Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Arm swelled up; Pins sticking on different parts; My big toe got numb; Tendonitis in ear - both ears. Caller states she has always had it since mid 40 or 50s but it was super loud/amplified; patient reports "loss of many words"; Rash over arms/got a rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up), PARAESTHESIA (Pins sticking on different parts), HYPOAESTHESIA (My big toe got numb), CONDITION AGGRAVATED (Tendonitis in ear - both ears. Caller states she has always had it since mid 40 or 50s but it was super loud/amplified) and APHASIA (patient reports "loss of many words") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029B20T and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tendonitis. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LEVOTHYROXINE SODIUM (SYNTHROID), CICLOSPORIN (RESTASIS), VITAMINS NOS and FISH OIL for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelled up), PARAESTHESIA (Pins sticking on different parts), HYPOAESTHESIA (My big toe got numb), CONDITION AGGRAVATED (Tendonitis in ear - both ears. Caller states she has always had it since mid 40 or 50s but it was super loud/amplified), APHASIA (patient reports "loss of many words") and VACCINATION SITE RASH (Rash over arms/got a rash on left arm). At the time of the report, PERIPHERAL SWELLING (Arm swelled up), PARAESTHESIA (Pins sticking on different parts), HYPOAESTHESIA (My big toe got numb), CONDITION AGGRAVATED (Tendonitis in ear - both ears. Caller states she has always had it since mid 40 or 50s but it was super loud/amplified), APHASIA (patient reports "loss of many words") and VACCINATION SITE RASH (Rash over arms/got a rash on left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provider by the reporter.  The patient had just been diagnosed with Drug Induced Lupus about two weeks ago at the time of the report.  This case concerns a 77 year-old female subject expected event  of  VACCINATION SITE RASH (relevant The event occurred approximately one week after the first dose of Spikeva. The event is consistent with the current understanding of the mechanism of action of the study medication (The benefit-risk relationship of  Spikevax  in not affected by this report   This case was linked to MOD-2021-314376 (Patient Link).; Sender's Comments: This case concerns a 77 year-old female subject expected event  of  VACCINATION SITE RASH (relevant The event occurred approximately one week after the first dose of Spikeva. The event is consistent with the current understanding of the mechanism of action of the study medication (The benefit-risk relationship of  Spikevax  in not affected by this report