Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 047B21A and 001B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: DEMEROL and Penicillin. Past adverse reactions to the above products included Allergy with DEMEROL and Penicillin. Concurrent medical conditions included COPD, Secondary polycythemia, Central sleep apnea syndrome, Occipital neuralgia, Hypothyroidism, Fibromyalgia and Oddi's sphincter constriction. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jun-2001 to an unknown date and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) from 01-Nov-2007 to an unknown date for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: negative (Negative) negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive again.         It was reported that patient had taken other medications/products within 2 weeks of starting COVID-19 treatment. Relapse of COVID. Patient had a negative test on Monday 23 MAY 2022, but experienced new respiratory symptoms on 26 MAY 2022. Tested positive again the morning on 27 MAY 2022. Device Date reported as 27May2022.    Company comment-This spontaneous case concerns a 46-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 16th to 19th May2022. She had a relapse of covid with new respiratory symptoms and a positive SARS-CoV-2 test after completing the treatment with Paxlovid. 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.; Sender's Comments: This spontaneous case concerns a 46-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 16th to 19th May2022. She had a relapse of covid with new respiratory symptoms and a positive SARS-CoV-2 test after completing the treatment with Paxlovid. 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.