Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: feels awful; very weak; tired; nausea; shaking and chills that were severe; shaking and chills that were severe; body aches; splitting headache; rapid heartbeat/fast heartbeat; took her temperature and had a bad fever of 98.3-degree F; This is a spontaneous report received from a consumer from Medical Information Team. A 64-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Feb2024 at 15:45 as dose number unknown, single (lot number unknown) at the age of 64 years, in left arm for immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "immunocompromised" (ongoing); "selective antibody deficiency" (ongoing), notes: IgG sub class 2; "asthma" (ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction: "drug allergy"; Clarithromycin, reaction: "drug allergy"; Erythromycin, reaction: "drug allergy"; Imitrex, reaction: "drug allergy". Vaccination history included: Moderna (unknown dose numbers, similar side effects), for COVID-19 immunization; Flu vaccine (did not have any reaction at all), for immunisation. The following information was reported: PAIN (non-serious) with onset 11Feb2024 at 13:00, outcome "not recovered", described as "body aches"; NAUSEA (non-serious) with onset 11Feb2024 at 13:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 11Feb2024 at 13:00, outcome "not recovered", described as "rapid heartbeat/fast heartbeat"; TREMOR (non-serious), CHILLS (non-serious) all with onset 11Feb2024 at 13:00, outcome "not recovered" and all described as "shaking and chills that were severe"; HEADACHE (non-serious) with onset 11Feb2024 at 13:00, outcome "not recovered", described as "splitting headache"; PYREXIA (non-serious) with onset 11Feb2024 at 13:00, outcome "not recovered", described as "took her temperature and had a bad fever of 98.3-degree F"; FEELING ABNORMAL (non-serious) with onset 12Feb2024, outcome "not recovered", described as "feels awful"; FATIGUE (non-serious) with onset 12Feb2024, outcome "not recovered", described as "tired"; ASTHENIA (non-serious) with onset 12Feb2024, outcome "not recovered", described as "very weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, tremor, chills, pain, headache, heart rate increased, pyrexia, feeling abnormal, asthenia, fatigue.  Additional Information: The patient reported to have presented several adverse reactions after administration of the Abrysvo vaccine. Starting late Sunday morning, on 11Feb2024 at 13:00, she started having nausea, shaking and chills that were severe and body aches. By the afternoon of that Sunday, she also developed splitting headache, rapid heartbeat and she took her temperature and had a bad fever of 98.3-degree F, which does not explain any of these. She still feels awful today, 12Feb2024, Monday, with a splitting headache, shaking, chills, body aches and nausea. She's also very weak and tired. She added that her husband got this vaccine, and he had no symptoms at all. The patient stated, "Why is that! I have similar side effects when I got the Moderna COVID vaccines. I did not have any reaction at all when I got the flu vaccine." The patient informed that she is immunocompromised, and she recognizes herself as such; specifically, that she has selective antibody deficiency historically (she is IgG sub class 2), as well as someone who has asthma. She was informed by her immunologist that she is not to be administered a live vaccine or mRNA vaccine and so she wanted information on what type of vaccine Abrysvo was. She was interested on information regarding the adverse reactions to be expected after administration of Abrysvo, as well as how long adverse reactions may last. She informed that she had all but one of the side effects that have been reported with all the testing with Abrysvo. The fast heartbeat she had was one side effect that was not reported when they did all the testing and she questioned if it was true that it is rare, and no one has reported this. Abrysvo was administered in a Pharmacy or Drug Store. The patient did not receive any other vaccines on the same date as and within 4 weeks prior Abrysvo. The patient was not taking any other medications within 2 weeks of the event starting. NDC number of Abrysvo: 00069-0344-05.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.