Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Scab, Skin lesion, Swollen tongue
Clinical narrative: Her voice was also affected, it became hoarse; On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb; On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb; On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb; On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb; On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy; Itchy pustule; On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy; On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy; On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Her voice was also affected, it became hoarse), AGEUSIA (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), SWOLLEN TONGUE (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), the first episode of HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) and the second episode of HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030335) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1, Lot no. 042L20A) on 18-Jan-2021, Moderna COVID-19 vaccine (Dose 2, Lot no. 030M20A) on 15-Feb-2021, Moderna COVID-19 vaccine (Dose 3, Lot no. 039021A) on 29-Oct-2021, Moderna COVID-19 vaccine (Dose 4 and Lot number. 001M21A) on 30-Apr-2022; for Product used for unknown indication: RSV on 11-Sep-2023; for an unreported indication: MODERNA COVID-19 VACCINE (Dose 5 and Lot number AS7140C) on 20-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and RSV. Concurrent medical conditions included Hypertension.    On 28-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced PRURITUS (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy), PUSTULE (Itchy pustule), BLISTER (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy), SKIN LESION (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy) and SCAB (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy). On 05-Oct-2023, the patient experienced DYSPHONIA (Her voice was also affected, it became hoarse), AGEUSIA (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), SWOLLEN TONGUE (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), the first episode of HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) and the second episode of HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb). On 12-Oct-2023, PRURITUS (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy), PUSTULE (Itchy pustule), BLISTER (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy), SKIN LESION (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy) and SCAB (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy) had resolved. At the time of the report, DYSPHONIA (Her voice was also affected, it became hoarse), AGEUSIA (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), SWOLLEN TONGUE (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) and the last episode of HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered DYSPHONIA (Her voice was also affected, it became hoarse), AGEUSIA (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), SWOLLEN TONGUE (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb), HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) and HYPOAESTHESIA ORAL (On 05Oct2023, she "lost her taste buds, her tongue was swollen and her lips and tongue became numb) to be related. No further causality assessments were provided for PRURITUS (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy), PUSTULE (Itchy pustule), BLISTER (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy), SKIN LESION (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy) and SCAB (On 01Oct2023, there was a ring of itchy pustules, blister, chicken pox like lesions surrounding the injection site. This became scabby and itchy).    Concomitant medication was not reported.  Treatment medication was not reported.  On an unspecified date, the patient underwent MRI and blood test. Company Comment: This is a spontaneous case concerning a 69-year-old female patient with no relevant medical history, who experienced the non-serious, unexpected, AESI event of Ageusia, together with other non-serious events. Event Ageusia occurred approximately 7 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, received as the sixth dose of COVID-19 vaccination schedule. The outcome of the event was reported as not recovered. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.