Reporte zur Charge U50309

Symptomtext

Potential anaphylactic type reaction; Difficulty breathing; Tightness in throat; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Site reaction with redness; This spontaneous case was received on 17-Feb-2021 from other health professional via Agency (reference number: SEQW21-00550) and concerned female patient of an unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date in Oct-2015, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose, route of administration and anatomical location: not reported) as influenza prophylaxis. The batch number reported was U50309. On an unknown date in 2015, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to Afluria. She experienced site reaction with redness, pain that was shooting to neck and back. Nurse stated that the patient had potential anaphylactic type reaction as she woke in the middle of the night and had difficulty breathing and tightness in throat. Patient did not seek medical attention immediately. On an unknown date in fall or winter, the patient was seen by medicine doctor (MD) to discuss the incident and was referred to a dermatologist. The patient had not had a flu shot since then. The outcome of the events was not reported. The reported assessed the events as related to Afluria Quadrivalent. Patient had an allergic reaction to Afluria in 2015. The events of 'anaphylactic type reaction', difficulty breathing and tightness in throat were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment:The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Patient had an allergic reaction to Afluria in 2015.; Sender's Comments: The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).