Age: 79.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Vaccination site pain, Vision blurred, Visual impairment
Clinical narrative: Vision very blurry; Vision became 'strained' next day after injection and continually worsened until became blurry with shadows then started cleaning on the fourth day; The patient had sore arm at the injetion site and it was minor; This spontaneous case was received on 08-Feb-2024, from other non-healthcare professional (consumer) via  Communications (reference number: SEQW24-00567), and concerned a 79-year-old, non-pregnant, female patient.  The patient's concurrent conditions included allergy to sulfa. The patient was not taking any concomitant medications. The patient has not been ever diagnosed with/tested positive for COVID-19 with no acute illnesses at the time of vaccination up to one month before and  with no chronic or long-standing health conditions. The patient's historical vaccines included four doses of Moderna Covid-19 vaccine, the first dose was received on 10-Feb-2021 (batch number: D15M20A), the second dose on 10-Mar-2021 (batch number: 03DA21A), the third dose on 26-Nov-2021 (batch number: 055H21A) and the fourth dose on 31-May-2022 (batch number: 004M21A), all for an unreported indication.   On 24-Nov-2023, on Friday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: arm and route of administration: not reported) as active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported.   On the same date, the patient was vaccinated with a non-company, co-suspect COVID-19 vaccine (reported as 'Spikevax (covid-19 vaccine, mRNA (2023-2024 formula)' (active ingredients not specified); dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.  On 25-Nov-2023, one day after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced vision impaired. Vision became 'strained' next day after injection and continually worsened until became blurry with shadows then started cleaning on the fourth day, as reported.  On 27-Nov-2023, three days after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced vision very blurry.  On 29-Nov-2023, the patient seek medical care and visited the physician's office/urgent care. Also, the patient visited physician's office/urgent care on 04-Dec-2023, as reported.  On an unspecified date in Nov-2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced soreness in arm at the injection site, that was minor.  On 02-Dec-2023, the patient recovered with with sequelae from the event of 'vision blurred'. Residual effects were reported as on and off poor vision. There were still times when vision was poor for short period, 1/2 a day, as reported.  At the time of initial reporting, the patient had not recovered from  'visual impairment' and  'vaccination site pain'.  The reporter did not provide a causality assessment. Vision impaired and vision very blurry was reported as mostly likely caused by mRNA-1273, as reported. Additionally, the patient did not experienced a similar event in the past, as reported.   The case was assessed as non-serious.  Company comment: A 79-year-old patient developed blurry vision, visual impairment, and vaccination site pain within six days after receiving the suspect product Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to compatible temporal relationship.; Reporter's Comments: Vision impaired and vision very blurry was reported as mostly likely caused by mRNA-1273, as reported. Additionally, the patient did not experienced a similar event in the past, as reported.; Sender's Comments: A 79-year-old patient developed blurry vision, visual impairment, and vaccination site pain within six days after receiving the suspect product Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to compatible temporal relationship.