Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Swelling
Clinical narrative: Patient mentioned she was in a lot of pain and swelling; Patient mentioned she was in a lot of pain and swelling; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021093868). This case was split from master case 2021755177 for a 61 years old female patient taking BNT162B2 and experienced pain and swelling. This non-serious solicited report (USASL2021093868) was reported to Amgen on 16Jun2021 by a consumer from a commercial program (PSP00086). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Apr2021 (age at vaccination was 61 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Apr2021 (age at vaccination was 61 years) dose 2, single for COVID-19 immunization. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No co-suspect medications were reported. The patient's concomitant medications included diclofenac (topical), calcium, Vitamin D (ergocalciferol), start and stop date unknown, taken for unspecified indication. Concomitant medications included diclofenac, calcium and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) all taken for an unspecified indication. The patient began etanercept (Enbrel) with Reusable Autoinjector 50 milligram, qwk (lot number: 1104398, expiry date: 31Jan2023) on 02Jun2021 and (lot number: 1121827, expiry date: 30Apr2023), taken for rheumatoid arthritis. The patient experienced ran down leg/then was a few drops on floor, had stomach ache, indigestion, low grade fever while receiving Enbrel, Reusable Autoinjector. On an unknown date in Jun2021, the patient stated that she had a stomach ache after taking Enbrel, had indigestion the day she takes the injection and the day after and for two days she had a low grade fever of 98.8 and 99. The patient stated that her rheumatologist was aware. On 16Jun2021, the patient took her Enbrel injection. The patient stated when she gave her third injection today, the Enbrel ran down leg and then was a few drops on floor not a puddle. She did not remember the status button flashing green the green bars in the progress bar. The patient stated that the AT (AutoTouch) did not alarm or have a red light. She did not feel the needle stick. She thought it was uneven. No treatment information was received. The outcome of the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events abdominal pain upper, dyspepsia and pyrexia. The causal relationship between the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia and Enbrel, Reusable Autoinjector was not provided by the consumer. Additional information was received on 01Jul2021 reported to Amgen by a consumer from a commercial program (PSP00046b) and involved a patient who stated part of the injection didn't go in, it went onto the floor, stress, flare in her knees/lot of pain, lot of swelling, while receiving Enbrel with Reusable Autoinjector. The patient stated she had five injections of Enbrel with Enbrel AutoTouch and Enbrel Mini Cartridge for treatment of rheumatoid arthritis. She had been instructed to use once a week. On an unknown date in 2021, the patient then further clarifies that she may have more like four and half injections due to she was under a lot of stress, she does not think the injection was level or even. Patient had a death in the family and her daughter had fallen and she was distracted. She did answer a bunch of questions when she stated this and she did contact her doctor and was instructed to take another dose and she just did not. Patient had been able to administer successful injections later, she had no problems with the injector. Patient stated it was a bad day, part of the injection didn't go in, it went onto the floor. The patient then mentioned that she just wants to walk. Patient was having a flare in her knees and that was why she was given the Medrol dosepak (methylprednisolone). Patient also had some diclofenac topical which she would try first. Patient stated she would like to walk and bend her knees. She had a lot of swelling. Patient had a lot of swelling and her doctor said a lot of people that didn't have underlying conditions had pain and swelling. Patient mentioned she was in a lot of pain and swelling. Patient received the Pfizer COVID-19 vaccines. The outcome of the event stress, arthralgia, joint swelling, was reported as unknown. Action taken with Enbrel, Reusable Autoinjector was reported as unknown for the events stress, arthralgia, and joint swelling. The causal relationship between the events stress, arthralgia, joint swelling, and Enbrel, Reusable Autoinjector was not provided by the consumer. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.