Symptomtext
Hypersensitivity reaction; Redness/erythema; Flu like symptoms; Bronchospasm /wheezing; Bronchospasm /wheezing; chest tightness; Numbness; Feeling hot; Flushing; Diarrhea; Abdominal cramping; pain has increased/feet hurt really bad, it's climbing up my legs,; body just seems to have gone haywire; real sensitive to heat; blood pressure had gone up; was up 5-6 times per night,; blisters on my arms/on my face; Diabetes; rash/rash on my arm and the lump,; chills; fever; Red knot at the site of injection; warm to the touch; sore arm/feet hurt really bad, it's climbing up my legs,; sweating; Itching/Itching/pruritus/itchy((knot); pain at injection site; Rash at the injection site; headache; itching at the injection site; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS (Diabetes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Graves' disease in 1993 and Glaucoma in 1993. Concurrent medical conditions included Hypothyroidism (Slow heart rate, dry skin, hair loss, osteoarthritis, neuropathy, ongoing to date) since 1996, Hyperthyroidism (increased heart rate, optical protrusions, Graves Disease, glaucoma) since 1993, Hay fever, Hypertension (Increase, high blood pressure) since February 2021, Depression (Worse from February 2021 through June 20) since February 2021, Anxiety (Worse from February 2021 through June 2021) since February 2021, Neuropathy (increased pain in feet and legs, increased numbness), Diabetes (did not have before. Metformin,HCL-ER,500MG), Asthma, Allergy to plants (ronchitis, Asthma, interstitial pneumonia, Allergy shots for 7 year) since 1991 and Autoimmune disorder NOS. Concomitant products included ALPRAZOLAM for Anxiety, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, LOSARTAN and HCTZ for Hypertension, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Neuropathy. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm/feet hurt really bad, it's climbing up my legs,), PRURITUS (Itching/Itching/pruritus/itchy((knot)), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (Rash at the injection site) and HEADACHE (headache). On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE MASS (Red knot at the site of injection). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness/erythema), INFLUENZA LIKE ILLNESS (Flu like symptoms), WHEEZING (Bronchospasm /wheezing), BRONCHOSPASM (Bronchospasm /wheezing), CHEST DISCOMFORT (chest tightness), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), FLUSHING (Flushing), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), 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), BLOOD PRESSURE INCREASED (blood pressure had gone up), INSOMNIA (was up 5-6 times per night,), BLISTER (blisters on my arms/on my face), RASH (rash/rash on my arm and the lump,), CHILLS (chills) and PYREXIA (fever). The patient was treated with LORATADINE at an unspecified dose and frequency; THYROID (ARMOUR THYROID) at a dose of 90 mcg; FLUTICASONE PROPIONATE (FLOVENT HFA) at a dose of 110mcg; METFORMIN HCL for Adverse event, at a dose of 500 mg; VITAMIN D3 at a dose of 25 MCG (1000 UT) and LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, at a dose of 37.5 microgram. At the time of the report, DIABETES MELLITUS (Diabetes), 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), BLOOD PRESSURE INCREASED (blood pressure had gone up), INSOMNIA (was up 5-6 times per night,) and BLISTER (blisters on my arms/on my face) outcome was unknown, HYPERHIDROSIS (sweating), VACCINATION SITE WARMTH (warm to the touch), PAIN IN EXTREMITY (sore arm/feet hurt really bad, it's climbing up my legs,), VACCINATION SITE MASS (Red knot at the site of injection), PRURITUS (Itching/Itching/pruritus/itchy((knot)), VACCINATION SITE RASH (Rash at the injection site) and HEADACHE (headache) had not resolved and HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness/erythema), INFLUENZA LIKE ILLNESS (Flu like symptoms), WHEEZING (Bronchospasm /wheezing), BRONCHOSPASM (Bronchospasm /wheezing), CHEST DISCOMFORT (chest tightness), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), FLUSHING (Flushing), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash/rash on my arm and the lump,), CHILLS (chills), VACCINATION SITE PAIN (pain at injection site) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Blood thyroid stimulating hormone: registered high (High) showed that thyroid hormone was out of control and registered high. On 23-Jul-2021, Blood thyroid stimulating hormone: registered high (High) showed that thyroid hormone was out of control and registered high. On an unknown date, Blood glucose: blood sugar had been ok (Inconclusive) it was always right around 100, or maybe 105, 109, but it's gone up to 179. Past allergic reaction to vaccine included shingles with flu symptoms. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-039684 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional information received and added events and lab data On 29-Jul-2021: Follow up received included significant information as :concomitant, treatment, events was added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.