Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pain in extremity, Spinal pain
Clinical narrative: anaphylactic reaction; pain shooting down/felt it going through her body, down the spinal cord, both legs into her feet; pain shooting down/felt it going through her body, down the spinal cord, both legs into her feet; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032169) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (not anaphylactic). Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 (Dose 2), Moderna covid-19 (Dose 3), Moderna covid-19 (Dose 5), Moderna covid-19 (Dose 1) and Moderna covid-19 (Dose 4); for Product used for unknown indication: FLU [INFLUENZA VACCINE]. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE], Moderna covid-19, Moderna covid-19, Moderna covid-19, Moderna covid-19 and Moderna covid-19. Concurrent medical conditions included Drug allergy (Dilaudid), Drug allergy (Demerol), Drug allergy (Codeine) and Iodine allergy.    On 25-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 25-Oct-2023, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), SPINAL PAIN (pain shooting down/felt it going through her body, down the spinal cord, both legs into her feet) and PAIN IN EXTREMITY (pain shooting down/felt it going through her body, down the spinal cord, both legs into her feet). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction), SPINAL PAIN (pain shooting down/felt it going through her body, down the spinal cord, both legs into her feet) and PAIN IN EXTREMITY (pain shooting down/felt it going through her body, down the spinal cord, both legs into her feet) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter It was reported that patient received other vaccines in the four weeks prior to COVID-19 vaccine. After vaccination patient experienced symptom of throat tightened, turned bright red, sweaty and dizzy, passing out and pain shooting down through her body, down the spinal cord, both legs into her feet. Company comment: This is a spontaneous case concerning a 68-year-old female patient with medical history of not anaphylactic hives, with concurrent allergy for many drugs who experienced the expected serious (due to medically significant) event of Anaphylactic reaction that occurred the same day after sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS).The patient also experienced non serious events of spinal pain and pain in extremity. It was reported that patient received other vaccines in the four weeks prior to COVID-19 vaccine. As reported after vaccination patient experienced symptom of throat tightened, turned bright red, sweaty and dizzy, passing out and pain shooting down through her body, down the spinal cord, both legs into her feet. At the time of the report the events were resolved. The events are assessed as related based on known safety profile and close temporal association. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.   No treatment medications provided by the reporter.