Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Feeling hot, Inappropriate schedule of product administration, Musculoskeletal stiffness
Clinical narrative: she had the 2nd dose of the Pfizer COVID Vaccine yesterday 12Aug2021 and her 1st dose was on 26Jul2021; joint pain/now experiencing joint pain and flare up of the joints; suspected fever; pain in the right arm; flare up of joints; stiffness; felt hot and her skin felt like it was burning; felt hot and her skin felt like it was burning; This is a spontaneous report from a contactable Nurse (patient) via Pfizer sponsored program.  A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number) via an unspecified route of administration in Arm Right on 12Aug2021 (at 67 years) as single dose for covid-19 immunisation. The patient was supposed to get the 2nd dose on 16Aug2021, however it was given on12Aug2021.Medical history included ongoing arthritis in her right foot , osteoarthritis in her major joints, degenerative arthritis through her whole spine, breast cancer diagnosed in Oct2013 with lymph node removal (she had surgery and 33 radiation treatments and 5.5 years of Arimidex which is an inhibitor and also took Letrazole for 5.5 years total), fibromyalgia, antiphospholipid syndrome (ATS) diagnosed years ago in 2006 and had antibodies for that , in Oct2019 she was getting short of breath and went to put her jeans on and her right leg was swollen and she went to the emergency room and had multiple blood clots in her lungs and a DVT in her right thigh.  The patient's concomitant medications included gabapentin , tizanidine as muscle relaxer. Previously on 26Jul2021 received the first dose of the vaccine (at the age of 67 years) in the right arm for covid-19 immunisation.Patient clarified that both doses of the COVID Vaccine were administered in her right arm because with her breast cancer history they took several lymph nodes out of her left arm and she can have nothing in her left arm. The patient received the vaccine on 12Aug2021  and 14 hours later (in Aug2021) started having complaints of pain in the right arm, joint pain, flare up of joints, and suspected fever (no temperature to report, skin felt warm and hot per HCP). Joint pain and flare up of the joints were serious as medically significant.The joint pain began in her arm a couple of hours after putting not ice but cool compresses on it and switching from warm to cool compresses. About 1:30am (Aug2021) she woke up with the fever that was not ongoing and subsided.Patient also stated that before she took her medications prescribed by her HCP and was fine and had the COVID Vaccine and 14 hours later she could not stand the pain in her right arm, she took her medications at night that she usually took and those were gabapentin and tizanidine and took two tramadol 100mg but did not want to keep popping the tramadol and limited herself on that due to her age but had to take it at 1:30 am and did not know what was going on. She took paracetamol (TYLENOL) with diphenhydramine hydrochloride (BENADRYL) so she could sleep and woke up with a fever at 1:00 am and her skin was burning (Aug 2021). Stated there was a cold breeze and she took the paracetamol (TYLENOL) at that time and more medication which she usually did not have to do and usually took her medications between 9:00 and 10:00 and that dose covered her throughout the night but last night was terrible and it was an acute flare up. Patient stated the medications she took that she had to take more of were another paracetamol (TYLENOL) extra Strength 500mg and those carry her through the night but last night was horrendous and was still horrendous.  Patient clarified the other medications she had to take more of were gabapentin 300 mg, two tramadol, and another tizanidine 4 mg and then took paracetamol (TYLENOL) extra strength 500mg (as reported).The reported events are related to the COVID vaccine because of how suddenly they came on and she usually got up in the middle of the night due to stiffness and felt hot and her skin felt like it was burning (Aug2021). Patient reported the events are medically significant and she had limitations due to mobility.The outcome of Joint pain was not recovered; outcome of the other events was unknown.The lot number for BNT162B2 was not provided and will be requested during follow up; Sender's Comments: The events of Arthralgia, Pyrexia, Pain in extremity, Condition aggravated, Musculoskeletal stiffness, Feeling hot, Skin burning sensation are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.