Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chronic obstructive pulmonary disease, Cyst, Diabetes mellitus, Illness
Clinical narrative: CYST ON CHEST/FACE/SHOULDER; Fever; Chills; UTI; DIABETES; HAD TORN A LIGAMENT IN KNEE; Chronic obstructive pulmonary disease; SICK; COULD HARDLY GET OUT OF BED; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (DIABETES) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced DIABETES MELLITUS (DIABETES) (seriousness criterion medically significant), LIGAMENT RUPTURE (HAD TORN A LIGAMENT IN KNEE) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease). In August 2022, the patient experienced URINARY TRACT INFECTION (UTI). On an unknown date, the patient experienced ILLNESS (SICK), MOBILITY DECREASED (COULD HARDLY GET OUT OF BED), CYST (CYST ON CHEST/FACE/SHOULDER), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIABETES MELLITUS (DIABETES) was resolving, LIGAMENT RUPTURE (HAD TORN A LIGAMENT IN KNEE), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease), CYST (CYST ON CHEST/FACE/SHOULDER) and URINARY TRACT INFECTION (UTI) had not resolved and ILLNESS (SICK), MOBILITY DECREASED (COULD HARDLY GET OUT OF BED), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medication was reported Patient received an unspecified pill for diabetes and numbers had been normal every day since then. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE  020343  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Diabetes mellitus, in the context of the second dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2 doses of mRNA-1273 vaccine on unknown dates. The patient also had knee ligament tear, illness, decreased in mobility, chronic obstructive pulmonary disease, cysts on chest, face, and shoulder, urinary tract infection, fever and chills. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Diabetes mellitus was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Follow up received wherein new events were added.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Diabetes mellitus, in the context of the second dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2 doses of mRNA-1273 vaccine on unknown dates. The patient also had knee ligament tear, illness, decreased in mobility, chronic obstructive pulmonary disease, cysts on chest, face, and shoulder, urinary tract infection, fever and chills. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Diabetes mellitus was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.