Age: 57.0
Sex: F
Vaccine: FLUC4, FLUC3
Symptoms: Ocular hyperaemia, Peripheral swelling, Pyrexia, Skin warm, Vaccination site pain
Clinical narrative: Could not sleep; I had redness to my eyes; Hand swelling; Warm spots at temper lobe; Redness issues in her left and right temporal lobe; Headache; Fever spiked/spikes in her body temperature of 100-102 F; Tenderness at injection site; This spontaneous case was received on 26-Jan-2022 from other non-healthcare professional (consumer) via regulatory authority (reference number: SEQW22-00403) and concerned 57-year-old female patient.  The patient's concurrent conditions included hypertension. The patient's concomitant medications included hydrochlorothiazide used for unreported indication.  On 19-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported), for prevention of seasonal influenza. The batch number was not reported, and expiry date was 30-Jun-2022.  On the same day, by 11:00 p.m., after receiving Flucelvax Quadrivalent, the patient had tenderness at injection site, headaches and warm spots at temporal (reported as 'temper') lobe. In addition, the patient experienced hand swelling, fevers, redness of eyes and could not sleep. She also had redness issues in her left and right temporal lobe. The patient thought that she was having a massive heart attack.   On 24-Nov-2021, the patient went to Urgent Care. She was discharged on the same day and was advised to contact her physician. The patient had a followed up with her physician and performed  blood tests, but no further details provided. Additionally, the patient visited a specialist for an eye examination, but no further details provided as well.  At the time of initial reporting, the patient had not recovered from the events of ' localized erythema' and 'fever'. The patient stated that she was still experiencing fever spikes in her body, temperature of 101-102 F and had redness issues in her left and right temporal lobe.   The outcome of other events was not reported.  The reporter assessed the events as related to Flucelvax Quadrivalent as they were adverse reactions to the vaccine.  The reporter assessed the events as serious.  Company comment: A 57-year-old female patient developed vaccination site pain, pyrexia, headache, ocular hyperemia, localised feeling of warmth, hand swelling, erythema and insomnia on the same day after vaccination with Flucelvax Quadrivalent. Causality for insomnia is assessed as not related due to biological implausibility. Causality for all the other events is assessed as possibly related due to plausible temporal relationship.; Reporter's Comments: Adverse reactions to the vaccine; Sender's Comments: A 57-year-old female patient developed vaccination site pain, pyrexia, headache, ocular hyperemia, localised feeling of warmth, hand swelling, erythema and insomnia on the same day after vaccination with Flucelvax Quadrivalent. Causality for insomnia is assessed as not related due to biological implausibility. Causality for all the other events is assessed as possibly related due to plausible temporal relationship.