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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||EJ6795 / 1||RA / OT|
Administered by: Other Purchased by: ??
Symptoms: Altered state of consciousness, Fatigue, Decreased appetite
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Other Medications: SOBRIL; ZOPICLONE; SINEMET; PARACET [PARACETAMOL]; TOILAX
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Constipation; Living in nursing home; Parkinson''s disease; Vitamin D deficiency
Diagnostic Lab Data:
CDC 'Split Type': NOPFIZER INC2021095256
Write-up: ALTERED STATE OF CONSCIOUSNESS; DECREASED APPETITE; TIREDNESS; This is a spontaneous report from a contactable other health professional downloaded from the Medicines Agency (MA) Regulatory Authority NO-NOMAADVRE-FHI-2021-U4eaa, Safety Unique Identifier NO-NOMAADVRE-E2B_00014164. An 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot#EJ6795) via intramuscular on 08Jan2021 at single dose for COVID-19 vaccination. The medical history included living in nursing home, parkinson''s disease, alzheimer''s disease, vitamin d deficiency, constipation. Concomitant medication included oxazepam (SOBRIL), zopiclone, carbidopa/ levodopa (SINEMET), paracetamol (PARACET), bisacodyl (TOILAX). On 09Jan2021, the patient developed tiredness and decreased appetite. From 16Jan2021 the patient became bedridden and had altered state of consciousness. The patient died on 18Jan2021. t was not reported if an autopsy was performed. The outcome of events was fatal. The case was considered to be Serious. Sender Comment: The report concerns a patient in her 80s, who became increasingly tired and fatigued and had a reduced appetite from the day after the first dose of the Covid-19 vaccine Comirnaty. One week later, the patient became bedridden and uncontactable, and died a few days later. The patient was a resident of a nursing home and had underlying diseases. The most common adverse reactions with Comirnaty in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. However, we cannot rule out that such relatively mild side effects may lead to a more serious course in severely debilitated patients. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In the individual case, however, it is difficult to know whether the symptoms are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient later died, the message is also classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reactions/events: Source of assessment was Pharmacovigilance Center, Result of Assessment was Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decreased appetite; Tiredness; Altered state of consciousness
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