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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||FF2782 / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Alanine aminotransferase, Aphthous ulcer, Aspartate aminotransferase, Body temperature, Haemoglobin, Headache, Hepatic function abnormal, Physical examination, Platelet count, Platelet count decreased, Pyrexia, Stomatitis, Viral infection, White blood cell count, White blood cell count decreased, Epstein-Barr virus test, Hepatic enzyme increased, Decreased appetite, Cytomegalovirus test, Hepatitis B virus test, Hepatitis C virus test, Hepatitis A virus test, Parvovirus B19 test, Influenza virus test, SARS-CoV-2 test
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
Hospitalized? Yes, days: 3
Write-up: Aphtha in the gum of lower dentition; hepatic enzyme increased; Hepatic function disorder; White blood cell decreased; Platelets decreased; headache; slight potential of the symptoms due to some viral infection disease; meal intake volume reduced to 30% of usual.; Stomatitis; pyrexia; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21128044. A 15-year and 0-month-old female patient received BNT162B2 (COMIRNATY; Solution for injection Lot number FF2782, Expiration date 30Nov2021), via an unspecified route of administration on 04Sep2021 at 12:00 (at the age of 15-year and 0-month-old) (age at first vaccination) as dose 1, single for COVID-19 immunisation. The patient''s medical history and the concomitant medications were not reported. Body temperature before vaccination was 36.5 degree Centigrade on 04Sep2021. The patient had no family history. On 04Sep2021 at 17:00 (5 hours after the vaccination), the patient had headache and it as mentioned that there was a slight potential of the symptoms due to some viral infection disease. On 04Sep2021, the patient had stomatitis, pyrexia and meal intake volume reduced to 30% of usual. On 07Sep2021, the patient experienced hepatic function disorder, white blood cell decreased, platelets decreased, hepatic enzyme increased. On 08Sep2021, the patient had developed aphtha in the gum of lower dentition. On 10Sep2021 (6 days after the vaccination), the patient was admitted to the hospital. On 13Sep2021 (9 days after the vaccination), the patient was discharged from hospital. The course of the event was as follows: On 04Sep2021, the patient received the 1st dose of vaccination of COMIRNATY. On the same day from evening, the patient presented with headache. From night, pyrexia of 38s degrees Centigrade and Stomatitis developed and the patient received prescribed paracetamol (CALONAL) orally with following up. Then, the symptoms were not improved, and the meal intake volume reduced to 30% of usual. On 07Sep2021, the patient presented to the clinic where the patient had received vaccination and underwent rapid Influenza antigen test and rapid COVID-19 antigen test with both negative results. Blood test results showed WBC (white blood cells) 1800/ul, Hb (hemoglobin) 13.3 g/dl, Plt (platelet) 113000/ul, AST (Aspartate transaminase ) 49 IU/l, ALT (Alanine transaminase) 31 IU/I, revealing white blood cell decreased, platelets decreased, and mild hepatic enzyme increased, the patient was referred to the hospital on 08Sep2021. The patient was fine and active by the time visiting the hospital but with pyrexia of 37.7 degrees Centigrade. physical examination showed no obvious abnormality except Aphtha in the gum of lower dentition. Blood test results showed WBC of 1500/ul, Hb 12.8 g/dl, Plt 112000/ul, AST 104 IU/I, ALT 66 IU/I, revealing white blood cell decreased, platelets decreased, and hepatic enzyme increased, the similar results in the tests by the previous physician; however, the degree of the change was mild, and the patient returned home with a direction to undergo in-home therapy with rest. After that, while pyrexia and headache disappeared. Blood test on another hospital visit on 10Sep2021 showed WBC of 1800/ul, Hb 12.5 g/dl, Plt 135000/ul, AST 539 IU/I, ALT 419 U/I, despite the symptoms of white blood cell decreased and platelets decreased had improved, the hepatic enzyme showed marked increase. For further detailed examinations, the patient was admitted to the pediatrics unit of the hospital. After admission, the patient was followed up under bedrest. On 11Sep2021, blood tests showed WBC of 2300/ul, Hb 12.3 g/dl, Plt 163000/ul, AST 400 IU/I, ALT 412 U/I, suggesting further increase in both white blood cells and platelets, while hepatic enzyme level tuned to decrease. Blood tests on 13Sep2021 showed WBC of 4200/ul, Hb 12.4 g/dl, Plt 258000/ul, AST 119 IU/I, ALT 246 U/I, suggesting normalized white blood cells and platelets. marked decrease in hepatic enzyme level. The patient''s fine systemic condition led to a decision that liver disorder would improve with time, the patient discharged from the hospital on the day. Further, to identify the causal factors of the liver disorder, serologic tests on hepatitis A, B, and C viruses, EV virus, cytomegalovirus, and parvovirus B19 were performed, revealing no findings suggestive of infections at all. The outcome was reported as recovered in Sep2021 for pyrexia and headache and on 17Sep2021 for hepatic function disorder, white blood cell decreased, platelets decreased, stomatitis, hepatic enzyme increased, aphtha in the gum of lower dentition and meal intake volume reduced to 30% of usual and viral infection. The reporting physician classified the event as serious (Hospitalized)and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause(s) of the event such as any other diseases that was a slight potential of the symptoms due to some viral infection disease. No follow-up attempts are needed. No further information is expected.
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