Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia, Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: More than 36 days after the first dose without receiving the second dose; COVID; After it she felt tired; After it she felt tired and had a sore arm.; wheezing a little bit; hoarse voice; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing a little bit), DYSPHONIA (hoarse voice), COVID-19 (COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) and FATIGUE (After it she felt tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (COPD for many years since 39 years old). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ROFLUMILAST (DALIRESP) for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced WHEEZING (wheezing a little bit) and DYSPHONIA (hoarse voice). On 03-Aug-2021, the patient experienced FATIGUE (After it she felt tired) and MYALGIA (After it she felt tired and had a sore arm.). On 24-Aug-2021, the patient experienced COVID-19 (COVID). In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). At the time of the report, WHEEZING (wheezing a little bit), DYSPHONIA (hoarse voice), COVID-19 (COVID), FATIGUE (After it she felt tired) and MYALGIA (After it she felt tired and had a sore arm.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant contains- Emergency rescue inhaler when needed Treatment includes- Antibiotics and steroid. Patient reported- Due to her infection, she had to delay her appointment for the second dose of the vaccine and to this day, she hasn't got it yet,(22Sep2021). Patient mentioned  she had COPD, so her lung specialist treated her COVID infection with antibiotics and steroid when she started wheezing a little bit.; Sender's Comments: This case concerns a 61-year-old, female patient with relevant medical history of COPD, who experienced the unexpected event of COVID 19 along with other non-serious events. The patient also experienced inappropriate schedule of vaccine administered as the second dose was postponed due to the event. The event occurred approximately 21 days after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since event occurred after first dose and the second dose was not yet administered at the time of report. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.