Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tongue haemorrhage, Vaccination site rash, Vaccination site swelling, Vascular pain
Clinical narrative: Deep veins are hurting; Tongue was seeping blood; Rapid heartbeats; Feeling it travel through her body; Shooting pains down the legs like neuropathy; Rash at injection site; Sore and swollen lymph nodes; Blood spots on her hands; Diagnosed with cytokine storm; Like her "immune system is attacking things"; Stomach pains; Swollen arm at injection site; Sore arm; Low grade fever; Fatigue; A spontaneous report was received from a consumer who was also a 64-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, swollen arm at injection site, low grade fever, fatigue, feeling it travel through her body, stomach pains, sore and swollen lymph nodes, shooting pains down legs like neuropathy, a rash at injection site, blood spots on hands, diagnosed with cytokine storm, like her immune system is attacking things, tongue seeping blood, rapid heart beats and deep veins are hurting.  The patient's medical history, as provided by the reporter, included allergies to hydrocodone and metal nickel, knee replacement surgery, appendectomy, Sjogren's syndrome, and walks 4 to 6 miles daily. Concomitant medications reported included over the counter (OTC) supplements (not specified), cevimeline and linaclotide.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after the injection, the patient experienced "regular side effects" including a sore arm, swollen arm at injection site, low grade fever, and fatigue.  On 14 Jan 2021, the patient started experiencing "horrible side effects" including "feeling it travel through her body", stomach pains, sore and swollen lymph nodes, a worsened swollen arm at injection site, shooting pains down the legs like neuropathy, and a rash at the injection site. She also had blood spots on her hands the size of a dime or nickel which faded away (unknown resolution date) and stated it was like her "immune system is attacking things". She went to see her rheumatologist who diagnosed her with cytokine storm and prescribed prednisone to help with inflammation.   On 15 Jan 2021, the patient saw her general practitioner and underwent blood tests and x-rays (results were pending).  On the night of 28 Jan 2021, she reported tasting blood and found her tongue was seeping blood. She also reported the stomach pain had become severe, had rapid heart beats, and it was like her "deep veins are hurting". She contacted her rheumatologist again and made another appointment.  On 29 Jan 2021, the patient reported that blood was still seeping out of her tongue and all the events were ongoing and getting worse.   Action taken with mRNA-1273 in response to the events was not reported.   The events, sore arm, swollen arm at injection site, low grade fever, fatigue, feeling it travel through her body, stomach pains, sore and swollen lymph nodes, shooting pains down legs like neuropathy, a rash at injection site, diagnosed with cytokine storm, like her immune system is attacking things, tongue seeping blood, rapid heart beats and deep veins are hurting, were considered not resolved. The event, blood spots on hands, was resolved on an unknown date.; Reporter's Comments: This case concerns a 64-year-old female patient with medical history of Sjogren's syndrome, who received their first of two planned doses of mRNA-1273 (Lot 025L20A), and who experienced the serious unlisted event of cytokine storm, the non-serious unlisted events of feeling abnormal, abdominal pain, immune system disorder, petehiae, tongue haemorrhage, heart rate increased, vascular pain, pain, and pain in extremity, and non-serious listed events of low grade fever, fatigue, sore and swollen lymph nodes, swollen arm and rash at injection site.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded.