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.
"Moderna COVID-19 Vaccine EUA" -- patient hospitalized with covid19 after receiving one dose moderna vaccine. 66 y.o. female with hypertension and diabetes admitted with sharp abd pain, nausea, vomiting for several days. CT abd with cecal distention, findings concerning for cecal volvulus. Extended resp panel positive for SARS-CoV-2 (received 1st dose of COVID vaccine on 3/22). Went to OR for exploratory laparotomy, lysis of adhesion and right colectomy. Patient was also found to be Covid-19 positive and needed supplemental oxygen in ED (3L NC at the time). Imaging showing bilateral pulmonary infiltrates/effusions (and also cecal volvulus, as stated above, pt underwent exloratory laparotomy, lysis of adhesion, right colectomy with ilecolostomy). Patient was recovering on medical floor when she clinically decompensated and needed increased oxygen and had a drop in blood pressure (confused, hypotensive, hypoxic). Labs notable for BUN 37, creatinine 2.16, procalcitonin 17.62, Hgb 6.4 (10 on admission). ABG 7.35/ 28/ 73/ 16/ 94% on nasal cannula. 1 unit PRBC given. BP continued to be borderline and was placed on vasopressor briefly. Empiric antibiotics vancomycin/cefepime/Flagyl, and patient was also started on remdesivir and dexamethasone. Nadir O2 sat was 82% on 3/31/2021. T=102.2 on 3/31/21. Patients had multiple family members with Covid-19. Treatments as stated above included Remdesivir and Dexamethasone. Cultures negative - exact source of sepsis unclear: bacterial pneumonia vs. covid vs. intra-abdominal source In ICU from 3/31 to 4/3. Medical floor 4/3 to 4/7. Patient was discharged home 4/7/21.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 046a21a |
| RECVDATE: | 05-14-2021 | RPT_DATE: |
| CAGE_YR: | 66 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 9 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | 3/30/21 Extended Resp Panel by PCR - SARS-CoV-2 positive 3/30/21 Blood culture - negative x2; 3/31/21 Blood culture - negative x2 Additional information for Item 19: 3/31/21 MRSA PCR - negative 3/31/21 Urinalysis/culture <6WBC, no bacteria 3/30/21 Pro-calcitonin 0.14 3/31/21 Pro-calcitonin 17.62 3/30/21 CT abdomen pelvis without contrast - Marked fluid distension of the cecum measuring nearly 10 cm in diameter with an air-fluid level noted with nondistention of the remainder of the colon. There is also some mild to moderate air and fluid distention of mid and distal small bowel loops with air-fluid level suggesting some element of obstruction. Findings are concerning for a cecal volvulus. Small bilateral pleural effusions and small pericardial effusion. Extensive patchy areas of alveolar infiltrate in both lower lung regions consistent with pneumonia. 3/30/2021 CT abdomen pelvis with contrast - Interval resolution of previously noted dilated small bowel loops and interval improvement in previously noted now mild to moderately air distended cecum with air-fluid level suggesting diminution in suspect cecal volvulus. Extensive bilateral lower lung infiltrates consistent with pneumonia, rule out COVID-19. 4/7/2021 CT chest with contrast - Patchy interstitial opacities in the lungs bilaterally with some associated ground-glass densities 3/30/21 Chest Xray - moderate bilateral pumonary infiltrates 3/31/21 Chest Xray - persistent patchy parenchymal areas of density throughout the lungs 4/4/21 Chest Xray - stable moderate bilateral pulmonary infiltrates 4/7/21 Chest Xray - persistent prominent interstitial markings throughout the lungs, improved. Persistent patchy areas of density at the lung bases, improved on the right and similar in appearance on the left. |
| V_ADMINBY: | |
| OTHER_MEDS: | Iron sulfate, Lantus, Levothyroxine, losartan, metformin, Nifedipine, Oxybutynin, ropinirole, simvastatin |
| CUR_ILL: | Generalized edema, Raynaud's phenomenon without gangrene |
| HISTORY: | Raynaud's syndrome without gangrene; Edema of extremities, diabetes, hypothyroidism |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | NKA |
| V_FUNDBY: |
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