Age: 40.0
Sex: F
Vaccine: COVID19-2, FLUA4, FLU4
Symptoms: Computerised tomogram normal, Condition aggravated, Dyskinesia, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Couldn't see; Was able to see a little bit but everything was blurry; Eyes were kind of shaking; Wasn't able to smile all the way; Blood pressure was really high; Blood sugar was low; Lower back pain/pain in both lower and middle of back; Left hand still feels weaker; This spontaneous case was retrieved on 07-Feb-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2565853-1), reported by other non-healthcare professional (consumer), and concerned a 40-year-old, female patient.   The patient's concurrent conditions included high blood pressure, allergy to sulfa, garlic, pineapple, shellfish and seasonal allergies. The patient's concomitant medications were not reported.  It was reported that on 14-Jan-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1'; route of administration: injection (reported as 'SYR'); anatomical location: right arm; indication: not reported). The batch number reported was P100465584. The reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent (influenza vaccine inact split 4v) instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.  On the same date, the patient was vaccinated with non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine, Bivalent (tozinameran, riltozinameran; dose: reported as '3'; route of administration: injection (reported as 'SYR'); anatomical location: left arm; indication: not reported). The batch number reported was GJ6796.  On the same date, that night, as reported, after receiving Afluria Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine, Bivalent, the patient felt lower back pain.  On 15-Jan-2023, the next day, as reported, the patient started having pain in both lower and middle of back.   On 16-Jan-2023, the next day, as reported, when the patient woke up the patient could not see. After five full minutes the patient was able to see a little bit, but everything was blurry. The patient went to an Urgent Care and was told that her blood pressure was really high and blood sugar was low. They called an Ambulance and took the patient to the emergency room (ER), where she underwent an electrocardiogram (EKG), computerised tomogram (CT) scan and chest X-ray, and all results were normal. The nurses noticed the patient's eyes were kind of shaking. The patient was not able to smile all the way and feared that could be a mini stroke, although it was never diagnosed. The patient was put on an unspecified intravenous (IV) therapy and blood pressure finally started coming down.   On an unspecified date in Jan-2023, the patient's left hand started feeling weaker.  On an unspecified date in Jan-2023, the patient was discharged with a prescription for lisinopril. The patient felt like she was just dismissed, and they did not listen to her. The patient was hoping to see a Primary Care Physician on 01-Feb-2023.  At the time of initial reporting, the patient had not recovered from the event of 'hands weakness of', and was recovering from the event of 'blood pressure increased'. As reported, the patient's left hand still felt weaker.  The outcome of all other events was unknown.  The reporter did not provide a causality assessment.   The events of 'vision loss' and stroke were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  Company comment: A 40-year-old patient experienced back pain on the same night after receiving the suspect product Afluria Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. The patient also developed loss of vision for five minutes and blurry vision after that, as well as non-specified eye movement disorder, impaired mouth movement, increased blood pressure, and decreased blood sugar, two days after vaccination. Thereafter, the patient's left hand felt weaker. Underlying medical history of high blood pressure contributed to the development of the events. Reportedly, the patient underwent an electrocardiogram (EKG), computerised tomogram (CT) scan and chest X-ray, and all results were normal. Nevertheless, more information regarding patient's diagnostic findings is needed. Therefore, due to lack of information, causality is unassessable for all events.; Sender's Comments: A 40-year-old patient experienced back pain on the same night after receiving the suspect product Afluria Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. The patient also developed loss of vision for five minutes and blurry vision after that, as well as non-specified eye movement disorder, impaired mouth movement, increased blood pressure, and decreased blood sugar, two days after vaccination. Thereafter, the patient's left hand felt weaker. Underlying medical history of high blood pressure contributed to the development of the events. Reportedly, the patient underwent an electrocardiogram (EKG), computerised tomogram (CT) scan and chest X-ray, and all results were normal. Nevertheless, more information regarding patient's diagnostic findings is needed. Therefore, due to lack of information, causality is unassessable for all events.