Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: But little muscle aches when she slept; Soreness and her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8723) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "But little muscle aches when she slept"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021, outcome "unknown", described as "Soreness and her arm".  Additional information: The reporter was informed about Event Details on Company aware date :3 May 2021.The product name Support. The Seriousness criteria :Hospitalization on Dates of Hospitalization 26Apr2021 - 29Apr2021.The two Doses for information Included in (Withheld) Support states she had a reporter  on the line calling about the Pfizer COVID Vaccine and states the reporter did told to a HCP and must have called Pfizer for the initial report because she got a packet in the mail from Pfizer with manufacturer report reference number :2021456239; states the reporter said since that time, she ended up in the emergency room and they gave her a medication because she was having anaphylactic shock and after the 2nd dose of the Pfizer COVID vaccine stated her lips and eyes had swelling and the swelling was so bad at one point she could not eat and her face was numb and her face was tingling. The reporter verified the report reference number and clarified to state the transferring agent's statement was incorrect and further clarified what has occurred; states her patient ID on the packet from Pfizer. Communication: Caller asks if her patient card from pharmacy would have the lot numbers for the Pfizer COVID vaccine and states the 1st dose administered on 26Mar2021 with lot ER8723 and the 2nd dose with lot EW0158 administered on 16Apr2021; states her patient card does not have the expiry dates or NDC numbers written on it.States for this information she has to catch her breath and just got out of the hospital after 15 days; states she received the Pfizer COVID shot on Friday 16Apr2021 for the 2nd dose and states she already knows she has a delayed reaction and is drug sensitive and deals with that in her life; states the 1st dose of the vaccine she had nothing but little muscle aches when she slept and soreness and her arm and no problems. States for the Pfizer COVID 2nd dose, typically her feet start itching and her hands itched and she took Benadryl and normally she would take Benadryl when she gets a reaction to something; no further details provided. States she went about her business and was taking Benadryl as needed and woke up Saturday and felt it a little bit but continued the Benadryl, on Sunday felt fine and had no side effects and no Benadryl and felt nothing; states she gardened all day on Sunday and was fine; states on Monday she felt fine through the whole day and was cleaning the kitchen after dinner; states after 5:00pm that day her lips and eyes swelled and her face was all flushed and swelled and given her history she knows she has to go get a shot; states she drove to urgent care and they could tell what happened and saw her face was visibly all swollen and she got a shot of Dexamethasone; states from her life experience in dealing with it the buck stops there and no matter what happens it stops with taking Dexamethasone.States her condition progressed from there and they gave her Prednisone to take and she got home and forgot she has a sensitivity to Prednisone and called the HCP to let him know that and he said to stick with Benadryl and go to the hospital because there is no alternative to Prednisone. States her face blew up again and was in the ER and they gave her a Medrol pack; states she was on fire from the inside out and knows what happened and called the HCP and put frozen rags on her face and she was flushing she assumes from the Medrol so she stopped the Medrol and called the HCP who told her to take Benadryl two every 4-6 hours as needed and she was taking Benadryl and her face blew up again and she went to the HCP to give her another shot of Dexamethasone.  States she was having what felt like intermittent internal swelling and throat swelling and swelling in her sinuses and tongue swelling and it swelled and un swelled. States she was flaring up and swelling and her HCP gave her antihistamines and steroids and the flaring still happened to her face, chest and back and she would swell with labored breathing, had visible swelling in her face and it got so bad that she went on last Monday to the PCP office and sat down and said to him after the swelling she got very dry and was so dry her lips felt like rocks and she does not know but was not able to swallow anymore and does not know how much physically her body could take. States her face felt so numb and felt like she had a shot of Novocain. States she was on Benadryl 25mg two times per day every four hours, was taking Zyrtec two times per day and also on top of that, had two Dexamethasone shots and was given oral Dexamethasone two times per day; states for the Dexamethasone oral and Dexamethasone shots she had no lot numbers, expiry dates or NDC numbers to provide at this time.States for the Benadryl she has the little tablets and the lot is AAF001, expiry date Sep2022 and there is no UPC number and caller states that maybe on the box which she does not have at this time.States for the Medrol she was given, she threw that away and has no lot number, expiry date or NDC to provide because she stopped it and threw it away.States she took the Medrol one full day along with the Benadryl and had 7 pills of the medrol and took one the next day without Benadryl and that is when she got all hot and pulled herself off of the Medrol and stopped it and threw the Medrol away. The reporter was states in the hospital, they pulled her off of everything and the swelling still happened and has no lot numbers for the medications in the hospital and states everything she listed in terms of medication was what she had at her house and when she got the the hospital the HCP took her off of everything and she changed HCPs. The reporter states for the Zyrtec 10mg she has lot 1811855, expiry Aug2023, and for the NDC states she is waiting for her new glasses to come in so she can read better and looks like she needs to get into the light to read the NDC number and has a friend read it to her and the NDC is 50580-726-94.The reporter states she has no lots, expiry dates or NDC numbers to provide for the Prednisone and did not took it and the HCP sent her to the hospital because she is sensitive to Prednisone and gave her the Medrol and she got rid of the Prednisone and knows what it does to her.States she left the Dexamethasone at her parent's house and stopped taking everything and the bottle is at her parents house and she has no lots, expiry dates, NDCs for the Dexamethasone oral or the Dexamethasone shots. States she went to the HCP and saw the PA and they treated her as a drug allergy and the HCP saw her and she explained she was so dry and her lips felt like rocks and her eyes had no tears and she was  drinking 6-8 bottles of water a day and knowing how dry she felt was drinking a ton of water. States her complain to the HCP at that time was her head was tingling and her face was numb and the dryness was so much she asked for fluids or something and does not know how much more physically her body could take and left the HCP office. States she then went back home at that time and they thought she was unconscious and she could hear and feel but could not move and was looking at her hand and trying to make it move; states she was so dry she felt like a stone and sent to the ER where they pumped her with fluids and gave her 7 bags of fluids and before that she passed out or was unconscious . States the whole time she was aware of what was happening and could see and hear and could not move or speak and could only move her eyes and as she was rehydrating later she felt a tear in her eye and it was like heaven. States she started being able to lick her lips and swallow and started coming around before that called her mother's practice and spoke to the HCP she was supposed to see that morning; went to the hospital Monday night and Tuesday morning and the dates of her hospitalization were last Monday evening she was brought in by ambulance to the ER and her brain is not functioning for a while and yesterday she was ok for the first time and this is not her and normally she can rattle off stuff. States she was having brain fog for two weeks; admitted to the hospital on 26Apr2021 and discharged on 29Apr2021.The reporter states she thought she was having a reaction to the antihistamines and thought it was the Medrol which was the steroid; states she knows she can take Benadryl and dexamethasone and does not think this was a reaction to antihistamines; states she thought the Medrol helped but when she was off of the Medrol it was still happening and was intermittent like flare ups and got worse, felt her muscles tighten on her and she could not control them, states she could hear the HCP talk and they said it looks like a seizure and looks like a stroke and she was having all the symptoms that would be a stroke or a seizure and her gait was off and she was uncoordinated.States she wound up in urgent care after the Pfizer COVID shots and these symptoms and the swelling she was having before she started having any antihistamines. States they ran allergy panels, did an autoimmune panel, did a drug screen, did brain scans and saw the HCP in the hospital; states her PCP turned her away and she wound up catatonic and this HCP was checking her for things she had never heard of and asked him if the antihistamines did this and he said there is not one marker in her body saying she has an inflammatory allergy and there was nothing; states through the mark up done one her regarding testing, she was going through these inflammations and had chest swelling, throat swelling and when she would stop breathing it would go up and down and they monitored her vitals and at no time were her vitals in jeopardy and at no time was she at risk for having a stroke and they did everything possibly they could to figure out rhyme or reason to his.States when the HCP came in after she was hydrated and told her what happened and wanted to start her on Benadryl, she said do me a favor and pull her off of everything and leave me here; states they pulled her off of everything and the swelling continued and the best way to describe it was intermittent internal swelling and her face swelled and her hands swelled and her feet had numbness and it felt like flare ups.States the first HCP information that is on the packet she received from Pfizer was her first HCP and now the HCP she saw in the hospital, she gave consent to treat her to and the HCP knows full well this happened due to drug sensitivity; states she called her initial doctor and said he probably should have listened and she received the packet from Pfizer with his name on it; states that HCP must have reached out to Pfizer; the packet has all this stuff to fill out and she thinks she knows this is rare regarding the reported events and she does not have a lot of things wrong with her but it is rare when something happens to her and she gave consent for her cardiologist and GYN to send records to her HCP.The reporter was states the first HCP this information was sent to it got way worse before it got better and it was very scary and this HCP treating her now wholeheartedly says it is not going to kill her and she just has to remain calm though it and let it happen and whatever is in her system from the Pfizer COVID shot let it cycle through her; states she is home and not taking antihistamines and is still getting hives, flushing which occurred before she started any antihistamines and her hands were tingling and states her brain tingling and face numbness went away after two days and now has finally subsided and the whole time her sinuses are flaring up and flaring down and she does not have seasonal allergies and no food allergies all she has is drug allergies; states she knows she can tolerate Benadryl and Dexamethasone and pops a Zyrtec when the pollen comes and she has no reaction to the Zyrtec. The reporter states her concern is that she is an adult and is barely able to handle what happened and she is afraid for children becoming eligible and afraid a mother will have to watch her child go through what the caller went through and the HCPs are not educated on it and she happened to find a HCP that understands what drug sensitivity is and knew what to look for and she is still having flare ups; states two days ago she was speaking like a stroke patient and could not go to the gym and tried but could not eat a banana three days ago and it got very scary before it got better.States she thought it was the medications she was taking and that is also why she said to the HCP to take her off of those medications and everything and he tested her and there was nothing in her body that indicated that what happened was related to those medications; states she hopes this will be taken seriously and will be looked into and she called her HCP and pharmacy and they had the appointment for her Pfizer COVID Vaccine and she acted accordingly and so did her HCP and it was bad. Caller states she wants Pfizer to know this and wants to know this is going to be taken seriously and not put aside. Communication: PC filed. Full report details not obtained due to caller states this is a follow up.The reporter was provided with the report reference number. There was a product complaint to report. Stated she went about her business and was taking Benadryl as needed and woke up Saturday and felt it a little bit but continued the Benadryl; her lips and eyes swelled and her face was all flushed and swelled and given her history she knows she has to go get a shot; states she drove to urgent care and they could tell what happened and saw her face was visibly all swollen and she got a shot of Dexamethasone. States her condition progressed from there; States she was having what felt like intermittent internal swelling and throat swelling and swelling in her sinuses and tongue swelling and it swelled and un swelled . States she was flaring up and swelling and her HCP gave her antihistamines and steroids and the flaring still happened to her face, chest and back and she would swell with labored breathing, had visible swelling in her face and it got so bad; States for the Benadryl she has the little tablets and the lot is AAF001, expiry date Sep2022 and there is no UPC number and caller states that maybe on the box which she does not have at this time. States for the Medrol she was given, she threw that away and has no lot number, expiry date or NDC to provide. States she took the Medrol one full day along with the Benadryl and had 7 pills of the medrol and took one the next day without Benadryl and that is when she got all hot and pulled herself off of the Medrol; Caller states for the Zyrtec 10mg she has lot 1811855, expiry Aug2023, and for the NDC states she is waiting for her new glasses to come in so she can read better and looks like she needs to get into the light to read the NDC number and has a friend read it to her and the NDC is 50580-726-94. States she has no lots, expiry dates or NDCs for the Dexamethasone oral or Dexamethasone shots. Contact Regulatory Authority.   No follow-up attempts are possible. No further information is expected.