Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Red blood cell sedimentation rate increased, Staphylococcal infection, Staphylococcus test positive, Surgery, Suspected transmission of an infectious agent via product
Clinical narrative: Tap of her shoulder that grew staph aureus (MSSA); I believe she was inoculated with MSSA from her vaccine injection; Thrombus in the left basilic veinand left cephalic vein; This spontaneous case was retrieved on 11-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1838075-1) with additional information received on 12-Aug-2022 from Seqirus's manufacturing quality assurance department, reported by other healthcare professional and concerned a 73-year-old, female patient.  The patient's concurrent conditions included allergy to latex, allergy to sulfate salts, spinal stenosis of lumbar region, osteoarthritis of knee, synovitis and tenosynovitis, PMR (polymyalgia rheumatica), OA (osteoarthritis), soft tissue rheumatism and hypertension. The patient's concomitant medications included Tylenol (paracetamol) and Ascorbic acid with rose hips (ascorbic acid, rosa canina) both used for an unreported indication. The patient's historical drugs included amlodipine, hydrochlorothiazide, hydroxychloroquine, lisinopril and sulphonamide antibiotic, penicillins, all with an associated reaction of hives and Prolia (denosumab) with an associated reaction of rash.   On 12-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: right arm (RA), dose and indication: not reported). The batch number reported was 312847 and expiry date was 24-May-2022.  On the same day, while receiving Fluad Quadrivalent, the patient felt like it went into the bone in her shoulder.   On 13-Oct-2021, the next day, it was painful and continued to worsen.   By 17-Oct-2021 she felt ill and had low energy. That week she was seen twice in urgent care, first time was prescribed a prednisone taper, decreased from 60 mg to 10 mg daily. Second time, when she went back on urgent care, was given doxycycline.   On approximately 21-Oct-2021, the patient went to her primary care physician (pcp) and was found to have elevated erythrocyte sedimentation rate (sed rate) and C-reactive protein (CRP). The patient was referred to the hospital where she had a tap of her shoulder that grew Staphylococcus aureus (methicillin sensitive Staphylococcus aureus-MSSA). The patient was admitted to the hospital and that evening had extensive surgical debridement. The reporter believed that she was inoculated with MSSA from her vaccine injection, and that the clinical symptoms were masked by the prednisone and could have been even more serious than it was. The reporter informed the pharmacy and they had not heard of any other infections in other customers.   On 22-Oct-2021, the patient was taken to the operating room for a right shoulder irrigation and debridement. There were no complications during the surgery and postoperatively, patient was admitted to the orthopedic floor. She was given empiric antibiotics. Infectious disease was consulted and recommended prolonged course of intravenous (IV) Ancef (cefazolin sodium). Patient was started on deep venous thrombosis (DVT) prophylaxis with ASA (acetylsalicylic acid) at a dose of 81 mg, two times a day given thromboembolic deterrent stockings (TEDS) and sequential compression devices (SCDs) and encouraged early mobilization. She was started on a bowel regimen, tolerated a diet, and voided appropriately prior to discharge. The shoulder drain was removed on first postoperative day (POD1). She was seen by therapy, occupational therapy, and case management who together recommended a plan for discharge.   On 28-Oct-2021, the patient was referred for left upper limb DVT ultrasound evaluation (LUE DVT) ultrasound due to left arm swelling and it revealed a thrombus in the left basilic vein and left cephalic vein. The midline was removed, and she instead received a tunnelled central catheter by vascular and interventional radiology (VIR). Hematology was consulted and recommended Eliquis (apixaban) at a dose of 10 mg twice daily for seven days, followed by 5 mg twice daily for a total of three months.    On 29-Oct-2021, the patient was seen by the Orthopedic Surgery team who felt that the patient was medically and surgically stable for discharge.   On 30-Oct-2021, the patient was discharged with a midline catheter in place and home services for prolonged IV Ancef.  At the time of initial reporting, the patient was still recovering from the events and she lost much range of motion (ROM) in her right shoulder.   The reporter considered the events of 'Methicillin sensitive Staphylococcus aureus infection' and 'suspected transmission of an infectious agent via a medicinal product' as related to Fuad Quadrivalent and did not provide causality assessment for the event of 'thrombus'. The reporter believed that she was inoculated with MSSA from her vaccine injection.   The events of 'Methicillin sensitive Staphylococcus aureus infection', 'suspected transmission of an infectious agent via a medicinal product' and 'thrombus' were assessed as serious due to hospitalization. In addition, the events of 'thrombus' and 'suspected transmission of an infectious agent via a medicinal product' were was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case has been entered onto Seqirus's database.  In conclusion of the quality assurance investigation, there have been no anomalies observed that could be considered a contributing factor in this case for the suspected transmission of an infectious agent. The batch review did not identify any potential impact on product quality, safety or efficacy. All deviations that were raised for batch 312847 and its monovalent, bulk and fill predecessors were closed with no batch impact. The review of related deviations for cumulative effective did not find anything that could be attributable to the case. No corrective and preventative actions (CAPAs) are therefore recommended.  Additional information was received on 08-Sep-2022 from Seqirus's manufacturing quality assurance department: Quality assurance investigation results were provided. Expiration date for Fluad Quadrivalent was provided. The narrative was amended accordingly.  Company comment: A 73-years-old patient was vaccinated with Fluad Quadrivalent. On the same day, while receiving Fluad Quadrivalent, the patient felt like it went into the bone in her shoulder. The following days, the pain continued to worsen and the patient felt ill with low energy. That week the patient was seen twice in urgent care, first time was prescribed a prednisone taper and second time, the patient was given doxycycline. The patient was found to have elevated erythrocyte sedimentation rate and C-reactive protein (CRP). Reportedly, a tap on patient's shoulder grew methicillin sensitive Staphylococcus aureus (MSSA). The patient was admitted to the hospital and had extensive surgical debridement. The reporter believed that MSSA was inoculated from her vaccine injection, and that the clinical symptoms were masked by the prednisone. There were no complications during the surgery and postoperatively. The patient was given empiric antibiotics, deep venous thrombosis (DVT) prophylaxis with acetylsalicylic acid, thromboembolic deterrent stockings (TEDS), sequential compression devices (SCDs) and encouraged early mobilization. Approximately a week later, the patient was referred for left upper limb deep vein thrombosis ultrasound evaluation (LUE DVT) due to left arm swelling and it revealed a thrombus in the left basilic vein and left cephalic vein. The midline was removed, and she instead received a tunnelled central catheter. Methicillin Sensitive Staph Aureus (MSSA) is common to normal skin flora, which is the likely aetiology of the infection. In conclusion of the quality assurance investigation, there have been no anomalies observed that could be considered a contributing factor in this case for the suspected transmission of an infectious agent. Therefore, causal role of the suspect vaccine is assessed as not related for the events of Staphylococcal infection and suspected transmission of an infectious agent via product. Considering that there were no signs of septicaemia and DVT is common complication of midline catheters, causality is assessed as not related for thrombosis.; Reporter's Comments: The reporter believed that she was inoculated with MSSA from her vaccine injection.; Sender's Comments: A 73-years-old patient was vaccinated with Fluad Quadrivalent. On the same day, while receiving Fluad Quadrivalent, the patient felt like it went into the bone in her shoulder. The following days, the pain continued to worsen and the patient felt ill with low energy. That week the patient was seen twice in urgent care, first time was prescribed a prednisone taper and second time, the patient was given doxycycline. The patient was found to have elevated erythrocyte sedimentation rate and C-reactive protein (CRP). Reportedly, a tap on patient's shoulder grew methicillin sensitive Staphylococcus aureus (MSSA). The patient was admitted to the hospital and had extensive surgical debridement. The reporter believed that MSSA was inoculated from her vaccine injection, and that the clinical symptoms were masked by the prednisone. There were no complications during the surgery and postoperatively. The patient was given empiric antibiotics, deep venous thrombosis (DVT) prophylaxis with acetylsalicylic acid, thromboembolic deterrent stockings (TEDS), sequential compression devices (SCDs) and encouraged early mobilization. Approximately a week later, the patient was referred for left upper limb deep vein thrombosis ultrasound evaluation (LUE DVT) due to left arm swelling and it revealed a thrombus in the left basilic vein and left cephalic vein. The midline was removed, and she instead received a tunnelled central catheter. Methicillin Sensitive Staph Aureus (MSSA) is common to normal skin flora, which is the likely aetiology of the infection. In conclusion of the quality assurance investigation, there have been no anomalies observed that could be considered a contributing factor in this case for the suspected transmission of an infectious agent. Therefore, causal role of the suspect vaccine is assessed as not related for the events of Staphylococcal infection and suspected transmission of an infectious agent via product. Considering that there were no signs of septicaemia and DVT is common complication of midline catheters, causality is assessed as not related for thrombosis.