Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Swollen tongue
Clinical narrative: Throat and tongue swelling; Throat and tongue swelling; Heart break; Rapid breathing; Fluish; Arm is a bit sore; This spontaneous case was received on 12-Oct-2020 from other non-health professional (consumer)(reference number: SEQW20-03435) and concerned a 59-year-old, female patient.  The patient's historical vaccine included flu shot after which the patient was a bit fluish and arm was a bit sore. The patient's relevant medical history included diabetes type 2, psoriatic arthritis, hypothyroid, hypogammaglobulinemia and allergies to medicines who have preservatives. The patient's concomitant medications included Synthroid (levothyroxine sodium), Advair (fluticasone propionate, salmeterol xinafoate), Singular (montelukast sodium) and Levemir (insulin detemir), for an unknown indication.  On 14-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left arm, and route of administration: intramuscular) for influenza prophylaxis. The batch number was not reported.  On the same day, 3/4 hours after receiving Flucelvax QIV, the patient's throat and tongue started swelling. The patient also experienced rapid breathing and heart break. Within one hour the symptoms started vanishing and in 2/3 hours the reaction was gone. The patient didn't need to use her Epipen (epinephrine). The patient was a bit "fluish" and her arm was a bit sore like never before.  On the same day, the patient recovered from all events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The event of 'throat swelling', swelling of tongue', 'heart disorder' and 'tachypnea' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with case 202005140, due to the same patient.  Company comment: A female patient, was vaccinated with Flucelvax QIV vaccine. On the same day, 3/4 hours after receiving vaccine, the patient developed pharyngeal swelling, tongue swelling, tachypnoea and cardiac disorder. The patient also developed pain in extremity and influenza like-illness (was a bit "fluish"). Causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology. Within one hour the symptoms started vanishing and in 2/3 hours the reaction was gone. Although, the patient didn't need to use Epipen (epinephrine), mentioned events may suggest hypersensitivity reaction and correspond to level 3 diagnostic certainty for anaphylaxis.; Sender's Comments: A female patient, was vaccinated with Flucelvax QIV vaccine. On the same day, 3/4 hours after receiving vaccine, the patient developed pharyngeal swelling, tongue swelling, tachypnoea and cardiac disorder. The patient also developed pain in extremity and influenza like-illness (was a bit "fluish"). Causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology. Within one hour the symptoms started vanishing and in 2/3 hours the reaction was gone. Although, the patient didn't need to use Epipen (epinephrine), mentioned events may suggest hypersensitivity reaction and correspond to level 3 diagnostic certainty for anaphylaxis.