Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Muscle tightness
Clinical narrative: The patient did experience headache; The patient stated she also had tight shoulder and neck muscles but was not sure if it was from the vaccine or her self induced stress from taking the the first dose; This is a spontaneous report from a contactable consumer or other non hcp. consumer based on information received by Pfizer. This case was split from master case 2021012261 for a female patient taking BNT162B2 and experienced Headache and Muscle tightness.  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, palpitations from an unknown date and unknown if ongoing , osteoporosis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL) taken for rheumatoid arthritis, start and stop date were not reported; folic acid  taken for an unspecified indication, start and stop date were not reported; zinc  taken for an unspecified indication, start and stop date were not reported; ascorbic acid (ESTER-C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. On an unspecified date patient experienced headache, the patient stated she also had tight shoulder and neck muscles but was not sure if it was from the vaccine or her self induced stress from taking the first dose. The patient underwent lab tests and procedures which included blood test unknown result on an unspecified date. The outcome of events was unknown.  This non-serious solicited report (USASL2021001441) was reported on 05Jan2021 by a consumer from a commercial program (PSP00180) and involves a 57-year-old female patient who stated the formulation of Enbrel she took in the past would burn while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with unknown formulation on an unknown date. The patient stated that, on an unknown date, the formulation of Enbrel she took in the past wold burn. On an unknown date, the patient switched to Enbrel with Single Dose Prefilled Autoinjector due to an unspecified reason. No treatment information was received. The outcome of the event injection site pain was reported as unknown. The causal relationship between the event injection site pain and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. additional information received on 04May2021: This case is upgraded to serious case. It was reported that the patient had osteonecrosis, broke her leg and was in a body cast for nine months, bleeding at her injection site that, bruising at injection, deathly afraid of needles, had cold or other infection and she had stopped taking Enbrel for a week or two week and while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient began Enbrel, Single Dose Prefilled Autoinjector for 17 years prior to this report. On an unknown date the patient was deathly afraid of needles and it take her two hours to work up the nerve to take her shot. Additionally, the patient had osteonecrosis. On an unknown date, the patient had cold or other infection and she had stopped taking Enbrel for a week or two week. Also, she had bleeding at her injection site that would last a minute or two. She also had bruising at injection site. On an unknown date in 2020 past year, the patient broke her leg and was in a body cast for nine months. No treatment information was received. The outcome of the event injection site haemorrhage was reported as recovered/resolved. The outcome of the events injection site bruising, lower limb fracture, fear of injection, osteonecrosis, nasopharyngitis, infection was reported as unknown. The event injection site haemorrhage was resolved on an unknown date. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain, injection site haemorrhage, injection site bruising, lower limb fracture, fear of injection and osteonecrosis. Action taken with Enbrel, Single Dose Prefilled Autoinjector was temporarily withheld for the events nasopharyngitis and infection. The causal relationship between the events injection site haemorrhage, injection site bruising, lower limb fracture, fear of injection, osteonecrosis, nasopharyngitis, infection and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. additional information received on 26May2021: This information received by a consumer from a commercial program (PSP00046b) and involves a already mixed and it burned for like two hours [PT: injection site pain], i know sinus infections/sinus infections, I get sick for a couple days her body got sick for a couple of days and most of the time she got the flu anyway, heart palpitations, osteoporosis, allergies were terrible and it had been allergies affecting her stuffy nose, sneezing, watery and itchy eyes she was getting tired, most of the syringes are in a sharps container, but there are maybe 5 plastic bags and she was afraid of needles and at the beginning she used to try to make sure she got every bubble out of the syringe, while receiving Enbrel, Single Dose Prefilled Syringe, Multiple Dose Vial Kit For Reconstitution. The patient's concomitant medication included Folic Acid and takes 80 mg of Zinc, Sambucas, Ester-C 2 tablets of 1000 mg each, multi-vitamin, pain mediation for 16 years, and vitamins. It was clarified that the patient began Enbrel, with Single Dose Prefilled Syringe for 17 years prior to this report. On an unknown date, the patient stated that she was afraid of needles and at the beginning she used to try to make sure she got every bubble out of the syringe. She stated that her fingernails would be black and blue from flicking the syringe to get the bubble out of the syringe. The patient said that she hyperventilates due to her fear of needles. Additionally the patient stated that if she said she was going for bloodwork and she was afraid of needles, that had nothing to do with your Enbrel. The patient stated that she had a box with she could not tell you how many needles she have in it as she could not find anywhere to take the sharps container. Most of the syringes were in a sharps container, but there were maybe five plastic bags with the syringes in them. Also, she had heart palpitations and because of that she could not take antihistamines. The patient had two medications for it she take every month. Additionally, she had osteoporosis and was told by her doctor to not take an anti-inflammatory medication when she takes the Coronavirus disease (COVID) Vaccine. The patient said she got blood work every three months. On an unknown date the patient ran out the syringe and could not get a refill fast enough. However, her doctor gave her a sample from the office. The patient took the Enbrel 25 mg lyophilized powder in a multiple-dose vial for reconstitution. She was on the multi-use vial and this sample was already mixed and it burned for like two hours. She never had reactions to Enbrel except this one time. Also, the patient stated that she do better without flu vaccines. When she get the flu vaccine, she get sick for a couple days even though she know it was not a live vaccine. The patient stated that her body got sick for a couple of days and most of the time she got the flu anyway. The last 5 years she have not gotten the flu vaccine and she had also not gotten the flu. Also she take vitamins and she have got sick less over the last few years. She did not feel sick except one time she went through a box of tissues in two days. She was sleeping with her windows open and she felt better in a room with the AC on with a HEPA filter. She did not take her shot that day though until she was sure she was not sick. On an unknown date in 2021 early this year, in the recent past the doctor leaves it up to the patient to take Enbrel, if she think she was getting sick or having allergies, so she skipped her Enbrel one week to see if she was getting sick. Also, the patient know sinus infections could be a side effect and she know to go on antibiotics right away with things like sinus infections so she did not get really sick. On an unknown date in MAR/2021, there were three times she did not take her Enbrel, but there was really bad pollen in our area. She had a stuffy nose, sneezing, watery and itchy eyes. She was getting tired, but when her immune system was working with allergies or a cold, she did not get sick much. The patient stated that her allergies were terrible and it had been allergies affecting her. She just have normal spring and fall allergies. No fever. On today 26May2021 the patient wanted to know if she could take her Enbrel shot and take the Pfizer COVID vaccine on Saturday 29May2021, the patient stated that she keep waiting for it. However, the patient decided to get it, but she checked with her doctor and they did not have any information about being on the Enbrel. She talked to her rheumatologist and she was told she could take her Enbrel before and after the vaccine. The patient wanted to know is being on Enbrel going to make the side effects of the COVID-19 vaccine worse. The patient advised there was no data. The patient said there were two things she wants to know, should she take her Enbrel today 26May2021 or did she need to wait a week after getting the Vaccine to take the Enbrel again. The patient said when she talks to her Doctor at her age it was kind of like the lesser of two evils and that was the only reason for getting the vaccine because her immune system and taking Enbrel she had a chance of having severe case of COVID and could wind up in the hospital on a ventilator or dead. The patient talked about how she did not want to have severe symptoms (such as throwing up, 106 degree fever, can't lift her head off the pillow) after getting the COVID vaccine by taking Enbrel and lowering her immune system too much. She would have Tylenol (acetaminophen) and Ibuprofen though to take if she needs it. She stated repeatedly how she was worried about getting side effects from the vaccine but also did not want to lower her immune system too much so that she did not respond to the vaccine. She also stated she knows they were collecting data on the COVID vaccines and Enbrel and wanted to know when that information was going to be released. She was advised there was no information on that and explained that information collected from calls was sent to the safety team. Treatment for the event palpitations included two medications she take every month. The outcome of the event injection site pain were reported as recovered/resolved. The outcome of the events fear of injection, illness, sinusitis, palpitations, osteoporosis, hypersensitivity, and incorrect disposal of product was reported as unknown. The event injection site pain were resolved on an unknown date. Action taken with Enbrel was reported as unknown for the events injection site pain, fear of injection, illness, palpitations, osteoporosis. Action taken with Enbrel was temporarily withheld for the events sinusitis and hypersensitivity. Action taken with Single Dose Prefilled Syringe was reported as unknown for the events injection site haemorrhage, injection site bruising, lower limb fracture, fear of injection, osteonecrosis, palpitations and osteoporosis. Action taken with Single Dose Prefilled Syringe was temporarily withheld for the events nasopharyngitis and infection. Action taken with Multiple Dose Vial Kit For Reconstitution was temporarily withheld for the events sinusitis and hypersensitivity. Action taken with Multiple Dose Vial Kit For Reconstitution was reported as unknown for the events illness. The consumer reported that the event fear of injection was not related to Enbrel. The consumer reported that the event injection site pain was possibly related to Enbrel. The causal relationship between the events illness, sinusitis, palpitations, osteoporosis, hypersensitivity, incorrect disposal of product and Enbrel was not provided by the consumer. The causal relationship between the events injection site pain, injection site haemorrhage, injection site bruising, lower limb fracture, fear of injection, osteonecrosis, nasopharyngitis, infection, illness, sinusitis, palpitations, osteoporosis, hypersensitivity, incorrect disposal of product and Single Dose Prefilled Syringe was not provided by the consumer. The causal relationship between the events injection site pain, injection site haemorrhage, injection site bruising, lower limb fracture, fear of injection, osteonecrosis, nasopharyngitis, infection, illness, sinusitis, palpitations, osteoporosis, hypersensitivity, incorrect disposal of product and Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. The follow up has been requested. Does not and will never have access to lot number. Version created to clarify that the patient was taking 80 milligram of zinc. additional information received on  09Jun2021: This follow up information was reported by patient. It was reported that the patient had had tight shoulder and neck muscles [muscle tightness] and headache [headache], while receiving Enbrel, Single Dose Prefilled Syringe, Multiple Dose Vial Kit For Reconstitution. The patient's historical condition included palpitations and osteoporosis. The patient's co-suspect medication included Covid-19 Vaccine. The patient had been on Enbrel for about 15 years. The patient was only seeking guidance if the COVID-19 vaccination was recommended to be taken and if so how when patient was on Enbrel. The patient restated her historical background and her research regarding COVID vaccine. The patient had educated herself with the differences each vaccine had to offer protection and was concerned with her T-cell and B-cell where they might negate the effectiveness of the vaccine when paired with the Enbrel. The patient spoke to ten different doctors with ten different answers. The patient was anxious and stressed about all of this and was hoping website had more medical information available to the public regarding the vaccines and interactions with Enbrel. The patient did temporarily stop her Enbrel for about 1 1/2 weeks so she could get her first injection of the Pfizer COVID-19 vaccination. The patient did experience headache but did not need to take any over the counter pain medicine. The patient stated she also had tight shoulder and neck muscles but was not sure if it was from the vaccine or her self induced stress from taking the first dose. The patient resumed her Enbrel and was due for the second Pfizer COVID-19 vaccine injection in about two weeks and was scared that the second injection would be more painful and what to do about it. The patient's health care professional was aware of her situation. The patient stated it was not caused by the Enbrel nor made worse and was very satisfied that Enbrel works well for her. The patient noticed that when she took the annual flu shot, it seemed to make her catch colds and sinus infection more easily and once patient stopped taking the flu shot, she felt the healthiest. The patient stated it had been over 7 to 8 years since she had a flu shot and had not been sick. The palpitations were a reaction to cold medicine- patient had a sensitivity to decongestants. Per the patient, Enbrel did not the cause nor made worse these events. The patient had learned how her body reacts and responds to over the counter medicines and antibiotics. The patient's health care professional (HCP) aware of this as well. If patient could feel a cold coming on or its just allergies her HCP is notified and the proper remedy was started. The outcome of the events headache and muscle tightness was reported as unknown. The consumer reported that the events fear of injection, headache, muscle tightness were not related to Enbrel. The causal relationship between the events of headache, muscle tightness and Single Dose Prefilled Autoinjector, Multiple Dose Vial Kit For Reconstitution was not provided by the consumer.    No follow-up attempts possible. No further information expected