Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Underdose, Wrong technique in product usage process
Clinical narrative: Red rashes; Redness mid humerous; Kind of like cellulitis; The vaccine didnt get enough into muscle tissue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 72-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Nov2023 at 14:00 as dose number unknown, 100 mg single (Batch/Lot number: unknown) at the age of 72 years, in left deltoid for immunisation; for immunisation, Device Lot Number: H739, Device Expiration Date: 01Apr2028. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Insomnia" (unspecified if ongoing), notes: insomnia issue,don't have a specific date; "regular UTI" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN taken for depression; WELLBUTRIN SR taken for anxiety disorder. Past drug history included: Antibiotics, notes: gets antibiotics every so often looks like she might be get regular UTI. Vaccination history included: Covid vaccine (prior to Abrysvo), for COVID-19; Flu vaccine (prior to Abrysvo), for immunization.The following information was reported: INCORRECT DOSE ADMINISTERED (intervention required) with onset 16Nov2023 at 14:00, outcome "not recovered", described as "The vaccine didnt get enough into muscle tissue"; CELLULITIS (intervention required) with onset 21Nov2023, outcome "not recovered", described as "Kind of like cellulitis"; RASH ERYTHEMATOUS (intervention required) with onset 21Nov2023, outcome "not recovered", described as "Red rashes"; ERYTHEMA (intervention required) with onset 21Nov2023, outcome "not recovered", described as "Redness mid humerous". The events "red rashes", "redness mid humerous" and "kind of like cellulitis" required physician office visit. Therapeutic measures were taken as a result of rash erythematous, erythema, cellulitis. Clinical course: As per agent, hcp calling on behalf of a patient who received the vaccine and developed red rashes into the arm and deltoid and wondering if she should be revaccinated.  As per HCP the 72 year old female received abyrsvo vaccine (NDC number of Abrysvo: 00069034405 and UPC number of Abrysvo: 3000690344058) and then developed redness mid humerous 5 days after vaccine receipt . States the patient was concerned if it was really administered in the deltoid area (due to the redness lower down) and if effective however the caller confirms the tech administered the vaccine in the deltoid area.  HCP states perhaps there was not enough muscle tissue to keep the vaccine in place as the patient had little muscle volume. States either the vaccine didnt get enough into muscle tissue and was more in subcutaneous area and trickled down the arm internally or it was close to a vessel or transferred to blood stream. HCP states he believes the vaccine will still be effective. Asking for information on inadvertent SQ administration. Patient has developed kind of a red rash area further down the arm then the deltoid and the provider said looks kind of like cellulitis and the patient was concerned, she thought that's where the vaccine was given but it wasn't, they were given up higher on the arm but they wanted to know if she needed to have the vaccine readministered, if it was not as affective if it was done lower. So, we are just trying to find that information for the patient. Patient presented to us yesterday and apparently had already been to the doctor at that point and so it was either started in on Monday or Tuesday of this week so, the 20th or the 21st. Events was still experiencing, it's not improved. When she came to pick up the prescription the doctor gave her to treated if cellulitis. It had increased in the redness area like the area of the redness. Treatment: started an antibiotic today for Doxycycline at 100 milligrams, to be taken one twice a day for 5 days. Causality: reporter stated, "I believe there is possibly correlation that I don't know but it's necessarily causation. So, the appearance of it 5 days after the administration but not in the site of the actual where the shot was given makes me think that she may have a connected issue there to it but not necessarily that it was a in the sense on an allergic type of reaction. It might just be that something associated with the vaccine, so I am hesitant to say that it was the vaccine that cause that itself and not maybe some other susceptibility that patient has because she is found chronic and frequent antibiotic so she may just have an immune system issue to begin with were." Causality for "the vaccine didnt get enough into muscle tissue", "red rashes", "redness mid humerous" and "kind of like cellulitis" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.