Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: COVID-19; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID-19) in a 46-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for COVID-19 prophylaxis.    Concurrent medical conditions included Stiff person syndrome, Asthma and Diabetes. Concomitant products included IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) for Stiff person syndrome.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (COVID-19) had resolved and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not reported.  This study aims to explore the overall impact of COVID-19 on stiff person syndrome spectrum disorders (SPSD) along with assessing if risk factors exist for severe COVID-19 in SPSD and if COVID-19 outcomes in SPSD patients vary for the Omicron variant compared to the previously identified variants of SARS-CoV-2.  This observational study investigated the impact of COVID-19 on patients with SPSD from March 2020 through December 2022. Severe COVID-19 case requiring hospitalization, which were also post-full-vaccination case.  COVID 19 symptoms were fever, dry cough, fatigue, body aches, sore throat, headache, and neurological symptoms were the most common symptoms among the cases. Fever was the most common symptom reported for both the post-full vaccination cases as well as the cases involving individuals not fully vaccinated. Neurological symptoms mainly included exacerbated SPSD symptoms, namely more severe, frequent, or diffuse spasms and stiff ness. Other neurological symptoms reported were incoordination and cognitive dysfunction.  Author concluded this study showed that COVID-19 risk factors existing in SPSD population are similar to those present in the general population. Risk factors of immunosuppressant therapies, benzodiazepines, and comorbidities like diabetes, existed in severe cases as well as the mild-to-moderate ones. Considering this and our study limitations, namely the small size and lack of a control group, we are unable to fully interpret how much each of these risk factors has contributed to the overall COVID-19 experience of our patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-774753 (E2B Linked Report).  Company Comment This is a literature non-study case concerning a 46-year-old female patient, with underlying diabetes and asthma, and receiving concomitant intravenous immunoglobulin (IVIG) and benzodiazepines, who experienced the unexpected and serious (due to hospitalization) event of COVID-19, which occurred after an unspecified dose of SPIKEVAX COVID-19 VACCINE NOS. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed.  An unspecified dose of AstraZeneca vaccine was also administered, remaining as a co-suspect product (Interchange of vaccine products and Revaccination with different COVID-19 vaccine are noted). No information disclosed about diagnostic tests performed. The patient required ICU admission, with invasive ventilation. Treatment received is unknown. At the time of the report, the event had resolved. Underlying asthma and diabetes, as well as concomitant IVIG and benzodiazepines, remain as risk factors for severe COVID-19 outcomes. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774753:Invalid case for 35 patients