Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dysstasia, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Pain in knees and wrist feels like it is pulsating), INSOMNIA (Cant sleep because of pain), INFLAMMATION (inflammation), MUSCULOSKELETAL STIFFNESS (leg stiffening at night) and PAIN IN EXTREMITY (arms hands legs in pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced INFLAMMATION (inflammation), MUSCULOSKELETAL STIFFNESS (leg stiffening at night), PAIN IN EXTREMITY (arms hands legs in pain) and DYSSTASIA (difficult to get up). On 05-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (Extremely muscle pain in legs and knees / muscle pains/excruciating muscle pain). On an unknown date, the patient experienced MUSCLE TWITCHING (Pain in knees and wrist feels like it is pulsating), INSOMNIA (Cant sleep because of pain), DIARRHOEA (diarrhea) and ARTHRALGIA (Pain in knees and wrist/extreme joint pain). The patient was treated with IBUPROFEN at a dose of 200 milligram; IBUPROFEN at a dose of 800 milligram; HYDROCODONE at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE TWITCHING (Pain in knees and wrist feels like it is pulsating), INSOMNIA (Cant sleep because of pain) and DIARRHOEA (diarrhea) outcome was unknown and INFLAMMATION (inflammation), MUSCULOSKELETAL STIFFNESS (leg stiffening at night), PAIN IN EXTREMITY (arms hands legs in pain), DYSSTASIA (difficult to get up), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (Pain in knees and wrist/extreme joint pain) and MYALGIA (Extremely muscle pain in legs and knees / muscle pains/excruciating muscle pain) had not resolved. Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. This case was linked to MOD-2021-175593. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up added: Serious event of Paralysis and other non-serious events added. Outcome of events updated as per narrative. On 07-Jul-2021: Follow-up information received on 07-JUL-2021 contains No Significant Information.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.