Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hypertension, Mobility decreased
Clinical narrative: Pain switching and running all over the body/horrible pain from top of head to toes/especially in the joints, shoulders, knees, hands and jaw; Pain in jaw; everything was twitching; blood pressure was high; shaking; have to be in bed for half the day still; feeling cold; weakness; Head pain; Pain in all parts of the body/pain was traveling all over the body/mainly muscles; chills/I had chills; Knee pain/Joint pain/Shoulder pain; tenderness in my arm after about 10 hours; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain switching and running all over the body/horrible pain from top of head to toes/especially in the joints, shoulders, knees, hands and jaw), PAIN IN JAW (Pain in jaw), MUSCLE TWITCHING (everything was twitching), HYPERTENSION (blood pressure was high) and TREMOR (shaking) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no allergies to (medications, food and other products). Patient has never COVID + test or diagnosis.  Concurrent medical conditions included Arrhythmia (Irregular heartbeat), Heartburn and Blood pressure high. Concomitant products included CLONIDINE for Blood pressure high, PROPAFENONE for Heartbeats irregular.    On 25-Nov-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced PAIN (Pain switching and running all over the body/horrible pain from top of head to toes/especially in the joints, shoulders, knees, hands and jaw), PAIN IN JAW (Pain in jaw), MUSCLE TWITCHING (everything was twitching), HYPERTENSION (blood pressure was high), TREMOR (shaking), MOBILITY DECREASED (have to be in bed for half the day still), FEELING COLD (feeling cold), ASTHENIA (weakness), HEADACHE (Head pain), MYALGIA (Pain in all parts of the body/pain was traveling all over the body/mainly muscles), CHILLS (chills/I had chills), ARTHRALGIA (Knee pain/Joint pain/Shoulder pain), VACCINATION SITE PAIN (tenderness in my arm after about 10 hours) and FATIGUE (tiredness). At the time of the report, PAIN (Pain switching and running all over the body/horrible pain from top of head to toes/especially in the joints, shoulders, knees, hands and jaw), MUSCLE TWITCHING (everything was twitching), TREMOR (shaking), MYALGIA (Pain in all parts of the body/pain was traveling all over the body/mainly muscles), CHILLS (chills/I had chills) and VACCINATION SITE PAIN (tenderness in my arm after about 10 hours) had resolved, PAIN IN JAW (Pain in jaw), HYPERTENSION (blood pressure was high), MOBILITY DECREASED (have to be in bed for half the day still), FEELING COLD (feeling cold), HEADACHE (Head pain) and ARTHRALGIA (Knee pain/Joint pain/Shoulder pain) outcome was unknown and ASTHENIA (weakness) and FATIGUE (tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure was high. On an unknown date, Body temperature: temperature was borderline (she did not record a value)..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered PAIN (Pain switching and running all over the body/horrible pain from top of head to toes/especially in the joints, shoulders, knees, hands and jaw), PAIN IN JAW (Pain in jaw), MUSCLE TWITCHING (everything was twitching), HYPERTENSION (blood pressure was high), TREMOR (shaking), MOBILITY DECREASED (have to be in bed for half the day still), FEELING COLD (feeling cold), ASTHENIA (weakness), HEADACHE (Head pain), MYALGIA (Pain in all parts of the body/pain was traveling all over the body/mainly muscles), CHILLS (chills/I had chills), ARTHRALGIA (Knee pain/Joint pain/Shoulder pain), VACCINATION SITE PAIN (tenderness in my arm after about 10 hours) and FATIGUE (tiredness) to be related.    Patient received OTC medication as concomitant for heartburn. Around midnight, she started experiencing horrible pain which was a level 8 or 9. The pain was jumping to different parts of the body and she could feel it from the top of her head to her toes. It was travelling all over the body, mainly felt in the muscles and joints. The pain was not consistently at a high level, it would sometimes be a 3 or 5 but then it would jump to level 8 or 9. After a few hours, the pain level went down to 2/3 and then almost disappeared. She has to be in bed half the day even now. She says that she had to call an emergency line where she spoke with a nurse over the phone. The nurse directed her to check her vitals. Her blood pressure was high and her temperature was borderline (she did not record a value). She said that she had never experienced anything like this before.   Patient did not experienced a similar event in the past.  Treatment medication information was not provided by the reporter.   This case was linked to MOD-2022-679542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Nov-2022: Live Significant Follow-up appended: New events, narrative updated.