Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: I may have a mild breakthrough from booster shot; feel like shit; booster dose received < 6 months after primary series; absolutely no taste/ she had absolutely no taste in her mouth; Aches; fever/Fever 102F after booster; chills; flu-like symptoms; pains/ Ache; Hot/left arm injection site hot to the touch after booster; upper arm was swollen/Left Arm Bicept Swollen after booster; hard knot on Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I may have a mild breakthrough from booster shot), VACCINATION SITE WARMTH (Hot/left arm injection site hot to the touch after booster), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pains/ Ache) and AGEUSIA (absolutely no taste/ she had absolutely no taste in her mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The medical history was not provided by the reporter" should be added instead of NULL flavour.  Previously administered products included for Product used for unknown indication: J & J (She states that she receive J & J COVID-19 vaccine in AUG2021.) in August 2021. Past adverse reactions to the above products included No adverse event with J & J. Concomitant products included CITALOPRAM, BUSPIRONE HYDROCHLORIDE (BUSPAR), MONTELUKAST, MELOXICAM, ATORVASTATIN, BACLOFEN, GABAPENTIN, LEVOTHYROXINE, COLECALCIFEROL (VITAMIN D3) and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced VACCINATION SITE WARMTH (Hot/left arm injection site hot to the touch after booster), VACCINATION SITE SWELLING (upper arm was swollen/Left Arm Bicept Swollen after booster) and VACCINATION SITE INDURATION (hard knot on Injection Site). On 10-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pains/ Ache), MYALGIA (Aches) and CHILLS (chills). 10-Dec-2021, the patient experienced PYREXIA (fever/Fever 102F after booster). On 11-Dec-2021, the patient experienced AGEUSIA (absolutely no taste/ she had absolutely no taste in her mouth). On an unknown date, the patient experienced VACCINATION COMPLICATION (I may have a mild breakthrough from booster shot), FEELING ABNORMAL (feel like shit) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose received < 6 months after primary series). The patient was treated with DICLOFENAC POTASSIUM (VOLTAREN ACTI) for Adverse event, at a dose of on shoulder. At the time of the report, VACCINATION COMPLICATION (I may have a mild breakthrough from booster shot), VACCINATION SITE WARMTH (Hot/left arm injection site hot to the touch after booster), PAIN (pains/ Ache), AGEUSIA (absolutely no taste/ she had absolutely no taste in her mouth), FEELING ABNORMAL (feel like shit), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose received < 6 months after primary series), VACCINATION SITE SWELLING (upper arm was swollen/Left Arm Bicept Swollen after booster), VACCINATION SITE INDURATION (hard knot on Injection Site), MYALGIA (Aches), PYREXIA (fever/Fever 102F after booster) and CHILLS (chills) outcome was unknown and INFLUENZA LIKE ILLNESS (flu-like symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2021, Body temperature: 102 (High) 102 F.         Other concomitant medication included Allergy medicine and wiexla  Company Comment: This case concerns a 60 year-old female patient with a history of Janssen COVID-19 vaccine who experienced the unexpected adverse event of special interest of ageusia which occurred 3 days after vaccination with mRNA-1273 administered as a booster third dose. The use of concomitant medication Janssen COVID-19 vaccine remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up received: Updated events verbatim and added treatment medication.; Sender's Comments: This case concerns a 60 year-old female patient with a history of Janssen COVID-19 vaccine who experienced the unexpected adverse event of special interest of ageusia which occurred 3 days after vaccination with mRNA-1273 administered as a booster third dose. The use of concomitant medication Janssen COVID-19 vaccine remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.