Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, COVID-19 immunisation, Confusional state, Interchange of vaccine products
Clinical narrative: confused; Patient had COVID-19; Interchange of vaccine products; Revaccination with different covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient had COVID-19), CONFUSIONAL STATE (confused), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002A21A and 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine). In August 2022, the patient experienced COVID-19 (Patient had COVID-19). On an unknown date, the patient experienced CONFUSIONAL STATE (confused). At the time of the report, COVID-19 (Patient had COVID-19) and CONFUSIONAL STATE (confused) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The onset date of COVID-19 was reported as mid of Aug-2022.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 76-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 approximately 9 months after receiving a booster dose of mRNA-1273. Patient had initially received mRNA-1273 in an appropriate schedule as primary vaccination series, and had also received a second booster dose with Pfizer COVID-19 vaccine approximately 3 months prior to event onset (interchange of vaccine products and well as revaccination with different COVID-19 vaccine were noted). Patient states that he had to seek an outpatient consult since he had a temperature of 102.5 and was confused. No information on diagnostic test, treatment received, course and outcome of the events was provided.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-642018 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 76-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 approximately 9 months after receiving a booster dose of mRNA-1273. Patient had initially received mRNA-1273 in an appropriate schedule as primary vaccination series, and had also received a second booster dose with Pfizer COVID-19 vaccine approximately 3 months prior to event onset (interchange of vaccine products and well as revaccination with different COVID-19 vaccine were noted). Patient states that he had to seek an outpatient consult since he had a temperature of 102.5 and was confused. No information on diagnostic test, treatment received, course and outcome of the events was provided.  The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-642018:Crosslinked with AE (Wife's Case)