Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Limb discomfort, Swollen tongue, Taste disorder
Clinical narrative: did not have a metallic taste in his mouth, but a funny taste; confusion; difficulty breathing; His tongue was kind of swelling; his pulse on his wrist and he found it's going pretty quick and he was not ok with this/he felt his heart rate go up; Patient still felt it in his arm where they gave him the shot.; having an allergic reaction; he felt that this feeling wasn't right; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (difficulty breathing), SWOLLEN TONGUE (His tongue was kind of swelling), LIMB DISCOMFORT (Patient still felt it in his arm where they gave him the shot.), TASTE DISORDER (did not have a metallic taste in his mouth, but a funny taste) and CONFUSIONAL STATE (confusion) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer; for COVID-19 prophylaxis: moderna covid. Past adverse reactions to the above products included No adverse effect with Pfizer and moderna covid. Concurrent medical conditions included Diabetes.    On 25-Nov-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In November 2024, the patient experienced LIMB DISCOMFORT (Patient still felt it in his arm where they gave him the shot.), FEELING ABNORMAL (he felt that this feeling wasn't right) and HYPERSENSITIVITY (having an allergic reaction). On 25-Nov-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced DYSPNOEA (difficulty breathing), SWOLLEN TONGUE (His tongue was kind of swelling), TASTE DISORDER (did not have a metallic taste in his mouth, but a funny taste), CONFUSIONAL STATE (confusion) and HEART RATE INCREASED (his pulse on his wrist and he found it's going pretty quick and he was not ok with this/he felt his heart rate go up). The patient was treated with Diphenhydramine hydrochloride (Benadryl) from November 2024 to November 2024 at a dose of 25 milligram, total 3 dosage form and Loratadine (Claritin) from November 2024 to November 2024 at a dose of 1 dosage form. At the time of the report, DYSPNOEA (difficulty breathing), SWOLLEN TONGUE (His tongue was kind of swelling) and LIMB DISCOMFORT (Patient still felt it in his arm where they gave him the shot.) had not resolved, TASTE DISORDER (did not have a metallic taste in his mouth, but a funny taste), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (he felt that this feeling wasn't right) and HYPERSENSITIVITY (having an allergic reaction) outcome was unknown and HEART RATE INCREASED (his pulse on his wrist and he found it's going pretty quick and he was not ok with this/he felt his heart rate go up) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2024, Heart rate: increased.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient had an immediate reaction. They gave him the shot, put on a band aid on it, and the patient left. As the patient was walking out, his breathing became labored and he had difficulty breathing and he felt his heart rate go up. He works out every day for at least a solid hour, and he felt that this feeling wasn't right. He thought it would go away. The patient does not have a metallic taste in his mouth, but a funny taste. His tongue was kind of swelling.  The patient tried to his pulse on his wrist and he found it's going pretty quick and he was not ok with this. The nurse offers him grape juice as he was sitting there. His breathing was very labored, the patient was concerned as his labored breathing was not going away.  The doctor said he thought the patient was having an allergic reaction, since his breathing was labored, If the patient would go into the ER, the doctor would treat him as if for anaphylactic shock. Patient's throat isn't closing, but he can't breathe well.  The patient took Benadryl 25mg took 2, took one Claritin. Within 5 minutes, really quick, the stopped, labored breathing stopped and his rapid heartbeat subsided. Patient's tongue was still kind of swollen, and he just took another 25mg of Benadryl. The patient woke up around 3 after passing out on his desk at home. Patient still felt it in his arm where they gave him the shot. Patient still felt that he still could possibly have to go to the ER - breathing had gotten a little labored, confusion had set in. Reporter causality was not reported.   This case was linked to MOD-2021-037554 (Patient Link).