Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Monoclonal B-cell lymphocytosis, Nausea, Oropharyngeal pain, Pain, Peripheral swelling
Clinical narrative: Inflammation; Nausea; Pain; patches of eczema; Had a terrible rash; fever; headache; very sore throat but but did not have signs of infectio in my throat. M; The area where I onc e had shingles when I was 23 became very itchy; Blood condition, MBL monoclonal B cell lymphocytosis, the low count type; Fatigue; Arm was swollen about double the size; hay fever/sneezing/itchy eyes; Allergies; This spontaneous case was reported by a consumer and describes the occurrence of MONOCLONAL B-CELL LYMPHOCYTOSIS (Blood condition, MBL monoclonal B cell lymphocytosis, the low count type), INFLAMMATION (Inflammation), NAUSEA (Nausea) and PAIN (Pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Itchy (when she was 23). Concurrent medical conditions included Drug allergy (Allergic to ibuprofen.) and Drug allergy. Concomitant products included CALCIUM for Bone disorder, VITAMIN D NOS for Bone disorder NOS, MULTIVITAMIN [VITAMINS NOS] and VITAMIN B COMPLEX for an unknown indication.   On 04-Feb-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 1:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLAMMATION (Inflammation) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and PAIN (Pain) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen about double the size) and FATIGUE (Fatigue). In April 2021, the patient experienced SEASONAL ALLERGY (hay fever/sneezing/itchy eyes). On an unknown date, the patient experienced MONOCLONAL B-CELL LYMPHOCYTOSIS (Blood condition, MBL monoclonal B cell lymphocytosis, the low count type) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (very sore throat but but did not have signs of infectio in my throat. M), PRURITUS (The area where I onc e had shingles when I was 23 became very itchy), ECZEMA (patches of eczema), HEADACHE (headache) and HYPERSENSITIVITY (Allergies). an unknown date, the patient experienced RASH (Had a terrible rash) and PYREXIA (fever). The patient was hospitalized on 14-May-2021 due to INFLAMMATION, NAUSEA and PAIN. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 02-Jul-2021, PERIPHERAL SWELLING (Arm was swollen about double the size), RASH (Had a terrible rash), PYREXIA (fever) and FATIGUE (Fatigue) had resolved. On 05-Dec-2021, INFLAMMATION (Inflammation), NAUSEA (Nausea) and PAIN (Pain) had resolved. At the time of the report, MONOCLONAL B-CELL LYMPHOCYTOSIS (Blood condition, MBL monoclonal B cell lymphocytosis, the low count type), OROPHARYNGEAL PAIN (very sore throat but but did not have signs of infectio in my throat. M), PRURITUS (The area where I onc e had shingles when I was 23 became very itchy), SEASONAL ALLERGY (hay fever/sneezing/itchy eyes), ECZEMA (patches of eczema) and HEADACHE (headache) outcome was unknown and HYPERSENSITIVITY (Allergies) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 15.8 (High) high around 15.8.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFLAMMATION (Inflammation), NAUSEA (Nausea), PAIN (Pain), PERIPHERAL SWELLING (Arm was swollen about double the size), RASH (Had a terrible rash), PYREXIA (fever) and FATIGUE (Fatigue) to be related. No further causality assessments were provided for MONOCLONAL B-CELL LYMPHOCYTOSIS (Blood condition, MBL monoclonal B cell lymphocytosis, the low count type), OROPHARYNGEAL PAIN (very sore throat but but did not have signs of infectio in my throat. M), PRURITUS (The area where I onc e had shingles when I was 23 became very itchy), SEASONAL ALLERGY (hay fever/sneezing/itchy eyes), ECZEMA (patches of eczema), HEADACHE (headache) and HYPERSENSITIVITY (Allergies).    Treatment information included heat and ice were noted. Patient cannot tolerate antiinflammatories and opiods.  Company comment: This case concerns an 80-year-old female patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of Monoclonal B-Cell lymphocytosis. The event occurred on an unknown date after receiving the second dose of mRNA-1273. Additionally, unexpected serious events of inflammation, pain and nausea were reported, on the same date after receiving the second dose of mRNA-1273. It is stated that the events led to hospitalization approximately one month after the apparition of the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events was considered serious as per the Important medical event list and due to hospitalization.   This case was linked to MOD-2021-404282, MOD-2021-404749.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Follow up received on 22-DEC-2021 which contains significant information, added additional events, Patient demographics,  medical history, dosage information, concomitants, treatment medications and narrative updated.; Sender's Comments: This case concerns an 80-year-old female patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of Monoclonal B-Cell lymphocytosis. The event occurred on an unknown date after receiving the second dose of mRNA-1273. Additionally, unexpected serious events of inflammation, pain and nausea were reported, on the same date after receiving the second dose of mRNA-1273. It is stated that the events led to hospitalization approximately one month after the apparition of the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events was considered serious as per the Important medical event list and due to hospitalization.