Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: she almost passed out; she could not breathe; she thought that she had a heart attack and she ended up in the hospital; she is looking for to describe what she is having and she calls it flares/ Patient then states that she thinks that these are flares/ached all over all day long and it was not just her wrists or knees; she is pretty much sleeping half of the day now / she just wanted to sleep all day; she feels like her Enbrel medication is not working for her like it used to; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASP2021122310), license party for etanercept (ENBREL).  This serious spontaneous report (USASP2021122310) was reported to Amgen on 04/AUG/2021 by a consumer and involves a female patient who experienced she almost passed out [PT: loss of consciousness], she could not breathe / she thought that she had a heart attack and she ended up in the hospital [PT: dyspnoea], she is looking for to describe what she is having and she calls it flares/ patient then states that she thinks that these are flares/ached all over all day long and it was not just her wrists or knees that ached and her whole body ached [PT: rheumatoid arthritis], she is pretty much sleeping half of the day now / she just wanted to sleep all day [PT: somnolence], she feels like her enbrel medication is not working for her like it used to [PT: therapeutic product effect decreased] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included inflammatory polyarthritis, rheumatoid arthritis/ra in her wrists and knees. No concomitant medications were provided.The patient's co-suspect medication included Methotrexate, Covid-19 Vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. The patient stated that she had been using Enbrel and methotrexate for about 3.5 years now. She started Enbrel in 2016 or 2017 and she thinks it was probably 2017. The patient stated that she had a new life with Enbrel and methotrexate. She was very healthy except for her RA (rheumatoid arthritis). The patient stated that she was curious because she knows how Enbrel works to suppress immune system (no further information available). The patient stated that she was told that she had to get vaccinated, the patient was wondering if it was safe to do that if someone was on RA medicine. On an unknown date, the patient stated that she was doing Enbrel and she had two Pfizer COVID-19 (corona virus disease vaccine-2019) vaccine. The patient stated that after about three weeks later of getting the second Pfizer COVID-19 vaccine she could not breathe and she thought that she had a heart attack, she was almost passed out and she ended up in the hospital and they did every test on her. Additionally, the patient stated that she felt as though that the Enbrel injection was fighting the Pfizer COVID-19 vaccine. She stated that the two did not work together because one was trying to suppress and the other was trying to lift up. Then, the patient mentioned that she felt like her Enbrel medication was not working for her like it used to. The patient stated that she did not think people using an immune suppressant drug and they should social distance and wear masks (during pandemic). The patient stated that she was talking about things she had with RA, she did not have them until now and then she found the word that she was looking for to describe what she was having and she called it flares. On an unknown date, the patient stated that she had never had any issues with Enbrel except for one time where the device malfunctioned and the medication did not go into her body. She had already let company know about this issue and she received the replacement as well. The patient stated that she wished that she would have never taken the Pfizer COVID-19 vaccine. The patient then randomly stated that she would not get a booster. The patient then stated that she saw her Chiropractor last week and she talked to her Chiropractor about her inflammation in her wrists and knees and she was told that it was only a slight amount of inflammation which was not like before she started taking Enbrel. The patient then stated that her Chiropractor told her to take turmeric at grocery store and so she went out to go get it and what she got has black pepper and turmeric in it and she states that her wrists and knees do not hurt at all now. The patient stated that now it was just the achy and tired thing for her. Patient then stated that she was told that this turmeric would boost her inflammation that she was feeling and it did (it is not fully clear what the patient was discussing here). The patient stated that she felt okay now except for being really tired at times. The patient stated that she did not get the inflammation now. The patient then stated that she felt like the Pfizer COVID-19 vaccine should not be used on people who are taking immune suppressing drugs. The patient stated that since she got the Pfizer COVID-19 vaccine her life has been deteriorating and she just wanted to let us know about her experience. 02/AUG/2021, this past Monday of this report, the patient stated she ached all over all day long and it was not just her wrists or knees but her whole body ached which was not normal. The patient also stated that she just wanted to sleep all day. She was pretty much sleeping half of the day now. The patient stated that she thought that these are flares that she was getting and she has been having them all along and her physician kept telling her that these flares would go away. No treatment information was received. The outcome of the event somnolence was reported as not recovered/not resolved. The outcome of the events loss of consciousness, dyspnoea, rheumatoid arthritis, therapeutic product effect decreased were reported as unknown. Action taken with Enbrel was reported as unknown for the events dyspnoea, loss of consciousness, somnolence, rheumatoid arthritis and therapeutic product effect decreased. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the events dyspnoea, loss of consciousness, somnolence, rheumatoid arthritis and therapeutic product effect decreased. The consumer reported that the event therapeutic product effect decreased was possibly related to Enbrel. The causal relationship between the events dyspnoea, loss of consciousness, somnolence, rheumatoid arthritis and Enbrel was not provided by the consumer. The causal relationship between the events dyspnoea, loss of consciousness, somnolence, rheumatoid arthritis, therapeutic product effect decreased and Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  Amgen comments: This safety report does not necessarily reflect a conclusion by Amgen 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.  Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.