Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Feeling cold, Hypoaesthesia
Clinical narrative: Tularemia; numbness and tingling on fingertips of both hands, extended to both legs and feet; numbness and tingling on fingertips of both hands, extended to both legs and feet; discomfort to be on her entire body; chills and coldness; chills and coldness; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TULARAEMIA (Tularemia) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rib fracture (fractured 3 ribs approximately 1 year ago). Concurrent medical conditions included Thyroid disorder, Depression and Hypertension. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), QUETIAPINE FUMARATE (SEROQUEL) and DIAZEPAM (VALIUM) for Depression, LISINOPRIL for Hypertension, HYDROCODONE and NAPROXEN SODIUM (ALEVE) for Pain, LEVOTHYROXINE for Thyroid disorder.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2021, the patient experienced HYPOAESTHESIA (numbness and tingling on fingertips of both hands, extended to both legs and feet), PARAESTHESIA (numbness and tingling on fingertips of both hands, extended to both legs and feet), DISCOMFORT (discomfort to be on her entire body), FEELING COLD (chills and coldness), CHILLS (chills and coldness) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced TULARAEMIA (Tularemia) (seriousness criterion medically significant). The patient was treated with CIPROFLOXACIN ongoing since an unknown date for Adverse event, at a dose of 500 mg twice a day and GABAPENTIN for Adverse event, at a dose of 300 mg twice a day. At the time of the report, TULARAEMIA (Tularemia), HYPOAESTHESIA (numbness and tingling on fingertips of both hands, extended to both legs and feet), PARAESTHESIA (numbness and tingling on fingertips of both hands, extended to both legs and feet), DISCOMFORT (discomfort to be on her entire body), FEELING COLD (chills and coldness), CHILLS (chills and coldness) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: normal (normal) Normal. On an unknown date, Magnetic resonance imaging neck: normal (normal) Normal. On an unknown date, Nerve conduction studies: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication Seroquel was prescribed for 100mg when necessary, but takes 25mg when necessary. Valium prescribed for 5mg when necessary, but takes 2.5mg when necessary.  Scan performed on of her lower abdomen to check on the adrenal function, result unknown. Patient started to experience numbness and tingling on fingertips of both hands 4 to 5 days after the second shot of the Moderna COVID 19 vaccine. The symptoms were on and off initially for a while before it becomes constant and extended to both legs and feet and  the discomfort to be on her entire body. A warm bath makes her feel better. She agrees that the sensation she experienced can be described as chills and coldness (but is an extension of the numbness and tingling. She mentioned that she now has to wear more; long sleeves in 70degF which was not her usual self  This is a Spontaneous case concerning a 58-year-old, female patient with medical history of depression, hypertension and thyroid disorder,  who experienced the unexpected serious (medically significant) event of Tularaemia and the non serious  unexpected events of paresthesia and hypoesthesia. The events occurred approximately 6 days after the second dose of mRNA 1273. MRI of neck and brain was performed along with nerve conduction studies which were normal.   The rechallenge is not applicable. The medical history of depression, hypertension and thyroid disorder are confounders for the events f paresthesia and hypoesthesia. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 58-year-old, female patient with medical history of depression, hypertension and thyroid disorder,  who experienced the unexpected serious (medically significant) event of Tularaemia and the non serious  unexpected events of paresthesia and hypoesthesia. The events occurred approximately 6 days after the second dose of mRNA 1273. MRI of neck and brain was performed along with nerve conduction studies which were normal.   The rechallenge is not applicable. The medical history of depression, hypertension and thyroid disorder are confounders for the events f paresthesia and hypoesthesia. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.