Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: pain has increased/feet hurt really bad, it's climbing up my legs; body just seems to have gone haywire; real sensitive to heat; thyroid hormone was out of control and registered high; blood pressure had gone up; rash on my arm and the lump; just felt like I had the flu; feet hurt really bad, it's climbing up my legs; was up 5-6 times per night; blisters on my arms/on my face; diabetes; neuropathy; lethargic and sluggish; fever; chills; Rash at the injection site; "Raised area below the rash." "It is tender."; Below the shot, Very hot to touch,warm to the touch; Red knot at the site of injection"Knot is bigger."; "Rash appeared about half inch to inch below the shot." itchy (knot); Rash/rash on my arm and the lump; Redness; Itching; Hot; Sore joints; Headache; perspiring; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (diabetes) and NEUROPATHY PERIPHERAL (neuropathy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Graves' disease since an unknown date. Previously administered products included for an unreported indication: radioactive iodine in 1995. Concurrent medical conditions included Autoimmune disorder and Temperature intolerance (been real sensitive to heat getting too close to the stove when the burners are on or going out in the sun). Concomitant products included THYROID (ARMOUR THYROID) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced HYPERHIDROSIS (perspiring) and HEADACHE (Headache). On 04-Feb-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Hot), RASH (Rash/rash on my arm and the lump) and ARTHRALGIA (Sore joints). On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Below the shot, Very hot to touch,warm to the touch), VACCINATION SITE INDURATION (Red knot at the site of injection"Knot is bigger."), VACCINATION SITE PRURITUS ("Rash appeared about half inch to inch below the shot." itchy (knot)), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN ("Raised area below the rash." "It is tender."). On an unknown date, the patient experienced DIABETES MELLITUS (diabetes) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), PAIN (pain has increased/feet hurt really bad, it's climbing up my legs), VACCINATION COMPLICATION (body just seems to have gone haywire), TEMPERATURE INTOLERANCE (real sensitive to heat), THYROID HORMONES INCREASED (thyroid hormone was out of control and registered high), HYPERTENSION (blood pressure had gone up), MASS (rash on my arm and the lump), INFLUENZA (just felt like I had the flu), PAIN IN EXTREMITY (feet hurt really bad, it's climbing up my legs), INSOMNIA (was up 5-6 times per night), BLISTER (blisters on my arms/on my face), LETHARGY (lethargic and sluggish), PYREXIA (fever) and CHILLS (chills). The patient was treated with METFORMIN for Sugar blood level increased, at a dose of 1 dosage form and VITAMIN D3 ongoing from July 2021 for Vitamin D deficiency, at a dose of 1 dosage form. At the time of the report, DIABETES MELLITUS (diabetes), NEUROPATHY PERIPHERAL (neuropathy), ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Hot), VACCINATION SITE WARMTH (Below the shot, Very hot to touch,warm to the touch), PAIN (pain has increased/feet hurt really bad, it's climbing up my legs), VACCINATION COMPLICATION (body just seems to have gone haywire), TEMPERATURE INTOLERANCE (real sensitive to heat), THYROID HORMONES INCREASED (thyroid hormone was out of control and registered high), HYPERTENSION (blood pressure had gone up), MASS (rash on my arm and the lump), INFLUENZA (just felt like I had the flu), PAIN IN EXTREMITY (feet hurt really bad, it's climbing up my legs), INSOMNIA (was up 5-6 times per night), BLISTER (blisters on my arms/on my face), HYPERHIDROSIS (perspiring), LETHARGY (lethargic and sluggish), RASH (Rash/rash on my arm and the lump), VACCINATION SITE INDURATION (Red knot at the site of injection"Knot is bigger."), VACCINATION SITE PRURITUS ("Rash appeared about half inch to inch below the shot." itchy (knot)), HEADACHE (Headache), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PAIN ("Raised area below the rash." "It is tender."), ARTHRALGIA (Sore joints), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Blood test: high (High) thyroid hormone was out of control and registered high.. On an unknown date, Blood glucose: 100 (Inconclusive) was always right around 100, or maybe 105, 109. On an unknown date, Blood pressure measurement: 179 (High) it was always right around 100, or maybe 105, 109, but it's gone up to 179.         The patient lost thyroid in 1996.  It was her body just overreacted to the shot in trying to produce the antibodies.  she had starting to sleep better but before she was up 5-6 times per night getting used to the increased urine flow from the metformin..  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.   This case was linked to MOD-2021-030982 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-JUN-2021 included reporters contact information, new events and onset date of events were updated. On 29-Jul-2021: Follow up received contains significant information- relevant medical history , laboratory data, concomitant and treatment medication and new events added. This case upgraded from non-serious to serious due to the addition of the events Neuropathy and Diabetes; Sender'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.