Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Head pressure between my ears; strange nose sensations where the cartilage joins the bone; 4 occasions of short earaches; weird pain that exists on the bridge of my nose; covid arm; some brain fog; Sore arm; I have not taken my second shot; Sometimes preventing me from going back to sleep; extreme fatigue; mild nausea/low grade nausea/feel like vomiting; chills; Covid Arm itchy; Covid Arm swelling; Covid Arm redness; soreness in left arm; headache; felt cold (temp 96F); active, trippy dreams/wild dreams; Wooziness; "awareness" of inner ears / strange ear sensation/ear pressure; longer time in deep sleep; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold (temp 96F)), PRODUCT DOSE OMISSION ISSUE (I have not taken my second shot), EAR DISCOMFORT ("awareness" of inner ears / strange ear sensation/ear pressure), SLEEP DISORDER (longer time in deep sleep) and INSOMNIA (Sometimes preventing me from going back to sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer (No prior medical history was reported.) in 2005, GERD in 2018, Osteopenia in 2015, Osteoporosis in 2015 and Overgrowth bacterial in 2017. Concomitant products included RISEDRONATE SODIUM (ACTONEL) for Osteoporosis, PRUCALOPRIDE SUCCINATE (MOTEGRITY) and MAGNESIUM OXIDE for Overgrowth bacterial, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VITAMIN D NOS for Vitamin D low.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING COLD (felt cold (temp 96F)), EAR DISCOMFORT ("awareness" of inner ears / strange ear sensation/ear pressure) and ABNORMAL DREAMS (active, trippy dreams/wild dreams). 20-Feb-2021, the patient experienced SLEEP DISORDER (longer time in deep sleep), DIZZINESS (Wooziness) and HEADACHE (headache). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Covid Arm itchy), VACCINATION SITE SWELLING (Covid Arm swelling), VACCINATION SITE ERYTHEMA (Covid Arm redness) and VACCINATION SITE PAIN (soreness in left arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I have not taken my second shot), INSOMNIA (Sometimes preventing me from going back to sleep), HEAD DISCOMFORT (Head pressure between my ears), NASAL DISCOMFORT (strange nose sensations where the cartilage joins the bone), EAR PAIN (4 occasions of short earaches), RHINALGIA (weird pain that exists on the bridge of my nose), VACCINATION COMPLICATION (covid arm), FEELING ABNORMAL (some brain fog), PAIN IN EXTREMITY (Sore arm), FATIGUE (extreme fatigue), NAUSEA (mild nausea/low grade nausea/feel like vomiting) and CHILLS (chills). The patient was treated with LORATADINE (CLARITINE) for Headache, at an unspecified dose and frequency. At the time of the report, FEELING COLD (felt cold (temp 96F)), PRODUCT DOSE OMISSION ISSUE (I have not taken my second shot), EAR DISCOMFORT ("awareness" of inner ears / strange ear sensation/ear pressure), SLEEP DISORDER (longer time in deep sleep), INSOMNIA (Sometimes preventing me from going back to sleep), ABNORMAL DREAMS (active, trippy dreams/wild dreams), HEAD DISCOMFORT (Head pressure between my ears), NASAL DISCOMFORT (strange nose sensations where the cartilage joins the bone), EAR PAIN (4 occasions of short earaches), VACCINATION COMPLICATION (covid arm), FEELING ABNORMAL (some brain fog), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Covid Arm itchy), VACCINATION SITE SWELLING (Covid Arm swelling), VACCINATION SITE ERYTHEMA (Covid Arm redness), VACCINATION SITE PAIN (soreness in left arm), FATIGUE (extreme fatigue), NAUSEA (mild nausea/low grade nausea/feel like vomiting) and CHILLS (chills) outcome was unknown and DIZZINESS (Wooziness), RHINALGIA (weird pain that exists on the bridge of my nose) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Antibody test: 244.3 (Positive) >0.8 is +ve. My result: 244.3. In May 2021, Antibody test: 3.74 (Positive) >1 is +ve. My result: 3.74. On 26-Jul-2021, Antibody test: 494.3 (Positive) >0.8 is +ve. My result: 494.3.     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.   MRI of brain did not show any issues.  Treatment medication includes Zyrtec and singulair combo for 42 days on Zyrtec and 32 days on singulair.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received: Medical history Thyroid cancer, GERD/REFLUX/LPR, Osteopenia and Osteoporosis were added. Lab test: Roche test and Siemens test were added. Concomitant medications include SYNTHROID, MOTEGRITY, MAGNESIUM OXIDE, VITAMIN D NOS, ACTONEL were added and Treatment medication CLARITINE was added. Events: Wooziness, Ear discomfort, Head pressure, Ear pain, Nasal discomfort, Insomnia, Nasal pain, Vaccination site pain, Headache, Fatigue extreme, Nausea, Vaccination site swelling, Vaccination site erythema, Vaccination site pruritus, Myalgia, Chills, Foggy feeling in head, Vaccination complication and I have not taken my second shot were added.