Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Began seeing zig-zags and transient flashes of light in the peripheral vision of her left eye/vision issues; Ocular migraine; Body aches; Headache; Gastrointestinal issues (nausea, vomiting, diarrhea); Gastrointestinal issues (nausea, vomiting, diarrhea); Gastrointestinal issues (nausea, vomiting, diarrhea); Feeling ''not like her usual self"; This spontaneous case was received on 18-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01989) and concerned a 60-year old, female patient.   The patient's concurrent condition included Hashimoto's disease. The patient's concomitant medications were not reported.   On 04-Sep-2020, around 2 pm, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for protection against seasonal influenza. The batch number was not reported.   On the same day, around 7 pm, the patient began seeing ''zig-zags'' and transient flashes of light in the peripheral vision of her left eye. She was also experiencing body aches, gastrointestinal issues (nausea, vomiting, diarrhea), and a headache.   On 05-Sep-2020, the patient stated that the issues started lessening somewhat, but she was still experiencing vision issues and the headache, and still feeling ''not like her usual self''.   On 06-Sep-2020, patient stated that she was feeling better, but still seeing the flashes of light in the peripheral vision of her left eye.  On an unspecified day, reported as presently, patient states she was experiencing a minor headache and body aches, diarrhea, and transient flashes of light in the peripheral vision of her left eye. Patient had also seen an ophthalmologist, who stated that there were no issues with her retina and suggested that the vision issues may have been caused by an ocular migraine. Patient will have a follow-up appointment with the ophthalmologist soon.  On an unspecified date, the outcome of the events vomiting, nausea, and feeling abnormal was resolved.  At the time of initial reporting on 18-Sep-2020, the outcome of the events headache, body aches, diarrhea, 'visual flashes', and migraine was not resolved.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: A 60-year-old female patient was administered Afluria Quadrivalent. On the same day, five hours later, the patient developed photopsia (Began seeing zig-zags and transient flashes of light in the peripheral vision of her left eye), pain, headache, nausea and vomiting. Patient had also seen an ophthalmologist, who stated that there were no issues with her retina and suggested that the vision issues may have been caused by an ocular migraine. Causality is assessed as possibly related for pain, headache, nausea and vomiting. For the events of ocular migraine and photopsia, causality was highly confounded by patient's concurrent condition, Hashimoto's disease. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to ''related'' in the safety database for reporting purposes); Sender's Comments: A 60-year-old female patient was administered Afluria Quadrivalent. On the same day, five hours later, the patient developed photopsia (Began seeing zig-zags and transient flashes of light in the peripheral vision of her left eye), pain, headache, nausea and vomiting. Patient had also seen an ophthalmologist, who stated that there were no issues with her retina and suggested that the vision issues may have been caused by an ocular migraine. Causality is assessed as possibly related for pain, headache, nausea and vomiting. For the events of ocular migraine and photopsia, causality was highly confounded by patient's concurrent condition, Hashimoto's disease. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes)