Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Allergist gave her a skin test from Afluria and she had a "bad skin reaction"; Allergist gave her a "watered down" version of Afluria and she had redness with raised areas; Allergist gave her a "watered down" version of Afluria and she had redness with raised areas; This spontaneous case was received on 26-Apr-2021 from a physician and other non-health professional (consumer) via Communications (reference number: SEQW21-01243) and concerned a 56-year-old female patient.  The patient's concurrent conditions were not reported. The patient's past medical history included anaphylactic reactions, but it was not clarified to what products. The patient historical influenza vaccine included 'Fluzone' for under 65 years (the doctor's office did not have records of exactly what vaccine was used) to which the patient developed anaphylactic reaction with labored breathing in 2014. The patient's concomitant medications were unknown.  Allergist was trying to find out what was in Fluzone vaccine and tried to narrow down the patient's reaction to what she was allergic to.  On an unknown date in Dec-2020, the patient was administered skin test from Afluria Quadrivalent and then the allergist vaccinated the patient with "watered down" version of Afluria Quadrivalent (influenza vaccine; dose, route of administration and anatomical location: not reported) as prophylactic vaccination. The batch number was not reported.   On an unspecified date in Dec-2020, after receiving skin test from Afluria Quadrivalent, the patient had a bad skin reaction and after receiving "watered down" version of Afluria Quadrivalent, the patient developed redness with raised areas. It was not reported if the patient received any treatment.  The outcome of the events was unknown.  The allergist assessed the events as related to Afluria Quadrivalent. The allergist told the patient that she could not have further flu shots after skin test from Afluria and 'watered down' version of Afluria administration.  Company comment: A 56-year-old female patient developed skin reaction, redness and swelling after administration of the suspect product, Afluria Quadrivalent. As reported, the patient was administered skin test from Afluria Quadrivalent and then the allergist vaccinated the patient with "watered down" version of vaccine, after which the events developed. Patient's medical history is significant for anaphylactic reactions to other vaccine products. Based on provided information, causal role of the suspect product could not be ruled out and is assessed as possibly related.; Reporter's Comments: The allergist assessed the events as related to Afluria Quadrivalent. The allergist told the patient that she could not have further flu shots after skin test from Afluria and 'watered down' version of Afluria administration.; Sender's Comments: A 56-year-old female patient developed skin reaction, redness and swelling after administration of the suspect product, Afluria Quadrivalent. As reported, the patient was administered skin test from Afluria Quadrivalent and then the allergist vaccinated the patient with "watered down" version of vaccine, after which the events developed. Patient's medical history is significant for anaphylactic reactions to other vaccine products. Based on provided information, causal role of the suspect product could not be ruled out and is assessed as possibly related.