Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: night sweats; low grade fever, 101.8; muscle aches; chills; body ache; some mild redness; itchy red welt on injection site (L deltoid); soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), PAIN (body ache), VACCINATION SITE ERYTHEMA (some mild redness), VACCINATION SITE PRURITUS (itchy red welt on injection site (L deltoid)) and VACCINATION SITE PAIN (soreness at vaccination site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder (thyroid removed / medication) in May 2001, Thyroidectomy NOS in May 2001, Vaccination site erythema, Vaccination site swelling, Vaccination site pruritus and Vaccination site rash. Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Hypertension (controlled with medication) since June 2001, Environmental allergy, Allergy to surgical sutures and Drug allergy. Concomitant products included OLMESARTAN for Hypertension, CALCIUM (CALCIUM SUPPL) for Supplementation therapy, LEVOTHYROXINE SODIUM (LEVOXYL) for Thyroid disorder, VITAMIN D3 for Vitamin D low.   On 24-Dec-2020 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (some mild redness), VACCINATION SITE PRURITUS (itchy red welt on injection site (L deltoid)) and VACCINATION SITE PAIN (soreness at vaccination site). On 21-Jan-2021 at 5:30 PM, the patient experienced PAIN (body ache) and CHILLS (chills). On 21-Jan-2021 at 11:30 PM, the patient experienced PYREXIA (low grade fever, 101.8) and MYALGIA (muscle aches). On 24-Jan-2021, the patient experienced NIGHT SWEATS (night sweats). On 23-Jan-2021, PAIN (body ache), CHILLS (chills), PYREXIA (low grade fever, 101.8) and MYALGIA (muscle aches) had resolved. On 25-Jan-2021, VACCINATION SITE ERYTHEMA (some mild redness), VACCINATION SITE PRURITUS (itchy red welt on injection site (L deltoid)) and VACCINATION SITE PAIN (soreness at vaccination site) had resolved. On 27-Jan-2021, NIGHT SWEATS (night sweats) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101.8 (High) low grade fever, 101.8.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  1/21/21 received second injection 9AM. Had more sorenss at the injections site with this injection and some mild redness and itching which lasted until 1/25/21. Treated with hydrocortisone cream.  1/21/21 at 9:30 PM I started to get chills and body aches. By 11:30 PM had low grade fever, 101.8 with muscle aches and chills. Took acetaminophen every 4 hours until started feeling well on 1/23/21 at 9:30 AM.  1/24/21- started having night sweats which lasted about 3 days. Then subsided.  Company Comment: This spontaneous report refer to a 65 year old female consumer who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination.and describes the occurrence of non-serious events of IGHT SWEATS (night sweats), PAIN (body ache), VACCINATION SITE ERYTHEMA (some mild redness), VACCINATION SITE PRURITUS (itchy red welt on injection site (L deltoid) and VACCINATION SITE PAIN (soreness at vaccination site). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Was the adverse events most likely caused by mRNA-1273?: Yes   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: This spontaneous report refer to a 65 year old female consumer who received mRNA-1273 and experienced AEs  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This spontaneous report refer to a 65 year old female consumer who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination.and describes the occurrence of non-serious events of IGHT SWEATS (night sweats), PAIN (body ache), VACCINATION SITE ERYTHEMA (some mild redness), VACCINATION SITE PRURITUS (itchy red welt on injection site (L deltoid) and VACCINATION SITE PAIN (soreness at vaccination site). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.