Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Nucleic acid test, SARS-CoV-2 test
Clinical narrative: Suspect product: BNT162B2; First positive test was on 5-May-2022 and again tested positive on 20-May-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First positive test was on 5-May-2022 and again tested positive on 20-May-2022) and INTERCHANGE OF VACCINE PRODUCTS (Suspect product: BNT162B2) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product BNT162B2 for an unknown indication.    Concurrent medical conditions included Heart disease, unspecified and Non-smoker.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of BNT162B2 (unknown route) 1 dosage form. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (First positive test was on 5-May-2022 and again tested positive on 20-May-2022). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Suspect product: BNT162B2). At the time of the report, COVID-19 (First positive test was on 5-May-2022 and again tested positive on 20-May-2022) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Suspect product: BNT162B2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) First time positive test.. On 20-May-2022, Nucleic acid test: positive (Positive) Positive.         No concomitant medications were reported.  Patient date of birth was reported.  It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized and also patient was not admitted to an intensive care unit. The patient did not experienced any new or worsened symptoms/signs during the COVID-19 illness. It was reported that patient was taking medications routinely prior to the event being reported. It was reported that no pre-existing disease worsened during the SARS-CoV2 infection. Patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. It was reported that the event did not require the initiation of new medication or other treatment or procedure.  It was reported that the Pfizer product had a causal effect to the adverse event reported.  No treatment information were reported.  Company Comment:  This spontaneous case concerns a 66-year-old male patient with medical history of heart disease and administration of co-suspect non-company product Pfizer BNT162B2, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 2 months and 22 days after receiving mRNA-1273 vaccine given as 4th dose in the COVID-19 vaccination series. The diagnosis of COVID-19 was documented by a positive SARS-CoV-2 test, and a positive Nucleic acid amplification test NAAT 15 days later.  Patient previously received 3 doses of mRNA-1273 vaccines consisting of a 2-dose primary series given 26 days apart, and a 3rd dose given 5 months and 25 days prior to current mRNA-1273 vaccine. The elderly age of the patient and medical history of heart disease could be considered as predisposing and contributory risk factors.   Dose series and date of administration for the co-suspect non-company brand COVID-19 vaccine Pfizer BNT162B2 were not reported.  However, patient considered Pfizer BNT162B2 product having a causal effect to the adverse event COVID-19; and thus, considered a confounder.  Interchange of vaccine products was also noted. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old male patient with medical history of heart disease and administration of co-suspect non-company product Pfizer BNT162B2, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 2 months and 22 days after receiving mRNA-1273 vaccine given as 4th dose in the COVID-19 vaccination series. The diagnosis of COVID-19 was documented by a positive SARS-CoV-2 test, and a positive Nucleic acid amplification test NAAT 15 days later.  Patient previously received 3 doses of mRNA-1273 vaccines consisting of a 2-dose primary series given 26 days apart, and a 3rd dose given 5 months and 25 days prior to current mRNA-1273 vaccine. The elderly age of the patient and medical history of heart disease could be considered as predisposing and contributory risk factors.   Dose series and date of administration for the co-suspect non-company brand COVID-19 vaccine Pfizer BNT162B2 were not reported.  However, patient considered Pfizer BNT162B2 product having a causal effect to the adverse event COVID-19; and thus, considered a confounder.  Interchange of vaccine products was also noted. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.