Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter.  Patient experienced Chills, headache, arm pain, muscle pain and fatigue as symptoms of covid-19.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment:  This spontaneous case concerns a 47-year-old female patient with no medical history reported,  who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown interval in the context of receiving the second dose of mRNA-1273 vaccine. Onset latency could not be determined as vaccination dates were not reported.  Patient experienced chills, headache, arm pain, muscle pain and fatigue prior to vaccination.  SARS-CoV-2 test was positive.  Patient previously received  a dose of mRNA-1273 vaccine given as first dose on an unknown date and interval, and 3rd dose with non-company brand COVID-19 vaccine Pfizer Tozinameran.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no medical history reported,  who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown interval in the context of receiving the second dose of mRNA-1273 vaccine. Onset latency could not be determined as vaccination dates were not reported.  Patient experienced chills, headache, arm pain, muscle pain and fatigue prior to vaccination.  SARS-CoV-2 test was positive.  Patient previously received  a dose of mRNA-1273 vaccine given as first dose on an unknown date and interval, and 3rd dose with non-company brand COVID-19 vaccine Pfizer Tozinameran.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.