Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Chills, Cough
Clinical narrative: cold feeling; stuffy head only; cough,painful cough; stuffy head cold; sinus issues; run a temp; body aches; allergies were bugging me; symptomatic breakthrough case diagnosed on November 22nd.; symptomatic COVID-19; Lack of Efficacy; Fever (100.4 Fahrenheit); Chills; Muscle aches; Nasal congestion/ runny nose; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (symptomatic breakthrough case diagnosed on November 22nd.) 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.     Concurrent medical conditions included IgA deficiency (IgA Deficient since birth), Anal cancer (Patient had anal cancer 14 years ago) since 2007 and Chronic respiratory disease (Since birth).   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 COVID-19 (symptomatic COVID-19) and DRUG INEFFECTIVE (Lack of Efficacy). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (symptomatic breakthrough case diagnosed on November 22nd.) (seriousness criterion medically significant), FEELING COLD (cold feeling), SINUS CONGESTION (stuffy head only), COUGH (cough,painful cough), NASOPHARYNGITIS (stuffy head cold), SINUSITIS (sinus issues), BODY TEMPERATURE INCREASED (run a temp), PAIN (body aches), NASAL CONGESTION (Nasal congestion/ runny nose), HEADACHE (headache), HYPERSENSITIVITY (allergies were bugging me), PYREXIA (Fever (100.4 Fahrenheit)), CHILLS (Chills) and MYALGIA (Muscle aches). 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, VACCINE BREAKTHROUGH INFECTION (symptomatic breakthrough case diagnosed on November 22nd.), COVID-19 (symptomatic COVID-19), DRUG INEFFECTIVE (Lack of Efficacy), NASAL CONGESTION (Nasal congestion/ runny nose), HYPERSENSITIVITY (allergies were bugging me), PYREXIA (Fever (100.4 Fahrenheit)), CHILLS (Chills) and MYALGIA (Muscle aches) outcome was unknown, FEELING COLD (cold feeling), SINUS CONGESTION (stuffy head only), COUGH (cough,painful cough) and NASOPHARYNGITIS (stuffy head cold) had not resolved and SINUSITIS (sinus issues), BODY TEMPERATURE INCREASED (run a temp), PAIN (body aches) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive, naso, NAA 2 DaAY TAT. On 22-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 100.4 (High) 100.4 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication included Regeneron.  Patient had painful cough due to increase in inhaler use.  Company Comment: This case concerns a 58-year-old female patient with relevant medical history of Anal Cancer, Immunocompromised and Chronic respiratory condition, who experienced the unexpected event of 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 COVID-19, Vaccine breakthrough infection and Drug ineffective occurred approximately 9 months after the second dose of mRNA-1273. Drug ineffective 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, Immunocompromised and Chronic respiratory condition remains as confounders for the occurrence of the events. The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow-up received that included patient medical history, lab data, new event and narrative updated.; Sender's Comments: This case concerns a 58-year-old female patient with relevant medical history of Anal Cancer, Immunocompromised and Chronic respiratory condition, who experienced the unexpected event of 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 COVID-19, Vaccine breakthrough infection and Drug ineffective occurred approximately 9 months after the second dose of mRNA-1273. Drug ineffective 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, Immunocompromised and Chronic respiratory condition remains as confounders for the occurrence of the events. The benefit risk relationship of mRNA-1273 is not affected by this report.