chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. FC3181 and FP9894) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 14-Aug-2021 and second dose on 10-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 (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), 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 (The patient received first dose on 14-Aug-2021 and second dose on 10-Apr-2022).    Concomitant medication information was not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722079 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:master case
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 002M21A and 002F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), 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 (Dose 1 and Dose 2 and administered on 2-Sep-2021 and 1-Apr-2022; beyond 35 days apart).    Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2023-722085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2023: Live followup received with no new information.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via body fluid, No adverse event
Clinical narrative: One son had Moderna all the way; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BODY FLUID (One son had Moderna all the way) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BODY FLUID (One son had Moderna all the way) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPOSURE VIA BODY FLUID (One son had Moderna all the way) had resolved 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 EXPOSURE VIA BODY FLUID (One son had Moderna all the way).    This case was considered for father of the 1st grandson.  No concomitant and treatment medications were reported.  He received Moderna all the way.  His partner (mother of the 1st grandson) received COVID-19 vaccinations, however it is not sure if she received Moderna.   This case was linked to US-MODERNATX, INC.-MOD-2023-722092 (Linked Report). This case was linked to MOD-2023-722087 (Parent-Child Link).   See case MOD-2023-722087 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722092:Case for Mother of 1st grandson
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exposure via body fluid, No adverse event
Clinical narrative: Had J and J and had Moderna for boosters; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BODY FLUID (Had J and J and had Moderna for boosters) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BODY FLUID (Had J and J and had Moderna for boosters) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPOSURE VIA BODY FLUID (Had J and J and had Moderna for boosters) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.     This case was considered for father of the 2nd grandson.  No concomitant and treatment medications were reported.  He received J and J and had Moderna for boosters.  His partner (mother of the 1st grandson) received COVID-19 vaccinations, however it is not sure if she received Moderna.   This case was linked to US-MODERNATX, INC.-MOD-2023-722093 (Linked Report). This case was linked to MOD-2023-722088 (Parent-Child Link).   See case MOD-2023-722088 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722093:Case for Mother of 2nd grandson
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Muscle discomfort
Clinical narrative: She had developed muscle problems in her arms and legs after the covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (She had developed muscle problems in her arms and legs after the covid vaccine) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Allergy to chemicals (carvone (essential oils)) and Mint allergy.   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 and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (She had developed muscle problems in her arms and legs after the covid vaccine). At the time of the report, MUSCLE DISCOMFORT (She had developed muscle problems in her arms and legs after the covid vaccine) outcome was unknown.            Concomitant medication was not reported.  Patient developed muscle problem after COVID vaccine. Treatment medication was not reported. Additionally it was reported, patient took Nurtec last night and had a reaction and still had lingering symptoms. Her throat was not right, it felt scratchy and was still gravelly. Her lips were swollen and her tongue was numb where she tried to push the tablet out of her mouth.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    No concomitant medications were provided. It was reported that 12, 1st doses of bivalent Moderna were administered from 24-28APR2023.  Patients between 6m-5y of age were involved.  Dosage text reported as unknown. No reported symptoms. No treatment medication was provided. This case contains information for the 2nd of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.; All doses were given 0.2 ml dosage form instead of 0.25 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.), UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml) and NO ADVERSE EVENT (no adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.), UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml) 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 WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 3rd out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    Dosage text for suspect product was reported as unknown.  No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023.  It was reported that the patients were of age between 6m-5y and reported no symptoms. No treatment medication was provided. This case contains information for the 4th of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: No adverse event; Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.; All doses were given at a 0.2mL instead of 0.25 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.), UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.) and UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.), UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL) 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 WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.) and UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL).    No concomitant medications were reported. 12 patients were administered 1st doses of bivalent Moderna from 24-APR-2023 to 28-APR-2023. Patients were between 6m-5y of age. No treatment information was provided.  This case was reported for patient 5 of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.).    No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients between 6m-5y of age were involved.  No reported symptoms. No treatment medication was provided. This case contains information for the 6th out of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.).    No concomitant medications were reported.  Doses were administered from 24-28-Apr-2023. Patients were between 6m-5y of age. No reported symptoms.  No treatment medications were reported.  This case contains information for the 7th of 12th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:patient no. 01 (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.).    Concomitant medication was not provided.  Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients were between 6m-5y of age. No reported symptoms. Treatment information was not provided. This case contains information for the 11th of 12th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:1st patient case (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.).    No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients between 6m-5y of age were involved.  No reported symptoms. No treatment medication was provided. This case contains information for the 10th patient out of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:1st patient case (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (no adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients between 6m-5y of age were involved.  No reported symptoms. No treatment medication was provided. This case contains information for the 8th of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:1st patient case (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients between 6m-5y of age were involved.  Dosage text reported as unknown. No reported symptoms. No treatment medication was provided. This case contains information for the 12th of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:1st patient case (Master case)
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023; No adverse event; Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD) and PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023).    Concomitant medication was not provided. It was unknown if patient ever been diagnosed or tested positive with COVID-19. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722195 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 24-Aug-2022 and second dose on 16-Sep-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 24-Aug-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 082B22A and 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Sep-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 24-Aug-2022 and second dose on 16-Sep-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 (First dose on 24-Aug-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), 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 (First dose on 24-Aug-2022 and second dose on 16-Sep-2022).    Concomitant medication was not provided. It was unknown if patient ever been diagnosed or tested positive with COVID-19. Treatment information was not reported.   This case was linked to MOD-2023-722151 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023; no adverse events have been reported; Dose of moderna vaccine given beyond use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date), PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023) and NO ADVERSE EVENT (no adverse events have been reported) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 066H22A and AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Apr-2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .5 milliliter. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023) and NO ADVERSE EVENT (no adverse events have been reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date), PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023) and NO ADVERSE EVENT (no adverse events have been reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse events have been reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date) and PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023).    No concomitant medications were reported.  Dose of the Moderna vaccine was given beyond the use by date. The bud was 13-Apr-2023 and the vaccine was given on 25-Apr-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report). This case was linked to MOD-2023-722201 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 002F21A and 021B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021).    Concomitant medication information was not provided. The dosage details of first, second and third doses was reported as 0.5. Treatment information was not reported.   This case was linked to MOD-2023-722207 (Patient Link).