Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (little weak overall), PAIN (generalized body aches), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area) and MOBILITY DECREASED (too immobilized) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 022M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Polycystic liver disease (Diagnosed at the age of 70) and Birt-Hogg-Dube syndrome (Diagnosed at the age of 70).Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (AIRDUO RESPICLICK) from 02-Sep-2021 to an unknown date for Asthma, METOPROLOL TARTRATE (LOPRESSOR) from 11-Oct-2021 to an unknown date, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) from 11-Oct-2021 to an unknown date and AMLODIPINE BESILATE (NORVASC) from 01-Oct-2021 to an unknown date for Blood pressure high, RIVAROXABAN (XARELTO) from 06-Jul-2021 to an unknown date for Fibrillation paroxysmal atrial, ALLOPURINOL (ZYLOPRIM) from 14-Sep-2021 to an unknown date for Gout, INFLUENZA VACCINE, DOXAZOSIN MESILATE (CARDURA) from 11-Jun-2021 to an unknown date, VITAMIN D3 from 04-Jan-2021 to an unknown date, FISH OIL from 24-Aug-2016 to an unknown date, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) from 24-Aug-2016 to an unknown date and B COMPLEX FORMULA 1 from 24-Aug-2016 to an unknown date for an unknown indication.On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 28-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ASTHENIA (little weak overall), FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering). On 29-Nov-2021, the patient experienced PAIN (generalized body aches) and ASTHENIA (terribly weak). In December 2021, the patient experienced THROAT IRRITATION (Scratchy throat). On an unknown date, the patient experienced RHINORRHOEA (Runny nose), LACRIMATION INCREASED (Watering eyes), PRODUCTIVE COUGH (Deep very heavy cough/Sputum/much phlegm), AGEUSIA (I lost my sense of taste and smell), ANOSMIA (I lost my sense of taste and smell), ABDOMINAL PAIN UPPER (abdomen sore), CHEST PAIN (Chest sore), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) ongoing since an unknown date for Adverse event, at a dose of 325 mg every 4-5 hours; BENZONATATE for Cough, at a dose of 200 mg capsule and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. In December 2021, THROAT IRRITATION (Scratchy throat) had resolved. At the time of the report, ASTHENIA (little weak overall), PAIN (generalized body aches), MOBILITY DECREASED (too immobilized), BODY TEMPERATURE INCREASED (probably had slight temperature), RHINORRHOEA (Runny nose), LACRIMATION INCREASED (Watering eyes), AGEUSIA (I lost my sense of taste and smell), ANOSMIA (I lost my sense of taste and smell), ABDOMINAL PAIN UPPER (abdomen sore), CHEST PAIN (Chest sore), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and FATIGUE (tired) outcome was unknown, FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), PRODUCTIVE COUGH (Deep very heavy cough/Sputum/much phlegm) and CHILLS (significant chills/teeth chattering) had resolved and ASTHENIA (terribly weak) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 19-Dec-2021, Body temperature: normal (normal) normal.On 29-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.On an unknown date, Bacterial test: negative (Negative) Negative.On an unknown date, Chest X-ray: negative (Negative) Negative.By Monday, 20-Dec-2021, he felt like he was coming out of it. What still plagued him however was extreme tiredness and a continued deep/heavy cough with sputum/phlegm still as very difficult to cough up. He was also weak and had body aches throughout Monday. Parenthetically, he had been weak into Tuesday (today) as well. It was on Tuesday, 22-Dec-2021, and he was feeling stronger but he was still a bit tired but had occasional heavy cough with sputum/phlegm. Received treatment for cough thankfully. Residual complications even today on 31-Dec-2021 with heavy cough (phlegm has also decreased considerably) but at a lesser frequency.No known allergies. Patient was not tested positive or diagnosed with covid-19. Patient was having multivitamins(2 tablets by mouth once daily). Patient's height was 67-inch, patients weight was 240 pounds. Company Comment: This spontaneous case concerns a 76-year-old male patient with concurrent medical conditions of polycystic liver disease, Birt-Hogg-Dube syndrome, asthma, fibrillation paroxysmal atrial and hypertension; who experienced non serious events of productive cough, chest pain, anosmia (AESI), abdominal pain upper, ageusia (AESI), among others. The events occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The patient was treated with paracetamol,  Benzonatate and Diphenhydramine. Patient stated residual complications with heavy cough but at a lesser frequency. Concurrent medical conditions remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.This case was linked to MOD-2021-402912, MOD-2022-437056 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 01-Jan-2022: Significant follow up received,  patient demographics, medical history, Product batch no, dose and concomitant medication updated. On 03-Jan-2022: Follow up received included no new information. Sender's Comments: This spontaneous case concerns a 76-year-old male patient with concurrent medical conditions of polycystic liver disease, Birt-Hogg-Dube syndrome, asthma, fibrillation paroxysmal atrial and hypertension; who experienced non serious events of productive cough, chest pain, anosmia (AESI), abdominal pain upper, ageusia (AESI), among others. The events occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The patient was treated with paracetamol,  Benzonatate and Diphenhydramine. Patient stated residual complications with heavy cough but at a lesser frequency. Concurrent medical conditions remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.