Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 antibody test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red itchy rash at injection site; Red itchy rash at injection site/L injection site covering entire deltoid with rash; Flu-like symptoms; Joint pain; Red itchy rash at injection site; Fatigue and Tiredness; L injection site site warmth; Injection site pain; L injection site swelling; Nausea; Headache; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE WARMTH (L injection site site warmth), VACCINATION SITE PRURITUS (Red itchy rash at injection site) and VACCINATION SITE RASH (Red itchy rash at injection site/L injection site covering entire deltoid with rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since 02-Jan-1976, Multiple myeloma (Not receiving any oncology medical treatment - Newly diagnosed ) since 19-Oct-2020, Sick sinus syndrome since 01-Jun-2017, Sleep apnea since 01-Jun-2000, Hypotension since 31-Dec-2000, Neuropathy, Congestive heart failure, Drug allergy (Ceclor) and Drug allergy (Codeine). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 01-Jan-2016 to an unknown date for Anginal discomfort, 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) and METOPROLOL SUCCINATE (TOPROL) 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 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath) and HEADACHE (Headache). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (L injection site site warmth), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (L injection site swelling) and NAUSEA (Nausea). On 05-Feb-2021, the patient experienced FATIGUE (Fatigue and Tiredness). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red itchy rash at injection site). On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ARTHRALGIA (Joint pain). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Red itchy rash at injection site) and VACCINATION SITE RASH (Red itchy rash at injection site/L injection site covering entire deltoid with rash). The patient was treated with EPINEPHRINE (EPIPEN) 03-Feb-2021 for Shortness of breath, at a dose of 1 dosage form. On 03-Feb-2021, DYSPNOEA (Shortness of breath) had resolved. On 07-Feb-2021, VACCINATION SITE ERYTHEMA (Red itchy rash at injection site) and VACCINATION SITE PAIN (Injection site pain) had resolved. On 11-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. On 17-Feb-2021, VACCINATION SITE WARMTH (L injection site site warmth), VACCINATION SITE PRURITUS (Red itchy rash at injection site), VACCINATION SITE RASH (Red itchy rash at injection site/L injection site covering entire deltoid with rash) and VACCINATION SITE SWELLING (L injection site swelling) had resolved. At the time of the report, FATIGUE (Fatigue and Tiredness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative for antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains non-significant information. On 20-May-2021: Follow-up information received on 20-MAY-2021 contains significant information: Added patient demographics, relevant medical history (Allergies: Ceclor, Codeine; Current condition: Multiple myeloma, Sick sinus syndrome, Asthma, Sleep apnea, Hypotension), concomitant medications (Neurotin, Xarelto, Toprol XL, Corlanor, Xopenex nebulizer solution) with start date, strength, route and indication for use. New events "Shortness of breath", "Injection site pain", "Headache", "Injection site swelling", "Injection site warmth", "Nausea", "Fatigue", "Tiredness", "Joint pain" were added. The outcome of the events changed (from unknown to resolved). On 20-May-2021: Follow-up received on 20-MAY-2021 and does not contain any new information. On 20-May-2021: Follow-up received on 20-MAY-2021 and does not contain any new information. On 20-May-2021: Follow-up information received on 20-MAY-2021 contains significant information: Included start date and stop date of second dose adverse events. On 20-May-2021: Follow-up information received on 20-MAY-2021 contains significant information: On 09-FEB-2021, new event "Flu-like symptoms" was added which resolved on 11-FEB-2021. On 03-Jun-2021: Follow-up information received on 03-JUN-2021 contains significant information: On 21-MAY-2021 new laboratory tests were included.