Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Blood thyroid stimulating hormone, Computerised tomogram head, Free thyroxine index, Full blood count
Clinical narrative: hypophysitis; worsening nausea; vomiting; Headache; Malaise; Arthralgia; acute pan hypopituitarism; abdominal pain; This literature-non-study case was reported in a literature article and describes the occurrence of HYPOPHYSITIS (hypophysitis), NAUSEA (worsening nausea), VOMITING (vomiting), HEADACHE (Headache), MALAISE (Malaise), ARTHRALGIA (Arthralgia), HYPOPITUITARISM (acute pan hypopituitarism) and ABDOMINAL PAIN (abdominal pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOPHYSITIS (hypophysitis) (seriousness criterion hospitalization), NAUSEA (worsening nausea) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), MALAISE (Malaise) (seriousness criterion hospitalization), ARTHRALGIA (Arthralgia) (seriousness criterion hospitalization), HYPOPITUITARISM (acute pan hypopituitarism) (seriousness criterion hospitalization) and ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization). The patient was treated with DEXAMETHASONE (intravenous) for Adverse event, at a dose of 4 milligram; COSYNTROPIN for Adverse event, at a dose of 250 microgram; PREDNISONE for Adverse event, at an unspecified dose and frequency and LEVOTHYROXINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOPHYSITIS (hypophysitis), NAUSEA (worsening nausea), VOMITING (vomiting), HEADACHE (Headache), MALAISE (Malaise), ARTHRALGIA (Arthralgia), HYPOPITUITARISM (acute pan hypopituitarism) and ABDOMINAL PAIN (abdominal pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, ACTH stimulation test: abnormal (abnormal) Stimulation test was performed. The adrenal response was markedly abnormal.. On an unknown date, Blood corticotrophin (7.2 pg/ml-63.3 pg/ml): 1.9 pg/ml (Low) Baseline adrenocorticotropic hormone (ACTH) was also low at 1.9 pg/mL (reference range, 7.2-63.3 pg/mL) which confirmed secondary adrenal insufficiency.. On an unknown date, Blood cortisol: <1.0 ug/dl Both random and morning cortisol levels were below detectable limits (<1.0 ug/dL). and abnormal (abnormal) The baseline cortisol level of <1.0 ug/dL increased to 2.4 ug/dL at 30 minutes and to 3.0 ug/dL at 60 minutes (normal response is > 18 ug/dL at either time point).. On an unknown date, Blood follicle stimulating hormone (1.5 miu/ml-12.4 miu/ml): 3.3 miu/ml (normal) follicle-stimulating hormone(FSH) of 3.3 mIU/mL (reference range, 1.5-12.4 mIU/mL). On an unknown date, Blood luteinising hormone (1.7 miu/ml-8.6 miu/ml): 1.9 miu/ml (normal) luteinizing hormone (LH) of 1.9 mIU/mL (reference range, 1.7-8.6 mIU/mL). On an unknown date, Blood pressure measurement: 114/78 mm/hg The blood pressure 114/78 mm/Hg. On an unknown date, Blood prolactin (4.0 ng/ml-15.2 ng/ml): 12.9 ng/ml (normal) hormonal workup revealed a prolactin level of 12.9 ng/mL (reference range, 4.0-15.2 ng/mL). On an unknown date, Blood sodium (135 mmol/l-145 mmol/l): 116 mmol/l (Low) Serum sodium level of 116 mmol/L (reference range, 135-145 mmol/L).. On an unknown date, Blood testosterone (193 ng/dl-740 ng/dl): 108 ng/dl (Low) 8 a.m. testosterone level of 108 ng/dL (reference range, 193-740 ng/dL) and normalized (normal) Plasma testosterone level normalized without testosterone replacement therapy. On an unknown date, Blood thyroid stimulating hormone (0.40 uiu/ml-4.50 uiu/ml): 0.13 uiu/ml (Low) The thyroid-stimulating hormone (TSH) was 0.13 uIU/mL (reference range, 0.40-4.50 uIU/mL) and free thyroxine (free T4) level was 0.4 ng/dL (reference range, 0.8-1.8 ng/dL), consistent with central hypothyroidism and 0.13 uiu/ml (Low) The thyroid-stimulating hormone (TSH) was 0.13 uIU/mL (reference range, 0.40- 4.50 uIU/mL). On an unknown date, Computerised tomogram head: abnormal As hormonal workup was consistent with secondary adrenal insufficiency, central hypothyroidism, and central hypogonadism, computed tomography (CT) of the brain was obtained. This showed eccentric 10 x 15 x 9 mm enlargement of the pituitary gland which was new compared with previous images from 2011.. On an unknown date, Free thyroxine index (0.8 ng/dl-1.8 ng/dl): 0.4 ng/dl (Low) free thyroxine (free T4) level was 0.4 ng/dL (reference range, 0.8-1.8 ng/dL), consistent with central hypothyroidism. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Heart rate: 68 beats per minute The pulse was 68 beats per minute. On an unknown date, Liver function test: normal (normal) normal. On an unknown date, Magnetic resonance imaging: abnormal Dedicated pituitary protocol magnetic resonance imaging (MRI) showed asymmetric enlargement of the pituitary gland with a larger more globular component on the right. The total gland measured 1.2 cm AP by 1.8 cm transverse by 0.8 cm craniocaudal, and there was thickening of the pituitary stalk, findings seen with hypophysitis. and diminished enlargement and empty sella After 1 month, follow-up magnetic resonance imaging (MRI) of the pituitary revealed markedly diminished enlargement of the gland with a mostly empty sella..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPOPHYSITIS (hypophysitis), NAUSEA (worsening nausea), VOMITING (vomiting), HEADACHE (Headache), MALAISE (Malaise), ARTHRALGIA (Arthralgia), HYPOPITUITARISM (acute pan hypopituitarism) and ABDOMINAL PAIN (abdominal pain) to be possibly related.    Patient received his first dose of the Moderna Covid-19 vaccine. Three days later, he noted the onset of nausea, malaise, and arthralgias. He used nonprescription non-steroidal anti-inflammatory drugs with minimal relief. Despite this, patient received his second dose of Moderna vaccine 28 days later. Two days following this, he began having worsening nausea, vomiting, and mid-epigastric abdominal pain prompting him to present to the emergency department.. Treatment was initiated with high-dose steroids and thyroid hormone replacement. Over the next 2 days, his blood sodium level normalized and symptoms resolved. He was discharged on prednisone and levothyroxine.  This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hypophysitis, acute pan hypopituitarism, abdominal pain, nausea, vomiting, headache, malaise and arthralgia. The events occurred 2 days after receiving the second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the events reported were only after the second dose. The reporter assessed the event as related to the product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.   This case was linked to MOD-2021-334910 (Patient Link).; Sender's Comments: This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hypophysitis, acute pan hypopituitarism, abdominal pain, nausea, vomiting, headache, malaise and arthralgia. The events occurred 2 days after receiving the second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the events reported were only after the second dose. The reporter assessed the event as related to the product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.