Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site itching moderate; Injection site redness and warmth; Injection site swelling; Injection site redness; Unable to perform daily activities; Joint pains; Headache; Body ache/muscle and body aches; Nausea; Diarrhoea; Injection site pain; fatigue and tiredness; arm was sore; Low grade fever, 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily activities), DIARRHOEA (Diarrhoea), VACCINATION SITE PRURITUS (Injection site itching moderate) and VACCINATION SITE WARMTH (Injection site redness and warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sick sinus syndrome on 01-Jun-2017, Sleep apnea on 01-Jun-2000, Hypotension on 21-Dec-2000 and Congestive heart failure. Concurrent medical conditions included Multiple myeloma (newly diagnosed, not receiving any oncology treatment) on 19-Oct-2020, Drug allergy (Ceclor), Drug allergy (Codeine), Asthma on 02-Jan-1976, Neuropathy and Angina pectoris. Concomitant products included METOPROLOL SUCCINATE (TOPROL) from 01-Jan-2016 to an unknown date for Angina pectoris, RIVAROXABAN (XARELTO) from 01-Aug-2019 to an unknown date for Anticoagulant therapy, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) from 01-Oct-2018 to an unknown date for Bronchospasm, IVABRADINE HYDROCHLORIDE (CORLANOR) from 01-May-2018 to an unknown date for Congestive heart failure, GABAPENTIN (NEURONTIN) from 01-Jan-2019 to an unknown date for Neuropathy, APIXABAN (ELIQUIS) for an unknown indication.   On 03-Feb-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 9:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and PYREXIA (Low grade fever, 99.2 F). On 02-Mar-2021 at 3:28 PM, the patient experienced DIARRHOEA (Diarrhoea), VACCINATION SITE PAIN (Injection site pain) and NAUSEA (Nausea). 02-Mar-2021 at 3:28 PM, the patient experienced FATIGUE (fatigue and tiredness). On 03-Mar-2021, the patient experienced MYALGIA (Body ache/muscle and body aches). On 03-Mar-2021 at 5:45 PM, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily activities), VACCINATION SITE PRURITUS (Injection site itching moderate), VACCINATION SITE WARMTH (Injection site redness and warmth), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pains) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) (oral) from 03-Mar-2021 to 04-Mar-2021 at a dose of UNK dosage form, qd. On 05-Mar-2021, PAIN IN EXTREMITY (arm was sore), DIARRHOEA (Diarrhoea), PYREXIA (Low grade fever, 99.2 F), FATIGUE (fatigue and tiredness) and HEADACHE (Headache) had resolved. On 09-Mar-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily activities), VACCINATION SITE PRURITUS (Injection site itching moderate), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Injection site pain), MYALGIA (Body ache/muscle and body aches), NAUSEA (Nausea) and ARTHRALGIA (Joint pains) had resolved and VACCINATION SITE WARMTH (Injection site redness and warmth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.4 f low grade fever. On 03-Mar-2021, Body temperature: 99.2 f fever. On 04-Mar-2021, Body temperature: 98.9 f fever. On 24-Mar-2021, Blood test: (Negative) negative for antibodies..         Concomitant medications include unspecified steroids and inhaler.  Treatment details include Tylenol.  Action taken with mRNA-1273 in response to the events was not Applicable  Patient is in clinical trial IMPACT study through a cancer institute. Secondary endpoint is tracking antibody levels after COVID vaccine. Preliminary bloodwork requested by her clinical trial doctor for immune profiling for COVID vaccine antibody was done on 24/Mar/2021 at 9:07 AM, and her test results were negative for antibodies (Quest # MR797820R).   Patient's race was reported as Black. It was reported on 20-MAY-2021, that there was no other potential causes for the events.   This case was linked to MOD-2021-067328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18-MAY-2021, and included no new information On 20-May-2021: Follow up was received on 20-MAY-2021, and reporter details, patient demographics, relevant medical history, vaccine information, concomitant medications, additional events, severity and outcome of events, causality of events, were updated On 03-Jun-2021: No specific follow-up information recorded.