Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Had Covid rebound. Tested positive again 3 days aftertesting negative and started having symptoms again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had Covid rebound. Tested positive again 3 days aftertesting negative and started having symptoms again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EN6202 Location of injection: Arm Left Vaccine Administration Time: 12:00 PM) on 02-Mar-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ER2613 Location of injection: Arm Left Vaccine Administration Time: 12:00 PM) on 23-Mar-2021 and airborne since an unknown date. Past adverse reactions to the above products included Allergy with airborne; and No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Hashimoto's disease.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Had Covid rebound. Tested positive again 3 days aftertesting negative and started having symptoms again). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Had Covid rebound. Tested positive again 3 days aftertesting negative and started having symptoms again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.    No concomitant medication were reported.  Company comment: This spontaneous case concerns a 56 year old female patient with relevant medical history of Hashimoto's disease, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 18 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series with Pfizer vaccine, the second dose being given about 8 months ago, with no reported adverse events. Interchange of vaccine products was noted. The patient was started on Paxlovid for COVID-19 infection for 5 days. Patient had COVID-19 rebound. She tested positive again with recurrence of symptoms 3 days after testing negative for COVID-19. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56 year old female patient with relevant medical history of Hashimoto's disease, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 18 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series with Pfizer vaccine, the second dose being given about 8 months ago, with no reported adverse events. Interchange of vaccine products was noted. The patient was started on Paxlovid for COVID-19 infection for 5 days. Patient had COVID-19 rebound. She tested positive again with recurrence of symptoms 3 days after testing negative for COVID-19. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.