chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms of 50% or more.  Patients were treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 27 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50% or more  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 38 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms of 50% or more.  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 12 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.).    This case contains information of 33 patients out of 42 reported by reporter.  Concomitant Medication use information was not provided by reporter.  Vaccine was given to patients for long COVID between March 2023 and 1 August 2023.  42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more. Vaccine was given within current guidelines except seven were under 65.  Patients were treated with skin lesions, brain, SBP 220, Tachycardia greater than or equal to 150 and body aches.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master Case (Patient 1out of 42 patients)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms of 50% or more.  Patients were treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient third out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.).    This case contains information of 13 patients out of 42 reported by reporter.  Concomitant Medication use information was not provided by reporter.  Vaccine was given to patients for long COVID between March 2023 and 1 August 2023.  42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more. Vaccine was given within current guidelines except seven were under 65.  Patients were treated with skin lesions, brain, SBP 220, Tachycardia greater than or equal to 150 and body aches.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master Case (Patient 1out of 42 patients)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more).    Concomitant medication was not reported.  Vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more. Vaccine was given within current guidelines except seven were under 65. Patients were treated for skin lesions, brain, systolic blood pressure 220, Tachycardia greater than or equal to 150 and body aches. Treatment medication was not reported.  This case contains information of 15th out of 42 reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    This case contains information about patient 06 out of 42 patients. Concomitant product use was not provided by the reporter. Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more. Vaccine was given within current guidelines except seven were under 65.  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.  No adverse reactions occurred. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 16 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 16 out of 42 patients
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 7 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Post-acute COVID-19 syndrome.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  This case contains information about patient 17 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Post-acute COVID-19 syndrome.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  This case contains information about patient 9 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50% or more.  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 18 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case Patient 1
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third 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, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He has previously received 2 doses of the primary series and 2 booster doses of the Moderna COVID-19 vaccine. He stated that he does not have his vaccination records on him at this time and he will not be able to provide that information as he was driving right now. He said that he could have possibly received his vaccinations in the year 2021, but he was not sure. With all 4 shots, he was sick for a day with fever and a sore arm. He said that the fever did not last one full day and that he would only be sick the night of the vaccination and felt okay the next day. The biggest thing for him was the sore arm. However, he said that he usually gets a sore arm from all his vaccinations. He said that he received his first two doses from the stated and thought that they were not careful in giving the shot. Therefore, he experienced more soreness in his arms with the first two shots. He received the 2 booster shots at a local pharmacy and he said that they were more careful in giving the shot, so he did not experience arm soreness as much as the primary series. He declined to provide the name of his vaccination provider. He did state that he had less reaction with the booster shots, possibly because of the low dosage.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 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 ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        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.   This case contains information about patient 02 out of 04 patients. No concomitant medication was provided by reporter. Four adult  patient was impact due to Moderna COVID-19 Vaccine for Illness. Reporter assumed patient  get sick because of the vaccine . Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-737834 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737834:Patient 2
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman; No adverse event; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman).    Concomitant and treatment medications were not reported.  Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman. Company comment This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious, event of maternal exposure during pregnancy and no adverse event was reported. The patient received the first dose of mRNA-1273. The event onset date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Last menstrual period and estimated date of delivery were not provided. No further clinical information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac failure congestive, Immunodeficiency
Clinical narrative: congestive heart failure; immunocompromised; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) and IMMUNODEFICIENCY (immunocompromised) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion medically significant) and IMMUNODEFICIENCY (immunocompromised) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure) and IMMUNODEFICIENCY (immunocompromised) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with a history no reported medical history, who experienced the serious (due to medically significant) unexpected, events of Cardiac failure congestive and Immunodeficiency, which occurred related to the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The outcome of both events was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact