Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Product quality issue, Sensory disturbance, Somnolence, Stress
Clinical narrative: fluid filled blister taht ruptured inside her mouth; Whitish quarter size area where another blister is forming (Iniside her mouth ); Discomfort which is mildly unpleasent ; Uncomfortable feeling in lower GI; Stomach pain; Urge to pass gas while on walk; When passed gas mucus with fecal matter passes; bowel movement in underwear; Mucus with fecal matter; "My head is swimming ''Brain swimming''; Fatigue; debilitating fatigue; Area around injection was pinkish; Lightheadness; Vaccination site pain; heart rate increased; Haemorrhoids exacerbated by constipation; Require more hydration than she needed before; pinched feeling at the base of left hand; right hand pain; Had to urinate two or three times a night; Headaches caused me to lose a night of sleep ; pulled an all-nighter / lossof sleep; more constipation ; little knobs of feces or condensed knobs of feces; Still not at baseline energy level and taht is interfering with ability to be active; More energetic; still not an baseline energy level and that is interfering with ability to be active; mind fog; Eye strain; Anxiety; Bone sprus ; knuckles have gotten knotty; stressed out; Has gotten out of shape; joint pain; one or the other knee is sore for a day and then goes away; intermittent headache; joint and muscle pain at site of old injuries; Tymlos affects my metabolic function; Grogginess; Urine is a little darker than normal, not the pale yellow color it should be; Mild lower GI issues; Product quality concern; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL DISCOMFORT (Discomfort which is mildly unpleasent ; Uncomfortable feeling in lower GI), ENERGY INCREASED (More energetic), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (still not an baseline energy level and that is interfering with ability to be active), FEELING ABNORMAL (mind fog) and ASTHENOPIA (Eye strain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ABALOPARATIDE (TYMLOS) injection for Osteoporosis.    The patient's past medical history included Fracture (Two fractures in past five years resolved) in 2016, Blood pressure decreased in 2021, Thready pulse in 2021 and Oral surgery (two years ago, patient think that that area never healed correctly) in 2019. Concurrent medical conditions included Osteoporosis since 2001, Constipation, Faecaloma (bowel (twice)), Cataract (which cause headaches during eye strain), Norovirus infection (10 years ago, Foodborne), Hemorrhoids, Bone spur, Autoimmune disorder (florid reaction/ Autoimmune condition caused by covid vaccine) and Headache (cataracts (which cause headaches during eye strain)).   On 15-Sep-2021, the patient started ABALOPARATIDE (TYMLOS) (Subcutaneous) 80 microgram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ENERGY INCREASED (More energetic), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (still not an baseline energy level and that is interfering with ability to be active), FEELING ABNORMAL (mind fog), ASTHENOPIA (Eye strain), ANXIETY (Anxiety), EXOSTOSIS (Bone sprus ; knuckles have gotten knotty), STRESS (stressed out), GENERAL PHYSICAL HEALTH DETERIORATION (Has gotten out of shape), THIRST (Require more hydration than she needed before), POLLAKIURIA (Had to urinate two or three times a night), INSOMNIA (Headaches caused me to lose a night of sleep ; pulled an all-nighter / lossof sleep), CONSTIPATION (more constipation ; little knobs of feces or condensed knobs of feces), ASTHENIA (Still not at baseline energy level and taht is interfering with ability to be active), PAIN IN EXTREMITY (pinched feeling at the base of left hand; right hand pain), METABOLIC DISORDER (Tymlos affects my metabolic function), SOMNOLENCE (Grogginess), CHROMATURIA (Urine is a little darker than normal, not the pale yellow color it should be), GASTROINTESTINAL DISORDER (Mild lower GI issues), PRODUCT QUALITY ISSUE (Product quality concern), ARTHRALGIA (joint pain; one or the other knee is sore for a day and then goes away), HEADACHE (intermittent headache) and MYALGIA (joint and muscle pain at site of old injuries). On 15-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around injection was pinkish), DIZZINESS (Lightheadness) and VACCINATION SITE PAIN (Vaccination site pain). In September 2021, the patient experienced HAEMORRHOIDS (Haemorrhoids exacerbated by constipation) and HEART RATE INCREASED (heart rate increased). On 19-Sep-2021, the patient experienced SENSORY DISTURBANCE ("My head is swimming ''Brain swimming'') and FATIGUE (Fatigue; debilitating fatigue). On 11-Oct-2021, the patient experienced FLATULENCE (Urge to pass gas while on walk), ANAL INCONTINENCE (When passed gas mucus with fecal matter passes; bowel movement in underwear) and MUCOUS STOOLS (Mucus with fecal matter). On 13-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 21-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Discomfort which is mildly unpleasent ; Uncomfortable feeling in lower GI). On 30-Nov-2021, the patient experienced ORAL MUCOSAL BLISTERING (fluid filled blister taht ruptured inside her mouth) and ORAL MUCOSAL DISCOLOURATION (Whitish quarter size area where another blister is forming (Iniside her mouth )). At the time of the report, ABDOMINAL DISCOMFORT (Discomfort which is mildly unpleasent ; Uncomfortable feeling in lower GI), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (still not an baseline energy level and that is interfering with ability to be active), FEELING ABNORMAL (mind fog), ANXIETY (Anxiety), CONSTIPATION (more constipation ; little knobs of feces or condensed knobs of feces), ASTHENIA (Still not at baseline energy level and taht is interfering with ability to be active), PAIN IN EXTREMITY (pinched feeling at the base of left hand; right hand pain), SENSORY DISTURBANCE ("My head is swimming ''Brain swimming''), SOMNOLENCE (Grogginess), GASTROINTESTINAL DISORDER (Mild lower GI issues) and DIZZINESS (Lightheadness) was resolving, ENERGY INCREASED (More energetic), PRODUCT QUALITY ISSUE (Product quality concern), VACCINATION SITE ERYTHEMA (Area around injection was pinkish) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown, ASTHENOPIA (Eye strain), EXOSTOSIS (Bone sprus ; knuckles have gotten knotty), STRESS (stressed out), GENERAL PHYSICAL HEALTH DETERIORATION (Has gotten out of shape), HAEMORRHOIDS (Haemorrhoids exacerbated by constipation), THIRST (Require more hydration than she needed before), ORAL MUCOSAL BLISTERING (fluid filled blister taht ruptured inside her mouth), ORAL MUCOSAL DISCOLOURATION (Whitish quarter size area where another blister is forming (Iniside her mouth )), POLLAKIURIA (Had to urinate two or three times a night), HEART RATE INCREASED (heart rate increased), ABDOMINAL PAIN UPPER (Stomach pain), METABOLIC DISORDER (Tymlos affects my metabolic function), CHROMATURIA (Urine is a little darker than normal, not the pale yellow color it should be), ARTHRALGIA (joint pain; one or the other knee is sore for a day and then goes away), FATIGUE (Fatigue; debilitating fatigue), HEADACHE (intermittent headache) and MYALGIA (joint and muscle pain at site of old injuries) had not resolved and INSOMNIA (Headaches caused me to lose a night of sleep ; pulled an all-nighter / lossof sleep), FLATULENCE (Urge to pass gas while on walk), ANAL INCONTINENCE (When passed gas mucus with fecal matter passes; bowel movement in underwear) and MUCOUS STOOLS (Mucus with fecal matter) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Heart rate (65-70): 100-104 (High) 100-104 during first injection. In November 2021, Heart rate (65-70): upto 90 (abnormal) upto 90 Now. On an unknown date, Blood pressure measurement: dropping after injection (Low) dropping after injection. On an unknown date, Heart rate (65-70): 80-90 (abnormal) Accelerates to 80-90 Resting Thready.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes no concomitant medications No treatment medications were reported. Patient did not think pollakiuria was due to Tymlos as she had been drinking more fluids because Tymlos affects her metabolic function.