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.
suspicion of Neuralgic amyotrophy/Brachial plexus neuritis; Radiculitis/left neck Radiculitis; Dyspnoea; Neck pain; Swelling from the left neck to face; Swelling from the left neck to face; Numbness in the entire left palm; severe pain in the vaccination site of left upper arm; nerve disorder of left upper arm; Painful L arm; suspected vagal reflex/vasovagal reflex; abnormal sensation; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21128908. A 14-year and 8-month-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular in left upper arm on 06Sep2021 (at the age of 14-year and 8-month-old) (Batch/Lot Number: FD0348; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation. Medical history was none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient's concomitant medications were not reported. The patient experienced abnormal sensation on 06Sep2021, nerve disorder of left upper arm on 06Sep2021, painful L arm on 06Sep2021, suspected vagal reflex/vasovagal reflex on 06Sep2021, severe pain in the vaccination site of left upper arm on 07Sep2021, numbness in the entire left palm on 11Sep2021, swelling from the left neck to face on 22Sep2021, dyspnoea on 23Sep2021, neck pain on 23Sep2021, suspicion of neuralgic amyotrophy/brachial plexus neuritis on 24Sep2021, radiculitis/left neck radiculitis on 24Sep2021. On 24Sep2021 (18 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 06Sep2021 (the day of the vaccination), the patient received the COVID-19 vaccination manufactured by Pfizer via intramuscular in left upper arm. Immediately after the vaccination, the patient appeared Painful L arm and nerve disorder of left upper arm. After that, the patient appeared a symptom of suspected vagal reflex, and BOSMIN 0.3 mg was injected in the right upper arm by intramuscular injection. From 07Sep2021 to 08Sep2021 (from 1 day after the vaccination to 2 days after the vaccination), the patient appeared severe pain in the vaccination site of left upper arm. On 11Sep2021 (5 days after the vaccination), the pain remained but improved, but the patient appeared Numbness in the entire left palm. On 22Sep2021 (16 days after the vaccination), the patient had an emergency outpatient visit to another hospital because she appeared Swelling from the left neck to face. On 23Sep2021 (17 days after the vaccination), the patient had an outpatient visit to the reporting hospital due to Dyspnoea and Neck pain in the middle of the night, and the patient was diagnosed with no apparent Swelling in the neck and face. On 24Sep2021 (18 days after the vaccination), the patient was admitted to the reporting hospital on suspicion of Neuralgic amyotrophy. A cervical spinal cord MRI was performed. There was no abnormality in spinal cord or radiculopathy and there was an abnormal signal in the left dorsal soft tissue. On 25Sep2021 (19 days after the vaccination), in order to distinguish between Brachial plexus neuritis and Radiculitis, cerebrospinal fluid test, nerve transmission test, and Somatosensory evoked potentials were scheduled to be ranked and under the careful examination. IVMP and so on was a treatment candidate. On 25Sep2021 (19 days after the vaccination), the result of Cerebrospinal fluid test was reported as negative. On 28Sep2021 (22 days after the vaccination), nerve transmission test was performed. On 29Sep2021 (23 days after the vaccination), from the result of NCS, it was considered that there was a possibility of left neck Radiculitis, and the patient was observed with analgesic drugs without protein increase in CSF. Therapeutic measures were taken as a result of the events. On 29Sep2021 (23 days after the vaccination), the outcome of the events was not recovered. The reporter classified the event as serious (hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: The Symptoms had appeared immediately after the intramuscular injection of the COVID-19 vaccine in the upper left arm, and the causal relationship could not be denied. There was an abnormal signal in the left dorsal soft tissue, and it was presumed that careful examination and treatment by the current hospitalization were appropriate. No follow-up attempts are possible. No further information is expected; Reporter's Comments: The Symptoms had appeared immediately after the intramuscular injection of the COVID-19 vaccine in the upper left arm, and the causal relationship could not be denied. There was an abnormal signal in the left dorsal soft tissue, and it was presumed that careful examination and treatment by the current hospitalization were appropriate.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FD0348 | OT | LA |
| RECVDATE: | 10-14-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210925; Test Name: cerebrospinal fluid test; Test Result: Negative ; Test Date: 20210929; Test Name: cerebrospinal fluid test; Result Unstructured Data: Test Result:without protein increase; Comments: the patient was observed with analgesic drugs without protein increase in CSF; Test Date: 20210924; Test Name: cervical spinal cord MRI; Result Unstructured Data: Test Result:no abnormality in spinal cord or radiculopathy; Comments: and there was an abnormal signal in the left dorsal soft tissue; Test Date: 20210928; Test Name: nerve transmission test; Result Unstructured Data: Test Result:there was a possibility of left neck Radiculitis |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101295290 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-13-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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