Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: her neck is very painful when she moves it, specially in the same side where she received the injection, It is more than a stiff neck.; she slept all day; She was shaking at night; That night she didn´t feel well, she didn´t feel good; She had a fever; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (her neck is very painful when she moves it, specially in the same side where she received the injection, It is more than a stiff neck.), HYPERSOMNIA (she slept all day), CHILLS (She was shaking at night), MALAISE (That night she didn´t feel well, she didn´t feel good) and PYREXIA (She had a fever) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Tested positive for Covid-19 about 1 year and a half or 2 years ago. She was asymptomatic.). Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 2), Pfizer (Dose 5), Pfizer (Dose 4) and Pfizer (Dose 3). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Arthritis and Allergy (Takes allergy medicine over the counter.). Concomitant products included MELOXICAM and GABAPENTIN for Arthritis.    On 16-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 16-Oct-2023, the patient experienced CHILLS (She was shaking at night), MALAISE (That night she didn´t feel well, she didn´t feel good) and PYREXIA (She had a fever). On 17-Oct-2023, the patient experienced HYPERSOMNIA (she slept all day). On 19-Oct-2023, the patient experienced NECK PAIN (her neck is very painful when she moves it, specially in the same side where she received the injection, It is more than a stiff neck.). At the time of the report, NECK PAIN (her neck is very painful when she moves it, specially in the same side where she received the injection, It is more than a stiff neck.), HYPERSOMNIA (she slept all day), CHILLS (She was shaking at night), MALAISE (That night she didn´t feel well, she didn´t feel good) and PYREXIA (She had a fever) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Reported that patient takes allergy medicine over the counter.  Reported that her neck was very painful, it was more than a stiff neck. She said she has never had a reaction like this before. It was severe and it was not getting better.  No treatment medications were reported. Company comment: This spontaneous case concerns a 70-year-old female patient, with medical history of arthritis treated with gabapentin reported, who experienced the unexpected, nonserious AESI of hypersomnia which occurred the next day after SPIKEVAX 2023-2024 PFS dose administration, which was the 6th dose of COVID-19 vaccination schedule. Previously the patient was vaccinated 5 times with TOZINAMERAN for which the exact vaccination dates are unknown; no events reported afterwards. Concurrent use of gabapentin can be considered as a confounder. The course of events was reported to start at night of the day of vaccination with fever, not feeling well and shaking during the night. The next day the patient didn´t feel good and slept all day. 3 days after vaccination the patient woke up with a very painful neck while moving, especially in the same side where injection was received. No further clinical information or details on etiologic and diagnostic work up with treatment were provided for medical review. Hypersomnia outcome was not recovered at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS vaccine is not affected by this report.