Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Ear pain, Ear swelling
Clinical narrative: chills/Teeth chattering; sweating; shaking; elevated body temperature; the arm that had the vaccine ached; headache of the forehead, upper head; swelling around my ears; my jaw hinge area ached on both sides; I had very little sleep; Ear ache; felt like my arms and legs were very hot; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 at 09:00 as dose 1, single (Lot number: HG6396) at the age of 62 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple chemical sensitivities" (unspecified if ongoing); "Atrial Fibrillation", start date: 17Mar2015, stop date: 30Jun2018, notes: Atrial L Fibrillation treated overnight in hospital; "WIsdom teeth removal-day surgery", start date: 05Jun1979, stop date: 10Jun1979, notes: Day surgery for removal of wisdom teeth (3rd morals) at age 17.; "tonsil and adenoid removal", start date: 01Jun1970, stop date: 15Jun1970, notes: surgery for tonsil and adenoid removal (age 8) overnight hospital stay; "tonsil and adenoid removal", start date: 01Jun1970, stop date: 15Jun1970, notes: surgery for tonsil and adenoid removal (age 8) overnight hospital stay; "nose cauterization for bleeding", start date: 07Jun1970, stop date: 20Jun1970, notes: Complication from tonsillectomy/adenoid removal. Surgical cauterization Stayed overnight in hopsital. The patient's family history included: "Graves Disease", stop date: 30Jun2018, notes: Graves disease resolved after treatment. Have been in remission since then. No meds needed for it. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot/batch number: EL3247, Route of administration: intramuscular, Anatomical Location: Arm right), administration date: 01Feb2021, for Covid-19 immunisation, reaction(s): "Slightly heightened (for a few days) immune system reactions", "Somewhat more uncomfortable post-vaccine time", "Normal post-vaccine reactions (a few days only each time)"; bnt162b2 (DOSE 2, SINGLE, Lot/batch number: EN6201, Route of administration: intramuscular, Anatomical Location: Arm right), administration date: 22Feb2021, for Covid-19 immunisation, reaction(s): "somewhat more uncomfortable post-vaccine time"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Time: 13:00, Lot/batch number: FH8030, Route of administration: intramuscular, Anatomical Location: Arm right), administration date: 02Nov2021, for Covid-19 immunisation, reaction(s): "immune system issues/Slightly heightened(for a few days) immune system reactions", "somewhat more uncomfortable post-vaccine time"; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Time: 08:30, Lot/batch number: GJ3277, Route of administration: intramuscular, Anatomical Location: Arm right), administration date: 02Nov2022, for Covid-19 immunisation, reaction(s): "somewhat more uncomfortable post-vaccine time", "adverse reactions". The following information was reported: EAR PAIN (non-serious) with onset 31Oct2023, outcome "recovered" (02Nov2023), described as "Ear ache"; INSOMNIA (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "I had very little sleep"; CHILLS (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "chills/Teeth chattering"; BODY TEMPERATURE INCREASED (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "elevated body temperature"; FEELING HOT (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "felt like my arms and legs were very hot"; HEADACHE (non-serious) with onset 31Oct2023, outcome "recovered" (02Nov2023), described as "headache of the forehead, upper head"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 31Oct2023, outcome "recovered" (02Nov2023), described as "my jaw hinge area ached on both sides"; TREMOR (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "shaking"; HYPERHIDROSIS (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "sweating"; EAR SWELLING (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "swelling around my ears"; VACCINATION SITE PAIN (non-serious) with onset 31Oct2023, outcome "recovered" (Nov2023), described as "the arm that had the vaccine ached"; FATIGUE (non-serious) with onset Nov2023, outcome "recovered" (04Nov2023). Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: As with my previous 4 doses, patient had normal side effects that were at times heightened and prolonged. With the 10-31-2023 dose described in this survey, within 12 hours of the vaccine. I experienced chills, sweating, shaking, teeth chattering and an elevated body temperature. It felt like patient's arms and legs were very hot. The arm that had the vaccine ached for about 12 hours after the side effects began. A headache of the forehead, upped head, and swelling around ears was felt. Patient's jaw hinge are ached on both sides and had very little sleep the night of Oct 31 - same day as the vaccine. Most symptoms resolved 48 hours after onset although the headache/ ears ache and jaw ache lasted until later. Thursday Nov. 2 All symptoms resolved by Friday morning November 3, felt fatigue for 2 days (48 hours), after the other symptoms had resolved. Fatigue resolved as of Saturday, Nov 4. Family history: Patient was in remission from Graves' disease and have been since June 2018. This was an endocrine disorder and autoimmune disease. Patient's late mother had the same condition. It can contribute to an over-reactive immune system.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321530 Same patient/same product, different dose/event;US-PFIZER INC-202201279899 Same patient/same product, different dose/event;