Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Feeling abnormal, Nasal congestion, Rash, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; Covid test turned out to be positive; initially a few rashes on which progressed; felt a little weird/; Exposed to a patient with Covid-19; brief/occasional chills; cough; sneezing; Strangely enough she had more energy than usual; Nasal congestion/She is still feeling stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion/She is still feeling stuffy), FEELING ABNORMAL (felt a little weird/), COUGH (cough), SNEEZING (sneezing) and DRUG INEFFECTIVE (Lack of efficacy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012l20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to a patient with Covid-19). On 04-Oct-2021, the patient experienced FEELING ABNORMAL (felt a little weird/) and RASH (initially a few rashes on which progressed). On 06-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (Covid test turned out to be positive). In October 2021, the patient experienced NASAL CONGESTION (Nasal congestion/She is still feeling stuffy), COUGH (cough), SNEEZING (sneezing), ENERGY INCREASED (Strangely enough she had more energy than usual) and CHILLS (brief/occasional chills). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nasal congestion/She is still feeling stuffy) and RASH (initially a few rashes on which progressed) had not resolved and FEELING ABNORMAL (felt a little weird/), COUGH (cough), SNEEZING (sneezing), DRUG INEFFECTIVE (Lack of efficacy), ENERGY INCREASED (Strangely enough she had more energy than usual), COVID-19 (Covid test turned out to be positive), EXPOSURE TO SARS-COV-2 (Exposed to a patient with Covid-19) and CHILLS (brief/occasional chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided.; Sender's Comments: This case concerns a 67-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19 together with other non-serious unexpected and expected events. Drug ineffective was considered also an additional event. The event of COVID-19 occurred approximately 8 months and 24 days after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.