chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Rash
Clinical narrative: SIDE EFFECTS; BODY RASH; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized 3 times with unspecified side effects, and body rash. The number of days of hospitalization was not reported and it was unspecified if the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects and body rash was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20230109707-Side effects-The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.     V0- 20230109707-Body rash-. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 36 year male of an unspecified race. The patient's height, and weight were not reported. The patient's past medical history included: right hip replacement, and concurrent conditions included: drug allergy (not reported), and other pre-existing medical conditions included: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) . The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-DEC-2021 08:00 in left arm for covid-19 prophylaxis. Age at time of vaccination 35 years old. No concomitant medications were reported.  On 27-DEC-2022 14:00, the patient had metallic taste that had lead to nausea and had covid-19 infection (suspected covid-19 infection, dose number in series 2) for which patient received treatment of Paxlovid (form of admin and route of admin were not reported, batch number: GF 4083, expiry: UNKNOWN) dose was not reported, administered on 27-DEC-2022 for treatment of covid-19. Date of last administration was 28-DEC-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: REACTIONS FOR 3 MONTHS AFTER THE VACCINE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced reactions for 3 months after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from reactions for 3 months after the vaccine. This report was non-serious. This case, from the same reporter is linked to 20230116143.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Blood pressure decreased, Blood pressure fluctuation, Blood pressure measurement, Fatigue
Clinical narrative: Today my blood pressure falls 103/69 / Then pops up 126/82; headaches; fatigue; back pains; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back pains), BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82), HEADACHE (headaches) and FATIGUE (fatigue) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jan-2023, 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 03-Jan-2023, the patient experienced BACK PAIN (back pains), HEADACHE (headaches) and FATIGUE (fatigue). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82). At the time of the report, BACK PAIN (back pains), BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82), HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure decreased: Today my blood pressure falls 103/69.. On an unknown date, Blood pressure measurement: Then pops up 126/82..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered BACK PAIN (back pains), BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82), HEADACHE (headaches) and FATIGUE (fatigue) to be related.    No concomitant medications were reported.  Patient had booster Monday January 2. The next day back pains, headaches and yesterday fine. Today patient blood pressure falls 103/69 and Fatigue, then pops up 126/82 within 3 hours. It would this be Moderna vaccine. Patient on blood thinners and beta blockers medications.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Non-significant follow-up appended
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Today my blood pressure falls 103/69 / Then pops up 126/82; headaches; fatigue; back pains; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back pains), BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82), HEADACHE (headaches) and FATIGUE (fatigue) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jan-2023, 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 03-Jan-2023, the patient experienced BACK PAIN (back pains), HEADACHE (headaches) and FATIGUE (fatigue). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82). At the time of the report, BACK PAIN (back pains), BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82), HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure decreased: Today my blood pressure falls 103/69.. On an unknown date, Blood pressure measurement: Then pops up 126/82..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered BACK PAIN (back pains), BLOOD PRESSURE FLUCTUATION (Today my blood pressure falls 103/69 / Then pops up 126/82), HEADACHE (headaches) and FATIGUE (fatigue) to be related.    No concomitant medications were reported.  Patient had booster Monday January 2. The next day back pains, headaches and yesterday fine. Today patient blood pressure falls 103/69 and Fatigue, then pops up 126/82 within 3 hours. It would this be Moderna vaccine. Patient on blood thinners and beta blockers medications.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Non-significant follow-up appended
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial).    Concomitant product information was not provided by the reporter.   It was reported that recently discovered the pediatric patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial. Patient incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial as the facility didn't carry the pediatric vials and no adverse reactions have been reported by the patient so far.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-695008 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695008:Same reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: The patient stated that he knows someone who's father had similar cardiac symptoms as him; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (The patient stated that he knows someone who's father had similar cardiac symptoms as him) in a 70-year-old male patient 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 an unknown date, 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 an unknown date, the patient experienced CARDIAC DISORDER (The patient stated that he knows someone who's father had similar cardiac symptoms as him). At the time of the report, CARDIAC DISORDER (The patient stated that he knows someone who's father had similar cardiac symptoms as him) outcome was unknown.            No concomitant medications were reported.  The reported stated that, the patient had cardiac symptoms and had to have surgery. The patient also received the vaccine in the same county as of reporter.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689920 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689920:Same reporter
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours) and NO ADVERSE EVENT (No adverse event) in a 5-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours).    No concomitant medication was provided by reporter.  The vial was initially stored in the refrigerator: 31Dec2022. The vial was first punctured: 5Jan2023 at 3:30 PM. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours.  No treatment medication was provided by reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7168B and 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jan-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023).    No concomitant drug information was provided.   Patient had received 4 monovalent doses. Dose 21 JAN2021 with Lot no 013L20A, Dose 2 on 15FEB2021 with Lot no. 016M20A, Dose 3 (First monovalent booster) 16NOV2021 with Lot no. 067F21A  and dose 4 (second monovalent booster) on 09MAY2022 Lot no. 001M21A  It was reported that the patient had received 6 Moderna doses.  The patient told the reporter that her doctor told her to go ahead and get another booster. Reporter  stated that the doctor must have not checked her vaccination card.   No treatment drug information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: feeling terrible; He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.; dizziness; fever; nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling terrible), HYPERHIDROSIS (He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.), DIZZINESS (dizziness), PYREXIA (fever) and NAUSEA (nausea) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with COVID in 2020.) in 2020.    On 02-Jan-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jan-2023, the patient experienced FEELING ABNORMAL (feeling terrible), HYPERHIDROSIS (He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.), DIZZINESS (dizziness), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (feeling terrible), HYPERHIDROSIS (He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.), DIZZINESS (dizziness), PYREXIA (fever) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter was calling on behalf of her husband. Reporter stated that her husband received 2nd dose of the Moderna COVID-19 vaccine on 02-Jan-2023. The patient started experiencing side effects like fever, nausea, dizziness and sweats the same night that patient received 2nd dose. Also said that the patient had been feeling terrible since receiving the vaccine. The patient was told that the side effects could last for 3 days but patient's side effects were ongoing at the time of report. Reporter would like to know if it was normal to experience side effects for so long.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 019H22A and 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent).    No concomitant medications were reported.  No treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 3 Moderna COVID-19 vaccines, but received the last dose (Bivalent Booster) Too early; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Moderna COVID-19 vaccines, but received the last dose (Bivalent Booster) Too early) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, 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 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Moderna COVID-19 vaccines, but received the last dose (Bivalent Booster) Too early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Moderna COVID-19 vaccines, but received the last dose (Bivalent Booster) Too early) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Moderna COVID-19 vaccines, but received the last dose (Bivalent Booster) Too early).    Concomitant medication was not reported.  Patient received Moderna first dose (monovalent) in Oct-2022 (Lot: 011B22A, Exp. Date: unknown) and second dose (monovalent) on 30-Nov-2022 (Lot: 083B22A & Exp. Date: unknown).  Patient received bivalent booster too early. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, 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 30-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date).    No concomitant medication information provided. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 30-Dec-2022.  The vial did not undergo any temperature excursions. No treatment information provided. This case contains information for the 1st of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-695101, US-MODERNATX, INC.-MOD-2023-695127, US-MODERNATX, INC.-MOD-2023-695166, US-MODERNATX, INC.-MOD-2023-695188 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695166:4 of 5 adult patient US-MODERNATX, INC.-MOD-2023-695188:5 of 5 adult patient US-MODERNATX, INC.-MOD-2023-695101:2 of 5 adult patient US-MODERNATX, INC.-MOD-2023-695127:3 of 5 adult patient
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing; the vaccine may have been refrozen; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    This case included information of patient 1st out of 4 specified patients. None of the patient were pregnant.  Concomitant products were not reported.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022. The vial did not undergo temperature excursion. The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen. Patient had no adverse event.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-695198, US-MODERNATX, INC.-MOD-2023-695263, US-MODERNATX, INC.-MOD-2023-695333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695263:3 of 4 patient US-MODERNATX, INC.-MOD-2023-695333:4 of 4 patient US-MODERNATX, INC.-MOD-2023-695198:2 of 4 patient
Sex: M
Vaccine: COVID19
Symptoms: Angioimmunoblastic T-cell lymphoma
Clinical narrative: Angioimmunoblastic T-cell lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma) in a male 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 an unknown date, 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 an unknown date, the patient experienced ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma) (seriousness criterion medically significant). At the time of the report, ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication were reported.  Patient was diagnosed with an angioimmunoblastic T cell lymphoma six months after having received the moderna vaccine. The patient had a poor prognosis at the time of diagnosis. No treatment medication were reported.  Company Comment: This spontaneous case concerns a male patient (age not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) event of Angioimmunoblastic T-cell lymphoma about six months after receiving a dose of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccination. The patient had a poor prognosis at the time of diagnosis. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the event reported as unknown. The benefit-risk relationship of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient (age not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) event of Angioimmunoblastic T-cell lymphoma about six months after receiving a dose of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccination. The patient had a poor prognosis at the time of diagnosis. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the event reported as unknown. The benefit-risk relationship of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccine is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 27-Dec-2022. Past adverse reactions to the above products included No adverse event with Flu shot.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster).    Concomitant products were not provided. Treatment medication were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-694841 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694841:1 patient out of 2
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Swine flu vaccine. Past adverse reactions to the above products included Guillain-Barre syndrome with Swine flu vaccine.    In April 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced CEREBROVASCULAR ACCIDENT (my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!) outcome was unknown.            The patients wife reported that patient had a massive stroke on 30 Apr 2022, 2 days after getting the second dose of Moderna. She asked whether he should have the vaccine since he had Guillain-Barre after the swine flu vaccine, the family doctor as well as pharmacist said he should take.  No concomitant products reported.  No treatment products reported.  Company comment: This is a spontaneous case concerning a male patient of an unknown age, with no relevant medical history reported, who experienced the serious (medically significant) AESI of Cerebrovascular accident, which occurred two days after the second dose of mRNA-1273. The event was described as a massive stroke. The patient's wife had asked whether the patient should have had the vaccine since he had Guillain-Barre after the swine flu vaccine and the family doctor as well as pharmacist said he should take the vaccine. No further clinical information, studies performed, hospitalization, treatment details were available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age, with no relevant medical history reported, who experienced the serious (medically significant) AESI of Cerebrovascular accident, which occurred two days after the second dose of mRNA-1273. The event was described as a massive stroke. The patient's wife had asked whether the patient should have had the vaccine since he had Guillain-Barre after the swine flu vaccine and the family doctor as well as pharmacist said he should take the vaccine. No further clinical information, studies performed, hospitalization, treatment details were available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, 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 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date).    No concomitant medication information provided. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 30-Dec-2022.  The vial did not undergo any temperature excursions. No treatment information provided. This case considered of 2nd patient of 5 adult patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Dec-2022, 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 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date).    No concomitant medication information provided. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 30-Dec-2022.  The vial did not undergo any temperature excursions. No treatment information provided. This case contains information for the 3rd of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:MASTER CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, 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 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date).    No concomitant medications were reported.  Vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was 30-Dec-2022.   The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 4th of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:MASTER CASE