Age: 63.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Eye pain, Fatigue, Headache, Illness, Muscle spasms
Clinical narrative: Eyes felt sore the day after vaccination; Sore arm; Eyebrows twiched involuntarily; Really sick on Sunday night after she got the vaccine; Sharp, stabbing pains felt behind her eyes/Headache; Felt fatigued; A low grade fever; Flucelvax Quadrivalent and Moderna COVID-19 vaccine were administered on the same day at the same anatomical location; Body/aches/General body pain; This spontaneous case  was received on 07-Feb-2024 from other non-healthcare professional via Med Communications (reference number SEQW24-00548) and a 63-year-old, female patient.   The patient's concurrent condition included osteoporosis. The patient's concomitant medications included clonazepam for anxiety, Alendronate (alendronate sodium) and cholecalciferol, both used for osteoporosis. The patient had no known allergies. The patient's historical vaccines included three doses of Pfizer BioNTech COVID-19 vaccine, the first dose received on 19-Feb-2021, the second dose received on 09-Mar-2021 and the third dose received 09-Oct-2021, all three received for unspecified indication, and three doses of COVID-19 vaccine (reported as Spikevax 2023-2024), the first dose received on 06-May-2022 (dose, route of administration, anatomical location and indication: not reported; batch number: 056M21A), the second dose received on 06-Oct-2022 (dose: 0.5 ml, anatomical location: left arm; route of administration and indication: not reported; batch number: 055F22B) and the third dose received on 04-Jun-2023 (dose: 0.5 ml; anatomical location: left arm; route of administration and indication: not reported; batch number: A57642B), after each of six COVID-19 vaccinations the patient experienced head and body/aches, fever and fatigue, as reported.  On 01-Oct-2023, at 3:00 pm, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as SPIKEVAX 2023-2024 (active ingredients not specified); dose: 0.5 ml; anatomical location: left arm; route of administration and indication: not reported). The batch number reported was AU3832B.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm; route of administration: injection; dose: not reported) (explicitly coded as 'Product administration error') for active immunization against influenza disease. The batch number reported was 944456.   On the same date, Sunday night, as reported, after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient felt really sick and typically had a fever. The patient experienced sharp, stabbing pains behind her eyes, body aches, and fatigue.  On 02-Oct-2023, one day after the vaccination, as reported, the patient's eyes felt sore and eyebrows twitched involuntarily. The headache was more severe. For the following six days, the patient felt fatigued (like carrying weight on my shoulders), body/aches/general body pain, a sore arm, and a low-grade fever. As each day wore on the fever lessened gradually as the days progressed, as reported.  On 10-Oct-2023, the patient had recovered from the event of 'pain in extremity'.  On an unspecified date in Oct-2023, (discrepantly reported as 09-Oct and 10-Oct), the patient had recovered from the event of 'headache'.  The outcome of the events of 'eye pain', 'spasms', and 'sickness' was not reported.  At the time of initial reporting, the patient had not recovered from the events of 'general body pain', fatigue, and 'pyrexia'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 63-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine in the left arm (explicitly coded as 'Product administration error'). On the same day following vaccination, the patient experienced pain, illness, headache, fatigue and pyrexia. One day later, the patient also experienced eye pain, pain in extremity and muscle spasms. Product administration error is assessed as not related as per company's conventions.  Although causality is confounded by administration of co-suspect COVID-19 vaccine, it is assessed as possible for pain, illness, headache, fatigue, pyrexia, eye pain, pain in extremity and muscle spasms, due to chronological plausibility.; Sender's Comments: A 63-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine in the left arm (explicitly coded as 'Product administration error'). On the same day following vaccination, the patient experienced pain, illness, headache, fatigue and pyrexia. One day later, the patient also experienced eye pain, pain in extremity and muscle spasms. Product administration error is assessed as not related as per company's conventions.  Although causality is confounded by administration of co-suspect COVID-19 vaccine, it is assessed as possible for pain, illness, headache, fatigue, pyrexia, eye pain, pain in extremity and muscle spasms, due to chronological plausibility.