Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Ear discomfort, Feeling cold
Clinical narrative: ice cold body; shivering-chills; leg pain; back pain; head pain; injection site soreness; shoulder pain; flushing; cramping neck pain; red hot ears; A spontaneous report was received from a 92-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced flushing with red hot ears (ear discomfort), mild soreness at the injection site (vaccination site pain), right-sided cramping neck pain (muscle spasms) accompanied by shoulder pain (arthralgia )radiating to the head (headache), leg pain (pain in extremity), back pain, body became ice cold, chills and shivering (chills).  The patient's medical history, as provided by the reporter, included pulmonary fibrosis, sleep apnea, acid reflux and prostatitis. Concomitant medications reported included aciphex and ativan.   On 20 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient experienced immediate flushing with red hot ears which persisted throughout the day and mild soreness at the injection site lasting approximately 24 to 48 hours. He experienced two instances of right-sided cramping neck pain accompanied by shoulder pain radiating to the head, lasting 5 to 10 minutes per episode between 20 Jan 2021 and 04 Feb2 021. These episodes were brief and have not returned and awaking to both legs and his back "filled with pains" on 23 Jan 2021. The leg pains subsided upon standing; back pain lasted all day 23 Jan2 021. The patient felt normal from 24 Jan 2021 until 04 Feb 2021.   On 04 Feb 2021, the patient's whole body became ice cold at approximately 3PM. By 3:15PM he was experiencing chills and shivering that lasted approximately one hour. Patient called his physician, and was directed to the Emergency Room (ER) immediately. There he received blood tests and prophylactic broad spectrum antimicrobial therapy immediately upon admission. Patient reports that Infectious Disease confirmed there were two strains of bacteria present in his bloodstream. From the patient additional samples were collected for culture to tailor antimicrobial therapy accordingly. He also said he was hospitalized for six days and discharged on 10 Feb 2021 with at home Iintravenous (IV) infusion device to administer continuous (24 hour) antibiotic therapy for a full 14 days. He was released from the hospital to his daughter's care.  He had no history of significant adverse events or allergic reactions post vaccine administration. He is concerned about the origin of the infection, as no source could be confirmed per Infectious Disease. The patient is concerned the infection could have stemmed from the vaccine or it's administration. He attests that his physician wants him to proceed with his second dose of Moderna.  Action taken with mRNA-1273 in response to the events is unknown.   The events, flushing with red hot ears, mild soreness at the injection site, right-sided cramping neck pain accompanied by shoulder pain radiating to the head, leg pain, back pain, body became ice cold, chills and shivering were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.