Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/ Sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 027B21A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Menopausal symptoms (hot flashes). Previously administered products included for Product used for unknown indication: Moxifloxacin and Augmentin since an unknown date. Past adverse reactions to the above products included Allergy with Augmentin and Moxifloxacin. Concurrent medical conditions included Asthma (mild persistent), Hypothyroidism, Dyskinesia of esophagus, GERD, Reflux esophagitis, Migraine and Hyperlipidemia. Concomitant products included LEVOTHYROXINE, LANSOPRAZOLE and AZELASTINE HYDROCHLORIDE for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced COVID-19 (COVID-19/ Sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ Sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, Laboratory test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The patient felt sick and tested positive with COVID-19 on 10-May-2022. She started Paxlovid on 11-May-2022 for COVID-19 and stopped on 16-May-2022. She felt better each day until 19-May-2022 and she experienced raspy in her throat. On the morning of 20 May, throat was irritated, and lungs felt heavy. She used hm test and it was positive. She had no fever, felt increasingly poorly. On 21 May, she felt the same all day with some increase in symptoms. On 22 May she had the same symptoms along with stuffy nose with some sinus ache, her lungs felt heavy and bronchial tubes felt congested. She had fever of 99.5 and did not feet well. Her device date was reported as 22-May-2022. No treatment medication was provided. Company comment-This spontaneous case concerns a 68-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19 (with SARS-CoV-2 test positive) 6 months 12 days after receiving third dose of mRNA-1273 vaccine. Patient reported sick and tested positive on 10th May 2022. Treated with Paxlovid from 11th May to 16th May 2022. After 3 days patient had symptoms of sore throat, sinus and lung congestion, tested positive for covid. She had received initial 2 doses of Moderna at an interval of 35 days. The outcome of the event was not resolved at the time of report. 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 68-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious  event of COVID-19 (with SARS-CoV-2 test positive) 6 months 12 days after receiving third dose of mRNA-1273 vaccine. Patient reported sick and tested positive on 10th May 2022. Treated with Paxlovid from 11th May to 16th May 2022. After 3 days patient had symptoms of sore throat, sinus and lung congestion, tested positive for covid. She had received initial 2 doses of Moderna at an interval of 35 days. The outcome of the event was not resolved at the time of report. 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.