chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 7th of 15 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live follow-up document received includes patient demographics (initial and DOB), vaccine administration date was updated. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy (Allergy to sulfa), Ragweed allergy, Allergic to cats and Grass allergy.    On 23-Feb-2023 at 12:32 PM, 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 23-Feb-2023 at 12:32 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) 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 (Vaccine given 1 day beyond BUD).    Concomitant product use was not provided by the reporter.  Patient administered the Moderna bivalent vaccine on 23-Feb-2023 and the Use by date was 22-Feb-2023.  Lot assessment conducted and determined, Analysis of the vials associated with storage excursion was complete. The vaccine administered on 23-Feb-2023 from lot number AS7170B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  Patient notified at time of initial discovery of event as well as notified when the lot assessment was complete.  Treatment information was not provided.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Headache, Nasopharyngitis
Clinical narrative: Cold-Like Symptoms; Headache; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of NASOPHARYNGITIS (Cold-Like Symptoms), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  Concurrent medical conditions included Drug allergy (Hydroxyzine) and Penicillin allergy.    On 23-Feb-2023 at 1:40 PM, 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 23-Feb-2023 at 1:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On 24-Feb-2023 at 9:00 AM, the patient experienced NASOPHARYNGITIS (Cold-Like Symptoms) and HEADACHE (Headache). On 27-Feb-2023, NASOPHARYNGITIS (Cold-Like Symptoms) and HEADACHE (Headache) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NASOPHARYNGITIS (Cold-Like Symptoms), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) to be related.    It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.  Moderna Bivalent Booster (AS7170B) used by date was reported as 22-Feb-2023. Upon lot assessment it was reported that the vaccine administered on 23-Feb-2023 from lot number AS7170B, maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The patient was notified at time of initial discovery of event as well as notified when the lot assessment was complete. The events did not cause the patient to seek medical care.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) and NO ADVERSE EVENT (no adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Seasonal allergy (Seasonal Allergies).    On 23-Feb-2023 at 3:33 PM, 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 23-Feb-2023 at 3:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) to be related and NO ADVERSE EVENT (no adverse event) to be not related.    Concomitant medication information was not reported.  It was reported that Moderna bivalent booster dose was administered on 23-Feb-2023, which is 1 day beyond the beyond use date.  Patient was notified about the incident at the time of initial discovery of event as well as notified when the lot assessment was completed.  No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; no adverse event; administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023 at 2:52 PM, 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 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event). On 23-Feb-2023, EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Dose administered after 30-day Use By 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)) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.) to be related and NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was unknown whether patient ever been diagnosed with or tested positive for COVID-19. It was unknown whether patient have acute illnesses at the time of vaccination or not. It was unknown whether patient taking any prescription, over the counter medication, dietary supplement or herbal remedies at the time of vaccination or at the time of adverse event. There are no any other potential causes reported. Patient did not experienced a similar event in the past. Event did not cause the patient to seek medical care. Lot assessment conducted and determined as follows, Analysis of the vials associated with storage excursion was completed. Patient notified at time of initial discovery of event as well as notified when the lot assessment was completed.   This case was linked to US-MODERNATX, INC.-MOD-2023-712565 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712565:Same reporter
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) and NO ADVERSE EVENT (no adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     The patient had no known allergies.     On 23-Feb-2023 at 1:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Feb-2023 at 1:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) to be related and NO ADVERSE EVENT (no adverse event) to be not related.    No concomitant medications were reported.   Vaccine use by date was reported as 22-Feb-2023.  The event did not cause the patient to seek medical care. There were no other potential causes reported. The patient did not experience similar events in the past.   No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: underwent temperature excursion, They were to be used within 24 hours but administered to patients on unknown dates; Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion, They were to be used within 24 hours but administered to patients on unknown dates), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) 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 POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion, They were to be used within 24 hours but administered to patients on unknown dates), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion, They were to be used within 24 hours but administered to patients on unknown dates), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) 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 POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion, They were to be used within 24 hours but administered to patients on unknown dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023).    No concomitant medication were reported.  It was reported that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case was reported for patient 21 out of 24.   This case was linked to US-MODERNATX, INC.-MOD-2023-713467 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to; Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) 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 POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) 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 POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to) and PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023).    No concomitant medication were reported.  It was reported that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case was reported for patient 10 out of 24.   This case was linked to US-MODERNATX, INC.-MOD-2023-713467 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: tightness of chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness of chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Prior to vaccination, was the patient diagnosed with COVID 19 was unknown.  Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) in March 2021 and Pfizer (Dose Number: 2 Batch/Lot No: Unknown.) in April 2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CHEST DISCOMFORT (tightness of chest). At the time of the report, CHEST DISCOMFORT (tightness of chest) had not resolved.            Concomitant medication was not reported. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID.  Patient experienced tightness of chest after taking her COVID vaccine booster shots and the condition persists until today. Upon further inquiry, it was noted that patient got injected with Pfizer vaccines 1st and 2nd dose, and a Moderna booster shot. Treatment medication was not reported. Since the vaccination, it was unknown whether patient been tested for COVID- 19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 939905, 027A21A and 031l20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2023, the patient experienced COVID-19 (Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive). At the time of the report, COVID-19 (Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had COVID symptoms after receiving shots, had sore throat. The COVID test turned out positive randomly. A week ago from the reporting day. patient had been quarantined.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2023: Live Significant Follow-Up information received: Vaccination details updated and patient information updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Incorrect route of product administration, Insomnia, Malaise
Clinical narrative: dizziness; restlessness; sleepless night; had injection site pain; body aches; subcutaneous injection; general malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), RESTLESSNESS (restlessness), INSOMNIA (sleepless night), VACCINATION SITE PAIN (had injection site pain) and DIZZINESS (dizziness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MALAISE (general malaise), VACCINATION SITE PAIN (had injection site pain), MYALGIA (body aches) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection). On 04-May-2021, the patient experienced RESTLESSNESS (restlessness) and INSOMNIA (sleepless night). On 05-May-2021, the patient experienced DIZZINESS (dizziness). On 02-Apr-2021, MALAISE (general malaise), VACCINATION SITE PAIN (had injection site pain) and MYALGIA (body aches) had resolved. On 07-May-2021, RESTLESSNESS (restlessness), INSOMNIA (sleepless night) and DIZZINESS (dizziness) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter considered MALAISE (general malaise), RESTLESSNESS (restlessness), INSOMNIA (sleepless night), VACCINATION SITE PAIN (had injection site pain), DIZZINESS (dizziness), MYALGIA (body aches) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) to be related.    Concomitant product use was not provided by the reporter.  The patient received vaccine 1 on 01-Apr-2021, in left arm (subcutaneous) experienced injection site pain and body aches in combination with general malaise that recovered the next day.  The patient received vaccine 2 on 04-May-2021, in left arm (subcutaneous) experienced restlessness, sleepless night, next day experienced dizziness, malaise, and body aches that took 3 days to recover, but did not seek medical attention.  The patient received vaccine 3 (booster) on 01-Nov-2021 in left arm (subcutaneous) experienced general malaise and recovered the next day without medical attention.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Restlessness, Vaccination site pain
Clinical narrative: dizziness; restlessness; sleepless night; had injection site pain; body aches; subcutaneous injection; general malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), RESTLESSNESS (restlessness), INSOMNIA (sleepless night), VACCINATION SITE PAIN (had injection site pain) and DIZZINESS (dizziness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MALAISE (general malaise), VACCINATION SITE PAIN (had injection site pain), MYALGIA (body aches) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection). On 04-May-2021, the patient experienced RESTLESSNESS (restlessness) and INSOMNIA (sleepless night). On 05-May-2021, the patient experienced DIZZINESS (dizziness). On 02-Apr-2021, MALAISE (general malaise), VACCINATION SITE PAIN (had injection site pain) and MYALGIA (body aches) had resolved. On 07-May-2021, RESTLESSNESS (restlessness), INSOMNIA (sleepless night) and DIZZINESS (dizziness) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter considered MALAISE (general malaise), RESTLESSNESS (restlessness), INSOMNIA (sleepless night), VACCINATION SITE PAIN (had injection site pain), DIZZINESS (dizziness), MYALGIA (body aches) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) to be related.    Concomitant product use was not provided by the reporter.  The patient received vaccine 1 on 01-Apr-2021, in left arm (subcutaneous) experienced injection site pain and body aches in combination with general malaise that recovered the next day.  The patient received vaccine 2 on 04-May-2021, in left arm (subcutaneous) experienced restlessness, sleepless night, next day experienced dizziness, malaise, and body aches that took 3 days to recover, but did not seek medical attention.  The patient received vaccine 3 (booster) on 01-Nov-2021 in left arm (subcutaneous) experienced general malaise and recovered the next day without medical attention.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) in an 8-month-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients).    No concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Vaccine information reported. On 28-Feb-2023: Follow up received contains no new information. On 28-Feb-2023: Patient demographics reported and vaccine details reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1
Age: 0.5
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9236B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    Previously administered products included for Product used for unknown indication: DIPHTHERIA TETANUS PERTUSSIS AND HEPATITIS-B on 31-Jan-2023, ROTARIX on 31-Jan-2023 and PREVENAR on 31-Jan-2023. Past adverse reactions to the above products included No adverse event with DIPHTHERIA TETANUS PERTUSSIS AND HEPATITIS-B, PREVENAR and ROTARIX. Concurrent medical conditions included GERD and Dairy intolerance. Concomitant products included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS PERTUSSIS AND HEPATITIS-B) for an unknown indication.   On 31-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Mar-2023, the patient received second dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (unknown route) 1 dosage form. On 01-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)) 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 EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)).    No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.) and NO ADVERSE EVENT (No adverse event) in an adult female patient 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.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On an unknown date, 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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.) 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 WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.).    No concomitant medications were reported. patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: No adverse event; Patient received double the dose of Moderna Covid-19 vaccine (monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)).    The date of the birth of the patient was reported as 2022.  No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Potential AE; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Potential AE) in an adult female patient 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 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 IMMUNISATION REACTION (Potential AE). At the time of the report, IMMUNISATION REACTION (Potential AE) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient received the last booster dose in last year and this was patient second booster dose.  No treatment medications were reported.   Reporter did not allow further contact
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 01-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP accidentally administered 0.25mL as a second primary series dose instead of 0.5mL).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 after receiving the Moderna vaccines.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19 after receiving the Moderna vaccines.) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (tested positive for Covid-19 after receiving the Moderna vaccines.). On 03-Feb-2023, COVID-19 (tested positive for Covid-19 after receiving the Moderna vaccines.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received 1st Dose of Moderna COVID-19 vaccine on 26-Feb-2021 with lot no 011A21A, 2nd dose on 23-Mar-2021 with lot no 007B21A, 3rd booster dose administered on 02-Nov-2021 with lot no 032F21A. No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date). 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 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use 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 (A dose of the Moderna COVID-19 bivalent vaccine was administered to patient on 21-Feb-2023, 3 days after the beyond use date).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 3rd patient out of 4 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713545, US-MODERNATX, INC.-MOD-2023-713548, US-MODERNATX, INC.-MOD-2023-713553 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713545:Patient 1 US-MODERNATX, INC.-MOD-2023-713548:Patient 2 US-MODERNATX, INC.-MOD-2023-713553:Patient 4
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose of the Moderna COVID-19 bivalent vaccine was administered to 4 patients on 21FEB2023, 3 days after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 bivalent vaccine was administered to 4 patients on 21FEB2023, 3 days after the beyond use 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Feb-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 bivalent vaccine was administered to 4 patients on 21FEB2023, 3 days after the beyond use date). 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 bivalent vaccine was administered to 4 patients on 21FEB2023, 3 days after the beyond use 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 (A dose of the Moderna COVID-19 bivalent vaccine was administered to 4 patients on 21FEB2023, 3 days after the beyond use date).    No concomitant drug was reported. It was reported that vaccine was administered beyond use date. Four recipients were administered vaccine all on the same day. This case contains information for the 1st of 4 patients described by the reporter. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713548, US-MODERNATX, INC.-MOD-2023-713552, US-MODERNATX, INC.-MOD-2023-713553 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713548:Patient 2 US-MODERNATX, INC.-MOD-2023-713552:Patient 3 US-MODERNATX, INC.-MOD-2023-713553:Patient 4