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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||FA5833 / 1||LA / OT|
Administered by: Other Purchased by: ??
Symptoms: Thrombosis, Off label use, Product use issue
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? Yes
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Other Medications: ANAFRANIL; KETOGAN [KETOBEMIDONE HYDROCHLORIDE]; ALVEDON
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to drug
Diagnostic Lab Data:
CDC 'Split Type': SEPFIZER INC2021674239
Write-up: Small blood clot in left arm; First dose AstraZeneca covid 19 vaccine, second dose Comirnaty; First dose AstraZeneca covid 19 vaccine, second dose Comirnaty; This is a spontaneous report from a contactable other healthcare professional, reporting on herself. A 49-year-old female patient received first dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 04Jun2021 (Lot Number: FA5833) as single dose for covid-19 immunisation (age of vaccination 49 years); first dose of covid-19 vaccine AstraZeneca (COVID-19 VACCINE ASTRAZENECA), intramuscular on 11Mar2021 10:00 (Lot Number: Unknown), as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included dose 1 of hepatitis B vaccine HBsAg (yeast) (ENGERIX B) taken for an unspecified indication on 02Jun2021 in left arm; clomipramine hydrochloride (ANAFRANIL) taken for an unspecified indication, start and stop date were not reported; ketobemidone hydrochloride (KETOGAN) taken for an unspecified indication, start and stop date were not reported; paracetamol (ALVEDON) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had first dose ofcovid-19 vaccine AstraZeneca and when the second dose was administered, it was changed to Pfizer BNT162B2 vaccine. The patient experienced small blood clot in left arm on 05Jun2021 09:00 which resulted in a physician office visit. No treatment had been given. The patient was not diagnosed with covid-19 prior vaccination and has not been tested for covid-19 post-vaccination. The outcome of the blood clot was recovering. No follow-up attempts are possible, no further information expected.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported Thrombosis and the use of bnt162b2 cannot be fully excluded. However, there event occurred within the circumstance of having to have used a different Covid vaccine type or brand as a first dose. This then confounds that reported drug event pair. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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