chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  The patient received booster in the end of Aug to middle of Oct-2022.     No treatment medications were reported.  This case contains information for the 12th of 20th patient described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 12 US-MODERNATX, INC.-MOD-2022-663016:Patient 12 US-MODERNATX, INC.-MOD-2022-662860: US-MODERNATX, INC.-MOD-2022-662881:Patient 12 US-MODERNATX, INC.-MOD-2022-663014:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were provided. 20 patients received 0.25mL instead of 0.5mL of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022. No treatment medication was provided.  This case contains information for the 14th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663011 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662859:Patient 2 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662861:Patient 4 US-MODERNATX, INC.-MOD-2022-662863:Patient 5 US-MODERNATX, INC.-MOD-2022-662865:Patient 6 US-MODERNATX, INC.-MOD-2022-662866:Patient 7 US-MODERNATX, INC.-MOD-2022-662869:Patient 8 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662873:Patient 10 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662876:Patient 12 US-MODERNATX, INC.-MOD-2022-662879:Patient 13 US-MODERNATX, INC.-MOD-2022-662958:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 16 US-MODERNATX, INC.-MOD-2022-663011:Patient 18
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with SODIUM CHLORIDE (SALINE NASAL SPRAY) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) for Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degrees F.. On an unknown date, SARS-CoV-2 test: Negative and Positive.         Patient reported that she caught Covid around the 5th of June. She said that the symptoms were fairly mild. She had nasal congestion which lasted 3 1/2 weeks. She kept testing negative and then finally tested positive for COVID-19. Caller used a neti pot a couple of times and the saline nasal spray and the constant draining made her cough so she took a cough drop and a Alka seltzer cold.   This case was linked to MOD-2022-662837 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with SODIUM CHLORIDE (SALINE NASAL SPRAY) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) for Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degrees F.. On an unknown date, SARS-CoV-2 test: Negative and Positive.         Patient reported that she caught Covid around the 5th of June. She said that the symptoms were fairly mild. She had nasal congestion which lasted 3 1/2 weeks. She kept testing negative and then finally tested positive for COVID-19. Caller used a neti pot a couple of times and the saline nasal spray and the constant draining made her cough so she took a cough drop and a Alka seltzer cold.   This case was linked to MOD-2022-662837 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with SODIUM CHLORIDE (SALINE NASAL SPRAY) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) for Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degrees F.. On an unknown date, SARS-CoV-2 test: Negative and Positive.         Patient reported that she caught Covid around the 5th of June. She said that the symptoms were fairly mild. She had nasal congestion which lasted 3 1/2 weeks. She kept testing negative and then finally tested positive for COVID-19. Caller used a neti pot a couple of times and the saline nasal spray and the constant draining made her cough so she took a cough drop and a Alka seltzer cold.   This case was linked to MOD-2022-662837 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant information was reported. It was reported that the dosage was changed to 0.5 ml. For the past month, nurse had been given 0.25 ml to 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster).    This case is for 2nd adult patient. No concomitant medications were reported. It was reported that total 3 Adult patients received Moderna's monovalent Pediatrics for primary series 6 to 11 years instead of Moderna's Bivalent booster dose. No treatment medication were provided.   This case was linked to MOD-2022-662872, MOD-2022-662909 (Linked Report).; Sender's Comments:  MOD-2022-662872:Adult-1 MOD-2022-662909:Adult-3
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster).    No concomitant medications were reported. No treatment details were reported. It was reported that total 3 Adult patients received Moderna's monovalent Pediatrics for primary series 6 to 11 years instead of Moderna's Bivalent booster dose.   This case was linked to MOD-2022-662872, MOD-2022-662904 (Linked Report).; Sender's Comments:  MOD-2022-662872:Adult-1 MOD-2022-662904:Adult-2
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662875 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 15 US-MODERNATX, INC.-MOD-2022-662860: MOD-2022-662875: US-MODERNATX, INC.-MOD-2022-663016:Patient 15 US-MODERNATX, INC.-MOD-2022-662881:Patient 15 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-662866:Patient 15 US-MODERNATX, INC.-MOD-2022-662861: US-MODERNATX, INC.-MOD-2022-662875:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 15
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    No concomitant medications were provided. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662887, US-MODERNATX, INC.-MOD-2022-662970, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974, US-MODERNATX, INC.-MOD-2022-662991, US-MODERNATX, INC.-MOD-2022-663001, US-MODERNATX, INC.-MOD-2022-663009, US-MODERNATX, INC.-MOD-2022-663012, US-MODERNATX, INC.-MOD-2022-663015, US-MODERNATX, INC.-MOD-2022-663040, US-MODERNATX, INC.-MOD-2022-663041, US-MODERNATX, INC.-MOD-2022-663044, US-MODERNATX, INC.-MOD-2022-663045, US-MODERNATX, INC.-MOD-2022-663047, US-MODERNATX, INC.-MOD-2022-663091, US-MODERNATX, INC.-MOD-2022-663128, US-MODERNATX, INC.-MOD-2022-663137, US-MODERNATX, INC.-MOD-2022-663147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662887:Same reporter US-MODERNATX, INC.-MOD-2022-662970:Same reporter US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662991:Same reporter US-MODERNATX, INC.-MOD-2022-663001:Same reporter US-MODERNATX, INC.-MOD-2022-663009:Same reporter US-MODERNATX, INC.-MOD-2022-663012:Same reporter US-MODERNATX, INC.-MOD-2022-663015:Same reporter US-MODERNATX, INC.-MOD-2022-663040:Same reporter US-MODERNATX, INC.-MOD-2022-663041:Same reporter US-MODERNATX, INC.-MOD-2022-663044:Same reporter US-MODERNATX, INC.-MOD-2022-663045:Same reporter US-MODERNATX, INC.-MOD-2022-663091:Same reporter US-MODERNATX, INC.-MOD-2022-663128:Same reporter US-MODERNATX, INC.-MOD-2022-663137:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 35-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    No concomitant medications were provided. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662887, US-MODERNATX, INC.-MOD-2022-662970, US-MODERNATX, INC.-MOD-2022-662974, US-MODERNATX, INC.-MOD-2022-662991, US-MODERNATX, INC.-MOD-2022-663001, US-MODERNATX, INC.-MOD-2022-663009, US-MODERNATX, INC.-MOD-2022-663012, US-MODERNATX, INC.-MOD-2022-663015, US-MODERNATX, INC.-MOD-2022-663040, US-MODERNATX, INC.-MOD-2022-663041, US-MODERNATX, INC.-MOD-2022-663044, US-MODERNATX, INC.-MOD-2022-663045, US-MODERNATX, INC.-MOD-2022-663091, US-MODERNATX, INC.-MOD-2022-663128, US-MODERNATX, INC.-MOD-2022-663137, US-MODERNATX, INC.-MOD-2022-663147 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-662961:Same reporter US-MODERNATX, INC.-MOD-2022-662887:Same reporter US-MODERNATX, INC.-MOD-2022-662970:Same reporter US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662991:Same reporter US-MODERNATX, INC.-MOD-2022-663001:Same reporter US-MODERNATX, INC.-MOD-2022-663009:Same reporter US-MODERNATX, INC.-MOD-2022-663012:Same reporter US-MODERNATX, INC.-MOD-2022-663015:Same reporter US-MODERNATX, INC.-MOD-2022-663040:Same reporter US-MODERNATX, INC.-MOD-2022-663041:Same reporter US-MODERNATX, INC.-MOD-2022-663044:Same reporter US-MODERNATX, INC.-MOD-2022-663045:Same reporter US-MODERNATX, INC.-MOD-2022-663091:Same reporter US-MODERNATX, INC.-MOD-2022-663128:Same reporter US-MODERNATX, INC.-MOD-2022-663137:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant information was reported. It was reported that the dosage was changed to 0.5 ml. For the past month, nurse had been given 0.25 ml to 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2022-662961, MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662973:Same reporter MODERNATX, INC.-MOD-2022-662961:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medication was not provided.  Pharmacist reported that 20 adult patients  received 0.25 ml instead of 0.5 ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 17th patient of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662875:Patient 11
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  It was reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.   No treatment medications were reported.  This case contains information for the 18th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:9 th patient US-MODERNATX, INC.-MOD-2022-662860:3 rd patient US-MODERNATX, INC.-MOD-2022-663016:Patient 18 US-MODERNATX, INC.-MOD-2022-662881:Patient 18 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-662866:Patient 17
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant medications were reported. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant drugs were not reported. It was reported that 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. For the past month, reporter had been giving 0.25 ml instead of 0.5 ml. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medication was provided. 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of august to middle of October 2022. No treatment medication was reported.   This case involved information about the patient 20.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663011, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-663014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662859:Patient 2 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662863:Patient 5 US-MODERNATX, INC.-MOD-2022-662865:Patient 6 US-MODERNATX, INC.-MOD-2022-662869:Patient 8 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662873:Patient 10 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662876:Patient 12 US-MODERNATX, INC.-MOD-2022-662879:Patient 13 US-MODERNATX, INC.-MOD-2022-662881:Patient 14 US-MODERNATX, INC.-MOD-2022-662958:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 16 US-MODERNATX, INC.-MOD-2022-663011:Patient 18 US-MODERNATX, INC.-MOD-2022-663014:Patient 19 US-MODERNATX, INC.-MOD-2022-663014:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: received 0.25 ml of bivalent dose; No Adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant medications were reported. Reported that reporter was giving 0.25 ml instead of 0.5 ml of Moderna bivalent vaccine. Reported that 19 patients received the half doses on 15Sep2022, 22Sep2022, 29Sep2022, and 06Oct2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant medication was not reported.  Nurse reported that 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Patient received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent dose). No concomitant medications were reported. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment information was provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant medications were reported.  It was reported that reporter was giving 0.25 ml instead of 0.5 ml of Moderna bivalent vaccine. Reported that 19 patients received the half doses on 15 Sep 2022, 22 Sep 2022, 29 Sep 2022, and 06 Oct 2022.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-662961, MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662961:Same reporter MODERNATX, INC.-MOD-2022-662973:Same reporter
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). No concomitant medication were reported.   The nurse reported that for the past month, a total of 19 patients received the half doses of Bivalent on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022, instead of 0.5 ml. No treatment information was provided by the reporter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: received 0.25 ml of bivalent dose; No Adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant medication was not provided.  Nurse reported that 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter