Age: 75.0
Sex: F
Vaccine: COVID19, FLUX, UNK, UNK
Symptoms: Head injury, Heart valve incompetence, Hypersomnia, Increased tendency to bruise, Injection site swelling
Clinical narrative: Hoarseness in throat/patient reported continued to had ongoing issues with voice and swallowing at times; Issues with pic lines and access to veins/nurses had difficulty accessing port; While in the hospital pt experienced tachycardia; Patient lost weight/Also reported that patient has lost some weight; Aspirating white foam; Sores in throat and lips; Sores in throat and lips; Sore on foot got infected and began swelling/foot began to ooze pus; Choking on food; Pseudomonas and klebsiella; Patient was recently hospitalized again with issues coughing; Vessel burst in eye; Pseudomonas and klebsiella/Pseudomonas infection in patients bladder; Mini strokes; Kidney and UTI infections in the past; Pneumonia bacteria in respiratory tract; Feeling out of breath; Patient reported continued to had ongoing issues with voice and swallowing at times; Foot pain/legs aching; Fibromyalgia; Losing voice/Patient reported that patient continues to have issues with voice; Contnuing pain in neck and shoulder; Hemorrhoids removed after having a colonoscopy; Patient got bit by cat on hand, it was very painful; POTS; Sinus issues and dripping; Lactaid intolerance; Swelling; Patient having issues with arthritis in hands; Diarrhea; Sever allergies to medications including levequin; Neck cramping; Metallic taste; Patient felt weak/ weakness right side of body; Not feel well; Received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site; Swelling in legs/ Swelling in feet; Feeling cold; Hit head; Patient has lost 4 inches of height; Fluctuating temperature; Also reported having back pain/ Sore back; Sinus issues and dripping; Contnuing pain in neck and shoulder; Patients body tends to not absorb vitamins at a normal rate; Pink eye; Patient reported dizziness and feeling like patient was going to pass out; Mast cell disorder; COVID-19 last week after feeling sick and having a vessel burst in pt eye; Muscle weakness; Trouble sleeping; Received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site; Bad week of IBS; Fatigue / tiredness/ been tired lately; Hip locking; Fell; 3 mild leaky valves in heart; Patient almost fell a few times recently; Patient bloodwork showed low white blood cell count; Ulcer in nose; Bronchitis flares up; Patient has been bruising easily; Atrophy; Redness; Indigestion; Kidney and UTI Infections in the past/UTI; Sleeping a lot; Reported that the PICC line came out due to what believes it being too short; Initial information regarding this unsolicited valid serious case downloaded without narrative, was received on 23-Jun-2023 from non-healthcare professional via regulatory authority (regulatory authority number: US-SHIRE-US202029740). The following narrative is based on the information retrieved from all other accessible data.  This case involves a 75 years old female patient who had mini strokes, kidney and UTI infections in the past, sores in throat and lips, pseudomonas and klebsiella/pseudomonas infection in patients bladder, sore on foot got infected and began swelling/foot began to ooze pus, patient was recently hospitalized again with issues coughing, vessel burst in eye, choking on food, pseudomonas and klebsiella, hoarseness in throat/patient reported continued to had ongoing issues with voice and swallowing at times, issues with pic lines and access to veins/nurses had difficulty accessing port, while in the hospital pt experienced tachycardia, patient lost weight/also reported that patient has lost some weight, aspirating white foam, feeling out of breath, pneumonia bacteria in respiratory tract, patient reported continued to had ongoing issues with voice and swallowing at times, foot pain/legs aching, fibromyalgia, losing voice/patient reported that patient continues to have issues with voice, continuing pain in neck and shoulder, hemorrhoids removed after having a colonoscopy, patient got bit by cat on hand, it was very painful, pots, sinus issues and dripping, lactaid intolerance, swelling, patient having issues with arthritis in hands, diarrhea, sores in throat and lips, sever allergies to medications including levequin, neck cramping, metallic taste, patient felt weak/ weakness right side of body, not feel well, received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site, swelling in legs/ swelling in feet, feeling cold, hit head, patient has lost 4 inches of height, fluctuating temperature, also reported having back pain/ sore back, sinus issues and dripping, contnuing pain in neck and shoulder, patients body tends to not absorb vitamins at a normal rate, pink eye, patient reported dizziness and feeling like patient was going to pass out, mast cell disorder, covid-19 last week after feeling sick and having a vessel burst in pt eye, muscle weakness, trouble sleeping, received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site, bad week of IBS, fatigue / tiredness/ been tired lately, hip locking, fell, 3 mild leaky valves in heart, patient almost fell a few times recently, patient bloodwork showed low white blood cell count, ulcer in nose, bronchitis flares up, patient has been bruising easily, atrophy, redness, indigestion, kidney and UTI infections in the past/UTI, sleeping a lot and reported that the picc line came out due to what believes it being too short after receiving vaccines covid-19 vaccine and influenza vaccine and while treated with levofloxacin [Levaquin] and immunoglobulin human normal [Cuvitru].  The patient's past medical history included Pseudomonas infection. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Tremor with born with this, Ehlers-Danlos syndrome, Primary immunodeficiency syndrome and Common variable immunodeficiency.  On an unknown date, the patient started taking levofloxacin (with an unknown dosage, frequency, strength, formulation, expiry date, batch number) for Product used for unknown indication and immunoglobulin human normal Solution for infusion at a dose of 8 g subcutaneous (with an unknown batch number, expiry date) for Primary immunodeficiency syndrome and Common variable immunodeficiency. On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number, strength, formulation, dosage, expiry date - not reported via unknown route in unknown administration site for prophylactic vaccination and covid-19 vaccine not produced by Sanofi Pasteur (lot number, strength, formulation, dosage, expiry date - not reported via unknown route in unknown administration site for covid-19 immunisation.  On an unknown date, (unknown latency), the patient developed an event of mini strokes (transient ischaemic attack), kidney and uti infections in the past (kidney infection), sores in throat and lips (pharyngeal ulceration), pseudomonas and klebsiella/pseudomonas infection in patients bladder (pseudomonas infection), sore on foot got infected and began swelling/foot began to ooze pus (localised infection), patient was recently hospitalized again with issues coughing (cough), vessel burst in eye (eye haemorrhage), choking on food (choking), pseudomonas and klebsiella (klebsiella infection), hoarseness in throat/patient reported continued to had ongoing issues with voice and swallowing at times (dysphonia), pic lines and access to veins/nurses had difficulty accessing port (poor venous access), while in the hospital pt experienced tachycardia (tachycardia), patient lost weight/also reported that patient has lost some weight (weight decreased), aspirating white foam (aspiration), feeling out of breath (dyspnoea), pneumonia bacteria in respiratory tract (pneumonia bacterial), patient reported continued to had ongoing issues with voice and swallowing at times (dysphagia), foot pain/legs aching (pain in extremity), fibromyalgia, losing voice/patient reported that patient continues to have issues with voice (aphonia), contnuing pain in neck and shoulder (arthralgia), hemorrhoids removed after having a colonoscopy (haemorrhoids), patient got bit by cat on hand, it was very painful (animal bite), pots (postural orthostatic tachycardia syndrome), sinus issues and dripping (upper-airway cough syndrome), lactaid intolerance (lactose intolerance), swelling, patient having issues with arthritis in hands (arthritis), diarrhea (diarrhoea), sores in throat and lips (cheilitis), sever allergies to medications including levequin (drug hypersensitivity), neck cramping (muscle spasms), metallic taste (dysgeusia), patient felt weak/ weakness right side of body (asthenia), not feel well (malaise), received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site (feeling abnormal), swelling in legs/ swelling in feet (peripheral swelling), feeling cold, hit head (head injury),  patient has lost 4 inches of height (body height decreased), fluctuating temperature (body temperature fluctuation), also reported having back pain/ sore back (back pain), sinus issues and dripping (sinus disorder), contnuing pain in neck and shoulder (neck pain), patients body tends to not absorb vitamins at a normal rate (malabsorption), pink eye (conjunctivitis), patient reported dizziness and feeling like patient was going to pass out (dizziness), mast cell disorder (mastocytosis), covid-19 last week after feeling sick and having a vessel burst in pt eye (covid-19), muscle weakness (muscular weakness), trouble sleeping (insomnia), received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site (injection site swelling), bad week of IBS (irritable bowel syndrome), fatigue / tiredness/ been tired lately (fatigue), hip locking (joint lock), fell (fall), 3 mild leaky valves in heart (heart valve incompetence), patient almost fell a few times recently (balance disorder), patient bloodwork showed low white blood cell count (white blood cell count decreased), ulcer in nose (nasal ulcer), bronchitis flares up (bronchitis), patient has been bruising easily (increased tendency to bruise), atrophy, redness (erythema), indigestion (dyspepsia), kidney and uti infections in the past/uti (urinary tract infection), sleeping a lot (hypersomnia), and reported that the picc line came out due to what believes it being too short (device issue) after receiving vaccines covid-19 vaccine and influenza vaccine and while treated with levofloxacin and immunoglobulin human normal.  Relevant laboratory test results included: Body height - On an unknown date:  [Lost 4 inches] SARS-CoV-2 test - On an unknown date: Positive Scan myocardial perfusion - On an unknown date:  [results unknown] Weight - On an unknown date:  [Decreased] White blood cell count - On an unknown date:  [Low count]  Action taken with Levofloxacin And Immunoglobulin Human Normal was unknown. Action taken with covid-19 vaccine and influenza vaccine (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the event patient reported continued to had ongoing issues with voice and swallowing at times, was Unknown for the event foot pain/legs aching, was Unknown for the event fibromyalgia, was Unknown for the event losing voice/patient reported that patient continues to have issues with voice, was Unknown for the event mini strokes, was Unknown for the event contnuing pain in neck and shoulder, was Unknown for the event hemorrhoids removed after having a colonoscopy, was Unknown for the event patient got bit by cat on hand, it was very painful, was Unknown for the event pots, was Not Recovered / Not Resolved for the event sinus issues and dripping, was Unknown for the event lactaid intolerance, was Unknown for the event swelling, was Unknown for the event kidney and uti infections in the past, was Unknown for the event patient having issues with arthritis in hands, was Unknown for the event diarrhea, was Unknown for the event feeling out of breath, was Unknown for the event sores in throat and lips, was Unknown for the event sever allergies to medications including levequin, was Unknown for the event pseudomonas and klebsiella/pseudomonas infection in patients bladder, was Unknown for the event neck cramping, was Unknown for the event sore on foot got infected and began swelling/foot began to ooze pus, was Unknown for the event metallic taste, was Unknown for the event patient felt weak/ weakness right side of body, was Not Recovered / Not Resolved for the event not feel well, was Unknown for the event vessel burst in eye, was Unknown for the event received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site, was Unknown for the event swelling in legs/ swelling in feet, was Unknown for the event feeling cold, was Unknown for the event hit head, was Unknown for the event patient has lost 4 inches of height, was Not Recovered / Not Resolved for the event patient was recently hospitalized again with issues coughing, was Unknown for the event fluctuating temperature, was Unknown for the event also reported having back pain/ sore back, was Unknown for the event choking on food, was Not Recovered / Not Resolved for the event sinus issues and dripping, was Unknown for the event pseudomonas and klebsiella, was Unknown for the event continuing pain in neck and shoulder, was Unknown for the event patients body tends to not absorb vitamins at a normal rate, was Unknown for the event pink eye, was Unknown for the event patient reported dizziness and feeling like patient was going to pass out, was Unknown for the event mast cell disorder, was Unknown for the event covid-19 last week after feeling sick and having a vessel burst in pt eye, was Not Recovered / Not Resolved for the event muscle weakness, was Unknown for the event received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site, was Unknown for the event while in the hospital pt experienced tachycardia, was Unknown for the event bad week of ibs, was Not Recovered / Not Resolved for the event fatigue / tiredness/ been tired lately, was Unknown for the event hip locking, was Unknown for the event fell, was Unknown for the event 3 mild leaky valves in heart, was Unknown for the event patient almost fell a few times recently, was Not Recovered / Not Resolved for the event hoarseness in throat/patient reported continued to had ongoing issues with voice and swallowing at times, was Unknown for the event patient bloodwork showed low white blood cell count, was Unknown for the event ulcer in nose, was Unknown for the event bronchitis flares up, was Unknown for the event patient has been bruising easily, was Unknown for the event atrophy, was Unknown for the event trouble sleeping, was Unknown for the event sores in throat and lips, was Unknown for the event redness, was Unknown for the event patient lost weight/also reported that patient has lost some weight, was Unknown for the event indigestion, was Unknown for the event aspirating white foam, was Unknown for the event pneumonia bacteria in respiratory tract, was Unknown for the event issues with pic lines and access to veins/nurses had difficulty accessing port, was Unknown for the event kidney and uti infections in the past/uti, was Unknown for the event sleeping a lot and was Unknown for the event reported that the picc line came out due to what believes it being too short.  Seriousness criteria: medically significant for the events choking, transient ischaemic attack, pseudomonas infection,, kidney infection, eye haemorrhage, pneumonia bacterial, klebsiella infection, aspiration; and hospitalization for the events pharyngeal ulceration, localised infection, cough, choking,  dysphonia, poor venous access, tachycardia, weight decreased, aspiration, cheilitis  Sender's comments: The company assessed the events of Pseudomonas infection, Klebsiella infection, Kidney infection, Localised infection, Poor venous access, Dysphonia, Cheilitis, Pharyngeal ulceration, Tachycardia, Choking, Weight decreased, Cough, Aspiration, Transient ischaemic attack, Pneumonia bacterial, and Eye haemorrhage as not related to CUVITRU and INFLUENZA vaccine. There is no compelling evidence to implicate suspect products to events. The events Transient ischaemic attack and Tachycardia were more consistent with the age related risk factors. The events Pseudomonas infection, Klebsiella infection, Kidney infection, Localised infection, and Pneumonia bacterial were more consistent with infectious processes and increased risk of infection associated with underlying common variable immunodeficiency. Poor venous access was more consistent with long term medical treatment and the challenge of vascular access and medical history of Ehlers-Danlos syndrome. Weight decreased was more consistent with complication of underlying condition. Cough, and Aspiration were possibly consistent with increased risk of lung disorder associated with underlying Common variable immunodeficiency in this elderly patient.; Sender's Comments: Sanofi company comment dated 29-JUN-2023: This case involves a 75 years old female patient who had mini strokes, kidney and UTI infections in the past, sores in throat and lips, pseudomonas and klebsiella/pseudomonas infection in patients bladder, sore on foot got infected and began swelling/foot began to ooze pus, patient was recently hospitalized again with issues coughing, vessel burst in eye, choking on food, pseudomonas and klebsiella, hoarseness in throat/patient reported continued to had ongoing issues with voice and swallowing at times, issues with pic lines and access to veins/nurses had difficulty accessing port, while in the hospital pt experienced tachycardia, patient lost weight/also reported that patient has lost some weight, aspirating white foam, feeling out of breath, pneumonia bacteria in respiratory tract, patient reported continued to had ongoing issues with voice and swallowing at times, foot pain/legs aching, fibromyalgia, losing voice/patient reported that patient continues to have issues with voice, continuing pain in neck and shoulder, hemorrhoids removed after having a colonoscopy, patient got bit by cat on hand, it was very painful, pots, sinus issues and dripping, lactaid intolerance, swelling, patient having issues with arthritis in hands, diarrhea, sores in throat and lips, sever allergies to medications including levequin, neck cramping, metallic taste, patient felt weak/ weakness right side of body, not feel well, received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site, swelling in legs/ swelling in feet, feeling cold, hit head, patient has lost 4 inches of height, fluctuating temperature, also reported having back pain/ sore back, sinus issues and dripping, continuing pain in neck and shoulder, patients body tends to not absorb vitamins at a normal rate, pink eye, patient reported dizziness and feeling like patient was going to pass out, mast cell disorder, covid-19 last week after feeling sick and having a vessel burst in pt eye, muscle weakness, trouble sleeping, received flu shot and reacted to it, feeling bad for a few days and having swelling at injection site, bad week of IBS, fatigue / tiredness/ been tired lately, hip locking, fell, 3 mild leaky valves in heart, patient almost fell a few times recently, patient bloodwork showed low white blood cell count, ulcer in nose, bronchitis flares up, patient has been bruising easily, atrophy, redness, indigestion, kidney and UTI infections in the past/UTI, sleeping a lot and reported that the picc line came out due to what believes it being too short after receiving vaccines covid-19 vaccine and influenza vaccine and while treated with levofloxacin [Levaquin] and immunoglobulin human normal [Cuvitru]. Although the role of suspect cannot be denied for the events, however lack of information regarding details surrounding the events, clinical course precludes the comprehensive assessment of this case. Furthermore, medical history of patient is also a confounding factor.