Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit increased, Headache, Heart rate increased, Hepatic enzyme abnormal, Hypersensitivity
Clinical narrative: migraine; hematocrit up; Sick as a dog for 24 hours; Slightly itchy; involuntary movement of my finger; rapid heart rate when I did anything strenuous; Covid 19; cold; Liver numbers were after chart/ALT: 273, AST: 246; Not feeling good; fatigue; Fever; muscle aches/Body ache; joint pain; headache; Felt like bladder infection; Hypersensitivity reaction characterized by hives, itching, irregular heartbeat, rash, diarrhea, abdominal cramping, and feeling hot; Did not sleep; Had to pee often; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME ABNORMAL (Liver numbers were after chart/ALT: 273, AST: 246), POLLAKIURIA (Had to pee often), ABDOMINAL PAIN UPPER (Stomach pain), MIGRAINE (migraine) and NASOPHARYNGITIS (cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gluten intolerance, Blood pressure high since 01-Mar-2010 and Hyperthyroidism since 01-Feb-2006. Concomitant products included HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDE (QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE) for Blood pressure high, OMEPRAZOLE for Heartburn, LEVOTHYROXINE for Thyroid disorder, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and VITAMIN D3 for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced POLLAKIURIA (Had to pee often), ABDOMINAL PAIN UPPER (Stomach pain), INSOMNIA (Did not sleep), CYSTITIS (Felt like bladder infection) and HYPERSENSITIVITY (Hypersensitivity reaction characterized by hives, itching, irregular heartbeat, rash, diarrhea, abdominal cramping, and feeling hot). On 28-Apr-2021, the patient experienced FATIGUE (fatigue), PYREXIA (Fever), MYALGIA (muscle aches/Body ache), ARTHRALGIA (joint pain) and HEADACHE (headache). On 07-May-2021, the patient experienced IMMUNISATION REACTION (Not feeling good). On 09-May-2021, the patient experienced HEPATIC ENZYME ABNORMAL (Liver numbers were after chart/ALT: 273, AST: 246) and NASOPHARYNGITIS (cold). On 05-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced MIGRAINE (migraine), HAEMATOCRIT INCREASED (hematocrit up), ILLNESS (Sick as a dog for 24 hours), PRURITUS (Slightly itchy), DYSKINESIA (involuntary movement of my finger) and HEART RATE INCREASED (rapid heart rate when I did anything strenuous). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 09-May-2021 to 13-May-2021 at a dose of PRN; IBUPROFEN (MOTRIN [IBUPROFEN]) (oral use) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) (oral use) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) from 09-May-2021 to 12-May-2021 at an unspecified dose and frequency. On 14-May-2021, PRURITUS (Slightly itchy) and HYPERSENSITIVITY (Hypersensitivity reaction characterized by hives, itching, irregular heartbeat, rash, diarrhea, abdominal cramping, and feeling hot) had resolved. At the time of the report, HEPATIC ENZYME ABNORMAL (Liver numbers were after chart/ALT: 273, AST: 246), POLLAKIURIA (Had to pee often), ABDOMINAL PAIN UPPER (Stomach pain), MIGRAINE (migraine), NASOPHARYNGITIS (cold), HAEMATOCRIT INCREASED (hematocrit up), ILLNESS (Sick as a dog for 24 hours), INSOMNIA (Did not sleep), COVID-19 (Covid 19), CYSTITIS (Felt like bladder infection), FATIGUE (fatigue), PYREXIA (Fever), MYALGIA (muscle aches/Body ache), ARTHRALGIA (joint pain), HEADACHE (headache), DYSKINESIA (involuntary movement of my finger) and HEART RATE INCREASED (rapid heart rate when I did anything strenuous) outcome was unknown and IMMUNISATION REACTION (Not feeling good) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 102. On 09-May-2021, Body temperature: 99.0. On 17-May-2021, Alanine aminotransferase: 72 IU/L. On 17-May-2021, Aspartate aminotransferase: 23 IU/L. On 17-May-2021, Blood alkaline phosphatase: 188 IU/L. On 17-May-2021, Red blood cell count: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   It was noted the patient experienced chills, severe body ache, urgency to urinate, upset stomach for 24 hours, then low fever on and off for two weeks.  Fever and rash from day 12 to 15.  Caller was almost 65 years old and got really sick from the second Moderna vaccine, full body rash and fever. patient got one booster the next time and was sick for 6 days on and off with fever and tired on and off. Almost 7 months ago around 07Apr2023 they got covid with a residual cough and was positive for 10 days. The booster was definitely better and they weren't as sick but they know it was a half dose. When she got their second shot, caller reports on Mother's day they got a full body rash and their liver numbers was 10 times higher than should be and did go back to normal. Fever on and off for 12 days and then rash with fever. It was super itchy, they gave her cream to put on.   Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2023: Significant follow-up received new event (Covid-19, itchy rash) added