Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Unevaluable event, Vaccination site rash, Vaccination site swelling
Clinical narrative: big toe got numb; loss of many words/ I couldn't find the words that I was trying to say; Tendonitis" in ear - both ears; sensation on the top of my foot neurological pain (like a neuropathy).; sensation on the top of my foot neurological pain (like a neuropathy).; Drug Induced Lupus erythematous; pins sticking on different parts: hands, legs, feet, back, basically over my body.; her arm swelled up and developed rash - same arm as injection; her arm swelled up and developed rash - same arm as injection; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (sensation on the top of my foot neurological pain (like a neuropathy).) and LUPUS-LIKE SYNDROME (Drug Induced Lupus erythematous) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 029B20T) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concurrent medical conditions included Aphasia. 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. In March 2021, the patient experienced VACCINATION SITE RASH (her arm swelled up and developed rash - same arm as injection) and VACCINATION SITE SWELLING (her arm swelled up and developed rash - same arm as injection). In August 2021, the patient experienced LUPUS-LIKE SYNDROME (Drug Induced Lupus erythematous) (seriousness criterion medically significant) and PARAESTHESIA (pins sticking on different parts: hands, legs, feet, back, basically over my body.). On 08-Sep-2021, the patient experienced NEUROPATHY PERIPHERAL (sensation on the top of my foot neurological pain (like a neuropathy).) (seriousness criterion medically significant) and SENSORY DISTURBANCE (sensation on the top of my foot neurological pain (like a neuropathy).). On an unknown date, the patient experienced HYPOAESTHESIA (big toe got numb), APHASIA (loss of many words/ I couldn't find the words that I was trying to say) and UNEVALUABLE EVENT (Tendonitis" in ear - both ears). On 08-Sep-2021, NEUROPATHY PERIPHERAL (sensation on the top of my foot neurological pain (like a neuropathy).) had resolved. At the time of the report, LUPUS-LIKE SYNDROME (Drug Induced Lupus erythematous), PARAESTHESIA (pins sticking on different parts: hands, legs, feet, back, basically over my body.), HYPOAESTHESIA (big toe got numb), APHASIA (loss of many words/ I couldn't find the words that I was trying to say), UNEVALUABLE EVENT (Tendonitis" in ear - both ears), VACCINATION SITE RASH (her arm swelled up and developed rash - same arm as injection) and VACCINATION SITE SWELLING (her arm swelled up and developed rash - same arm as injection) outcome was unknown and SENSORY DISTURBANCE (sensation on the top of my foot neurological pain (like a neuropathy).) had resolved.            Treatment information was not provided.  Company Comment: This case concerns a 78-year-old female patient with no relevant medical history who experienced serious unexpected events neuropathy peripheral and lupus-like syndrome. The event lupus like syndrome occurred approximately five months after the second dose of Spikevax. whereas the event neuropathy peripheral occurred approximately six months after the second dose of Spikevax. Rechallenge was not applicable. Patient's advanced age is a potential confounder. The benefit-risk relationship of drug is not affected by this report   This case was linked to MOD-2021-314357 (Patient Link).; Sender's Comments: This case concerns a 78-year-old female patient with no relevant medical history who experienced serious unexpected events neuropathy peripheral and lupus-like syndrome. The event lupus like syndrome occurred approximately five months after the second dose of Spikevax. whereas the event neuropathy peripheral occurred approximately six months after the second dose of Spikevax. Rechallenge was not applicable. Patient's advanced age is a potential confounder. The benefit-risk relationship of drug is not affected by this report