Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Couldn't get a deep breath of oxygen for about 6 weeks; Welt was kind of white; Didn't feel well; Injection site was hard and raised; Developed a huge welt, that looked like a giant hive at the injection site and was the size of a silver dollar; Tired; Injection site itched horribly for about a week; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't get a deep breath of oxygen for about 6 weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSPNOEA (Couldn't get a deep breath of oxygen for about 6 weeks) (seriousness criterion medically significant), SKIN DISCOLOURATION (Welt was kind of white), MALAISE (Didn't feel well), VACCINATION SITE INDURATION (Injection site was hard and raised), VACCINATION SITE URTICARIA (Developed a huge welt, that looked like a giant hive at the injection site and was the size of a silver dollar), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Injection site itched horribly for about a week). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 25-Feb-2021, VACCINATION SITE INDURATION (Injection site was hard and raised) and VACCINATION SITE PRURITUS (Injection site itched horribly for about a week) had resolved. At the time of the report, DYSPNOEA (Couldn't get a deep breath of oxygen for about 6 weeks) had resolved and SKIN DISCOLOURATION (Welt was kind of white), MALAISE (Didn't feel well), VACCINATION SITE URTICARIA (Developed a huge welt, that looked like a giant hive at the injection site and was the size of a silver dollar) and FATIGUE (Tired) outcome was unknown.            Concomitant product use was not provided by the reporter.  Beginning 18-FEB-2021 she began having side effects. Patient developed a huge welt that looked like a giant hive at the injection site, and was the size of a silver dollar. She also stated the welt was kind of white. She stated that the injection site was hard and raised and itched horribly for about a week. She also didn't feel well and was tired. Patient further stated that she couldn't get a deep breath of oxygen for about 6 weeks. She stated that she has spoken to her doctor. Patient was now wondering if she should get the booster shot considering her side effects.  Treatment for the events included use of lots of water.  Company comment: This case concerns a 75-year-old female patient with no relevant medical history, who experienced the unexpected event of Dyspnea. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 75-year-old female patient with no relevant medical history, who experienced the unexpected event of Dyspnea. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.