Sex: F
Vaccine: COVID19
Symptoms: Blood corticotrophin, Blood gonadotrophin, Blood growth hormone, Diabetes insipidus, Growth hormone deficiency
Clinical narrative: Hypophysitis; diabetes insipidus; hypothyroidism; Growth hormone deficiency; Hypogonadism; This is a literature report.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOPHYSITIS (medically significant), 2 days after the suspect product(s) administration, outcome "recovering"; DIABETES INSIPIDUS (medically significant), 2 days after the suspect product(s) administration, outcome "recovering"; HYPOTHYROIDISM (medically significant), 2 days after the suspect product(s) administration, outcome "recovering"; GROWTH HORMONE DEFICIENCY (medically significant), 2 days after the suspect product(s) administration, outcome "recovering"; HYPOGONADISM (medically significant), 2 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood corticotrophin: Normal; Blood gonadotrophin: Hypogonadism; Blood growth hormone: GH insufficiency; Lactotrop Axis: Normal; Magnetic resonance imaging: thickening of the pituitary stalk was found; Thyroid function test: Hypothyroidism. Therapeutic measures were taken as a result of hypophysitis, diabetes insipidus, hypothyroidism, growth hormone deficiency, hypogonadism. Clinical details: Symptoms were reported as headache, polydipsia, and polyuria. Diagnostic was Hypophysitis. Clinical presentations: Post-vaccination inflammatory pituitary disease was the most common condition in five patients. The ratio was in favor of women (3/2). The onset was quite fast, ranging from one day to a maximum of seven days post-vaccination. Among these patients, fours patients had received the Pfizer-BioNTech BNT162b2 vaccine versus a single patient with the AstraZeneca ChAdOx1 nCov-19 vaccine. All hypophysitis cases presented symptoms suggestive of a hypothalamic-pituitary involvement. The classic presentation of hypophysitis dose not differ from that encountered in patients with post-vaccinal involvement. Among them, they found headaches, which were the most frequent symptom in almost all of the patients. The tumoral syndrome caused by hypophysitis might be the cause of these and other symptoms, in particular visual blurring. Hypophysitis, apart from sellar, infra- and supra-sellar tumor syndromes, also causes hormonal deficits that they found in these patients. Anterior pituitary involvement was present in three cases. Two patients had hypopituitarism in three axes (corticotroph, gonadotroph, and thyreotroph), indicating the intensity of the inflammation. One patient had only isolated corticotropic involvement, which was evoked by the symptoms of acute in these case was post-pituitary damage which was the most frequent, with four out of five patients being affected. Post-pituitary involvement was evoked by the typical polyuro polydipsic syndrome found in all patients. The carving for water reached up to 8 L in some patients, and the sudden onset raised suspicion of acute ADH deficiency (after eliminating hyperglycemia in particular). All patients had a water restriction test which showed an initial parameters normalized with the addition of desmopressin which made it possible to concentrate urine, confirming the diagnosis of ADH deficiency. All patients received desmopressin at discharge, together with the treatment of other pituitary deficits.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.