Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Hypersomnia
Clinical narrative: sleeping a little bit longer; blood sugar began to rise/ blood sugar was upper 200s/ 3-4 days after was in upper 300s/ Been around 350 / every night was right around 350, but last night was 425; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a little bit longer) and BLOOD GLUCOSE INCREASED (blood sugar began to rise/ blood sugar was upper 200s/ 3-4 days after was in upper 300s/ Been around 350 / every night was right around 350, but last night was 425) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No previous Covid-19 infection.  The patient's past medical history included Disorder retinal. Previously administered products included for Drug use for unknown indication: Moderna COVID-19 Vaccine (1st dose, lot number 004M20A, vaccination site left arm) on 11-Feb-2021, Moderna COVID-19 Vaccine (2nd dose, lot number 023M20A, vaccination site left arm) on 12-Mar-2021, Moderna COVID-19 Vaccine (first Moderna Covid-19 vaccine booster dose, lot number 048C21A and vaccination site left arm) on 27-Oct-2021; for Product used for unknown indication: Shingles Vaccine. Past adverse reactions to the above products included No adverse event with Shingles Vaccine; and No adverse reaction with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Diabetes.    On 13-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Dec-2022, the patient experienced HYPERSOMNIA (sleeping a little bit longer) and BLOOD GLUCOSE INCREASED (blood sugar began to rise/ blood sugar was upper 200s/ 3-4 days after was in upper 300s/ Been around 350 / every night was right around 350, but last night was 425). At the time of the report, HYPERSOMNIA (sleeping a little bit longer) and BLOOD GLUCOSE INCREASED (blood sugar began to rise/ blood sugar was upper 200s/ 3-4 days after was in upper 300s/ Been around 350 / every night was right around 350, but last night was 425) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: blood sugar began to rise/ Daily low point was 104, and 140 later on. Higher in the morning. 2-3 days after her blood sugar was upper 200s. 3-4 days after was in upper 300s. Been around 350 around the 15-16th of December/ blood sugar every night was right around 350, but last night was 425.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient's blood sugar began to rise the day after receiving the most recent dose of the vaccine. She had been controlling her blood sugar with diet and exercise up to that point. Daily low point was 104, and 140 later on. Higher in the morning. 2-3 days after her blood sugar was upper 200s. 3-4 days after was in upper 300s. Been around 350 around the 15-16th of December. Her blood sugar every night was right around 350, but last night was 425. She had not been taking any medication. Her diet has been constant. She had been taking supplements which up until now have been effective including Curalin. She had not had any other symptoms of high blood sugar like exhaustion. She had been sleeping a little bit longer. No nerve pain. She did not have any prior issues with her blood sugar throughout prior doses.  Company comment-This spontaneous case concerns an elderly female patient aged 71 years with medical history of diabetes reported, who experienced the unexpected non serious AESI of Hypersomnia and unexpected non-serious event of Blood glucose increased one day after fourth dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Patient's blood sugar began to rise after vaccination, upper 200s to around 350. She has not had any other symptoms of high blood sugar like exhaustion. She has been sleeping a little bit longer. No nerve pain. The outcome of the events was not resolved at the time of report. No further details available. Primary vaccination series was administered in an appropriate schedule followed by 3rd booster dose prior to current vaccination. Elderly age of the patient could be confounder to the event Hypersomnia and medical history as confounder to the event Blood glucose increased. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Follow up received wherein secondary reporter added, new event added and I Narrative updated.; Sender's Comments: This spontaneous case concerns an elderly female patient aged 71 years with medical history of diabetes reported, who experienced the unexpected non serious AESI of Hypersomnia and unexpected non-serious event of Blood glucose increased one day after fourth dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Patient's blood sugar began to rise after vaccination, upper 200s to around 350. She has not had any other symptoms of high blood sugar like exhaustion. She has been sleeping a little bit longer. No nerve pain. The outcome of the events was not resolved at the time of report. No further details available. Primary vaccination series was administered in an appropriate schedule followed by 3rd booster dose prior to current vaccination. Elderly age of the patient could be confounder to the event Hypersomnia and medical history as confounder to the event Blood glucose increased. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.