Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphoma, Pain in extremity
Clinical narrative: Sore arm; Headache; Diagnosed with lymphoma / cancer this year (February); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Diagnosed with lymphoma / cancer this year (February)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced LYMPHOMA (Diagnosed with lymphoma / cancer this year (February)) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) on 27-Feb-2021 at an unspecified dose and frequency. At the time of the report, LYMPHOMA (Diagnosed with lymphoma / cancer this year (February)), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Patient was diagnosed with lymphoma in perhaps in February 2021/ March 2021. patient was not sure of exact date. Company Comment : This spontaneous report concerns a 67 year old female patient with no relevant medical history who experienced a serious unexpected event of lymphoma. The event occurred unknown duration after the first or second dose of mRNA-1273. The patient additionally experienced non-serious events of pain in extremity and headache after both the doses. However, the outcome of the events after each dose is not reported. The benefit risk relationship of mRNA-1273 is not affected by this report. The event lymphoma was reported as non-serious, but was automatically upgraded as serious as per IME list. Based on the available information and as per medical judgement(considering the nature of the event), it was retained as serious.   This case was linked to MOD-2021-357784 (Patient Link).; Sender's Comments: This spontaneous report concerns a 67 year old female patient with no relevant medical history who experienced a serious unexpected event of lymphoma. The event occurred unknown duration after the first or second dose of mRNA-1273. The patient additionally experienced non-serious events of pain in extremity and headache after both the doses. However, the outcome of the events after each dose is not reported. The benefit risk relationship of mRNA-1273 is not affected by this report. The event lymphoma was reported as non-serious, but was automatically upgraded as serious as per IME list. Based on the available information and as per medical judgement(considering the nature of the event), it was retained as serious.