Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: I also had experienced coughing, muscle and joint aches; I also had experienced coughing, muscle and joint aches; I also had experienced coughing, muscle and joint aches; breakthrough infection; Lack of drug effect; I had a a breakthrough COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I also had experienced coughing, muscle and joint aches), VACCINE BREAKTHROUGH INFECTION (breakthrough infection), DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (I had a a breakthrough COVID-19 infection) and MYALGIA (I also had experienced coughing, muscle and joint aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 030M20A and 091021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PREGABALIN, SEVELAMER, AMLODIPINE, ATORVASTATIN, DICYCLOVERINE (DICYCLOMINE-S), SACUBITRIL, VALSARTAN (ENTRESTO), LEVOTHYROXINE, NORTRIPTYLINE, METOPROLOL, TRIAMTERENE, ELUXADOLINE (VIBERZI), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), PROBIOTICS NOS, CELECOXIB, ESCITALOPRAM, AZELASTINE, PANTOPRAZOLE, CICLOSPORIN (RESTASIS), MARIJUANA, CANNABIDIOL, VITAMIN B COMPLEX (B COMPLEX (B50)), ASCORBIC ACID (C VITAMIN), CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM), GLUCOSAMINE;MAGNESIUM, FISH OIL, MILK THISTLE [SILYBUM MARIANUM], TURMERIC [CURCUMA LONGA RHIZOME] and VACCINIUM MACROCARPON (CRANBERRY EXTRACT [VACCINIUM MACROCARPON]) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (breakthrough infection). 01-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (I had a a breakthrough COVID-19 infection). On an unknown date, the patient experienced COUGH (I also had experienced coughing, muscle and joint aches), MYALGIA (I also had experienced coughing, muscle and joint aches) and ARTHRALGIA (I also had experienced coughing, muscle and joint aches). At the time of the report, COUGH (I also had experienced coughing, muscle and joint aches), VACCINE BREAKTHROUGH INFECTION (breakthrough infection), MYALGIA (I also had experienced coughing, muscle and joint aches) and ARTHRALGIA (I also had experienced coughing, muscle and joint aches) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (I had a a breakthrough COVID-19 infection) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Tylenol was reported as treatment medication. Company Comment: This is a spontaneous case concerning a 78-year-old female patient with no relevant medical history reported who experienced the unexpected event of vaccine breakthrough infection and the AESI event of COVID-19. The events occurred the day after a third dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.Sender's Comments: This is a spontaneous case concerning a 78-year-old female patient with no relevant medical history reported who experienced the unexpected event of vaccine breakthrough infection and the AESI event of COVID-19. The events occurred the day after a third dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.