Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Sinusitis, Vomiting
Clinical narrative: felt like having sinus infection; Lack of drug effect; she had COVID-19; Throwing up; Fatigued/She felt exhausted at that time; Really nauseated; Felt really sick; She was down for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (felt like having sinus infection), ILLNESS (Felt really sick), DEPRESSED MOOD (She was down for 5 days), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (she had COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 046A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced ILLNESS (Felt really sick), DEPRESSED MOOD (She was down for 5 days), VOMITING (Throwing up), FATIGUE (Fatigued/She felt exhausted at that time) and NAUSEA (Really nauseated). On 18-Jan-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (she had COVID-19). On an unknown date, the patient experienced SINUSITIS (felt like having sinus infection). On 07-Sep-2021, DEPRESSED MOOD (She was down for 5 days) and VOMITING (Throwing up) had resolved. At the time of the report, SINUSITIS (felt like having sinus infection), ILLNESS (Felt really sick), DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (she had COVID-19), FATIGUE (Fatigued/She felt exhausted at that time) and NAUSEA (Really nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative.         Patient also mentioned that she had COVID-19 on 18Jan2022 and was administered with monoclonal antibodies on 20Jan2022. She felt exhausted at that time, like she went out to work and felt like having sinus infection on steroids. She thought she had Omicron at that time. Her repeat Covid-19 test on 28Jan2022 was negative.  Company comment: This spontaneous case concerns a 50 year old female patient with no relevant medical history who experienced the unexpected non serious event of Drug ineffective after 9 months and 24 days of receiving the second dose of mRNA-1273 vaccine when she reportedly had Covid 19 and was administered monoclonal antibodies. The interval between the 2 doses was approximately 31 days. The patient also received a booster dose after about 5 months and 9 days after the second dose as per the source document. Repeat covid test after 10 days of having covid 19 was negative. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event retained as non serious as per Regulatory Authority reporting.    This case was linked to MOD-2022-494502, MOD-2022-494417 (Patient Link).; Sender's Comments: This spontaneous case concerns a 50 year old female patient with no relevant medical history who experienced the unexpected non serious event of Drug ineffective after 9 months and 24 days of receiving the second dose of mRNA-1273 vaccine when she reportedly had Covid 19 and was administered monoclonal antibodies. The interval between the 2 doses was approximately 31 days. The patient also received a booster dose after about 5 months and 9 days after the second dose as per the source document. Repeat covid test after 10 days of having covid 19 was negative. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event retained as non serious as per Regulatory Authority reporting.