Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis, Hypophagia, Influenza, Nausea
Clinical narrative: weight loss; lack of energy; feeling hot and then cold; perspiring or sweating; worsened asthma described as cough coming and going; Anorexia; Food not tasting good whenever eating; more pronounced lower back and knee pain and no energy when walking; shortness of breath when moving or exerting; side effects; Decreased fluid in legs; Flu; pain in stomach; cough; more pronounced lower back and knee pain and no energy when walking / Pain between shoulder blades; nausea; low grade FEVER; started running high temp 1-3 degrees above normal; Extremly tired; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss), ASTHENIA (lack of energy), FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold), HYPERHIDROSIS (perspiring or sweating) and ASTHMA (worsened asthma described as cough coming and going) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041620A and 05M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphedema (Pain worse / Swelling worse) since 2017, Allergic asthma, Immobile (immobile with two bad knees, Lower back pain and knee pain), Esophageal spasm (More frequent / stronger) since 1987, Fibromyalgia (Extremely tired) since 1999, Blood pressure (Very high) since 2003, GERD (Pain in stomach/Loss weight) since 1997, Drug allergy (Opana - Itching), Drug allergy (Hydromorphone-Itching.), Drug allergy (Darvocet- Nausea), Allergy to Morphine (Morphine-Itching), Drug allergy (Hydrocodone-Itching), Drug allergy (Tramadol- Nausea), Drug allergy (Propoxy-Itching), Drug allergy (Codeine  - spasm in esophagus), Drug allergy (Trazodone- Nausea), Drug allergy (Ambien CR- Severe depression), Drug allergy (Bethanechol- Spasms in esophagus for 5 hours.), Allergy to antibiotic (Amoxicillin - Severe reflux &Lip swelling), Allergy to antibiotic (Clarithromycin -bad diarrhea), Drug allergy (Montelukast - daily migraine headaches), Injection (omalizumab injections - spasms in esophagus / itching), Drug allergy (Theophylline- Itching), Drug allergy (Divalproex SOD Dr 250 mg - hallucinating & sleep walking (including bad fall)), Allergy to antibiotic (Minocycline - Anaphylatic reaction), Allergy to antibiotic (Clindamycin - breathing problems), Drug allergy (Cyclobenzaprine - Nausea , fast heartbeat, esophageal spasms), Drug allergy (teriparatide- Dizziness & nausea), Drug allergy (Isradipine - headache), Drug allergy (Meloxicam - Headache), Drug allergy (mirtazipine - Pain in chest), Drug allergy (Nortriptyline - Trouble breathing), Drug allergy (Topiramate - Spasms in esophagus , itching), Drug allergy (metaxalone- Irregular heartbeat , nausea , headaches), Drug allergy (Neomycin - bad diarrhea), Allergy to antibiotic (Metronidazole - bad diarrhea) and Injection (Synvisc injections in knees - Severe allergic swelling that lasted for days & less severe swelling for months very painful) since May 2009. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CANDESARTAN for Blood pressure management, LATANOPROST for Glaucoma, TAPENTADOL HYDROCHLORIDE (NUCYNTA) and TAPENTADOL HYDROCHLORIDE (NUCYNTA ER) for Pain, LEVOTHYROXINE for Thyroid disorder, RABEPRAZOLE SODIUM (RABEPRAZOLE EC), PRAMIPEXOLE, PARACETAMOL (TYLENOL), CIMETIDINE, MIRABEGRON, OXYBUTYNIN, MILK THISTLE [SILYBUM MARIANUM], COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX), VITAMIN B COMPLEX, COENZYME Q10 [UBIDECARENONE] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (weight loss), ASTHENIA (lack of energy), FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold), HYPERHIDROSIS (perspiring or sweating), ASTHMA (worsened asthma described as cough coming and going), DECREASED APPETITE (Anorexia), HYPOPHAGIA (Food not tasting good whenever eating), BACK PAIN (more pronounced lower back and knee pain and no energy when walking), DYSPNOEA (shortness of breath when moving or exerting), VACCINATION COMPLICATION (side effects), PRE-EXISTING CONDITION IMPROVED (Decreased fluid in legs), INFLUENZA (Flu), ABDOMINAL PAIN UPPER (pain in stomach), COUGH (cough), ARTHRALGIA (more pronounced lower back and knee pain and no energy when walking / Pain between shoulder blades), NAUSEA (nausea), PYREXIA (low grade FEVER; started running high temp 1-3 degrees above normal) and FATIGUE (Extremly tired). The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency and RIFAXIMIN (XIFAXAN) for Fever, at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (weight loss), ASTHENIA (lack of energy), FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold), HYPERHIDROSIS (perspiring or sweating), DECREASED APPETITE (Anorexia), HYPOPHAGIA (Food not tasting good whenever eating), BACK PAIN (more pronounced lower back and knee pain and no energy when walking), DYSPNOEA (shortness of breath when moving or exerting), VACCINATION COMPLICATION (side effects), PRE-EXISTING CONDITION IMPROVED (Decreased fluid in legs), INFLUENZA (Flu), ABDOMINAL PAIN UPPER (pain in stomach), COUGH (cough), ARTHRALGIA (more pronounced lower back and knee pain and no energy when walking / Pain between shoulder blades) and FATIGUE (Extremly tired) outcome was unknown and ASTHMA (worsened asthma described as cough coming and going), NAUSEA (nausea) and PYREXIA (low grade FEVER; started running high temp 1-3 degrees above normal) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 97.5 (normal) 97.5 degrees and 99.5 (Inconclusive) Patient had low grade temperature from 98.5 to 99.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional unspecified concomitant medications included TherTears, Tumeric, and an Allergy tablet, all administered once daily.  She was treated with an antibiotic and received two rounds of a steroid dose pack about two weeks apart for asthma symptoms. But the antibiotics caused diarrhea and had to be discontinued.   On 09-Mar-2021, the patient presented to the Emergency Room (ER) for shortness of breath, coughing, and pain between her shoulder blades. An electrocardiogram was performed without any findings. A heart attack and COVID-19 were ruled out. She was not admitted to the hospital. The ER physician told her that her symptoms were due to the second Moderna COVID-19 dose. Her asthma symptoms were noted to have improved since the ER visit.  The Ondanestron prescribed for nausea had not been working for her and at the time of the report she was supposed to start a new medicine for the nausea.   This case was linked to MOD-2021-210920.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Updated Patient Age and demographics, Race, Ethnic group . Added patient medical history and batch/lot numbers were added . Added Concomitant medications and New events added. Outcome for pyrexia, asthma, and nausea updated to not recovered/not resolved