chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage) in a 4-year-old patient of an unknown gender 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Symptomatic myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Symptomatic myocarditis) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.      The patient's past medical history included COVID-19 (Symptomatic myocarditis occurred in the patient during acute COVID-19 infection, followed by recurrence of symptoms after the first dose of mRNA COVID-19 vaccine).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Symptomatic myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Symptomatic myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging heart: Proven myocarditis after the second dose of mRNA COVID-19 vaccine..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Symptomatic myocarditis) to be related.    No concomitant and treatment medications were reported.  Symptomatic myocarditis occurred in the patient during acute COVID-19 infection, followed by recurrence of symptoms after the first dose of mRNA COVID-19 vaccine and subsequent recurrence of cardiac MRI-proven myocarditis after the second dose of mRNA COVID-19 vaccine. Company comment This literature-non-study case reported by other Health Care Professional concerning a 45-year-old male patient with medical history of COVID-19 infection with myocarditis, who experienced the serious, medically significant, expected event of Myocarditis (AESI). It is described that after the first dose of mRNA-1273, the patient experienced myocarditis symptoms that recurred after the second dose, where myocarditis was confirmed by MRI. It is uncertain if myocarditis due to COVID-19 before vaccination was full recovered. Treatment details of the event was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case reported by other Health Care Professional concerning a 45-year-old male patient with medical history of COVID-19 infection with myocarditis, who experienced the serious, medically significant, expected event of Myocarditis (AESI). It is described that after the first dose of mRNA-1273, the patient experienced myocarditis symptoms that recurred after the second dose, where myocarditis was confirmed by MRI. It is uncertain if myocarditis due to COVID-19 before vaccination was full recovered. Treatment details of the event was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling jittery, Insomnia
Clinical narrative: Sluggish/Does not felt like doing anything except lay on couch; Real tired; Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering; Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering; Had jitters; Could not sleep; This spontaneous case was reported by a patient and describes the occurrence of FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch), PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) and FATIGUE (Real tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 939905, 014M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Demerol), Sulfonamide allergy (Sulfa), Hay fever and Blood pressure high. Concomitant products included FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2022, the patient experienced FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) and CHILLS (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering). On 21-Jul-2022, the patient experienced SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch) and FATIGUE (Real tired). The patient was treated with TICAGRELOR (BRILINTA) at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch), FATIGUE (Real tired) and CHILLS (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) outcome was unknown and PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Body temperature: 99.7 99.7 degrees Fahrenheit and 98.7 98.7 degrees Fahrenheit.         Concomitant medications information included: Blood pressure medicines (unspecified) and over the counter fish oil. The patient not had COVID test or diagnosis.   This case was linked to MOD-2022-611794 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: Sluggish/Does not felt like doing anything except lay on couch; Real tired; Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering; Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering; Had jitters; Could not sleep; This spontaneous case was reported by a patient and describes the occurrence of FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch), PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) and FATIGUE (Real tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 939905, 014M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Demerol), Sulfonamide allergy (Sulfa), Hay fever and Blood pressure high. Concomitant products included FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2022, the patient experienced FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) and CHILLS (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering). On 21-Jul-2022, the patient experienced SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch) and FATIGUE (Real tired). The patient was treated with TICAGRELOR (BRILINTA) at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch), FATIGUE (Real tired) and CHILLS (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) outcome was unknown and PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Body temperature: 99.7 99.7 degrees Fahrenheit and 98.7 98.7 degrees Fahrenheit.         Concomitant medications information included: Blood pressure medicines (unspecified) and over the counter fish oil. The patient not had COVID test or diagnosis.   This case was linked to MOD-2022-611794 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patients received half a dose for booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patients received half a dose for booster) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (patients received half a dose for booster). At the time of the report, ACCIDENTAL UNDERDOSE (patients received half a dose for booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611786:Patient 2
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Hypokinesia, Impaired work ability, Pain in extremity
Clinical narrative: cannot move my finger; Pain in Finger/ Pain in leg/ he started experiencing pain in his first finger or thumb/ thumb is in a lot of pain/ lot pain in his hands; unable to walk; He has not been able to go to work due to this problem; This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (cannot move my finger), PAIN IN EXTREMITY (Pain in Finger/ Pain in leg/ he started experiencing pain in his first finger or thumb/ thumb is in a lot of pain/ lot pain in his hands), GAIT INABILITY (unable to walk) and IMPAIRED WORK ABILITY (He has not been able to go to work due to this problem) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient experienced HYPOKINESIA (cannot move my finger), PAIN IN EXTREMITY (Pain in Finger/ Pain in leg/ he started experiencing pain in his first finger or thumb/ thumb is in a lot of pain/ lot pain in his hands) and GAIT INABILITY (unable to walk). In 2022, the patient experienced IMPAIRED WORK ABILITY (He has not been able to go to work due to this problem). At the time of the report, HYPOKINESIA (cannot move my finger), PAIN IN EXTREMITY (Pain in Finger/ Pain in leg/ he started experiencing pain in his first finger or thumb/ thumb is in a lot of pain/ lot pain in his hands), GAIT INABILITY (unable to walk) and IMPAIRED WORK ABILITY (He has not been able to go to work due to this problem) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown whether the patient had any allergies or COVID.  Patient did not receive any vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient did not have similar events in the past. Events got worsened, patient visited his primary care physician.  No treatment medication was reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna vaccine booster dose after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17-Jun-2022 and administered on 21-Jul-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 019F21A and 025A21A) for COVID-19 vaccination. The patient never had been diagnosed or tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Immunocompromised, Drug allergy (Compazine) and Drug allergy (Reglan). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 21-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna vaccine booster dose after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17-Jun-2022 and administered on 21-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna vaccine booster dose after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 17-Jun-2022 and administered on 21-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had received the first booster on 21-Jul-2022. On 06-Apr-2021, the patient received second dose (manufacturer unknown), full dose, with lot number 031A21A. Concomitant medication list was not provided. Number of doses per vial was 1 vial per 1 dose. The vial was initially stored in the refrigerator on 17-Jun-2022. The vial had not undergone any temperature excursions. The patient had not reported any reactions after being observed for 15 minutes. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial stored in the refrigerator more than 12 hours; Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 12 hours) in a 76-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jul-2022 at 1:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 12 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. On 19-JUL-2022 vial was initially stored in the refrigerator. On 19-JUL-2022 at 10:00 vial was first punctured. Vial did not undergo any temperature excursion. The patient did not reported any other Adverse Reactions or Side Effects. Treatment details was not reported by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 014M20A and 032L20A) for COVID-19 prophylaxis.     The patient not had COVID test or diagnosis.  Concurrent medical conditions included Drug allergy (allergy to Demerol), Sulfonamide allergy (Sulfa allergy) and Hay fever. Concomitant products included FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to MYOCARDIAL INFARCTION. The patient was treated with TICAGRELOR (BRILINTA) for Heart attack, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.            Concomitant medication included blood pressure medicines (unspecified).  Company Comment : This spontaneous case concerns a 74 year old male, with a no relevant medical history reported who experienced the serious (hospitalization, medically significant) unexpected adverse event of special interest Myocardial infarction, which occurred 18 days after the third dose of mRNA-1273 vaccine administration. The outcome of the event was unknown. The patient was hospitalized for 2 days and was treated with TICAGRELOR (BRILINTA), at an unspecified dose and frequency. No other information regarding treatment or course in the hospital was provided. Patient's age and gender could be confounders for the event.  The benefit -risk relationship of mRNA -1273 is not affected by this report.   This case was linked to MOD-2022-611782 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74 year old male, with a no relevant medical history reported who experienced the serious (hospitalization, medically significant) unexpected adverse event of special interest Myocardial infarction, which occurred 18 days after the third dose of mRNA-1273 vaccine administration. The outcome of the event was unknown. The patient was hospitalized for 2 days and was treated with TICAGRELOR (BRILINTA), at an unspecified dose and frequency. No other information regarding treatment or course in the hospital was provided. Patient's age and gender could be confounders for the event.  The benefit -risk relationship of mRNA -1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: My brother had heart problems after his Moderna Covid-19 booster shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISCOMFORT (My brother had heart problems after his Moderna Covid-19 booster shot) 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 21-Jul-2022, the patient experienced CARDIAC DISCOMFORT (My brother had heart problems after his Moderna Covid-19 booster shot). At the time of the report, CARDIAC DISCOMFORT (My brother had heart problems after his Moderna Covid-19 booster shot) had not resolved.            No Concomitant medications were reported.  Adverse Event cause patient to seek medical care. Adverse event outcome was reported as Ongoing.  Patient had to take blood thinners for the treatment   This case was linked to US-MODERNATX, INC.-MOD-2022-611900, US-MODERNATX, INC.-MOD-2022-611860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611900:MOD22-019253(reporters case) US-MODERNATX, INC.-MOD-2022-611860:(reporters case) 2nd booster dose
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, SARS-CoV-2 antibody test
Clinical narrative: He believes all 4 shots were full dose; This spontaneous case was reported by a patient and describes the occurrence of OVERDOSE (He believes all 4 shots were full dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 049C21A, 023M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (He believes all 4 shots were full dose). At the time of the report, OVERDOSE (He believes all 4 shots were full dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2022, SARS-CoV-2 antibody test: SARS COV 2 antibody was zero.   It was reported patient has been on Rheumatory Arthritis Rituxan infusion for some years at time of reporting. Patient had stopped the infusion of Rituxan after last COVID shot on 24-Jan-2022. Patient did not had COVID. Patient stated that  was told verbally that he does not have enough Protein. Treatment details were not reported by the reporter.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine on 21 Jul 2022 where the expiration date was on 13 Feb 2022), PRODUCT STORAGE ERROR (Date vial was moved from freezer to refrigerator was on 27 JUN 2022, stored even after expiration date) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial came out of a refrigerator at 40 degrees Fahrenheit and kept in room at temperature 81 degrees Fahrenheit) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine on 21 Jul 2022 where the expiration date was on 13 Feb 2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial came out of a refrigerator at 40 degrees Fahrenheit and kept in room at temperature 81 degrees Fahrenheit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was moved from freezer to refrigerator was on 27 JUN 2022, stored even after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine on 21 Jul 2022 where the expiration date was on 13 Feb 2022), PRODUCT STORAGE ERROR (Date vial was moved from freezer to refrigerator was on 27 JUN 2022, stored even after expiration date) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial came out of a refrigerator at 40 degrees Fahrenheit and kept in room at temperature 81 degrees Fahrenheit) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was a pediatric patient receiving vaccine for patients 6 months through 5 years of age. No concomitant medications were reported. It was reported that the vial had reached maximum temperature of 81 degrees Fahrenheit, and minimum temperatures of 40 degrees Fahrenheit. The duration of excursion was about 1 hour. It was reported that the date vial was moved from freezer to refrigerator, was on 27-Jun-2022 and they were returned to the refrigerator after vaccination. The vaccine was inspected and no changes in the state were observed. Proposed desired Use by date was on 21-Jul-2022. Number of vials/doses impacted was reported as one vial. The vial was punctured at 11:15 AM. No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 077C21B, 006B21A and 022M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The reporter had used the online Temperature excursion tool and was comfortable that her patient was valid and that the affected vaccine was viable for future doses. Side effects after any doses was unknown. The temperature in the refrigerator that the Moderna Covid-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. Excursion vaccination date was 08-Jul-2022 with batch number 014B22A. No treatment medications were reported.  Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2022: Follow up received included significant information added patient demographics and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: My left arm, where I had the shot, is hot; My left arm, where I had the shot, is red; My left arm, where I had the shot, is hard; My left arm, where I had the shot, is tender; My left arm, where I had the shot, is bigger than the palm of my hand; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (My left arm, where I had the shot, is hot), VACCINATION SITE ERYTHEMA (My left arm, where I had the shot, is red), VACCINATION SITE INDURATION (My left arm, where I had the shot, is hard), VACCINATION SITE PAIN (My left arm, where I had the shot, is tender) and VACCINATION SITE SWELLING (My left arm, where I had the shot, is bigger than the palm of my hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 024M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2022, the patient experienced VACCINATION SITE WARMTH (My left arm, where I had the shot, is hot), VACCINATION SITE ERYTHEMA (My left arm, where I had the shot, is red), VACCINATION SITE INDURATION (My left arm, where I had the shot, is hard), VACCINATION SITE PAIN (My left arm, where I had the shot, is tender) and VACCINATION SITE SWELLING (My left arm, where I had the shot, is bigger than the palm of my hand). The patient was treated with MENTHOL (BIOFREEZE [MENTHOL]) at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (My left arm, where I had the shot, is hot), VACCINATION SITE ERYTHEMA (My left arm, where I had the shot, is red), VACCINATION SITE INDURATION (My left arm, where I had the shot, is hard), VACCINATION SITE PAIN (My left arm, where I had the shot, is tender) and VACCINATION SITE SWELLING (My left arm, where I had the shot, is bigger than the palm of my hand) had not resolved.            Concomitant medications details were not reported by the reporter.  Patient had received first booster.  it was reported patient not seek medical care for adverse event.  patient not experienced similar events in the past  patient adverse event ongoing also symptoms worsened   This case was linked to US-MODERNATX, INC.-MOD-2022-611797 (E2B Linked Report). This case was linked to MOD-2022-611860 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611797:MOD22-019253 (reporters brother case)
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Feeling cold, Hypokinesia, Motor dysfunction
Clinical narrative: Lost his lost balance a couple of times; Falling towards the left side; Loss of motor skills; Felt like his body froze; Could not move, feet nor body/could not lift himself from the floor; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (not hospitalized) in January 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 2) and Pfizer (Dose Number: 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Heartbeats skipped (Heart (skip in his heart)) and Diabetic. Concomitant products included APIXABAN (ELIQUIS) for Heartbeats skipped.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Slight fever). On 16-Jul-2022, the patient experienced BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor). On 16-Jul-2022, PYREXIA (Slight fever) had resolved. On 17-Jul-2022, BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies.  The patient was on a bunch of medications but did not provide any names.  Caller stated that the patient who always gets slight fevers with vaccine, but experience after his last Moderna booster. Patient's side affects started on Saturday, 16Jul2022, in the morning and at 2 AM and lasted 1 day.  Adverse event did not caused the patient to seek medical care.  No treatment medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Lost his lost balance a couple of times; Falling towards the left side; Loss of motor skills; Felt like his body froze; Could not move, feet nor body/could not lift himself from the floor; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (not hospitalized) in January 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 2) and Pfizer (Dose Number: 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Heartbeats skipped (Heart (skip in his heart)) and Diabetic. Concomitant products included APIXABAN (ELIQUIS) for Heartbeats skipped.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Slight fever). On 16-Jul-2022, the patient experienced BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor). On 16-Jul-2022, PYREXIA (Slight fever) had resolved. On 17-Jul-2022, BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies.  The patient was on a bunch of medications but did not provide any names.  Caller stated that the patient who always gets slight fevers with vaccine, but experience after his last Moderna booster. Patient's side affects started on Saturday, 16Jul2022, in the morning and at 2 AM and lasted 1 day.  Adverse event did not caused the patient to seek medical care.  No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial stored in the refrigerator more than 24 hours; Received expired first primary dose beyond  12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond  12 hours post puncture) and PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 24 hours) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2022 at 9:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond  12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond  12 hours post puncture) and PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 24 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 13-JUL-2022. Date and Time when the vial was first punctured on 20-JUL-2022 at 07:45 AM. The vial was in the refrigerator post puncture for 24 hours. The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Skin swelling
Clinical narrative: armpit got swollen but within a week, it was pretty much gone; fever went up to 100.5/dealing with this for 10 days; This spontaneous case was reported by a patient and describes the occurrence of SKIN SWELLING (armpit got swollen but within a week, it was pretty much gone) and PYREXIA (fever went up to 100.5/dealing with this for 10 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Brain injury. Previously administered products included for Drug use for unknown indication: Pfizer shots (fever of 102), Pfizer booster (Pfizer booster) and Pfizer shots (fever of 102). Past adverse reactions to the above products included Fever with Pfizer shots and Pfizer shots; and Skin swelling with Pfizer booster. Concurrent medical conditions included Allergy to nuts (cashews) and Sulfonamide allergy (sulfa).    On 10-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced SKIN SWELLING (armpit got swollen but within a week, it was pretty much gone) and PYREXIA (fever went up to 100.5/dealing with this for 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SKIN SWELLING (armpit got swollen but within a week, it was pretty much gone) and PYREXIA (fever went up to 100.5/dealing with this for 10 days) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2022, Body temperature: 99 on third day temperature was dropped down to 99. In July 2022, Body temperature: 98.5-99.6 F. and 100.5 100.5 F.         Concomitant product use was not provided by the reporter. Patient did not have other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not have COVID-19 or diagnosis with COVID-19 positive.  Patient initial body temperature was 97.5-98.5 . Patient symptoms  slightly improved on the tenth day as 21-Jul-2022. Patient took phone appointment with doctor on 21-Jul-2022  for adverse event. Patient  took treatment medication first couple of days. Patient stopped treatment medication as treatment medication not helped to patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Dry eye, Eye irritation, Eye pruritus, Impaired quality of life
Clinical narrative: Burning eyes; hurting my quality of life; Itching eyes; Meibomian gland is swollen; Feels like I have sand in my eyes; Diagnosed with Dry eye on February 2022; This spontaneous case was reported by a patient and describes the occurrence of OCULAR DISCOMFORT (Feels like I have sand in my eyes), DRY EYE (Diagnosed with Dry eye on February 2022), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life) and EYE PRURITUS (Itching eyes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eye (Mild case of dry eye such as Itchiness before the pandemic, became worse during pandemic) and Attention deficit hyperactivity disorder (+). Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Attention deficit hyperactivity disorder.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced DRY EYE (Diagnosed with Dry eye on February 2022). On an unknown date, the patient experienced OCULAR DISCOMFORT (Feels like I have sand in my eyes), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life), EYE PRURITUS (Itching eyes) and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland is swollen). The patient was treated with LIFITEGRAST (XIIDRA) at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (Feels like I have sand in my eyes), DRY EYE (Diagnosed with Dry eye on February 2022), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life), EYE PRURITUS (Itching eyes) and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland is swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: Had no allergies, but reacted much later. On an unknown date, SARS-CoV-2 test: (Negative) Always tested Negative for COVID-19.         Patient's height was reported as 5'2  Patient was asking if she could take 2nd Booster dose. Patient had mild case of dry eye such as itchiness before the pandemic, but symptoms became worse during the pandemic. Patient was not sure if the event was related to Moderna vaccine.  Patient seek medical care from Opthalmologist. It was reported that the symptoms got worse.