Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site hypoaesthesia, Vaccination site pain, Vaccination site paraesthesia, Vaccination site rash
Clinical narrative: Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand; rash on my left arm around the injection site; Numbness in her deltoid at the injection site, that radiates distally; Paresthesia in her deltoid at the injection site, that radiates distally; Soreness at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046-B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Guillain-Barre syndrome in 1990. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, OXYCODONE for Nerve pain, AMLODIPINE, LEVOTHYROXINE SODIUM (LEVOXYL) and SENNA [SENNA ALEXANDRINA] for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 04-May-2021 at 4:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HYPOAESTHESIA (Numbness in her deltoid at the injection site, that radiates distally) and VACCINATION SITE PARAESTHESIA (Paresthesia in her deltoid at the injection site, that radiates distally). On 08-May-2021, the patient experienced PARAESTHESIA (Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand) (seriousness criterion medically significant) and VACCINATION SITE RASH (rash on my left arm around the injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 3 dosage form. On 30-Apr-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. On 22-May-2021, VACCINATION SITE RASH (rash on my left arm around the injection site) had resolved. At the time of the report, PARAESTHESIA (Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand) and VACCINATION SITE PARAESTHESIA (Paresthesia in her deltoid at the injection site, that radiates distally) had not resolved and VACCINATION SITE HYPOAESTHESIA (Numbness in her deltoid at the injection site, that radiates distally) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was hospitalized on 05-May-2021 and discharged on 08-May-2021 due to unknown reason. On 08-May-2021, the patient developed paresthesia developed on the tips of both toes and fingertips of right hand and entire left arm. Then it progressed, and still to this day 11-Jun-2021, it is affecting her bilateral feet, bilateral ankles, and entire right hand. She also developed a rash on her left arm around the injection site, which started on 08-May-2021. It went away after about 2 weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additionally,  patient's medical history of Guillain-Barre syndrome is a confounding factor that may play a possible contributory role. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received on 11-Jun-2021 and contains information regarding the reporter, the patient demographics, additional events (paresthesia, rash on her left arm) and the case was upgraded to serious.; 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, a causal relationship cannot be excluded. Additionally,  patient's medical history of Guillain-Barre syndrome is a confounding factor that may play a possible contributory role. Further information has been requested.