Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Insomnia, Oedema, Oropharyngeal discomfort, Paraesthesia
Clinical narrative: trouble falling asleep at times as my body would refuse to fall asleep; would feel a choking feeling; pitting in my ankle and part of arm by elbow; easily bruise now when i give blood, tender bruising on body; get sore easily and tender bruising; still not close to my normal self; indent in my forehead now looks like a wrinkle/crease; missed work numerous days; black and blue at the donating blood injection site; equilibrium off, dizzy, losing balances as patient closed eyes; equilibrium off, dizzy, losing balances as patient closed eyes/dizziness and lightheadedness; burning sensations unbearable pain in the back of the head with pressure nearly exploded/pain and burning and pressure felt like it was constant; bad headache; feeling of having stroke symptoms alike; burning sensation, pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm; pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm/tingling sensation come-and-go from the left arm and leg; Foggy feeling in head, felt off; losing focus, brain fog; sensation of the throat closing; light headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation, pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm), PARAESTHESIA (pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm/tingling sensation come-and-go from the left arm and leg), FEELING ABNORMAL (Foggy feeling in head, felt off), FEELING ABNORMAL (losing focus, brain fog) and OROPHARYNGEAL DISCOMFORT (sensation of the throat closing) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included ANA positive (History of positive ANA test) on 09-Jan-2019 and Blood donation (Patient has been donating blood on numerous occasions throughout the past two months) since an unknown date. Concurrent medical conditions included Hypothyroidism on 08-Jan-2015, Allergy (red dye), Anxiety, Cholesterolosis NOS and Sexual dysfunction. Concomitant products included ASA for Anticoagulant therapy, DIAZEPAM for Anxiety, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, TADALAFIL (CIALIS) from 12-Jan-2017 to an unknown date for Sexual dysfunction, LEVOTHYROXINE SODIUM (SYNTHROID) from 09-Jan-2015 to an unknown date for Thyroid disorder NOS, CALCIUM from 12-Jan-2018 to an unknown date, ZINC from 03-Jan-2020 to an unknown date, MAGNESIUM from 07-Jan-2020 to an unknown date and VITAMIN D NOS from 08-Jan-2018 to an unknown date for Vitamin supplementation.    On 25-Feb-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced BURNING SENSATION (burning sensation, pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm), PARAESTHESIA (pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm/tingling sensation come-and-go from the left arm and leg), FEELING ABNORMAL (Foggy feeling in head, felt off) and FEELING ABNORMAL (losing focus, brain fog). 02-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (sensation of the throat closing) and HEADACHE (light headache). On 23-Mar-2021, the patient experienced FEELING ABNORMAL (feeling of having stroke symptoms alike). On 26-Apr-2021, the patient experienced BALANCE DISORDER (equilibrium off, dizzy, losing balances as patient closed eyes), DIZZINESS (equilibrium off, dizzy, losing balances as patient closed eyes/dizziness and lightheadedness), BURNING SENSATION (burning sensations unbearable pain in the back of the head with pressure nearly exploded/pain and burning and pressure felt like it was constant) and HEADACHE (bad headache). On 27-Apr-2021, the patient experienced INJECTION SITE BRUISING (black and blue at the donating blood injection site). On an unknown date, the patient experienced INSOMNIA (trouble falling asleep at times as my body would refuse to fall asleep), CHOKING SENSATION (would feel a choking feeling), OEDEMA (pitting in my ankle and part of arm by elbow), CONTUSION (easily bruise now when i give blood, tender bruising on body), TENDERNESS (get sore easily and tender bruising), FEELING ABNORMAL (still not close to my normal self), SKIN DISORDER (indent in my forehead now looks like a wrinkle/crease) and IMPAIRED WORK ABILITY (missed work numerous days). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form as required; METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and GABAPENTIN ongoing since an unknown date for Adverse event, at a dose of 300 milligram at bedtime. At the time of the report, BURNING SENSATION (burning sensation, pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm), PARAESTHESIA (pinching needles from the left leg, thigh/up and down the leg, and then up to the left arm/tingling sensation come-and-go from the left arm and leg), FEELING ABNORMAL (Foggy feeling in head, felt off), FEELING ABNORMAL (losing focus, brain fog), OROPHARYNGEAL DISCOMFORT (sensation of the throat closing), BALANCE DISORDER (equilibrium off, dizzy, losing balances as patient closed eyes), DIZZINESS (equilibrium off, dizzy, losing balances as patient closed eyes/dizziness and lightheadedness), BURNING SENSATION (burning sensations unbearable pain in the back of the head with pressure nearly exploded/pain and burning and pressure felt like it was constant), HEADACHE (light headache) and HEADACHE (bad headache) had not resolved and INJECTION SITE BRUISING (black and blue at the donating blood injection site), FEELING ABNORMAL (feeling of having stroke symptoms alike), INSOMNIA (trouble falling asleep at times as my body would refuse to fall asleep), CHOKING SENSATION (would feel a choking feeling), OEDEMA (pitting in my ankle and part of arm by elbow), CONTUSION (easily bruise now when i give blood, tender bruising on body), TENDERNESS (get sore easily and tender bruising), FEELING ABNORMAL (still not close to my normal self), SKIN DISORDER (indent in my forehead now looks like a wrinkle/crease) and IMPAIRED WORK ABILITY (missed work numerous days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Computerised tomogram: clean (normal) clean.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 23Mar2021, the patient was seen in the Emergency Room with the feeling of having stroke symptoms. Testing was done but there was no known diagnosis and no medications were give. The patient was released the same night.   On 26Apr2021, the patient again went to the Emergency Room. A CT scan (location not specified) was completed and was clean according to the patient. It was noted by the patient that blood work was not completed when the patient was in the Emergency Room/Hospital. The patient stated that independent blood work was pending with a different healthcare provider.  Upon follow-up received on 02Jun2021, the patient noted that he has had extensive blood work done along with MRI's, a CT scan (noted above), doppler tests, a brachial ankle test, carotid and DVT ultrasounds. Specific dates and results of the aforementioned testing was not reported.  The patient also noted that he has been seen by neurology, cardiology, allergy and immunology as well as rheumatology all over the past three months. Results and findings from these evaluations were not reported. The patient stated that he did not take the second dose of the vaccine.  Upon follow up received on 22-Jul-2021 reporter stated that neuro issues had not gone away and as a matter of fact went away last week with daughter and it was borderline impossible at times. The dizziness and lightheadedness was present. The pain and burning and pressure felt like it was constant.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up included updated patient medical history, medications, updated event outcomes, new events, new treatment medication and information regarding consultations and clinical course. On 22-Jul-2021: Event verbatim was updated from 'equilibrium off, dizzy, losing balances as patient closed eyes'  to equilibrium off, dizzy, losing balances as patient closed eyes/dizziness and lightheadedness and from 'burning sensations unbearable pain in the back of the head with pressure nearly exploded' to burning sensations unbearable pain in the back of the head with pressure nearly exploded/pain and burning and pressure felt like it was constant. Reporter's comment regarding event outcome added. corresponding field and narrative was updated accordingly.