Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Chills, Computerised tomogram, Dyspepsia, Eye discharge
Clinical narrative: Hypothyroidism; Heartburn; Hernia; Meibomian gland obstruction; Sickness; Generalized aching; lethargic; sweating; eye discharge; Lymphadenopathy cervical; Chills; interchange of vaccine products; Revaccination with different COVID  19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHYROIDISM (Hypothyroidism) in a 63-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 IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Bone marrow transplant (ALLOTRANSPLANT) and Bladder catheterization (ALLOTRANSPLANT). Concurrent medical conditions included Infection staphylococcal (to right big toe) since April 2020, Type 2 diabetes mellitus, Dry eyes and Osteoporosis. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for COVID-19 vaccination.   On 01-Jul-2017, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 23-Apr-2018, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to at an unspecified dose once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTHYROIDISM (Hypothyroidism) (seriousness criterion medically significant), DYSPEPSIA (Heartburn), HERNIA (Hernia), MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland obstruction), ILLNESS (Sickness), PAIN (Generalized aching), LETHARGY (lethargic), HYPERHIDROSIS (sweating), EYE DISCHARGE (eye discharge), LYMPHADENOPATHY (Lymphadenopathy cervical), CHILLS (Chills), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID  19 vaccine). The patient was treated with METFORMIN at an unspecified dose and frequency; APIXABAN (ELIQUIS) at an unspecified dose and frequency; PREGABALIN (LYRICA) at an unspecified dose and frequency; LEVOTHYROXINE at an unspecified dose and frequency and ACICLOVIR at an unspecified dose and frequency. At the time of the report, HYPOTHYROIDISM (Hypothyroidism), DYSPEPSIA (Heartburn), HERNIA (Hernia), ILLNESS (Sickness), PAIN (Generalized aching), LETHARGY (lethargic), HYPERHIDROSIS (sweating), EYE DISCHARGE (eye discharge), LYMPHADENOPATHY (Lymphadenopathy cervical), CHILLS (Chills), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID  19 vaccine) outcome was unknown and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland obstruction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Computerised tomogram: Good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had no known allergies.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of Lymphadenopathy cervical, Heartburn, Hernia, Meibomian gland obstruction, Sickness, Generalized aching, Chills, Lethargic, Sweating, Eye discharge, hypothyroidism was not provided for Imbruvica.  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.  Company comment.  This spontaneous case concerns a 63  year  old, female patient with relevant current condition of Type 2 diabetes mellitus, who experienced the serious (medically significant) event of hypothyroidism, (along other non  serous events). The patient received a dose of mRNA-1273 vaccine, reported as third dose of her COVID  19 immunization schedule; previously she had two doses of Tozinameran COVID  19 vaccines (Revaccination with different COVID  19 vaccine and interchange of vaccine products is considered). Vaccination date with mRNA  1273 vaccine and event onset date were not reported; hence latency and temporal association cannot be properly assessed. The patient was treated with levothyroxine. No further clinical details were provided for medical review. Co-suspect product ibrutinib (imbruvica) and patient´s age, gender and mentioned medical history could be confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63  year  old, female patient with relevant current condition of Type 2 diabetes mellitus, who experienced the serious (medically significant) event of hypothyroidism, (along other non  serous events). The patient received a dose of mRNA-1273 vaccine, reported as third dose of her COVID  19 immunization schedule; previously she had two doses of Tozinameran COVID  19 vaccines (Revaccination with different COVID  19 vaccine and interchange of vaccine products is considered). Vaccination date with mRNA  1273 vaccine and event onset date were not reported; hence latency and temporal association cannot be properly assessed. The patient was treated with levothyroxine. No further clinical details were provided for medical review. Co-suspect product ibrutinib (imbruvica) and patient´s age, gender and mentioned medical history could be confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.