chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease
Clinical narrative: Graves Disease; This literature-non-study case was reported in a literature article and describes the occurrence of BASEDOW'S DISEASE (Graves Disease) in a 63-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 BASEDOW'S DISEASE (Graves Disease) (seriousness criterion medically significant). At the time of the report, BASEDOW'S DISEASE (Graves Disease) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BASEDOW'S DISEASE (Graves Disease) to be related.    Case series of Graves disease following mRNA SARS-CoV-2 vaccination, with symptoms and altered thyroid function tests developing within 7 days of the first dose. Based on the timing of signs and symptoms relative to administration of the vaccine and the absence of other probable causes, we consider the vaccine as a potential contributor to the diagnosis. The viral spike protein, delivered indirectly through an encoded mRNA vaccine, may be capable of triggering an inflammatory cascade and immune response triggering thyroid dysfunction  Company comment: This literature study case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Graves disease after mRNA- 1273 Moderna vaccine. The event occurred approximately 7 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, severity of the disease and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This literature study case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Graves disease after mRNA- 1273 Moderna vaccine. The event occurred approximately 7 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, severity of the disease and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperthyroidism, Thyroid stimulating immunoglobulin, Thyroiditis
Clinical narrative: thyroiditis; Thyrotoxicosis; This literature-non-study case was reported in a literature article and describes the occurrence of HYPERTHYROIDISM (Thyrotoxicosis) in a 37-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.   LITERATURE REFERENCE:(Privacy)    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROIDITIS (thyroiditis) and HYPERTHYROIDISM (Thyrotoxicosis) (seriousness criterion medically significant). At the time of the report, THYROIDITIS (thyroiditis) and HYPERTHYROIDISM (Thyrotoxicosis) was resolving. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid stimulating immunoglobulin: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THYROIDITIS (thyroiditis) and HYPERTHYROIDISM (Thyrotoxicosis) to be related.    Relevant concomitant medications were not reported.  Treatment information was not provided. Company Comment: This case concerns a 37-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESIs of thyroiditis with Thyrotoxicosis. The events occurred at approximately 10-20 days after a dose of mRNA-1273 vaccine. Thyroid stimulating immunoglobulin was negative  and no autonomous nodules were found. The patient was treated with non-steroidal anti-inflammatory drugs. The outcome was recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 37-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESIs of thyroiditis with Thyrotoxicosis. The events occurred at approximately 10-20 days after a dose of mRNA-1273 vaccine. Thyroid stimulating immunoglobulin was negative  and no autonomous nodules were found. The patient was treated with non-steroidal anti-inflammatory drugs. The outcome was recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Myocardial infarction; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:    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 MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Myocardial infarction) 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 and treatment medication use were not provided. Authors comment: We are unable to attribute the cause of the patient's MI to the Moderna vaccine unless further data are published. As healthcare providers, we need to be aware of attempts to correlate bad outcomes with the vaccine without substantiated data, and anticipate patient questions that may arise from these reports. Any research on the topic should be written carefully and avoid overstating the findings.   Company comment: This literature non-study case concerns a 96-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) event of Myocardial infarction after mRNA- 1273 Moderna vaccine. The onset of the event occurred one hour after the first dose of mRNA- 1273 vaccine. The patient was medically managed and discharged three days later. No further information is available at this moment. Patient´s elderly age remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This literature non-study case concerns a 96-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) event of Myocardial infarction after mRNA- 1273 Moderna vaccine. The onset of the event occurred one hour after the first dose of mRNA- 1273 vaccine. The patient was medically managed and discharged three days later. No further information is available at this moment. Patient´s elderly age remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection post vaccination; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid infection post vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid infection post vaccination). At the time of the report, COVID-19 (covid infection post vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information provided. The patient received first vaccine, then was exposed and got Covid, was no longer under quarantine.  This is a regulatory authority case concerning  a patient or unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. 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 regulatory authority case concerning  a patient or unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. 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: Dyschromatopsia, Visual impairment
Clinical narrative: White vision; Eye sight never recovered; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHROMATOPSIA (White vision) and VISUAL IMPAIRMENT (Eye sight never recovered) 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 DYSCHROMATOPSIA (White vision) and VISUAL IMPAIRMENT (Eye sight never recovered). At the time of the report, DYSCHROMATOPSIA (White vision) outcome was unknown and VISUAL IMPAIRMENT (Eye sight never recovered) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-432897.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive to COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive to COVID 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive to COVID 19). At the time of the report, COVID-19 (tested positive to COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  Patient scheduled second vaccine shot was on 30-Jan-2021.  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 covid -19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.  No treatment medication were provided.; Sender's Comments: 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 covid -19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with BAMLANIVIMAB for Adverse reaction, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  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 covid -19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events 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 patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of covid -19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 (if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine). At the time of the report, COVID-19 (if a patient test positive for Covid-19 how long should they wait before getting the Moderna Vaccine, when can they get the second dose of the vaccine) 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 information provided by the reporter No treatment information provided by the reporter  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 Covid -19. The event occurred approximately on an unknown day 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.; Sender's Comments: 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 Covid -19. The event occurred approximately on an unknown day 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: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) 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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.  The reporter initially reported a potential connection between the vaccine and shingles. Since then the reporter realized that there was no connection between the vaccine and shingles.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, Illness
Clinical narrative: Got sick from the vaccine; In bed for two days; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Got sick from the vaccine) and DECREASED ACTIVITY (In bed for two days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Immune disorder (NOS) since an unknown date.    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 ILLNESS (Got sick from the vaccine) and DECREASED ACTIVITY (In bed for two days). At the time of the report, ILLNESS (Got sick from the vaccine) outcome was unknown and DECREASED ACTIVITY (In bed for two days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient stated that her family had immune issues and genetic issues. She further stated that, she and her brother got sick from the vaccine. She herself and her brother were in bed for two days. No treatment medication was reported.   This case was linked to MOD-2021-434459 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: It is driving her insane; Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb; Almost fell; First Dose 11Oct2021, Second dose 30Dec2021; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It is driving her insane), HYPOAESTHESIA (Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb), DIZZINESS (Almost fell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 11Oct2021, Second dose 30Dec2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced FEELING ABNORMAL (It is driving her insane), HYPOAESTHESIA (Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb), DIZZINESS (Almost fell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 11Oct2021, Second dose 30Dec2021). On 30-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 11Oct2021, Second dose 30Dec2021) had resolved. At the time of the report, FEELING ABNORMAL (It is driving her insane), HYPOAESTHESIA (Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb) and DIZZINESS (Almost fell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.   Patient stated she just tried to kept moving everything, but it was not helped her.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: gradual major headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (gradual major headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, Stroke and Shortness of breath. Concurrent medical conditions included Heart disorder. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Cardiac disorder, FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) for Heart disease, unspecified.    On 29-Dec-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (gradual major headache). At the time of the report, HEADACHE (gradual major headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had ibuprofen that was prescribed to him before, so asking if he could take these. No treatment medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101; This spontaneous case was reported by a physician assistant and describes the occurrence of PYREXIA (Fever of 101) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (Fever of 101). At the time of the report, PYREXIA (Fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101 (High) 101 Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-435165, MOD-2021-435192 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021). On 15-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-435133 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021) 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 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 22Jan2021, second on 01Apr2021) had resolved.            No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-435504, MOD-2021-026441 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine receved; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine receved) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 06-Dec-2021 at 2:20 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine receved). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine receved) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Dec-2021 at 4:14 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  After receiving the booster dose of Moderna COVID-19 Vaccine, the patient did not have any immediate issues and had not contacted to notify of any adverse reactions/events.   This case was linked to MOD-2021-407228 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Expired product administered
Clinical narrative: Booster dose of an expired vaccine; Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) to be not related. No further causality assessment was provided for ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose).    No concomitant and treatment medications were reported. The patient had no known allergies. There were no any other potential causes of the event. Vaccine was maintained in cold chain process for storage. Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose. The patient did not had any immediate issues.   This case was linked to MOD-2021-407228 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Provided booster dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Provided booster dose of an expired vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Provided booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Provided booster dose of an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: arm pain; felt really bad; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt really bad), CHILLS (Chills) and PYREXIA (fever) 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 PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt really bad), CHILLS (Chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt really bad), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: .2 ml of an adult Pfizer dose given to a 9 year old female, no immediate adverse events occurred after the vaccine
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Dehydration, Flushing, Speech disorder
Clinical narrative: Patient left the facility and went to eat at a neighboring restaurant where she lost ability to communicate, became flush, and EMS was called. When we followed up with the patient that same evening, patient states she was treated for dehydration and released from the hospital after receiving IV fluids.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient felt dizzy and lightheaded after the vaccine, she was coming in and out of lucidness. 911 was called and EMTs took her to the hospital
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Specialist consultation, Ultrasound scan, Ventricular extrasystoles
Clinical narrative: The day after receiving the second dose of the Pfizer COVID 19 vaccine I started having premature ventricular contractions. At the time I did not know what they were and so I contacted my doctor thinking I was experiencing something related to reflux but concerned it could be heart related.  On May 1st, I was transported to the Emergency Room for an unrelated accident and while in transport the EMT asked if I usually had PVC's.  I asked for clarification on what that meant and then realized what I had been feeling for the last couple of weeks were PVC's.  Between the ER and multiple cardiology visits since I have had an EKG, x-ray, ultrasound, and a two week heart monitor.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: The day after receiving the second dose of the Pfizer COVID 19 vaccine I started having premature ventricular contractions. At the time I did not know what they were and so I contacted my doctor thinking I was experiencing something related to reflux but concerned it could be heart related.  On May 1st, I was transported to the Emergency Room for an unrelated accident and while in transport the EMT asked if I usually had PVC's.  I asked for clarification on what that meant and then realized what I had been feeling for the last couple of weeks were PVC's.  Between the ER and multiple cardiology visits since I have had an EKG, x-ray, ultrasound, and a two week heart monitor.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Electrocardiogram normal, Fall, Head injury, Presyncope
Clinical narrative: Vaccinated: 7:50PM Reaction: 7:50PM Pt with syncope fell and hit floor after vaccination; hit head, mid posterior nodule ~1.0-1.5cm. Pt with known vasovagal episodes usually in response to blood. Vitals: 102/46, 59, 12, O2 100% -> @7:58: 103/55, 84, 14, O2 100% -> 98/50, 102, 14, O2 100% Patient was stable and released from vaccination site with recommendation to follow up with healthcare provider. Pt went to ED from clinic to rule out concussion. Per ED note, extremely low risk for significant intracranial traumatic injury and would not benefit from head imaging at this time and syncope most consistent with vasovagal syncope.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vaccinated: 7:50PM Reaction: 7:50PM Pt with syncope fell and hit floor after vaccination; hit head, mid posterior nodule ~1.0-1.5cm. Pt with known vasovagal episodes usually in response to blood. Vitals: 102/46, 59, 12, O2 100% -> @7:58: 103/55, 84, 14, O2 100% -> 98/50, 102, 14, O2 100% Patient was stable and released from vaccination site with recommendation to follow up with healthcare provider. Pt went to ED from clinic to rule out concussion. Per ED note, extremely low risk for significant intracranial traumatic injury and would not benefit from head imaging at this time and syncope most consistent with vasovagal syncope.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt dizzy, lightheaded and nauseous about 5 minutes after vaccination. Provided him with a bottle of water and sat with him for about 15 minutes more (20 minutes wait time total) until he felt well enough to leave.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: The patient describes a one inch red itchy area that developed the next evening after vaccination about one to two inches under the injection site.  The area is itchy.  It has since grow to 5 inches in diameter and is slightly "puffy."  She has no complaints of pain, just itching.  Tolerable but persistent.  This was her booster dose.  She reports no issues with previous two doses.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulities
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Mechanical urticaria
Clinical narrative: 11 days after receiving the Moderna COVID vaccine booster, I developed intense dermatographia. I sought medical treatment when I was unable to suppress the symptoms with Benadryl and was advised to switch to Zyrtec. So far, the symptoms are mostly managed through 10-20 mg of Zyrtec per day and by avoiding eggs in my diet. I am still experiencing symptoms and am trying a gluten-free diet as an effort to reduce inflammation. To date I've had symptoms for 23 days. Symptoms have abated somewhat since the first onset, but I have not yet been able to wean off oral antihistamines.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine administrator was administering a child's Pfizer vaccine today and forgot to dilute it with sodium chloride 0.9% first.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Dyspnoea, Fibrin D dimer increased, Presyncope
Clinical narrative: patient developed  gradually progressive dyspnea.  had a near syncopal event.  found to have pulmonary embolism (moderate clot burden) with evidence of R heart strain and was hospitalized for monitoring.    she is recovering and on anticoagulation.  negative thrombotic risk panel.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Right ventricular dysfunction
Clinical narrative: patient developed  gradually progressive dyspnea.  had a near syncopal event.  found to have pulmonary embolism (moderate clot burden) with evidence of R heart strain and was hospitalized for monitoring.    she is recovering and on anticoagulation.  negative thrombotic risk panel.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Patient had sore arm, fever, fatigue, etc
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Loss of personal independence in daily activities, Pruritus, Skin texture abnormal
Clinical narrative: Starts by feeling heat in the face, head and all over the body, then itchiness develops and then redness and hives across the body. The skin turns red and bumpy and it's impossible to stop scratching  because is needed to relieve itchiness. It started on 12/24. Had never this in the past. It's impossible to sleep or do anything during the day if left untreated. The only allergy med that has worked well is Zyrtec (10mg). After one week  (12/30) I tried stopping Zyrtec. After 24 hrs when the med wore out hives started appearing again and in the timeframe of 32-48hrs after the last med was taken hives become so intense that was impossible to sustain it anymore. Doc appointment is scheduled for 1/11 because I am currently not in my home area where my insurance covers me but I am taking Zyrtec daily. It's impact usually starts wearing off around 18-20hrs
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Urticaria
Clinical narrative: Starts by feeling heat in the face, head and all over the body, then itchiness develops and then redness and hives across the body. The skin turns red and bumpy and it's impossible to stop scratching  because is needed to relieve itchiness. It started on 12/24. Had never this in the past. It's impossible to sleep or do anything during the day if left untreated. The only allergy med that has worked well is Zyrtec (10mg). After one week  (12/30) I tried stopping Zyrtec. After 24 hrs when the med wore out hives started appearing again and in the timeframe of 32-48hrs after the last med was taken hives become so intense that was impossible to sustain it anymore. Doc appointment is scheduled for 1/11 because I am currently not in my home area where my insurance covers me but I am taking Zyrtec daily. It's impact usually starts wearing off around 18-20hrs
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Auditory disorder, Tinnitus
Clinical narrative: Tinnitus of left ear & abnormal auditory perception of left ear.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccinator was administering a child's Pfizer vaccine and forgot to dilute it with sodium chloride 0.9% first.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced fatigue, sore arm, and a slight fever.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Mechanical urticaria, Pruritus, Sensitive skin
Clinical narrative: To be clear, I am presuming at this point that this is vaccine-related as I don't have any other valid explanation for my symptoms. I began experiencing itchiness in random body locations sometime in the morning on Wednesday, December 22, 2021 (almost exactly 2 weeks after receiving my Covid booster - Moderna). After not thinking much of my itchiness, I realized I was actually breaking out in hives (or urticaria) at random intervals over my whole body. They would appear in a location, last an hour or so, slowly fade and disappear, only to reappear shortly thereafter in a new body location. I took Benadryl at night, but that did nothing for my daytime symptoms and the itchiness was awful. I sought medical attention via my PCP on Monday, December 27, 2021. She and I discussed varying degrees of treatment and we decided together to just try OTC Claritin before trying steroids. The Claritin did and continues to help manage the symptoms at a tolerable level but I do continue to have breakthrough hives. Throughout all of this the hives have been consistently worse at night between bedtime and dinner. The only other explanation aside from the vaccine that I thought may have been the cause was a women's PMS vitamin supplement called FLO Vitamins that I began taking daily about 6 days prior to my symptom onset. I have not taken these in over 2 weeks now and yet my symptoms persist. I have also noticed that I experience Dermatographia along with the hives, where my skin is now extremely sensitive to any abrasion and causes redness and hives in any minimally scraped or abraded area (for example, I reached behind the couch to get something and my forearm rubbed against the couch as I did this and had a massive area of redness and hives in that location for about an hour subsequently). I have never in my life experienced hives or Dermatographia prior to my symptom onset on December 22, 2021. I have had no recent environmental changes, nor do I suffer from any food or topical allergy normally.