Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Back disorder, Balance disorder, Condition aggravated, Dyspnoea
Clinical narrative: back problems/issues; had trouble with her balance; very weak and could not open her eyes; back problems/issues; felt very tired/fatigued; cannot breathe and can no longer use her muscles; cannot breathe and can no longer use her muscles; lost some weight; This is a spontaneous report received from a Pharmacist and a Consumer or other non HCP from medical information team.  A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Mar2025 as dose 1, single (Lot number: LN5496, Expiration Date: 30Sep2025) at the age of 75 years for immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing); "High cholesterol" (ongoing); "back problems/issues" (ongoing), notes: back problems/issues. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (hospitalization) with onset 25Mar2025, outcome "unknown", described as "felt very tired/fatigued"; BACK DISORDER (hospitalization) with onset Apr2025, outcome "unknown", CONDITION AGGRAVATED (hospitalization) with onset 25Apr2025, outcome "unknown" and all described as "back problems/issues"; BALANCE DISORDER (hospitalization) with onset Apr2025, outcome "unknown", described as "had trouble with her balance"; ASTHENIA (hospitalization) with onset Apr2025, outcome "unknown", described as "very weak and could not open her eyes"; DYSPNOEA (hospitalization, life threatening), MUSCLE RIGIDITY (hospitalization, life threatening) all with onset 2025, outcome "unknown" and all described as "cannot breathe and can no longer use her muscles"; WEIGHT DECREASED (hospitalization) with onset 2025, outcome "unknown", described as "lost some weight". The patient was hospitalized for dyspnoea, muscle rigidity, weight decreased, fatigue, back disorder, condition aggravated, balance disorder, asthenia (start date: 29Apr2025). Clinical course: the patient was administered rsv vaccine prot.subunit pref 2v on 24Mar2025. It was believed that was the first time she was administered rsv vaccine prot.subunit pref 2v. The reporter's father stated the patient felt very tired the first day after getting the vaccine and she had to lay down. She was fatigued. The reporter's father called and was concerned since she was very tired, and he was wondering about the side effects; since it was shortly after getting vaccine. The reporter (a pharmacist), a caregiver to his mother (patient), stated that his mother had a side effect with rsv vaccine prot.subunit pref 2v and that she was currently "hospitalized, cannot breathe and can no longer use her muscles."  The patient lost some weight, and the reporter believed her weight was 68 kilograms based on a chart note. The patient's issues with not being able to breathe and no longer able to use her muscles was a progression. The reporter stated he did not know, but maybe around 25Apr2025 or 26Apr2025, she started complaining about back problems/issues. Even though she had back problems/issues before, she did have back problems when the reporter went to visit her around that time. She also had trouble with her balance. It kind of progressed, and she started losing balance when he visited her on the 26Apr2025. The patient had to grab something everywhere she went. Then she was found leaning and laying. The patient was admitted to the hospital on 29Apr2025. The patient was very weak and could not open her eyes. The patient was in the hospital on a ventilator and was probably various medications. The reporter stated that he thinks the events were related to rsv vaccine prot.subunit pref 2v. The patient underwent the following laboratory tests and procedures: Weight: lost. Therapeutic measures were taken as a result of dyspnoea, muscle rigidity, weight decreased, fatigue, back disorder, condition aggravated, balance disorder, asthenia.; Sender's Comments: There is not a reasonable possibility that the reported events dyspnoea, muscle rigidity, weight decreased, fatigue, back disorder, condition aggravated, balance disorder, asthenia were related to the suspect product event most likely due to patient underlying contributory factors