Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Palpitations, Paraesthesia, Pyrexia
Clinical narrative: Still has muscle twitching; legs feel pretty weird; Left arm feeling like it has been stung by a bee; Feeling icky; Left and right lower legs were twitching; Heart was racing while sitting down working/Heart rate was 102; Tingling sensation in her whole jaw up to her forehead; Upper half of her left arm is red; Left arm was tender at the injection site/Left arm where she received the shot is hurting; her jaw felt like it was locking; Anxiety that has been really bad, she can't function; Face tingling, left side a tingling sensation on left finger tips/Tingling in her jaw; "pins & needles" sensation in face; "feeling like ants crawling on face"; "not much" appetite; blood pressure was at 141/94 when the highest its been before is 130/84/ blood pressure was 166/112, 25-apr-2021 evening her blood pressure was elevated 150/95; palms are a bit sweaty; blood pressure was 166/112; heart was racing; Heart pounding really fast; pressure/tension on the head which was different from a headache; bad muscle/body aches; fatigued; bad headache/massive headache; Chills; Fever of of 101F/Temperature 99; muscle aches/body aches; Tension headache; little dizzy; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was racing while sitting down working/Heart rate was 102), TENSION HEADACHE (Tension headache), MUSCULAR WEAKNESS (bad muscle/body aches), PALPITATIONS (Heart pounding really fast) and HEAD DISCOMFORT (pressure/tension on the head which was different from a headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tamiflu (hives and throat swelling)) and Environmental allergy. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced TENSION HEADACHE (Tension headache), DIZZINESS (little dizzy), ARTHRALGIA (Joint pain), HEADACHE (bad headache/massive headache), CHILLS (Chills), PYREXIA (Fever of of 101F/Temperature 99) and MYALGIA (muscle aches/body aches).   On 17-Apr-2021, the patient experienced MUSCULAR WEAKNESS (bad muscle/body aches) and FATIGUE (fatigued). On 19-Apr-2021, the patient experienced PALPITATIONS (Heart pounding really fast) and HEAD DISCOMFORT (pressure/tension on the head which was different from a headache). On 20-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure was at 141/94 when the highest its been before is 130/84/ blood pressure was 166/112, 25-apr-2021 evening her blood pressure was elevated 150/95) and HEART RATE INCREASED (heart was racing). 20-Apr-2021, the patient experienced HYPERHIDROSIS (palms are a bit sweaty). 20-Apr-2021, the patient experienced HYPERTENSION (blood pressure was 166/112).    On 23-Apr-2021, the patient experienced PARAESTHESIA (Face tingling, left side a tingling sensation on left finger tips/Tingling in her jaw), FACIAL PAIN ("pins & needles" sensation in face), FORMICATION ("feeling like ants crawling on face") and DECREASED APPETITE ("not much" appetite). 23-Apr-2021, the patient experienced TRISMUS (her jaw felt like it was locking). 23-Apr-2021, the patient experienced ANXIETY (Anxiety that has been really bad, she can't function). On 17-May-2021, the patient experienced VACCINATION SITE PAIN (Left arm was tender at the injection site/Left arm where she received the shot is hurting). On 18-May-2021, the patient experienced PALPITATIONS (Heart was racing while sitting down working/Heart rate was 102), PARAESTHESIA (Tingling sensation in her whole jaw up to her forehead), FEELING ABNORMAL (Feeling icky), MUSCLE TWITCHING (Left and right lower legs were twitching) and VACCINATION SITE ERYTHEMA (Upper half of her left arm is red). On an unknown date, the patient experienced MUSCLE TWITCHING (Still has muscle twitching), LIMB DISCOMFORT (legs feel pretty weird) and PAIN (Left arm feeling like it has been stung by a bee). On 16-Apr-2021, DIZZINESS (little dizzy) and CHILLS (Chills) had resolved. On 18-Apr-2021, HEADACHE (bad headache/massive headache), PYREXIA (Fever of of 101F/Temperature 99) and MYALGIA (muscle aches/body aches) had resolved. At the time of the report, PALPITATIONS (Heart was racing while sitting down working/Heart rate was 102), MUSCULAR WEAKNESS (bad muscle/body aches), PALPITATIONS (Heart pounding really fast), HEAD DISCOMFORT (pressure/tension on the head which was different from a headache), HYPERHIDROSIS (palms are a bit sweaty), HEART RATE INCREASED (heart was racing), LIMB DISCOMFORT (legs feel pretty weird), TRISMUS (her jaw felt like it was locking), PARAESTHESIA (Tingling sensation in her whole jaw up to her forehead), PAIN (Left arm feeling like it has been stung by a bee), FEELING ABNORMAL (Feeling icky), MUSCLE TWITCHING (Left and right lower legs were twitching), ANXIETY (Anxiety that has been really bad, she can't function), ARTHRALGIA (Joint pain), FATIGUE (fatigued), VACCINATION SITE PAIN (Left arm was tender at the injection site/Left arm where she received the shot is hurting) and VACCINATION SITE ERYTHEMA (Upper half of her left arm is red) outcome was unknown, TENSION HEADACHE (Tension headache), PARAESTHESIA (Face tingling, left side a tingling sensation on left finger tips/Tingling in her jaw), FACIAL PAIN ("pins & needles" sensation in face), FORMICATION ("feeling like ants crawling on face") and DECREASED APPETITE ("not much" appetite) had not resolved, BLOOD PRESSURE INCREASED (blood pressure was at 141/94 when the highest its been before is 130/84/ blood pressure was 166/112, 25-apr-2021 evening her blood pressure was elevated 150/95) and HYPERTENSION (blood pressure was 166/112) was resolving and MUSCLE TWITCHING (Still has muscle twitching) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 101f (High) 101F and 99 99. On 20-Apr-2021, Blood pressure measurement: 166/112 (High) 166/112 and 141/94 (High) 141/94. On 20-Apr-2021, Chest X-ray: normal chest x-ray (normal) Patient's X-ray at the emergency room came back normal.. On 20-Apr-2021, Hepatic enzyme: elevated (High) Elevated. On 20-Apr-2021, Laboratory test: normal bloodwork (normal) Patient's bloodwork at the emergency room came back normal.. On 25-Apr-2021, Blood pressure measurement: 150/95 (High) 150/95. On 18-May-2021, Blood pressure measurement: 146/95 at the er (High) 146/95 at the ER. On 18-May-2021, Heart rate: 102 (High) 102. In 2021, Electrocardiogram: normal (normal) Normal.         Concomitant medication included diphenhydramine (BENADRYL) and zolpidem (AMBIEN). Treatment included acetaminophen (TYLENOL), ibuprofen (ADVIL). The patient had body aches, headache, and temperature of 99 for two days following her second dose of the vaccine. She visited the emergency room (ER) for the first time on 20-Apr-2021. The second visit to the ER was on 23-Apr-2021 for locked jaw and tightness, head pressure, elevated blood pressure, and a tingling sensation on her left finger tips. On 25apr2021, the evening her blood pressure was elevated 150/95. Her PCP has prescribed her as needed blood pressure medication. On 18-May-2021, the patient went back to the ER for the third time. The prior two weeks, she had been feeling great. The night of 17-May-2021, her left arm was tender at the injection site. The morning of 18-May-2021, she was feeling icky. Her left and right lower legs were twitching. Her heart was racing while sitting down working. Her heart rate was 102 in the ER. The patient also had a tingling sensation in her whole jaw up to her forehead. Her blood pressure was elevated (146/95) in the ER.  She stated her symptoms usually start with the left arm feeling like it has been stung by a bee, then the lower leg spasms start, then tingling in the jaw, heart racing and an increase in her blood pressure occur. This has been the pattern for all three times she has gone to the ER.   She reports experiencing anxiety that has been really bad lately which started about one week after receiving the second shot. She has good and bad days. When the anxiety is really bad, she can't function. She has never had panic attacks or anxiety in the past. Her left arm where she received the shot is hurting and the upper half of her left arm is red. It is tender right below the injection site. The patient has seen her HCP. He prescribed aspirin. She is scheduled to see a cardiologist on 20-May-2021.   This case was linked to MOD-2021-081704 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: On 21-Apr-2021: Additional events added which are GINGIVAL BLEEDING (gums started bleeding) (seriousness criterion medically significant as per source document), HYPERTENSION (blood pressure was 166/112), HEART RATE INCREASED (heart was racing), MUSCLE TWITCHING (still has muscle twitching) and LIMB DISCOMFORT (legs feel pretty weird). On 23-Apr-2021: Follow-up received on 23-apr-2021 includes : Patient's past medical history and prior vaccine history is updated. Event outcome is updated.   On 26-Apr-2021: Significant Follow-up received on 26-apr-2021 includes : Patient called in to add more information to her case AE update Lockjaw and jaw tightness. On 18-May-2021: Events of heart was racing while sitting down working, left arm tender at the injection site/left arm where she received the shot is hurting, upper half of her left arm is red, left arm feeling like it has been stung by a bee, feeling icky, left and right lower legs were twitching, anxiety that has been really bad were added. Event of muscle aches updated to muscle aches/body aches. Outcome updated for events muscle aches/body aches, bad headache/massive headache.Environmental allergy added to current conditions. Lab data added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.