Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | Mf2162 | OT / LA |
itchiness, erythema, warmth, and a tender lump at the injection site (left arm); itchiness, erythema, warmth, and a tender lump at the injection site (left arm); itchiness, erythema, warmth, and a tender lump at the injection site (left arm); itchiness, erythema, warmth, and a tender lump at the injection site (left arm); itchiness, erythema, warmth, and a tender lump at the injection site (left arm); left axillary swelling; discolored hyperpigmentation area at the injection site; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 04Oct2025 as dose 1, single (Lot number: Mf2162) at the age of 50 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Congenital heart disease (Ebstein's Anomaly)" (unspecified if ongoing); "Bioprosthetic Tricuspid Valve" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "CFS" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; BNT162B2 OMICRON (LP.8.1) taken for covid-19 immunisation, on 06Sep2025 as dose 1, single; WARFARIN; TORSEMIDE; ATENOLOL; BABY ASPIRIN; VITAMIN D3. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Ampicillin, reaction(s): "Allergy"; Erythromycin, reaction(s): "Allergy"; Codeine, reaction(s): "Allergy"; Fluorescein, reaction(s): "Allergy". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 07Oct2025 at 19:00, outcome "not recovered" and all described as "itchiness, erythema, warmth, and a tender lump at the injection site (left arm)"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE MASS (non-serious) all with onset 07Oct2025 at 19:00, outcome "not recovered" and all described as "itchiness, erythema, warmth, and a tender lump at the injection site (left arm) "; SWELLING (non-serious) with onset 07Oct2025 at 19:00, outcome "not recovered", described as "left axillary swelling"; VACCINATION SITE DISCOLOURATION (non-serious) with onset Oct2025, outcome "not recovered", described as "discolored hyperpigmentation area at the injection site". The events "itchiness, erythema, warmth, and a tender lump at the injection site (left arm) ", "itchiness, erythema, warmth, and a tender lump at the injection site (left arm)" and "left axillary swelling" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site warmth, vaccination site pain, vaccination site mass, swelling. Additional information: the patient experienced a delayed reaction to her first RSV vaccination which was given at a (redacted) pharmacy on 04Oct2025. The patient did not receive any other vaccines on the same date as RSV vaccine. Three days after, the patient began developing itchiness, erythema, warmth, and a tender lump at the injection site (left arm) which worsened over the next several days. The patient also developed left axillary swelling. She saw her PCP on 09Oct2025 and was started on a 6-day tapering Dosepak of oral Methylprednisolone for this severe reaction, as well as scheduled for a left axillary (underarm) ultrasound due to the swelling, which was performed on 14Oct2025. On 17 days post-vaccine, the patient still have a mild lump and tenderness as well as have been left with a discolored hyperpigmentation area at the injection site.
Medical History/Concurrent Conditions: Chronic fatigue syndrome; Ebstein's anomaly; Hypothyroidism; Tricuspid valve replacement
SYNTHROID; WARFARIN; TORSEMIDE; ATENOLOL; BABY ASPIRIN; VITAMIN D3
Test Date: 20251014; Test Name: left axillary (underarm) ultrasound; Result Unstructured Data: Test Result:unknown results