Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anal fissure, Autoimmune thyroiditis, Heart rate, Hypoaesthesia, Migraine
Clinical narrative: Hashimoto disease; Anal fissures; Migraines; Tension headaches; Scalp hurts; Psoriasis flare up between buttocks; Reaction to Moderna booster/entire left side of the body numb; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimoto disease) in a 51-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 product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram every three months. In October 2021, the patient experienced HYPOAESTHESIA (Reaction to Moderna booster/entire left side of the body numb). On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimoto disease) (seriousness criterion medically significant), ANAL FISSURE (Anal fissures), MIGRAINE (Migraines), TENSION HEADACHE (Tension headaches), PAIN OF SKIN (Scalp hurts) and PSORIASIS (Psoriasis flare up between buttocks). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimoto disease), ANAL FISSURE (Anal fissures), MIGRAINE (Migraines), TENSION HEADACHE (Tension headaches) and PAIN OF SKIN (Scalp hurts) outcome was unknown and PSORIASIS (Psoriasis flare up between buttocks) and HYPOAESTHESIA (Reaction to Moderna booster/entire left side of the body numb) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate: 2 - 3 points higher than normal, increased. On an unknown date, Pain assessment: 7 out of 10.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient had plaque psoriasis flare ups in between her buttocks that were painful and had spoken with the   Physician told patient to give it some more time. After last Moderna booster, almost the entire left side of her body went numb within an hour after receiving her vaccine.  The patient had anal fissures that have gotten worse since starting. She had ponytail syndrome where she got migraines or tension headaches after wearing a pony tail and that her scalp hurts where plaques used to be after taking the pony tail out. The patient had hashimoto disease.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of psoriasis flare up between buttocks was not working, heart rate was two to three point higher than normal, anal fissures, migraines, tension headaches, hashimoto disease and scalp hurts was not provided. The reporter's causality for the event(s) of reaction to Moderna booster/entire left side of the body numb with Skyriz was no reasonable possibility. Company comment-This spontaneous case concerns a female patient aged 51 years with no relevant medical history reported, who experienced the unexpected serious (medically significant)  event of Autoimmune thyroiditis on unknown dates in the context of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date was not disclosed.  Patient had received initial two doses of mRNA-1273 at an interval of one month and third dose seven months later. Patient had numbness of entire left side of body lasting for a week after booster. Her heart rate was increased by two to three points   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Significant live follow-up appended. Event information, suspect drug information, laboratory/diagnostic procedures and narrative description was updated.  Company comment: This spontaneous case concerns a female patient aged 51 years with no relevant medical history reported, who experienced the unexpected serious (medically significant)  event of Autoimmune thyroiditis on unknown dates in the context of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date was not disclosed.  Patient had received initial two doses of mRNA-1273 at an interval of one month and third dose seven months later. Patient had numbness of entire left side of body lasting for a week after booster. Her heart rate was increased by two to three points higher then normal. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 51 years with no relevant medical history reported, who experienced the unexpected serious (medically significant)  event of Autoimmune thyroiditis on unknown dates in the context of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date was not disclosed.  Patient had received initial two doses of mRNA-1273 at an interval of one month and third dose seven months later. Patient had numbness of entire left side of body lasting for a week after booster. Her heart rate was increased by two to three points higher then normal. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.