Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Dyspnoea, Hypoaesthesia, Pharyngeal swelling, Tachycardia
Clinical narrative: Could not feel legs/Numbness in leg; Tachycardia; trouble breathing; Allergic to polysorbate which was in the medication; THROAT SWELLED/ throat swelled shut/ Throat swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Could not feel legs/Numbness in leg), TACHYCARDIA (Tachycardia), DYSPNOEA (trouble breathing) and ALLERGIC REACTION TO EXCIPIENT (Allergic to polysorbate which was in the medication) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication and HYDROCODONE for an unknown indication.    Concurrent medical conditions included Drug allergy and Sulfonamide allergy.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) 11.25 milligram and HYDROCODONE (unknown route) at an unspecified dose. In February 2021, the patient experienced PHARYNGEAL SWELLING (THROAT SWELLED/ throat swelled shut/ Throat swelling). On an unknown date, the patient experienced HYPOAESTHESIA (Could not feel legs/Numbness in leg) (seriousness criterion hospitalization), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), DYSPNOEA (trouble breathing) (seriousness criterion hospitalization) and ALLERGIC REACTION TO EXCIPIENT (Allergic to polysorbate which was in the medication) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to ALLERGIC REACTION TO EXCIPIENT, DYSPNOEA, HYPOAESTHESIA and TACHYCARDIA. At the time of the report, HYPOAESTHESIA (Could not feel legs/Numbness in leg), TACHYCARDIA (Tachycardia), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (THROAT SWELLED/ throat swelled shut/ Throat swelling) outcome was unknown and ALLERGIC REACTION TO EXCIPIENT (Allergic to polysorbate which was in the medication) had resolved.            Relevant concomitant medications were not reported.  Sulfa and hydrocodone were also considered as co-suspect. Patient was allergic to sulfa and hydrocodone.  The patient could not feel legs, had tachycardia, trouble breathing and was allergic to Polysorbate which was in the medication. She went to emergency room, pumped with fluids and medicine and was in hospital for two days.  Treatment information was not provided.  Company Comment : This is a spontaneous case concerning a 33-year-old female patient with no reported medical history, who experienced the unexpected serious (hospitalization) adverse events of ALLERGIC REACTION TO EXCIPIENT (Allergic to polysorbate which was in the medication), DYSPNOEA, HYPOAESTHESIA (Could not feel legs/Numbness in leg) and TACHYCARDIA, which occurred unknown after the second dose of mRNA-1273 vaccine administration. The patient could not feel her legs, had tachycardia, trouble breathing and was allergic to polysorbate which was in the medication. She went to emergency room, was infused with IV fluids and medicine and was in hospital for two days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-592688 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 33-year-old female patient with no reported medical history, who experienced the unexpected serious (hospitalization) adverse events of ALLERGIC REACTION TO EXCIPIENT (Allergic to polysorbate which was in the medication), DYSPNOEA, HYPOAESTHESIA (Could not feel legs/Numbness in leg) and TACHYCARDIA, which occurred unknown after the second dose of mRNA-1273 vaccine administration. The patient could not feel her legs, had tachycardia, trouble breathing and was allergic to polysorbate which was in the medication. She went to emergency room, was infused with IV fluids and medicine and was in hospital for two days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.