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.
Pfizer Dose 1 2/5/21 (lot not listed in system) Pfizer Dose 2 2/26/21 (lot not listed in system) COVID Positive 9/2/21 9/2/21: Patient is a 77 yo male with medical history of CAD , Parkinson disease, Prediabetes, HLD, OSA He presented with SOB, non productive cough and fever . he also endorses abdominal pain and being fatigued He denies sick/ COVID contacts but says wife also has similar complaints 3 days after his illness started He is COVID vaccinated In the ER vitals remarkable for fever and elevated SBP 140- 170 with RR 30s and requiring 2 L supplemental oxygen CXR showed mild bilateral airspace disease in the lower lobes, may represent atelectasis or infectious infiltrates. CT abdomen done showed mesenteric stranding in right lower quadrant and a trace amount of free fluid, suggesting adjacent infection or inflammation. The appendix is not visualized, indeterminate for appendicitis. However patient states his appendix has been removed CBC, CMP were wnl, VBG was wnl, trop negative , UA unremarkable , PT/INR unremarkable . Blood cultures sent in the ER He received tylenol 650, Duoneb, 2g IV Ceftriaxone, 2.7 L LR , 4 mg IV Zofran in the ER 9/17/21: Patient is a 77 yo male with medical history of CAD , Parkinson disease, Prediabetes, HLD, OSA who presented with SOB, non productive cough and fever. He is COVID vaccinated. In the ER vitals remarkable for fever and elevated SBP 140- 170 with RR 30s and requiring 2 L supplemental oxygen. CXR showed mild bilateral airspace disease in the lower lobes, may represent atelectasis or infectious infiltrates. CT abdomen done showed mesenteric stranding in right lower quadrant and a trace amount of free fluid, suggesting adjacent infection or inflammation. CBC, CMP were wnl, VBG was wnl, trop negative , UA unremarkable , PT/INR unremarkable. COVID PCR returned POSITIVE. He received Tylenol 650, Duoneb, 2g IV Ceftriaxone, 2.7 L LR , 4 mg IV Zofran in the ER. Pt was subsequently admitted to the hospitalist service for further evaluation and management. Pt was started on Dexamethasone and Remdesivir. Ceftriaxone was continued. Pt with increasing O2 needs ultimately requiring 100% OptiFlow. Pulmonology was consulted at that time. Pt was started on Actemra. Pt also developed enteritis during admission was was treated with a 7 day course of Flagyl. Pt with fluctuating O2 needs. Pt did not desire intubation. Ultimately pt and family decided on comfort cares and home hospice. 9/20/21: Patient deceased.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | lot not listed | IM |
| RECVDATE: | 10-27-2021 | RPT_DATE: |
| CAGE_YR: | 76 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 09-20-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 16 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | see above |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | amlodipine 2.5 mg PO QD aspirin 81 mg PO QD atorvastatin 80 mg PO QD carbidopa-levofopa 25-100 mg PO TID clopidogrel 75 mg PO QD doxazosin 4 mg PO HS furosemide 20 mg PO QD hyoscyamine 0.125 mg SL Q6h PRN lorazepam 0.5 mg PO Q4h PRN metopro |
| CUR_ILL: | CAD OSA peripheral neuropathy Parkinson's osteoarthritis back pain |
| HISTORY: | CAD OSA peripheral neuropathy Parkinson's osteoarthritis back pain |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-27-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | NKDA |
| V_FUNDBY: |
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