Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Herpes simplex, Urticaria
Clinical narrative: Skin lesion; a severe increase in my chronic idiopathic urticaria; a severe increase in my chronic idiopathic urticaria; increase in hives; developed a large herpes lesion on the lower right side of my chin; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Other Case identifier(s): 2023NVX-US-000001838 (Novavax).  A 60-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 30Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 12Oct2023 as dose 1, 0.5 ml single (Lot number: 5683MF012) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes simplex", start date: 1981 (ongoing), notes: Herpes simplex outbreaks on face and both eyes; "Chronic spontaneous urticaria", start date: 2014 (ongoing). Concomitant medication(s) included: VITAMIN D3 1000; L-LYSINE (ongoing). Past drug history included: Cyclosporin, reaction(s): "Drug hypersensitivity"; Zirgan, reaction(s): "drug hypersensitivity". Vaccination history included: Moderna cove-19 vaccine (DOSE 1), administration date: Mar2021, for COVID-19 IMMUNIZATION, reaction(s): "Chronic spontaneous urticaria", "Herpes simplex"; Moderna cove-19 vaccine (DOSE 2), administration date: Apr2021, for COVID-19 IMMUNIZATION, reaction(s): "Chronic spontaneous urticaria", "Herpes simplex"; Moderna cove-19 vaccine (DOSE 3), administration date: Oct2021, for COVID-19 IMMUNIZATION, reaction(s): "Chronic spontaneous urticaria", "Herpes simplex". The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 08Nov2023, outcome "not recovered" and all described as "a severe increase in my chronic idiopathic urticaria"; RASH VESICULAR (non-serious) with onset 08Nov2023, outcome "not recovered", described as "developed a large herpes lesion on the lower right side of my chin"; URTICARIA (non-serious) with onset 08Nov2023, outcome "not recovered", described as "increase in hives"; SKIN LESION (non-serious) with onset 13Nov2023, outcome "not recovered".  Additional information: The patient was vaccinated with intramuscular Novavax Covid-19 Vaccine (2023-2024 Formula) 0.5 ml dose 1 (dose 4 of COVID-19 vaccine) in the left arm on 12Oct2023 at a pharmacy. Co-suspect medications included Abrysvo (RSV vaccine prot. subunit pref 2V) on 30Oct2023. Approximately 9 days after receiving the RSV vaccine, she began to experience a severe increase in her chronic idiopathic urticaria (CIU), similar to what she had experienced after 3 prior Moderna mRNA covid vaccine injections. On 13Nov23, she also developed a large herpes lesion on the lower right side of her chin, also similar to flares she began to experience after the initial mRNA vaccines. Because she received 2 different vaccines with only 2 and 1/2 weeks in between, she knew it was not possible to confirm that one or the other caused the adverse effects with any certainty, but she reported for COVID shot as the side effects mirror what she had experienced previously with the mRNA vaccines, and she also reported the increase in hives through the V-Safe check-in for the RSV shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.