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Life Threatening? No
Write-up: Febrile illness, probably infection; PNEUMONIA; unrest; malaise; This is a spontaneous report downloaded from the Agency Agency-WEB NO-NOMAADVRE-FHI-2021-Ua4gp, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00018606. A contactable physician reported that an 88-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular route on 17Feb2021 at 14:20 (batch/lot number EP9598), at single dose (second dose, administered into left arm) for covid-19 immunisation. Medical history included multimorbidity, cardiac failure, pneumonia (three pneumonias during the last six months), living in residential institution, atrial fibrillation, dementia and renal failure. The patient''s concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation. The patient experienced febrile illness, probably infection on 28Feb2021, pneumonia on 28Feb2021, and unrest and malaise both on 19Feb2021 with outcome of recovered on an unspecified date in Feb2021. Dose 2 of the covid-19 vaccine Comirnaty was given 14 days after completion of treatment for the third penumonia. Some unrest and malaise two days after vaccination (19Feb2021) with c-reactive protein around 90, but recovered after this. Became abruptly worse 28Feb2021 and died 03Mar2021. Reporter perceives that the patient probable died of a new pneumonia. The patient underwent lab tests and procedures which included c-reactive protein: 90 mg/l on 19Feb2021. It was not reported if an autopsy was performed. Sender''s Comments: Background: Man in his 80s, lived in a nursing home. Known heart failure, atrial fibrillation, kidney failure, dementia. During the last six months had three pneumonias, and has generally worsened during this period with weight loss and increasing frailty. Dose 2 of the covid-19 vaccine Comirnaty was given 14 days after completion of treatment for the third pneumonia. Some unrest and malaise two days after vaccination (19.02.2021) with CRP rise to almost 90, but recovered after this. Became so abruptly worse 28.02.21 and died 03.03.21. Reporter perceives that it is overwhelmingly probable that he died of a new pneumonia. Comments: The vaccine is non-live and therefore cannot cause the disease one is being vaccinated against or any other infections. Symptoms such as general malaise and fever may still occur in the first few days after vaccination. Such systemic side effects are often more pronounced after the second dose than after the first dose of this vaccine. CRP elevation, that the patient initially experienced, is currently not listed under side effects in the approved Summary of Product Characteristics for Comirnaty, but theoretically it is conceivable that an acute inflammation in connection with vaccination may give a transient slight increase. However, it is not expected that such an immunological response alone will produce a CRP of 90. Symptoms as mentioned above are usually short-term and transient, but we cannot rule out that such relatively mild side effects may be more pronounced or lead to a more severe course in the elderly or debilitated patients. We consider a direct causal relationship between the vaccine and pneumonia 1 and a half week after vaccination to be unlikely. When vaccinating elderly patients with underlying diseases, some serious events, including death, may occur relatively shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine may have contributed to some of the symptoms at the beginning of the course of this disease, and possibly a worsening of the patient''s underlying disease / condition. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Febrile illness, probably infection; PNEUMONIA
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