Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Headache, Oesophageal irritation, Rhinorrhoea
Clinical narrative: Rebound/tested again and was positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound/tested again and was positive) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048627A) for COVID-19 vaccination.  Previously administered products included for Drug use for unknown indication: COMIRNATY (Dose Number: 1 Batch/Lot No: EN6213) on 27-Feb-2021, COMIRNATY (Dose Number: 2 Batch/Lot No: ER2613 Location of Injection: Leg Left) on 20-Mar-2021 and COMIRNATY (Dose Number: 3 Batch/Lot No: 30135BA Location of injection: Arm Left) on 01-Oct-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY, COMIRNATY and COMIRNATY. Concurrent medical conditions included Drug allergy (No drug was reported.).  On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022 at 7:00 AM, the patient experienced COVID-19 (Rebound/tested again and was positive). On 18-May-2022, COVID-19 (Rebound/tested again and was positive) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-1 test: positive (Positive) Positive. In May 2022, SARS-CoV-1 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.   Concomitant medication included active drug substance generic dayquil and nyquil from 01-May-2022 to 04-May-2022. The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. The COVID-19 rebound; tested negative for 3 days after treatment ended, on the 5th day patient woke up with a sore throat and cough, tested again and was positive. The device date was 22-May-2022. The patient received an unspecified treatment from 04-May-2022 to 08-May-2022 for COVID-19 treatment.  Company comment: This spontaneous case concerns a 68-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 1 month and 16 days after vaccination with a fourth dose of mRNA-1273. The first three doses of COVID-19 vaccination were comirnaty, thus an interchange of vaccine products was also noted in the case. 3 days after treatment has ended, the patient tested negative for Covid-19. On the 5th day, the patient complained of sore throat again tested positive for Covid-19. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 1 month and 16 days after vaccination with a fourth dose of mRNA-1273. The first three doses of COVID-19 vaccination were comirnaty, thus an interchange of vaccine products was also noted in the case. 3 days after treatment has ended, the patient tested negative for Covid-19. On the 5th day, the patient complained of sore throat again tested positive for Covid-19. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.