Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Dizziness, Feeling drunk
Clinical narrative: Feeling dizzy / feels light dizzy spells; Feels drunk; ''Inside a ship" / balance and equilibrium is slightly off; This spontaneous case was received on 12-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number SEQW20-03377) and concerned an adult, female patient.   The patient's concurrent conditions included thyroid and cholesterol (as reported). The patient's concomitant medications included atorvastatin and Synthroid (levothyroxine sodium), both used for unreported indication.   On 05-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left upper arm) for influenza prophylaxis. The batch number reported was 276567.  On the same day, after receiving Flucelvax QIV, the patient felt dizzy.   On an unspecified date in Oct-2020, the patient was feeling light dizzy spells. Also, she felt drunk and inside a ship. Her balance and equilibrium were slightly off.   At the time of initial reporting on 12-Oct-2020, the patient had not recovered from events.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Balance disorder, dizziness and feeling drunk were associated with the use of the suspect product Flucelvax QIV. The event of dizziness occurred on the same day after administration while other 2 events were reported on an unspecified day in October. Chronology is suggestive for dizziness and unclarified for other two events. The patient's concurrent conditions included thyroid and cholesterol (undefined). The patient's concomitant medications included atorvastatin and Synthroid (levothyroxine sodium), both used for unreported indications. With information presented, causality is assessed as unlikely related for dizziness due to suggestive temporal relationship and reported confounders - levothyroxine sodium. Balance disorder can be a result of dizziness and chronology is also unclarified, making causality unlikely related due to possible connections with reported dizziness. Feeling drunk is unspecified event and also has unclarified chronology, therefore causality as unassessable due to lack of information. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes); Sender's Comments: Balance disorder, dizziness and feeling drunk were associated with the use of the suspect product Flucelvax QIV. The event of dizziness occurred on the same day after administration while other 2 events were reported on an unspecified day in October. Chronology is suggestive for dizziness and unclarified for other two events. The patient's concurrent conditions included thyroid and cholesterol (undefined). The patient's concomitant medications included atorvastatin and Synthroid (levothyroxine sodium), both used for unreported indications. With information presented, causality is assessed as unlikely related for dizziness due to suggestive temporal relationship and reported confounders - levothyroxine sodium. Balance disorder can be a result of dizziness and chronology is also unclarified, making causality unlikely related due to possible connections with reported dizziness. Feeling drunk is unspecified event and also has unclarified chronology, therefore causality as unassessable due to lack of information. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes)