Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Patient had a cellulitis it stayed in the arm will not go to any wear in her body; Patient had bacterial infection; In bed for 10 days; Fever; Bad swelling in the left arm, Arm swell up; Arm got very hot; This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (Patient had a cellulitis it stayed in the arm will not go to any wear in her body) and BACTERIAL INFECTION (Patient had bacterial infection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016822A, 013F21A, 006M20A and QFA2036) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (she is taking allergy pills). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Patient had a cellulitis it stayed in the arm will not go to any wear in her body) (seriousness criterion medically significant), BACTERIAL INFECTION (Patient had bacterial infection) (seriousness criterion medically significant), ILLNESS (In bed for 10 days), PYREXIA (Fever), VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) and VACCINATION SITE WARMTH (Arm got very hot). At the time of the report, CELLULITIS (Patient had a cellulitis it stayed in the arm will not go to any wear in her body), BACTERIAL INFECTION (Patient had bacterial infection), ILLNESS (In bed for 10 days), PYREXIA (Fever), VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) and VACCINATION SITE WARMTH (Arm got very hot) outcome was unknown.            Patient was not taking other medication except for allergy pills and aspirin once in a while.  Patient was scared to get her 2nd booster. patient had bacterial infection. Patient had a cellulitis it stayed in the arm will not go to any wear in her body. Now patient afraid to get the flu shot or any other vaccine.  No treatment medication was provided.  Company comment:  This is a spontaneous case concerning a 78-year-old female patient, with unspecified medical history of allergy (the patient reported taking allergy pills), who experienced the unexpected serious, medically significant events of cellulitis and bacterial infection, and non-serious events of illness (In bed for 10 days), pyrexia, vaccination site swelling and vaccination site warmth. All events occurred on unknown days after the administration of fourth (booster) dose of mRNA-1273. The patient's previous vaccination series included 2 doses of mRNA-1273 (primary series) and one booster dose of mRNA-1273 vaccine. Outcome of all events was unknown. The patient reported no side effects after the primary vaccination series, however, "similar side effects" were reported after the third and fourth dose of mRNA-1273. The patient was using aspirin (unknown dates, reported as "once in a while") and "allergy pills", without the specified allergy. The patient did not have COVID-19 test and had "no acute and chronic illnesses at the time of vaccination". No further relevant information was reported. The patient's advanced age (78) remains as a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-659196 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old female patient, with unspecified medical history of allergy (the patient reported taking allergy pills), who experienced the unexpected serious, medically significant events of cellulitis and bacterial infection, and non-serious events of illness (In bed for 10 days), pyrexia, vaccination site swelling and vaccination site warmth. All events occurred on unknown days after the administration of fourth (booster) dose of mRNA-1273. The patient's previous vaccination series included 2 doses of mRNA-1273 (primary series) and one booster dose of mRNA-1273 vaccine. Outcome of all events was unknown. The patient reported no side effects after the primary vaccination series, however, "similar side effects" were reported after the third and fourth dose of mRNA-1273. The patient was using aspirin (unknown dates, reported as "once in a while") and "allergy pills", without the specified allergy. The patient did not have COVID-19 test and had "no acute and chronic illnesses at the time of vaccination". No further relevant information was reported. The patient's advanced age (78) remains as a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.