Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Influenza vaccine on 11-Nov-2024; for COVID-19 prophylaxis: Spikevax NOS (Had 7 doses). Past adverse reactions to the above products included No adverse effect with Influenza vaccine and Spikevax NOS. Concurrent medical conditions included Blood pressure high. On 10-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In December 2024, the patient experienced PRURITUS (Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled). At the time of the report, PRURITUS (Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled) was resolving. The patient was taking cholesterol and high blood pressure medications. The patient received her COVID shot on 10-Dec-2024. Within a few days, she developed an intense, widespread itch all over her body. Although there was no visible rash or redness, the itch was so severe that she scratched herself until she bled, but the scratching brought no relief, she consulted a dermatologist, an allergist, an internist, and an endocrinologist. All of them conducted various tests, but no one could determine the cause of her symptoms. She believed the only possible trigger might have been the Moderna vaccine, although she hoped she was wrong especially since she was due for another shot and was terrified of experiencing the same reaction again. She mentioned that this was the first adverse reaction she had ever experienced from a COVID vaccine, despite having received seven doses previously. The itchiness affected her entire body but was particularly severe on her thighs, legs, and feet. The condition disrupted her sleep, as the constant itching kept her awake at night. She tried allergy pills, creams, and ointments, but nothing provided lasting relief. The patient had such a terrible reaction, felt so itchy that she was scratching till bled and the itching did not stop, no rash, nothing you could see visibly, but whole body was just one big itch. She used salves and lotions from the doctors that helped, whenever she stopped using the topical treatments, the itch would return. She said it had almost been a year and she currently had slight itchiness. It had gotten progressively better but it had taken all of these months. Itching was slight, not as horrible or as horrendous as it was last winter and last spring and summer. It was unknown if the patient experienced any additional symptoms or events. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2025: Live non-significant follow-up information accepted: Event verbatim and narrative was updated.
Blood pressure high