Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Immediate post-injection reaction, Paraesthesia oral, Pyrexia
Clinical narrative: low grade fever; tongue started tingling/area around the mouth started tingling; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Asthma, Anaphylaxis (anaphylaxis reaction to Fasenra) and Congestive heart failure (CHF).    On 25-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PARAESTHESIA ORAL (tongue started tingling/area around the mouth started tingling). On 26-Oct-2023, the patient experienced PYREXIA (low grade fever) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (EPIPEN [EPINEPHRINE]) on 27-Oct-2023 at an unspecified dose and frequency; EPINEPHRINE (EPIPEN [EPINEPHRINE]) on 25-Oct-2023 at an unspecified dose and frequency; PREDNISONE ongoing from 27-Oct-2023 at a dose of 60 milligram and PREDNISONE on 25-Oct-2023 at a dose of 20 milligram. On 27-Oct-2023, PYREXIA (low grade fever) had resolved. On 28-Oct-2023, PARAESTHESIA ORAL (tongue started tingling/area around the mouth started tingling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2023, Body temperature: 100.5.         The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The dosage text was reported as unknown. No concomitant medication was reported. The patient took the first dose on 15-Feb-2021, second dose on 15-Mar-2021, third dose on 31-Nov-2021, fourth dose on 01-Jul-2022 and fifth dose on 15-Oct-2022.   The patient after receiving the injection, she immediately felt a reaction, the tongue started tingling, area around the mouth started tingling. When the patent got home she needed to do something about it or go to the ER. The patient had epi pen and prednisone at home. Her husband gave the epipen injection and also took 20mg of prednisone. That seemed to be ok. The patient had low grade fever of 100.5 for thursday and friday. Friday night, the allergic symptoms returned, used 2nd epi pen and took 60mg prednisone, and on 28th, the patient was titrating down from prednisone.  Company Comment This spontaneous case concerns a 73-year-old female patient with medical history of Influenza vaccination, Concurrent medical conditions included Asthma, Anaphylaxis (anaphylaxis reaction to Fasenra) and Congestive heart failure who experienced the seriousness criterion medically significant unexpected events of pyrexia  and the unexpected event of paresthesia oral the same day after 6th. dose of mRNA-1273.815 vaccine. No concomitant medication was reported. The medical history of Asthma, Anaphylaxis is a confounder for the event paresthesia oral. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.