Sex: M
Vaccine: FLUX
Symptoms: Bell's palsy, Crocodile tears syndrome, Eyelid function disorder, Facial paralysis, Illness
Clinical narrative: Crocodile tears syndrome as a result of Bell's palsy; Became very ill from the prednisone as it was too strong; Bells Palsy; Complete facial paralysis; Could not even close his eyes while sleeping; This spontaneous case was received on 23-Mar-2022 from other non-healthcare professional (consumer) via regulatory authority (reference number: SEQW22-01026) and concerned a male patient of unreported age.  The patient's medical history and concomitant medications were not reported. The patient had multiple unspecified vaccines (not flu vaccine) at the time he joined in 2012 without any reactions.   On 02-Nov-2013, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose: reported as '5cc', route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 08849211A. The vaccine title was influenza Inj Quadrivalent pres free Manufacturer: CSL Biotherapies. The patient thought the vaccine was Fluad manufactured by CSL Biotherapies, but was unsure.   On unspecified day in Nov-2013, about seven days after receiving influenza virus vaccine polyvalent, the patient developed extreme Bell's palsy with complete facial paralysis rated with 6 on the House-Brackmann Scale. It was also reported that he was unable to close his eye while sleeping. Initially, the patient went to the pharmacy and was advised to go to the hospital.   On unspecified date, the patient went to the clinic and was seen by medical doctor (MD), who diagnosed him Bell's Palsy. The patient was given prednisone and Z pack (azithromycin) as corrective treatment, but he became very ill from the prednisone as it was too strong.  On unspecified date in 2014, reported as about 12 to 14 months later, the patient was about 90% recovered.  On an unspecified date, reported as about a year after that, the patient developed Crocodile Tears Syndrome as a result of the Bell's Palsy.  The outcome of the events Crocodile tears syndrome and 'illness' was not reported.  The reporter assessed all events except for 'illness' (reported as 'ill from the prednisone') as related to influenza virus vaccine polyvalent. The patient received the flu vaccine and had a horrible reaction. He got permanent exemption from flu vaccines. The patient did not provide the causality assessment between 'illness' and influenza virus vaccine polyvalent  The events of Bell's palsy'and facial paralysis were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: About seven days after receiving influenza virus vaccine polyvalent, the patient developed extreme Bell's palsy with complete facial paralysis rated with 6 on the House-Brackmann Scale. It was also reported that he was unable to close his eye while sleeping. Reportedly, on unspecified date, the patient was diagnosed Bell's Palsy. The patient experienced illness associated with prednisone an unknow amount of time after vaccination. The patient also developed crocodile tears syndrome reportedly as a result of the Bell's Palsy, about 1-2 years after vaccination. Based on plausible temporal relationship and lack of alternative aetiology, causality is assessed as possibly related for the events Bell's pals, complete facial paralysis and associated lagophthalmos. Causality for the event ill-ness is assessed as not related due to alternative cause, therapy with prednisone. Causality for the event crocodile tears syndrome is also assessed as not related, since it is considered as consequence of Bell's palsy. The patient's medical history and concomitant medications were not reported. With provided information Brighton Collaboration criteria for Bell's palsy meets level 3 of diagnostic certainty.; Reporter's Comments: The patient received the flu vaccine and had a horrible reaction. He got permanent exemption from flu vaccines.; Sender's Comments: About seven days after receiving influenza virus vaccine polyvalent, the patient developed extreme Bell's palsy with complete facial paralysis rated with 6 on the House-Brackmann Scale. It was also reported that he was unable to close his eye while sleeping. Reportedly, on unspecified date, the patient was diagnosed Bell's Palsy. The patient experienced illness associated with prednisone an unknow amount of time after vaccination. The patient also developed crocodile tears syndrome reportedly as a result of the Bell's Palsy, about 1-2 years after vaccination. Based on plausible temporal relationship and lack of alternative aetiology, causality is assessed as possibly related for the events Bell's pals, complete facial paralysis and associated lagophthalmos. Causality for the event ill-ness is assessed as not related due to alternative cause, therapy with prednisone. Causality for the event crocodile tears syndrome is also assessed as not related, since it is considered as consequence of Bell's palsy. The patient's medical history and concomitant medications were not reported. With provided information Brighton Collaboration criteria for Bell's palsy meets level 3 of diagnostic certainty.