return to results page

VAERS ID: 1000395

AGE: 31| SEX: F|State: FR

Description

Occipital headache; Spasms; Extrapyramidal symptoms; Diaphragmatic spasm; Breathing difficult; Movements involuntary; Neck cramps; Tremor; Chest tightness; Chills; Encephalitis post immunisation; Excess sweating; Serum sickness; Shaking; Breathlessness; Redness generalised; Feeling of warmth; Skin red; Urticaria; Rash; Immediate hypersensitivity reaction; This is a spontaneous report from a contactable physician downloaded the European Medicines Agency (EMA) EudraVigilance-WEB [regulatory authority number HR-HALMED-300041685 ]. A 31-year-old female patient received 1st dose of bnt162b2 (COMIRNATY, lot number: EL1491), intramuscular on 05Jan2021 09:55 at 0.3 mL, once a day for prophylaxis. Medical history included ongoing migraine (Occasional migraine-type headaches. Rarely migraine headaches). Concomitant medication included ibuprofen (BRUFEN) for occasional migraine-type headaches. The patient experienced occipital headache, spasms, extrapyramidal symptoms, diaphragmatic spasm, breathing difficult, movements involuntary, neck cramps, tremor, chest tightness, chills, encephalitis post immunisation, excess sweating, serum sickness, shaking and breathlessness on 06Jan2021; events seriousness criteria was hospitalization and medically significant. The patient also experienced redness generalised, feeling of warmth, skin red, urticaria, rash and immediate hypersensitivity reaction on 05Jan2021; events seriousness criteria was medically significant. The patient underwent lab tests and procedures which included blood pressure diastolic: 72 mmhg on 06Jan2021, blood pressure systolic: 130 mmhg on 06Jan2021, magnetic resonance imaging brain (MR mozga): Discrete cortex edema left frontoparietal in Roland region; Cerebral edema reg. FP l.sin. e causa aperta on 06Jan2021. The outcome of events was recovered in Jan2021. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Yesterday, one specialist (32 years old, no history of comorbidities or allergies) got a rash, urticaria, redness 45 minutes after vaccination, was in Emergency Room, was given corticosteroids there and was fine. Today, the mother reported that she had developed extrapyramidal symptoms with convulsions and with heavy sweating (symptoms between extrapyramidal symptoms and epileptic seizures). She was hospitalized. Diagnosis: Acute serum sickness. Encep. postman. I.O. Description (course, symptoms): Urticaria. Day 1: 30-40 min after gene vaccination. redness with heat waves - with therapy withdrawal symptoms. Day 2: 20 hours after vaccination repeat inic. symptoms with transient spasms of the muscles of the thorax and neck, and occipital headache, shortness of breath. Received therapy:Day 1: Synopen, SoluMedrol 80 mg, inf. Day 2: Drank tbl Contrala, dexamethason 4 mg, no effect, then th in Emergency room: Inf. Normabel, Propofol titrated. Diseases at the time of receiving the preparation (which were known to the doctor (vaccinator)): Rarely migraine headaches. Diseases at the time of receiving the preparation (which were not known to the doctor (splitter)): None. So far healthy, occasional migraine-type headaches, last a week ago. They always begin with pressure in the depths of the left eye, after half an hour the development of always left-sided headache, often with nausea and vomiting. Of the therapy only Brufen pp. She had no recent infectious events. Current disturbances: The day before admission, 05Jan2021 was vaccinated with Pfizer vaccine for SARS-CoV-2 (09:55 hours). About 40 minutes after the vaccination, redness appeared on the skin of the allergic type, and Synopen and Dexamethasone were prescribed in the emergency department, after which the disturbances regressed and she was fine during the day. In the morning on the day of admission, redness of the skin reappears with a feeling of lack of air with tightness and "cramps" in the neck and diaphragm, a feeling of tremor of the limbs and lower jaw without loss of consciousness. He describes involuntary movements as a feeling of chills and tremors. It denies other focal neurological outbursts. MRI of the brain - oral finding after examination of the sent CD: discrete cortex edema left frontoparietal in the Roland region, without clear signs of diffusion restriction, FLAIR neat. In OB administered: Ca-gluconate, diazepam 10 mg iv, Ringer 500 mg iv, 5% glu, 80 mg SoluMedrol + 80 mg Solumedrol, 1000 ml F.O, 10% Mannitol 250 ml F.O, Propofol. The anesthesiologist titled Diprivan on the way. During the observation, the patient reported spasmodic spasms in the diaphragmatic area on several occasions, accompanied by a feeling of shortness of breath (saturation normal SO2 98-99), occupies a semi-flexion position of the torso (in anteflexion) with a mild extension in the neck. done LP_ liquor completely neat Consulted prof. - finding nonspecific, however recommends monitoring, EEG and pulse th Medrola, and if there is no effect, ev. IvIg. Ordinated 500 mg Solu Medrola iv. with amp. Control Upon admission to the ward the patient adequately, without involuntary movements, states that she feels well. Neurological status normal, meningeal syndrome negative. Cardiacly compensated, afebrile, RR 130/72. She states that she does not remember part of the events in General Hospital and transport (she received propofol). Diagnosis: in Obs _ allergic reaction to the vaccine. Cerebral edema reg. FP l.sin. e causa aperta. Migraine. Conclusion: The dynamics of the development of the clinical picture and the processing done so far exclude the possibility of post-vaccination CNS syndrome. The patient is now of completely normal neurological status and without signs of neurological disease. Differential diagnosis may be edema as a consequence of an earlier migraine attack (6 days earlier). As for clinical symptoms, she is much more likely to have developed diaphragmatic spasm as a result of treating an allergic reaction after receiving the vaccine (antihistamines and corticosteroids). Sender Comment: 14Jan2021: Causality between hypersensitivity reactions (evaluated as immediate) and related symptoms and vaccine administration is assessed as probable / likely. Causality between neurological reactions and vaccine administration is assessed as unlikely. Neurological symptoms are likely to be associated with administration of antihistamines (chloropyramine) and corticosteroids (dexamethasone and methylprednisolone), administered for the treatment of hypersensitivity reactions. Additionally, serum sickness classically presents with fever, which was not reported in this case, and the symptoms typically occur one to two weeks after exposure. Conclusion of neurologist is supported: Development of clinical signs and symptoms and results of test and procedures exclude the possibility of post vaccination CNS syndrome. The neurological status of the patient is now completely normal, without any signs of neurological disease. Diagnostically, edema could have resulted consequently after earlier migraine attack (6 days earlier). Regarding clinical symptoms, it is more likely that diaphragmatic spasm developed as a consequend Sender's comments: 14Jan2021: Causality between hypersensitivity reactions (evaluated as immediate) and related symptoms and vaccine administration is assessed as probable/likely. Causality between neurological reactions and vaccine administration is assessed as unlikely. Neurological symptoms are likely to be associated with administration of antihistamines (chloropyramine) and corticosteroids (dexamethasone and methylprednisolone), administered for the treatment of hypersensitivity reactions. Additionally, serum sickness classically presents with fever, which was not reported in this case, and the symptoms typically occur one to two weeks after the exposure. Conclusion of neurologist is supported: "Development of clinical signs and symptoms and results of test and procedures exclude the possibility of post vaccination CNS syndrome. The neurological status of the patient is now completely normal, without any signs of neurological disease. Diagnostically, edema could have resulted consequently after earlier migraine attack (6 days earlier). Regarding clinical symptoms, it is more likely that diaphragmatic spasm developed as a consequence of hypersensitivity reactions treatment after vaccine administration (antihistamines and corticosteroids).

Symptoms

Blood pressure diastolic, Dyskinesia, Feeling hot, Oxygen saturation, Urticaria, Blood pressure systolic, Dyspnoea, Headache, Rash, Chest discomfort, Encephalitis post immunisation, Hyperhidrosis, Serum sickness, Chills, Erythema, Magnetic resonance imaging brain, Tremor, Diaphragmatic spasm, Extrapyramidal disorder, Muscle spasms, Type I hypersensitivity

Vaccines

VAX DATE: 04 January 2021 | ONSET DATE: 04 January 2021 | DAYS TO ONSET: 0
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • EL1491

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
Y
LAB_DATA:
Test Date: 20210106; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:72 mmHg; Test Date: 20210106; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:130 mmHg; Test Date: 20210106; Test Name: MR mozga; Result Unstructured Data: Test Result:Discrete cortex edema; Comments: Discrete cortex edema left frontoparietal in Roland region; Cerebral edema reg. FP l.sin. e causa aperta.; Test Date: 20210106; Test Name: SO2; Result Unstructured Data: Test Result:98-99
V_ADMINBY:
OTH
OTHER_MEDS:
BRUFEN
CUR_ILL:
Migraine (Occasional migraine-type headaches. Rarely migraine headaches.)
HISTORY:
PRIOR_VAX:
SPLTTYPE:
HRPFIZER INC2021053801
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
Y
ALLERGIES:
V_FUNDBY:
return to results page

Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.

AND PLEASE read the FAQ first.

OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.