Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Weight decreased
Clinical narrative: I was so sick I needed to go to the hospital; lost a couple of pounds; pain, especially her back; pain all over body; Fever; chills; appetite was so-so; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (I was so sick I needed to go to the hospital), BACK PAIN (pain, especially her back), PAIN (pain all over body), PYREXIA (Fever) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer in 1998.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2020, the patient experienced DECREASED APPETITE (appetite was so-so). On 01-Mar-2021, the patient experienced CHILLS (chills) (seriousness criterion medically significant). On 09-Mar-2021, the patient experienced BACK PAIN (pain, especially her back) (seriousness criterion medically significant), PAIN (pain all over body) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 13-Mar-2021, the patient experienced MALAISE (I was so sick I needed to go to the hospital) (seriousness criterion medically significant) and WEIGHT DECREASED (lost a couple of pounds). On 13-Mar-2021, MALAISE (I was so sick I needed to go to the hospital) had resolved. At the time of the report, BACK PAIN (pain, especially her back), PAIN (pain all over body), PYREXIA (Fever), CHILLS (chills), DECREASED APPETITE (appetite was so-so) and WEIGHT DECREASED (lost a couple of pounds) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details included Ibuprofen, paracetamol and naproxen. 01Mar2021, the patient just had chills the next day.  On 09Mar2021,  a week later,  the patient experienced a fever, chills, pain all over her body, especially to her back.  Her appetite was so-so but she could smell and taste. On 10Mar2021, the patient went to the Urgent Care and a rapid COVID test was done and she had a flu test. The test resolute for COVID was negative and the flu test result was not provided.  On 12Mar2021, she called her family doctor and he refused to see her because she stated she had a fever. She said that her family doctor advised her that she might have COVID, she started cry on the phone because she remembered  how it felt to have a near death experience when she had cancer 23 years ago. On 13Mar2021 the patient went to the hospital because her symptoms wouldn't get better. She was in the Emergency Room (ER ) of the hospital for less than 24 hours and they tested her for COVID which was negative. She had lost a couple of pounds because she had been sick.  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.