有害事象報告詳細

VAERS ID	1348594
性別	女性
年齢
州コード	FR
製薬会社	ファイザー
ロット番号	EX7389
ワクチン接種回数	1
接種日	2021-04-30
発生日	2021-05-01
状態

症状

四肢の痛み(Pain in extremity)
発熱(Pyrexia)
前失神(Presyncope)
寒気(Chills)
無力症(Asthenia)
嘔吐(Vomiting)
腹痛(Abdominal pain)
胸部X線(Chest X-ray)
心室性期外収縮(Ventricular extrasystoles)
心電図(Electrocardiogram)
発作(Seizure)
腹痛が少ない(Abdominal pain lower)
便秘(Constipation)
鼓腸(Flatulence)
呼吸音が異常に聞こえる(Breath sounds abnormal)
血圧測定(Blood pressure measurement)
ラ音(Rales)
胆嚢障害(Gallbladder disorder)
体温(Body temperature)
心拍数(Heart rate)
酸素飽和度(Oxygen saturation)
呼吸数(Respiratory rate)
身体検査(Physical examination)
超音波腹部(Ultrasound abdomen)
高熱(Hyperpyrexia)
心雑音(Cardiac murmur)
大動脈動脈硬化症(Aortic arteriosclerosis)
脂肪肝(Hepatic steatosis)
子宮平滑筋腫(Uterine leiomyoma)
血栓症後症候群(Post thrombotic syndrome)

罹患中の病気

持病

Medical History/Concurrent Conditions: Aortic stenosis; Artificial cardiac pacemaker user; Bradycardia; Factor V Leiden mutation; Hospitalisation; Hypertensive heart disease; Pulmonary thromboembolism; Syncope

その他医療

LEVOPRAID [LEVOSULPIRIDE]; PANTORC; DELORAZEPAM; CARDURA; MIRTAZAPINE; COUMADIN; STILNOX; LASIX [FUROSEMIDE]

以前のワクチン接種

アレルギー

臨床検査

Test Date: 20210505; Test Name: Blood pressure; Result Unstructured Data: Test Result:unknown results; Test Date: 20210505; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210505; Test Name: Chest X-ray; Result Unstructured Data: Test Result:No pathological distension; Comments: No pathological distension of the colic frame or jejunal loops.
No air-fluid levels.
No signs of free air; Test Date: 20210505; Test Name: ELECTRO-CARDIOGRAM; Result Unstructured Data: Test Result:Normofrequent arterial fibrillation, rare Ventricu; Comments: Normofrequent arterial fibrillation, rare Ventricular Ectopic Beats, no acute ST-T changes.
; Test Date: 20210505; Test Name: Heart rate; Result Unstructured Data: Test Result:unknown results; Test Date: 20210505; Test Name: Oxygen saturation; Test Result: 97 %; Comments: Arterial Oxygen Saturation 2 06% aa at 12:09 aa, at 13:35 re-evaluation Arterial Oxygen Saturation 2 97% aa; Test Date: 20210505; Test Name: physical examination; Result Unstructured Data: Test Result:oriented and cooperative; Comments: Objective exam: oriented and cooperative.
Reduced vesicular sounds with fine crepitations in right basal area.
Valid, rhythmic heart tones with systolic murmur.
Painful and tender abdomen in right hypogastrium without signs of peritonism with turbid peristalsis.
Negative Murphy.
Negative Giordano.
No declivous oedema, pain on medial side of thigh bilaterally without signs of inflammation, bilateral post-phlebitic syndrome in the legs.
The patient moves the four limbs; Test Date: 20210505; Test Name: Respiratory rate; Result Unstructured Data: Test Result:unknown results; Test Date: 20210505; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:Ultrasound examination; Comments: Ultrasound examination performed in the emergency room and markedly hampered by the patient's habitus and widespread intestinal meteorism.
Liver only partially assessed intercostally, modestly increased in volume with diffusely hyperechogenic echostructure as per steatosis; some isolated parenchymal microcystic aspects concomitant.
Gallbladder distended, with walls not significantly thickened but contents finely corpusculated.
Pancreas masked as meteorism.
Spleen within limits.
Kidneys bilaterally in place in the absence of obvious uretero- pyelocaliectasis; some bilateral parenchymal cystic formations the largest of which approximately 6 cm at the left lower pole.
Diffuse calcific atheromasia of the portions of the abdominal aorta that could be explored.
Full bladder, transonic content; no free effusion in abdomen at present.
Uterus of globular and lumpy appearance, with some contextual calcific images of presumably fibromyomatous nature.

症状詳細

bilateral post-phlebitic syndrome in the legs; widespread intestinal meteorism; Liver only partially assessed intercostally, modestly increased in volume with diffusely hyperechogenic echostructure as per steatosis; Gallbladder distended; Diffuse calcific atheromasia of the portions of the abdominal aorta; Uterus of globular and lumpy appearance, with some contextual calcific images of presumably fibromyomatous nature; rare Ventricular Ectopic Beats; systolic murmur; Painful and tender abdomen in right hypogastrium; fever/body temperature was 38 centigrade; chills; alimentary vomiting; abdominal pain; asthenia; pre-lipothymia; bilateral pain in the thighs; convulsion; hyperpyrexia; Constipation; Breath sounds decreased; Crackles lung; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, number IT-MINISAL02-725416.
A 79-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via intramuscular in the right arm on 30Apr2021 16:04 (Lot number: EX7389, Expiration Date: 31Aug2021) at 0.
3 ml, single dose for COVID-19 immunisation.
Medical history included hypertensive heart disease, artificial cardiac pacemaker user, pulmonary thromboembolism, aortic stenosis, factor v leiden mutation, bradycardia, all were from unknown date and unknown if ongoing; and syncope on 29 march with hospitalisation.
No existence of drug allergies.
Concomitant medications included levosulpiride (LEVOPRAID [LEVOSULPIRIDE]), pantoprazole sodium sesquihydrate (PANTORC), delorazepam, doxazosin mesilate (CARDURA), mirtazapine, warfarin sodium (COUMADIN), zolpidem tartrate (STILNOX), furosemide (LASIX [FUROSEMIDE]).
On 01May2021, patient was admitted to the emergency room following the administration of the first dose of the vaccine for SARS-CoV-2, with fever with chills, alimentary vomiting and abdominal pain associated with asthenia and pre-lipothymia.
The patient reported bilateral pain in the thighs.
The patient had not evacuated for 4 days, but reported gases.
After vaccine on 01May2021, the patient had convulsions and hyperpyrexia, constipation, breath sounds decreased, crackles lung.
Lab data on 05May2021 included blood pressure with unknown results; body temperature was 38 centigrade.
1p chest x-ray abdomen: No pathological distension of the colic frame or jejunal loops.
No air-fluid levels.
No signs of free air.
Electro-cardiogram: Normofrequent arterial fibrillation, rare Ventricular Ectopic Beats, no acute ST-T changes.
Measures taken (First visit: Arterial Oxygen Saturation 2 06% aa at 12:09 aa, at 13:35 re-evaluation Arterial Oxygen Saturation 2 97% aa tc 38 Chest x-ray, full abdomen ultrasound, lab tests).
Follow-up on 05May2021, patient referred to attending physician for information and further evaluation.
It was recommended: augmentin 1 g 1 pill every 8 h for 7 days; milk enzymes (e.
g.
, Enterolactis) 1 sachet per meal; adequate hydration; paracetamol 1000 mg 1 pill max 3 times/day).
Heart rate with unknown results.
Objective exam: oriented and cooperative.
Reduced vesicular sounds with fine crepitations in right basal area.
Valid, rhythmic heart tones with systolic murmur.
Painful and tender abdomen in right hypogastrium without signs of peritonism with turbid peristalsis on 01May2021.
Negative Murphy.
Negative Giordano.
No declivous oedema, pain on medial side of thigh bilaterally without signs of inflammation, bilateral post-phlebitic syndrome in the legs.
The patient moved the four limbs.
Respiratory rate with unknown results.
Ecography complete abdomen ultrasound examination performed in the emergency room and markedly hampered by the patient's habitus and widespread intestinal meteorism.
Liver only partially assessed intercostally, modestly increased in volume with diffusely hyperechogenic echostructure as per steatosis; some isolated parenchymal microcystic aspects concomitant.
Gallbladder distended, with walls not significantly thickened but contents finely corpusculated.
Pancreas masked as meteorism.
Spleen within limits.
Kidneys bilaterally in place in the absence of obvious uretero- pyelocaliectasis; some bilateral parenchymal cystic formations the largest of which approximately 6 cm at the left lower pole.
Diffuse calcific atheromasia of the portions of the abdominal aorta that could be explored.
Full bladder, transonic content; no free effusion in abdomen at present.
Uterus of globular and lumpy appearance, with some contextual calcific images of presumably fibromyomatous nature.
Events reported as medically significant and resulted in emergency room visit.
Treatment received for events.
The outcome of events was recovering.
Sender comment: possible typo: indicated in the report spo2 06%, probable typo.
At the re-evaluation at 13:35, body temperature 38.
syncope on 29 March with hospitalisation.
01Apr2021 insertion - emergency room triage report: stated 'After vaccine on1May2021, the patient had convulsions and hyperpyrexia'.
No follow-up attempts are needed.
No further information is expected.