Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pain, Myalgia, Vaccination site discolouration, Vaccination site pain
Clinical narrative: skin discoloration in injection area left arm, the spot became lighter that regular skin left arm; burning sensation in injection site left arm; little hurt; arm continued to hurt which was diagnosed as myalgia; first injection was administered wrong way not in muscle but maybe bone; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (skin discoloration in injection area left arm, the spot became lighter that regular skin left arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (first injection was administered wrong way not in muscle but maybe bone), VACCINATION SITE PAIN (burning sensation in injection site left arm), INJECTION SITE PAIN (little hurt) and MYALGIA (arm continued to hurt which was diagnosed as myalgia) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU in 2021. Concurrent medical conditions included Sinus disorder NOS, Blood pressure high, Anxiety, Sleep disorder NOS and Memory impaired. Concomitant products included PIROXICAM and PAROXETINE for Anxiety, VALSARTAN and NIFEDIPINE for Blood pressure high, CYANOCOBALAMIN (B-12 DOTS) for Memory disturbance, LORAZEPAM for Sleep disorder, EZETIMIBE (ZETIA), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and VITAMIN D NOS for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (first injection was administered wrong way not in muscle but maybe bone), INJECTION SITE PAIN (little hurt) and MYALGIA (arm continued to hurt which was diagnosed as myalgia). On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (burning sensation in injection site left arm). On 08-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (skin discoloration in injection area left arm, the spot became lighter that regular skin left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and MENTHOL (ASPERCREME HEAT PAIN RELIEVING) at a dose of 1 dosage form. On 05-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (first injection was administered wrong way not in muscle but maybe bone) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (skin discoloration in injection area left arm, the spot became lighter that regular skin left arm), VACCINATION SITE PAIN (burning sensation in injection site left arm), INJECTION SITE PAIN (little hurt) and MYALGIA (arm continued to hurt which was diagnosed as myalgia) had not resolved.            Diagnostic tests included ultrasound of the arm and no findings were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, injection site pain, vaccination site pain, vaccination site discoloration, a causal relationship cannot be excluded.  This report also refers to a case of Incorrect route of product administration for mRNA-1273, lot # unknown.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Event outcome updated. On 09-Jul-2021: Event, medical history and concomitant medication added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, injection site pain, vaccination site pain, vaccination site discoloration, a causal relationship cannot be excluded.  This report also refers to a case of Incorrect route of product administration for mRNA-1273, lot # unknown.