Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Malaise, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: infection was still there and not cleared up; felt unwell and experienced fatigue, tiredness, and joint aches in her toes and fingers.; Hives; joint aches in her toes and fingers; felt unwell and experienced fatigue, tiredness, and joint aches in her toes and fingers.; Hot Sensation; leg became red, swollen, and hot to the touch.; leg became red, swollen, and hot to the touch.; Cellulitis; Leg Pain; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced leg pain/pain in extremity, cellulitis, leg became red/erythema, swollen/peripheral swelling, and hot to the touch/feeling hot, felt unwell/malaise and experienced fatigue, tiredness, and joint aches in her toes and fingers/arthralgia, hives all over her body/urticaria, infection was still there and not cleared up/ infection.  The patient's medical history included thyroid disorder, cellulitis, and glaucoma.  Concomitant medications included levothyroxine, staten, eye drops, and acetylsalicylic acid.   on 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 19-FEB-2021, the patient noticed her leg hurt. She did not think too much of it and went to a clinic and received her first dose of the vaccine in her left arm that day. Later that evening, her leg became red, swollen, and hot to the touch. She stated that leg just blew up later that day. She was diagnosed with cellulitis and started to take Bactrim for the infection. On 25-Feb-2021, she felt unwell and experienced fatigue, tiredness, and joint aches in her toes and fingers. She woke up that night with hives all over her body that lasted for three days. However, she had no breathing issues. Her symptoms ultimately resolved on their own. This day was also her last dose of the Bactrim. On 01-Mar-2021, the infection was still there and not cleared up. She started to take a 10 day course of Doxycycline. On 11-Mar-2021, her leg infection was still not better and she started to take a 5 day course of Ciprofloxacin. On 19-Mar-2021, she cancelled her scheduled appointment to receive her second dose of the vaccine because she is not sure whether all the symptoms she experienced were from the antibiotics or the Moderna vaccine. She is afraid to get the second dose in fear that she will have a worse allergic reaction the second time around.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The events fatigue, tiredness, and joint aches in toes and fingers, and hives all over body were resolved on an unknown date.  The outcome of events leg pain, cellulitis, leg pain became red, swollen, and hot to the touch, hives leg just blew up later that day, cellulitis, felt unwell  infection was still there and not cleared up, not sure whether all the symptoms she experienced were from the antibiotics or the moderna vaccine, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Noting the history of cellulitis may remain as risk factors. There are no contact details, so no further information has been requested.