Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Neoplasm malignant, Pyrexia
Clinical narrative: currently receiving cancer; Cellulitis and the area that has cellulitis is red; Heart rate up to 114; was in bed for 48 hours; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (currently receiving cancer) and CELLULITIS (Cellulitis and the area that has cellulitis is red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEART RATE INCREASED (Heart rate up to 114), BED REST (was in bed for 48 hours) and PYREXIA (Fever of 102F). On an unknown date, the patient experienced NEOPLASM MALIGNANT (currently receiving cancer) (seriousness criterion medically significant) and CELLULITIS (Cellulitis and the area that has cellulitis is red) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Heart rate increased, at an unspecified dose and frequency. At the time of the report, NEOPLASM MALIGNANT (currently receiving cancer) outcome was unknown, CELLULITIS (Cellulitis and the area that has cellulitis is red) had not resolved and HEART RATE INCREASED (Heart rate up to 114), BED REST (was in bed for 48 hours) and PYREXIA (Fever of 102F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 102 (High) 102 F. In March 2021, Heart rate: 114 (High) 114. In 2021, Antibody test: 800 800  September or October.         Concomitant medications were not reported  Either on 04-Feb-2021 or 08-Feb-2021: The patient received first dose of moderna vaccine. Either on 04-Mar-2021 or 08-Mar-2021: The patient received second dose of moderna vaccine. The patient experienced fever, heart rate of up to 114, was in bed for 48 hours. When the heart rate was increasing, she consulted her cardiologist who advised she take 2 Tylenols. The fever and heart rate got better. She went to go see her cardiologist, but as a general appointment 2 weeks after experiencing these. It was reported that she was not going to get the booster, because she was currently receiving cancer treatment. She tested for the antibody levels in September or October and it came out as 800. But then, Omicron came out and her doctor recommended that she get the booster shot. She was going to delay the shot until after the 3rd cancer treatment, but went for it anyways and got the shot only 33 days after the 2nd cancer treatment. She is also receiving IV treatment for cellulitis and the area that has cellulitis is red.   Company comment: This spontaneous case concerns a 74-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Neoplasm malignant and Cellulitis. The onset of the events occurred on an unknown date after the second dose of mRNA- 1273 vaccine. Very limited information is available regarding the Neoplasm malignant, other than the patient received cancer treatment after the second dose. Cellulitis occurred at an unknown date after the second dose, and the patient was receiving intravenous treatment at the time of the report, approximately 10 months after the second dose. No information was provided regarding the site of cellulitis and circumstances leading to the event. Cancer treatment might be a confounder for this event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-439924, MOD-2022-440019, MOD-2022-440131 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Neoplasm malignant and Cellulitis after mRNA- 1273 vaccine. The onset of the events occurred on an unknown date after the second dose of mRNA- 1273 vaccine. Very limited information is available regarding the diagnosis of Neoplasm malignant, other than the patient received cancer treatment after the second dose. Cellulitis occurred at an unknown date after the second dose, and the patient was receiving intravenous treatment at the time of the report, prior to the booster dose, approximately 10 months after the second dose. No information was provided regarding the site of cellulitis and circumstances leading to the event. Cancer treatment might be a confounder for this event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.