Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Heart rate increased, Hyperacusis
Clinical narrative: lethargy; Nearly fainted; Body aches; Nauseous; Rash; Drowsiness; My body was tired; Body aches; My jaw hurt; Earlobes were sensitive; My heart was racing; Fever of 102 degrees Farenheight.; Sweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), SYNCOPE (Nearly fainted), PAIN IN JAW (My jaw hurt), PAIN (Body aches) and HYPERHIDROSIS (Sweats) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis since 01-Mar-2014 and Osteoporosis since 01-Mar-2014. Concomitant products included CELECOXIB (CELEBREX) and GABAPENTIN for Arthritis, METHOCARBAMOL for Muscle relaxant, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis.   On 05-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced HYPERHIDROSIS (Sweats) and PYREXIA (Fever of 102 degrees Farenheight.). 03-Sep-2021, the patient experienced CHILLS (Chills). On 04-Sep-2021, the patient experienced SOMNOLENCE (Drowsiness), HYPERACUSIS (Earlobes were sensitive), HEART RATE INCREASED (My heart was racing), FATIGUE (My body was tired) and MYALGIA (Body aches). 04-Sep-2021, the patient experienced PAIN IN JAW (My jaw hurt). On 05-Sep-2021, the patient experienced SYNCOPE (Nearly fainted) and PAIN (Body aches). 05-Sep-2021, the patient experienced NAUSEA (Nauseous). 05-Sep-2021, the patient experienced RASH (Rash). On 06-Sep-2021, the patient experienced LETHARGY (lethargy). At the time of the report, SOMNOLENCE (Drowsiness) and MYALGIA (Body aches) had resolved with sequelae, SYNCOPE (Nearly fainted), PAIN IN JAW (My jaw hurt), HYPERACUSIS (Earlobes were sensitive), HEART RATE INCREASED (My heart was racing), LETHARGY (lethargy), FATIGUE (My body was tired) and NAUSEA (Nauseous) was resolving, PAIN (Body aches) had not resolved and HYPERHIDROSIS (Sweats), PYREXIA (Fever of 102 degrees Farenheight.), RASH (Rash) and CHILLS (Chills) had resolved. Residual effects include Drowsiness/Lethargic.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 degrees Farenheit.         No concomitant medication was reported No treatment medication was reported Patient reported that after the second dose, she began sweating and suddenly felt exhaused.  In morning, she had body aches, jaw hurt terribly, earlobes were sensitive, had fever of 102 degrees .Aches got worse throughout the day.  Her heart was racing, but her body was tired.  She was unable to leave the bed throughout the day. Then in second morning after the second dose she still had aches and pains throughout her body, and I developed a rash on my abdomen.  Fever was still present.  I attempted to get out of bed and go outside, but within minutes felt faint and nauseous, and had to return to bed for the rest of the day. On the third morning after the second dose, she did not go to work, still felt lingering nausea and tiredness, but was able to move about the house in a limited way.  The rash had gone away.  The lethargy remained for a few more days, and she finally started feeling better by the end of the week.   This case was linked to MOD-2021-335279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Significant follow up received. Patient's demography, relevant medical history, batch/lot number and concomitant medication, additional events, outcome of the events were updated.; Sender's Comments: This case concerns a  62-year-old female patient  with no previous relevant medical history who experienced the unexpected event of syncope. The event occurred  1 day after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge is not applicable as no additional dosing will be given. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Event Syncope  was automatically upgraded as serious as per RA list, however as per RA  and as per medical judgement was assessed as non-serious.