chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Hypertension, Hypotension, Illness
Clinical narrative: Violently ill; Low blood pressure; Went into high hypertension; Had really strong reactions; Fever; Chills; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: Got low blood pressure and Went into high hypertension.     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 relevant concomitant medications were reported.   Patient started treatment on 22-Sep-2022 with Moderna Bivalent COVID-19 vaccine dose 5 for COVID-19 immunization. It was reported the patient was violently ill, got low blood pressure and he went into high hypertension, had fevers, chills, testing his kidney, and had really strong reactions  The lab data also reported, unspecified testing of kidney.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: Violently ill; Low blood pressure; Went into high hypertension; Had really strong reactions; Fever; Chills; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Violently ill), HYPOTENSION (Low blood pressure), HYPERTENSION (Went into high hypertension), IMMUNISATION REACTION (Had really strong reactions), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: Got low blood pressure and Went into high hypertension.     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 relevant concomitant medications were reported.   Patient started treatment on 22-Sep-2022 with Moderna Bivalent COVID-19 vaccine dose 5 for COVID-19 immunization. It was reported the patient was violently ill, got low blood pressure and he went into high hypertension, had fevers, chills, testing his kidney, and had really strong reactions  The lab data also reported, unspecified testing of kidney.  No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted Covid in the 3rd week of August 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Contracted Covid in the 3rd week of August 2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Contracted Covid in the 3rd week of August 2022). At the time of the report, COVID-19 (Contracted Covid in the 3rd week of August 2022) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-659562 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659562:Wife Case
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: no adverse event; Bivalent Booster Vaccine leaked out of the syringe/Liquid Vaccine rolled down the patient's arm; Patient did not receive the entire dose of the Bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (Bivalent Booster Vaccine leaked out of the syringe/Liquid Vaccine rolled down the patient's arm), UNDERDOSE (Patient did not receive the entire dose of the Bivalent booster) and NO ADVERSE EVENT (no adverse event) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-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 14-Oct-2022, the patient experienced DEVICE CONNECTION ISSUE (Bivalent Booster Vaccine leaked out of the syringe/Liquid Vaccine rolled down the patient's arm) and UNDERDOSE (Patient did not receive the entire dose of the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Bivalent Booster Vaccine leaked out of the syringe/Liquid Vaccine rolled down the patient's arm), UNDERDOSE (Patient did not receive the entire dose of the 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 assessments were provided for DEVICE CONNECTION ISSUE (Bivalent Booster Vaccine leaked out of the syringe/Liquid Vaccine rolled down the patient's arm) and UNDERDOSE (Patient did not receive the entire dose of the Bivalent booster).    No concomitant medications were reported. The patient received all previous shots of Moderna COVID-19 vaccines. The patient received first dose on Oct-2021 (Lot number & Expiry Date: unknown) and 2nd dose on  Apr-2022 (Lot number & Expiry Date: unknown) . No treatment medications were reported.   This case was linked to MOD-2022-659413 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Had adverse event to the Moderna Vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Had adverse event to the Moderna Vaccine) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had adverse event to the Moderna Vaccine) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (Had adverse event to the Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a spontaneous case concerning a male patient of an unknown age, with no reported medical history, who experienced the unexpected and serious (hospitalization) event of immunisation reaction (reported as Had adverse event to the Moderna Vaccine). The vaccination date with an unspecified dose of mRNA-1273.222 vaccine and the event´s onset date were not reported; hence, latency could not be properly assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age, with no reported medical history, who experienced the unexpected and serious (hospitalization) event of immunisation reaction (reported as Had adverse event to the Moderna Vaccine). The vaccination date with an unspecified dose of mRNA-1273.222 vaccine and the event´s onset date were not reported; hence, latency could not be properly assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on OCT-2021 and 2nd shot on APR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on OCT-2021 and 2nd shot on APR-2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on OCT-2021 and 2nd shot on APR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on OCT-2021 and 2nd shot on APR-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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on OCT-2021 and 2nd shot on APR-2022).    Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-659377 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: 30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022; No adverse event; Received Expired Monovalent booster after 30-day Use By Date; Received Monovalent instead of Bivalent Booster by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake), PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake), PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) 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 EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake) and PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022).    Concomitant drugs were not reported. It was reported that  the monovalent 6 years to 11 years individual vial of size 2.5 mL was unknown when initially stored in refrigerator but 30 day beyond use date was 30-Sep-2022. The patient was supposed to receive Bivalent vaccine. The vial did not undergo any temperature excursion. Treatment medications were not provided. This case was reported for patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-659434, US-MODERNATX, INC.-MOD-2022-659439 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659434:same reporter US-MODERNATX, INC.-MOD-2022-659439:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022; No adverse event; Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022).    No concomitant drug were reported.  HCP wanted to know how to proceed with a pediatric patient (6 months to 5 years of age) that received a Monovalent vaccine greater than 12 hours post punctured. No side effects have been reported yet. HCP did not have any Medical History information from the patient. Vial size was reported as 2.5 mL.  On 20-Sep-2022, the vial was initially stored in the refrigerator. On 05-Oct-2022 9 am vial was first punctured.  Vial was stored in the fridge at correct temperature. Vial did not undergo any temperature excursions. It was reported that 5 doses were drawn 1 minute per dose.  No treatment drug were reported.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no allergic condition. Patient had never tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 13-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally administered Moderna Covid 19 monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported.  Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted Covid in the 3rd week of August 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted Covid in the 3rd week of August 2022) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Contracted Covid in the 3rd week of August 2022). At the time of the report, COVID-19 (Contracted Covid in the 3rd week of August 2022) outcome was unknown.    No concomitant medications were reported. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-659361 (E2B Linked Report). This case was linked to MOD-2021-218172 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659361:Husband Case
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: broke out in shingles/a large 6x2 inch swath; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (broke out in shingles/a large 6x2 inch swath) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (broke out in shingles/a large 6x2 inch swath). At the time of the report, HERPES ZOSTER (broke out in shingles/a large 6x2 inch swath) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported.   The patient got moderna vaccine 6 weeks ago  in order to keep her job. 2 weeks ago she broke out in shingles, a large 6x2 inch swath, and was in significant pain for days. She never previously had nor been exposed to shingles.  The event significant pain was subsumed under diagnosis of shingles.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL 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 (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow up received contains lot number had been added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received Moderna bivalent booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna bivalent booster 0.25mL dose) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna bivalent booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna bivalent booster 0.25mL 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 Moderna bivalent booster 0.25mL dose).    No concomitant medications were reported.  The reporter asked for guidance on how to proceed in the current scenario, enquiring would the patient need a new full dose or could the patient receive a half dose.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up received includes significant information : batch number was added.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL 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 (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported. No treatment medications were reported.  This is patient number six out of nine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up  Significant information accepted (Batch/lot number has been added)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL 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 (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported. No treatment medications were reported.  This is patient number six out of nine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up  Significant information accepted (Batch/lot number has been added)
Age: 29.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  The reporter asked for guidance on how to proceed with the patient, enquiring would the patient need a new full dose or can the patient receive a half dose.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up received includes batch number was added.
Age: 29.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  The reporter asked for guidance on how to proceed with the patient, enquiring would the patient need a new full dose or can the patient receive a half dose.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up received includes batch number was added.
Age: 42.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received wherein batch/lot number was added.
Age: 42.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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 Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received wherein batch/lot number was added.
Age: 35.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-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. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL 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 (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow-up received is significant. Batch/lot number was added.