Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Cold sweat, Consciousness fluctuating, Hypotension, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: In and out of consciousness; Syncopal episode; Lips were turning blue; Shaky for about a week; Dizziness; Could not hear or see; Could not tell what was going on; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Apr2024 as dose number unknown, single (Lot number: HF5012) at the age of 78 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Blood pressure", start date: Nov2016 (unspecified if ongoing); "Osteoporosis", start date: May2022 (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; PROLIA taken for osteoporosis. The following information was reported: SENSORY LOSS (non-serious) with onset 05Apr2024, outcome "recovered" (2024), described as "Could not hear or see; Could not tell what was going on"; DIZZINESS (non-serious) with onset 05Apr2024, outcome "recovered" (2024); ALTERED STATE OF CONSCIOUSNESS (medically significant) with onset 05Apr2024, outcome "recovered" (2024), described as "In and out of consciousness"; LIP DISCOLOURATION (non-serious) with onset 05Apr2024, outcome "recovered" (2024), described as "Lips were turning blue"; NERVOUSNESS (non-serious) with onset 05Apr2024, outcome "recovered" (12Apr2024), described as "Shaky for about a week"; SYNCOPE (medically significant) with onset 05Apr2024, outcome "recovered" (2024), described as "Syncopal episode". The events "in and out of consciousness", "syncopal episode", "lips were turning blue", "shaky for about a week", "dizziness" and "could not hear or see; could not tell what was going on" required emergency room visit. The patient underwent the following laboratory tests and procedures: lab work: everything else was fine; Scan: everything else was fine; Scan brain: everything else was fine. Therapeutic measures were taken as a result of altered state of consciousness, syncope, lip discolouration, nervousness, sensory loss.  Additional information: Patient stated, "Well, I believe let says the ER (Emergency Room) described it as a syncopal episode, dizziness. I was in and out of consciousness, my lips were turning blue. I could not hear or see; I was going to fall and people were swarming around and I could not tell what was going on." Consumer stated she received treatment. She was still at the pharmacy when she started having this. The pharmacy people were the ones who called the ambulance, and the ambulance people took her straight to the emergency room where they did brain scans, heart scans, lab work. They kept her there for 4 hours trying to find out of anything other than the vaccine and they concluded that everything else was fine. All those scans, everything they did, but it was only the vaccine that could explain it. They said that it was safe to not have her stay overnight in the hospital. The doctor did prescribe the anti-dizziness pill, but he said he did not expect it to happen again (Has not taken it as she did not experience it again). But she did pick that prescription just in case. She was kind of shaky for about a week after, just shaky. She thought it was from the first time being in an ambulance and first time being in an ER like that and just the shock of it. It was completely unexpected from her but she is fine now. She was in the ER the whole time and they would take her to different tests that they needed to do. So, she was not officially hospitalized. Upon leaving the emergency room she has not received the lab reports, they were sent directly to her doctor and has not seen them.