Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Fatigue, Headache
Clinical narrative: Cough; Chest congestion; Body aches; Chills; Headache; Felt exhausted; Voice was in and out, voice is gone, can barely talk, voice was horse; Achy and sore voice; Temperature would go up, fever; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), DYSPHONIA (Voice was in and out, voice is gone, can barely talk, voice was horse), PAIN (Achy and sore voice), COUGH (Cough) and PYREXIA (Temperature would go up, fever) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0451321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nasal congestion from 15-Apr-2021 to 20-Apr-2021, Fatigue from 15-Apr-2021 to 20-Apr-2021, Ache from 15-Apr-2021 to 20-Apr-2021 and Sore throat (One week before second dose, allergies were acting up... developed a sore throat) in April 2021. Concurrent medical conditions included Thyroid disorder and Allergy (Unspecified allergies). Concomitant products included LEVOTHYROXINE SODIUM (UNITHROID) for Thyroid disorder.    On 24-Apr-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPHONIA (Voice was in and out, voice is gone, can barely talk, voice was horse). 25-Apr-2021, the patient experienced PAIN (Achy and sore voice), PYREXIA (Temperature would go up, fever) and FATIGUE (Felt exhausted). On 25-Apr-2021 at 6:00 AM, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On 26-Apr-2021, the patient experienced LOWER RESPIRATORY TRACT CONGESTION (Chest congestion). On 26-Apr-2021 at 7:00 AM, the patient experienced COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) on 25-Apr-2021 for Myalgia and Headache, at a dose of 1 dosage form. On 28-Apr-2021, PYREXIA (Temperature would go up, fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 29-Apr-2021, MYALGIA (Body aches) had resolved. At the time of the report, LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), PAIN (Achy and sore voice), COUGH (Cough) and FATIGUE (Felt exhausted) had resolved and DYSPHONIA (Voice was in and out, voice is gone, can barely talk, voice was horse) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Negative. On 19-Apr-2021, Influenza virus test: negative (Negative) Negative. On 19-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 19-Apr-2021, Streptococcus test: negative (Negative) Negative.         Patient reported that concomitant products also included an unspecified sinus medication.  The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: The follow-up was received on 6-JULY-2021 and has updates regarding additional adverse events, concomitant products, patient history and events outcome.