Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 5 | — | — |
got Covid for the second time; COVID-19; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of DRUG INEFFECTIVE (COVID-19), COVID-19 (COVID-19) and COVID-19 (got Covid for the second time) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunisation. Previously administered products included for COVID-19 immunisation: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: Unknown. Location of injection: Arm Right) on 25-Mar-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: Unknown. Location of injection: Arm Right) on 16-Apr-2021, Moderna (Dose Number: 3; booster (single); Batch/Lot No: Unknown. Location of injection: Arm Right) on 08-Nov-2021 and Moderna (Dose Number: 4; booster (single); Batch/Lot No: Unknown. Location of injection: Arm Right) on 18-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Ehlers-Danlos syndrome and Allergy. On 31-Oct-2023 at 1:00 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Jan-2024, the patient experienced DRUG INEFFECTIVE (COVID-19) (seriousness criterion medically significant) and COVID-19 (COVID-19) (seriousness criterion medically significant). On 07-Apr-2025, the patient experienced COVID-19 (got Covid for the second time) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 20-Jan-2024 to 25-Jan-2024 at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (COVID-19), COVID-19 (COVID-19) and COVID-19 (got Covid for the second time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2024, SARS-CoV-2 test: Positive. In 2024, SARS-CoV-2 test: Positive. On 07-Apr-2025, SARS-CoV-2 test: Positive. Concomitant medication use information was not provided by reporter. The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment. Patient had nothing major and was not too troubled. Patient finished Paxlovid 5-day course on Thursday morning 25-Jan-2024. Patient had completely cleared symptoms for a few days but started to feel sick again on Saturday 27-Jan-2024 and tested positive again for COVID on Saturday evening. For the past three days, patient had an extremely stuffy runny nose, sore throat and glassy eyes. No fever though. Patient was on day 11 from testing positive the first time and still sick with active symptoms and positive COVID at home antigen test. Patient had yet to return to work. On 08-Apr-2025, the patient stated before she paid for a telehealth visit and before she paid for a blood draw that was going to cost her to make sure her kidney and liver things were in order. She got COVID for the second time, her first time was in Jan-2024, and it went through her insurance. She did not want to take again because she had an underlying health risk and she was 53 and it would be smart for her to take it, her doctor would want her to take it, but she did not have the money to pay. The patient stated they had not even okayed that she can get Paxlovid yet because of they want to check her hepatic function. Therapeutic reasons were taken as a result of COVID-19. The device date was reported as 30-Jan-2024. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2025: Significant follow-up received: Case was upgraded to serious valid case from non-serious tracking only. Patient details (gender, age group, pregnancy status and race) was updated, medical history was updated, added lab data, suspect was updated to SPIKEVAX 2023-2024, Paxlovid was updated to treatment drug, event COVID-19 rebound was updated to COVID-19, additional event of COVID-19 (second episode) and drug ineffective was added, and narrative was updated.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Allergy; Ehlers-Danlos syndrome
Test Date: 20240127; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 2024; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20250407; Test Name: COVID-19 antigen test; Test Result: Positive