Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Respiratory tract congestion, SARS-CoV-2 test, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: she breaths in deeply, there is a sensation of "water lag" in the lungs; tested positive for Covid; immediate itching on the injection site; persisted to become a swollen area; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid), RESPIRATORY TRACT CONGESTION (she breaths in deeply, there is a sensation of "water lag" in the lungs), VACCINATION SITE PRURITUS (immediate itching on the injection site) and VACCINATION SITE SWELLING (persisted to become a swollen area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22A, 012H21B, 045B21A and 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (allergy to sulfa) and Sunscreen sensitivity (some years back). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2022, the patient experienced VACCINATION SITE PRURITUS (immediate itching on the injection site) and VACCINATION SITE SWELLING (persisted to become a swollen area). On 14-Jul-2022, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (she breaths in deeply, there is a sensation of "water lag" in the lungs). At the time of the report, COVID-19 (tested positive for Covid) had resolved with sequelae and RESPIRATORY TRACT CONGESTION (she breaths in deeply, there is a sensation of "water lag" in the lungs), VACCINATION SITE PRURITUS (immediate itching on the injection site) and VACCINATION SITE SWELLING (persisted to become a swollen area) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications was reported. Medical history was not related to mentioned adverse event and both Acute and Chronic illnesses at the time of Vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The adverse event does not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient had not experienced a similar event in the past. Adverse event outcome was reported as residual cough from Covid. The symptoms had not improved or worsened. Patient reported that after she got 2nd booster dose of the Moderna Covid-19 vaccine, she immediately got itching on the injection site and this persisted to become a swollen area (3-4 inches long by 2 inches wide). That stayed like that (the swelling and itchiness) for a few days. The patient tested positive for Covid on 14Jul2022, the course was not that bad, fever for 4 days slight head cold and cough (she still had a little residue of cough and but has been improving), if she breaths in deeply, there was a sensation of water lag in the lungs. No treatment information was reported. Company comment: This spontaneous case concerns a female patient aged 67 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 (with a positive SARS-CoV-2 test) that occurred 22 days after second booster dose of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine at an interval of 28 days, first booster after 7 months followed by second booster after 7 months.. Patient had fever for 4 days, slight headache, cold and cough. She still has little residual of cough but is improving, On deep breath she can feel the sensation of congestion. No treatment details available. Outcome of the event Covid 19 was resolving with sequel at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non-serious) assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a female patient aged 67 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 (with a positive SARS-CoV-2 test) that occurred 22 days after second booster dose of mRNA-1273 vaccination. Patient had received initial two doses of same vaccine at an interval of 28 days, first booster after 7 months followed by second booster after 7 months. Patient had fever for 4 days, slight headache, cold and cough. She still has little residual of cough but is improving, On deep breath she can feel the sensation of congestion. No treatment details available. Outcome of the event Covid 19 was resolving with sequel at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non-serious) assessed as per medical judgement and available information.