Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
Clinical narrative: elevated heart rate; anxiety; prostatic specific antigen increased; a little soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness on the arm), TACHYCARDIA (elevated heart rate), ANXIETY (anxiety) and PROSTATIC SPECIFIC ANTIGEN INCREASED (prostatic specific antigen increased) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Nose surgery). Concurrent medical conditions included Type 2 diabetes mellitus (Patient has a history of Type 2 Diabetes mellitus with hyperglycemia, with long term current use of insulin.), PSA (Elevated PSA), Benign prostatic hyperplasia (Benign prostatic hyperplasia without lower urinary tract symptoms.), Back pain (Patient has Lower back pain.), Vitamin D deficiency, Post-traumatic stress disorder, Essential hypertension, GERD (Patient has chronic Gastro esophageal reflux disease), Nasal congestion and Constipation. Concomitant products included LISINOPRIL from 25-Jan-2003 to an unknown date for Hypertension, INSULIN for Type 2 diabetes mellitus, TADALAFIL from 27-Aug-2018 to an unknown date, TAMSULOSIN from 21-Aug-2019 to an unknown date, ASPIRIN [ACETYLSALICYLIC ACID] from 21-Jan-2010 to an unknown date and ATENOLOL from 24-May-2021 to an unknown date for an unknown indication.   On 26-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (a little soreness on the arm) and PROSTATIC SPECIFIC ANTIGEN INCREASED (prostatic specific antigen increased). On an unknown date, the patient experienced TACHYCARDIA (elevated heart rate) and ANXIETY (anxiety). The patient was treated with LORAZEPAM (ATIVAN) on 24-Apr-2021 for Adverse event, at an unspecified dose and frequency; METOPROLOL TARTRATE (LOPRESSOR) on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency; POTASSIUM CHLORIDE on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency; NORMAL SALINE on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] on 24-Apr-2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Blood pressure, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little soreness on the arm), TACHYCARDIA (elevated heart rate), ANXIETY (anxiety) and PROSTATIC SPECIFIC ANTIGEN INCREASED (prostatic specific antigen increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Prostatic specific antigen: 17.6 (High) Patient stated that before receiving his first dose of vaccine the PSA levels were 8.1-8.7 but after receiving his second dose it showed 17.6. On 18-May-2021, Blood pressure measurement: 112/72 (Inconclusive) Patient's blood pressure at 08:30pm was 112/72 mmHg and 152/92 (Inconclusive) Patient's blood pressure was 152/92 mmHg. On 18-May-2021, Body temperature: 98.4 (Inconclusive) Patient's body temperature was 98.4° F. On 18-May-2021, Heart rate: 66 (Inconclusive) Patient's heart rate was 66 beats per minute, 106 (Inconclusive) Patient's heart rate was 106 beats per minute, 99 (Inconclusive) Patient's heart rate was 99 beats per minute, 89 (Inconclusive) Patient's heart rate was 89 beats per minute and 122 (Inconclusive) 122 beats per minute. On 18-May-2021, Oxygen saturation: 98 (normal) Patient's O2 saturation was 98%. In 2021, Blood pressure measurement: 144/88 (Inconclusive) Patient's blood pressure was 144/88 mmHg. In 2021, Body temperature: 98.4 (Inconclusive) Patient's body temperature was 98.4° F. In 2021, Heart rate: 87 (Inconclusive) 87 beats per minute. In 2021, Oxygen saturation: 100 (normal) Patient's O2 saturation was 100%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient informed his physician and was advised to have another PSA next week and to consult a Urologist. On an unknown date, patient's respiration rate was 16 and on 18-May-2021, patient's respiration rate was 20. Patient reportedly had heart palpitations. On 24-Apr and 08-May-2021, patient's blood pressure and heart rate was elevated.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's previous history of diabetes mellitus and hypertension could be confounders for tachycardia. Post-traumatic stress disorder could be a confounder for anxiety event as well as previous elevated prostatic antigen and benign prostatic hyperplasia could be confounders for the increased prostatic specific antigen. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up 4 received included lab investigation and medical history was updated On 13-Aug-2021: Follow-up 3 received contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's previous history of diabetes mellitus and hypertension could be confounders for tachycardia. Post-traumatic stress disorder could be a confounder for anxiety event as well as previous elevated prostatic antigen and benign prostatic hyperplasia could be confounders for the increased prostatic specific antigen. Further information has been requested.