Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Fatigue
Clinical narrative: Weak; Voice was slightly hoarse; Tired; Head hurt like it was about to explode; Nauseous; Dizzy; Right eye got blurry; Thought she was getting a vertigo attack; Breathing was slightly affected; This spontaneous case was received on 02-Oct-2020, from other non-health professional via Health Authority (reference number: SEQW20-02848) and concerned a 62-year old, female patient.  The patient's medical history included asthma, and vertigo. The patient's concomitant medications included Meclizine (meclozine) for vertigo.  On 02-Oct-2020, at 1 pm, patient was vaccinated with unspecified Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration, anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported.  On the same day, at 4 pm, the patient felt nauseous and dizzy and her head hurt like it was about to explode. Her right eye got blurry around this time. The patient took medizine for vertigo and thought she was getting a vertigo attack, but the medication did not help. The patient also felt that her breathing was slightly affected but was not sure if asthma was the cause.   On unspecified date, the patient recovered from the events, but she was still feeling tired, weak and her voice was slightly hoarse.  At time of initial reporting on 02-Oct-2020, the patient was recovering from the events tired, weak and 'hoarse voice'.  The reporter stated that was unsure if this was the vaccine that caused her issues or if "maybe it just happened to her, she was the oddball".  The reporter assessed the case as non-serious.  Company comment: A 62-year old, female patient was administered Flucelvax QIV vaccine. The patient developed nausea, dizziness, headache, vertigo, dyspnoea, asthenia, fatigue and vision blurred after receiving vaccine. The patient's medical history included asthma, and vertigo. The patient's concomitant medications included Meclizine for vertigo. Causality was confounded for the events of vertigo and dyspnoea, however, cannot be totally excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes). For all remaining events, causality is assessed as possibly related due to plausible chronology.; Reporter's Comments: The reporter stated that was unsure if this was the vaccine that caused her issues or if "maybe it just happened to her, she was the oddball".; Sender's Comments: A 62-year old, female patient was administered Flucelvax QIV vaccine. The patient developed nausea, dizziness, headache, vertigo, dyspnoea, asthenia, fatigue and vision blurred after receiving vaccine. The patient's medical history included asthma, and vertigo. The patient's concomitant medications included Meclizine for vertigo. Causality was confounded for the events of vertigo and dyspnoea, however, cannot be totally excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes). For all remaining events, causality is assessed as possibly related due to plausible chronology.