Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Herpes zoster, Lethargy, Pain in extremity
Clinical narrative: diagnosed with shingles; still dealing with the pain/ pain was really severe. pain level was 5 to 6, then arc to 10, then come back down / pain going down arm, shoulder blade and down neck; reports started having really severe back pain that went down the arm and up the neck on left side in scapul; determined it was arthritis; lethargy; Went to ER due to shoulder pain; Patient took her blood pressure and it was 180/117; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (reports started having really severe back pain that went down the arm and up the neck on left side in scapul), ARTHRITIS (determined it was arthritis), HERPES ZOSTER (diagnosed with shingles), LETHARGY (lethargy) and ARTHRALGIA (Went to ER due to shoulder pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ovarian cancer from 1975 to 01-Aug-2020, Thyroid cancer (7 years later) on 01-Aug-2020, Skin cancer on 01-Aug-2020, Bone cancer on 01-Aug-2020, Colon cancer on 01-Aug-2020 and Bowel resection from 1920 to 01-Aug-2020. Concurrent medical conditions included Allergic reaction to analgesics (codeine allergy, throws up 20 minutes after taking.), Allergic reaction to analgesics (Demerol allergy, throws up 20 minutes after taking.), Thyroid disorder NOS, Diarrhea, Phantom pain, Glaucoma, Macular degeneration, Mood disorder NOS and Heartburn. Concomitant products included COLESEVELAM for Diarrhea, OMEPRAZOLE for Heartburn, SERTRALINE for Mood disorder NOS, GABAPENTIN for Phantom pain, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMINS [VITAMINS NOS], LATANOPROST and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced BACK PAIN (reports started having really severe back pain that went down the arm and up the neck on left side in scapul), ARTHRITIS (determined it was arthritis), LETHARGY (lethargy), ARTHRALGIA (Went to ER due to shoulder pain) and BLOOD PRESSURE INCREASED (Patient took her blood pressure and it was 180/117). On 05-May-2022, the patient experienced HERPES ZOSTER (diagnosed with shingles) and PAIN IN EXTREMITY (still dealing with the pain/ pain was really severe. pain level was 5 to 6, then arc to 10, then come back down / pain going down arm, shoulder blade and down neck). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) at a dose of 12 tablets three times a day; PARACETAMOL (TYLENOL) at a dose of 650 milligram, every 4 to 6 hours. and LOSARTAN on 07-May-2022 for Blood pressure increased, at a dose of 50 milligram. At the time of the report, BACK PAIN (reports started having really severe back pain that went down the arm and up the neck on left side in scapul), ARTHRITIS (determined it was arthritis), HERPES ZOSTER (diagnosed with shingles), LETHARGY (lethargy), ARTHRALGIA (Went to ER due to shoulder pain) and BLOOD PRESSURE INCREASED (Patient took her blood pressure and it was 180/117) outcome was unknown and PAIN IN EXTREMITY (still dealing with the pain/ pain was really severe. pain level was 5 to 6, then arc to 10, then come back down / pain going down arm, shoulder blade and down neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, Blood pressure measurement: 180/117 (High) 180/117. On 03-May-2022, Electrocardiogram: arthritis was determined arthritis was determined. On 03-May-2022, Heart rate: 98 (High) pulse was high (98 bpm). On 03-May-2022, X-ray limb: arthritis was determinedarthritis was determined arthritis was determined.         Other concomitant medications included align probiotic for unknown indication and AREDS 2 (unspecified) for glaucoma and macular degeneration.  Percocet 12 tablets was taken three times a day and was finished 2 days ago. The primary care doctor examined shoulder, back, and neck, and diagnosed the patient with shingles. Patient reports she was still dealing with the pain, but used up all narcotic. Patient has never been tested positive or diagnosed with COVID-19. It was unknown that Other vaccines given within 1 month prior to Moderna COVID-19 vaccine or not. There was no history of Myocarditis/pericarditis. Patient had a history of 5 different type of metastatic cancer.  Symptoms of chest pain, musculoskeletal chest pain, acute chest syndrome, chest discomfort, dyspnoea (Difficult labored breathing), dyspnoea at rest, dyspnoea exertional, palpitations, syncope (fainting from drop in BP), myocardial edema, cardiomyopathy, Painful respiration and angina pectoris was denied by the patient.  Company Comment: This is a spontaneous case concerning an 82-year-old female patient with medical condition of phantom pain, who experienced the unexpected non-serious adverse event of special interest, Arthritis and other non-serious events like Back Pain, Lethargy, Arthralgia, Pain in Extremity, and Herpes Zoster. As reported, 10 days after receiving the fourth dose of mRNA-1273 Vaccine the patient started having really severe back pain that went down the arm and up the neck on left side in scapula. Patient took her blood pressure, and it was 180/117. She then went to ER due to shoulder pain. X-ray of shoulder, lab works, and EKG was done and determined it was arthritis. Prescribed with Percocet for pain. Consult was done with a primary care doctor and was prescribed losartan for blood pressure. The primary care doctor also examined the patient and diagnosed the patient with shingles. Patient reports she is still dealing with the pain. The medical history of phantom pain remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 82-year-old female patient with medical condition of phantom pain, who experienced the unexpected non-serious adverse event of special interest, Arthritis and other non-serious events like Back Pain, Lethargy, Arthralgia, Pain in Extremity, and Herpes Zoster. As reported, 10 days after receiving the fourth dose of mRNA-1273 Vaccine the patient started having really severe back pain that went down the arm and up the neck on left side in scapula. Patient took her blood pressure, and it was 180/117. She then went to ER due to shoulder pain. X-ray of shoulder, lab works, and EKG was done and determined it was arthritis. Prescribed with Percocet for pain. Consult was done with a primary care doctor and was prescribed losartan for blood pressure. The primary care doctor also examined the patient and diagnosed the patient with shingles. Patient reports she is still dealing with the pain. The medical history of phantom pain remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.