Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Sinusitis, Suspected COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus issues), FEELING COLD (cold feeling), SINUS CONGESTION (stuffy head only), BODY TEMPERATURE INCREASED (run a temp) and COUGH (cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 002A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included Anal cancer (Patient had anal cancer 14 years ago) in 2007. Concurrent medical conditions included Immunocompromised (Ig deficient). On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced SUSPECTED COVID-19 (symptomatic COVID-19) and DRUG INEFFECTIVE (Lack of Efficacy). On an unknown date, the patient experienced SINUSITIS (sinus issues), FEELING COLD (cold feeling), SINUS CONGESTION (stuffy head only), BODY TEMPERATURE INCREASED (run a temp), COUGH (cough), NASOPHARYNGITIS (stuffy head cold), MYALGIA (body aches), HEADACHE (headache) and HYPERSENSITIVITY (allergies were bugging me). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus issues), BODY TEMPERATURE INCREASED (run a temp), COUGH (cough), MYALGIA (body aches) and HEADACHE (headache) had resolved, FEELING COLD (cold feeling), SINUS CONGESTION (stuffy head only) and NASOPHARYNGITIS (stuffy head cold) had not resolved and SUSPECTED COVID-19 (symptomatic COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and HYPERSENSITIVITY (allergies were bugging me) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 22-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.On an unknown date, Body temperature: high (High) high.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication was not provided. Treatment medication Regeneron.Company Comment: This case concerns a 58-year-old female patient with relevant medical history of Anal Cancer and is Immunocompromised, who experienced the unexpected event of symptomatic COVID-19 (adverse event of special interest), Sinusitis, Feeling cold, Sinus congestion, Body temperature increased, Cough, Nasopharyngitis; and the expected events of Myalgia, Headache and Hypersensitivity. The events symptomatic COVID-19  and  Lack of effect occurred approximately 9 months after the second dose of mRNA-1273. Other non-serious events occurred at an unknown date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided.  Lack of effect was also considered for this case. and was retained as such, having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. The patient's medical history of Anal Cancer and Immunocompromised state remain as confounders for the occurrence of the events. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 58-year-old female patient with relevant medical history of Anal Cancer and is Immunocompromised, who experienced the unexpected event of symptomatic COVID-19 (adverse event of special interest), Sinusitis, Feeling cold, Sinus congestion, Body temperature increased, Cough, Nasopharyngitis; and the expected events of Myalgia, Headache and Hypersensitivity. The events symptomatic COVID-19  and  Lack of effect occurred approximately 9 months after the second dose of mRNA-1273. Other non-serious events occurred at an unknown date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided.  Lack of effect was also considered for this case. and was retained as such, having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. The patient's medical history of Anal Cancer and Immunocompromised state remain as confounders for the occurrence of the events. The benefit risk relationship of mRNA-1273 is not affected by this report.