Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping; she had a headache and that she slept for a full day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Open heart surgery (recent heart surgery - valve repair, maze procedure, atrial abutment (Sep-1993)) in September 1993, Heart valve operation (Recent heart surgery - valve repair) in September 1993 and Cox-Maze procedure (Maze procedure) in September 1993. Previously administered products included for Product used for unknown indication: Pfizer vaccine (previous vaccine dose). Past adverse reactions to the above products included No adverse effect with Pfizer vaccine. Concurrent medical conditions included Blood pressure high (high blood pressure (normal yesterday 26-May-2025)). On 23-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In May 2025, the patient experienced HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day). The patient was treated with Paracetamol (Tylenol) in May 2025 at an unspecified dose and frequency. In May 2025, HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day) had resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient received the Spikevax (2024-2025) vaccination early on Friday of last week (23-May-2025) and had a reaction to it. She had a headache and that she slept for a full day. After receiving her dose, she was unable to think about doing much, other than sleeping. The reporter denied any severe pain. She had roughly 10 COVID vaccines, all Moderna except 1 Pfizer. She had contacted Moderna before, after receiving her first vaccine, as she experienced a really strange reaction but everything kind of settled itself. The reporter stated that it was not catastrophic, but just unusual. Patient did not recall what her reaction was. No other details provided. It was unknown if the patient experienced any additional symptoms/events. Patient's reactions were resolved with a couple of Tylenol. This case was linked to MOD-2021-049524 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Blood pressure high (high blood pressure (normal yesterday 26-May-2025)); Cox-Maze procedure (Maze procedure); Heart valve operation (Recent heart surgery - valve repair); Open heart surgery (recent heart surgery - valve repair, maze procedure, atrial abutment (Sep-1993))