Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Skin infection, Syncope, Tachycardia, Urinary tract infection, Urticaria
Clinical narrative: Syncope/fainting; Hallucination; Hypotension; Asthenia; Tachycardia; Neutrophil count decreased (low neutrophils); Red blood cell sedimentation rate increased (high sedimentation rate); Lipids increased (high lipids); Skin infection; Urticaria (full body hives); Urinary tract infection; Drug ineffective; COVID-19; vomiting; Clostridium difficile infection (clostridium difficile currently); Headache; Chills; Fatigue; fever (pyrexia); body aches (pain); Hypoglycaemia; Nausea; Adrenal disorder (issue with adrenal function); This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; sarilumab (KEVZARA), first regimen since Oct2019 (Lot number: 9L718J, Expiration Date: 30Jun2023) at 150 mg (150 mg every other week), subcutaneous, second regimen since Oct2019 (Lot number: OL438F, Expiration Date: 30Jun2023) at 150 mg (150 mg every other week), subcutaneous and third regimen) at 150 mg weekly (150 mg qw (every week)) for rheumatoid arthritis, crohn's disease. The patient's relevant medical history included: "nonfamilial hypogammaglobulinemia/Hypogammaglobulinemia, unspecified" (unspecified if ongoing); "disorder involving immune mechanism unspecified" (unspecified if ongoing); "Amyloidosis" (unspecified if ongoing); "Neutropenia" (unspecified if ongoing); "Tachycardia paroxysmal" (unspecified if ongoing); "Cranial nerve palsies multiple" (unspecified if ongoing); "Gastrooesophageal reflux disease" (unspecified if ongoing); "Rhinitis allergic" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "rheumatoid arthritis unspecified" (unspecified if ongoing); "Regional Enteritis of small and Large Intestines" (unspecified if ongoing). Concomitant medication(s) included: LMX 4; HEPARIN; EPINEPHRINE; DIPHENHYDRAMINE; ACETAMINOPHEN; LMX [LIDOCAINE]; HIZENTRA; FLUDROCORTISONE ACETATE; FEMRING; HYDROCORTISONE; DECADRON [DEXAMETHASONE ACETATE]; AJOVY [FREMANEZUMAB]; RIZATRIPTAN; DRISDOL; PREDNISONE; CLOBETASOL; NADOLOL; ALBUTEROL SULFATE HFA; SYNTHROID; CYPROHEPTADINE HCL; ZOFRAN [ONDANSETRON]; DECADRON [DEXAMETHASONE]; HYDROXYZINE HYDROCHLORIDE; NORMAL SALINE; SODIUM CHLORIDE; PRIVIGEN. Past drug history included: Flagyl, notes: with 250 mg tablet; Coumadin, notes: with 1 mg tablet; Norvasc, notes: with 10 mg tablet; Biaxin, notes: with 250 mg tablet; Ceftriaxone, notes: with 1 gm vial 5% ointment; Hydromorphone, notes: with er 12 mg tas er 24b; Clindamycin hcl, reaction(s): "Ongoing Drug hypersensitivity", notes: with capsule; Warfarin sodium, notes: with 1 mg tablet; Midazolam hcl, notes: with 5 mg/5 ml vial; Lidocaine, reaction(s): "Ongoing Drug hypersensitivity", notes: with 4 % cream, 3 % cream (g); Bleph, notes: with eye drops; Tetracycline hcl, notes: with capsule; Fentanyl, reaction(s): "Ongoing Drug hypersensitivity", notes: 100 mcg/hr patch td72; Bactrim, notes: 400mg-80mg tablet; Ciprofloxacin hydrochloride, notes: cipro with 250 mg tablet; Chlorhexidine gluconate, notes: with 2% cloth; Sulfamethoxazole, reaction(s): "Ongoing Drug hypersensitivity", notes: tmp ss tablet; Amoxicillin, reaction(s): "Ongoing Drug hypersensitivity", notes: 250 mg capsule; Levofloxacin, reaction(s): "Ongoing Drug hypersensitivity", notes: 250 mg tablet; Vancocin, reaction(s): "Ongoing Drug hypersensitivity", notes: 125 mg capsule; Norethindrone, reaction(s): "Ongoing Drug hypersensitivity", notes: m35 mg tablet; Vancomycin hcl, reaction(s): "Ongoing Drug hypersensitivity", notes: 1 g vial; Ceftraixone, reaction(s): "Ongoing Drug hypersensitivity"; Clarithromycin, reaction(s): "Ongoing Drug hypersensitivity"; Cleocin hcl, reaction(s): "Ongoing Drug hypersensitivity"; Quinolones, reaction(s): "Ongoing Drug hypersensitivity". The following information was reported: ADRENAL DISORDER (non-serious) with onset Feb2021, outcome "unknown", described as "Adrenal disorder (issue with adrenal function)"; HYPOGLYCAEMIA (non-serious) with onset Feb2021, outcome "unknown"; NAUSEA (non-serious) with onset Feb2021, outcome "recovered"; CHILLS (non-serious) with onset 24Feb2021, outcome "unknown"; FATIGUE (non-serious) with onset 24Feb2021, outcome "unknown"; HEADACHE (non-serious) with onset 24Feb2021, outcome "unknown"; PAIN (non-serious) with onset 24Feb2021, outcome "unknown", described as "body aches (pain)"; PYREXIA (non-serious) with onset 24Feb2021, outcome "unknown", described as "fever (pyrexia)"; CLOSTRIDIUM DIFFICILE INFECTION (medically significant) with onset 2024, outcome "not recovered", described as "Clostridium difficile infection (clostridium difficile currently)"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant), outcome "unknown"; SYNCOPE (medically significant), outcome "unknown", described as "Syncope/fainting"; HALLUCINATION (medically significant), outcome "unknown"; HYPOTENSION (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown"; TACHYCARDIA (non-serious), outcome "unknown"; NEUTROPHIL COUNT DECREASED (non-serious), outcome "unknown", described as "Neutrophil count decreased (low neutrophils)"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), outcome "unknown", described as "Red blood cell sedimentation rate increased (high sedimentation rate)"; LIPIDS INCREASED (non-serious), outcome "unknown", described as "Lipids increased (high lipids)"; SKIN INFECTION (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "Urticaria (full body hives)"; URINARY TRACT INFECTION (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown". The events "drug ineffective ", "covid-19", "clostridium difficile infection (clostridium difficile currently)", "syncope/fainting", "hallucination", "headache", "hypoglycaemia", "nausea", "chills", "fatigue", "fever (pyrexia)", "body aches (pain)", "hypotension", "asthenia", "tachycardia", "neutrophil count decreased (low neutrophils)", "red blood cell sedimentation rate increased (high sedimentation rate)", "lipids increased (high lipids)", "skin infection", "urticaria (full body hives)", "urinary tract infection", "adrenal disorder (issue with adrenal function)" and "vomiting" required physician office visit. The patient underwent the following laboratory tests and procedures: Lipids: High; Neutrophil count: decreased; Red blood cell sedimentation rate: High. The action taken for sarilumab was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19, clostridium difficile infection, syncope, hallucination, headache, hypoglycaemia, nausea, chills, fatigue, pyrexia, pain, hypotension, asthenia, tachycardia, neutrophil count decreased, red blood cell sedimentation rate increased, lipids increased, skin infection, urticaria, urinary tract infection, adrenal disorder, vomiting. Clinical course: The patient's family history was not provided. side effects from third covid vaccine, vomiting. She reported that she had first Pfizer vaccine on 24Feb2021 and side effects were noted starting evening of injection. The patient reported onset of full body hives (urticaria) and has struggled with managing them since 29Apr2021. The patient also had fatigue. Patient's doctor was aware, the patient reported this after Privigen infusion. The patient went to doctor on 01Jul2021. Patient also reported had side effects from third Pfizer covid vaccine lasted 3 days and this is immune response to vaccine (adverse drug reaction). Labs done 28Oct showed low neutrophils (neutrophil count decreased), high sedimentation rate (red blood cell sedimentation rate increased), high lipids (lipids increased). Patient treated with dificid. two-piece adhesive barriers. Corrective treatment: Finished antibiotic for urinary tract infection and not reported for others. Company comment: Based on the limited information provided, the causal role of company drug to cause the events cannot be denied but lack of information regarding family history precludes comprehensive case assessment. Moreover, due to the presence of multiple concomitant medications the role of suspect drug in the development of the events cannot be assessed in isolation.  Reporter Comment: 17Sep2021: 150 mg (Sarilumab) 15 SAR153191IV(sarilumab) 15, 27Oct2021: 150 mg (Sarilumab) SAR153191IV(sarilumab), 16Nov2021: 150 mg (Sarilumab) SAR153191IV(sarilumab), 04Feb2022: 150 mg (Sarilumab) SAR153191IV(sarilumab), 06Apr2022: 150 mg (Sarilumab) SAR153191IV(sarilumab), 29Oct2024: Kevzara (150 mg) KEVZARA (SAR153191IV); Reporter's Comments: 17Sep2021: 150 mg (Sarilumab) 15 SAR153191IV(sarilumab) 15, 27Oct2021: 150 mg (Sarilumab) SAR153191IV(sarilumab), 16Nov2021: 150 mg (Sarilumab) SAR153191IV(sarilumab), 04Feb2022: 150 mg (Sarilumab) SAR153191IV(sarilumab), 06Apr2022: 150 mg (Sarilumab) SAR153191IV(sarilumab), 29Oct2024: Kevzara (150 mg) KEVZARA (SAR153191IV)