Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 032B21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Mild/moderate asthma), Crohn's disease, Irritable bowel syndrome, Depression, Penicillin allergy and Anxiety. Concomitant products included LITHIUM CARBONATE from 01-Apr-2019 to 24-May-2022, CETIRIZINE from 01-Mar-2022 to 28-May-2022, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) from 16-May-2022 to 28-May-2022, VITAMIN D NOS from 10-May-2022 to 28-May-2022, OXYMETAZOLINE HYDROCHLORIDE (AFRIN [OXYMETAZOLINE HYDROCHLORIDE]) from 19-May-2022 to 28-May-2022, IBUPROFEN from 13-May-2022 to 28-May-2022, ACETAMINOPHEN from 13-May-2022 to 26-May-2022, AZITHROMYCIN from 25-May-2022 to an unknown date and MECOBALAMIN (METHYL B12) from 01-Apr-2022 to 28-May-2022 for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-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 21-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative. On 24-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive. On an unknown date, Body temperature: 102.2 (High) fever 102.2F.         Concomitant medications reported were Organic Market (Methylated B12) from 1-Apr-2022 to 28-May-2022 and Giant(Cetirizine)1-Mar-2022 to 28-May-2022. Covid-19 symptoms included: fever 102.2F, aches, cough, congestion, chest pain and chest tightness. Reporter reported that patient tested negative for COVID on 5/21 and 5/23, but sore throat returned and tested positive for COVID again on 5/24, and confirmed at urgent care clinic on 5/27. PCP diagnosed as secondary infection and started ant biotics on 5/25. Symptoms progressed and patient went to urgent care on 5/27. Was advised that it was reinfection with COVID. Treatment medications included: cough suppressants and corticosteroids. Device Date : 28May2022  Company comment: This is a spontaneous case concerning a 32-year-old female patient with medical conditions of Asthma and Crohn's disease, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred approximately 6 months and 15 days after the patient had completed three doses of mRNA-1273 (Spikevax), last dose being given on 08 Nov 2021. Patient was also treated with a 5-day course of Paxlovid from 14 May. Patient experienced symptoms of fever, aches, cough, congestion, chest pain and chest tightness and on 24-May-2022 SARS-CoV-2 antibody test was Positive which was confirmed at urgent care clinic on 27 may. It was reported that it was reinfection with COVID. Outcome of the event was not resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 32-year-old female patient with medical conditions of Asthma and Crohn's disease, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred approximately 6 months and 15 days after the patient had completed three doses of mRNA-1273 (Spikevax), last dose being given on 08 Nov 2021. Patient was also treated with a 5-day course of Paxlovid from 14 May. Patient experienced symptoms of fever, aches, cough, congestion, chest pain and chest tightness and on 24-May-2022 SARS-CoV-2 antibody test was Positive which was confirmed at urgent care clinic on 27 may. It was reported that it was reinfection with COVID. Outcome of the event was not resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.