Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Intentional product use issue, Migraine, Nausea, Neck pain
Clinical narrative: Migraine; Finding myself very depressed; Painful neck/Top part of my neck is very tender on my skull; Cant sleep well; Ear ache; ears are plugged, ringing/ears are plugged again and have ringing and crackling; Ears are plugged; I will not get the 2nd Vaccine/I am scheduled to have the 2nd Vaccine on the 26th. There is no way I will get.; Light hurts my eyes; Been going to bed early because so tired; My eyes hurt; Felt like my head was foggy, can't think really clear/floaty feeling; Vertigo; Could not stand up; Sky high blood pressure; Metallic test in mouth; Very dizzy/ so dizzy she could not walk/ severely dizzy/ stayed dizzy and light headed for the day; Woke up in the middle of the night to go to the bathroom and found I had no balance and I was severely dizzy/Dizziness after I rise to go to the bathroom or get up for other reasons; Balace off most of the day/Had no balance/no balance/Woke up very off balance; Nauseous/ felt nauseous probably from the dizziness; Headache; My arm was sore; Felt little sluggish for the day/still sluggish; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very dizzy/ so dizzy she could not walk/ severely dizzy/ stayed dizzy and light headed for the day), DIZZINESS POSTURAL (Woke up in the middle of the night to go to the bathroom and found I had no balance and I was severely dizzy/Dizziness after I rise to go to the bathroom or get up for other reasons), VERTIGO (Vertigo), DYSSTASIA (Could not stand up) and HYPERTENSION (Sky high blood pressure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore) and SLUGGISHNESS (Felt little sluggish for the day/still sluggish). On 01-Mar-2021, the patient experienced DIZZINESS (Very dizzy/ so dizzy she could not walk/ severely dizzy/ stayed dizzy and light headed for the day), DIZZINESS POSTURAL (Woke up in the middle of the night to go to the bathroom and found I had no balance and I was severely dizzy/Dizziness after I rise to go to the bathroom or get up for other reasons), BALANCE DISORDER (Balace off most of the day/Had no balance/no balance/Woke up very off balance), NAUSEA (Nauseous/ felt nauseous probably from the dizziness) and HEADACHE (Headache). On 02-Mar-2021, the patient experienced DYSGEUSIA (Metallic test in mouth). On 04-Mar-2021, the patient experienced VERTIGO (Vertigo), DYSSTASIA (Could not stand up) and HYPERTENSION (Sky high blood pressure). On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like my head was foggy, can't think really clear/floaty feeling). On 12-Mar-2021, the patient experienced EYE PAIN (My eyes hurt). On 13-Mar-2021, the patient experienced FATIGUE (Been going to bed early because so tired). On 15-Mar-2021, the patient experienced PHOTOPHOBIA (Light hurts my eyes). On 26-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (I will not get the 2nd Vaccine/I am scheduled to have the 2nd Vaccine on the 26th. There is no way I will get.). On 04-Apr-2021, the patient experienced EAR DISCOMFORT (Ears are plugged) and TINNITUS (ears are plugged, ringing/ears are plugged again and have ringing and crackling). On 06-Apr-2021, the patient experienced EAR PAIN (Ear ache) and INSOMNIA (Can't sleep well). On 07-Apr-2021, the patient experienced NECK PAIN (Painful neck/Top part of my neck is very tender on my skull). On 08-Apr-2021, the patient experienced MIGRAINE (Migraine) and DEPRESSION (Finding myself very depressed). The patient was treated with METOCLOPRAMIDE for Vertigo, at a dose of 25 milligram; HYDROCHLOROTHIAZIDE ongoing from 09-Apr-2021 for Blood pressure high, at a dose of 25 milligram once a day; DIMENHYDRINATE (DRAMAMINE) on 10-Apr-2021 for Dizziness, at an unspecified dose and frequency; MAGNESIUM on 10-Apr-2021 for Migraine, at a dose of 400 mg; VITAMIN B2 [RIBOFLAVIN] on 10-Apr-2021 for Migraine, at an unspecified dose and frequency; VITAMIN B12 NOS on 20-Apr-2021 at an unspecified dose and frequency; VITAMIN D NOS on 20-Apr-2021 at an unspecified dose and frequency; MECLIZINE [MECLOZINE] ongoing from 04-Mar-2021 for Vertigo, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 27-Feb-2021, PAIN IN EXTREMITY (My arm was sore) had resolved. On 26-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (I will not get the 2nd Vaccine/I am scheduled to have the 2nd Vaccine on the 26th. There is no way I will get.) had resolved. At the time of the report, DIZZINESS (Very dizzy/ so dizzy she could not walk/ severely dizzy/ stayed dizzy and light headed for the day) was resolving, DIZZINESS POSTURAL (Woke up in the middle of the night to go to the bathroom and found I had no balance and I was severely dizzy/Dizziness after I rise to go to the bathroom or get up for other reasons), VERTIGO (Vertigo), HYPERTENSION (Sky high blood pressure), FEELING ABNORMAL (Felt like my head was foggy, can't think really clear/floaty feeling), BALANCE DISORDER (Balance off most of the day/Had no balance/no balance/Woke up very off balance) and HEADACHE (Headache) had not resolved and DYSSTASIA (Could not stand up), EAR DISCOMFORT (Ears are plugged), DYSGEUSIA (Metallic test in mouth), SLUGGISHNESS (Felt little sluggish for the day/still sluggish), EYE PAIN (My eyes hurt), PHOTOPHOBIA (Light hurts my eyes), MIGRAINE (Migraine), TINNITUS (ears are plugged, ringing/ears are plugged again and have ringing and crackling), DEPRESSION (Finding myself very depressed), EAR PAIN (Ear ache), NECK PAIN (Painful neck/Top part of my neck is very tender on my skull), INSOMNIA (Cant sleep well), NAUSEA (Nauseous/ felt nauseous probably from the dizziness) and FATIGUE (Been going to bed early because so tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: high (High) High at ER. On 04-Mar-2021, Full blood count: normal (normal) normal limits; nothing clinically significant. On 09-Mar-2021, Blood pressure measurement: very high (High) Took blood pressure while in virtual appointment with MD. On 10-Mar-2021, Blood pressure measurement: high (High) Still a bit down but high. On 15-Mar-2021, Blood pressure measurement: 130-140s (normal) Down to 130 to 140s. On 17-Mar-2021, Blood pressure measurement: 130 (normal) Down in 130s. On 18-Mar-2021, Blood pressure measurement: perfect (normal) Blood pressure was perfect at Vascular department exam. On 18-Mar-2021, Ultrasound scan: unknown (normal) Normal, Vascular Department ruled out blood clots.. On 24-Mar-2021, Blood pressure measurement: up this morning (High) BP was up this morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  On 03-Mar-2021 the patient sought advice of a nurse due to the patient's symptoms of dizziness and issues with balance over the last few days. The nurse advised the patient that due to her age she should go to the Emergency Room (ER) to rule out a stoke.   On 04-Mar-2021 at 09:00, the patient presented to the ER where several tests were performed, all were unremarkable and ruled out stroke. The patient was diagnosed with Vertigo and prescribed treatment and was referred to a Cardiologist for a heart monitor. The patient was discharged at 18:00 with recommendation to follow-up with her Primary Care Provider (PCP).  On 23-Mar-2021, the patient had unspecified lab work done to check her kidneys. The results were reportedly provided on 06-Apr-2021 but no findings were provided by the reporter.  On 24-Mar-2021, due to her ear discomfort the patient tried the Epley exercise to see if crystals moved in her ear canal but it did not help to relieve her symptoms.   On 07-Apr-2021 the patient applied heat on her neck as treatment for her symptoms of neck pain.  On 08-Apr-2021 the patient presented to an Ear, Nose, and Throat (ENT) doctor for evaluation. Her examination was unremarkable, her ear canal was normal without signs of crystals or anything out of balance. The doctor suggested her symptoms were signs of Migraines, prescribed vitamin therapy and provided literature to help with treatment of her symptoms.  The patient has kept a journal since the onset of her symptoms began. She believes the adverse event(s) are most likely caused by mRNA-1273. Additional treatment for the events included Physical Therapy, alterations in diet, and occasional sleeping pills (NOS).  Returned the heart monitor to cardiologist department by 15:00 on 06-Mar-2021, results were normal, Electrocardiogram-normal limits; nothing clinically significant, Magnetic resonance imaging-normal limits; nothing clinically significant, no stroke.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initial additional On 13-Jul-2021: Initial additional, continued journal entries provided. On 27-Jul-2021: Follow up received: NNI.