Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Recovered and tested negative (home test) on 25-May-2022. Symptoms started back on 31-May-2022 and tested positive again; Dose 1 and 2 Pfizer / BioNTech/Dose 3 Moderna 027H213; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Recovered and tested negative (home test) on 25-May-2022. Symptoms started back on 31-May-2022 and tested positive again) and INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer / BioNTech/Dose 3 Moderna 027H213) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H213) for COVID-19 vaccination.     Patient had unknown past drug allergy.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: ER8731) on 09-Apr-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ER8736) on 30-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (Allergy to unknown drug.).    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer / BioNTech/Dose 3 Moderna 027H213). In May 2022, the patient experienced COVID-19 (Recovered and tested negative (home test) on 25-May-2022. Symptoms started back on 31-May-2022 and tested positive again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Recovered and tested negative (home test) on 25-May-2022. Symptoms started back on 31-May-2022 and tested positive again) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer / BioNTech/Dose 3 Moderna 027H213) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported.  Patient tested positive again on 31-May-2022, the symptoms were worse than before Paxlovid. Symptoms included runny nose, congestion and light cough. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This spontaneous case concerns a 54-year-old, male patient with no reported relevant medical conditions, who experienced the unexpected, non-serious adverse event of special interest COVID-19. Interchange of vaccine products was also reported wherein the patient received Tozinameran as primary COVID-19 vaccine series 7 months prior to mRNA-1273. The infection occurred approximately 6 months after receiving mRNA-1273 as third COVID-19 vaccine dose wherein he was treated with a full course NIRMATRELVIR/RITONAVIR (Paxlovid). The patient recovered and tested negative, using home test, after treatment. However, 6 days after the initial negative, the patient noted recurrence of runny nose, congestion and light cough which was reportedly worse than before. He then underwent COVID-19 testing which revealed a positive test. Clinical course during recurrence of symptoms and treatment administered after were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old, male patient with no reported relevant medical conditions, who experienced the unexpected, non-serious adverse event of special interest COVID-19. Interchange of vaccine products was also reported wherein the patient received Tozinameran as primary COVID-19 vaccine series 7 months prior to mRNA-1273. The infection occurred approximately 6 months after receiving mRNA-1273 as third COVID-19 vaccine dose wherein he was treated with a full course NIRMATRELVIR/RITONAVIR (Paxlovid). The patient recovered and tested negative, using home test, after treatment. However, 6 days after the initial negative, the patient noted recurrence of runny nose, congestion and light cough which was reportedly worse than before. He then underwent COVID-19 testing which revealed a positive test. Clinical course during recurrence of symptoms and treatment administered after were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.