Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Depression, Device difficult to use, Device malfunction, Dizziness, Drug dose omission by device
Clinical narrative: high pain level of seven out of ten; Enbrel came in styrofoam in cardboard box with ice pack only one unit has worked/sureclick not working did not give injection/syringe did not inject part of yellow safety cap was out but not all the w; Sureclick not working did not give injection/syringe did not inject part/no dose administered/3/4 from this lot number; the medication started to squirt out everywhere getting on her and her clothes; usually gets a red mark and a "little swell" after each injection but not with this one; flare of RA/after receiving her COVID -19 booster she had a major flare up, her arm "swelled up like a football" that lasted for a couple of weeks; worsening neuropathy from ankle to toes on left side; Hair loss; Nausea/having nausea that lasted up to a week then decreased over time; decreased appetite; Weight loss; dizziness; SVT Issue; Depression; anemia; Injection site bruising; Patient reports more pain from Enbrel sureclick than previously/burning/ symptoms very swollen burning and itching at site for 5 days after/beginning (of using Enbrel) it would burn and itch butas her; Nausea, rash, swelling, burning and itching at injection site/ symptoms very swollen burning and itching at site for 5 days after/she usually gets a red mark and a "little swell" after each injection/; Nausea, rash, swelling, burning and itching at injection site/symptoms very swollen burning and itching at site for 5 days after/beginning (of using Enbrel) it would burn and itch butas her immune sys; Nausea, rash, swelling, burning and itching at injection site; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: USAMGEN- USASP2021072400), license party for etanercept (ENBREL). This spontaneous report (USASP2021072400) was reported ton 10May2021 by a consumer and involves a 62-year-old female patient who experienced nausea [PT: nausea], decreased appetite [PT: decreased appetite], weight loss [PT: weight decreased], dizziness [PT: dizziness], SVT (supraventricular tachycardia) issue [PT: supraventricular tachycardia], depression [PT: depression], anemia [PT: anaemia], injection site bruising [PT: injection site bruising] while receiving Enbrel with Single Dose Prefilled Syringe and Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included other specified rheumatoid arthritis, multiple sites. The patient's concomitant medications included Cardizem (diltiazem), folic acid, hydrochlorothiazid, isosorbide dinitrate, potassium, Xarelto (rivaroxaban). No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date in Apr2021. On an unknown date in 2021, the patient stated that, the Single Dose Prefilled Syringe formulation was more difficult to use due to RA (rheumatoid arthritis) limitations in fingers and that caused her bruising at injection site. Therefore, on an unknown date in 2021, the patient started using Single Dose Prefilled Autoinjector formulation. Also, the patient reported nausea that has progressively gotten better with each dose of Enbrel. The patient had decreased appetite and weight loss of 20 lbs (pounds). Also, the patient has ongoing SVT issues and will require ablation in the next few weeks to manage tachycardia and reported dizziness and anemia related to SVT. Also, the patient's depression is ongoing. No treatment information was received. The outcome of the events decreased appetite, weight decreased, dizziness, supraventricular tachycardia, depression, anaemia, injection site bruising were reported as not recovered/not resolved. The outcome of the event nausea was reported as recovering/resolving. Action taken with Enbrel was continued for the event injection site bruising. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events nausea, decreased appetite, weight decreased, dizziness, anaemia, supraventricular tachycardia and depression. Action taken with Single Dose Prefilled Syringe was withdrawn for the event injection site bruising. The causal relationship between the events injection site bruising, nausea, decreased appetite, weight decreased, dizziness, anaemia, supraventricular tachycardia, depression and Enbrel and Single Dose Prefilled Syringe and Single Dose Prefilled Autoinjector was not provided by the consumer.   No follow up attempts are possible. No further information is expected.   Follow-up (08Jul2021): This is a follow-up spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGENUSASP2021072400), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 08/JUL/2021: It was reported that the patient had more pain from Enbrel SureClick than previously [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector. On an unknown date in 2021, the patient had more pain from Enbrel SureClick than previous formulation Single Dose Prefilled Syringe. The outcome of the event injection site pain was reported as not recovered/not resolved. Action taken with Enbrel was continued for the event injection site pain. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the event injection site pain. Action taken with Single Dose Prefilled Syringe was withdrawn for the event injection site pain. The consumer reported that the event injection site pain was possibly related to Enbrel. The causal relationship between the event injection site pain and Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector was not provided by the consumer.   No follow up attempts are required. No further information is expected.   Follow-up (17Aug2021): This is a follow-up spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASP2021072400), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 17/AUG/2021: The patient reported nausea, rash, swelling, burning and itching at injection site [PT: injection site pain, PT: nausea, PT: injection site rash, PT: injection site pruritus, PT: injection site swelling] while receiving Enbrel with Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector. On an unknown date in 2021, the patient had nausea, rash, swelling, burning and itching at injection site. The outcome of the events nausea, injection site pain, injection site rash, injection site pruritus, injection site swelling was reported as not= recovered/not resolved. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the events nausea and injection site pain. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site rash, injection site pruritus and injection site swelling. The consumer reported that the events nausea injection site rash, injection site pruritus, injection site swelling were possibly related to Enbrel. The causal relationship between the events nausea, injection site pain, injection site rash, injection site pruritus and Single= Dose Prefilled Syringe, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up.   No follow up attempts are required. No further information is expected.   Follow-up (25Oct2021): This is a follow-up spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGENUSASP2021072400), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 25/OCT/2021: This case is upgraded to serious. In this follow up report, the patient experienced flare of RA (rheumatoid arthritis) [PT: rheumatoid arthritis], worsening neuropathy from ankle to toes on left side [PT: neuropathy peripheral], hair loss [PT: alopecia], symptoms very swollen burning and itching at site for 5 days after [PT: injection site swelling, PT: injection site pruritus and PT: injection site pain] while receiving Enbrel with Single Dose Prefilled Syringe and Single Dose Prefilled Autoinjector. On an unknown date in 2021, the patient experienced worsening neuropathy from ankle to toes on left side. Also, the patient experienced hair loss that continues while on medication and also had high pain level of seven out of ten. On an unknown date in 2021, the patient received the "COVID booster" and had flare of RA (rheumatoid arthritis). On an unknown date in 2021, about two months ago, the patient had injection site reactions with Enbrel with symptoms very swollen burning and itching at site for five days after injection and that happened with both injections from PFS (prefilled syringe). The outcome of the events rheumatoid arthritis, neuropathy peripheral, alopecia were reported as not recovered/not resolved. Action taken with Enbrel was reported as unknown for the events rheumatoid arthritis, neuropathy peripheral and alopecia. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, neuropathy peripheral and alopecia. Action taken with Single Dose Prefilled Syringe was reported as unknown for the events injection site pain, injection site pruritus, injection site swelling, rheumatoid arthritis, neuropathy peripheral and alopecia. The consumer= reported that the events rheumatoid arthritis, neuropathy peripheral, alopecia were possibly related to Enbrel. The causal relationship between the events rheumatoid arthritis, neuropathy peripheral, alopecia and Single Dose Prefilled Syringe and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up.  No follow up attempts are required. No further information is expected.   Comments: This safety report does not necessarily reflect a conclusion that etanercept, devices, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  Follow up (27Oct2021): This is a follow up spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGENUSASP2021072400), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 27/OCT/2021: The outcome of the previously reported event PT: Injection site swelling, Injection site pruritus, Rheumatoid arthritis has been updated to recovered/resolved. The outcome of the previously reported event PT: Nausea has been updated Recovering/Resolving. In this follow up, it was reported tha the patient experienced after receiving her covid - 19 booster she had a major flare up, her arm "swelled up like a football" that lasted for a couple of weeks [PT: rheumatoid arthritis], having nausea that lasted up to a week then decreased over time, [PT: nausea], arm "swelled up like a football [PT: injection site swelling], beginning (of using enbrel) it would burn and itch butas her immune system became suppressed it went away [PT: injection site pruritus], beginning (of using enbrel) it would burn and itch butas her immune system became suppressed it went away [PT: injection site pain], the medication started to squirt out everywhere getting on her and her clothes [PT: accidental exposure to product], usually gets a red mark and a "little swell" after each injection but not with this one [PT: injection site erythema] while receiving Enbrel, Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included Covid-19 Vaccine. On an unknown date in 2021, the patient usually gets a red mark and a little swell after each injection but not with this one. The consumer continued to say that in the beginning of using Enbrel it would burn and itch but as her immune system became suppressed it went away. Consumer also reported having nausea that lasted up to a week then decreased over time, now it lasts less than a couple hours and helps when she eats yogurt. The patient stated that after receiving her COVID -19 (corona virus disease- 2019) booster she had a major flare up, her arm swelled up like a football that lasted for a couple of weeks. On 27/OCT/2021, the patient stated that while attempting to administer her Enbrel using SureClick pen, the patient injected like she always had but after the needle pierced her skin the yellow in the window stopped it would not move further down. After waiting for five minutes, no click was heard, so patient lifted the pen from leg and the medication started to squirt out everywhere getting on her and her clothes. The outcome of the event nausea was reported as recovering/resolving. The outcome of the events rheumatoid arthritis, injection site swelling, injection site pruritus, injection site pain were reported as recovered/resolved. The outcome of the events accidental exposure to product, injection site erythema were reported as unknown. The events rheumatoid arthritis, injection site swelling, injection site pruritus, injection site pain were resolved on an unknown date in 2021.Action taken with Enbrel and Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site erythema. The causal relationship between the events accidental exposure to product, injection site erythema and Enbrel with Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector was not provided by the consumer.   No follow up attempts are possible, no further information is requested.   Comments: This safety report does not necessarily reflect a conclusion that etanercept, devices, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.   Follow up (22Jun2022): This is a follow up spontaneous report received from contactable reporter (s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGENUSASP2021072400. ADDITIONAL INFORMATION RECEIVED ON 22/JUN/2022: In this follow up, it was reported as the patient had burning when she gives injection [PT: injection site pain], Enbrel came in styrofoam in cardboard box with ice pack only one unit has worked/sureclick not working did not give injection/syringe did not inject part of yellow safety cap was out but not all the way/ no dose administered [PT: device difficult to use], Sureclick not working did not give injection/syringe did not inject part/no dose administered [PT: drug dose omission by device] while receiving Enbrel with Single Dose Prefilled Syringe. The patient reported that Sureclick injector Enbrel came in styrofoam in cardboard box with ice pack only one unit has worked. The patient reported new batch coming tomorrow. The patient called to reported Enbrel Sureclick autoinjector did not work. The patient reported 3/4 from this lot number that she received have not worked, the replacements for first 2 that did not work were due to arrive tomorrow. The patient reported that she had been using Sureclicks for over a year and usually feels burning when she gives injection, injection site was red after injection, and that she hears a click when injection was finished. The patient reported that none of these things happened with this attempt and that needle guard appears to be partially deployed. No treatment information was received. The outcome of the events device difficult to use and drug dose omission by device was reported as unknown. The causal relationship between the events device difficult to use and drug dose omission by device and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. Lot number has been updated. The reporter declined consent for follow up.   No follow up attempts are possible. No further information is expected.  Comment: This safety report does not necessarily reflect a conclusion that etanercept and device caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. Enbrel is under agreement.