chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: I am running a temperature of 100.7; today I feel really bad; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I am running a temperature of 100.7) and FEELING ABNORMAL (today I feel really bad) in an 81-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth 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 PYREXIA (I am running a temperature of 100.7) and FEELING ABNORMAL (today I feel really bad). At the time of the report, PYREXIA (I am running a temperature of 100.7) and FEELING ABNORMAL (today I feel really bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7.     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.   Patient had a co cover booster. Day after vaccination patient felt really bad and running a temperature of 100.7. Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they accidentally administered a dose of the Moderna COVID-19 Vaccine Bivalent booster instead of a dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (they accidentally administered a dose of the Moderna COVID-19 Vaccine Bivalent booster instead of a dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 WRONG PRODUCT ADMINISTERED (they accidentally administered a dose of the Moderna COVID-19 Vaccine Bivalent booster instead of a dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they accidentally administered a dose of the Moderna COVID-19 Vaccine Bivalent booster instead of a dose of 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 (they accidentally administered a dose of the Moderna COVID-19 Vaccine Bivalent booster instead of a dose of the primary series).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated that they accidentally administered a dose of the Moderna COVID-19 vaccine Bivalent booster instead of a dose of the primary series. It was unknown if patient reported any AE, or if there was any treatment given.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse event; 5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) 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 (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions).    No concomitant product reported by reporter.  5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions. It was unknown if patient received any other vaccine in the 4 prior to COVID-19 vaccine.  No treatment medication reported by reporter.  Case included information of patient 2 of 5 patients.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: gotten Covid-19 twice/experienced cold, cough, body pain/testing positive for covid twice; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (gotten Covid-19 twice/experienced cold, cough, body pain/testing positive for covid twice) in a 0-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. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Second dose with Pfizer), PFIZER BIONTECH COVID-19 VACCINE (First dose with Pfizer) and PFIZER BIONTECH COVID-19 VACCINE (one booster with Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (gotten Covid-19 twice/experienced cold, cough, body pain/testing positive for covid twice). At the time of the report, COVID-19 (gotten Covid-19 twice/experienced cold, cough, body pain/testing positive for covid twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive and Positive.     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.  It was reported patient had testing positive for covid twice. Patient reported had Covid and a cough for almost 2 months since they got the vaccine. patient took the Pfizer vaccine in the past and just got the Moderna booster and had been experiencing side effects.  Patient reported they got the Moderna booster in October and since then they had gotten Covid-19 twice. patient reports side effects started within the next two days after had the Moderna booster.  Patient reported they got two vaccines with Pfizer and one booster with Pfizer.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; No adverse event; patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) 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 (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions).    No concomitant product reported by reporter.  It was unknown if patient received any other vaccine in the 4 prior to COVID-19 vaccine.  No treatment medication reported by reporter.  Case included information of patient 3 of 5 patients.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022; Erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022).    No concomitant medications were reported.  Vial size was reported as 5.5 mL.  Vial did not undergo any temperature excursion. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event). On 13-May-2022, NO ADVERSE EVENT (No adverse event) outcome was unknown. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022).    This case is for adult patient 4 from 7 adult patients who received monovalent dose on 23-Feb-2022, as described by the reporter. No concomitant medications were reported. The vial could be either from individual vials or unbroken cartons and was of the size of 2.5 ml. 7 adult patients received monovalent dose on 23-feb-2022 which was shipped on 13-jan-2022 thawed in a cooler while being transported. The vial did not undergo any temperature excursions.Treatment in formation was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176, US-MODERNATX, INC.-MOD-2022-682100 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Follow-up contains: Reporter added , Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682100:Monovalent (Same reporter; Adult patient 4 from 7 Adult patients Monovalent shots on 23FEB2022)
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022; No adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 55-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. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion).    Concomitant medication not reported. Treatment medication not reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022; No Adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 59-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. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-17 Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681465 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681465:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness after Bivalent Booster; Low Fever after Bivalent Booster; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness after Bivalent Booster) and PYREXIA (Low Fever after Bivalent Booster) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 029B22A) for COVID-19 vaccination.     Previously administered products included for Cancer: Rituxan from 2020 to 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Rituxan. Concurrent medical conditions included Cancer since 2019 and Immunocompromised.    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced DIZZINESS (Dizziness after Bivalent Booster) and PYREXIA (Low Fever after Bivalent Booster). On 29-Oct-2022, DIZZINESS (Dizziness after Bivalent Booster) and PYREXIA (Low Fever after Bivalent Booster) had resolved.            No concomitant medications were provided.  The patient received First Primary monovalent dose on 09-Feb-2021 with lot number 007M20A, second primary monovalent dose on 09-Mar-2021 with lot number 002A21A, third dose monovalent (not sure if half dose) on 14-Aug-2021 with lot number 088D21A. Antibody tests on May-2021 and Jan-2022 showed no detectable antibody.  As the patient was on Rituxan the vaccines were not effective on patient, it did not make antibodies and on an unknown date in Sep-2022 patient received Evusheld antibody pack to prevent COVID disease.  No treatment medication was provided.   This case was linked to MOD-2022-682288 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot) 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 PRODUCT ADMINISTRATION INTERRUPTED (Patient received 1st primary Moderna dose on 4/16/21 and never came back for the 2nd shot).    Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; gave expired monovalent dose l; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051b22a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired monovalent dose l) 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 (gave expired monovalent dose l).    Concomitant drugs were not reported. The monovalent individual vial of 5.5 ml size was stored initially in refrigerator on 20-Nov-2022 and did not underwent any temperature excursion. Treatment medications were not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in fridge post puncture; No adverse event; Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) 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 EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture).    No concomitant medications were reported. Individual vials were used. The vial was initially stored in the refrigerator on 22-Oct-2022. The vial was first punctured on 17-Nov-2022 at 8 AM. 2 Patient were given the vaccine on 18-Nov-2022 at 2:23 PM and 11:43 AM. The pre-drawn syringes were put back in the fridge post punctured. The vial did not undergo any temperature excursions. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682303:Same reporter
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: Patient had COVID Disease 5 months after 4th dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had COVID Disease 5 months after 4th dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 033F21A, 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-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 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (Patient had COVID Disease 5 months after 4th dose). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. In September 2022, COVID-19 (Patient had COVID Disease 5 months after 4th dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Body temperature: 101.3 101.3 F. In September 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. Patient had symptoms fever and chills which lasted for 2 days. Doctor told patient to get Booster in Dec-2022.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in fridge post puncture; No adverse event; Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) 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. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) 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 EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture).    No concomitant medications were reported.  It was reported that individual vials of Moderna COVID-19 vaccine, Bivalent was initially stored in the refrigerator on 22-Oct-2022. The vial was first punctured on 17-Nov-2022 at 8 AM. The vaccine was administered to 2 patients on 18-Nov-2022 at 11:43 AM and 2:23PM.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682297 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682297:Same reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered a dose of the Moderna Covid-19 vaccine that had expired on 28NOV2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Covid-19 vaccine that had expired on 28NOV2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder. Concomitant products included CARBAMAZEPINE, COLECALCIFEROL (VITAMIN D3) and PHENYTOIN SODIUM for an unknown indication.    On 02-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Covid-19 vaccine that had expired on 28NOV2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Covid-19 vaccine that had expired on 28NOV2022) 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 (Administered a dose of the Moderna Covid-19 vaccine that had expired on 28NOV2022).    It was reported that no other adverse reactions reported. Individual vial was used and vail size was 5.5ml. Vial thawed straight out of the freezer. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received vaccine 1 day after manufacturer expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date) 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 (Received vaccine 1 day after manufacturer expiration date).    No concomitant medication was reported. No treatment medication was reported. In the facility, the patient was injected a vaccine 1 days after manufacturer expiration date. The information was unknown whether the vial was stored in the refrigerator.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received a bivalent booster as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose) 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 (received a bivalent booster as a first dose).    No concomitant information was reported. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture; No adverse event; A Dose was administered more than 12 hours post puncture as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose), PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose), PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture) 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 (A Dose was administered more than 12 hours post puncture as a second dose) and PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture).    No concomitant drug was reported. Reporter stated that the monovalent vaccine was kept in fridge after the vial was punctured. No treatment drug was reported.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: The needle displaced from syringe and some of the vaccine spilled out.; No adverse event; The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.), DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.), DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.) 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 UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.) and DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.).    The concomitant medication was not reported by reporter. Caller was not sure whether the patient got full dose or not. The treatment medication was not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient accidentally received bivalent booster instead of primary series dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient accidentally received bivalent booster instead of primary series dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 WRONG PRODUCT ADMINISTERED (Patient accidentally received bivalent booster instead of primary series dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient accidentally received bivalent booster instead of primary series dose) 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 accidentally received bivalent booster instead of primary series dose).    It was unknown if patient reported any AEs, any treatment was given or if the patient was under any concomitant or regular medication.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) 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 ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    No concomitant medications were reported. It was reported that administrations occurred over the course of approximately 1 month. Patient had no reported symptoms, no additional doses or treatments.  This case was for the 1st patient out of 5 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682550, US-MODERNATX, INC.-MOD-2022-682547, US-MODERNATX, INC.-MOD-2022-682548, US-MODERNATX, INC.-MOD-2022-682546 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682550:same reporter US-MODERNATX, INC.-MOD-2022-682547:same reporter US-MODERNATX, INC.-MOD-2022-682548:same reporter US-MODERNATX, INC.-MOD-2022-682546:same reporter