Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Diarrhoea, Erythema, Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: The redness was now moving lateral, close to under the arm/The redness moved more towards under side part of my arm/My arm was a deeper red ,it took 4 days for the redness to go away; very itchy/ It's Very pruritic.; there was redness / It's a very large red patch over injection site/ injection site was very red well below the deltoid area, off-center of my arm and to the right right/very red; injection site was painful, vaccine lingered in my arm for 5 days; nausea for 2 days; It wasn't injected correctly. She pinched my arm.Clearly, it was given subcutaneously/Received the second booster dose in a subcutaneous route instead of intramuscularly; It looked like cellulitis, develop a minor cellulitis, that it was prolong for 5 days/ localized cellulitis response; very warm/warm to touch/it was warm to touch; diarrhea for 2 days; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of CELLULITIS (It looked like cellulitis, develop a minor cellulitis, that it was prolong for 5 days/ localized cellulitis response) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 017F21A, 030L20A and 012L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to .25 milliliter. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Jul-2022, the patient experienced CELLULITIS (It looked like cellulitis, develop a minor cellulitis, that it was prolong for 5 days/ localized cellulitis response) (seriousness criterion medically significant), VACCINATION SITE WARMTH (very warm/warm to touch/it was warm to touch), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It wasn't injected correctly. She pinched my arm.Clearly, it was given subcutaneously/Received the second booster dose in a subcutaneous route instead of intramuscularly), DIARRHOEA (diarrhea for 2 days), VACCINATION SITE ERYTHEMA (there was redness / It's a very large red patch over injection site/ injection site was very red well below the deltoid area, off-center of my arm and to the right right/very red), VACCINATION SITE PAIN (injection site was painful, vaccine lingered in my arm for 5 days) and NAUSEA (nausea for 2 days). On 23-Jul-2022, the patient experienced VACCINATION SITE PRURITUS (very itchy/ It's Very pruritic.). On 24-Jul-2022, the patient experienced ERYTHEMA (The redness was now moving lateral, close to under the arm/The redness moved more towards under side part of my arm/My arm was a deeper red ,it took 4 days for the redness to go away). On 24-Jul-2022, DIARRHOEA (diarrhea for 2 days) and NAUSEA (nausea for 2 days) had resolved. On 25-Jul-2022, VACCINATION SITE ERYTHEMA (there was redness / It's a very large red patch over injection site/ injection site was very red well below the deltoid area, off-center of my arm and to the right right/very red) had resolved. At the time of the report, CELLULITIS (It looked like cellulitis, develop a minor cellulitis, that it was prolong for 5 days/ localized cellulitis response) had resolved with sequelae, VACCINATION SITE WARMTH (very warm/warm to touch/it was warm to touch), ERYTHEMA (The redness was now moving lateral, close to under the arm/The redness moved more towards under side part of my arm/My arm was a deeper red ,it took 4 days for the redness to go away), VACCINATION SITE PRURITUS (very itchy/ It's Very pruritic.) and VACCINATION SITE PAIN (injection site was painful, vaccine lingered in my arm for 5 days) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It wasn't injected correctly. She pinched my arm.Clearly, it was given subcutaneously/Received the second booster dose in a subcutaneous route instead of intramuscularly) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that, on 25-Jul-2022 the redness moved more towards under side part of my arm. On 26-Jul-2022: The demarcation was not as red. It was like a moving target and very pruritic. Patient had pictures. Patient never had this kind of reaction before. Patient mentioned she would like to be re vaccinated. No events had caused office visit, Urgent care, ER and hospitalization. Over all the symptoms had improved. Treatment details were not reported. Company comment: This spontaneous case concerns a 70-years-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Cellulitis among other non-serious events on same day after the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. It was reported that 3 days later the redness moved more towards under side part of my arm. Later with the demarcation was not as red. It was described as a moving target and very pruritic. Patient never had this kind of reaction before. The Concomitant medication, treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2022-614389 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Live Follow-up  received : No new information. On 28-Jul-2022: Live Follow-up received : Patient age added, Event outcome (Vaccination site erythema) updated On 28-Jul-2022: Follow-up received include : No new information; Sender's Comments: This spontaneous case concerns a 70-years-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Cellulitis among other non-serious events on same day after the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. It was reported that 3 days later the redness moved more towards under side part of my arm. Later with the demarcation was not as red. It was described as a moving target and very pruritic. Patient never had this kind of reaction before. The Concomitant medication, treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.