Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site erythema, Vaccination site pain
Clinical narrative: having vivid dreams / wonders if she should even go to sleep because her dreams are so vivid/the dreams are all over the place and bizarre; some night not sure if she wants to go to sleep bc she knows it wont be a restful night of sleep; left arm soreness; redness at the injection site; malaise; little bit of a temperature; if she stretches her arm out to reach for something, she can feel like a trigger point or soreness point that becomes evident as she's reaching; still has soreness in arm where she received the injection/Arm pain occurs when she pushes on the site as well as when she extends arm up to chin level can feel a localized pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). This 67-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 09:40 (Batch/Lot Number: EN6204) as DOSE 2, SINGLE (at the age of 67-yesr-old) for covid-19 immunisation. Medical history included ongoing Diabetic Type 2, ongoing Hashimoto's thyroiditis, ongoing Cholesterol, ongoing anxiety. Concomitant medication(s) included ongoing metformin, semaglutide (OZEMPIC) ongoing; levothyroxine ongoing; atorvastatin ongoing; celecoxib (CELEXA [CELECOXIB]) ongoing. Historical vaccine included BNT162B2 on 26Feb2021 for Covid-19 Immunization Dose: 1 First dose: 9:40AM Lot Number / Expiry Date: EN6202 Route, Anatomical Location: left upper arm. Flu vaccine in Aug2020 for immunization and experienced malaise, fever. The patient received her second dose of the Pfizer COVID-19 vaccine on 19Mar2021 and since then still had soreness in arm where she received the injection as well as having vivid dreams, some night not sure if she wanted to go to sleep because she knew it wont be a restful night of sleep. Arm pain occured when she pushed on the site as well as when she extended arm up to chin level can feel a localized pain at the injection site. Looking to see if we had any information on the dreams and arm pain this far out. As well as she agreed to join a clinical trial out of the (Withheld), where she worked for many years, the trial was for the booster dose, however she was not sure if she wanted to pursue this if the possibility that getting a third dose might make the dreams worse. A review of the Prescribing Information for Pfizer COVID-19 Vaccine did not find information regarding vivid dreams. As the Prescribing Information did not include all adverse reactions that had been reported or that may occur, patient was suggested to consult with doctor/healthcare provider about what she had experienced/ were experiencing. She added that the left arm soreness, she can press on the injection site and she got tenderness but if she stretched her arm out to reach for something, she could feel like a trigger point or soreness point that becomes evident as she's reaching. She did have some localized redness at the injection site but that was it. About 48 hours after she received the injection everything else was gone, her malaise and a little bit of a temperature. She was relieved, since that time she basically had full use of her arm. The dreaming started to the point where, it was more like the intensity of the dream. Like convoluted subjects and people. She was trying to get good sleep and she was not reading or doing anything wild before bed. Sometimes she thought she should just stay awake because she was not getting restful sleep. The dreams are all over the place and bizarre. The reason she was calling was because she worked for the University of (WITHHELD) for 30 years and the University announced that a Covid 19 vaccine group would be chosen for a third Pfizer Covid 19 vaccine booster. She signed up to be a part of the group but she's wondering if she was chosen and received a Covid 19 vaccine booster, would that booster make her symptoms worse. Before she agrees to be a part of the group she thought she'd call to check on it. She reports she's had labs done for a regular check up and those were all in normal range. No new medications have been added. Her Metformin was changed to the extended release version in May2021. She's been on all her medications for a while. When probing for adverse events related to other vaccines she reports when she's received the flu vaccine she had experienced malaise and fever. She received her last flu vaccine in Aug2020. She doesn't have any product information. NDC/Lot/Expiry not known. No anaphylactic reactions to any medications. Patient did not get any vaccine within four weeks prior to the first administration date of the suspect vaccine. The outcome of the events was not recovered.