Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dignosed with COVID-19; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Dignosed with COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 3 Route of administration: Intramuscular and dose 0.3 milliliter) on 18-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 26-May-2022, the patient experienced COVID-19 (Dignosed with COVID-19). At the time of the report, COVID-19 (Dignosed with COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: positive (Positive) nasopharyngeal rapid-antigen test showed positive. On an unknown date, Body temperature: 100 f max 100 F Max.         The patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions.  Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination or at the time of adverse event were reported as none.  The event did not cause the patient to seek medical care. No other potential causes were identified.   The patient did not have cardiovascular disease, chronic respiratory conditions, diabetes, cancer, HIV (Human Immunodeficiency Virus)/AIDS (Acquired Immunodeficiency Syndrome), other immune-deficiency conditions/immunosuppressive medications, liver-related conditions and obesity (BMI greater than or equal to 30) any of the high-risk medical conditions prior to COVID-19 diagnosis.  The patient's vital signs at any medically attended clinic visits and/or during hospitalization such as respiratory rate, heart rate, oxygen saturation and blood pressure were not noted.  COVID-19 symptoms experienced by the patient were reported as fever (Temp Max 100 F), chills and headache for 3 days. Patient did not had shortness of breath, cough, muscle aches, nausea/vomiting, Diarrhea, Nasal congestion/runny nose, loss of taste and loss of smell.  The patient did not have clinical and/or radiographical evidence of pneumonia.  The patient did not require non-invasive supplemental oxygen.  Treatment details for SARS-CoV-2 infection were provided as none.  The patient did not exhibit signs or symptoms of new/worsening dysfunction includes multiorgan failure, gastrointestinal dysfunction, acute renal dysfunction, neurologic dysfunction, respiratory dysfunction, acute cardiac injury, hematologic/vascular disorders and dermatologic disorders.  No laboratory tests were performed other than COVID-19 antigen rapid test.  Company comment: This is a spontaneous case of interchange of vaccine products (received as first and second dose mRNA-1273 vaccine (administered in an appropriate interval) and TOZINAMERAN vaccine as booster dose) concerning a 55-year-old male patient with no medical history reported who experienced the unexpected non- serious AESI COVID-19 1 months and 26 days after a dose of mRNA-1273 vaccine, given as a second booster dose of COVID vaccine schedule, was administered. COVID nasopharyngeal antigen rapid test was positive.  It was reported patient had fever, chills, and headache for 3 days. The event did not cause the patient to seek medical care. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  This case was linked to MOD-2022-593849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2022: The follow up information received contains no new information. On 01-Jul-2022: The follow up information received contains no new information.; Sender's Comments: This is a spontaneous case of interchange of vaccine products (received as first and second dose mRNA-1273 vaccine (administered in an appropriate interval) and TOZINAMERAN vaccine as booster dose) concerning a 55-year-old male patient with no medical history reported who experienced the unexpected non- serious AESI COVID-19 1 months and 26 days after a dose of mRNA-1273 vaccine, given as a second booster dose of COVID vaccine schedule, was administered. COVID nasopharyngeal antigen rapid test was positive.  It was reported patient had fever, chills, and headache for 3 days. The event did not cause the patient to seek medical care. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.