Sex: M
Vaccine: COVID19
Symptoms: Asthenia, C-reactive protein increased, Dysstasia, Extra dose administered, Hypersomnia
Clinical narrative: The patient states her husband had the shot. He became quite weak.; The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.; The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.; The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those; The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (The patient states her husband had the shot. He became quite weak.), HYPERSOMNIA (The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.), FEEDING DISORDER (The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.), INTERCHANGE OF VACCINE PRODUCTS (The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those) and COVID-19 IMMUNISATION (The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: influenza on 10-Oct-2023 and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and influenza.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ASTHENIA (The patient states her husband had the shot. He became quite weak.), HYPERSOMNIA (The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.), FEEDING DISORDER (The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.), INTERCHANGE OF VACCINE PRODUCTS (The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those) and COVID-19 IMMUNISATION (The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those). In October 2023, ASTHENIA (The patient states her husband had the shot. He became quite weak.), HYPERSOMNIA (The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.) and FEEDING DISORDER (The patient states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat.) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those) and COVID-19 IMMUNISATION (The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2023, C-reactive protein: C-reactive protein was 4.3 or 4.6. On 13-Oct-2023, Red blood cell sedimentation rate: ESR was 40.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The reporter states her husband had the shot. He became quite weak. He didn't have fever. For 48 hours, all he did was sleep. He could hardly eat. He couldn't stand up alone. When they contacted a physician, he did an ESR and C-reactive protein on 13Oct2023. Both were remarkedly elevated. ESR was 40 and C-reactive protein was 4.3 or 4.6. She looked up online and people reported a high C-reactive protein. She is calling to report this. The patient adds that his symptoms have improved. The patient reports that her husband had previous Pfizer COVID19 Vaccines and he didn't have negative responses to those.  Company Comment This spontaneous case concerns a male patient of unknown age with medical history of Previously administered  Pfizer Covid-19 and influenza vaccine with no adverse events who experienced the unexpected events of hypersomnia (AESI), asthenia, feeding disorder, interchange of vaccine products and covid-19 immunisation the same month after a dose of SPIKEVAX 2023-2024 vaccine. On 13-Oct-2023, C-reactive protein was 4.3 or 4.6 and Red blood cell sedimentation rate was 40.  The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine  is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-746281 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746281:Invalid case for online people