Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
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).
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