Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Suspected COVID-19; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (Suspected COVID-19) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for Prophylactic vaccination.    Concurrent medical conditions included Allergy NOS.   On 02-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In May 2022, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (Suspected COVID-19) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            No concomitant medication information provided.This report was associated with product quality complaint 90000235216. On an unspecified date in May-2022 the patient had COVID-19 infection (dose number in series 2) (suspected covid-19 infection) which led to suspected clinical vaccination failure (dose number in series 1). It started with intense congestion and then the rest of the symptoms followed (dose number in series 2). Senders Comment- COVID-19 Vaccine ad26.cov2 suspected clinical vaccination failure. The events had a compatible/suggestive temporal relationship was unlabeled and had unknown scientific possibility. There was other factors more likely to be with the events than the drug. Specifically special situations. Therefore this events was considered not related. Company comment:This spontaneous case concerns a female patient aged 33 years with no relevant medical history reported, who experienced the unexpected serious medically significant AESI of Covid 19 on an unknown date after receiving a dose (2nd dose) of mRNA-1273 vaccine in the covid 19 vaccination series. Additionally Interchange of vaccine products was noted as patient had received a dose of vaccination with co suspect JANSSEN COVID-19 VACCINE 133 days prior to current vaccination. Patient had suspected COVID-19, started treatment with Paxlovid for 5 days. No further clinical course, lab reports or treatment details were reported.  Outcome of the event Covid 19 was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 33 years with no relevant medical history reported, who experienced the unexpected serious medically significant AESI of Covid 19 on an unknown date after receiving a dose (2nd dose) of mRNA-1273 vaccine in the covid 19 vaccination series. Additionally Interchange of vaccine products was noted as patient had received a dose of vaccination with co suspect JANSSEN COVID-19 VACCINE 133 days prior to current vaccination. Patient had suspected COVID-19, started treatment with Paxlovid for 5 days. No further clinical course, lab reports or treatment details were reported.  Outcome of the event Covid 19 was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.