Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0181) via an unspecified route of administration, administered in arm left on 21Jun2021 (at the age of 59-year-old) at dose 2, single for COVID-19 immunization. Medical history included allergies to food, allergies to drugs, she is EpiPen carrier, she has so many allergies to drugs and food. It is astronomical. She is not a hypochondriac. These are not the normal symptoms, but she doesn't really know. She has over 200 allergies. Patient states it is too many to list. The main things are cats, pollen, trees, grass, nature unfortunately. She also has problems with food allergies and can't have peanuts and citrus. Trees are bluegrass tree, ragweed, oleander, olive tree. She can't take Methylprednisolone. There is only one antibiotic that she can take and that is Doxycycline. Everything else she breaks out, wheezes, and has hives. The doctors say she is a hypochondriac and they give her antibiotics. She goes to the pharmacy and takes them and is back in the ER. They can't believe she is allergic to what she is. She can't take Tylenol. She cannot take Ibuprofen because it triggers asthma when she takes it for fever and aches and pains. She has ruptured breast implants that are silicone. She had a CT scan. A mammogram ruptured them on both sides. Patient does not have NDC, lot, and expiry to provide for Methylprednisolone, antibiotics, Tylenol, and Ibuprofen. Her entire family went with Pfizer. They felt like Pfizer was her best bet as allergic as she is. Because she is a caregiver a nurse said she could get the shot but the nurse didn't want to give it because of patient allergies. They said to wait to get the one dose because if patient had anaphylactic reaction she would not be able to get the second one, but caller wanted to do Pfizer. Everyone needs to do it. Her whole family got it and she is the one suffering. Does she need to go to ER or just let it ride out? When it is stabbing to that degree it concerns her. Prior Vaccinations (within 4 weeks) was None. Concomitant medications included levothyroxine sodium (TIROSINT) at 25ml gel pill taken for thyroid disorder and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for during allergy season or when very asthmatic. Additional Information for Concomitant Products albuterol: She has had asthma since she was 11. Has had it her whole life, but only takes albuterol during allergy season or when very asthmatic. She has not had to take it for a while. Adverse events following prior vaccination: with a Tetanus shot she had wheezing and hives. Caller doesn't have NDC, lot, and expiry or manufacturer. The Tetanus shot was given in a hospital after cutting herself. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0217) via an unspecified route of administration, administered in arm left on 06Jun2021 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation and patient experienced Few days after first dose left sided chest achiness, she was wheezing and had to take a breathing treatment, resolved. With the first shot back on 06Jun2021 at 3AM she was wheezing really loud and had to take a breathing treatment. Her lungs were full of fluid and that got under control. Reporter clarified that at about 3:30AM or 4:00AM on 07Jun2021 she woke up wheezing. Someone woke her up and she took Albuterol. Her lungs were rapidly filling up with fluids. It was some kind of reaction. After the Albuterol breathing treatment, it was under control. First dose 06Jun2021, second 21Jun2021 Few days after first dose left sided chest achiness. Still had it when got second dose on 21Jun2021. First dose the next morning she was wheezing and had to take a breathing treatment, resolved. 28Jun2021 couldn't get up walk, talk, achy, nausea, threw up three times. Finally getting her sea legs bag. Sharp stabbing pain yesterday head right side. Today after exertion left. 22Jun2021 Hives up until 23Jun2021. Is this a normal side effect. Fingers. Sharpest pains ever experienced. Mainly what was happening. Crackly pops in my head. Punch in the side of my head. Stabbing. One side then the next. Friend had it got the most extreme migraine. Sharp stabbing. Literally knuckles punch the. Yesterday. Home care provider for patient mom. Patient provider will yesterday 6th day of second. Lost three immediate family members. Mom is 84Y. Concerned about the new variant strain. Left to right. Patient have never had this kind of stabbing. We appreciate it. Thought it was important to bring it to the attention. Patient seem to not get back to myself. Potential duplicate AE. Patient has her card in front of her. She received Pfizer first dose on 06Jun2021. She got the shot in her left arm. She did quite well. She didn't really have any issues. She got the second dose on 21Jun2021 in the left arm at the same. Patient talked to VAERS and made a report. She is an EpiPen carrier. She was concerned about getting the shot. She had three family members die from COVID. Her whole family did fine with Pfizer except her. She is having problems after the shot. She is on the 6th day. On Monday, 28Jun2021, her brother had to stay home to help her because she couldn't get up and couldn't walk. She was down for the count. Did not have much fever or anything. More or less it hit her like a ton of bricks. She takes care of her mom and her brother couldn't go in to work because caller couldn't take care of her mom. Reporter couldn't walk or talk. Her family said she should go to the ER, but she said they would only observe at hospital. She is not fully vaccinated and with variant strains and all that she didn't want to go in the ER. She got both of her shots between 4PM and 4:30PM. She did have hives on left side of body. With the second shot on Monday, she couldn't get out of bed, had achy pain, nausea, threw up three times, was weak at knees, wobbly, and felt bad. Today, she finally feels like she got her sea legs back and is not wobbling around. She has had some chest pain. It is dead center and stops her in her tracks. She is 59 years old and in relatively ok health, not great. The main thing she wanted to say is she has musculoskeletal stabbing pains throughout her body. She feels them in her head especially when she exerts herself. It feels like someone is punching her in the side of the temple. It is scaring her the most. It is sharp stabbing pains in her head. Yesterday she had to lay down because they were so bad. It felt like on the right side of brain someone was taking knuckles and punching her on right side of head temple. Today when she exerted herself it started on the left side of head. Today she has not been up and moving a lot. She feels like there is a vice around her head at the moment. Patient got welts on the left side and underneath her chin and face felt itchy. That subsided. At the injection site both times, she had a lot of injection pain. That is to be expected. Mainly. Patient called the ER due to Pfizer vaccine and she was having a lot of pain in her head and chest pain. One of the chest pains stopped her in her tracks. Patient is the caregiver for her mom and she had no one to take care of her mom, so she did not call an ambulance. She is now on 6th day. She doesn't want to be an alarmist. Her brother, grandmother, and aunt passed from COVID. Their family was devastated. The family researched and made sure to get vaccinated. The elders went first. Caller's son had COVID at one point prior to getting COVID vaccine. He and caller were the last to get the COVID vaccine together. Caller feels like it is important to know she is not doing as well as she thought. Reporter clarified the hives, welts, and the itchy chin and face happened on 22Jun2021. It hit her the next day after the second dose. She had that up until the 23rd. Her back was really itchy and it was beet red. She didn't take any Benadryl. Caller is an asthmatic. She didn't have EpiPen because it had expired and she has not been able to get to a doctor because she takes care of her mom. She has really stabbing, sharp pains in fingers and arms. It is Extremely intense sharp pain in different parts of her body, but not in her legs or lower extremities. It is mainly in the wrist, arms, and head. That is worrying her the most. The head, it is lasting. It was like a knuckle hitting her on right side of head yesterday and left side today. It stops her. She knows about endocarditis. A couple of days after the first Pfizer COVID vaccine she had chest pain. It was left side or center achiness. She told her brother before she got the second shot on 21Jun2021 she had achy chest pain and was concerned about getting the second shot. Time the Vaccination Was Given: between 4PM and 4:30PM. Adverse event did not lead to Physician Office and Emergency Room, she called the ER. Patient lab data included CT scan results was unknown and A mammogram ruptured them on both sides. PSCC Communication: PC filed, Description of Product Complaint: Patient reporting adverse events with the Pfizer COVID Vaccine. She received Pfizer first dose on 06Jun2021 and the second dose on 21Jun2021. She is having problems after the shot. Reporter stated that she is not fully vaccinated and with variant strains and all that she didn't want to go in the ER. Pfizer COVID Vaccine first dose: lot number: EW0217, expiry: unknown, NDC: unknown, dose: unknown. Pfizer COVID Vaccine second dose: lot number: EW0181, expiry: unknown, NDC: unknown, dose: unknown. Sample of the product available to be returned, if requested (Y/N) was not provided. Outcome of the event hives was resolved on 23Jun2021 and remaining all other events was unknown.