Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Weird Shock like feeling in fingers wrist, ankle and back), PRURITUS (itching), PALPITATIONS (irregular heart rate / palpitations) and DIZZINESS (dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis, Hypersensitivity NOS and Hives. Concurrent medical conditions included Drug allergy (Sulfa drugs - nausea, lightheadedness; Adult strength medications - nausea, headache, fatigue), Latex allergy (reaction: striation, hives, neck stiffness, difficulty breathing) since 2014 and Allergy to animal (Goat products when ingested; Reaction: ulceration in mouth and throat). Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal), VITAMIN B [VITAMIN B NOS] for Vitamin deficiency. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and VACCINATION SITE SWELLING (swelling at injection site). On 27-Jan-2021, the patient experienced PARAESTHESIA (Weird Shock like feeling in fingers wrist, ankle and back), PRURITUS (itching), PALPITATIONS (irregular heart rate / palpitations), DIZZINESS (dizziness), CHILLS (chills), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE ERYTHEMA (erythema at the injection site). On 30-Jan-2021, the patient experienced ASTHENIA (extremity weakness). On 01-Feb-2021, PARAESTHESIA (Weird Shock like feeling in fingers wrist, ankle and back) and ASTHENIA (extremity weakness) had resolved. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), PALPITATIONS (irregular heart rate / palpitations), DIZZINESS (dizziness), CHILLS (chills), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (erythema at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Weird Shock like feeling in fingers wrist, ankle and back), PRURITUS (itching), PALPITATIONS (irregular heart rate / palpitations), DIZZINESS (dizziness), ASTHENIA (extremity weakness), CHILLS (chills), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE ERYTHEMA (erythema at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) to be possibly related. Treatment included Benadryl 12.5 mg / 5 ml oral (PO), every 4 hours (q4h) on unspecified dates. The patient was seen by their primary care physician (PCP) and was given several days of steroids to help calm the "fight or flight mechanism" as described by the patient. The patient fully recovered on day 7 with no subsequent events. 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. The patient's medical history of anaphylaxis and hypersensitivity remain as confounders. This case was linked to MOD-2021-073084 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Additional event reported, reporter causality provided, concomitant medications updated, patient's medical history provided, events' outcomes and resolution dates provided; 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. The patient's medical history of anaphylaxis and hypersensitivity remain as confounders.