Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Cough, Fatigue, Malaise
Clinical narrative: had a dry cough/spasmodic type of cough/cough got worse; started having pain in the back; pain in the side of her chest; Then she found out she was positive for covid-19.; she started feeling worse; thought it was bronchospasm; she was tired; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (had a dry cough/spasmodic type of cough/cough got worse), BACK PAIN (started having pain in the back), CHEST PAIN (pain in the side of her chest), COVID-19 (Then she found out she was positive for covid-19.) and MALAISE (she started feeling worse) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COUGH (had a dry cough/spasmodic type of cough/cough got worse), BACK PAIN (started having pain in the back), CHEST PAIN (pain in the side of her chest), COVID-19 (Then she found out she was positive for covid-19.), MALAISE (she started feeling worse), BRONCHOSPASM (thought it was bronchospasm) and FATIGUE (she was tired). The patient was treated with CEPHALEXIN [CEFALEXIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (had a dry cough/spasmodic type of cough/cough got worse), BACK PAIN (started having pain in the back), CHEST PAIN (pain in the side of her chest), COVID-19 (Then she found out she was positive for covid-19.), MALAISE (she started feeling worse), BRONCHOSPASM (thought it was bronchospasm) and FATIGUE (she was tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood pressure measurement: high (High) blood pressure  high and low (Low) blood pressure Low.. In September 2021, Body temperature: 101 (High) 101 F. In September 2021, Chest X-ray: normal (normal) chest x-ray normal and normal (normal) chest x-ray normal. In September 2021, Oxygen saturation: 97 (normal) 97, 98 (normal) 98, 99 (normal) 99 and 100 (normal) 100. In September 2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications included blood pressure medication (Unspecified).  The patient went to the infusion center and got monoclonal antibodies. She immediately started to feel better. The next day, the patient had spasm so bad at one point she thought she was going to lose consciousness. She was given an inhaler with steroids. This opened up her chest. She was on the road to recovery. She also states that she was tired and had to rest if she did little things around the house.  Company Comment: This event concerns a 77 year old female with no relevant history who experienced the non-serious unlisted event of COVID-19 and Bronchospasm approximately 7+ months after the second dose of mRNA-1273. Re-challenge is unknown as no information is reported about the first dose. Benefit-risk relationship of mRNA-1273 is not affected by this report. The case was assessed as serious by unknown source; however, based on the test results of several normal oxygen levels and clear chest X-rays, lack of COVID-19 pneumonia and the minimal treatment required the events are considered non-serious per medical judgement.; Sender's Comments: This event concerns a 77 year old female with no relevant history who experienced the non-serious unlisted event of COVID-19 and Bronchospasm approximately 7+ months after the second dose of mRNA-1273. Re-challenge is unknown as no information is reported about the first dose. Benefit-risk relationship of mRNA-1273 is not affected by this report. The case was assessed as serious by unknown source; however, based on the test results of several normal oxygen levels and clear chest X-rays, lack of COVID-19 pneumonia and the minimal treatment required the events are considered non-serious per medical judgement.