Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wound complication
Clinical narrative: Feeling sick; Red and felt like it was on fire; Mosquito bites came back up again on left arm that caused the arm to be swollen; Mosquito bites came back up again on left arm that caused the arm to be swollen; Red and felt like it was on fire; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukaemia. Concomitant products included RITUXIMAB (RITUXAN) for Chronic lymphocytic leukaemia.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced WOUND COMPLICATION (Red and felt like it was on fire), PERIPHERAL SWELLING (Mosquito bites came back up again on left arm that caused the arm to be swollen), ARTHROPOD BITE (Mosquito bites came back up again on left arm that caused the arm to be swollen) and SKIN BURNING SENSATION (Red and felt like it was on fire). On 16-Sep-2021, the patient experienced MALAISE (Feeling sick) (seriousness criterion hospitalization). At the time of the report, MALAISE (Feeling sick) outcome was unknown and WOUND COMPLICATION (Red and felt like it was on fire), PERIPHERAL SWELLING (Mosquito bites came back up again on left arm that caused the arm to be swollen), ARTHROPOD BITE (Mosquito bites came back up again on left arm that caused the arm to be swollen) and SKIN BURNING SENSATION (Red and felt like it was on fire) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: white count went down.         The patient got some mosquito bites a while back it was swollen for a while but went down after the steroids.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns an elderly female patient aged 74 years with relevant medical history of Chronic lymphocytic leukaemia on RITUXAN, who experienced the unexpected, serious (Hospitalization) event of Malaise that occurred unspecified days after second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient was feeling sick had an allergic reaction to mosquito bite so was hospitalized. The Clinical course, Concomitant medication, investigations, treatment details were not available. Outcome of event was reported as unknown. The medical history remains a confounder to the event . The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-623566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up appended On 01-Nov-2021: Significant Follow Up Appended (Live FU) _ Event information, narrative description updated.; Sender's Comments: This spontaneous case concerns an elderly female patient aged 74 years with relevant medical history of Chronic lymphocytic leukaemia on RITUXAN, who experienced the unexpected, serious (Hospitalization) event of Malaise that occurred unspecified days after second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient was feeling sick had an allergic reaction to mosquito bite so was hospitalized. The Clinical course, Concomitant medication, investigations, treatment details were not available. Outcome of event was reported as unknown. The medical history remains a confounder to the event . The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.