Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Spinal pain, Vaccination site pain
Clinical narrative: joint inflammation; cold/Flu-like symptoms/chills/slight fever/ severe head hold developed/sneezing/runny nose/blocked sinuses/body aches; Stiffness/joint stiffness/joint stiffness increased; bone pain; difficult to walk; Joint pain had moved into my ankles, knees, hips, wrists, shoulders and spine/joints continue to be very painful; soreness in arm shot location; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (joint inflammation), NASOPHARYNGITIS (cold/Flu-like symptoms/chills/slight fever/ severe head hold developed/sneezing/runny nose/blocked sinuses/body aches ), JOINT STIFFNESS (Stiffness/joint stiffness/joint stiffness increased), BONE PAIN (bone pain) and GAIT DISTURBANCE (difficult to walk) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (GC FLU [INFLUENZA VACCINE INACT SPLIT 4V]) for an unknown indication.    On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Nov-2022, the patient experienced ARTHRITIS (joint inflammation), NASOPHARYNGITIS (cold/Flu-like symptoms/chills/slight fever/ severe head hold developed/sneezing/runny nose/blocked sinuses/body aches ), JOINT STIFFNESS (Stiffness/joint stiffness/joint stiffness increased), BONE PAIN (bone pain), GAIT DISTURBANCE (difficult to walk), ARTHRALGIA (Joint pain had moved into my ankles, knees, hips, wrists, shoulders and spine/joints continue to be very painful) and VACCINATION SITE PAIN (soreness in arm shot location). The patient was treated with MELOXICAM at a dose of 15 milligram and PARACETAMOL (TYLENOL ARTHRITIS) at a dose of 650 milligram every 8-10 hours. At the time of the report, ARTHRITIS (joint inflammation), JOINT STIFFNESS (Stiffness/joint stiffness/joint stiffness increased), BONE PAIN (bone pain), GAIT DISTURBANCE (difficult to walk), ARTHRALGIA (Joint pain had moved into my ankles, knees, hips, wrists, shoulders and spine/joints continue to be very painful) and VACCINATION SITE PAIN (soreness in arm shot location) had not resolved and NASOPHARYNGITIS (cold/Flu-like symptoms/chills/slight fever/ severe head hold developed/sneezing/runny nose/blocked sinuses/body aches ) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient received moderna vaccine dose one on 04-Feb-2021 batch number 013M20A intramuscular route of administration, second dose on 03-Mar-2021 batch number 029A21A intramuscular route of administration, first booster dose on 01-Dec-2021 batch number 045J21A intramuscular route of administration. Second booster on 07-Apr-2022 batch number 002M21A intramuscular route of administration. Patient experienced mild flu-like symptoms and soreness in arm shot location all resolved in 2-days after all previous doses. It was unknown if the patient experienced any additional symptoms/events.  Company Comment: This spontaneous case concerns a 75-year-old, female patient with no medical history information reported who experienced the unexpected, non-serious, adverse event of special interest of Arthritis which occurred 3 days after receiving mRNA-1273.222 vaccine taken as fifth dose (third booster dose) of COVID-19 immunization series. The patient has received mRNA-1273 as first four doses of COVID-19 immunization with reported events of flu-like symptoms and vaccination site pain. The patient initially developed flu-like symptoms, chills and fever a few hours after receiving the booster and flu vaccinations. This was followed on subsequent days by head discomfort, sneezing, rhinorrhea, blocked sinuses and body pain. There was also joint stiffness which has worsened accompanied by bone and joint pains involving the ankles, knees, hips, wrist, shoulder, and spine. Physician consultation was done but no diagnosis was provided. She was prescribed with Meloxicam and Tylenol which afforded no relief of joint pains. Arthritis has not resolved at the time of report. Advanced age is a risk factor for arthritis. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to MOD-2022-687902 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old, female patient with no medical history information reported who experienced the unexpected, non-serious, adverse event of special interest of Arthritis which occurred 3 days after receiving mRNA-1273.222 vaccine taken as fifth dose (third booster dose) of COVID-19 immunization series. The patient has received mRNA-1273 as first four doses of COVID-19 immunization with reported events of flu-like symptoms and vaccination site pain. The patient initially developed flu-like symptoms, chills and fever a few hours after receiving the booster and flu vaccinations. This was followed on subsequent days by head discomfort, sneezing, rhinorrhea, blocked sinuses and body pain. There was also joint stiffness which has worsened accompanied by bone and joint pains involving the ankles, knees, hips, wrist, shoulder, and spine. Physician consultation was done but no diagnosis was provided. She was prescribed with Meloxicam and Tylenol which afforded no relief of joint pains. Arthritis has not resolved at the time of report. Advanced age is a risk factor for arthritis. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.