Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Joint swelling, Lymphadenopathy, Neck pain, Swelling
Clinical narrative: swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the left side of her neck; swelling/swelling went to the back, the shoulder blade up the left side of her neck; redness; pain started at injection site; pain went from her elbow to shoulder and then up her shoulder and up to the neck; pain went from her elbow to shoulder and then up her shoulder and up to the neck/she still has arthritic type pain in left arm socket.; couldn't lift her left arm at all; deep ache/ to her back; crying; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (lot number reported as "EN or W 0161, EN0161 or EW0161") at a single dose for COVID-19 immunisation. Medical history included diabetic from 2008, blood clots , COVID-19 (reported as April; year unknown), insulin dependent in 2014 , Protein S deficiency, genetic disorder that makes her have blood clots, neuropathy. Concomitant medications included warfarin sodium (COUMADIN) taken for Protein S deficiency, genetic disorder that makes her have blood clots from 2007 to an unspecified stop date; gabapentin taken for neuropathy from Sep2019. Patient stated that she gets a mild case of the flu when she gets the flu vaccine, but she doesn't remember back to childhood. She got an MMR booster about 20 years ago and had no problems then. Family Medical History: both parents had diabetes; mother has Protein S deficiency as well that causes blood clots. The vaccine was administered at healthcare facility. The patient did receive previous immunization with a Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination.  The patient received her first shot on Monday 12Apr2021 and was fine until 12 hours later. Her arm swelled up and she couldn't lift it. Then the swelling went to the back, the shoulder blade up the left side of her neck. She could feel her lymph nodes and so she was icing it, taking Tylenol and the swelling has gone down. The redness was gone but she still has arthritic type pain in left arm socket. She can lift and move the left arm, but it hurts, and it also hurts when she turns her head to the right. She received the Pfizer COVID vaccine in her left arm. The pain started at injection site and then went from her elbow to shoulder and then up her shoulder and up to the neck. Her family was commenting on her neck being swollen. She received her shot at 4:30 PM on 12Apr2021. The redness and swelling started at around 5:00 AM on 13Apr2021. A couple hours after Pfizer COVID vaccine injection the pain started. She waited for 30 minutes because she takes coumadin for a history of blood clots, nurse wanted to wait to make sure her arm wouldn't bleed. She has been taking Benadryl ointment and icing it for 3 days as treatment for the events. She got up at two this morning to go to the bathroom and noticed she could still feel the pain when she turns her head to the right. She had swollen submandibular lymph nodes and could feel two of them before. When she woke up, she could not feel her lymph nodes. Everything has recovered except for the pain. The patient stated that on the first day the symptoms were disabling, and she couldn't lift her left arm at all. They got better once she started icing it and rested instead of doing chores. She keeps popping Tylenol every 6 hours, Benadryl and refilling ice bag with one ice bag on neck and one ice bag on arm. There was a deep ache right now in the socket that goes up her neck and down the shoulder blade to her back. Right now, she doesn't like to be in any pain and would say the pain was mild compared to how it was, the pain was so bad she was rocking and crying. Her brother gave her one of her mother's pain pills, one Vicodin because she was in so much pain. She can control the pain now with the extra strength Tylenol. She got the Pfizer COVID vaccine for lots of reasons. She has a lot of health problems, she had COVID virus last April and that was why she was having this reaction since she already has antibodies. She takes care of her mother who was sicker than she was. She was out in the real world and she doesn't want to bring anything home or get anything herself. She thought gabapentin would have made it to where she did not have the arthritic pain from vaccine. She takes gabapentin for neuropathy. She was diabetic and that may have something to do with it too. Patient stated that everyone else in her family got Johnson and Johnson and nobody had reactions. She was supposed to get at the Johnson and Johnson shot first but with the shortage it was switched over the to Pfizer COVID vaccine. This was her first dose of the Pfizer COVID vaccine. Redness and swelling started at around 5:00 AM 13Apr2021. Pain started around 6:30 PM. The events did not require emergency room visit or hospitalization. She was at the urgent care yesterday where she gets her INR checked and the nurse said she didn't see any swelling but believed she was in pain because the she didn't want to lift the left arm. The reporter assessed the events swelling, redness, and pain were considered serious (disabling). Outcome of the events vaccination site pain, neck pain, arthralgia, and back pain was recovering, for event crying was unknown, for event swollen submandibular lymph nodes was recovered on unspecified date, while for events swelling, joint swelling and redness was recovered on 16Apr2021.  Information on the lot/batch number has been requested.dft; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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