Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Initial insomnia, Interchange of vaccine products, Product quality issue, SARS-CoV-2 test
Clinical narrative: This report was associated with product quality complaint; Confirmed COVID-19; Difficulty falling asleep; Patient received Covid-19 vaccine ad26.CoV2.s; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Confirmed COVID-19), INITIAL INSOMNIA (Difficulty falling asleep), PRODUCT QUALITY ISSUE (This report was associated with product quality complaint) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Covid-19 vaccine ad26.CoV2.s) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 16-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Feb-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Covid-19 vaccine ad26.CoV2.s). On 01-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Confirmed COVID-19) and INITIAL INSOMNIA (Difficulty falling asleep). On an unknown date, the patient experienced PRODUCT QUALITY ISSUE (This report was associated with product quality complaint). On 03-Mar-2022, COVID-19 (Confirmed COVID-19) and INITIAL INSOMNIA (Difficulty falling asleep) had resolved. At the time of the report, PRODUCT QUALITY ISSUE (This report was associated with product quality complaint) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Covid-19 vaccine ad26.CoV2.s) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient had no known allergies. No concomitant medication information was reported.  It was reported that the report has been associated with product quality compliant.   It was also reported that the events had a compatible/suggestive temporal relationship, unlabeled and had unknown scientific plausibility, there were other factors more likely to be associated with the events than Janssen Covid-19 Vaccine, so the events were considered as not related to Janssen Covid-19 Vaccine.  No treatment medication information was reported.  Company comment: This is a spontaneous case concerning a 55-year-old, male patient with no reported medical history and with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine Janssen) as previous dose, who experienced the unexpected non-serious AESI event of Covid-19 and the unexpected non-serious event of difficulty falling asleep. Product quality complaint (unspecified) and interchange of vaccine product was also reported. The events Covid-19 and difficulty falling asleep occurred approximately 13 days after the unknown dose number of mRNA-1273 vaccine administration. On unknown date, the patient tested positive for Covid-19 virus test.  No other information surrounding the events was reported. The outcome of the events Covid-19 and difficulty falling asleep was reported as resolved from the time of last observation. The vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine Janssen) as previous dose and the 13 days interval between the administration of the unknown dose number of mRNA-1273 vaccine and the occurrence of the event Covid-19 remain confounders for the event Covid-19 and reported product quality complaint. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old, male patient with no reported medical history and with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine Janssen) as previous dose, who experienced the unexpected non-serious AESI event of Covid-19 and the unexpected non-serious event of difficulty falling asleep. Product quality complaint (unspecified) and interchange of vaccine product was also reported. The events Covid-19 and difficulty falling asleep occurred approximately 13 days after the unknown dose number of mRNA-1273 vaccine administration. On unknown date, the patient tested positive for Covid-19 virus test. No other information surrounding the events was reported. The outcome of the events Covid-19 and difficulty falling asleep was reported as resolved from the time of last observation. The vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine Janssen) as previous dose and the 13 days interval between the administration of the unknown dose number of mRNA-1273 vaccine and the occurrence of the event Covid-19 remain confounders for the event Covid-19 and reported product quality complaint. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.