Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site extravasation, Underdose
Clinical narrative: Patient and pharmacist suspect that some of the vaccine leaked out of the injection site after the vaccine was administered / Patient is concerned that she did not get the entire dose of the vaccine; Patient and pharmacist suspect that some of the vaccine leaked out of the injection site after the vaccine was administered / Patient is concerned that she did not get the entire dose of the vaccine; This spontaneous case was received on 20-Aug-2021 via Med Communications (reference number: SEQW21-01661) from a pharmacist and concerned a 70-year-old, female patient.   The patient's medical history was not reported. The patient was not taking any concomitant medications. The patient reported she normally had side effects after receiving a vaccine.  On 19-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose: 0.5 ml and anatomical location: left deltoid) for influenza prophylaxis. The batch number reported was 312842 and expiration date 19-May-2022. The vaccine was administered with no issues and the patient felt great after her vaccination.   On the same day, an unknown amount of time after receiving Fluad Quadrivalent, when the patient peeled back the band-aid that was placed on her arm after the injection she noticed that there was a lot of fluid in the cotton pad that was not blood or bodily fluid. The patient and pharmacist suspected that some of the vaccine leaked out of the injection site after the vaccine was administered and ended up on the cotton pad of the band-aid. The patient was concerned that she did not get the entire dose of the vaccine (explicitly coded as 'Incomplete dose administered').  Patient stated that she was due for her COVID-19 booster dose and would reach out to pharmacist in Oct-2021, well after her booster dose regarding revaccination.   The outcome of the event 'vaccination site extravasation' was not reported.   The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: On the same date after receiving Fluad Quadrivalent, the patient peeled back the band-aid that was placed on her arm after the injection and she noticed that there was a lot of fluid in the cotton pad. The patient and pharmacist suspected that some of the vaccine leaked out of the injection site after the vaccine was administered. Vaccination site extravasation is assessed as not related to the vaccine. Incorrect dose is assessed as not related, per company's conventions.; Sender's Comments: On the same date after receiving Fluad Quadrivalent, the patient peeled back the band-aid that was placed on her arm after the injection and she noticed that there was a lot of fluid in the cotton pad. The patient and pharmacist suspected that some of the vaccine leaked out of the injection site after the vaccine was administered. Vaccination site extravasation is assessed as not related to the vaccine. Incorrect dose is assessed as not related, per company's conventions.