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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 51-year-old man developed nausea, malaise, and arthralgia, vomiting, and mid-epigastric abdominal pain after receiving first and second dose of mRNA-1273 COVID-19 Vaccine [route and dosage not stated].
The man, who had no significant history, received his first dose of the mRNA-1273 Moderna Covid-19 vaccine. Three days later, he experienced malaise, nausea, and arthralgias. He received unspecified non-steroidal anti-inflammatory drugs and showed mild relief. Eventually, 28 days later, he received the mRNA-1273 Moderna vaccine's second dose. He was admitted due to developed severe nausea, vomiting, and mid-epigastric abdominal discomfort two days later. His heart rate was 68 beats per minute, his blood pressure was 114/78 mm Hg, and his weight was 77.1kg at the time of presentation. He appeared fatigued, although his physical examination was generally unremarkable. Laboratory tests revealed decreased serum sodium levels and whole blood counts, while liver function tests and kidney tests were unremarkable. TSH and free T4 levels were markedly decreased, associated with central hypothyroidism. Cortisol levels at random and in the morning were both below detectable levels.
The man's treatment was started with dexamethasone. He underwent several laboratory investigations and diagnosed with hypopituitarism and hypophysitis. He than treated with a high dose of unspecified steroids and unspecified thyroid hormone replacement. His blood sodium level returned to normal during the next two days, and his symptoms disappeared. Prednisone and levothyroxine were prescribed before he was discharged.
Reference
- Murvelashvili N, et al. A Case of Hypophysitis Following Immunization With the mRNA-1273 SARS-CoV-2 Vaccine. Journal of Investigative Medicine High Impact Case Reports 9: no pagination, 25 Sep 2021. Available from: URL: 10.1177/23247096211043386 [DOI] [PMC free article] [PubMed]
