Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cold-stimulus headache, Dysphonia, Ear, nose and throat examination, Headache
Clinical narrative: Soreness in each arm after each vaccine dose, lying on that particular arm; Headaches would develop into a migraine headache; Nerve shiver would run up to the crown of my head; Brain freeze on the crown of my head; It hurt; Started losing my voice, voice gets raspy when talking a lot; Fluid on my left ear; sometimes lean to the right because can't seem to get balance right; Headache in base of neck, excruciating headache, worst headache; Inflamed area over a nerve on left back of my throat; Developed vision problems, couldn't see very well; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in each arm after each vaccine dose, lying on that particular arm), MIGRAINE (Headaches would develop into a migraine headache), NEURALGIA (Nerve shiver would run up to the crown of my head), COLD-STIMULUS HEADACHE (Brain freeze on the crown of my head) and PAIN (It hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 008L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Dental treatment on 06-May-2021. Concurrent medical conditions included Migraine (which occur about 4 times a year). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3, ASPIRIN [ACETYLSALICYLIC ACID], GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]) and ZINC for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VISUAL IMPAIRMENT (Developed vision problems, couldn't see very well). On 09-Jun-2021, the patient experienced INFLAMMATION (Inflamed area over a nerve on left back of my throat). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in each arm after each vaccine dose, lying on that particular arm), MIGRAINE (Headaches would develop into a migraine headache), NEURALGIA (Nerve shiver would run up to the crown of my head), COLD-STIMULUS HEADACHE (Brain freeze on the crown of my head), PAIN (It hurt), DYSPHONIA (Started losing my voice, voice gets raspy when talking a lot), MIDDLE EAR EFFUSION (Fluid on my left ear), BALANCE DISORDER (sometimes lean to the right because can't seem to get balance right) and HEADACHE (Headache in base of neck, excruciating headache, worst headache). The patient was treated with PREDNISONE from 10-May-2021 to 23-May-2021 at a dose of 10 mg, 12 days; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in each arm after each vaccine dose, lying on that particular arm), MIGRAINE (Headaches would develop into a migraine headache), NEURALGIA (Nerve shiver would run up to the crown of my head), COLD-STIMULUS HEADACHE (Brain freeze on the crown of my head), PAIN (It hurt), DYSPHONIA (Started losing my voice, voice gets raspy when talking a lot), MIDDLE EAR EFFUSION (Fluid on my left ear), BALANCE DISORDER (sometimes lean to the right because can't seem to get balance right), VISUAL IMPAIRMENT (Developed vision problems, couldn't see very well), INFLAMMATION (Inflamed area over a nerve on left back of my throat) and HEADACHE (Headache in base of neck, excruciating headache, worst headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Ophthalmological examination: normal (normal) normal. On 03-May-2021, Magnetic resonance imaging: normal (normal) spine MRI. On 03-May-2021, Magnetic resonance imaging head: normal (normal) normal. On 11-May-2021, Bone scan: negative (Negative) Negative. On 18-May-2021, Blood test: normal (normal) normal. On 26-May-2021, Swallow study: negative (Negative) Negative. On 28-May-2021, Swallow study: negative (Negative) Negative. On 05-Jun-2021, Ear, nose and throat examination: inconclusive (Inconclusive) Fine on the right side of my throat, inflamed area over a nerve on left back of my throat; and tonsils were fine..         Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-222468 (Patient Link).