Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hiatus hernia, Incorrect route of product administration, Nausea, Wrong product administered
Clinical narrative: Dry mouth; hiatal hernia; BNT162B2, BNT162B2 OMI BA.4-5 on 16Oct2023; route of administration: subcutaneous; Nauseated; Gastric erythema; Acid reflux; This is a spontaneous report received from a Nurse from medical information team.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2023 as dose 4 (booster), single (Lot number: GJ5342) at the age of 81 years subcutaneous, in arm for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) at 2-4 aspirin 2-4 times a week. The patient didn't receive BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 the Monovalent (12+); no reaction), for COVID-19 immunization; Bnt162b2 (DOSE 2 the Monovalent (12+); no reaction), for COVID-19 immunization; Bnt162b2; bnt162b2 omi ba.4-5 (DOSE 3 the Bivalent (12 +); no reaction), for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Oct2023, outcome "recovering", described as "Acid reflux"; GASTRIC MUCOSA ERYTHEMA (non-serious) with onset Oct2023, outcome "unknown", described as "Gastric erythema"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 16Oct2023, outcome "unknown", described as "BNT162B2, BNT162B2 OMI BA.4-5 on 16Oct2023"; NAUSEA (non-serious) with onset 16Oct2023, outcome "recovering", described as "Nauseated"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Oct2023, outcome "unknown", described as "route of administration: subcutaneous"; DRY MOUTH (non-serious), outcome "recovering"; HIATUS HERNIA (non-serious), outcome "unknown", described as "hiatal hernia". The event "nauseated" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for aspirin [acetylsalicylic acid] was unknown. Therapeutic measures were taken as a result of nausea, gastric mucosa erythema, gastrooesophageal reflux disease, hiatus hernia. Additional information included: It was reported that the patient called about the Pfizer 23-24 (12+) Covid injection. On 16Oct2023 had the Pfizer 23-24 (12+). Four hours after she became nauseated. Has been nauseated for five months. Had to go on Prilosec, Nexium, Pepcid and had to have an endoscopy. Found that she had gastric erythema (redness of lining of stomach). Was told that it was due to excess alcoholism. She does not drink. Could be non-steroid Advil but she does not take. Was taking 2-4 Aspirin 2-4 times a week. Said it may be due to aspirin. Has not had aspirin for three months. Said she has a hiatal hernia and acid reflux and erythema of stomach wall because they did a couple of biopsies. Does not know if the doctors think its from the Covid injection. Has been nauseated four hours after the injection and has been nauseated. Nexium has helped. Is not as nauseated as she was but is on medication. Is following an acid reflux diet such as no chocolate and no citrus. Drinks ginger tea. Exercises six time a week, 50 minutes each time. Is very active. Was told that aspirin could cause erythema and by taking two tablets 2-4 times a week could cause it. Would that be enough to cause it. Nauseated: Is not as bad because she is taking Nexium. Is on an acid reflux diet. Gastric erythema: Is still dealing with dry mouth and nausea. Is more dry mouth than nausea. Dry mouth: Nausea progressed more to dry mouth effect. Has had it all along. No date specified. If she is not nauseated the she had dry mouth. Is better because she is not having nausea as much as she is having dry mouth effect. Treatment: Is just taking Nexium 20mg once a day. Attempted to capture seriousness; seriousness provided as is not serious but significant knows its there but it does not stop her from doing normal activities. Acid reflux: Is taking Nexium to control that. Has improved. Is on medication and watching her diet. Attempted to capture seriousness; seriousness provided as its tolerable. Clarified that she has had acid reflux before in her life. Has taken medication before in her life. Acid reflux had it 3-4 years before injection and maybe 10 years before injection maybe 15 years before injection. Had it the last 20-25 years and taken medication before it and was better. Investigations: Had a biospy from the endoscopy and the doctor called it reactive gastropathy. Is often not a problem and does not require treatment. Clarified that the reactive gastropathy is the same gastric erythema. Had this in Oct2023.