Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: leg pain; Body aches that went berserk; A lot of internal gas, was very flatulent, couldn't stop belching; A lot of internal gas, was very flatulent, couldn't stop belching; He hasn't been able to sleep through the night; almost paralyzed from the pain, he couldn't move; right hip pain; Thought that his diverticulitis was acting up; Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe"; immediately had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Thought that his diverticulitis was acting up), BACK PAIN (Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe"), PAIN IN EXTREMITY (leg pain), ARTHRALGIA (right hip pain) and MYALGIA (Body aches that went berserk) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back disorder. Concurrent medical conditions included Diverticulitis. Concomitant products included DOXYCYCLINE for Diverticulitis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (immediately had a sore arm). On 27-Feb-2021, the patient experienced DIVERTICULITIS (Thought that his diverticulitis was acting up) (seriousness criterion medically significant), BACK PAIN (Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe") (seriousness criterion medically significant), ARTHRALGIA (right hip pain) (seriousness criterion medically significant), ERUCTATION (A lot of internal gas, was very flatulent, couldn't stop belching), FLATULENCE (A lot of internal gas, was very flatulent, couldn't stop belching), INSOMNIA (He hasn't been able to sleep through the night) and MOBILITY DECREASED (almost paralyzed from the pain, he couldn't move). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain) (seriousness criterion medically significant) and MYALGIA (Body aches that went berserk) (seriousness criterion medically significant). The patient was treated with TIZANIDINE at a dose of 1 dosage form; IBUPROFEN for Pain, at a dose of 1 dosage form and MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) at a dose of 1 dosage form. At the time of the report, DIVERTICULITIS (Thought that his diverticulitis was acting up), MYALGIA (Body aches that went berserk), ERUCTATION (A lot of internal gas, was very flatulent, couldn't stop belching), FLATULENCE (A lot of internal gas, was very flatulent, couldn't stop belching), INSOMNIA (He hasn't been able to sleep through the night), MOBILITY DECREASED (almost paralyzed from the pain, he couldn't move) and VACCINATION SITE PAIN (immediately had a sore arm) outcome was unknown and BACK PAIN (Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe"), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (right hip pain) had not resolved.            Patient reported that his blood type 0+ and he considered him self to have a really good immune system. Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: 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. events arthralgia, myalgia and back pain are consider serious as per medical judgement based on duration and refractory to treatment.   This case was linked to MOD-2021-248408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04 MAY 2021, added treatment medication, updated patient demographics and reporter email id. On 05-Jul-2021: Follow-up information received on 05 JUL 2021, added new event leg pain and changed outcome to not resolved for event back pain and hip pain.; 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. events arthralgia, myalgia and back pain are consider serious as per medical judgement based on duration and refractory to treatment.