Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: got really sick; sweating , sweat so bad which was awful; chills; her glands swelled , had trouble with her glands/swelling; mouth got really dry; feeling like being high or sedated; her body and legs started shaking uncontrollable; COVID-like-symptoms; pain in a side of her neck; excruciating pain in her stomach; soreness in her glands; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling like being high or sedated), ILLNESS (got really sick), HYPERHIDROSIS (sweating , sweat so bad which was awful), SUSPECTED COVID-19 (COVID-like-symptoms) and NECK PAIN (pain in a side of her neck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027l21a, 005c21a and 005c21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer surgery. Concurrent medical conditions included Tumor (Patient has 3 tumors on her stomach and was diagnosed with those 3 tumors) since 2019, Acid reflux (esophageal), Diabetic, Blood pressure high, Drug allergy (aspirin), Penicillin allergy (penicillium), Drug allergy (codeine), Drug allergy (all of the cholesterol drugs except for the one she takes), Drug allergy (some other eye drug), Allergy to chemicals (glascol) and Drug allergy (ULTRAM).   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced SUSPECTED COVID-19 (COVID-like-symptoms), NECK PAIN (pain in a side of her neck), ABDOMINAL PAIN UPPER (excruciating pain in her stomach), PAIN (soreness in her glands) and TREMOR (her body and legs started shaking uncontrollable). On 23-Jun-2022, the patient experienced FEELING ABNORMAL (feeling like being high or sedated) and DRY MOUTH (mouth got really dry). On 24-Jun-2022, the patient experienced ILLNESS (got really sick), HYPERHIDROSIS (sweating , sweat so bad which was awful), CHILLS (chills) and LYMPHADENOPATHY (her glands swelled , had trouble with her glands/swelling). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of every 4 hours. On 23-Jun-2022, DRY MOUTH (mouth got really dry) had resolved. At the time of the report, FEELING ABNORMAL (feeling like being high or sedated) outcome was unknown, ILLNESS (got really sick), HYPERHIDROSIS (sweating , sweat so bad which was awful), SUSPECTED COVID-19 (COVID-like-symptoms), NECK PAIN (pain in a side of her neck), ABDOMINAL PAIN UPPER (excruciating pain in her stomach), PAIN (soreness in her glands), CHILLS (chills) and LYMPHADENOPATHY (her glands swelled , had trouble with her glands/swelling) was resolving and TREMOR (her body and legs started shaking uncontrollable) had resolved.            Patient concomitant medications included for high blood pressure, diabetes, acid reflux medication and cholesterol. Patient had been in remission for years. After the first booster dose 5 minutes after injection patient started to experience and mentioned mouth got really dry for 15 mins, she sat and started feeling like being high or sedated, she drank water and got home. On Fri at 9 she got sick, her glands swelled up, had trouble with her glands and later the night she had chills and was sweating, she sweat so bad which was awful. Patient mentioned being frightened. It was reported that patient was too sick to go to medical care. On the day of reporting, it was mentioned that patient started to feel better on that day.  It was reported patient never had COVID positive test nor diagnosed with it. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Company Comment: This spontaneous case concerns a 71-year-old female patient with a relevant medical history of Tumor (was diagnosed with 3 tumors on her stomach) and she has a cancer surgery for the same in 2019 and Acid reflux (esophageal), who experienced the unexpected non-serious AESI of Suspected COVID-19 on an unknown date in June 2022, while the third dose of mRNA-1273 vaccine was administered on 23-Jun-2022. and non-serious events like Abdominal pain upper, Lymphadenopathy. After the first booster dose patient started to experience dry mouth, she sat and started feeling like being high or sedated, she drank water and got home. Next day she got sick, her glands swelled up, had trouble with her glands and later the night she had chills and sweating. Patient mentioned being frightened. Patients medical history of Tumor could be confounding for the event Lymphadenopathy and Abdominal pain upper and Acid reflux could be confounding for the event Abdominal pain upper. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Sender's Comments: This spontaneous case concerns a 71-year-old female patient with a relevant medical history of Tumor (was diagnosed with 3 tumors on her stomach) and she has a cancer surgery for the same in 2019 and Acid reflux (esophageal), who experienced the unexpected non-serious AESI of Suspected COVID-19 on an unknown date in June 2022, while the third dose of mRNA-1273 vaccine was administered on 23-Jun-2022. and non-serious events like Abdominal pain upper, Lymphadenopathy. After the first booster dose patient started to experience dry mouth, she sat and started feeling like being high or sedated, she drank water and got home. Next day she got sick, her glands swelled up, had trouble with her glands and later the night she had chills and sweating. Patient mentioned being frightened. Patients medical history of Tumor could be confounding for the event Lymphadenopathy and Abdominal pain upper and Acid reflux could be confounding for the event Abdominal pain upper. The benefit-risk relationship of mRNA-1273 is not affected by this report.