Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: became symptomatic and tested positive (instant home test) morning of May 11, 2022/Symptoms were mild - cough (dry and productive), sore throat, headache, stomach ache, runny nose, fatigue, light-headedness, slightly elevated temperature (99.8) 3 day; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (became symptomatic and tested positive (instant home test) morning of May 11, 2022/Symptoms were mild - cough (dry and productive), sore throat, headache, stomach ache, runny nose, fatigue, light-headedness, slightly elevated temperature (99.8) 3 day) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 012F21A, 027A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory infection (numerous upper respiratory infections), Fusion lumbar spine (Lumbar back fusion L4-L5) and Knee reconstruction (Left knee ACL repair). Concurrent medical conditions included Dust allergy, Allergy to molds, Allergy to animal dander (cat dander), Allergy to plants (oak trees), Allergy to metals (allergy to nickel-reaction was severe skin blistering), Asthma, Allergy to antibiotic (Tetracycline and derivatives), Allergy to antibiotic (Minocycline and derivatives), Drug allergy (codeine) and Opioid toxicity (Allergy to other opiates). Concomitant products included PARACETAMOL (TYLENOL), IBUPROFEN (ADVIL [IBUPROFEN]), PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) and TERBINAFINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (became symptomatic and tested positive (instant home test) morning of May 11, 2022/Symptoms were mild - cough (dry and productive), sore throat, headache, stomach ache, runny nose, fatigue, light-headedness, slightly elevated temperature (99.8) 3 day). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 17-May-2022 for COVID-19 treatment, at a dose of Took Paxlovid for 5 days. At the time of the report, COVID-19 (became symptomatic and tested positive (instant home test) morning of May 11, 2022/Symptoms were mild - cough (dry and productive), sore throat, headache, stomach ache, runny nose, fatigue, light-headedness, slightly elevated temperature (99.8) 3 day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive (instant home test) morning.. In May 2022, Body temperature: 99.8 (High) slightly elevated temperature (99.8). On 20-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on May 20. On 26-May-2022, SARS-CoV-2 test: positive (Positive) On the morning of May 26 tested positive.         The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.  Device Date was reported as 26May2022.  Company Comment: This spontaneous case concerns a 61-year-old, male patient with relevant medical history of Asthma and past drug history of administration of three doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient developed COVID-19 symptoms and tested positive for SARS-CoV-2 via instant home test. He took and completed a 6-day course of Paxlovid (nirmatrelvir, ritonavir) from 12May2022 to 17May2022. Symptoms were reported to be mild which included cough (dry and productive), sore throat, headache, stomach ache, runny nose, fatigue, light-headedness, and slightly elevated temperature (99.8F) 3 days into symptoms. It was reported that the symptoms worsened for several days and then eventually resolved. The patient was asymptomatic and tested negative for SARS-CoV-2 3 days after treatment with Paxlovid. However, after 6 days (15 days from the initial COVID-19 infection), it was reported that the patient experienced runny nose, headache, cough and sore throat which were similar to the initial COVID-19 symptoms. The patient again tested positive for SARS-CoV-2 via instant home test. It was reported that he had a strong response as the line developed almost immediately. The patient was awaiting guidance from his physician at the time of the report. The patient's medical history of Asthma, which is a known risk factor for COVID-19, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old, male patient with relevant medical history of Asthma and past drug history of administration of three doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient developed COVID-19 symptoms and tested positive for SARS-CoV-2 via instant home test. He took and completed a 6-day course of Paxlovid (nirmatrelvir, ritonavir) from 12May2022 to 17May2022. Symptoms were reported to be mild which included cough (dry and productive), sore throat, headache, stomach ache, runny nose, fatigue, light-headedness, and slightly elevated temperature (99.8F) 3 days into symptoms. It was reported that the symptoms worsened for several days and then eventually resolved. The patient was asymptomatic and tested negative for SARS-CoV-2 3 days after treatment with Paxlovid. However, after 6 days (15 days from the initial COVID-19 infection), it was reported that the patient experienced runny nose, headache, cough and sore throat which were similar to the initial COVID-19 symptoms. The patient again tested positive for SARS-CoV-2 via instant home test. It was reported that he had a strong response as the line developed almost immediately. The patient was awaiting guidance from his physician at the time of the report. The patient's medical history of Asthma, which is a known risk factor for COVID-19, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.