unexpected serious adverse event of special interest, Atrial Fibrillation. The event occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is not applicable since no information about the second dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of an unknown age with relevant medical history of Atrial Fibrillation, who experienced the unexpected serious adverse event of special interest, Atrial Fibrillation. The event occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is not applicable since no information about the second dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid-19 after the second dose, and tested positive on 16Sep2021; Lack of Efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid-19 after the second dose, and tested  and DRUG INEFFECTIVE (Lack of Efficacy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced COVID-19 and DRUG INEFFECTIVE. At the time of the report, COVID-19 (had covid-19 after the second dose, and tested positive on 16Sep2021) and DRUG INEFFECTIVE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 16-Sep-2021, SARS-CoV-2 test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  It was reported that Patient also had the booster dose.  This is a spontaneous case concerning a 77-year-old, male patient with no reported medical history, who experienced the unexpected, non serious, AESI event of Covid-19 and unexpected, non serious event of drug ineffective. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days and a booster dose. The events Covid-19 and drug ineffective occurred 218 days after the second dose of mRNA-1273 vaccine administration with positive Covid-19 test result. No reported treatment medication. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Possible vaccine hypersensitive anaphylaxis; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Possible vaccine hypersensitive anaphylaxis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Possible vaccine hypersensitive anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Possible vaccine hypersensitive anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Reporter stated they got a vaccine hypersensitive anaphylaxis follow up form that only had initials and age of the patient involved and because of that they wouldn't be able to fill the form.  Company comment: This spontaneous case concerns a 70 year female with no medical history reported. who experienced Serious ( medically significant ) , expected event of Anaphylactic reaction which occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , date of vaccination also was not reported . The re-challenge for this case is not applicable since the outcome of the event was unknown and also the dose numbers are unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Followup received contains no new information.; Sender's Comments: This spontaneous case concerns a 70 year female with no medical history reported. who experienced Serious ( medically significant ) , expected event of Anaphylactic reaction which occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , date of vaccination also was not reported . The re-challenge for this case is not applicable since the outcome of the event was unknown and also the dose numbers are unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-. At the time of the report, SARS-COV-2 TEST POSITIVE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 28-Dec-2021, SARS-CoV-2 test 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 reported.  Company comment: This is a spontaneous case concerning a 36-year-old, male patient with no reported medical history, who experienced the unexpected, non serious, AESI event of SARS-CoV-2 test positive. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days. The event SARS-CoV-2 test positive occurred 305 days after the second dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-433545 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pneumonia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and MALAISE (wasn't feeling good). At the time of the report, PNEUMONIA (pneumonia) and MALAISE (wasn't feeling good) outcome was unknown.            Concomitant product use was not provided by reporter. Treatment information was not provided. It was reported that the patient was not feeling good for Christmas and was hospitalized for pneumonia. She was expected to be released around Saturday. The patient got the two Moderna shots more than 6 months ago.  Reporter didn't want to answer questions to report to Safety.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced unexpected event of pneumonia (seriousness criteria hospitalization and medically significant). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient received two Moderna vaccines more than 6 months ago, she  wasn't feeling good for Christmas and was hospitalized for pneumonia. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up information included no new information. On 29-Dec-2021: Follow-up information included no new information. Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced unexpected event of pneumonia (seriousness criteria hospitalization and medically significant). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient received two Moderna vaccines more than 6 months ago, she wasn't feeling good for Christmas and was hospitalized for pneumonia. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for an unknown indication.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Dec-2021 to 23-Dec-2021 due to SEIZURE. The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Adverse event, at an unspecified dose and frequency and VALPROATE SEMISODIUM (DEPAKOTE) for Adverse event, at a dose of 1 dosage form twice a day. At the time of the report, SEIZURE (Seizure) outcome was unknown.            No concomitant medication reported. Exactly a month after receiving the booster dose of the Moderna COVID 19 vaccine, she had a seizure (23 Dec 2021). The seizure was at home and she had to be taken with an ambulance to the hospital. She was in the hospital for one day, with husband called the ambulance at about 3:30 am and she was back home by 6:30 pm. Initially she was not taking any medication, but she was later prescribed Keppra. She had a bad reaction to Keppra and was switched to Depakote 500 mg twice a day. She has an appointment with her doctor tomorrow. She has never had seizure or nothing before in her entire life.  Company comment: This spontaneous case concerns a 58-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant and hospitalization) event of Seizure (AESI) after mRNA- 1273 vaccine. The event occurred approximately 1 month after the booster dose of mRNA- 1273 vaccine. The patient was hospitalized for one day. Treatment with Levetiracetam was prescribed and then switched to Valproate. Very limited information is available regarding diagnostic work-up and potential triggers of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-433967, MOD-2021-433968 (Patient Link). Sender's Comments: This spontaneous case concerns a 58-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant and hospitalization) event of Seizure (AESI) after mRNA- 1273 vaccine. The event occurred approximately 1 month after the booster dose of mRNA- 1273 vaccine. The patient was hospitalized for one day. Treatment with Levetiracetam was prescribed and then switched to Valproate. Very limited information is available regarding diagnostic work-up and potential triggers of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had my booster on 12/06/21 and suffered a stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (had my booster on 12/06/21 and suffered a stroke) 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 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had my booster on 12/06/21 and suffered a stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (had my booster on 12/06/21 and suffered a stroke) 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 relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred 13 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. 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 relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred 13 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Concomitant products included GABAPENTIN for an unknown indication.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). At the time of the report, SEIZURE (Seizure) had not resolved.            Since past Tuesday, patient suffered a seizure, and has been in the hospital ever since then. So far, the doctors have not been able to figure out what the problem was. No Treatment information was provided.  Company comment: This spontaneous case concerns a 25-year-old female patient with no medical history and co-administration of Influenza vaccine, who experienced the unexpected serious (hospitalization and medically significant) event of Seizure after mRNA- 1273 vaccine. The event occurred approximately 6 days after the booster dose of mRNA- 1273 vaccine and led to hospitalization. Very limited information is available regarding course of hospitalization, diagnostic work-up and treatment received. Co-administration of Influenza Vaccine remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old female patient with no medical history and co-administration of Influenza vaccine, who experienced the unexpected serious (hospitalization and medically significant) event of Seizure after mRNA- 1273 vaccine. The event occurred approximately 6 days after the booster dose of mRNA- 1273 vaccine and led to hospitalization. Very limited information is available regarding course of hospitalization, diagnostic work-up and treatment received. Co-administration of Influenza Vaccine remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy
Clinical narrative: Booster given 12 hours after vial puncture; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information were not provided. Vaccine administered to the patient more than 12 hours post vial puncture, specifically 4 days later.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hernia repair, Hypertension
Clinical narrative: Hernia surgery; Blood pressure was running 150/90; This spontaneous case was reported by a consumer and describes the occurrence of HERNIA REPAIR (Hernia surgery) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RELUGOLIX (ORGOVYX) and ENZALUTAMIDE for an unknown indication.    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 HERNIA REPAIR (Hernia surgery) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure was running 150/90). The patient was treated with IBUPROFEN for Hernia, at a dose of 600 mg. At the time of the report, HERNIA REPAIR (Hernia surgery) and HYPERTENSION (Blood pressure was running 150/90) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/90 (High) Blood pressure was running 150/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: This Spontaneous case concerns a 67-year-old, male patient, with no reported medical history, who experienced the unexpected, serious(hospitalization) event of hernia repair. The event occurred after receiving an unknown dose number of mRNA-1273 vaccine on an unknown date. Rechallenge was not applicable, as vaccination date, dose number and events dates are not available. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report. Seriousness criteria of hospitalization was captured for the event according to SD, however; there was no information provided on hospitalization dates, clinical course and/or discharge summary.   Reporter did not allow further contact; Sender's Comments: This Spontaneous case concerns a 67-year-old, male patient, with no reported medical history, who experienced the unexpected, serious(hospitalization) event of hernia repair. The event occurred after receiving an unknown dose number of mRNA-1273 vaccine on an unknown date. Rechallenge was not applicable, as vaccination date, dose number and events dates are not available. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report. Seriousness criteria of hospitalization was captured for the event according to SD, however; there was no information provided on hospitalization dates, clinical course and/or discharge summary.
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: Kidney infection; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection). The patient was treated with CIPROFLOXACIN for Adverse event, at an unspecified dose and frequency. At the time of the report, KIDNEY INFECTION (Kidney infection) outcome was unknown.            Patient had kidney infection. Patient insisted in it not having anything to do with the vaccine. Patient needs to take an antibiotic.  Company Comment: The only reported evens in this case is non-serious, hence no CC is required.   This case was linked to MOD-2021-435541, MOD-2021-026441 (Patient Link).; Sender's Comments: The only reported evens in this case is non-serious, hence no CC is required.