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.
Photophobia; Phonophobia; Rotatory vertigo, need to hold onto the wall.; Rotatory vertigo with nausea; Dizziness; Headache; First and second injection with MODERNA COVID-19/ booster injection of COMIRNATY; First and second injection with MODERNA COVID-19/ booster injection of COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-RE20220604. A 70-year-old female patient received BNT162b2 (COMIRNATY), on 15Nov2021 as dose 3 (booster), single (Lot number: FH3226) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Carotid artery atheroma" (unspecified if ongoing); "Catamenial migraine" (unspecified if ongoing); "Thyroiditis" (unspecified if ongoing); "Hypercholesterolaemia" (unspecified if ongoing); "having contracted COVID-19" (unspecified if ongoing), notes: not at risk of developing a serious form of COVID-19. Concomitant medication(s) included: TAHOR; L THYROXIN HENNING; RESITUNE. Vaccination history included: moderna coviD-19 vaccine (Dose 1., batch number: 3001657, left arm., intramuscular injection), administration date: 18Apr2021, for Covid-19 immunization; moderna coviD-19 vaccine (Dose 2., batch number: 3002335 , left arm., intramuscular injection), administration date: 16May2021, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "First and second injection with MODERNA COVID-19/ booster injection of COMIRNATY"; DIZZINESS (medically significant) with onset 23Nov2021, outcome "recovering"; HEADACHE (medically significant) with onset 23Nov2021, outcome "recovering"; NAUSEA (non-serious) with onset 23Nov2021, outcome "unknown", described as "Rotatory vertigo with nausea"; VERTIGO (non-serious) with onset 23Nov2021, outcome "unknown", described as "Rotatory vertigo, need to hold onto the wall."; PHONOPHOBIA (non-serious) with onset Dec2021, outcome "unknown"; PHOTOPHOBIA (non-serious) with onset Dec2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: (unspecified date) No expansive process, notes: Age-appropriate leukoaraiosis. No abnormality of the cerebellopontine angles. No sequence in T2. No obvious signs of haemorrhage or venous thrombosis; SARS-CoV-2 test: (unspecified date) Positive; Specialist consultation: (24Mar2021) persistence of vertigo, notes: but less intense, persistence of unusual headaches. Physiotherapeutic medical care is beneficial. Doubt about post-vaccination aseptic meningitis; Visual analogue scale: (Dec2021) 8.5. Therapeutic measures were taken as a result of dizziness, headache, photophobia, phonophobia, vertigo, nausea. Clinical course: In the Beginning of Dec2021 Patient felt Very intense holocranial pulsing headaches for 3 days. They feel different from the usual migraines.
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| RECVDATE: | 11 May 2022 |
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| RECOVD: | N |
| LAB_DATA: | Test Name: Reassuring cerebral Magnetic Resonance Imaging; Result Unstructured Data: Test Result:No expansive process; Comments: Age-appropriate leukoaraiosis. No abnormality of the cerebellopontine angles. No sequence in T2. No obvious signs of haemorrhage or venous thrombosis.; Test Name: Test SARS-CoV-2; Test Result: Positive ; Test Date: 20210324; Test Name: Consultation; Result Unstructured Data: Test Result:persistence of vertigo; Comments: but less intense, persistence of unusual headaches. Physiotherapeutic medical care is beneficial. Doubt about post-vaccination aseptic meningitis.; Test Date: 202112; Test Name: Visual Analogue Scale; Result Unstructured Data: Test Result:8.5 |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | TAHOR; L THYROXIN HENNING; RESITUNE |
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| HISTORY: | Medical History/Concurrent Conditions: Carotid artery atheroma; COVID-19 (not at risk of developing a serious form of COVID-19); Hypercholesterolaemia; Menstrual migraine; Thyroiditis |
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| SPLTTYPE: | FRPFIZER INC202200656798 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 10 May 2022 |
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