chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Product dose omission issue
Clinical narrative: received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it) and EXPOSURE DURING PREGNANCY (Vaccine 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.    In April 2021, the patient received first 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it) had resolved and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy ) 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 medications were not reported. No treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Eye disorder, Magnetic resonance imaging head, Mobility decreased
Clinical narrative: On/off fuzzy or wavy lines in the eye; eye disorder NOS; Loss vision; Dizziness; bed all the day and couldnt move at least for 30 hrs; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Loss vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (bed all the day and couldnt move at least for 30 hrs). On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 17-Mar-2021, the patient experienced BLINDNESS (Loss vision) (seriousness criterion medically significant). On 11-May-2021, the patient experienced EYE DISORDER (eye disorder NOS). On an unknown date, the patient experienced EYE DISORDER (On/off fuzzy or wavy lines in the eye). On 26-Feb-2021, MOBILITY DECREASED (bed all the day and couldnt move at least for 30 hrs) had resolved. On 17-Mar-2021, BLINDNESS (Loss vision) had resolved. On 11-May-2021, EYE DISORDER (eye disorder NOS) had resolved. At the time of the report, EYE DISORDER (On/off fuzzy or wavy lines in the eye) and DIZZINESS (Dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Ophthalmological examination: couldn't find any eye damage (normal) Couldn't find any eye damage. On 02-Apr-2021, Magnetic resonance imaging head: shows mild atrophy (abnormal) shows mild atrophy and everything seem okay.         Concomitant product was not reported. Laboratory investigations included brain MRI and the result showed mild atrophy. Treatment details was not reported.  Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination
Clinical narrative: On/off fuzzy or wavy lines in the eye; eye disorder NOS; Loss vision; Dizziness; bed all the day and couldnt move at least for 30 hrs; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Loss vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (bed all the day and couldnt move at least for 30 hrs). On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 17-Mar-2021, the patient experienced BLINDNESS (Loss vision) (seriousness criterion medically significant). On 11-May-2021, the patient experienced EYE DISORDER (eye disorder NOS). On an unknown date, the patient experienced EYE DISORDER (On/off fuzzy or wavy lines in the eye). On 26-Feb-2021, MOBILITY DECREASED (bed all the day and couldnt move at least for 30 hrs) had resolved. On 17-Mar-2021, BLINDNESS (Loss vision) had resolved. On 11-May-2021, EYE DISORDER (eye disorder NOS) had resolved. At the time of the report, EYE DISORDER (On/off fuzzy or wavy lines in the eye) and DIZZINESS (Dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Ophthalmological examination: couldn't find any eye damage (normal) Couldn't find any eye damage. On 02-Apr-2021, Magnetic resonance imaging head: shows mild atrophy (abnormal) shows mild atrophy and everything seem okay.         Concomitant product was not reported. Laboratory investigations included brain MRI and the result showed mild atrophy. Treatment details was not reported.  Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: How does this vaccine effect pregnant women; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (How does this vaccine effect pregnant women) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (How does this vaccine effect pregnant women). At the time of the report, EXPOSURE DURING PREGNANCY (How does this vaccine effect pregnant women) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure during pregnancy, Head discomfort, Myalgia, SARS-CoV-2 test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), HEAD DISCOMFORT (Congested in her head), MYALGIA (She has some arm and body ache) and EXPOSURE DURING PREGNANCY (pregnant and took the vaccine while pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 30A21A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant and took the vaccine while pregnant). On 12-Jul-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced HEAD DISCOMFORT (Congested in her head) and MYALGIA (She has some arm and body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, EXPOSURE DURING PREGNANCY (pregnant and took the vaccine while pregnant) had resolved. At the time of the report, COVID-19 (tested positive for Covid), HEAD DISCOMFORT (Congested in her head) and MYALGIA (She has some arm and body ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-255612 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up information received on 18-JUL-2021 contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Mild side effects) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild side effects). At the time of the report, IMMUNISATION REACTION (Mild side effects) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No relevant concomitant medications were provided. No treatment information was provided. This case was linked to MOD-2021-262513 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002622A) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) 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 relevant concomitant medications were reported. No treatment information was provided. Patient had gestation period of 32 weeks. Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Translation received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Mobility decreased, Neurological symptom, Pyrexia
Clinical narrative: seizures; was in bed for 3 or 4; Neurologic symptoms; Severe diarrhea; High fever 103°F; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizures) in a female 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.     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 SEIZURE (seizures) (seriousness criterion medically significant), MOBILITY DECREASED (was in bed for 3 or 4), NEUROLOGICAL SYMPTOM (Neurologic symptoms), DIARRHOEA (Severe diarrhea) and PYREXIA (High fever 103°F). At the time of the report, SEIZURE (seizures), MOBILITY DECREASED (was in bed for 3 or 4), NEUROLOGICAL SYMPTOM (Neurologic symptoms), DIARRHOEA (Severe diarrhea) and PYREXIA (High fever 103°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) High fever 103°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.  Company Comment - This case concerns female patient (unknown age) with no relevant medical history, who experienced the unexpected event of seizures with neurological symptoms. The event occurred unspecified date after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.   This case was linked to MOD-2021-325426 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up information received contains no newinformation.; Sender's Comments: This case concerns female patient (unknown age) with no relevant medical history, who experienced the unexpected event of seizures with neurological symptoms. The event occurred unspecified date after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; was in bed for 3 or 4; Neurologic symptoms; Severe diarrhea; High fever 103°F; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizures) in a female 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.     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 SEIZURE (seizures) (seriousness criterion medically significant), MOBILITY DECREASED (was in bed for 3 or 4), NEUROLOGICAL SYMPTOM (Neurologic symptoms), DIARRHOEA (Severe diarrhea) and PYREXIA (High fever 103°F). At the time of the report, SEIZURE (seizures), MOBILITY DECREASED (was in bed for 3 or 4), NEUROLOGICAL SYMPTOM (Neurologic symptoms), DIARRHOEA (Severe diarrhea) and PYREXIA (High fever 103°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) High fever 103°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.  Company Comment - This case concerns female patient (unknown age) with no relevant medical history, who experienced the unexpected event of seizures with neurological symptoms. The event occurred unspecified date after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.   This case was linked to MOD-2021-325426 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up information received contains no newinformation.; Sender's Comments: This case concerns female patient (unknown age) with no relevant medical history, who experienced the unexpected event of seizures with neurological symptoms. The event occurred unspecified date after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Bladder disorder, Body temperature
Clinical narrative: Bladder disorder; Had an infection with bacteria; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISORDER (Bladder disorder) and BACTERIAL INFECTION (Had an infection with bacteria) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Immune disorder (NOS).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLADDER DISORDER (Bladder disorder) (seriousness criterion hospitalization) and BACTERIAL INFECTION (Had an infection with bacteria) (seriousness criterion hospitalization). The patient was hospitalized on sometime in September 2021 due to BLADDER DISORDER. The patient was treated with Surgery (Bladder removed on 10-Sep-2021) for Bladder disorder. At the time of the report, BLADDER DISORDER (Bladder disorder) and BACTERIAL INFECTION (Had an infection with bacteria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101.6 degree F since 6am and 101.6 Degree F at 9:15am.         Patient state they had been sick and been taking antibiotics but has stop doing that for a few days to be able to get the shot. The patient had an infection with a bacteria from taking a lot of antibiotics.  Company comment: This case concerns a  63 year old female patient, with medical history of immune disorder and being under dialytic treatment, who experienced serious unexpected events of bladder disorder and bacterial infection after second dose of mRNA-1273. The events occurred 5 months after second dose of mRNA-1273. The re-challenge is not applicable. Patient´s medical history remains a confounder. The benefit-risk relationship of Spikevax in not affected by this report.   This case was linked to MOD-2021-346562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: This case concerns a  63 year old female patient, with medical history of immune disorder and being under dialytic treatment, who experienced serious unexpected events of bladder disorder and bacterial infection after second dose of mRNA-1273. The events occurred 5 months after second dose of mRNA-1273. The re-challenge is not applicable. Patient´s medical history remains a confounder. The benefit-risk relationship of Spikevax in not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (get Covid/ could have been much worse) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Initial series 1 dose) and Pfizer vaccine (Initial series 2 dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (get Covid/ could have been much worse). At the time of the report, COVID-19 (get Covid/ could have been much worse) outcome was unknown. Not Provided. No concomitant medications was reported. The patient received primary series of Pfizer and then received Moderna Booster dose. The patient was fully vaccinated but had COVID and said that it could be much worse. No treatment drug details was reported. Company comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the non-serious unexpected AESI COVID-19. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. No further details were provided for medical review, The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the non-serious unexpected AESI COVID-19. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. No further details were provided for medical review, The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for Covid-19 after 2nd booster.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 040C21A, 01M20A and 02L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient tested positive for Covid-19 after 2nd booster). At the time of the report, COVID-19 (Patient tested positive for Covid-19 after 2nd booster) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported. Dose of first and second dose was reported as full. It was unknown if the AE caused patient to seek medical care. Patient had not experienced a similar event in the past. No treatment drugs were reported. Patient would like to schedule 3rd booster with Moderna. Since patient had Covid, wanted to know how long should patient wait before getting the new Moderna Covid-19 booster. Company Comment: This is an spontaneous case concerning a 76-years-old female patient with NO medical history reported who experienced the unexpected AESI of COVID-19, 40 days after the 4th. dose of mRNA-1273 vaccine. On 6-Jul-2022, SARS-CoV-2 test Positive. Also, as there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement. This case was linked to MOD-2022-646999 (Patient Link). Sender's Comments: Company Comment:    This is an spontaneous case concerning a 76-years-old female patient with NO medical history reported who experienced the unexpected AESI of COVID-19, 40 days after the 4th. dose of mRNA-1273 vaccine. On 6-Jul-2022, SARS-CoV-2 test Positive. Also, as there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Decreased appetite, Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: Not feeling good; Did not feel like eating; Inappropriate schedule of vaccine administered; Left Arm hurt; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Not feeling good), DECREASED APPETITE (Did not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE PAIN (Left Arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 013M20A, 030L20A and 004M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, Lupus-like syndrome, Blood pressure high and High cholesterol. Concomitant products included METHOTREXATE, METOPROLOL, SIMVASTATIN and SPIRONOLACTONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced IMMUNISATION REACTION (Not feeling good), DECREASED APPETITE (Did not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE PAIN (Left Arm hurt). At the time of the report, IMMUNISATION REACTION (Not feeling good), DECREASED APPETITE (Did not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE PAIN (Left Arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high cholesterol. On an unknown date, Blood pressure measurement: high blood pressure.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided by the reporter.  The patient received a 3 dose 100mcg primary series as she was immunocompromised and received a fourth Moderna booster dose. The patient reports no adverse reactions or side effects with the first, second and first-booster doses. Patient was felt like she was coming down with the flu.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Not feeling good; Did not feel like eating; Inappropriate schedule of vaccine administered; Left Arm hurt; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Not feeling good), DECREASED APPETITE (Did not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE PAIN (Left Arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 013M20A, 030L20A and 004M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, Lupus-like syndrome, Blood pressure high and High cholesterol. Concomitant products included METHOTREXATE, METOPROLOL, SIMVASTATIN and SPIRONOLACTONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced IMMUNISATION REACTION (Not feeling good), DECREASED APPETITE (Did not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE PAIN (Left Arm hurt). At the time of the report, IMMUNISATION REACTION (Not feeling good), DECREASED APPETITE (Did not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE PAIN (Left Arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high cholesterol. On an unknown date, Blood pressure measurement: high blood pressure.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided by the reporter.  The patient received a 3 dose 100mcg primary series as she was immunocompromised and received a fourth Moderna booster dose. The patient reports no adverse reactions or side effects with the first, second and first-booster doses. Patient was felt like she was coming down with the flu.
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Possible breakthrough infection after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAKTHROUGH COVID-19 (Possible breakthrough infection after receiving Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 BREAKTHROUGH COVID-19 (Possible breakthrough infection after receiving Moderna COVID-19 vaccine). At the time of the report, BREAKTHROUGH COVID-19 (Possible breakthrough infection after receiving Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided.  It was reported that patient had either received all Pfizer doses or Moderna doses previously, and had contracted COVID recently. However, reporter was not sure if the vaccine administered was Pfizer or Moderna.  No treatment drug information was provided.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. The patient experienced the unexpected non-serious AESI event of breakthrough Covid-19 (possible breakthrough infection after receiving Moderna Covid-19 vaccine). It was reported that the patient either received all Pfizer doses or Moderna doses previously, and had contracted Covid-19 recently. No further clinical information was available for medical review. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-644263 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. The patient experienced the unexpected non-serious AESI event of breakthrough Covid-19 (possible breakthrough infection after receiving Moderna Covid-19 vaccine). It was reported that the patient either received all Pfizer doses or Moderna doses previously, and had contracted Covid-19 recently. No further clinical information was available for medical review. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-644263:same reporter
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Lttle achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Lttle achy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 003B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Lttle achy). At the time of the report, PAIN (Lttle achy) outcome was unknown.            Patient reported taking unspecified concomitant medications.  Patient had never tested positive for COVID. Patient received the Flu shot 1 week after receiving the booster dose.  No treatment medications were reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022; No adverse event; Received an expired 2nd primary dose after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd primary dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 19-AUG-2022 and administered on 19-SEP-2022).    Vial size was reported as 5.5 ml  NDC 80777-0273-99 Unpunctured in broken cartons  (Unpunctured vials) and vial doesn't undergo any temperature excursions. No concomitant information were reported by the reporter. No treatment information were reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Headache, Nausea
Clinical narrative: can't eat anything while feeling so nauseated; also has a bad headache; felt really horrible; really nauseated since yesterday evening for at least 8 hours now; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (can't eat anything while feeling so nauseated), FEELING ABNORMAL (felt really horrible), NAUSEA (really nauseated since yesterday evening for at least 8 hours now) and HEADACHE (also has a bad headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 1:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced FEELING ABNORMAL (felt really horrible) and NAUSEA (really nauseated since yesterday evening for at least 8 hours now). On an unknown date, the patient experienced FEEDING DISORDER (can't eat anything while feeling so nauseated) and HEADACHE (also has a bad headache). At the time of the report, FEEDING DISORDER (can't eat anything while feeling so nauseated), FEELING ABNORMAL (felt really horrible), NAUSEA (really nauseated since yesterday evening for at least 8 hours now) and HEADACHE (also has a bad headache) had not resolved.            No concomitant medication were reported. It was reported that patient received the bivalent booster yesterday at 1:30 PM central time. She was okay at first, but felt really horrible, really nauseated since yesterday evening for at least 8 hours now. She did not know when it was okay for her to vomit. She did not know if she was going to reduce the effectiveness of the vaccine if she vomits. She also had a bad headache, and she cannot take something for it because she had to eat food to coat her stomach and she cannot eat anything while she was feeling so nauseated. No treatment medication was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: myalgia/painful shots in her body; painful shots in her head; painful shots in her arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (myalgia/painful shots in her body), HEADACHE (painful shots in her head) and VACCINATION SITE PAIN (painful shots in her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (myalgia/painful shots in her body), HEADACHE (painful shots in her head) and VACCINATION SITE PAIN (painful shots in her arm). At the time of the report, MYALGIA (myalgia/painful shots in her body), HEADACHE (painful shots in her head) and VACCINATION SITE PAIN (painful shots in her arm) had resolved.      No concomitant medications were reported.  The vaccine side affects that lasted 5 hours.  Patient was expecting the same things with booster vaccine.  No treatment medications were reported.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 15-Sep-2022, the vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine), PRODUCT STORAGE ERROR (Vaccine was expired on 15-Sep-2022, the vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 006M21A and 006M21A) for an unknown indication.     The patient had no allergies The patient never tested positive to COVID 19.    On 19-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 15-Sep-2022, the vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine), PRODUCT STORAGE ERROR (Vaccine was expired on 15-Sep-2022, the vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 15-Sep-2022, the vial was initially stored in the refrigerator on 20-Sep-2022).    The patient was not taking any concomitant medication. It was reported that Individual vial with 5.5 ml size. The vial did not undergo any temperature excursions. No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient had Allergies with medications, food and other products was reported as unknown.  Patient ever had COVID positive test was reported as unknown.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of Vaccination was reported as unknown.  Previously administered products included for Product used for unknown indication: COVID-19 vaccination (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 vaccination.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.).    No concomitant drug were reported.   The patient received full dose.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown.  The patient experienced a similar event in the past was reported as unknown.  Symptoms improved or worsened was reported as unknown.  The vial size was 5.5 mL.  The vial was initially stored in the refrigerator was reported as unknown.  The vial did not undergo any temperature excursions.  No treatment drug were reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: patient had shingles with a rash on her back/itching; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (patient had shingles with a rash on her back/itching) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation and Congestive heart failure. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Atrial fibrillation and Congestive heart failure.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (patient had shingles with a rash on her back/itching). At the time of the report, HERPES ZOSTER (patient had shingles with a rash on her back/itching) outcome was unknown.            The most recent monovalent vaccine occurred 6 month ago. She used a cream as a treatment medication to help with the itching.   Reporter did not allow further contact