Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Interchange of vaccine products, Nausea
Clinical narrative: Patient received a dose of Janssen COVID-19 vaccine approximately 8 months prior to mRNA-1273 vaccination; Nausea; weakness; loss of appetite for food or drink; Nausea; weakness; loss of appetite for food or drink; Nausea; weakness; loss of appetite for food or drink; Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment), ASTHENIA (Nausea; weakness; loss of appetite for food or drink), DECREASED APPETITE (Nausea; weakness; loss of appetite for food or drink), NAUSEA (Nausea; weakness; loss of appetite for food or drink) and INTERCHANGE OF VACCINE PRODUCTS (Patient received a dose of Janssen COVID-19 vaccine approximately 8 months prior to mRNA-1273 vaccination) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.    Co-suspect product included non-company product SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.    Previously administered products included for Product used for unknown indication: Janssen (Dose number: 1, batch/lot No: 1802068 and location of injection: right arm vaccine administration time: 02:00 PM) on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Cancer, Blood pressure high, High cholesterol, Drug allergy and Allergy to antibiotic.   On 22-Nov-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient started SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). On 28-May-2022 at 11:00 AM, the patient experienced ASTHENIA (Nausea; weakness; loss of appetite for food or drink), DECREASED APPETITE (Nausea; weakness; loss of appetite for food or drink) and NAUSEA (Nausea; weakness; loss of appetite for food or drink). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a dose of Janssen COVID-19 vaccine approximately 8 months prior to mRNA-1273 vaccination). At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) and INTERCHANGE OF VACCINE PRODUCTS (Patient received a dose of Janssen COVID-19 vaccine approximately 8 months prior to mRNA-1273 vaccination) outcome was unknown and ASTHENIA (Nausea; weakness; loss of appetite for food or drink), DECREASED APPETITE (Nausea; weakness; loss of appetite for food or drink) and NAUSEA (Nausea; weakness; loss of appetite for food or drink) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-May-2022, the patient received co-suspect product Pfizer (active drug substance: COVID 19 Treatment) for treatment of COVID-19. Lot number reported was 300691085301 and date of last administration was 28-May-2022.  The patient's treatment included change in antibiotic and nausea medicine.  Company Comment:  This is a spontaneous case concerning a 62-year-old female patient with relevant concurrent medical conditions of Cancer and High blood pressure and concomitant medication of Aurobino, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 vaccine as second COVID-19 vaccination. Patient had received a dose of Janssen COVID-19 vaccine with no reported adverse event, approximately 8 months prior to mRNA-1273 vaccination (Interchange of vaccine products). Patient took a COVID-19 treatment for three days and noted nausea, weakness and loss of appetite. These symptoms occurred on the same day that the concomitant drug Aurobino started which had a active substance of Sulfamethoxazole/Bactrim, which is an anti-infective drug and may suggest onset of another infection, which can be considered confounders to the symptoms of nausea, weakness and loss of appetite. Patient's medication was changed and patient was given a medication for nausea. No further details about the diagnostic procedures were provided. Outcome of the event COVID-19 was unknown. The relevant concurrent medical conditions of Cancer remains as a confounder for the symptoms of nausea, weakness and loss of appetite, while the High blood pressure remains as a confounder for the symptom of nausea. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old female patient with relevant concurrent medical conditions of Cancer and High blood pressure and concomitant medication of Aurobino, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 vaccine as second COVID-19 vaccination. Patient had received a dose of Janssen COVID-19 vaccine with no reported adverse event, approximately 8 months prior to mRNA-1273 vaccination (Interchange of vaccine products). Patient took a COVID-19 treatment for three days and noted nausea, weakness and loss of appetite. These symptoms occurred on the same day that the concomitant drug Aurobino started which had a active substance of Sulfamethoxazole/Bactrim, which is an anti-infective drug and may suggest onset of another infection, which can be considered confounders to the symptoms of nausea, weakness and loss of appetite. Patient's medication was changed and patient was given a medication for nausea. No further details about the diagnostic procedures were provided. Outcome of the event COVID-19 was unknown. The relevant concurrent medical conditions of Cancer remains as a confounder for the symptoms of nausea, weakness and loss of appetite, while the High blood pressure remains as a confounder for the symptom of nausea. The benefit-risk relationship of mRNA-1273 is not affected by this report.