chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion with our Moderna Covid-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) in a 31-year-old 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. 045H22A) for COVID-19 prophylaxis.     The information was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-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) 1 dosage form. On 17-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion).    No concomitant medications was reported. The temperature excursion occurred for both monovalent and bivalent. 27 total doses were administered post excursion.  No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022 at 2:25 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-May-2022 at 2:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) 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 (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022).    Patient's race was reported. No concomitant medications were reported. The event did not cause the patient to seek medical care. The patient did not have any adverse effects from this vaccine.  The dates of the first two doses was unknown. It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714990.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714990:patient S-E
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lot number AS1903B was involved in a temperature excursion that to place at HCP office on 13-Feb-2023; No adverse event; Patient administered the vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lot number AS1903B was involved in a temperature excursion that to place at HCP office on 13-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 15-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lot number AS1903B was involved in a temperature excursion that to place at HCP office on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lot number AS1903B was involved in a temperature excursion that to place at HCP office on 13-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine which underwent temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lot number AS1903B was involved in a temperature excursion that to place at HCP office on 13-Feb-2023) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered the vaccine which underwent temperature excursion).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715951 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715951:Master Case - Child
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023; No adverse event; lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023, it was administered to patient on 04-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023, it was administered to patient on 04-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 2-year-old 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 04-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023, it was administered to patient on 04-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023, it was administered to patient on 04-Mar-2023) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023) and POOR QUALITY PRODUCT ADMINISTERED (lot numbers AS1903B was involved in a temperature excursion that took place at HCP office on 13-Feb-2023, it was administered to patient on 04-Mar-2023).    No concomitant drug was reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715951 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715951:Master Case - Child
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) and NO ADVERSE EVENT (No adverse event) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022 at 2:25 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-May-2022 at 2:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) 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 (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022).    Patient's race was reported. No concomitant medications were reported. The event did not cause the patient to seek medical care. The patient did not have any adverse effects from this vaccine.  The dates of the first two doses was unknown. It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714990 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714990:Patient S-E
Age: 69.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion. This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in a 69-year-old 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. 045H22A) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Mar-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 07-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) The concomitant medication was not reported by reporter. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The treatment medication was not reported by reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2023-715674:Master Case.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-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) 1 dosage form. On 23-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.).    The concomitant medication was not reported by reporter. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
Age: 62.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old 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. 045H22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-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) 1 dosage form. On 14-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
Age: 80.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in an 80-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-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 01-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine).    Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 74.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Had temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Dose was administered post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 74-year-old 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. 045H22A) 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) 1 dosage form. On 21-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Had temperature excursion with our Moderna Covid-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st and 2nd doses administered. 27 total doses were administered post excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion with Moderna Covid-19 vaccine; No adverse event; doses were administered post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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) 1 dosage form. On 15-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st & 2nd doses administered. 27 total doses were administered post excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 21.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with Moderna COVID-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old 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. 045H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On 07-Mar-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 07-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st & 2nd doses administered. 27 total doses were administered post excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
Age: 52.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Dose was administered post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 52-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-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 01-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 40.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with Moderna COVID-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 40-year-old 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. 045H22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 28-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) 1 dosage form. On 28-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st & 2nd doses administered. 27 total doses were administered post excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 47.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 47-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-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-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine).    Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Magnetic resonance imaging, Muscle spasms, Palpitations, Stenosis
Clinical narrative: mild stenosis/ burning sensation and numbness in legs and hands/still in pain; Heart palpitations; muscle spasms in the hands; This spontaneous case was reported by a non-health professional and describes the occurrence of STENOSIS (mild stenosis/ burning sensation and numbness in legs and hands/still in pain), PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (muscle spasms in the hands) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 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. In 2022, the patient experienced STENOSIS (mild stenosis/ burning sensation and numbness in legs and hands/still in pain), PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (muscle spasms in the hands). The patient was treated with Physical therapy (Physiotherapy) for Stenosis. At the time of the report, STENOSIS (mild stenosis/ burning sensation and numbness in legs and hands/still in pain) had not resolved and PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (muscle spasms in the hands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: No specific issue showed up in lab reports. On an unknown date, Magnetic resonance imaging: MRI was normal with diagnosis of mild stenosis.         No concomitant medication information was reported.  The patient received second booster dose of Moderna vaccine in Oct-2022, and after 4 days of administration, he got burning sensation and numbness in legs and hands, heart palpitations and muscle spasms in the hands.  The patient consulted with the physicians.  The patient was still in pain and being treated with heavy pain medications and was also on physiotherapy.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster) 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 WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster).    No concomitant medications were provided. The patient had got their 2 primary series. No treatment medication was provided. This case contains information for the 2nd of 2 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716157 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716157:1st Child Female Twin Patient
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 12-Feb-2021/removed from freezer to thaw on 20-Mar-2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2021/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2021/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2021/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2021/removed from freezer to thaw on 20-Mar-2023).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial was removed from freezer to thaw 20-Mar-2023.  The vial did not undergo any temperature excursions.  The patient had shots around 8:30 this morning.  No side effects had been reported.   No treatment medications were reported.  This case contains information for the 2nd of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716275, US-MODERNATX, INC.-MOD-2023-716279 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716275:Patient 1 out of 3 Patients US-MODERNATX, INC.-MOD-2023-716279:Patient 3 out of 3 Patients