Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Imperception, Menstrual disorder, Oesophageal oedema, Pain, Pain in extremity
Clinical narrative: Dizziness/dizzy; Perception felt off/she couldn't balance, she felt drunk; Perception felt off/she couldn't balance, she felt drunk; Brain Fog; Menstrual symptoms/It was extremely heavy in Jan and it lasted 2 weeks; she had to stay in bed and this lasted one month; her stomach expanded and it was really swollen; Esophagus swelled: She couldn't swallow food or water; dehydrated; Tight chest pain; she couldn't swallow anything; her legs get this electric shock it goes through her legs it keeps her up, goes from her lower back to her legs; allergic reaction; Arm Hurts: pain kept going further, it was going down her arm and was in the left side of her body; the left side hurting traveled to other areas of her body where she had old injuries like whip lash and her lower back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 11Aug2021 at 16:00 as dose 1, single (Lot number: EW0185) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Type 1 diabetes; "Ehlers-Danlos syndrome", start date: 2017 (unspecified if ongoing). The patient's family history included: "allergies" (unspecified if ongoing), notes: mom was born with allergies. Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Aug2021, outcome "recovering", described as "Arm Hurts: pain kept going further, it was going down her arm and was in the left side of her body"; PAIN (non-serious) with onset Aug2021, outcome "recovering", described as "the left side hurting traveled to other areas of her body where she had old injuries like whip lash and her lower back"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "allergic reaction"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness/dizzy"; BALANCE DISORDER (non-serious), IMPERCEPTION (non-serious), outcome "unknown" and all described as "Perception felt off/she couldn't balance, she felt drunk"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain Fog"; MENSTRUAL DISORDER (non-serious), outcome "recovered with sequelae", described as "Menstrual symptoms/It was extremely heavy in Jan and it lasted 2 weeks"; BEDRIDDEN (non-serious), outcome "unknown", described as "she had to stay in bed and this lasted one month"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "her stomach expanded and it was really swollen"; OESOPHAGEAL OEDEMA (non-serious), outcome "unknown", described as "Esophagus swelled: She couldn't swallow food or water"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated"; CHEST PAIN (non-serious), outcome "unknown", described as "Tight chest pain"; DYSPHAGIA (non-serious), outcome "unknown", described as "she couldn't swallow anything"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "her legs get this electric shock it goes through her legs it keeps her up, goes from her lower back to her legs". The events "allergic reaction", "arm hurts: pain kept going further, it was going down her arm and was in the left side of her body", "dizziness/dizzy", "perception felt off/she couldn't balance, she felt drunk", "brain fog", "the left side hurting traveled to other areas of her body where she had old injuries like whip lash and her lower back", "she had to stay in bed and this lasted one month", "her stomach expanded and it was really swollen", "esophagus swelled: she couldn't swallow food or water", "dehydrated", "tight chest pain", "she couldn't swallow anything" and "her legs get this electric shock it goes through her legs it keeps her up, goes from her lower back to her legs" required physician office visit. The events "menstrual symptoms/it was extremely heavy in jan and it lasted 2 weeks" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: heart was fine, notes: Date: Not Provided; Result: Not Provided. Therapeutic measures were taken as a result of hypersensitivity, pain in extremity, dizziness, balance disorder, imperception, feeling abnormal, menstrual disorder, pain, bedridden, abdominal distension, oesophageal oedema, dehydration, chest pain, dysphagia, electric shock sensation.  Clinical course: Caller was reporting side effects after getting the Pfizer COVID Vaccine and would like to know if there were similar reports to what she was experiencing. Caller stated that she experienced the following: "allergic reaction, arm hurt, dizziness, walking like drunk or needed a cane to walk, while driving, it seems her perception was off, brain fog that had not stopped or on going, disrupted menstrual cycle and massive menstrual bleeding, felt like her stomach expanded, swollen esophagus, and chest pain." Caller mentioned that she also "had old injury that had started to flare up again after getting the vaccine." Caller also stated that she experienced "loss of balance like she's on a boat that was not moving." Caller clarified that her experience was not as simple as fatigue and not exactly as fatigue; she also mentioned that she knows how fatigue feels like and she was not just experiencing fatigue. Caller expressed her frustration when "everybody describe it just as fatigue" since it was "not a regular side effect." Caller stated that she received her first dose last 11Aug2022 with the lot number EW0185. Caller mentioned that she had Type 1 Diabetes and was taking insulin, and not being fully vaccinated prevents her from getting back to her job as a preschool teacher. Caller stated that the side effect she was reporting "lasted for the whole month" and mentioned "she was not experiencing it now". Caller also mentioned that she "could not swallow water for 5 days and it was hard for her not to take liquid since she was diabetic." Caller also stated that "her doctor was not very helpful to her" and "inflammation was mentioned but no one explained it to her." Caller mentioned that when she accompanied her daughter in "name withheld" to get vaccinated, there was a waiver that provided the link to Pfizer Website and she saw that some symptoms she experienced are listed there (like listed examples of severe allergic reactions) but not all. Caller also stated that she was "thinking that the vaccine was not administered properly and this caused her the side effects." Caller stated that "the vaccine shot was not in the middle of my deltoid muscle." Caller also stated that she reached out to her vaccine provider as well but was not given enough information. Caller was seeking more information from Pfizer about her situation. Additional Context: Caller calling about the Covid-19 Vaccine. States she got her 1st shot in Aug2021 and had many symptoms listed as an allergic reaction. States she was getting no help from her doctor and still hadn't got the 2nd shot, she does not know what to do. Asks if I give you a lot number will you know if there was something wrong with that group of vaccines or if anything was reported. Caller was asking for example how does she find out if she was allergic to anything that was in the vaccine. Adds she was not an antivaxxer, she feels really lost, she was a preschool teacher and wants to be protected from the kids, and can't work. Adds she was also a type I diabetic and at risk. Her doctor was not being helpful at all and this was really disappointing. States she called before but did not talk with a nurse, she does not think she spoke to agent. HCP: States she went to (name withheld)first and saw a different doctor in the same office. Her doctor wasn't available. There are residents, fellows and all that. She doesn't know who she saw but she had an EKG done then another doctor came in, she thinks it was the supervising doctor. then she saw a different doctor at the same office another time she went. States she went 3 times, the doctors should have reported this. States it was really bad lasted one month. She scheduled her daughters second shot , and was reading the Pfizer sign on the waiver and read about reactions that could happen and that was when she read about her symptoms and she was now trying to advocate for herself. She wants to be protected. Event: She got her 1st shot not at a (name withheld), it was at a little doctors office and states that the location of the shot was not in the middle of the deltoid. People were posting pictures of their Band-Aids and they were in the middle of the arm, hers was on the outer side. Wonders if it was the way it was administered or if it was something she was allergic to, she really doesn't know. Arm Hurts: pain kept going further, it was going down her arm and was in the left side of her body. Dizziness: the next day she was like dizzy, every morning for like 2 weeks when she walked to the car to take her daughter to school it looked like she was drunk. She was always at the car before her daughter, but her daughter made it to the car before she did. Felt like she needed a cane. Perception felt off: when she was driving she felt like her perception was off even when she was driving and when she walked she couldn't balance, she felt drunk. States these all happened the next day. A lot of other things happened. Brain Fog: Ongoing. Menstrual symptoms: She got her period 4-5 days after the shot. States it was heavy, she had to call her doctor and thought should she go the the emergency department. It was extremely heavy in Jan and it lasted 2 weeks and she went to the emergency room and they didn't know what was causing it. Now she had 2 periods that haven't been incredibly heavy. Adds she didn't have the symptoms everyone else had like Covid symptoms, cold or flu, none of that. States the left side hurting traveled to other areas of her body where she had old injuries like whip lash and her lower back where she had pain and issues before. States she had to stay in bed and this lasted one month. Stomach expanded: States eventually her stomach expanded and it was really swollen. Esophagus swelled: She couldn't swallow food or water and so she became dehydrated and it was really scary for her. She was insulin dependent so this scared her. she had to have food and keep everyone ok. Tight chest pain: this is when she called her doctor and she couldn't swallow anything. The doctor did an EKG and said the heart was fine. That was was probably an inflammatory response and her immune system was doing its job. Everyone the caller knows had a couple of days of feeling sick. Caller felt really uncared for and went home and was dehydrated, the doctor said she could go to the hospital but she was afraid to go because she didn't want to get Covid. Treatment: States she had been using natural medicine and that had helped. It was homeopathy. It was a remedy that she uses and there are multiple different ones. Certain ones have helped with the pain and then there was one that helped with her esophagus. Caller does not have any NDC, lot or expiry to provide. Product: It was administered at clinic. As she was reading the card she states she can never understand doctors hand writing. Thinks something says 8UQ NUV, it could also say sugar she doesn't know. Caller originally provides lot number: EUX185, then corrects herself and states that this was all off her daughters vaccination card not hers, then gets her vaccination card. Caller then proceeds to states that when she was laying down at night her legs get this electric shock it goes through her legs it keeps her up, goes from her lower back to her legs. That went on for a month. The scariest part was not being able to swallow water. That lasted 5 days. States she did not get a rash. Then clarifies that the only ongoing symptom she had was the brain fog and questions about her mensural symptoms that had been on and off. Adds that the esophagus she had a problem for a long time with reflex and she was supposed to do a colonoscopy and endoscopy but she never had it that bad so after the shot happened it was so extreme. Seems like it made everything so extreme. Just seems like it made everything so extreme. Medical Conditions: Ehlers-Danlos syndrome: it was a genetic disorder of the connective tissue in the body maybe it may have something to do with this and she called the (Name withheld) hotline and talked to them about it and they recommended getting the vaccine. States that this was all so extreme, it made everything feel extreme. She wishes someone could tell her for sure that this was her immune system or was it an allergic reaction. She was afraid to get the second dose because she was afraid it will be worse or she will end up in a wheelchair because she was so dizzy and in pain. Adds she was supposed to get the endoscopy, she hadn't done that yet, it was her fault, she hadn't scheduled it yet because she was scared. Vaccination Facility Type: Doctors office. History of all previous immunization: N/A. Caller adds that when she looked online there was a lot of choices on the website, she read that doctors don't have much experience giving shots, nurses have more experiences. She had a picture of her Band-Aid if anyone needs its. Additional Vaccines Administered on Same Date: No. Adverse Event (AE) Details: Caller states her arm started hurting right away. She got the vaccine at 4:00pm and that evening her arm was hurting. The left side of her body was hurting in the middle of the night. and then the next day when she was taking her daughter to school was when she was walking like she was drunk like she wanted to hold on to something. Additional Information: Emergency Room: she was told to go but she didn't. she was very strong willed. Physician office: yes, she had 3 visits. Prior Vaccinations: Not provided. AEs following prior vaccinations: yes, it was a long time ago, she does not know what vaccine it was but it was a vaccine that you get when you travel to a third world country, it was in 1993, whatever shot they recommend you get when you go. She had a terrible reaction and had to reschedule the trip. States it was given to her in her thigh, many things have changed since then. Not had a shot since then. Caller does not have name of product, NDC, lot or expiry to provide. Patient's Medical History: Type 1 diabetes, Ehlers-Danlos syndrome. Family Medical History: her mom was born with allergies, she does not really know any other family members who had allergies to vaccines, she had heard of people with egg allergies and for them not to get certain vaccines. Thinks when she called Pfizer before they said there was no egg in this vaccine, do you know. Test: EKG, adds well she keeps pushing to be allergy tested but (name withheld) waitlist was months and months wait for any specialty. Her primary care she saw said she really didn't have anybody with these symptoms, this was weird because she had read all about people with allergic reactions to this and it was listed on Pfizer's information about allergies.  A final statement is not entered.