Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive test for SARS-Cov2 on 20-MAY-2022; sore throat, congestion, post-nasal drip) and INTERCHANGE OF VACCINE PRODUCTS (Vaccinated with two doses of Moderna then one dose of Pfizer) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 029K20A and 025J20A) for COVID-19 prophylaxis. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. The patient's past medical history included Pacemaker insertion (cardiac) and Cardiac pacemaker replacement. Concurrent medical conditions included Heart block, AFib, Sleep apnea, Asthma and Non-smoker. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), ATOGEPANT (QULIPTA), FLUTICASONE PROPIONATE (FLUOREN), HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), PROMETHAZINE, DIAZEPAM, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) and ELETRIPTAN HYDROBROMIDE (RELPAX) for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Vaccinated with two doses of Moderna then one dose of Pfizer). On 20-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive test for SARS-Cov2 on 20-MAY-2022; sore throat, congestion, post-nasal drip). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) from 03-Jun-2022 to 13-Jun-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive test for SARS-Cov2 on 20-MAY-2022; sore throat, congestion, post-nasal drip) and INTERCHANGE OF VACCINE PRODUCTS (Vaccinated with two doses of Moderna then one dose of Pfizer) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. The patient was not admitted to an Intensive Care Unit. Company Comment: This is a spontaneous case of interchange of vaccine products for this 61-year-old, male patient with relevant medical history of Cardiac conditions (Heart block, Atrial Fibrillation, status post Pacemaker insertion, status post Cardiac valve replacement) and Asthma; past drug history of administration of two doses of the mRNA-1273 vaccine; and history of co-suspect administration of one dose (third dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, non-serious of COVID-19. The event occurred approximately 1 month after receiving a dose (fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2 (type of test was unknown). On an unspecified date, it was reported that the patient experienced sore throat, congestion and post-nasal drip. No information about the clinical course was provided. It was also reported that the patient received an 11-day course of Augmentin (amoxicillin/clavulanic acid), unspecified dose and frequency, as an 'additional therapy' for COVID-19. The event COVID-19 had resolved at the time of the report. The medical history of Cardiac conditions (Heart block, Atrial Fibrillation, status post Pacemaker insertion, status post Cardiac valve replacement) and Asthma, which are known risk factors for COVID-19, remain as confounders. The history of co-suspect administration of one dose (third dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This is a spontaneous case of interchange of vaccine products for this 61-year-old, male patient with relevant medical history of Cardiac conditions (Heart block, Atrial Fibrillation, status post Pacemaker insertion, status post Cardiac valve replacement) and Asthma; past drug history of administration of two doses of the mRNA-1273 vaccine; and history of co-suspect administration of one dose (third dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, non-serious of COVID-19. The event occurred approximately 1 month after receiving a dose (fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2 (type of test was unknown). On an unspecified date, it was reported that the patient experienced sore throat, congestion and post-nasal drip. No information about the clinical course was provided. It was also reported that the patient received an 11-day course of Augmentin (amoxicillin/clavulanic acid), unspecified dose and frequency, as an 'additional therapy' for COVID-19. The event COVID-19 had resolved at the time of the report. The medical history of Cardiac conditions (Heart block, Atrial Fibrillation, status post Pacemaker insertion, status post Cardiac valve replacement) and Asthma, which are known risk factors for COVID-19, remain as confounders. The history of co-suspect administration of one dose (third dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.