Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood thyroid stimulating hormone, COVID-19 pneumonia, Chest X-ray
Clinical narrative: subtle scattered ground-glass opacities in the lingula and posterior lower lobes; transaminitis; TSH level was still elevated; This literature-non-study case was reported in a literature article and describes the occurrence of HYPERTHYROIDISM (TSH level was still elevated) and COVID-19 PNEUMONIA (subtle scattered ground-glass opacities in the lingula and posterior lower lobes) in a 55-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.        The patient's past medical history included Autologous hematopoietic stem cell transplant (16 months before COVID-19 diagnosis.) in 2021. Concurrent medical conditions included B-cell acute lymphoblastic leukemia, Hypogammaglobulinemia, Hypothyroidism and Immunosuppression. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced HYPERTHYROIDISM (TSH level was still elevated) (seriousness criterion medically significant) and HYPERTRANSAMINASAEMIA (transaminitis). In June 2022, the patient experienced COVID-19 PNEUMONIA (subtle scattered ground-glass opacities in the lingula and posterior lower lobes) (seriousness criterion medically significant). In 2022, the patient experienced HYPERTHYROIDISM (TSH level was still elevated) (seriousness criterion medically significant) and HYPERTRANSAMINASAEMIA (transaminitis). The patient was treated with BEBTELOVIMAB in 2022 at an unspecified dose and frequency; NIRMATRELVIR;RITONAVIR from 2022 to 2022 at an unspecified dose and frequency and NIRMATRELVIR;RITONAVIR from 2022 to 2022 at an unspecified dose and frequency. In 2022, HYPERTHYROIDISM (TSH level was still elevated), COVID-19 PNEUMONIA (subtle scattered ground-glass opacities in the lingula and posterior lower lobes) and HYPERTRANSAMINASAEMIA (transaminitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Alanine aminotransferase: 79 U/L. In 2022, Aspartate aminotransferase: 50 U/L Day 14 of nirmatrelvir-ritonavir therapy. In 2022, Blood thyroid stimulating hormone: The value was 4.7 IU/ml, 7 IU/ml and 1 week after end of nirmatrelvir-ritonavir therapyit had normalized.. In 2022, Chest X-ray: Normal on day 88 of infection. In 2022, Computerised tomogram thorax: on day 135 demonstrated subtle scattered ground-glass opacities in the lingula and posterior lower lobes. and chest CT appearance at the time of second infection was similar to earlier findings. In 2022, SARS-CoV-2 test: (Positive) Nasal, (Positive) Nasal, (Positive) Nasal, (Positive) Nasal, (Positive) Nasal, (Positive) Nasal, Nasal-inconclusive, (Positive) Nasal, (Negative) Nasal, (Negative) Nasal, (Negative) Nasal, (Negative) Nasal and. In June 2022, SARS-CoV-2 test (Positive) Nasal. On 01-Aug-2022, Gene sequencing: Sequencing performed on available isolates from days 50 revealed Omicron variant BA.1.1 with the K444N mutation, associated with bebtelovimab resistance.. On 01-Aug-2022, SARS-CoV-2 test: At the time of second infection SARS CoV-2 virus was detected by PCR testing of a nasal swab sample, with a cycle threshold of 40.7.. On 21-Aug-2022, Gene sequencing: Sequencing performed on available isolates from days 70 revealed Omicron variant BA.1.1 with the K444N mutation, associated with bebtelovimab resistance.. On 17-Oct-2022, Gene sequencing: Sequencing performed on available isolates from days 127 revealed Omicron variant BA.1.1 with the K444N mutation, associated with bebtelovimab resistance..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient was initially treated with bebtelovimab on day 1 after COVID-19 diagnosis but reported persistent cough, postnasal drip, and fatigue. Over the ensuing months, he continued to experience a disruptive and worsening cough.   Because of the patient's progressive symptoms with continued PCR detection of SARS-CoV-2, nirmatrelvir-ritonavir therapy was started on day 142 of initial diagnosis.  On day 7 of therapy, the patient reported a slight improvement in his cough. By day 14, he reported noticeable improvement, with inconclusive detection of SARS CoV-2 with nasal swab sampling. By day 18, his symptoms were much improved, the SARS CoV-2 PCR result was negative, and nirmatrelvir-ritonavir was discontinued.   The patient experienced mild transaminitis on day 14 of therapy which resolved after completion of therapy.  One month after viral clearance, the patient presented with new fever, nausea, vomiting, and diarrhea. SARS CoV-2 virus was detected by PCR testing. Patient received a 5-day course of nirmatrelvir-ritonavir, with swift resolution of symptoms.   Author stated that, that was not clear whether this detection reflected recurrence, a false positive result, as suggested by the low-level viral detection, or a new COVID-19 exposure.  Company comment: This is a literature non-study case concerning a 55-year-old male patient with Medical History Autologous hematopoietic stem cell transplant (16 months before COVID-19 diagnosis.) in 2021, Concurrent medical conditions included B-cell acute lymphoblastic leukemia, Hypogammaglobulinemia, Hypothyroidism, Immunosuppression and Concomitant product of levothyroxine for hypothyroidism, who experienced the serious unexpected medically significant AESI hyperthyroidism (reported as SH level was still elevated) and the unexpected serious medically significant event COVID-19 pneumonia. Non Serious event hypertransaminasaemia (reported as transaminitis) was also mentioned in the article. Relevant diagnostic test included Alanine aminotransferase of 79 U/L (reference range not provided), and aspartate aminotransferase of 50 U/L (reference range not provided), on Day 14 of nirmatrelvir-ritonavir therapy, baseline Blood thyroid stimulating hormone of 4.7 IU/mL (reference range, 0.45 IU/mL), Four days after the end of therapy, the TSH level was still elevated, at 7.0 IU/mL, but 1 week later it had normalized, Computerised tomogram of thorax performed on day 135 demonstrated subtle scattered ground-glass opacities in the lingula and posterior lower lobes and chest CT appearance at the time of second infection was similar to earlier findings, Chest X-Ray resulted Normal on day 88 of infection, Gene Sequencing performed on available isolates from days 50, 70 and 127 revealed Omicron variant BA.1.1 with the K444N mutation, associated with bebtelovimab resistance. The event occurred after receiving a dose of mRNA-1273 vaccine (event and vaccine dates were not provided). The patient received 2 doses of the Moderna vaccine.  No concomitant medication was provided. Treatment applied included bebtelovimab, nirmatrelvir, and ritonavir. The events were reported as resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2023: Follow up received by safety on 07-Jul-2023 has email and full text article and contains significant information. Reporter details, patient history, lab data, concomitant and treatment products and event details updated.; Sender's Comments: Company comment: This is a literature non-study case concerning a 55-year-old male patient with Medical History Autologous hematopoietic stem cell transplant (16 months before COVID-19 diagnosis.) in 2021, Concurrent medical conditions included B-cell acute lymphoblastic leukemia, Hypogammaglobulinemia, Hypothyroidism, Immunosuppression and Concomitant product of levothyroxine for hypothyroidism, who experienced the serious unexpected medically significant AESI hyperthyroidism (reported as SH level was still elevated) and the unexpected serious medically significant event COVID-19 pneumonia. Non Serious event hypertransaminasaemia (reported as transaminitis) was also mentioned in the article. Relevant diagnostic test included Alanine aminotransferase of 79 U/L (reference range not provided), and aspartate aminotransferase of 50 U/L (reference range not provided), on Day 14 of nirmatrelvir-ritonavir therapy, baseline Blood thyroid stimulating hormone of 4.7 IU/mL (reference range, 0.45 IU/mL), Four days after the end of therapy, the TSH level was still elevated, at 7.0 IU/mL, but 1 week later it had normalized, Computerised tomogram of thorax performed on day 135 demonstrated subtle scattered ground-glass opacities in the lingula and posterior lower lobes and chest CT appearance at the time of second infection was similar to earlier findings, Chest X-Ray resulted Normal on day 88 of infection, Gene Sequencing performed on available isolates from days 50, 70 and 127 revealed Omicron variant BA.1.1 with the K444N mutation, associated with bebtelovimab resistance. The event occurred after receiving a dose of mRNA-1273 vaccine (event and vaccine dates were not provided). The patient received 2 doses of the Moderna vaccine.  No concomitant medication was provided. Treatment applied included bebtelovimab, nirmatrelvir, and ritonavir. The events were reported as resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.