Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Mouth swelling, Muscular weakness, Myalgia, Nasal congestion
Clinical narrative: pneumonia; collapsed right lung; swelling of the mouth and tongue; swelling of the mouth and tongue; hives all over her body; itchiness all over her body; unable to void; swelling of face, eyes, and lips; swelling of face, eyes, and lips; facial paralysis; DVT; swelling of face, eyes, and lips; back pain; tachycardia; stomach pain; renal problems; redness and pain in her eyes; dizziness; nausea; vomiting; diarrhea; tremoring; redness and pain in her eyes; slurring her words; temperature of 102 F; pain, muscle weakness, acheyness; chills, shivering; myalgia; headache; joint pain, arthritic pain; nasal congestion; difficulty swallowing; bad cough; anorexia; Initial information received on 14-Nov-2019 and additional information received on 15-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 86 years old female patient who experienced swelling of face, eyes, and lips (Face oedema), facial paralysis (Facial paralysis), DVT (Deep vein thrombosis), back pain (back pain), tachycardia (tachycardia), stomach pain (Abdominal pain upper), anorexia (Decreased appetite), tremoring (tremor), redness and pain in her eyes (Eye pain) (Ocular hyperaemia), slurring her words (Dysarthria), renal problems (Renal disorder), joint pain, arthritic pain (Arthralgia), nasal congestion (nasal congestion), difficulty swallowing (Dysphagia), bad cough (cough), dizziness (dizziness), nausea (nausea), vomiting (vomiting), diarrhea (Diarrhoea), chills, shivering (chills), unable to void, which is very atypical (dysuria), myalgia (Myalgia), headache (headache), temperature of 102 f (pyrexia) and pain, muscle weakness, acheyness (muscular weakness), pneumonia (pneumonia), a collapsed right lung (Pneumothorax) and has had swelling of the mouth and tongue (Swollen tongue and mouth swelling), itchiness and hives all over her body (Pruritus and urticaria) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Family history were not provided. Patients medical history included, ongoing Lung neoplasm malignant with reports that patient had a bad reaction to last immunotherapy treatment and completed her immunotherapy for lung cancer on June 12, 2019.  On 20-Oct-2019, the patient received a 0.5 mL first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (frequency once) lot number not reported via unknown route in unknown administration site.  On 20-Oct-2019, the patient began to feel bad, muscle weakness, acheyness (asthenia), chills, shivering (chills), myalgia, headache, bad cough (cough), difficulty swallowing (dysphagia), anorexia (decreased appetite) and nasal congestion, joint pain, arthritic pain (arthralgia) about two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized 24 days after this event occurred.  On 12-Nov-2019, the patient developed a serious temperature of 102 F (body temperature increased), slurring her words (dysarthria) 23 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized 1 day after this event occurred.  On 13-Nov-2019, the patient developed a serious back pain, nasal congestion, stomach pain (abdominal pain upper), tremoring (tremor), swelling of face, eyes, and lips (face swelling, eye edema, swelling lip), renal problems (renal disorder), unable to void, which is very atypical (dysuria), dizziness, nausea, vomiting, diarrhea (diarrhoea) 24 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient was hospitalized on the same day this event occurred. On the same day, patient had serious tachycardia, facial paralysis, redness and pain in her eyes (eye pain and ocular hyperaemia).   On an unknown date, the patient developed a serious DVT (deep vein thrombosis), pneumonia (pneumonia), a collapsed right lung (Pneumothorax) and has had swelling of the mouth and tongue (Swollen tongue and mouth swelling), itchiness and hives all over her body (Pruritus and urticaria) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant and life-threatening. The patient was hospitalized on the same day this event occurred. Relevant laboratory test results included: Ultrasound: DVT has been found in her right leg Blood pressure measurement - On an unknown date: 77/46 Eosinophil count - On an unknown date: high  Final diagnosis was pain, muscle weakness, achiness, headache, myalgia, chills, shivering, bad cough, difficulty swallowing, nasal congestion, joint pain, arthritic pain, anorexia, temperature of 102 F, slurring her words, diarrhea, vomiting, nausea, dizziness, renal problems, tremoring, stomach pain, Severe back pain, facial paralysis, swelling of face, eyes, and lips, redness and pain in her eyes, redness and pain in her eyes, tachycardia, pneumonia (pneumonia), a collapsed right lung (Pneumothorax) and has had swelling of the mouth and tongue (Swollen tongue and mouth swelling), itchiness and hives all over her body (Pruritus and urticaria) and DVT.   The patient was treated with ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for Deep vein thrombosis. When a catheter was inserted, 1L of urine was removed from her bladder.  The patient outcome is reported as unknown for all the events.   Information on the batch number was requested.; Sender's Comments: This case concerns a 86 years old female patient who presented with pain, muscle weakness, acheyness, headache, myalgia, chills, shivering, bad cough, difficulty swallowing, nasal congestion, joint pain, arthritic pain, anorexia, temperature of 102 f, slurring her words, diarrhea, vomiting, nausea, dizziness, renal problems, tremoring, stomach pain, Severe back pain, facial paralysis, swelling of face, eyes, and lips, redness and pain in her eyes, redness and pain in her eyes, tachycardia and DVT after vaccination with FLUZONE HIGH DOSE and was hospitalized. The time to onset is compatible with role of vaccine except the events deep vein thrombosis, tachycardia, redness and pain in her eyes. However, patient's medical condition at time of vaccination and complete lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.