Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysbiosis, Dyspepsia, Eructation, Feeling hot, Flatulence
Clinical narrative: Dysbiosis; Morning diarrhea; Low blood sugar symptoms; Mood issues; Inflammation; Not digesting sugar/fibers; Bladder Infection; aches and pains (not muscular); Pain under arms/sides; Chills feeling in body; Nausea; Digestive issues got aggravated; Loss of appetite/Not much of appetite; Gas/Lots of gas on both ends (mouth and bottom); Burping/Lots of gas on both ends (mouth and bottom); Warm feeling in body and mouth/ Feeling hot all over/Mouth was very hot; Pain in upper right quadrant of stomach/Sick to my stomach/radiating stomach pain; Pain upper right near the breast; Sweating in the mornings; Mentally Depressed; Anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPEPSIA (Digestive issues got aggravated), DECREASED APPETITE (Loss of appetite/Not much of appetite), FLATULENCE (Gas/Lots of gas on both ends (mouth and bottom)), ERUCTATION (Burping/Lots of gas on both ends (mouth and bottom)) and FEELING HOT (Warm feeling in body and mouth/ Feeling hot all over/Mouth was very hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Allergic to Sulfites), Hashimoto's disease since 2005, Hypothyroidism and Inflammatory bowel disease. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Allergy, THYROID (ARMOUR THYROID) and LEVOTHYROXINE for Hypothyroidism, FAMOTIDINE (PEPCID AC), PROGESTERONE, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D3 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DYSPEPSIA (Digestive issues got aggravated), DECREASED APPETITE (Loss of appetite/Not much of appetite), FLATULENCE (Gas/Lots of gas on both ends (mouth and bottom)), ERUCTATION (Burping/Lots of gas on both ends (mouth and bottom)), FEELING HOT (Warm feeling in body and mouth/ Feeling hot all over/Mouth was very hot), ABDOMINAL PAIN UPPER (Pain in upper right quadrant of stomach/Sick to my stomach/radiating stomach pain), BREAST PAIN (Pain upper right near the breast), HYPERHIDROSIS (Sweating in the mornings), DEPRESSION (Mentally Depressed), ANXIETY (Anxiety), PAIN (aches and pains (not muscular)), AXILLARY PAIN (Pain under arms/sides), CHILLS (Chills feeling in body) and NAUSEA (Nausea). On an unknown date, the patient experienced CYSTITIS (Bladder Infection), DYSBIOSIS (Dysbiosis), DIARRHOEA (Morning diarrhea), BLOOD GLUCOSE DECREASED (Low blood sugar symptoms), MOOD SWINGS (Mood issues), INFLAMMATION (Inflammation) and DYSPEPSIA (Not digesting sugar/fibers). At the time of the report, DYSPEPSIA (Digestive issues got aggravated), DECREASED APPETITE (Loss of appetite/Not much of appetite), FLATULENCE (Gas/Lots of gas on both ends (mouth and bottom)), ERUCTATION (Burping/Lots of gas on both ends (mouth and bottom)), ABDOMINAL PAIN UPPER (Pain in upper right quadrant of stomach/Sick to my stomach/radiating stomach pain), DEPRESSION (Mentally Depressed), ANXIETY (Anxiety), PAIN (aches and pains (not muscular)), DIARRHOEA (Morning diarrhea), MOOD SWINGS (Mood issues), DYSPEPSIA (Not digesting sugar/fibers) and AXILLARY PAIN (Pain under arms/sides) had not resolved and FEELING HOT (Warm feeling in body and mouth/ Feeling hot all over/Mouth was very hot), BREAST PAIN (Pain upper right near the breast), HYPERHIDROSIS (Sweating in the mornings), CYSTITIS (Bladder Infection), DYSBIOSIS (Dysbiosis), BLOOD GLUCOSE DECREASED (Low blood sugar symptoms), INFLAMMATION (Inflammation), CHILLS (Chills feeling in body) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received, added events and concomitant medication. On 29-Jun-2021: Follow-up received on 29-Jun-2021 and contains non significant information. On 29-Jun-2021: Significant follow-up received: Update patient demographics, Other relevant history added, new concomitant medication added, new event added