Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Post-acute COVID-19 syndrome
Clinical narrative: She had long haul COVID symptoms; back to baseline, which was very poor; did not get second dose >36 days; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (She had long haul COVID symptoms) and FEELING ABNORMAL (back to baseline, which was very poor) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was hospitalized twice. It was very severe.) in August 2021 and Cardiac pacemaker insertion. Concurrent medical conditions included Autoimmune disorder NOS.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (She had long haul COVID symptoms) (seriousness criterion disability), FEELING ABNORMAL (back to baseline, which was very poor) (seriousness criterion disability) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get second dose >36 days). At the time of the report, POST-ACUTE COVID-19 SYNDROME (She had long haul COVID symptoms) had not resolved and FEELING ABNORMAL (back to baseline, which was very poor) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get second dose >36 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient got a lot of medical conditions and autoimmune conditions. Unfortunately, they were  quite severe. She suffered an onset of COVID, and they put a pacemaker in her. She passed on life and came back. A year later, in August 2021, she developed COVID again. She was hospitalized twice. It was very severe.  Concomitant medication not reported. Treatment medication not reported.  Company comment: This spontaneous case concerns a 62-year-old female patient, with history of severe COVID-19 requiring hospitalization in at least one occasion and an unspecified autoimmune disorder, who experienced the serious (disability) unexpected events of Post-acute COVID-19 syndrome and feeling abnormal, after receiving the first dose of mRNA-1273 vaccine. No onset date was provided for the events, hence latency cannot be properly assessed. Inappropriate schedule of vaccination was also noted since patient has not received the second dose of mRNA-1273 vaccine. No further relevant clinical information was available for medical reviewing. Patient's history of severe COVID-19 and unspecified autoimmune disorder, remain as confounders for the reported events and their seriousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with history of severe COVID-19 requiring hospitalization in at least one occasion and an unspecified autoimmune disorder, who experienced the serious (disability) unexpected events of Post-acute COVID-19 syndrome and feeling abnormal, after receiving the first dose of mRNA-1273 vaccine. No onset date was provided for the events, hence latency cannot be properly assessed. Inappropriate schedule of vaccination was also noted since patient has not received the second dose of mRNA-1273 vaccine. No further relevant clinical information was available for medical reviewing. Patient's history of severe COVID-19 and unspecified autoimmune disorder, remain as confounders for the reported events and their seriousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.