Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Lymphadenopathy, Type IV hypersensitivity reaction
Clinical narrative: Could not sleep post first vaccine; Second Dose on day 37; Severe COVID Arm 7 days post first Vaccine; Itchy Injection Site from Shoulder to Elbow; Red Injection Site from Shoulder to Elbow; Swollen Injection Site from Shoulder to Elbow; Swollen Lymph Nodes in groin area post first vaccine; Joint Pains post first vaccine; Chills post first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose on day 37), TYPE IV HYPERSENSITIVITY REACTION (Severe COVID Arm 7 days post first Vaccine), INSOMNIA (Could not sleep post first vaccine), INJECTION SITE PRURITUS (Itchy Injection Site from Shoulder to Elbow) and INJECTION SITE ERYTHEMA (Red Injection Site from Shoulder to Elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Severe COVID Arm 7 days post first Vaccine), INJECTION SITE PRURITUS (Itchy Injection Site from Shoulder to Elbow), INJECTION SITE ERYTHEMA (Red Injection Site from Shoulder to Elbow), INJECTION SITE SWELLING (Swollen Injection Site from Shoulder to Elbow), LYMPHADENOPATHY (Swollen Lymph Nodes in groin area post first vaccine), ARTHRALGIA (Joint Pains post first vaccine) and CHILLS (Chills post first vaccine). On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose on day 37). On an unknown date, the patient experienced INSOMNIA (Could not sleep post first vaccine). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) at an unspecified dose and frequency. On 10-Feb-2021, LYMPHADENOPATHY (Swollen Lymph Nodes in groin area post first vaccine) and CHILLS (Chills post first vaccine) outcome was unknown. On 16-Feb-2021, INJECTION SITE PRURITUS (Itchy Injection Site from Shoulder to Elbow) and INJECTION SITE SWELLING (Swollen Injection Site from Shoulder to Elbow) outcome was unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose on day 37), TYPE IV HYPERSENSITIVITY REACTION (Severe COVID Arm 7 days post first Vaccine), INSOMNIA (Could not sleep post first vaccine), INJECTION SITE ERYTHEMA (Red Injection Site from Shoulder to Elbow) and ARTHRALGIA (Joint Pains post first vaccine) outcome was unknown.            Other treatment information include cold compress for an unknown indication. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-039362 (Patient Link).