Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac function test normal, Cardiac stress test normal, Feeling of body temperature change, Headache, Hypersomnia
Clinical narrative: slept most of the afternoon; Patient felt sluggish; flu like symptoms; runny nose; and felt like he had a temperature; headache; The patient received the vaccine in his left arm The patient felt a sore arm starting later 26OCT2023; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (slept most of the afternoon), SLUGGISHNESS (Patient felt sluggish), MALAISE (the patient felt worse), INFLUENZA LIKE ILLNESS (flu like symptoms) and RHINORRHOEA (runny nose) in a 78-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:The patient has two Tick born disease Lyme Disease and Borelia. The patient takes 2 antibiotics and Probiotics. The patient has had a history of two tick bites. Felt like I had the flu from the tick bite last Spring. The patient says that if he relaxes and rests that he feels better. The patient did ask his Doctor treating him for Lyme Disease and also asked his General Practitioner if he could take the Covid-19 vaccine and they said that he could. The patient recently had several heart tests including a stress test and they came out well.  The patient's past medical history included Tick bite (The patient had a history of two tick bites.) and Flu (Felt like I had the flu from the tick bite last Spring.) in 2022. Previously administered products included for Product used for unknown indication: pfizer (dose 3), INFLUENZA, pfizer (dose 2) and pfizer (dose 1). Past adverse reactions to the above products included No adverse event with INFLUENZA, pfizer, pfizer and pfizer. Concurrent medical conditions included Lyme disease (The patient takes 2 antibiotics and Probiotics.) and Borrelia infection (The patient takes 2 antibiotics and Probiotics.).    On 26-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 26-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (The patient received the vaccine in his left arm The patient felt a sore arm starting later 26OCT2023). On 27-Oct-2023, the patient experienced HYPERSOMNIA (slept most of the afternoon), SLUGGISHNESS (Patient felt sluggish), MALAISE (the patient felt worse), INFLUENZA LIKE ILLNESS (flu like symptoms), RHINORRHOEA (runny nose), PYREXIA (and felt like he had a temperature) and HEADACHE (headache). At the time of the report, HYPERSOMNIA (slept most of the afternoon), SLUGGISHNESS (Patient felt sluggish) and PYREXIA (and felt like he had a temperature) outcome was unknown, MALAISE (the patient felt worse) was resolving and INFLUENZA LIKE ILLNESS (flu like symptoms), RHINORRHOEA (runny nose), HEADACHE (headache) and VACCINATION SITE PAIN (The patient received the vaccine in his left arm The patient felt a sore arm starting later 26OCT2023) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2023, Body temperature: increased. On an unknown date, Cardiac stress test: normal. On an unknown date, Investigation: normal.         The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient felt a sore arm starting later 26-Oct-2023. When the patient woke up on 27-Oct-2023, the patient woke up with flu like symptoms. Patient felt sluggish. The patient walked his dog and noticed that was a struggle. The patient was a substitute teacher and did that this afternoon and that was quite a struggle. As the day went on the patient felt worse and that peaked around 3 to 4PM. When the patient got home from teaching, the patient went to sleep and woke up around 6PM. The patient ate dinner and feels slightly better now. Patient also had a headache, runny nose, slept most of the afternoon and felt like he had a temperature. No treatment medication was reported. Company comment- This spontaneous case concerns a 78-year-old male patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI hypersomnia the following day a dose of SPIKEVAX 2023-2024, given as a fourth dose of COVID vaccine schedule, was administered.  Previously the patient received 3 doses of TOZINAMERAN vaccine, given as first, second and third doses (revaccination with different COVID-19 vaccine and interchange of vaccine products). It was reported that the patient felt a sore arm starting later the same day of vaccination. When the patient woke up the following day, he had flu like symptoms. He felt sluggish.  As the day went on the patient felt worse and that peaked around 3 to 4PM. When he got home from teaching, the patient went to sleep and woke up around 6PM. He ate dinner and felt slightly better then. Patient also had a headache, runny nose, slept most of the afternoon and felt like he had a temperature. No treatment medication was reported. The benefit risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.