Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Renal function test, Somnolence, Urine output, Vaccination site erythema, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Reported feeling ill (ILLNESS), DEHYDRATION (She was feeling dehydrated (DEHYDRATION)), PALPITATIONS (Heart racing (PALPITATIONS)), NEURALGIA (Nerve pain (NEURALGIA)) and ABDOMINAL DISTENSION (Bloated and gassy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ASFOTASE ALFA (STRENSIQ) solution for injection for Hypophosphatasia and ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) for Vitamin D supplementation. The patient's past medical history included Pain in extremity and Surgery. Concurrent medical conditions included Drug allergy (Allergy to Benadryl), Drug allergy (Allergy to hydrocortisone) and Hypophosphatasia. On 23-Mar-2022, the patient ASFOTASE ALFA (STRENSIQ) (unknown route) dosage was changed to 80 microgram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, ASFOTASE ALFA (STRENSIQ) (unknown route) at an unspecified dose On an unknown date, ASFOTASE ALFA (STRENSIQ) (unknown route) dosage was changed to at an unspecified dose. and ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) (unknown route) 2000 international unit once a day. On an unknown date, the patient experienced ILLNESS (Reported feeling ill (ILLNESS), DEHYDRATION (She was feeling dehydrated (DEHYDRATION)), PALPITATIONS (Heart racing (PALPITATIONS)), NEURALGIA (Nerve pain (NEURALGIA)), ABDOMINAL DISTENSION (Bloated and gassy), DIARRHOEA (Developed bad diarrhea (DIARRHOEA)), PAIN (Pain), SOMNOLENCE (Drug makes her sleepy (Somnolence)/it makes her groggy), VACCINATION SITE REACTION (Injection site reaction on thigh and stomach, some mild skin reactions, injection in the incorrect area of her thigh, which caused a reaction and pain [Injection site reaction]), ARTHROPOD BITE (Removed a deer tick from the back of her neck), DRY SKIN (Skin feels a little bit dryer [Dry skin]), BENIGN BREAST NEOPLASM (Benign breast neoplasm), PAIN IN EXTREMITY (The patient reported she used to have extreme pain in her feet), CHILLS (Patient reported chills and a feeling of bones vibrating when laying down, perception of chills, continues to have intermittent chills), FATIGUE (FATIGUE), VACCINATION SITE ERYTHEMA (has minor redness (with shot 3 and 4), redness doubled in size to sites), VACCINATION SITE PAIN (injection in the incorrect area of her thigh, which caused a reaction and pain), INJECTION SITE URTICARIA (Welts (Injection site urticaria)) and INJECTION SITE PRURITUS (Itching to areas, slight itching (Injection site pruritus)). On 06-Jun-2022, PAIN (Pain) had resolved. At the time of the report, ILLNESS (Reported feeling ill (ILLNESS), DEHYDRATION (She was feeling dehydrated (DEHYDRATION)), PALPITATIONS (Heart racing (PALPITATIONS)), NEURALGIA (Nerve pain (NEURALGIA)), ABDOMINAL DISTENSION (Bloated and gassy), DIARRHOEA (Developed bad diarrhea (DIARRHOEA)), SOMNOLENCE (Drug makes her sleepy (Somnolence)/it makes her groggy), ARTHROPOD BITE (Removed a deer tick from the back of her neck), DRY SKIN (Skin feels a little bit dryer [Dry skin]), BENIGN BREAST NEOPLASM (Benign breast neoplasm) and FATIGUE (FATIGUE) outcome was unknown, VACCINATION SITE REACTION (Injection site reaction on thigh and stomach, some mild skin reactions, injection in the incorrect area of her thigh, which caused a reaction and pain [Injection site reaction]), VACCINATION SITE ERYTHEMA (has minor redness (with shot 3 and 4), redness doubled in size to sites), INJECTION SITE URTICARIA (Welts (Injection site urticaria)) and INJECTION SITE PRURITUS (Itching to areas, slight itching (Injection site pruritus)) had resolved and PAIN IN EXTREMITY (The patient reported she used to have extreme pain in her feet), CHILLS (Patient reported chills and a feeling of bones vibrating when laying down, perception of chills, continues to have intermittent chills) and VACCINATION SITE PAIN (injection in the incorrect area of her thigh, which caused a reaction and pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Renal function test: Abnormal. On an unknown date, Urine output: Increased. On an unknown date, Vitamin D: Decreased. No concomitant medication was reported. It was reported that the patient noticed with the 0.8 dosing, her redness doubled in size to sites, compared to the 0.44 dosing. The patient wanted to split her volume evenly between the syringes versus withdrawing 0.8mL from one of the 80mg/0.8mL vials and 0.44mL from the second 80mg/0.8mL vial. She wanted to withdraw 0.62ml from each of the two to get the same total daily dose. She reported that she felt it was easier to withdraw the medication this way and spoke with her doctor and she was okay with it. She also reported that during the first month she had skin reactions and redness from the reactions. She did not have any reactions the second month and reported that she does not even get a bump and so it was hard for her to even tell where she gave the injection. She also fluctuated on the days of the week she gives the injections, but she did it every other day and only for 3 days a week. She also reported taking vitamin D which makes her sleepy, her vitamin D levels were low, and was falling asleep before she was getting her dose of asfotase alfa on some nights. She reports sleeping very deeply and getting into REMS sleep. She also reported that she feels human again and was in less pain. The product complaint number included PR131136. No treatment medication was provided.