Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral coldness, Product administration error, Vaccination site pain
Clinical narrative: Hypochondriac; From shoulder to elbow has a little bit of nerve pain; she ripped band-Aid off ,a lot of dried blood on Band-Aid and she thinks maybe the nurse hit a; Half numb/could hardly feel her fingers; Sharp shooting pains going down arm below injection site; Headache on the left side of her head; Hypothermic; Sharp shooting pains going down arm/pain went up neck and down shoulder area; Arm got really heavy/arm felt like dead weight; Couldn't get fingers to move; Really cold/felt like she had been dipped in menthol; Cool feeling on hands and feet; Neurological issue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Hypothermic) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included MS, Brain lesion and Stroke. Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (Second dose) on 26-Jul-2021 and COVID-19 VACCINE NRVV AD26 (First dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 and COVID-19 VACCINE NRVV AD26. Concurrent medical conditions included Atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS), BECLOMETASONE DIPROPIONATE (QVAR), LORATADINE (CLARITIN [LORATADINE]), DILTIAZEM, GABAPENTIN, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), METHOCARBAMOL, SPIRONOLACTONE, NEBIVOLOL and TRAMADOL for an unknown indication.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced HYPOTHERMIA (Hypothermic) (seriousness criterion medically significant), PAIN (Sharp shooting pains going down arm/pain went up neck and down shoulder area), LIMB DISCOMFORT (Arm got really heavy/arm felt like dead weight), MOBILITY DECREASED (Couldn't get fingers to move), FEELING COLD (Really cold/felt like she had been dipped in menthol), PERIPHERAL COLDNESS (Cool feeling on hands and feet), NEUROLOGICAL SYMPTOM (Neurological issue), PRODUCT ADMINISTRATION ERROR (she ripped band-Aid off ,a lot of dried blood on Band-Aid and she thinks maybe the nurse hit a), HYPOAESTHESIA (Half numb/could hardly feel her fingers), VACCINATION SITE PAIN (Sharp shooting pains going down arm below injection site) and HEADACHE (Headache on the left side of her head). On 05-Jan-2022, the patient experienced NEURALGIA (From shoulder to elbow has a little bit of nerve pain). On an unknown date, the patient experienced ILLNESS ANXIETY DISORDER (Hypochondriac). On 04-Jan-2022, PRODUCT ADMINISTRATION ERROR (she ripped band-Aid off ,a lot of dried blood on Band-Aid and she thinks maybe the nurse hit a) had resolved. At the time of the report, HYPOTHERMIA (Hypothermic), PAIN (Sharp shooting pains going down arm/pain went up neck and down shoulder area), LIMB DISCOMFORT (Arm got really heavy/arm felt like dead weight), MOBILITY DECREASED (Couldn't get fingers to move), FEELING COLD (Really cold/felt like she had been dipped in menthol), PERIPHERAL COLDNESS (Cool feeling on hands and feet), NEUROLOGICAL SYMPTOM (Neurological issue), NEURALGIA (From shoulder to elbow has a little bit of nerve pain), ILLNESS ANXIETY DISORDER (Hypochondriac), HYPOAESTHESIA (Half numb/could hardly feel her fingers), VACCINATION SITE PAIN (Sharp shooting pains going down arm below injection site) and HEADACHE (Headache on the left side of her head) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, Body temperature: 98.7 to 96 (Low) Temperature went from 98.7 to 96 and was hypothermic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was hypothermic and it took her about and hour to get warmed up after she was given heated blankets.  Patient ended up going to the ER.  Company comment:This is a spontaneous case concerning a 53-year-old female patient with no relevant history provided, who experienced the serious unexpected event of Hypothermia(seriousness criterion medically significant) with other non serious events. Hypothermia occurred on the same day the patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine).It was reported that patient was hypothermic and it took her about and hour to get warmed up after she was given heated blankets. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  It was stated that patient was already on Claritin, gabapentin and tramadol and took all of those to help with the side effects   This case was linked to MOD-2022-440722 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 53-year-old female patient with no relevant history provided, who experienced the serious unexpected event of Hypothermia(seriousness criterion medically significant) with other non serious events. Hypothermia occurred on the same day the patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine).It was reported that patient was hypothermic and it took her about and hour to get warmed up after she was given heated blankets. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.