Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Feeling hot, Pruritus, Varicose vein
Clinical narrative: Bulging Veins on the bottom part of calf; Bright red/itchy/hot arm after Covid Vaccine; Bright red/itchy/hot arm after Covid Vaccine; Bright red/itchy/hot arm after Covid Vaccine; This is a solicited report based on information received by Pfizer (MFR. CONTROL NO.: 21K-163-4137424-00). A contactable consumer (patient) reported that a 66-year-old female patient received bnt162b2 (Batch/Lot number was not reported), second dose intramuscular on 01Mar2021 at the age of 65-year-old as single dose, first dose intramuscular on 01Feb2021 66-year-old as single dose for covid-19 immunization, adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate Free for rheumatoid arthritis. The patient had no medical history nor concomitant medications. No known allergies. The patient experienced bulging veins on the bottom part of calf on an unspecified date, bright red/itchy/hot arm after covid vaccine in 2021. The events were reported as serious per medically significant. Solicited report from the Regulatory Authority by a consumer of a 65 years old female with events of bulging veins on the bottom part of calf and non-serious bright red/itchy/hot arm after covid vaccine with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced bulging veins on the bottom part of calf. In 2021, the patient experienced bright red/itchy/hot arm after covid vaccine. In 2021, the bright red/itchy/hot arm after covid vaccine resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient had two prior procedures for her bulging veins. She had them on the bottom part of her calf. She had covid vaccine and after each vaccine she had bright red, itchy and hot arm that lasted for ten days each. No concomitants was taken. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 01Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken for adalimumab was unknown. The outcome of events for bulging veins on the bottom part of calf was unknown, for other events was resolved in 2021. The reporter's causality for adalimumab (HUMIRA) for the events of bulging veins on the bottom part of calf, bright red/itchy/hot arm after covid vaccine was not provided. RA's opinion is that there is no reasonable possibility that the events of bulging veins on the bottom part of calf, bright red/itchy/hot arm after covid vaccine are related to adalimumab (HUMIRA).  Causality for bnt162b2 for events of Varicose veins of lower extremities per reporter (Drug/Vaccine) was not reported; for bright red/itchy/hot arm after covid vaccine per reporter (Drug/Vaccine) was not related. The reporter's assessment of the causal relationship of the event (Varicose veins of lower extremities) with the suspect product 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; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events malaise and vaccination site pain cannot be established.