Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Illness, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Sick, feeling sick, sick every day), VISUAL IMPAIRMENT (Vision problems, eye changes), FEELING ABNORMAL (Had several bad days off and on), DIZZINESS (Dizziness) and BURNING SENSATION (Felt like burning from inside out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Brain tumor operation (Brain Tumor removed) in January 2021. Concurrent medical conditions included Drug allergy (Lipitor (atorvastatin)), Drug allergy (Morphine), Penicillin allergy, Bee sting hypersensitivity, Hypothyroidism since 1990, Chronic kidney disease stage 3 since 12-Feb-2019, Hyperlipidemia since 31-May-2014, Heart disorder (Heart muscle disorder) since 24-Aug-2018 and Diabetes (Pre-diabetes) since 06-Nov-2018. Concomitant products included PRAVASTATIN from 2005 to an unknown date for Cholesterol high, LEVOTHYROXINE SODIUM (SYNTHROID) from 1990 to an unknown date for Hypothyroidism, ESTROGENS CONJUGATED (PREMARIN) for Hysterectomy, METHOCARBAMOL (ROBAXIN) from 04-Jan-2021 to an unknown date for Muscle spasm, GABAPENTIN (NEURONTIN) from 2019 to an unknown date for Nerve pain.   On 02-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ILLNESS (Sick, feeling sick, sick every day), VISUAL IMPAIRMENT (Vision problems, eye changes), FEELING ABNORMAL (Had several bad days off and on), DIZZINESS (Dizziness), MYALGIA (Horrible body aches), PYREXIA (Fever) and CHILLS (Chills). On 05-Feb-2021, the patient experienced BURNING SENSATION (Felt like burning from inside out), FEELING COLD (Freezing cold), DECREASED APPETITE (No appetite), NAUSEA (Nausea, Terrible Nausea) and FATIGUE (Extreme fatigue). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; HYDROMORPHONE HYDROCHLORIDE (DILAUDID) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick, feeling sick, sick every day), VISUAL IMPAIRMENT (Vision problems, eye changes), DIZZINESS (Dizziness), NAUSEA (Nausea, Terrible Nausea) and FATIGUE (Extreme fatigue) had not resolved, FEELING ABNORMAL (Had several bad days off and on), BURNING SENSATION (Felt like burning from inside out), FEELING COLD (Freezing cold), DECREASED APPETITE (No appetite), MYALGIA (Horrible body aches) and PYREXIA (Fever) outcome was unknown and CHILLS (Chills) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contact details added, patient demographics added, product details added, updated concomitant medications, two new events updated , treatment medications added. On 29-May-2021: New events; vision problems/eye changes and dizziness were added. The event outcome changed from unknown to not resolved. On 30-May-2021: Patient demographic details were updated, relevant medical history was updated, vaccine facility details were added, concomitant medication list was updated. On 01-Jun-2021: Event outcome for chills updated from unknown to recovered/resolved.