Age: 84.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash over her entire body head to toe and it was red and itchy; This is a spontaneous report received from a contactable reporter (nurse). An 84-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Oct2023 at 16:30 as dose number unknown, 0.5 ml single (lot number HM0172, expiration date 28Feb2025) at the age of 84 years intramuscular, in right deltoid for immunisation; for immunisation; pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 19Oct2023 as dose number unknown, single (lot number GT6702, expiration date 31Oct2024) at the age of 84 years intramuscular, in left deltoid for immunisation; for immunisation. The patient's relevant medical history included: "COPD", start date: 2015 (unspecified if ongoing); "pulmonary fibrosis", start date: 2019 (unspecified if ongoing); "CVA" (unspecified if ongoing). Concomitant medication included: FLUZONE HIGH DOSE taken for immunisation, on 02Oct2023 as dose number unknown, single. Vaccination history included: Prevnar 13 (lot number I77780, expiry date 31Jan2017), administration date: 30Sep2015, when the patient was 76-year-old, for immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 20Oct2023, outcome "recovering", described as "rash over her entire body head to toe and it was red and itchy". The events "rash over her entire body head to toe and it was red and itchy" required physician office visit. Therapeutic measures were taken as a result of rash erythematous.  Additional Information: The nurse was calling about Abrysvo vaccine. They gave the patient the vaccine on 19Oct2023 at the physician's office. On 20Oct2023 the patient began having a rash over her entire body head to toe and it was red and itchy, and they started her on dexamethasone and called in betamethasone cream for the patient to use as well. The patient called them on the 20th and came in on the 20th and again on the 22nd because the rash was not getting any better. As of today, 31Oct2023, the rash is better and the patient was seen yesterday and now, they have to wean her off dexamethasone. Seriousness criteria: The nurse reported the event as not serious. It is not life threatening and was just more of an annoyance and was on the whole body and was itchy and the patient looked like a lobster, and it was over the entire face and was head to toe. The nurse stated that the reported event is not significant. The nurse reported that the patient has pulmonary fibrosis and history of CVA in the past. Pulmonary fibrosis was probably in 2019 and the CVA was prior to Abrysvo vaccine but the nurse does not have the date when the CVA occurred, and these are all chronic conditions. The patient also has long standing COPD and thinks the COPD began in 2015 and then it went into pulmonary fibrosis. Causality was reported as unknown, but they wanted to report it because that was the newest thing the patient got, and the patient had never had the RSV vaccine before. The events did not require a visit to the Emergency Room but required a visit to the physician's office. The patient was not hospitalized for the event. The patient has no illness at the time of the vaccination. The patient has no family medical history relevant to the event. The patient previously had vaccination with Fluzone High Dose on 02Oct2023 and no adverse event followed. NDC number of Abrysvo: 00069-0344-05. NDC number of Prevnar 20: 0005-2000-10. It was also reported, "other products: no".  The information on the device batch/lot number for rsv vaccine prot.subunit pref 2v and; pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.