Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating); Vaccinated arm became itchy and painful; Vaccinated arm became itchy and painful; Nausea; Fatigue; Difficulty breathing; Felt as though one half of my body was being weighed down and dragging; Tightness in chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox (aged 4) and Arm fracture (23 years ago) in 1998. Previously administered products included for Arm fracture: Morphine (23 years ago; reportedly had rash and was treated with diphenydramine (BENADRYL).) in 1998. Past adverse reactions to the above products included Rash with Morphine. Concurrent medical conditions included Drug allergy (morphine-rash), Alcohol use (occasional) and Non-smoker.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing), DISCOMFORT (Felt as though one half of my body was being weighed down and dragging), CHEST DISCOMFORT (Tightness in chest), NAUSEA (Nausea) and FATIGUE (Fatigue). On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccinated arm became itchy and painful) and VACCINATION SITE PAIN (Vaccinated arm became itchy and painful). On 16-Mar-2021, the patient experienced HERPES ZOSTER (Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating)) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating)) was resolving, DYSPNOEA (Difficulty breathing), DISCOMFORT (Felt as though one half of my body was being weighed down and dragging), CHEST DISCOMFORT (Tightness in chest), VACCINATION SITE PRURITUS (Vaccinated arm became itchy and painful) and VACCINATION SITE PAIN (Vaccinated arm became itchy and painful) outcome was unknown and NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.            The patient reported no significant medical history. She reported immediately having difficulty breathing (also reported as 3 hours later). She noted a tightness in her chest and had to take her mask off. She rested at home but felt as though one half of her body was being weighed down and dragging with no other symptoms suggestive of a transient ischemic attack (TIA). On 15-MAR-2021, the vaccinated arm became extremely itchy and painful. On 16-MAR-2021, a small rash developed on her left arm. By the night of 17-MAR-2021, the patient realized that there was absolutely nothing normal about it and the rash had spread throughout the entire left arm, and the pain was excruciating and unbearable. There were tiny red pimples over the arm. The doctor said it followed "the nerve." No biopsy or specimen was obtained. The next morning, it was more intense. The inner forearm had pruritus which seemed like a bug bite. She saw a rash and went to the school nurse and was told it was in the vaccination spot. She covered it with a sock to apply pressure. On 18-MAR-2021, the patient went to the doctor and was diagnosed with shingles. Treatment medication included: valacyclovir started on 18-MAR-2021, naproxyn started on 18-MAR-2021, ondansetron for nausea prn, and nortriptyline until the rash resolved. Four days later, she was beginning to feel better with some rash resolution.  Company comment: This case concerns a 43-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected dyspnea, discomfort, chest discomfort, and expected nausea, fatigue, vaccination site pruritus, vaccination site pain. Latency within 3 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-111460 (E2B Linked Report). This case was linked to MOD-2021-110352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Events added; treatment details added; product dosage updated; medical history updated; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected dyspnea, discomfort, chest discomfort, and expected nausea, fatigue, vaccination site pruritus, vaccination site pain. Latency within 3 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-111460:Same reporter/different patient