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VAERS Report 2157361

Case Report Section

Vaer Report Details

Age: 59 years old

Gender: Male

State: Outside US

Patient Died?
No
Vaccine information

Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)

Type: Influenza virus vaccine, quadrivalent, cell-culture-derived

Manufacturer: SEQIRUS

Lot: unknown


Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: ff2382


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-10-18
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

patient received both comirnaty and flucelvax tetra on 18oct2021; pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees; pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees; active surveillance co-administration this is a non-interventional study report from the regulatory authority-web. regulatory number: it-minisal02-843292. a 59 year-old male patient received bnt162b2 (comirnaty), intramuscular, administration date 18oct2021 (lot number: ff2382, expiration date: 31mar2022) at the age of 59 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation; influenza vaccine inact sag 4v (flucelvax tetra [influenza vaccine inact sag 4v]), intramuscular, administration date 18oct2021 (lot number: unknown) for immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation; covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. the following information was reported: product use issue (medically significant) with onset 18oct2021, outcome "unknown", described as "patient received both comirnaty and flucelvax tetra on 18oct2021"; vaccination site pain (medically significant), pyrexia (medically significant) all with onset 18oct2021, outcome "recovered" (20oct2021) and all described as "pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees". the patient underwent the following laboratory tests and procedures: body temperature: (18oct2021) above 37 degrees. therapeutic measures were taken as a result of vaccination site pain, pyrexia and treatment included simultaneous intake of tachipirina. the reporter's assessment of the causal relationship of the "patient received both comirnaty and flucelvax tetra on 18oct2021" and "pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees" with the suspect product(s) bnt162b2 was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on currently known drug safety profile, a causal association between the reported events pyrexia and vaccination site pain and bnt162b2 cannot be excluded

Lab Data
test date: 20211018; test name: body temperature; result unstructured data: test result:above 37 degrees
List of symptoms
pyrexia body temperature vaccination site pain product use issue
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na