Received Nov 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Hypothyroidism; Other mast cell neoplasms of uncertain behaviour; Terrible taste in mouth; Memory is not very good; Infection in mouth; After the Moderna Covid vaccine, got horrible rash or gotten 4 boosters and still got a rash; Horrible rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHYROIDISM (Hypothyroidism) and HAEMATOPOIETIC NEOPLASM (Other mast cell neoplasms of uncertain behaviour) in a 71-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Avapritinib (Ayvakit) for Hematopoietic neoplasm. No Medical History information was reported. On 14-Jun-2025, the patient started Avapritinib (Ayvakit) (unknown route) 25 milligram once a day. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTHYROIDISM (Hypothyroidism) (seriousness criterion medically significant), HAEMATOPOIETIC NEOPLASM (Other mast cell neoplasms of uncertain behaviour) (seriousness criterion medically significant), TASTE DISORDER (Terrible taste in mouth), MEMORY IMPAIRMENT (Memory is not very good), ORAL INFECTION (Infection in mouth), REACTION TO PREVIOUS EXPOSURE TO ANY VACCINE (After the Moderna Covid vaccine, got horrible rash or gotten 4 boosters and still got a rash) and RASH (Horrible rash). The patient was treated with Thyroid renew for Hypothyroidism, at an unspecified dose and frequency. At the time of the report, HYPOTHYROIDISM (Hypothyroidism), HAEMATOPOIETIC NEOPLASM (Other mast cell neoplasms of uncertain behaviour), TASTE DISORDER (Terrible taste in mouth), MEMORY IMPAIRMENT (Memory is not very good), ORAL INFECTION (Infection in mouth) and REACTION TO PREVIOUS EXPOSURE TO ANY VACCINE (After the Moderna Covid vaccine, got horrible rash or gotten 4 boosters and still got a rash) outcome was unknown and RASH (Horrible rash) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medications were not reported. It was reported that on an unknown date, the patient experienced hypothyroidism, terrible taste in mouth, memory was not very good, rash, infection in mouth and after the Moderna COVID vaccines, the patient got horrible rash or got 4 boosters and still got a rash (reaction to previous exposure to any vaccine). The patient had terrible taste in her mouth when she woke up in the morning and even after brushing her teeth. The patient mentioned that she had an infection in her mouth a while ago and her memory was not very good to begin with. Patient got a horrible rash after the Moderna COVID vaccines and it took months to go away. She had gotten 4 boosters and still got a rash, but it was not as bad. The action taken with AVAPAITINIB in relation to the events hypothyroidism, taste disorder, memory impairment, rash, oral infection, and reaction to previous exposure to any vaccine was dosage maintained.; Reporter's Comments: MAH causality for Oral infection was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Ayvakit