Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Peripheral swelling, Product dose omission issue, Pruritus
Clinical narrative: Itching/  itching on fingers and toes; palpitations; Abdominal cramping; erythema; tingling in lower legs and calves; pain/ shooting pain; purplish toes; lesions, on fingers and toes; I was instructed by Moderna after the first vaccination to refrain from obtaining the second vaccine.; Welts (Blisters) on Toes and Fingers/itchy welt; Hevay lungs; Swelling of fingers and toes; Ocular Migraine; Wheezing/bronchospasm; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing/bronchospasm), MIGRAINE (Ocular Migraine), URTICARIA (Welts (Blisters) on Toes and Fingers/itchy welt), RESPIRATION ABNORMAL (Hevay lungs) and PERIPHERAL SWELLING (Swelling of fingers and toes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity reaction (wheezing, some hives, body or muscle aches, GI upset), Hives and Hay fever. Previously administered products included for an unreported indication: FLU VACCINE VII (wheezing; heart palpitations; nausea-like malaise) in 2009. Concurrent medical conditions included Food allergy (food, wheat or gluten, nightshade foods) since 2002 and Raynaud's phenomenon (some improvement in the past year; fewer episodes and had had none this year).    On 08-Apr-2021 at 1:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced WHEEZING (Wheezing/bronchospasm). On 11-Apr-2021, the patient experienced MIGRAINE (Ocular Migraine), RESPIRATION ABNORMAL (Hevay lungs) and PERIPHERAL SWELLING (Swelling of fingers and toes). On 12-Apr-2021, the patient experienced URTICARIA (Welts (Blisters) on Toes and Fingers/itchy welt). On an unknown date, the patient experienced PRURITUS (Itching/  itching on fingers and toes), PALPITATIONS (palpitations), ABDOMINAL PAIN (Abdominal cramping), ERYTHEMA (erythema), PARAESTHESIA (tingling in lower legs and calves), PAIN (pain/ shooting pain), BLUE TOE SYNDROME (purplish toes), SKIN LESION (lesions, on fingers and toes) and PRODUCT DOSE OMISSION ISSUE (I was instructed by Moderna after the first vaccination to refrain from obtaining the second vaccine.). On 28-Apr-2021, WHEEZING (Wheezing/bronchospasm), MIGRAINE (Ocular Migraine) and URTICARIA (Welts (Blisters) on Toes and Fingers/itchy welt) had resolved, RESPIRATION ABNORMAL (Hevay lungs) outcome was unknown. On 24-May-2021, PERIPHERAL SWELLING (Swelling of fingers and toes) had resolved. At the time of the report, PRURITUS (Itching/  itching on fingers and toes), PALPITATIONS (palpitations), ABDOMINAL PAIN (Abdominal cramping), ERYTHEMA (erythema), PARAESTHESIA (tingling in lower legs and calves), PAIN (pain/ shooting pain), BLUE TOE SYNDROME (purplish toes) and SKIN LESION (lesions, on fingers and toes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I was instructed by Moderna after the first vaccination to refrain from obtaining the second vaccine.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (erythema) to be related and PRURITUS (Itching/  itching on fingers and toes) to be possibly related. No further causality assessments were provided for WHEEZING (Wheezing/bronchospasm), MIGRAINE (Ocular Migraine), URTICARIA (Welts (Blisters) on Toes and Fingers/itchy welt), RESPIRATION ABNORMAL (Hevay lungs), PERIPHERAL SWELLING (Swelling of fingers and toes), PALPITATIONS (palpitations), ABDOMINAL PAIN (Abdominal cramping), PARAESTHESIA (tingling in lower legs and calves), PAIN (pain/ shooting pain), BLUE TOE SYNDROME (purplish toes), SKIN LESION (lesions, on fingers and toes) and PRODUCT DOSE OMISSION ISSUE (I was instructed by Moderna after the first vaccination to refrain from obtaining the second vaccine.).    No concomitant medications were reported.  Treatment medications were unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-089344 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Patient medical history was reported. On 19-Jul-2021: Suspect dosing time, additional current condition, events: skin lesion and missed dose all were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089344: