Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep deficit, Vaccination site pain
Clinical narrative: Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night; Tenderness which is sometimes felt, sometime not felt , in the lymph nodes; Pain during the injection of the second dose; Body odor sweat, body odor being secreted from that one right arm; woke up soaking wet four times during the night/not sleeping; Pronounced aortic pulse; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night), SKIN ODOUR ABNORMAL (Body odor sweat, body odor being secreted from that one right arm), SLEEP DEFICIT (woke up soaking wet four times during the night/not sleeping), PULSE ABNORMAL (Pronounced aortic pulse) and LYMPH NODE PAIN (Tenderness which is sometimes felt, sometime not felt , in the lymph nodes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006H20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hot flashes and Pulse abnormalities (aortic pulse- few times over past years). Concurrent medical conditions included Fibromyalgia since 1991, Vulvodynia (vulvodynia, pelvic) since 2019, Pelvic floor dysfunction and Drug allergy (Seldane (terfenadine)). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) from an unknown date to 12-Apr-2021 for Pain, GABAPENTIN from an unknown date to 18-Apr-2021 for Pelvic pain, VITAMIN B12 NOS, VITAMIN D3, MAGNESIUM, MELATONIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 13-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain during the injection of the second dose). On 14-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night) and LYMPH NODE PAIN (Tenderness which is sometimes felt, sometime not felt , in the lymph nodes). In March 2021, the patient experienced SKIN ODOUR ABNORMAL (Body odor sweat, body odor being secreted from that one right arm), SLEEP DEFICIT (woke up soaking wet four times during the night/not sleeping) and PULSE ABNORMAL (Pronounced aortic pulse). On 13-Mar-2021, VACCINATION SITE PAIN (Pain during the injection of the second dose) had resolved. At the time of the report, NIGHT SWEATS (Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night), PULSE ABNORMAL (Pronounced aortic pulse) and LYMPH NODE PAIN (Tenderness which is sometimes felt, sometime not felt , in the lymph nodes) had not resolved and SKIN ODOUR ABNORMAL (Body odor sweat, body odor being secreted from that one right arm) and SLEEP DEFICIT (woke up soaking wet four times during the night/not sleeping) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: negative (Negative) Extensive blood work with negative results.         Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient had prolotherapy, a new therapy for a pre-existing condition. The patient took a Benadryl prior to the second dose's injection as per the advice of her HCP. The symptoms are still ongoing more than two months after receiving the second dose of mRNA-1273.   This case was linked to MOD-2021-022772 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient demographic details were updated, relevant medical history was added, concomitant product details were updated, event outcomes for night sweats, lymph node pain and pronounced aortic pulse was updated from unknown to not recovered/ not resolved.; Sender's Comments:  MOD-2021-022772:First Dose