Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Immediate post-injection reaction, Injection site pain, Migraine, Myalgia
Clinical narrative: Extra dose administered; he was diagnosed with a virus; Heart racing; White blood cell count increased; he has a diagnosis of A-Fib; Soreness at injection site; Chills; Myalgia; Arthralgia; Migraine; This serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis.   Previously administered products included Arexvy with an associated reaction of injection site pain (1st dose of arexvy received on 22nd November 2023 from batch 93PD7 expiry date 22 October 2024). Concomitant products included diltiazem.   On 09-OCT-2024, the patient received the 2nd dose of Arexvy (right arm) .5 ml. On 09-OCT-2024, 4 hrs after receiving Arexvy, the patient experienced injection site pain (Verbatim: Soreness at injection site) (serious criteria hospitalization, disability and other: serious as per reporter) and extra dose administered (Verbatim: Extra dose administered) (serious criteria hospitalization, disability and other: serious as per reporter). In OCT-2024, the patient experienced chills (Verbatim: Chills) (serious criteria hospitalization, disability and other: serious as per reporter), myalgia (Verbatim: Myalgia) (serious criteria hospitalization, disability and other: serious as per reporter), arthralgia (Verbatim: Arthralgia) (serious criteria hospitalization, disability and other: serious as per reporter), migraine headache (Verbatim: Migraine) (serious criteria hospitalization, disability and other: serious as per reporter) and viral infection (Verbatim: he was diagnosed with a virus) (serious criteria hospitalization, disability and other: serious as per reporter). On 05-NOV-2024, the patient experienced heart racing (Verbatim: Heart racing) (serious criteria hospitalization, disability and other: serious as per reporter). In NOV-2024, the patient experienced white blood cell count increased (Verbatim: White blood cell count increased) (serious criteria hospitalization, disability and other: serious as per reporter) and atrial fibrillation (Verbatim: he has a diagnosis of A-Fib) (serious criteria hospitalization, disability, GSK medically significant and other: serious as per reporter). The outcome of the injection site pain, heart racing and atrial fibrillation were resolved and the outcome of the chills, myalgia, arthralgia and migraine headache were not resolved and the outcome of the white blood cell count increased and extra dose administered were unknown and the outcome of the viral infection was not reported.   It was unknown if the reporter considered the injection site pain, chills, myalgia, arthralgia, migraine headache, white blood cell count increased, heart racing, viral infection, atrial fibrillation and extra dose administered to be related to Arexvy.     The company considered the injection site pain, chills, myalgia, arthralgia, migraine headache, white blood cell count increased, heart racing, viral infection, atrial fibrillation and extra dose administered to be unrelated to Arexvy.   Linked case(s) involving the same patient:  US2024137576   Additional Information: GSK receipt date: 05-NOV-2024. Reporter was the patient who received 2 doses of the AREXVY vaccine at the same pharmacy approximately one year apart. Reported after first dose of suspect vaccine there was soreness at the injection site that resolved.  Patient could not remember any more details about the first injection due to the lapse of time. Reported after the second dose of suspect vaccine he had soreness at the injection site immediately that eventually resolved.  Also, reported after second dose he had chills, myalgia, arthralgia, and migraines that resolved but then reoccurred. Patient reported that he went to the emergency department past weekend and was admitted for the symptoms mentioned.  His hospital stay was from November 1st 2024 to November 3rd 2024. During his hospital stay, he reported that his white blood cells were elevated and he was diagnosed with a virus.  Patient stated that he had a diagnosis of A-Fib that had always been controlled with medication.  However, today November 5th 2024 his heart was raced and he had to take an extra dose of his medication.  Patient reported that he was gone to his physician and had an Echocardiogram. It was unknown if administering pharmacy had reported the second dose of AREXVY.; Sender's Comments: Case of 73-year-old male patient  with multiple events for Arexvy vaccine. There is insufficient evidence to establish a conclusive causal relationship. The case is confounded by comorbidities. US-GSK-US2024137576:Same patient/Dose 2