Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Headache
Clinical narrative: Lack of drug effect; tested positive for covid-19; Bad headache; chills; fever; sore throat; congestion; coughing; sneezing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), COUGH (coughing), SNEEZING (sneezing) and DRUG INEFFECTIVE (Lack of drug effect) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 31-Oct-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), COUGH (coughing), SNEEZING (sneezing), HEADACHE (Bad headache), CHILLS (chills) and PYREXIA (fever). On 01-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (tested positive for covid-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), COUGH (coughing), SNEEZING (sneezing), HEADACHE (Bad headache), CHILLS (chills) and PYREXIA (fever) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, SARS-CoV-2 test: positive (Positive) tested positive for covid-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), COUGH (coughing), SNEEZING (sneezing), DRUG INEFFECTIVE (Lack of drug effect), HEADACHE (Bad headache), CHILLS (chills), PYREXIA (fever) and COVID-19 (tested positive for covid-19) to be possibly related.    No concomitant medication was reported. Patient included anatomical location of suspect product right dominant arm (not sure) for both doses.  It was reported symptoms are ongoing.  This case concerns a 41-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of COVID-19 and lack of drug effect was considered as an additional event. Other unexpected and expected, non-serious events were also reported. The events occurred approximately 8 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 41-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of COVID-19 and lack of drug effect was considered as an additional event. Other unexpected and expected, non-serious events were also reported. The events occurred approximately 8 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.