Sex: F
Vaccine: FLUC3
Symptoms: Immunisation reaction, Incorrect product formulation administered, Inflammation, Injection site induration, Injection site pain
Clinical narrative: Heightened immune responses; Experiencing heightened  pain responses/An immense increase in pain/Wake up in pain; An immense increase in inflammation; Wake up swollen; The cupping marks turn into a massive histamine reactions/The are itchy and red; Inappropriate formulation of vaccine administered; Expired vaccine used; Significant injection site reaction - hot; Significant injection site reaction - the area was risen; Significant injection site reaction - painful; Significant injection site reaction - hard to the touch; This spontaneous case was received on 26-Oct-2022  from other non-health care professional (patient) via Communications (reference number: SEQW22-05066) with additional information received on 01-Nov-2022 from the same source (reference number: SEQW22-05280) and on 02-Nov-2022 from Seqirus' manufacturing quality assurance department (being processed together) and concerned a female patient of unspecified age.  The patient's concurrent condition included muscle tightness. The patient's concomitant medications were not reported. The patient had been receiving cupping therapy for muscle tightness for a while. No other vaccines, injections, or medications were given, started, or changed during the period since the vaccine was administered.  On 26-Sep-2022, the patient was vaccinated with expired Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number reported was 252380 and expiry date was 31-May-2019 (explicitly coded as 'Expired vaccine used' and 'Inappropriate formulation of vaccine administered').  On 26-Sep-2022, immediately following and for four days after receiving Flucelvax Quadrivalent, the patient had a significant injection site reaction. The reaction was roughly three inches in length by two and a half inches in width. The area was risen, painful, hot, and hard to the touch.   On 27-Sep-2022, the day following vaccination and every time the patient had received cupping since, the cupping marks turned into a massive histamine reactions expanding past the diameter of the cups. They were itchy and red but did not subside with cold showers, hydrocortisone cream, or calamine lotion. Additionally, the patient's body had had an immense increase in pain and inflammation. Every morning since receiving Flucelvax the patient woke up swollen and in pain. Ibuprofen alleviated some of the inflammation but a great deal still persisted.  On an unspecified date in 2022, in the period since the patient received Flucelvax, decreased efficacy of pain reliever and anesthetic had also been noted. Several topical numbing agents as well as Novocaine (procaine) had no efficacy during attempts to use them during two dental appointments even after increasing dose. The patient's body had also been experiencing heightened immune and pain responses since vaccination.   On 30-Sep-2022, four days after onset, the patient recovered from the events of 'vaccination site pain', 'vaccination site induration', 'vaccination site swelling' and 'vaccination site warmth'.   The outcome of the remaining events was unknown..   The reporter assessed all events as related to Flucelvax Quadrivalent, as no other vaccines, injections, or medications were given, started, or changed during the period since the vaccine was administered which led them to believe it was indeed a side effect of the Flucelvax vaccine.  Company comment: A female patient of unspecified age was vaccinated with expired Flucelvax Quadrivalent (explicitly coded as 'Expired vaccine used' and 'Inappropriate formulation of vaccine administered'). Immediately following vaccination, the patient experienced vaccination site warmth, vaccination site swelling, vaccination site pain and vaccination site induration. The patient had been receiving cupping therapy for muscle tightness for a while. The day following vaccination and every time the patient had received cupping since, the cupping marks turned into a massive histamine reaction expanding past the diameter of the cups. They were itchy and red but did not subside with cold showers, hydrocortisone cream, or calamine lotion. Additionally, the patient's body had had an immense increase in pain and inflammation. Every morning since receiving Flucelvax the patient woke up swollen and in pain. The patient's body had also been experiencing heightened immune and pain responses since vaccination, as reported. No other vaccines, injections, or medications were given, started, or changed during the period since the vaccine was administered. Information regarding relevant laboratory findings and diagnostic data was not provided. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, with the currently available information and plausible temporal relationship. Expired vaccine used and inappropriate formulation of vaccine administered are assessed as unrelated per company's conventions.; Reporter's Comments: No other vaccines, injections, or medications were given, started, or changed during the period since the vaccine was administered which lead them to believe it was indeed a side effect of the Flucelvax vaccine.; Sender's Comments: A female patient of unspecified age was vaccinated with Flucelvax Quadrivalent. Immediately following vaccination, the patient experienced vaccination site warmth, vaccination site swelling, vaccination site pain and vaccination site induration. The patient had been receiving cupping therapy for muscle tightness for a while. The day following vaccination and every time the patient had received cupping since, the cupping marks turned into a massive histamine reaction expanding past the diameter of the cups. They were itchy and red but did not subside with cold showers, hydrocortisone cream, or calamine lotion. Additionally, the patient's body had had an immense increase in pain and inflammation. Every morning since receiving Flucelvax the patient woke up swollen and in pain. The patient's body had also been experiencing heightened immune and pain responses since vaccination, as reported. No other vaccines, injections, or medications were given, started, or changed during the period since the vaccine was administered. Information regarding relevant laboratory findings and diagnostic data was not provided. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, with the currently available information and plausible temporal relationship.