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.
Pt is a 33 y/o male who presents to the ED with c/o of left le swelling progressing over the last 4 days. Pt has no other c/o. Denies fever, cough, cp, abd pain, n/v/d. Pt has had his first COVID vaccine 1/30. Patient was noted to be tachycardic to the 120's in the ER, after 1L of normal saline still tachycardic to the 110's. Lower extremity doppler was negative for DVT, however PE protocol CTA of the chest was positive for a PE, report follows. Patient was given lovenox and flown to Medical Center for higher level of care.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EL9261 | IM | LA |
| RECVDATE: | 02-10-2021 | RPT_DATE: |
| CAGE_YR: | 32 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 5 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | 2/4/21 CTA of the chest: Bilateral lower lobe pulmonary emboli. Mild ascites. Cholelithiasis. 2/4/21 LE doppler, left leg: Examination difficult to perform, no definite thrombosis. Suspect that the findings are due to lymphedema. Perhaps compression hose fitting would be appropriate. 2/4/21 Labs: Specimen: BLOOD. Spec Collect Date/Time: 02/04/2021 2:36 PM Lab Arrival Date/Time: 02/04/2021 2:45 PM Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _PT (TOP) 10.6 sec 9.8 - 12.8 [3873] 02/04/21 15:13 _INR (TOP) 0.93 0.85 - 1.11 [3873] 02/04/21 15:13 PTT (TOP) 34.8 sec 25.1 - 36.5 [3873] 02/04/21 15:13 Performing Lab Site(s): ============================================================================================================================ KEY: A=Abnormal L=Abnormal Low H=Abnormal High *=Critical value TR=Therapeutic Range Specimen: BLOOD. Spec Collect Date/Time: 02/04/2021 2:36 PM Lab Arrival Date/Time: 02/04/2021 2:45 PM Res Site Test name Result Flg Units Ref. range Code Result Dt/Time WBC-XE 5.80 10*3/uL 4.39 - 10.61 [3873] 02/04/21 15:00 RBC-XE 5.97 H M/uL 4.60 - 5.86 [3873] 02/04/21 15:00 HGB-XE 15.7 g/dL 14.0 - 17.7 [3873] 02/04/21 15:00 HCT-XE 49.4 % 41.1 - 52.7 [3873] 02/04/21 15:00 MCV-XE 82.7 fL 79.7 - 99.9 [3873] 02/04/21 15:00 MCH-XE 26.3 L pg 27.0 - 33.6 [3873] 02/04/21 15:00 MCHC-XE 31.8 L g/dL 32.3 - 35.3 [3873] 02/04/21 15:00 PLT-XE 239 10*3/uL 125 - 400 [3873] 02/04/21 15:00 MPV-XE 8.9 L fL 9.0 - 11.6 [3873] 02/04/21 15:00 NEUT% 70.8 % 46.7 - 78.5 [3873] 02/04/21 15:00 LYMPH% 20.1 % 9.7 - 46.8 [3873] 02/04/21 15:00 MONO% 5.0 % 1.2 - 13.2 [3873] 02/04/21 15:00 EO% 3.3 % 0.0 - 5.8 [3873] 02/04/21 15:00 BASO% 0.5 % 0.0 - 1.0 [3873] 02/04/21 15:00 NRBC 0.0 /100WBC 0.0 - 1.0 [3873] 02/04/21 15:00 IM GRAN% 0.3 % 0.0 - 0.8 [3873] 02/04/21 15:00 RDW-XE 15.8 H % 12.0 - 14.8 [3873] 02/04/21 15:00 NEUT# 4.07 10*3/uL 1.78 - 5.38 [3873] 02/04/21 15:00 LYMPH# 1.16 L 10*3/uL 1.32 - 3.57 [3873] 02/04/21 15:00 MONO# 0.29 L 10*3/uL 0.30 - 0.82 [3873] 02/04/21 15:00 EO# 0.19 10*3/uL 0.04 - 0.54 [3873] 02/04/21 15:00 BASO# 0.03 10*3/uL 0.01 - 0.08 [3873] 02/04/21 15:00 IG# 0.02 10*3/uL [3873] 02/04/21 15:00 NRBC# 0.00 10*3/uL 0.00 - 0.01 [3873] 02/04/21 15:00 Performing Lab Site(s): ============================================================================================================================== KEY: A=Abnormal L=Abnormal Low H=Abnormal High *=Critical value TR=Therapeutic Range Specimen: BLOOD. Spec Collect Date/Time: 02/04/2021 2:36 PM Lab Arrival Date/Time: 02/04/2021 2:44 PM Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _CALCULATED OSMOLALITY 297 H mOsm/kg 275 - 295 [3873] 02/04/21 15:37 Eval: Neonatal: may be as low as 266 Eval: >60 yrs old: 280 - 301 T BILI-19 0.7 mg/dL 0.1 - 1.2 [3873] 02/04/21 15:37 Eval: Per manufactures instructions, intereferance substance of IgG >28 gm/L Eval: may affect Total Bilirubin results. Clincal judgement is recommended. No Eval: significant interference was shown in the bilirubin concentration Eval: ranges >5.9 mg/dL, medical risk for the newborn population is most Eval: unlikely. GLUCOSE-RANDOM-09 93.0 mg/dL 74.0 - 106.0 [3873] 02/04/21 15:37 Eval: NEONATES: 40 - 60 mg/dL Eval: CHILDREN: 60 - 100 mg/dL BUN-09 6.0 mg/dl 6.0 - 20.0 [3873] 02/04/21 15:37 Eval: 18 - 60 year old = 6-20 mg/dL Eval: 60 - 90 year old = 8-23 mg/dL CREATININE 0.6 mg/dL 0.5 - 1.5 [3873] 02/04/21 15:37 SODIUM-09 141.0 mEQ/L 136.0 - 145.0 [3873] 02/04/21 15:37 POTASSIUM-09 4.1 mEQ/L 3.5 - 5.1 [3873] 02/04/21 15:37 Eval: PLASMA reference range: 3.4 - 4.5 mmol/L CHLORIDE-09 107.5 H mEQ/L 98.0 - 107.0 [3873] 02/04/21 15:37 CO2-09 24.0 mEQ/L 22.0 - 29.0 [3873] 02/04/21 15:37 ANION GAP-09 10.00 0.00 - 14.00 [3873] 02/04/21 15:37 CALCIUM-09 8.2 L mg/dL 8.6 - 10.2 [3873] 02/04/21 15:37 T PROTEIN-09 5.6 L gm/dL 6.6 - 8.7 [3873] 02/04/21 15:37 ALBUMIN-09 2.6 L gm/dL 3.5 - 5.2 [3873] 02/04/21 15:37 ALK PHOS-09 122.0 IU/L 42.0 - 134.0 [3873] 02/04/21 15:37 Eval: CHILDREN: Eval: <1 day old: <260 U/L Eval: 6 days-6 months: <467 U/L Eval: 1-3 yrs: <292 U/L Eval: 1-12 years: <312 U/L Eval: 13-17 yrs(f): <195 U/L Eval: 13-17 yrs(m): <406 U/L AST-09 21.0 IU/L 10.0 - 40.0 [3873] 02/04/21 15:37 ALT-09 22.0 IU/L 10.0 - 41.0 [3873] 02/04/21 15:37 ESTIMATED GFR >60 mL/min [3873] 02/04/21 15:37 Specimen: NASOPHARYNGEAL CAVITY. Spec Collect Date/Time: 02/04/2021 12:45 PM Lab Arrival Date/Time: 02/04/2021 2:05 PM Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _FLU A (Gx) NEGATIVE [3873] 02/04/21 14:57 _FLU B (Gx) NEGATIVE [3873] 02/04/21 14:57 _RSV (Gx) NEGATIVE [3873] 02/04/21 14:57 Internal QC 4PLEX VALID [3873] 02/04/21 14:57 _SARS (GX) NEGATIVE [3873] 02/04/21 14:57 Eval: POSITIVE-The 2019 novel coronavirus (SARS-CoV-2) target nucleic acids are Eval: detected. Eval: Eval: PRESUMPTIVE POSITIVE- The 2019 novel coronavirus (SARS-CoV-2) target Eval: nucleic acids may be present. Sample is retested. For samples with Eval: repeated presumptove positive results, additional confirmatory testing Eval: may be conducted to differentiate between SARs-CoV-2 and SARS-CoV-1 or Eval: othr Sarbecovirus currently unknown to infect humans, for epidemiological Eval: purposes or clinical management. Eval: Eval: NEGATIVE- The 2019 novel coronavirus (SARS-CoV-2) target nucleic acids Eval: are not detected. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | FUROSEMIDE 20MG TABLET TAKE ONE (1) TABLET BY MOUTH EVERY ACTIVE MORNING FOR EXCESS FLUID LIDOCAINE 5% PATCH APPLY 1 PATCH TO CLEAN NON-HAIRY AREA ACTIVE ON SKIN DAILY *LEAVE ON FOR 12 HOURS AND THEN REMOVE FOR 12 HOURS* LISINOPR |
| CUR_ILL: | 12/22/20 was in Emergency room for a viral URI with a negative COVID test. |
| HISTORY: | 1)Nephrotic syndrome - 2)Proteinuria - 3) Pre DM 4) Obesity |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 02-10-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | No known drug allergies |
| V_FUNDBY: |
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