Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Malaise, Vaccination site haemorrhage, Weight
Clinical narrative: they didn't aspirate either; had a slight feeling of something going into her arm; blood on her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263), in left arm and on 18Feb2021 as dose 2, single (Lot number: EL926F), in left arm for covid-19 immunization. The patient's relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: had Pneumonia 2 years ago in 1 lung; "diabetes" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "ulcer in her esophagus" (unspecified if ongoing); "To maintain her cholesterol" (unspecified if ongoing); "Headache" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "autoimmune deficiency" (unspecified if ongoing); "Allergic to sulfa" (unspecified if ongoing), notes: she received her allergy shots but is unsure of the date. Concomitant medication(s) included: PANTOPRAZOLE taken for esophageal ulcer, gastroesophageal reflux disease; LIPITOR taken for blood cholesterol; ALLERGY & HAYFEVER RELIEF; ALENDRONATE oral taken for osteoporosis; VITAMIN D NOS; METFORMIN taken for diabetes mellitus, stop date: Aug2021; JANUVIA taken for diabetes mellitus; ASPIRIN [ACETYLSALICYLIC ACID] taken for headache. Past drug history included: Zantac, notes: Found in her 40's she had an ulcer in her esophagus.  The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset Jan2021, outcome "unknown", described as "blood on her arm"; MALAISE (non-serious) with onset Jan2021, outcome "recovered" (2021), described as "had a slight feeling of something going into her arm"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "they didn't aspirate either". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller went to sites in her area and found these sites are not aspirating. Outside of Pfizer just from the little blood that may be seen this may just be from puncture of the needle. She knows the vaccine is supposed to be aspirated and she is wondering if Pfizer knows of any areas that were aspirating. Agent wasn't able to help and referred her to her HCP and local health authority. After caller's 2nd COVID-19 vaccine she had on Thursday had a drop of blood on the needle. Agent confirms caller stated on Thursday she saw a little blood. On Saturday she had a reaction with a little red mark that was 3-4 inches long on her right arm. She had a temperature and took Tylenol and Aspirin. This is the only reaction she reported there. In January and February, she felt a prick when the needle went into her arm, and it went away within 15 minutes after the vaccine. Aspirin: Extra Strength Headache Relief has aspirin underneath the name on the bottle. Also has acetaminophen and is going to see a doctor today to see if she has the right aspirin. Pantoprazole: Found in her 40's she had an ulcer in her esophagus. Has been on Zantac or something since her 40's. Caller clarifies details provided by the transfer agent. The vaccine she received with the reaction was her COVID-19 vaccine booster dose. She had 2 vaccines shots approximately 14 months ago. She had no problem with her 1st 2 doses of the COVID-19 vaccines except having blood on her arm. The first 2 doses were administered properly. She had a slight feeling of the vaccine and states she was aware of the feeling due to receiving Allergy Shots for 40 years. Her first 2 doses of the COVID-19 vaccine she had no swelling, and the pricked feeling went away within 15 minutes. She told the person administering the vaccine that she could feel that in her arm and was told to wait 15 minutes and then the feeling went away. Her first 2 doses of the COVID-19 vaccine were given in Jan2021 and Feb2021. She received her Booster of the COVID-19 vaccine in Sep2021. The Pharmacist was hiding her arm, but she could see a large drop of blood after the needle came out. Didn't realize till she was walking out that pharmacist didn't aspirate. She understands how this was very important as the needle needs to go in a muscle and not poke in a vein. She can't believe the protocol for vaccine administration doesn't aspirate. At the (pharmacy withheld), the pharmacist was not using aspiration. She received the vaccine on a Thursday and by Saturday she had a reaction. She called the hotline number for COVID vaccinations for hospitals because she was told she was having this reaction. She had a red lump that was 3-4 inches long and 1-2 inches wide on her right arm, she also had a slight fever and slight headache. She called the hospital line and told the hospital she was having a reaction. She was told to go to the drugstore and get Tylenol with Aspirin and she did that night on Saturday. The Tylenol with Aspirin did help, and her reaction was gone. She was taking her temperature into Sunday and her temperature declined by Sunday and her arm recuperated by Monday. Event Details: Red lump that was 3-4 inches long and 1-2 inches wide on her right arm: She received her COVID-19 booster dose on 03Sep2021. She remembers calling the hotline on Saturday but might have been Sunday. She thought she called 2 days later but states she has notes on when she called the hospital because she called the pharmacy back and asked where she needed to call to report her reaction and what to do. She thought her reaction was 2 days out and not the next day, but she could reverify this later. Her reaction was 1 or 2 days out when she noticed it. The red lump recovered 2 days later because she knew if on Monday her arm wasn't better, she was going to go see a doctor. Clarifies her arm took a day and a half to recover. She wonders if the day she received her COVID-19 booster dose was right. Her arm resolved itself in at least 36 hours and she was recovered completely. Slight fever and slight headache: As soon as she started having a reaction she knew and felt like she had a fever. She knew she had some symptoms that were taught about as a lay person. She already knew something was wrong and called into the hospital. She already knew something was wrong as part of the lump had redness and lump was larger than the redness. She states the lump was warm and 2-3 inches long and 1-2 inches wide. Confirms that the lump on her arm and slight headache and slight fever all started around the same time and recovered completely together. Treatment: She was told to go to (Pharmacy withheld) and get the brand product Allergy relief. This medication had a little bit of aspirin, and the bottle says allergy relief: diphenhydramine, hydrochloride 25 mg, and antihistamine. She only had to take this medication one or two times to get relief. Her reactions resolved on Sunday as she called Saturday morning and on Sunday-on-Sunday morning she knew she would have to go to the doctor Monday if her symptoms did not resolve. She thought there was 2 days. In 2021 she had the initial vaccines and she felt when the needle went into her arm. She received the vaccines at a drive thru at a sports area and she went in the middle of the night and got the shot. She had a sensation at time the shot was given as she had this sensation years before as she has received Allergy shots once a month for 40 years, when she was having cough and was found to have 1 or 2 little allergies. From time to time in 40 years she has felt a little overdose in her arm. Product name and NDC/LOT/EXP for allergy shot not probed over call. She had that tiny feeling when got first COVID-19 vaccine in her arm and told the people administering her first dose of the COVID-19 vaccine she could feel this going in her arm. She was told to wait 15 minutes and see if the feeling goes away, and it did. She was told if the feeling came back to drive to a hospital. Something happened with the COVID-19 vaccine booster or really, she thinks because the needle was drawn when blood was in the syringe. She thinks she received the shot in her vein. Thinks pharmacist was trying to hide and she didn't think to look down until she saw red drop of blood. She felt like he didn't tell her and moved her arm so she couldn't see the needle. She wouldn't have known at the time one way or another. The podcast she listens to have a whole session about aspiration and states she can't believe the protocol for vaccine administration isn't aspirating and other countries is doing aspiration. Vaccines are not designed to go in the vein and need to go in the muscle. She remembered and listened to that and saw blood and went back to (Pharmacy withheld) and was asking and just realized she had a shot that wasn't aspirated. She spoke to a pharmacist and asked does (Pharmacy withheld) aspirate and she was told, (Pharmacy withheld) is not trained in that and so aspiration is not done. She made her appointment for her second COVID-19 booster at (Pharmacy withheld) and called (Pharmacy withheld) before her appointment Monday, yesterday and asked (Pharmacy withheld) why they don't aspirate. (Pharmacy withheld) told her the company isn't training on that and she canceled her appointment and needs to find someone that can aspirate. She has a comorbidity and can't respond or heal herself with medicine for Pneumonia. She has been social distancing for 2 years and had Pneumonia 2 years ago in 1 lung and found she doesn't have the proper antibodies to protect from Pneumonias. Her antibodies were tested in August and September 6 months after receiving her 2 initial COVID-19 Vaccines and she had a tiny improvement in the Pneumonia area and had a good response in the other area. Then states she did not have a good response in the pneumonia area. But she still where's an N95 and a face shield. She doesn't want a breakthrough infection.  Concomitant Medications: She wasn't taking Metformin in Sep2021 as she reached her goal weight. She was on Januvia but wasn't taking any diabetes medications at the time of her Booster dose in Sep2021. Atorvastatin: She was overweight and had family history of heart failure, so cardiologist put her on a statin and she has never had an issue. She had to use 2 medicines to get her cholesterol down and lost a lot of weight. Currently taking Vitamin D and a multivitamin. Metformin: 500mg one tablet a day. Went off last August when dropping to low in the morning because she had lost a lot of weight and didn't need the powerful dose but decided to go back on, so she has some diabetic medicine in her system. Januvia: Was for diabetes but was too strong. Not currently taking. Alendronate: 70mg one tablet by mouth weekly; She just started this in the last couple of months. For osteoporosis.  Medical Conditions: She is following up with a couple doctors and has been social distancing for 2 years and has started to get out more with her dog as she has found a face shield and N95. She doesn't want to get an infection. She doesn't want to mess around with booster but wants the booster administered properly. No doubt if the vaccine is not aspirated, the vaccine can go in a vein, and she doubts Pfizer expects the vaccine to go in the vein. That means is not educating their distribution points if the government is not sending information out then should. No excuse for (Pharmacy withheld) and (Pharmacy withheld) and should be on the governments and CDC says aspiration is important. Therefore she was calling Pfizer she can find a place to get the product properly inserted. She is the only one who has documented this and has realized the vaccine is not aspirated. Another country invented an at home test kit and then additional countries did, and the current kit was not as good as the initial kit released. All countries need to act more like a team in this. She is going to go to (Pharmacy withheld) but she doesn't think (Pharmacy withheld) aspirates either.  Reporter Details: Looking for someone who knows how to apply the booster. She was born with an Immune Deficiency she was born with and for her would be very dangerous to get COVID as she doesn't have a resistance to Pneumonia and so that is why she is very careful with keeping on top of things like getting these COVID-19 vaccines.  Patient Details: Weight: between 117-120 pounds.  PQC Details: Caller voiced that she is having trouble finding someone in her area who knows how to aspirate when giving the second booster Pfizer Covid 19 Vaccine. Per caller she is finding that (pharmacy withheld) and (pharmacy withheld) are not trained to aspirate. Caller would like to find someone in the (place name withheld) area who can administer the second booster with the prescription she has from her doctor that aspirates. She had the first booster in Sept at (pharmacy withheld). She noticed that a drop of blood came out on her arm. She realized from her own studies what they do in other countries from the doctors and those involved with Covid that it's important that you aspirate by pulling back on the plunger to see if there's blood there. Which means you have hit an artery or vein instead of a muscle. If there is blood you retract the needle and squeeze the blood out and then stick back in hoping to get a muscle and not a vein. On the first booster shot in September when she seen the drop of blood on Thurs, she didn't realize at the time they didn't know how to aspirate. On Saturday she started to have a reaction to the shot. Caller reported a large red lump and 3-4 inches long on her right arm that she had the vaccine in, having a fever, along with headache. She thinks it may have been because it went into a vein. She called a covid clinic and was advised what to get from the pharmacy she thinks was a combo of Tylenol and aspirin in which she started to feel better. Caller voiced that she is reluctant to get the second booster unless she can find someone in her area that's trained to aspirate. Per caller she has an autoimmune deficiency which is why she wants to make sure she gets the vaccine properly. In spike of her vaccinations if she gets an infection caller voiced that she probably wouldn't make it as she has a resistant to fighting off infections. She knows the pharmacies that are giving the shot do not have their employees trained to aspirate. Per caller the Health Department for the area could not advise her on the location to go for the vaccine. Caller asking the distribution with the Pfizer Covid 19 Vaccine locations in her area. Caller voiced that when she had the first two vaccines in Jan & Feb, she had a slight feeling of something going into her arm and it only lasted a little bit but was gone in 15 minutes. In which they didn't aspirate either.