Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after his 2nd booster dose of Moderna vaccine (Monovalent); Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent); Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after his 2nd booster dose of Moderna vaccine (Monovalent)), COVID-19 IMMUNISATION (Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent)) and INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 014520A and 029L20A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 3 and 1st booster dose of Pfizer Covid-19 vaccine with lot number as FH8027) on 11-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced COVID-19 IMMUNISATION (Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent)) and INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent)). On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19 after his 2nd booster dose of Moderna vaccine (Monovalent)). At the time of the report, COVID-19 (Tested positive for COVID-19 after his 2nd booster dose of Moderna vaccine (Monovalent)) had resolved and COVID-19 IMMUNISATION (Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent)) and INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st booster dose of Pfizer (Tozinameran) vaccine after 2-dose primary series of Moderna vaccine (Monovalent)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant and treatment medications were not reported.  Patient received full dose for first and second vaccination.It was unknown whether patient received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns an 81-year-old male patient, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 on an unknown date after receiving the mRNA-1273 vaccine as 4th dose (as 2nd booster). Onset latency could not be determined as onset date of event was not provided. On an unknown date, SARS-CoV-2 test was reported positive. Patient sought medical care, but details were not provided. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Patient received 2-dose primary series of mRNA-1273 vaccine at an interval of 43 days which is not in accordance with the recommended vaccine interval. Approximately 8 months later, patient received 1st booster dose of Tozinameran vaccine (Revaccination with different COVID-19 vaccine and Interchange of vaccine products noted). The current mRNA-1273 vaccine as 2nd booster was given approximately 7 months after Tozinameran. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-647011.; Sender's Comments: This spontaneous case concerns an 81-year-old male patient, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 on an unknown date after receiving the mRNA-1273 vaccine as 4th dose (as 2nd booster). Onset latency could not be determined as onset date of event was not provided. On an unknown date, SARS-CoV-2 test was reported positive. Patient sought medical care, but details were not provided. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Patient received 2-dose primary series of mRNA-1273 vaccine at an interval of 43 days which is not in accordance with the recommended vaccine interval. Approximately 8 months later, patient received 1st booster dose of Tozinameran vaccine (Revaccination with different COVID-19 vaccine and Interchange of vaccine products noted). The current mRNA-1273 vaccine as 2nd booster was given approximately 7 months after Tozinameran. The benefit-risk relationship of mRNA-1273 is not affected by this report.