Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus disorder, Tremor, Urine abnormality
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Symptoms (Bad Sore Throat and HA, then Asthma)/COVID disease after 2nd primary dose), ASTHMA (Asthma got worst after 2nd primary dose/Increased Asthma medication frequency from PRN to twice a day after 2nd primary dose/worst Asthma 14 days after 2nd primary dose), BREAST PAIN (pain in right breast travel to left breast), SINUS CONGESTION (Sinus clogging) and DYSPNOEA (Difficulty Breathing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Family history included Diabetes, Blood pressure high and Heart disease, unspecified. Concurrent medical conditions included Hypothyroidism (takes Synthroid 75MCG, She did not take any other medications.) and Asthma. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BREAST PAIN (pain in right breast travel to left breast), SINUS CONGESTION (Sinus clogging), DYSPNOEA (Difficulty Breathing), PAIN IN EXTREMITY (pain traveled to toes), LYMPH NODE PAIN (pain in traveled to left lymph node), PYREXIA (Fever at nights (not measured)), ARTHRALGIA (Joint pain) and CHILLS (chills). On 18-Mar-2021, the patient experienced COVID-19 (COVID Symptoms (Bad Sore Throat and HA, then Asthma)/COVID disease after 2nd primary dose) and ASTHMA (Asthma got worst after 2nd primary dose/Increased Asthma medication frequency from PRN to twice a day after 2nd primary dose/worst Asthma 14 days after 2nd primary dose). On 20-Mar-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). On 09-Mar-2021, SINUS CONGESTION (Sinus clogging) and DYSPNOEA (Difficulty Breathing) had resolved. On 01-Apr-2021, COVID-19 (COVID Symptoms (Bad Sore Throat and HA, then Asthma)/COVID disease after 2nd primary dose) had resolved. In 2021, BREAST PAIN (pain in right breast travel to left breast), PAIN IN EXTREMITY (pain traveled to toes), LYMPH NODE PAIN (pain in traveled to left lymph node), PYREXIA (Fever at nights (not measured)), ARTHRALGIA (Joint pain) and CHILLS (chills) had resolved. At the time of the report, ASTHMA (Asthma got worst after 2nd primary dose/Increased Asthma medication frequency from PRN to twice a day after 2nd primary dose/worst Asthma 14 days after 2nd primary dose) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: (Positive) Positive. The patient had family history of diabetes, high blood pressure and heart disease but the patient did not have these medical conditions. It was reported that, 8-10 hours after vaccination the patient had pain in right breast traveled to left breast, then traveled to left lymph node then traveled to toes and Joint pain, fever at nights (not measured), chills, then sinus clogging and difficulty breathing. On 18-Mar-2021, the patient had COVID-19 symptoms (bad sore throat and headache, then asthma) and had PCR test positive on 20-Mar-2021. On 18-Apr-2021, the patient's asthma got worst and started using Albuterol at least twice a day (Prior to vaccination only used as needed once a year). The patient had not seen her doctor yet. Company comment: This is a spontaneous case concerning a 53 year-old, female patient with no relevant medical history, who experienced the non-serious unexpected, AESI of COVID-19, 14 days after the second dose of mRNA-1273 vaccine. The patient reported COVID-19 symptoms as sore throat and headache. The outcome of the event COVID-19 was reported as recovered. Patient didn´t have a medical consult and no treatment was reported. Additionally, drug ineffective was considered in the case since correct schedule of primary series with mRNA-1273 vaccine was reported (29-day interval). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 53 year-old, female patient with no relevant medical history, who experienced the non-serious unexpected, AESI of COVID-19, 14 days after the second dose of mRNA-1273 vaccine. The patient reported COVID-19 symptoms as sore throat and headache. The outcome of the event COVID-19 was reported as recovered. Patient didn´t have a medical consult and no treatment was reported. Additionally, drug ineffective was considered in the case since correct schedule of primary series with mRNA-1273 vaccine was reported (29-day interval). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.