Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: drug ineffective; COVID-19; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Running nose) and DRUG INEFFECTIVE (drug ineffective) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHINORRHOEA (Running nose). On 27-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (drug ineffective). At the time of the report, COVID-19 (COVID-19) and RHINORRHOEA (Running nose) outcome was unknown and DRUG INEFFECTIVE (drug ineffective) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         No concomitant medication were reported.  No treatment medication were reported. The pain did not get better or worse with the booster. Her pain is in her upper leg, and she feels it more when she walks up and down her stairs. She had a running nose a week after getting the booster which led her to getting tested for COVID 19. She tested positive for COVID 19 on 27DEC2021.   Company comment: This spontaneous case concerns a 79-year-old female patient, with no reported medical history, who experienced the unexpected non serious AESI of COVID 19 and non serious event of rhinorrhoea. Drug ineffective was also captured as an additional event. The event of rhinorrhoea occurred approximately a week after the third dose of mRNA-1273, while the event of COVID 19 occurred 6 days after third dose. As reported, the patient had a running nose which led her to getting tested for COVID 19 and she tested positive on SARS-CoV-2 test. The patient had continuing pain in her upper leg, and she feels more when she walks up and down her stairs, which occurred after 1st dose of Moderna vaccine (described in linked case) and did not get better or worse after booster dose. Patient's rhinorrhoea could have been the symptom of COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-512669, MOD-2022-512678 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old female patient, with no reported medical history, who experienced the unexpected non serious AESI of COVID 19 and non serious event of rhinorrhoea. Drug ineffective was also captured as an additional event. The event of rhinorrhoea occurred approximately a week after the third dose of mRNA-1273, while the event of COVID 19 occurred 6 days after third dose. As reported, the patient had a running nose which led her to getting tested for COVID 19 and she tested positive on SARS-CoV-2 test. The patient had continuing pain in her upper leg, and she feels more when she walks up and down her stairs, which occurred after 1st dose of Moderna vaccine (described in linked case) and did not get better or worse after booster dose. Patient's rhinorrhoea could have been the symptom of COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.