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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||EM0477 / UNK||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Asthenia, Blood creatinine, Condition aggravated, Confusional state, Death, Diarrhoea, Dyspnoea, Fall, Neck pain, Pain, Paresis, Pyrexia, Urinary retention, Spinal disorder, Peripheral venous disease
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: ASPIRIN CARDIO; EPRIL; PANTOPRAZOL ACTAVIS; ZOLDORM; MST CONTINUS; MIRTAZAPIN MEPHA
Preexisting Conditions: Medical History/Concurrent Conditions: Renal impairment; Spinal disorder
Diagnostic Lab Data: Test Date: 202103; Test Name: Blood creatinine; Result Unstructured Data: Test Result:118
CDC 'Split Type': CHPFIZER INC2021497168
Write-up: Exitus letalis; paresis hand and arm right side; chronic venous insufficiency; Urinary retention; confusional state; diarrhoea; very severe neck pain; nocturnal fall; pain exacerbation of his panvertebral syndrome/pain; pain exacerbation of his panvertebral syndrome; pain exacerbation of his panvertebral syndrome; fever; weakness; dyspnoea; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-14555. A 94-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 28Jan2021 (Lot Number: EM0477) as single dose for covid-19 immunisation. Medical history included renal impairment function, vertebral syndrome. Concomitant medication included acetylsalicylic acid (ASPIRIN CARDIO); enalapril maleate (EPRIL); pantoprazole sodium sesquihydrate (PANTOPRAZOL ACTAVIS); zolpidem tartrate (ZOLDORM), morphine sulfate (MST CONTINUS) taken for vertebral syndrome; mirtazapine (MIRTAZAPIN MEPHA). On 28Jan2021, the patient was vaccinated with Comirnaty. 14 days later, on 11Feb2021, patient develops fever, weakness and dyspnea. On 12Feb2021, Nocturnal fall: pain exacerbation of his panvertebral syndrome. On 16Feb2021, very severe neck pain, more than normal, probably as a result of the fall. On 17Feb2021, renewed fall, found by neighbor next to the bed, had knocked with his stick for help. Decision to enter care home, since the pain can only be treated inadequately in the home environment. On 18Feb2021, MST 10 2x/day, care home admission, in the evening confusional state, diarrhoea On 23Feb2021, further pain exacerbation, increase of MST 2 x 20mg Mirtazapine 15mg at night. On 25Feb2021, Urinary retention, urinary catheter. On 03Mar2021, especially chronic venous insufficiency; paresis hand and arm right side. On 12Mar2021, Exitus letalis. The patient underwent lab tests and procedures which included blood creatinine: 118 on Mar2021. The outcome of the event unknown cause of death was fatal, pain was not recovered, other events was unknown. The patient died on 12Mar2021. It was not reported if an autopsy was performed. A causal relationship between Comirnaty and death was assessed as being unlikely. Sender''s comment (a regulatory authority): Death occurred 43 days after administration of the Comirnaty vaccine in a 94-year-old, polymorbid man. To date, no deaths of elderly people in causal correlation with Covid-19 mRNA-based vaccines are known in the literature. In the immediate aftermath of vaccination, no ADEs of any kind were reported. Only 14 days after vaccination did fever, weakness, and dyspnea occur, which likely promoted the fall. Fever and weakness, although related to the vaccine as described in the monograph and in the international literature, since they occurred 2 weeks after the administration, speak little for a causal correlation. Moreover, it is not possible to exclude other possible causes, such as the infectious one, in this very elderly patient who, however, took care of his wife and therefore it is likely to assume that he went out of the house and carried out minimal activities that could expose him to the risk of infections. In view of the absence of data from the literature for death related to Covid-19 vaccines, given that we cannot exclude other possible causes for the decline in general conditions (first of all the fall), in view of the weak temporal correlation, we judge the causal link between the Comirnaty vaccine and the death of this elderly gentleman unlikely. Reporter comment: Death occurred 43 days after administration of the Comirnaty vaccine. The patient expressed several times that he was ready to die. He was exhausted from caring for his sick, visually impaired wife.; Reporter''s Comments: Death occurred 43 days after administration of the Comirnaty vaccine. The patient expressed several times that he was ready to die. He was exhausted from caring for his sick, visually impaired wife.; Sender''s Comments: Based on Pfizer policy, all death cause unknown events are assessed to be related to the subject drugs. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.; Reported Cause(s) of Death: death.
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