Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Burning sensation, Cognitive disorder, Feeling abnormal, Injection site induration
Clinical narrative: hasn't felt all that good; feel achy; she has long covid; Her arm was sore at the injection site/tenderness; injection site It was a little hard; there was fresh blood there. She is 76, so she is not having a period; burning sensation; multiple myeloma; This spontaneous case was reported by a patient and describes the occurrence of PLASMA CELL MYELOMA (multiple myeloma) and UROGENITAL HAEMORRHAGE (there was fresh blood there. She is 76, so she is not having a period) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 13-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 15-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced BURNING SENSATION (burning sensation). In October 2023, the patient experienced PLASMA CELL MYELOMA (multiple myeloma) (seriousness criterion medically significant). On 16-Oct-2023, the patient experienced UROGENITAL HAEMORRHAGE (there was fresh blood there. She is 76, so she is not having a period) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (hasn't felt all that good), PAIN (feel achy), POST-ACUTE COVID-19 SYNDROME (she has long covid), INJECTION SITE PAIN (Her arm was sore at the injection site/tenderness) and INJECTION SITE INDURATION (injection site It was a little hard). At the time of the report, PLASMA CELL MYELOMA (multiple myeloma), UROGENITAL HAEMORRHAGE (there was fresh blood there. She is 76, so she is not having a period), BURNING SENSATION (burning sensation) and POST-ACUTE COVID-19 SYNDROME (she has long covid) had not resolved and FEELING ABNORMAL (hasn't felt all that good), PAIN (feel achy), INJECTION SITE PAIN (Her arm was sore at the injection site/tenderness) and INJECTION SITE INDURATION (injection site It was a little hard) outcome was unknown.            No concomitant medication was reported. The patient noticed a little burning sensation. On 16-Oct-2023 there was fresh blood there. Last week the patient was diagnosed with multiple myeloma. The patient will start chemo this week. The patient had not taken any drug over the counter or prescription drug yet. The patient also had long COVID and has no memory. It's been a year since the patient had COVID, but her processing skills and memory are gone. The patient also had site tenderness. The arm was sore at the injection site. It was a little hard. The patient did feel achy. Lately the patient hasn't felt all that good. The patient never had cancer and never had chemo.  Company comment: This spontaneous case concerns a 76-year-old, female patient with medical history of COVID 19, who experienced the unexpected serious (medically significant) events of plasma call myeloma and urogenital hemorrhage along with other non serious events. The events of plasma call myeloma and urogenital hemorrhage occurred approximately 2-3 days after the sixth dose of SPIKEVAX 2023-2024 PFS. As reported, the patient noticed a little burning sensation 2 days post 6th dose and was wondering if vaccine can cause urinary infection. on the following day there was fresh blood there, as reported. It was also reported that the prior week patient was diagnosed with multiple myeloma (unclear if before or after the 6th dose). The patient also reported she had long COVID and has no memory a year since the patient had COVID and described having site tenderness and being a little hard post vaccination and feeing achy. Based on provided information and considering nature of event, age as risk factor and non suggestive temporality the event of plasma cell myeloma is assessed as not related. Event of memory impairment is also assessed as not related as it can be attributed to long COVID and patient's advanced age. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745727:Same reporter, Different dose