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.
Patient was transfer to ED from an outside hospital for concerns of hypotension likely secondary to MIS-C vs post-COVID vaccine myocarditis. Per family, symptoms started on Wednesday 9/29 with general malaise and some difficulty breathing. The patient was evaluated by the PCP where he received a COVID test, which was negative, and a Strep swab which was found to be positive. The patient was sent home with an Amoxicillin prescription. Thereafter, the patient experienced decrease in oral intake and diarrhea. Additional complaints included dizziness upon standing and ambulating. The patient was receiving acetaminophen and ibuprofen at home. There has been no recent travel and no new animal exposures. The patient recently received the second COVID vaccine 2 weeks prior. On Saturday, 10/2, symptoms persisted prompting a visit to an Urgent Care where he received IV fluids and IV steroids. At his time the antibiotics were switched to from amoxicillin to clindamycin. On (Sunday 10/3), the patient presented to an outside hospital ED after waking with chills, chest pain, and difficulty breathing. Per report, patient was in the process of being discharged when his blood pressures dropped into the 70s and 80s range. With new hypotension post receiving a total of 3 L of normal saline, the decision was made to transfer to ED for further treatment. In ED: Patient complained of chest pain and blood pressures were intermittently in the mid 80's. He was given 1L IVF via bolus and started MIVF. EKG normal, cardiology contacted who recommended epinephrine drip initiation for BP support. The patient was anxious and started on wall O2 via face-mask for comfort only. Lab work-up was repeated and significant for an inflammatory process with elevated Procalcitonin, D-dimer, and Fibrinogen. COVID IgG positive and COVID capsid positive, demonstrative of likely previous COVID infection and current immunized status. Thrombocytopenic to 81, leukocytosis to 18.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FC3181 | IM | |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FE3592 | IM |
| RECVDATE: | 10-06-2021 | RPT_DATE: |
| CAGE_YR: | 14 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 3 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Sunday 10/3, At the ED the patient underwent a broad workup: CXR, CT head, CT abdomen, and abdominal ultrasound (for appendicitis). Overall unremarkable, however, CT abdomen demonstrated tiny dense pulmonary nodule "incompletely imaged though highly likely benign", and a liver w/ "hepatic steatosis" (also seen on ultrasound). Outside hospital labs: Blood cultures drawn and no growth, procalcitonin 14, lactic acid 3.0, urinalysis was w/out signs of infection but with 20-50 WBC, BMP all WNL, COVID PCR negative, CBC: WBC 16, Hgb 16 Hct 42, plt 87, 84% neutrophils, hepatic panel w/ mildly elevated transaminases, lipase 132, and mono negative. Pt was given ibuprofen, acetaminophen, Mylanta, famotidine, ceftriaxone (at 1940) and clindamycin (most recently at 2238). |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Amoxicillin, clindamycin, ondansetron |
| CUR_ILL: | Wednesday 9/29 with general malaise and some difficulty breathing. PCP was seen, COVID test negative but Strep swab positive. Sent home with Amoxicillin . During this time, had decreased oral intake and diarrhea. Patient experienced dizziness upon standing and ambulating. He was receiving acetaminophen and ibuprofen at home. No recent travel. The patient received the second COVID vaccine 2 weeks ago prior, on 9/19/2021. Saturday, 10/2, symptoms persisted and the patient went to Urgent Care where he received IV fluids and IV steroids. Antibiotics for strep throat were switched from amoxicillin to clindamycin. |
| HISTORY: | Obesity, Asthma, Borderline hypertension |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-06-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Latex |
| V_FUNDBY: |
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