Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Very similar to the initial Covid-19 symptoms; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Very similar to the initial Covid-19 symptoms) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: N/A  Location of injection: Arm Left) on 04-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech. Concurrent medical conditions included Drug allergy.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Very similar to the initial Covid-19 symptoms) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 22-May-2022, COVID-19 (Very similar to the initial Covid-19 symptoms) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine.  The patient had past drug history (unknown drug) due to which patient experienced reaction Allergy.  Patient developed recurrence of nasal congestion, rhinorrhea, cough, and headache on 16-May-2022. Very similar to the initial Covid- 19 symptoms. The patient did not experienced fever. Rapid Covid-19 antigen test was positive. Symptoms resolved after about one week on 22-May-2022.  The patient received unknown drug of Pfizer from  07-May-2022 to 11-May-2022 for Treatment of COVID-19.  The device date was reported as 27-May-2022.  Company comment-This spontaneous case concerns a 72-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection on an unknown date after receiving the 4th dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with Pfizer drug starting on 7-May-2022 for covid 19 treatment for 5 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. Patient had recurrence of nasal congestion, cough, rhinorrhea and headache similar to initial Covid 19 infection five days after completion of Pfizer drug. Rapid Covid-19 antigen test was positive and symptoms resolved after 1 week. Patient has received a dose of TOZINAMERAN 190 days prior to mRNA-1273 vaccine (interchange of vaccine products). The current pandemic situation of COVID 19 may remain as confounder and elderly age remains a risk factor to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a 72-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection on an unknown date after receiving the 4th dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with Pfizer drug starting on 7-May-2022 for covid 19 treatment for 5 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. Patient had recurrence of nasal congestion, cough, rhinorrhea and headache similar to initial Covid 19 infection five days after completion of Pfizer drug. Rapid Covid-19 antigen test was positive and symptoms resolved after 1 week. Patient has received a dose of TOZINAMERAN 190 days prior to mRNA-1273 vaccine (interchange of vaccine products). The current pandemic situation of COVID 19 may remain as confounder and elderly age remains a risk factor to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.