Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weak; flu symptoms; feeling that the body was really heavy as she couldn't walk on the first night after vaccination; feeling that the body was really heavy as she couldn't walk on the first night after vaccination; She feels very sick every single day; slight cough; is extremely dizzy; headaches; fever; chills; nausea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), INFLUENZA (flu symptoms), DISCOMFORT (feeling that the body was really heavy as she couldn't walk on the first night after vaccination), GAIT INABILITY (feeling that the body was really heavy as she couldn't walk on the first night after vaccination) and ILLNESS (She feels very sick every single day) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles Vaccine (First Dose) on 31-Jan-2022 and Shingles Vaccine (Second Dose) on 27-Apr-2022. Past adverse reactions to the above products included No adverse effect with Shingles Vaccine and Shingles Vaccine. Concomitant products included Celecoxib (Celexal) and Pantoprazole sodium sesquihydrate (Protonix) for an unknown indication.    On 18-Sep-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), INFLUENZA (flu symptoms), DISCOMFORT (feeling that the body was really heavy as she couldn't walk on the first night after vaccination), GAIT INABILITY (feeling that the body was really heavy as she couldn't walk on the first night after vaccination), ILLNESS (She feels very sick every single day), COUGH (slight cough), DIZZINESS (is extremely dizzy), HEADACHE (headaches), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with Ibuprofen (Advil) at a dose of when needed. On 28-Sep-2024, ASTHENIA (weak), INFLUENZA (flu symptoms), DISCOMFORT (feeling that the body was really heavy as she couldn't walk on the first night after vaccination), GAIT INABILITY (feeling that the body was really heavy as she couldn't walk on the first night after vaccination), ILLNESS (She feels very sick every single day), COUGH (slight cough), DIZZINESS (is extremely dizzy), HEADACHE (headaches), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient was not vaccinated 4 weeks before the last administration of the Spikevax vaccine. She stated that she was about to have the flu vaccine afterward, but she did not.  The patient stated that she had previous vaccinations with Moderna which breezed right through, as they did not produce any problem, but the last one almost killed her. She also stated that the previous vaccine produced a little bit of sore arm which did not bother her.   The patient had a slight cough that never had before and still had it since the vaccine was administered, had horrible flu symptoms and severe dizziness ever since. The patient went to the emergency room, but they did not find anything wrong with her.   This case was linked to MOD-2024-774810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2024: Live non-significant follow-up added: references added. On 08-Oct-2024: Live significant follow-up received included outcome of the event updated and reference numbers added. On 08-Oct-2024: Live non-significant follow-up added: references added, and narrative updated.