Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Procedural vomiting, Ultrasound testes, Venous operation
Clinical narrative: First vein ablation on 4/18/2022 on her right leg's great saphenous vein/ left leg vein ablation done on 5/9/2022; she is having a little pain/back pain; after this surgery, she was vomiting almost nonstop at first, this got better where she vomited intermittently; Blood pressure was high 171/94 and at home was 181/114; Right leg was swollen and felt weird and couldn't lift leg to get into bed/ left leg is also very swollen; She gasps for air at times if she lifts her left leg; a swollen lymph node under her arm; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) from License Party. Other Case identifier(s): US-AMGEN INC-22-0098915-SR-01, US-AMGEN-USASL2022063223.  A 36-year-old female patient received etanercept (ENBREL), since 03Mar2022 (Lot number: 1137076, Expiration Date: 30Jun2024) at 50 mg weekly for psoriatic arthropathy; BNT162b2 (BNT162B2), as dose 3 (booster), single, (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (ongoing), notes: current medical condition. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single ), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, single ), for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "a swollen lymph node under her arm"; BACK PAIN (non-serious) with onset 2022, outcome "not recovered", described as "she is having a little pain/back pain". The action taken for BNT162b2 was unknown; for etanercept was dosage not changed.  The reporter's assessment of the causal relationship of "she is having a little pain/back pain" and "a swollen lymph node under her arm" with the suspect product(s) BNT162b2 and etanercept 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.  Follow-up(01Jun2022): This is a solicited follow-up report received from contactable reporter (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-22-0154480-SR-01, US-AMGEN-USASL2022063223.  ADDITIONAL INFORMATION RECEIVED ON 01/JUN/2022: In this follow up it was reported that the patient who had first vein ablation on 4/18/2022 on her right leg's great saphenous vein/ left leg vein ablation done on 5/9/2022 [PT: venous operation], right leg was swollen and felt weird and couldn't lift leg to get into bed [PT: procedural vomiting], blood pressure was high 171/94 and at home was 181/114 [PT: hypertension], right leg was swollen and felt weird and couldn't lift leg to get into bed/ left leg is also very swollen [PT: peripheral swelling], She gasps for air at times if she lifts her left leg [PT: dyspnoea] while receiving Enbrel with Single Dose Prefilled Autoinjector. Approximately 1 month 2 weeks later, on 18/APR/2022, the patient had 1st vein ablation on her right leg's great saphenous vein. After the surgery she felt great . The patient held Enbrel injection one week before and after each of ablation. Then she had the left leg vein ablation done on 09/MAY/2022. On an unknown date in 2022, she did not do so well after this surgery, she was vomiting almost nonstop at first, this got better where she vomited intermittently. On an unknown date in 2022, the patient's right leg was swollen and felt weird and couldn't lift leg to get into bed. She gasps for air at times if she lifts her left leg. She saw the surgeon who canceled the last vein ablation to have been done on 31/MAY/2022. On 31/MAY/2022, she saw her health professional and her blood pressure was high 171/94 and at home is was 181/114. Her left leg was also very swollen. On 01/JAN/2022, she had bilateral ultrasound. She was going to contact her rheumatologist today as well. The outcome of the events venous operation, procedural vomiting, hypertension, peripheral swelling, dyspnoea were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector Temporarily Withheld for event venous operation. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events hypertension, peripheral swelling, procedural vomiting and dyspnoea The causal relationship between the events, venous operation, procedural vomiting, hypertension, peripheral swelling, dyspnoea and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested.  Enbrel is under agreement with the RA.  RA comment: This individual case report does not change the safety profile of the product.  RA's Causality Assessment: The event gasping, swelling of legs, blood pressure high, post procedural vomiting, venous operation, swollen lymph nodes, back pain was assessed unrelated to etanercept.; Sender's Comments: Based on available information and known profile of drug, a possible contributory role of BNT162B2 cannot be excluded for the reported event Swollen lymph nodes.   Other events represented intercurrent conditions unrelated to both suspect products.  Based on available information in the case the reported events  Venous operation, procedural vomiting, hypertension, peripheral swelling,  dyspnoea, are assessed as unrelated to both the suspect drugs -  etanercept and BNT162B2 and more likely related to intercurrent/ underlying medical condition.