이상반응 보고

VAERS ID	2013313
성별	남성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	2
접종일	2021-06-08
발병일	2021-07-24
상태	입원 사망

증상

발열(Pyrexia)
설사(Diarrhoea)
호흡곤란(Dyspnoea)
통증(Pain)
메스꺼움(Nausea)
발진(Rash)
가려움증(Pruritus)
연하 곤란(Dysphagia)
호산구 비율(Eosinophil percentage)
산소포화도 감소(Oxygen saturation decreased)
청색증(Cyanosis)
C 반응성 단백질(C-reactive protein)
배뇨곤란(Dysuria)
혈액 크레아틴 포스포키나제(Blood creatine phosphokinase)
부패(Sepsis)
구염(Stomatitis)
체온(Body temperature)
산소 포화도(Oxygen saturation)
전반적인 신체 건강 악화(General physical health deterioration)
알라닌 아미노전이효소(Alanine aminotransferase)
아스파르테이트 아미노전이효소(Aspartate aminotransferase)
백혈구 수(White blood cell count)
포부(Aspiration)
점막 염증(Mucosal inflammation)
과다 복용(Overdose)
스티븐스-존슨 증후군(Stevens-Johnson syndrome)
혈관 이식(Vascular graft)
심근허혈(Myocardial ischaemia)
산증(Acidosis)
패혈성 심근염(Myocarditis septic)

이환 중 질병

Bone neoplasm malignant; Diabetes mellitus; Lacunar infarction; Myocardial infarction; Prostate cancer; Rheumatoid arthritis

지병

Medical History/Concurrent Conditions: Acute myocardial infarction; Ex-smoker (For 30 years); Helicobacter pylori infection; Neuropathic pain; Radiotherapy

기타 의료

FAMOTIDINE; BAYASPIRIN; BEZAFIBRATE; METHYCOBAL; EPADEL-S; IFENPRODIL; SEIBULE; CELECOXIB; MUCOSTA; PREDONINE [PREDNISOLONE]; RANMARK; RHEUMATREX [METHOTREXATE]; FOLIAMIN [FOLIC ACID]

이전 예방접종

알레르기

임상 검사

Test Date: 20210720; Test Name: ALT; Result Unstructured Data: Test Result:8 IU/l; Test Date: 20210810; Test Name: ALT; Result Unstructured Data: Test Result:10 IU/l; Test Date: 20210813; Test Name: ALT; Result Unstructured Data: Test Result:51 IU/l; Test Date: 20210816; Test Name: ALT; Result Unstructured Data: Test Result:73 IU/l; Test Date: 20210818; Test Name: ALT; Result Unstructured Data: Test Result:37 IU/l; Test Date: 20210720; Test Name: AST; Result Unstructured Data: Test Result:12 IU/l; Test Date: 20210810; Test Name: AST; Result Unstructured Data: Test Result:18 IU/l; Test Date: 20210813; Test Name: AST; Result Unstructured Data: Test Result:46 IU/l; Test Date: 20210816; Test Name: AST; Result Unstructured Data: Test Result:55 IU/l; Test Date: 20210818; Test Name: AST; Result Unstructured Data: Test Result:136 IU/l; Test Date: 20210720; Test Name: CK; Result Unstructured Data: Test Result:45 IU/l; Test Date: 20210810; Test Name: CK; Result Unstructured Data: Test Result:53 IU/l; Test Date: 20210813; Test Name: CK; Result Unstructured Data: Test Result:69 IU/l; Test Date: 20210816; Test Name: CK; Result Unstructured Data: Test Result:82 IU/l; Test Date: 20210817; Test Name: CK; Result Unstructured Data: Test Result:103 IU/l; Test Date: 20210818; Test Name: CK; Result Unstructured Data: Test Result:1400 IU/l; Test Date: 20210815; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.
4 Centigrade; Test Date: 20210816; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.
1 Centigrade; Test Date: 20210818; Test Name: Pyrexia; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210720; Test Name: CRP; Test Result: 0.
24 mg/dl; Test Date: 20210810; Test Name: CRP; Test Result: 4.
96 mg/dl; Test Date: 20210813; Test Name: CRP; Test Result: 7.
3 mg/dl; Test Date: 20210816; Test Name: CRP; Test Result: 23.
16 mg/dl; Test Date: 20210818; Test Name: CRP; Test Result: 23.
56 mg/dl; Test Date: 20210810; Test Name: Eos; Test Result: 6 %; Test Date: 20210813; Test Name: Eos; Test Result: 2 %; Test Date: 20210816; Test Name: Eos; Test Result: 1 %; Test Date: 20210818; Test Name: Eos; Test Result: 5 %; Test Date: 20210816; Test Name: SPO2; Test Result: 88.
9 %; Test Date: 20210720; Test Name: WBC; Result Unstructured Data: Test Result:3.
7 x10 3/mm3; Test Date: 20210810; Test Name: WBC; Result Unstructured Data: Test Result:3.
9 x10 3/mm3; Test Date: 20210813; Test Name: WBC; Result Unstructured Data: Test Result:4.
9 x10 3/mm3; Test Date: 20210816; Test Name: WBC; Result Unstructured Data: Test Result:2.
4 x10 3/mm3; Test Date: 20210818; Test Name: WBC; Result Unstructured Data: Test Result:0.
5 x10 3/mm3

증상 상세

difficulty with food intake; Acidosis; Cyanosis; myocardial ischemia was suspected; septic cardiomyopathy was suspected; Bypass surgery; Aspiration of gastric juice like substance due to sputum inhalation; general condition deterioration; Possibility of drug-induced mucositis; Oxygen saturation(SPO2): 88.
9%.
; pyrexia at 40 degrees Centigrade; Stomatitis; Stools watery/Diarrhoea; The pain was strong; The patient hadn't been urinating; Feeling queasy; Dyspnea; Stevens-Johnson syndrome; skin eruption in head, back, and limbs; Itching; overdose; Sepsis; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency.
Regulatory authority report number is i21106241.
A 72-year-old male patient received the second dose of COVID-19 vaccine (Manufacture unknown, Lot number and Expiration date: unknown), 0.
5 ml via intramuscular on 24Jul2021 as dose 2, single for COVID-19 immunisation.
The patient had no allergies, past drug event, drinking habit.
Relevant medical history included: Prostate cancer (ongoing); Rheumatoid arthritis (ongoing); Multiple metastatic bone tumors (ongoing); Diabetes mellitus (ongoing); Myocardial infarction (ongoing); Lacunar infarction (ongoing); Helicobacter pylori infection (not ongoing); Neuropathic pain; acute myocardial infarction (AMI); Ex-smoker (not ongoing), notes: For 30 years; Radiotherapy.
Concomitant medications included: Famotidine (FAMOTIDINE D Tablet 20mg), oral, stop date: 17Aug2021; Acetylsalicylic acid (BAYASPIRIN Tablet 100mg), oral; Bezafibrate(BEZAFIBRATE SR Tablet 100mg), oral, stop date: 17Aug2021; Mecobalamin (METHYCOBAL Tablet 259mg), oral, stop date: 17Aug2021; Ethyl Icosapentate (EPADEL-S900), oral, stop date: 17Aug2021; Ifenprodil Tartrate (IFENPRODIL Tablet 10mg), oral, stop date: 17Aug2021; Miglitol (SEIBULE Tablet 50mg) oral, ; Celecoxib (CELECOXIB Tablet 100mg) oral, ; Rebamipide (MUCOSTA Tablet 100ng), oral, stop date: 17Aug2021; Prednisolone (PREDONINE Tablet 5mg), oral, start date: 20Jul2021, stop date: 16Aug2021; Denosumab (RANMARK SUBCUTANEOUS INJECTION 120mg), subcutaneous, start date: 14Jun2021, stop date: 02Aug2021; Methotrexate (RHEUMATREX Tablet 2mg), oral ; Folic Acid (FOLIAMIN Tablet 5mg) oral.
From 08Jun2021 to 10Aug2021, the patient received enzalutamide (XTANDI), orally at 160 mg once daily for prostate cancer.
From 14Jun2021 to 16Aug2021, the patient received mirogabalin besilate (TARLIGE), orally at 20 mg twice daily for neuropathic pain.
Vaccination history included: Covid-19 vaccine (1st dose, Manufacture unknown), for COVID-19 immunisation.
On 27Jul2021(3 days after the vaccination), the patient experienced Stevens-Johnson syndrome.
On 13Aug2021 (20 days after the vaccination), the patient was admitted to the hospital.
The course of the event was as follows:On 27Jul2021, the patient experienced skin eruption in head, back, and limbs, and he also experienced itching.
On 03Aug 2021, Betamethasone Butyrate Propionate (ANTEBATE OINTMENT), Heparinoid (HEPARINOID CREAM), Olopatadine Hydrochloride (OLOPATADINE Tablet ) were started.
On 06Aug2021, symptoms of back was improved, itching was recovering, eruption of limbs was continued.
Medication was continued.
On 10Aug2021, enzalutamide was discontinued.
The patient had cough, dyspnoea.
On 12Aug2021, the patient experienced feeling queasy.
The patient had red lips, and different character rash fom before appeared on lower lip.
On 13Aug2021, the patient was admitted to hospital due to difficulty with food intake.
Temporary prescription of AZ gargle water containing Lidocaine Hydrochloride Monohydrate (Xylocaine 4%) was administered (3-4 times a day).
The patient had erythema on the whole body, especially terrible on the back, and the itchy skin eruption worsened.
Stools watery and diarrhea developed.
Redness all over the oral cavity, lichen planus, erosions on the lips appeared.
The pain was strong.
The patient hadn't been urinating.
On 14Aug2021, Codeine Phosphate Hydrate(CODEINE PHOSPHATE POWDER 1%) 2g x 3 times a day was prescribed for cough.
Triamcinolone Acetonide (ORTEXER Oral Ointment 0.
1%) was prescribed for stomatitis.
On 15Aug2021, pyrexia at 38.
4 degrees Centigrade developed.
And pyrexia resolved after using Acetaminophen (ACELIO) 0.
5V.
On 16Aug2021, the patient visited dermatologist, diagnosed with Stevens-Johnson syndrome (SJS).
And visited otolaryngologist, discussed possibility of drug-induced mucositis.
Mirogabalin besilate, oral prednisolone were discontinued.
Prednisolone Sodium Succinate (PREDONINE for Injection 20mg) was used with 75 mg once a day for three days.
pyrexia at 38.
1 degrees Centigrade developed.
And pyrexia resolved after using Acetaminophen 0.
5V.
Oxygen saturation(SPO2): 88.
9%.
On 17Aug2021, the patient experienced aspiration of gastric juice like substance due to sputum inhalation, and dyspnoea.
The patient was moved to ICU due to general condition deterioration.
There was some epidermal exfoliation and exudate, and applied gauze to the wound.
Erythema markedly worsened.
On 18Aug2021, Percutaneous CardioPulmonary Support (PCPS), Intra-aorticballoon pumping (IABP) were inserted.
pyrexia at 40 degrees Centigrade developed.
Oral and skin eruption could not be confirmed due to post bypass surgery.
Myocardial ischemia, septic cardiomyopathy was suspected.
On 19Aug2021, acidosis continued, cyanosis symptoms appeared all over the body.
The patient was hospitalized for dysphagia (start date: 13Aug2021).
The events "stevens-johnson syndrome", "possibility of drug-induced mucositis" and "pyrexia at 40 degrees centigrade" were evaluated at the physician office visit.
The event "general condition deterioration" was evaluated at the emergency room visit.
Other laboratory tests included:On 20Jul2021, alanine aminotransferase(ALT): 8 IU/l, aspartate aminotransferase(AST): 12 IU/l, blood creatine phosphokinase(CK):45 IU/l, c-reactive protein(CRP): 0.
24 mg/dl; white blood cell count(WBC): 3.
7 x10^3/mm3;On 10Aug2021, ALT 10 IU/l, AST: 18 IU/l , CK: 53 IU/l, CRP : 4.
96 mg/dl; Eosinophil(Eos): 6 %; WBC: 3.
9 x10^3/mm3;On 13Aug2021, ALT: 51 IU/l, AST: 46 IU/l, CK: 69 IU/l, CRP: 7.
3 mg/dl; EOS: 2 %; WBC: 4.
9 x10^3/mm3;On 16Aug2021, ALT: 73 IU/l, AST: 55 IU/l, CK: 82 IU/l, CRP: 23.
16 mg/dl; EOS: 1 %; WBC: 2.
4 x10^3/mm3;On 17Aug2021, CK: 103 IU/l.
On18Aug2021, ALT:37 IU/l, AST: 136 IU/l, CK: 1400 IU/l, CRP: 23.
56 mg/dl; EOS: 5 %; WBC: 0.
5 x10^3/mm3.
Therapeutic measures were taken as a result of stevens-johnson syndrome, vascular graft, rash, pruritus, stomatitis, mucosal inflammation, oxygen saturation decreased, pyrexia.
The reported cause of death was stevens-johnson syndrome.
It was not reported if an autopsy was performed.
On 19Aug2021 (26 days after the vaccination), the outcome of the event was fatal and all other events was unknown.
The patient died.
The reporting pharmacist classified the event Stevens-Johnson syndrome as serious (death), and the seriousness of the other events was not provided.
The reporting pharmacist classified enzalutamide, mirogabalin besilate as other suspect drug.
The reporting pharmacist classified the causal relationship between the suspected drugs and death was related.
The causality between the events and COVID-19 vaccine was not provided.
Other treatment/diagnosis that may affect the occurrence of side effects: radiotherapy.
The reporting pharmacist commented as follows:The patient developed sepsis following the onset of SJS with enzalutamide as the suspect drug.
The patient, who was originally an AMI patient, could not stop the deterioration of his general condition and died.
It was considered that the onset of SJS was the trigger for the series of events.
The lot number for BNT162B2 was not provided and will be requested during follow up.
; Reported Cause(s) of Death: Stevens-Johnson syndrome