VAERS ID: 2331191

AGE: | SEX: M|STATE: FR

Description

malaise; blood pressure of 7; numbness in the right arm; sensation of electric shocks and intense burning sensation; sensation of electric shocks and intense burning sensation; Paresthesia; Painful rash/ redness and pimples under the right armpit and on the chest as well as in the back, causing very intense pain; Shoulder pain/ pain in the right shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: FR-AFSSAPS-TS20221415 (RA). A 59-year-old male patient received BNT162b2 (COMIRNATY), on 27Sep2021 as dose 2, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Infarction" (not ongoing); "Proctocolitis ulcerative" (ongoing); "road accident with multiple fractures" (unspecified if ongoing); "Herniated disc" (unspecified if ongoing). Concomitant medication(s) included: IMUREL [AZATHIOPRINE] taken for colitis ulcerative. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN.), for Covid-19 immunization. The following information was reported: RASH (medically significant) with onset 11Oct2021, outcome "not recovered", described as "Painful rash/ redness and pimples under the right armpit and on the chest as well as in the back, causing very intense pain"; PARAESTHESIA (medically significant) with onset 11Oct2021, outcome "not recovered", described as "Paresthesia"; ARTHRALGIA (medically significant) with onset 11Oct2021, outcome "not recovered", described as "Shoulder pain/ pain in the right shoulder"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 11Oct2021, outcome "unknown", described as "blood pressure of 7"; HYPOAESTHESIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "numbness in the right arm"; ELECTRIC SHOCK SENSATION (non-serious), BURNING SENSATION (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "sensation of electric shocks and intense burning sensation"; MALAISE (non-serious), outcome "unknown". The events "paresthesia", "painful rash/ redness and pimples under the right armpit and on the chest as well as in the back, causing very intense pain", "shoulder pain/ pain in the right shoulder", "malaise", "blood pressure of 7", "numbness in the right arm" and "sensation of electric shocks and intense burning sensation" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (11Oct2021) 7; SARS-CoV-2 test: (28Mar2022) Negative. Therapeutic measures were taken as a result of paraesthesia, rash, arthralgia, malaise, blood pressure abnormal, hypoaesthesia, electric shock sensation, burning sensation. On 11Oct2021 onset of redness and pimples under the right armpit and on the chest as well as in the back, causing very intense pain, sensation of electric shocks and intense burning sensation + pain in the right shoulder, especially at night; with numbness in the right arm. Patient went through different phases of pain that could go down to malaise, then to fall with a blood pressure of about 7. Patient had tried several pain treatments that had not really worked. Currently patient was being monitored by the pain centre since 08Apr2022 and patient was trying a treatment with Gabapentin 1000 3 times a day, associated with codeine Klipal 600 and patient had a capsaicin patch on 13Apr2022. For the moment there are not yet any positive effects. Treatment in progress: FIVASA 800 mg, IMUREL 50 and 25 mg, TAHOR 80 mg, APROVEL 300 mg, PLAVIX 75 mg, BISOCE 2.5 mg, IMODIUM. Painkillers were prescribed but, according to him, no real improvement was felt. Since 08Apr2022 (6 months after Dose 2), he has been monitored in a pain centre. Treatment with GABAPENTIN 1000 3 x/day combined with KLIPAL CODEINE 600 was initiated. A Capsaicin patch was placed on 13Apr2022. On 27Apr2022, the patient specified that there was not yet any improvement. Persistence of symptoms 6 months later. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events cannot be completely excluded based on temporal association and known drug safety profile 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,Linked Report(s) : FR-PFIZER INC-202200878627 Same reporter/patient diff AE/product;

Symptoms

Arthralgia, Blood pressure abnormal, Blood pressure measurement, Burning sensation, Electric shock sensation, Hypoaesthesia, Malaise, Paraesthesia, Rash, SARS-CoV-2 test

Vaccines

VAX DATE: 09-27-2021| ONSET DATE: 10-11-2021| DAYS TO ONSET: 14
NameDose #TypeManufacturerLotRouteSite
COVID19 (COVID19 (PFIZER-BIONTECH)) 2 COVID19 PFIZER\BIONTECH OT LA

RECVDATE:06-24-2022
RPT_DATE:
CAGE_YR:
CAGE_MO:
DIED:U
DATEDIED:
L_THREAT:U
ER_VISIT:U
HOSPITAL:U
HOSPDAYS:
X_STAY:U
DISABLE:U
RECOVD:N
LAB_DATA:Test Date: 20211011; Test Name: blood pressure; Result Unstructured Data: Test Result:7; Test Date: 20220328; Test Name: SARS-CoV-2 test; Test Result: Negative
V_ADMINBY:OTH
OTHER_MEDS:IMUREL [AZATHIOPRINE]
CUR_ILL:Proctocolitis ulcerative
HISTORY:Medical History/Concurrent Conditions: Fracture; Herniated disc; Infarction
PRIOR_VAX:
SPLTTYPE:FRPFIZER INC202200843705
FORM_VERS:2
TODAYS_DATE:06-23-2022
BIRTH_DEFECT:U
OFC_VISIT:U
ER_ED_VISIT:Y
ALLERGIES:
V_FUNDBY:

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