Received Feb 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
tired; redness/all red on my arm; itching/felt something itching on their arm; was a little hot, feeling a little warm on their arm; hurting/it is red on their arm and is hurting; had a slight headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 91-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Feb2026 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing); "Afib" (unspecified if ongoing); "gallbladder problems" (unspecified if ongoing); "severe Aortic stenosis" (unspecified if ongoing); "allergic to a lot of things" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 13Feb2026, outcome "unknown", described as "had a slight headache"; VACCINATION SITE PAIN (non-serious) with onset 18Feb2026, outcome "unknown", described as "hurting/it is red on their arm and is hurting"; VACCINATION SITE PRURITUS (non-serious) with onset 18Feb2026, outcome "unknown", described as "itching/felt something itching on their arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Feb2026, outcome "unknown", described as "redness/all red on my arm"; VACCINATION SITE WARMTH (non-serious) with onset 18Feb2026, outcome "unknown", described as "was a little hot, feeling a little warm on their arm"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: The patient stated that the vaccine was administered at the doctor's office by a qualified person. After 7 days, on 18Feb2026, the patient experienced sudden redness, itching, and pain at the injection site. The patient reported headache and tiredness. She stated she did not feel the needle go in or come out, had no irritation initially, wore a band-aid and forgot about it until removing it the next day (13Feb2026), noting a small blood spot, which she attributed to taking a blood thinner. The patient reported having a mild, intermittent headache since Friday (13Feb2026) morning. On 18Feb2026, the patient noticed itching on their arm, looked at the site and saw redness and warmth. She contacted the doctor's office and were told that the reaction was unusual and to call back if symptoms persisted for one or two weeks. The patient stated she searched online and read about possible side effects, including Guillain-Barre Syndrome, which worried her. The patient asked what to do if symptoms lasted more than two days. The patient would use cold compresses and take paracetamol since she was told to do it. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Medical History/Concurrent Conditions: AFib; Allergy; Aortic stenosis; Cancer; Gallbladder disorder