Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Hyperhidrosis
Clinical narrative: Wakes up all sweat; Feels the fingers numb both on hands and feet; Touble breathing, becoming more shallow and more rapid; Cough for a couple of days (on the 3th and 4th day); Also had diarrhea; extremities cold; Had violent chills couldn't stop shivering/the teeth were shattering; Constant pain in the muscles; Recurrent fever of 100.1°F; Arm sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm sore), HYPERHIDROSIS (Wakes up all sweat), HYPOAESTHESIA (Feels the fingers numb both on hands and feet), DYSPNOEA (Touble breathing, becoming more shallow and more rapid) and COUGH (Cough for a couple of days (on the 3th and 4th day)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE DR), MELATONIN (MELATONIN GUMMIES) and ZOLPIDEM for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 31-Jan-2021, the patient experienced PYREXIA (Recurrent fever of 100.1°F). On an unknown date, the patient experienced HYPERHIDROSIS (Wakes up all sweat), HYPOAESTHESIA (Feels the fingers numb both on hands and feet), DYSPNOEA (Touble breathing, becoming more shallow and more rapid), COUGH (Cough for a couple of days (on the 3th and 4th day)), DIARRHOEA (Also had diarrhea), PERIPHERAL COLDNESS (extremities cold), CHILLS (Had violent chills couldn't stop shivering/the teeth were shattering) and MYALGIA (Constant pain in the muscles). On 05-Jan-2021, PAIN IN EXTREMITY (Arm sore) had resolved. At the time of the report, HYPERHIDROSIS (Wakes up all sweat), HYPOAESTHESIA (Feels the fingers numb both on hands and feet), PERIPHERAL COLDNESS (extremities cold) and PYREXIA (Recurrent fever of 100.1°F) outcome was unknown and DYSPNOEA (Touble breathing, becoming more shallow and more rapid), COUGH (Cough for a couple of days (on the 3th and 4th day)), DIARRHOEA (Also had diarrhea), CHILLS (Had violent chills couldn't stop shivering/the teeth were shattering) and MYALGIA (Constant pain in the muscles) had resolved.            The patient received the Moderna COVID-19 Vaccine's first dose on it's right arm on 02 Jan 2021, and had no issues, just that the arm sore and it lasted 3 days. On 30 Jan 2021, the patient received the second dose of the Moderna COVID-19 Vaccine and on the after noon of the day after the symptoms started. The caller reported that the symptoms have been going ever since and include recurrent fever of 100.1°F, which the caller says it comes and goes several times a day, may be two to three times a day. Also that the patient wakes up all sweat and that feels the extremities cold. Patient feels the fingers numb, both on hands and feet. The patient also experienced trouble breathing and becoming more shallow and more rapid. Patient also experienced cough for a couple of days (on the 3th and 4th day), but the now it's only in the morning. On the days 3th and 4th the patient had violent chills, couldn't stop shivering and that it went up for hours. Also stated that the teeth were shattering and that the patient said chills but it was like for 8 hours, the reporter said it thought it was going to shock. The caller tried to keep it as warm as possible and reported that used lot of blankets and heat packs, and said that while it was holding it, it was still shivering and shaking. The patient also had diarrhea and that one of the symptoms that has from the beginning is constant pain in the muscles. Patient also used Tylenol, Ice pack and 600 mg Ibuprofen, which helped.  The action taken with mRNA-1273 was not applicable  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: 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.