Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: She has been administering the 65+ bivalent dose to her patients who have symptoms of long-haul COVID; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID 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 (She has been administering the 65+ bivalent dose to her patients who have symptoms of long-haul COVID) 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 third 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). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She has been administering the 65+ bivalent dose to her patients who have symptoms of long-haul COVID) 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 (She has been administering the 65+ bivalent dose to her patients who have symptoms of long-haul COVID) 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 (She has been administering the 65+ bivalent dose to her patients who have symptoms of long-haul COVID).    This case contains information for the 26th patient out of 42 patients as described by the reporter.  No concomitant medication information was reported.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asked to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who had symptoms of long-haul COVID and had seen 88-90 percent of success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters among which 38 patients had improvement of symptoms (50% or more). The doses were administered as per current guidelines, except for some doses which were administered to patients having ages less than 65. Patients were treated for skin lesions, brain related problem, systolic blood pressure of 220, tachycardia of heart rate greater than or equal to 150, and body aches.  No adverse reactions had occurred.  No treatment information was reported.   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