Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash pruritic, Renal disorder, Tongue discomfort, Vaccination site erythema
Clinical narrative: right kidney hurts; redness down the back and the side of the injection arm; nauseous; rash of a good size on her torso and back that itched terribly; lips numb and tingling; tongue numb (burning numbness), swollen, tingling and painful; chills; body aches; sore throat; swollen lymph nodes on the sides of the neck; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (lips numb and tingling), TONGUE DISCOMFORT (tongue numb (burning numbness), swollen, tingling and painful), CHILLS (chills), PAIN (body aches) and OROPHARYNGEAL PAIN (sore throat) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for Pernicious anemia, FISH OIL, VITAMINS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN), ALPHA-AMYLASE SWINE PANCREAS, CELLULASE, LIPASE, PROTEASE NOS (DIGESTIVE ENZYME), LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST SODIUM (SINGULAIR), ATORVASTATIN CALCIUM (LIPITOR) and CALCIUM for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PARAESTHESIA ORAL (lips numb and tingling), TONGUE DISCOMFORT (tongue numb (burning numbness), swollen, tingling and painful), CHILLS (chills), PAIN (body aches), OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes on the sides of the neck). On 27-Jan-2021, the patient experienced NAUSEA (nauseous) and RASH PRURITIC (rash of a good size on her torso and back that itched terribly). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness down the back and the side of the injection arm). On an unknown date, the patient experienced RENAL DISORDER (right kidney hurts). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 30-Jan-2021 at an unspecified dose and frequency. On 22-Jan-2021, TONGUE DISCOMFORT (tongue numb (burning numbness), swollen, tingling and painful), CHILLS (chills) and PAIN (body aches) had resolved. On 29-Jan-2021, NAUSEA (nauseous) and RASH PRURITIC (rash of a good size on her torso and back that itched terribly) had resolved. At the time of the report, PARAESTHESIA ORAL (lips numb and tingling), OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen lymph nodes on the sides of the neck), VACCINATION SITE ERYTHEMA (redness down the back and the side of the injection arm) and RENAL DISORDER (right kidney hurts) 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non significant follow up received on 19-APR-2021, no new information; 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.