Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Facial paralysis, Feeling abnormal, Palpitations, Throat tightness
Clinical narrative: Throat felt it would close up; Bell's palsy/my face appeared droopy/water spilled down my face when I tried to drink/face was worse/couldn't close eyes/can not blow or whistle; Heart racing; I felt kind of off, not my normal self/didn't feel right; Could not swallow/needs to drink with a straw; Could not breathe; Pain was up to her ear; Pain was up to her ear; This spontaneous case was received on 10-Feb-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-00450) and concerned a 49-year-old, female patient.  The patient's concurrent conditions included asthma, acid reflux, vitamin K deficiency and fibromyalgia. The patient's concomitant medications included unspecified Nexium (esomeprazole), Cartia XT (diltiazem hydrochloride), Zyrtec (cetirizine hydrochloride) and unspecified multivitamin, all used for an unreported indication.  On 17-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location, route of administration: not reported) as flu prophylaxis. The batch number was not reported.  On 18-Nov-2020, next day after receiving Flucelvax Quadrivalent, the patient felt kind of off and not normal self. The patient's heart was racing.  On 19-Nov-2020, two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy.  On 20-Nov-2020, three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy.   On an unspecified date in Nov-2020 (since as reported), the patient went to the doctor and asked if this would be permanent and the doctor told her that they did not know and that they would need to wait and see. There was nothing that could be done. The patient reported that she had disabled son who liked blowing bubbles and when he asked her to blow bubbles for him, she remembered that she could not blow or whistle. The patient needed to drink with a straw and was afraid that this would last for the rest of her life. The patient also could not breathe, she could not swallow, and the pain was up to her ear.  At the time of initial reporting on 10-Feb-2021, the patient was recovering from all events since that was not as bad as it was before.  The reporter did not provide causality assessment.  The event of 'Bell's palsy' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 49-year-old patient was administered Flucelvax Quadrivalent. Next day after receiving Flucelvax Quadrivalent, the patient developed palpitations and felt kind off and not normal self. Two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. Three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. The patient also could not breathe, she could not swallow, and the pain was up to her ear. Causal role of the suspect vaccine was confounded for dyspnoea and throat tightness, since the patient's concurrent conditions included asthma. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 1 diagnostic certainty for Facial paralysis.; Sender's Comments: A 49-year-old patient was administered Flucelvax Quadrivalent. Next day after receiving Flucelvax Quadrivalent, the patient developed palpitations and felt kind off and not normal self. Two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. Three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. The patient also could not breathe, she could not swallow, and the pain was up to her ear. Causal role of the suspect vaccine was confounded for dyspnoea and throat tightness, since the patient's concurrent conditions included asthma. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 1 diagnostic certainty for Facial paralysis.