Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Headache, Inappropriate schedule of product administration, Injection site swelling, Paraesthesia
Clinical narrative: inappropriate schedule of vaccine administered; Mild paresthesia on right thigh area like tingling sensation; tingling crawling sensation; Head ache; Pain and swelling site of injection; Localized pain; 1/2 inch diameter at site of injection; Hardness on area; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation), FORMICATION (tingling crawling sensation), VACCINATION SITE INDURATION (Hardness on area), HEADACHE (Head ache) and INJECTION SITE SWELLING (Pain and swelling site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension in 2003, Allergy to animal dander (Allergic to cat dander) and Shellfish allergy (Allergic to raw shrimp). Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension, MEDROXYPROGESTERONE, POTASSIUM CHLORIDE (K-TAB) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced VACCINATION SITE INDURATION (Hardness on area), INJECTION SITE SWELLING (Pain and swelling site of injection) and VACCINATION SITE PAIN (Localized pain; 1/2 inch diameter at site of injection). On 23-Dec-2020, the patient experienced PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation), FORMICATION (tingling crawling sensation) and HEADACHE (Head ache). On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 25-Dec-2020, VACCINATION SITE INDURATION (Hardness on area), INJECTION SITE SWELLING (Pain and swelling site of injection) and VACCINATION SITE PAIN (Localized pain; 1/2 inch diameter at site of injection) had resolved. On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation) and FORMICATION (tingling crawling sensation) had not resolved and HEADACHE (Head ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not seek treatment or advise from her physician.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Medical history updated, patient demographic details updated, concomitant medications updated, event outcome updated, new event inappropriate schedule of vaccine added based on 2nd dose information received; 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.