Sex: F
Vaccine: FLUA4
Symptoms: Animal bite, Blood culture negative, Blood lactic acid, C-reactive protein increased, Cellulitis
Clinical narrative: Right hand cellulitis; This clinical trial case, initially received on 12-Feb-2024 with additional information received on 13-Feb-2024, was reported by a health professional and concerns an elderly female subject. Weight: 179 kg; Height: 69 cm  The subject was enrolled in the study  Past medical history included Cataract bilateral, Bilateral knee replacement, Bilateral cataract removal, Squamous cell carcinoma right lower leg, Squamous cell carcinoma right lower leg removal. At the time of the event the subject had Osteoarthritis, generalized, Macular degeneration, Tinnitus, Seasonal allergies, Hypercholesterolemia, Hair loss. Concomitant medication: refer to appropriate report section.  The subject's historical vaccine included influenza vaccine (brand not specified), received on 22-Sep-2022, for unreported indication. The patient had influenza vaccinations within three previous influenza seasons.  Administration of company suspect drug(s): On 28-Nov-2023 08:54, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular, anatomical location: left deltoid. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 02-Feb-2024, the subject experienced Right hand cellulitis (Hospitalized, outcome: Recovered / Resolved, stop date: 19-Aug-2024). Intensity: Severe   On 27-Jan-2024, 61 days after receiving blinded study vaccine aQIVc HD vs QIVr vs aQIV, the subject was bitten by a cat on her right hand. The subject started treatment of Keflex (cefalexin), 500 mg, for right hand cellulitis, by her dermatologist.  On 29-Jan-2024, the subject stopped treatment with Keflex.   On 30-Jan-2024, the subject presented to the emergency room (ER) for worsening symptoms, then sent home.  On an unspecified date in 2024, the subject had transient improvement followed by increased erythema and swelling with reduced range of motion (ROM) of her 4th and 5th right fingers. The subject denied fevers, chills, or other symptoms. On exam, her temperature 97.7ºF, pulse 78 bpm, respirations 15 rpm, BP 135/75 mmHg, SpO2 95% on room air. The rest of the subject's exam revealed only erythema and swelling of her right hand with an eschar covered wound on the dorsum and reduced ROM of her 4th and 5th fingers. Right hand x-ray revealed soft tissue swelling c/w cellulitis, but no evidence of bone changes or osteomyelitis; there was incidental evidence of CPPD crystal deposition at the wrist. Pertinent labs included WBC 6.2 K/mm3 (4.3-11.0), lactic acid 1.7 mmol/L (0.5- 2.2), and CRP 2.1 mg/dl (0-0.3).  On 01-Feb-2024, the subject presented to ER with right arm pain five days following cat bite to her right hand.  On 02-Feb-2024, two months and 6 days days after receiving blinded study vaccine aQIVc HD vs QIVr vs aQIV, the subject was admitted to the hospital.  On an unspecified day in Feb-2024, blood and wound cultures were obtained (no growth at time of discharge). The subject was treated with IV Unasyn 3 gm q 6 hr per ID recommendation. The surgery consultant found no evidence of abscess and agreed with antibiotic choice.   On 04-Feb-2024, the subject was discharged from the hospital on Augmentin 875 mg twice a day (BID) for 11 days with follow up to primary care provider (PCP) in 1-2 weeks, as the subject showed gradual improvement.   Lab tests: Feb-2024 blood and wound cultures: No growth at time of discharge Unspecified date in 2024 lactid acid: 1.7 mmol/L (0.5-2.2); blood pressure: 135/75 mmHG, Body temperature: 97.7 F, pulse (heart rate): 78 bpm, SpO2: 95% on room air, respirations: 15 rpm, CRP: 2.1 mg/dL (0-0.3), WBC: 6.2 K/mm3 (4.3-11.0), right hand x-ray: Soft tissue swelling c/w cellulitis, but no evidence of bone changes or osteomyelitis; there was incidental evidence of CPPD crystal deposition at the wrist  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable Treatment medication: Augmentin, 875 mg Twice a day, Dexamethasone, Keflex 500 mg, Unasyn 3 mg Four times a day  Reporter's assessment: The Investigator considered the events Right hand cellulitis as severe and serious due to seriousness criterion of hospitalization. The event was assessed as not related to the study vaccine. The alternative cause for the event was reported as 'concomitant disease'.  The subject remained blinded in the study.  Follow-up received on 02-Mar-2024 with additional information received on 04-Mar-2024, 06-Mar-2024, and 07-Mar-2024 (being processed together) from Investigator: Amoxicillin removed as an treatment. Keflex (cefalexin), ceftriaxone, methylprednisolone, Augmentin (amoxicillin sodium, clavulanate potassium), dexamethasone, and Unasyn (ampicillin sodium, sulbactam sodium) added as treatments. Verbatim for Adverse event changed from from Right Hand Wound Infection to Right Hand Cellulitis and LLT recoded from 'wound infection' to 'cellulitis of hand'. Route of administration and anatomical location for the study vaccine added. Lab data added. Emergency Room Visit ticked. Narrative and case comment were amended accordingly.  Follow-up received on 08-Mar-2024 with additional information received on 12-Mar-2024 (being processed together) from the Investigator: Treatment medication of methyprednisolone and ceftriaxone removed. Start date for the serious adverse event and hospitalization changed from '01-Feb-2024' to '02-Feb-2024'. The narrative was amended accordingly.  Follow-up (13-Nov-2024) received from investigator: Outcome of event updated, stop date of event provided. Fields and narrative updated.; Reporter's Comments: The Investigator assessed the event of 'cellulitis of hand' as severe and serious due to seriousness criterion of hospitalization. The event was assessed as not related to the study vaccine. The alternative cause for the event was reported as 'concomitant disease'.  Company Comment: On 27-Jan-2024, 61 days after receiving blinded study vaccine aQIVc HD vs QIVr vs aQIV, the subject was scratched by a cat on right hand. Subject started treatment with Keflex (cefalexin). Subject had worsening of symptoms - increased erythema, swelling, reduced range of motion of 4th and 5th right finger. Right hand X-ray revealed soft tissue swelling c/w cellulitis, with no evidence of bone changes or osteomyelitis. On 02-Feb-2024, 67 days after receiving the blinded study vaccine, the subject was admitted to the hospital due to right arm pain five days following cat bite on her right hand. The surgery consultant found no evidence of abscess and agreed with antibiotic choice. The subject started treatment with ceftriaxone and methylprednisolone for cellulitis in hand. In line with investigator's causality assessment, causality is assessed as not related due to biological implausibility. Alternative cause is of scratch/ bite from a cat.