Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Anaphylactic reaction; Hand blew up; Itching/pruritus generalized; Numbness; Hot skin; Feeling hot; swelling of hand and wrist up to elobow; Lymph nodes under the arm are twice the size; Chills; Arm is red/Redness/Hand is red; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A, 00A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CLL (CLL/ Remission).   On 29-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and PRURITUS (Itching/pruritus generalized). 28-Oct-2021, the patient experienced LIMB DISCOMFORT (Hand blew up), HYPOAESTHESIA (Numbness), SKIN WARM (Hot skin), FEELING HOT (Feeling hot), PERIPHERAL SWELLING (swelling of hand and wrist up to elobow), LYMPHADENOPATHY (Lymph nodes under the arm are twice the size), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm is red/Redness/Hand is red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ALEGRA) ongoing from 27-Oct-2021 for Adverse event, at a dose of 1 dosage form and BUDESONIDE (DESONID) (topical) ongoing from 28-Oct-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), LIMB DISCOMFORT (Hand blew up), PRURITUS (Itching/pruritus generalized), HYPOAESTHESIA (Numbness), SKIN WARM (Hot skin), FEELING HOT (Feeling hot), PERIPHERAL SWELLING (swelling of hand and wrist up to elobow), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm is red/Redness/Hand is red) had not resolved and LYMPHADENOPATHY (Lymph nodes under the arm are twice the size) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99 (High) 99.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction), PRURITUS (Itching/pruritus generalized), HYPOAESTHESIA (Numbness), SKIN WARM (Hot skin), FEELING HOT (Feeling hot), PERIPHERAL SWELLING (swelling of hand and wrist up to elobow), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm is red/Redness/Hand is red) to be possibly related. No further causality assessments were provided for LIMB DISCOMFORT (Hand blew up) and LYMPHADENOPATHY (Lymph nodes under the arm are twice the size).    Concomitant information was not provided.  Company comment: This case concerns a 67-year-old, male patient with medical history of Chronic lymphocytic leukaemia, who experienced the expected serious event of anaphylactic reaction together with other non-serious events. The event occurred approximately 1 day after the booster dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the event occurred after the third dose. Very limited information is provided regarding the event; clarification is requested. The medical history of Chronic lymphocytic leukaemia remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up received contains updated patient demographics, historical condition, lab data, treatment medication and events.; Sender's Comments: This case concerns a 67-year-old, male patient with medical history of Chronic lymphocytic leukaemia, who experienced the expected serious event of anaphylactic reaction together with other non-serious events. The event occurred approximately 1 day after the booster dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the event occurred after the third dose. Very limited information is provided regarding the event; clarification is requested. The medical history of Chronic lymphocytic leukaemia remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.