Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hypersomnia, Hypokinesia, Illness, Muscle spasms
Clinical narrative: chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitations; extreme PMS; Diarrhea; Fatigue; sleeping on and off all day; shakes; trouble moving and walking; terrible cramping like menstruation; bloated; had a painful stomach; pain moved to the chest area; body aches; chest pain; body pain; lung congestion; so much muscle pain - Muscle pain throughout the body was intense; sick; Muscle pain; fever; Nausea; Headache; chills; Fatigue/ extreme fatigue; shortness of breath; Weakness in her body, muscle and legs; Intense pain; Sore throat; Shaking; Diarrhea; Dizziness; severe stomach cramps - PMS type; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lung congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date, Bronchitis, Hives since an unknown date, Hypersensitivity reaction since an unknown date, Irritable bowel syndrome in 2000 and Reflux esophagitis. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Irritable bowel syndrome, Penicillin allergy (penicillin allergy), Drug allergy (arestin), Allergy to antibiotic (allergy to macrolides) and Allergy to antibiotic (ketolides used for red rashes). Concomitant products included ERYTHROMYCIN, DENOSUMAB (PROLIA), ARTHROBENE PLUS, VITAMIN D3 and DOXYCYCLINE HYCLATE for an unknown indication.    On 07-Mar-2021 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), the first episode of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced ILLNESS (sick) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense). On 12-May-2021, the patient experienced PULMONARY CONGESTION (lung congestion) (seriousness criterion medically significant). On 24-May-2021, the patient experienced CHEST PAIN (chest pain) and PAIN (body pain). On 08-Jun-2021, the patient experienced MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL DISTENSION (bloated), ABDOMINAL PAIN UPPER (had a painful stomach), CHEST PAIN (pain moved to the chest area), TREMOR (shakes), HYPOKINESIA (trouble moving and walking) and MYALGIA (body aches). On 09-Jun-2021, the patient experienced HYPERSOMNIA (sleeping on and off all day), the second episode of DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations) and HEART RATE IRREGULAR (irregular heart rate/palpitations). The patient was treated with PARACETAMOL (TYLENOL) on 28-Mar-2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 08-Jun-2021 at a dose of 500 mg; ARNICA MONTANA (ARNICA 30C) at a dose of 2 Tablets; MAGNESIUM at a dose of 500 mg four times per day; LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing from 09-Jun-2021 for Diarrhea, at a dose of 2 mg as required and CHLORPHENAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (ALLERGY RELIEF MEDICINE) ongoing since an unknown date at a dose of 180 mg once a day. On 18-Mar-2021, DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), DIZZINESS (Dizziness), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved, ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type) had not resolved. At the time of the report, PULMONARY CONGESTION (lung congestion), ILLNESS (sick), ABDOMINAL DISTENSION (bloated), CHEST PAIN (pain moved to the chest area), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness), TREMOR (shakes), HYPOKINESIA (trouble moving and walking), HYPERSOMNIA (sleeping on and off all day), PAIN (body pain), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations), HEART RATE IRREGULAR (irregular heart rate/palpitations), FATIGUE (Fatigue), MYALGIA (body aches) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense) outcome was unknown and MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL PAIN UPPER (had a painful stomach) and the last episode of DIARRHOEA (Diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/75 mmhg (High) 193/75 mmHg. On 17-Mar-2021, Body temperature: 98.8 degree celsius (Inconclusive) 98.8 degree Celsius. On 17-Mar-2021, Heart rate: 60 breaths per minute (Low) 60 breaths per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 2 papaya chewable tabs for stomach.  The patient is taking allergy 10 -plus, refresh lubricant eye drops, refresh optive advanced eyedrops every 2-3 hours as needed for both eyes, trace mineral drops -8 drops(3-4 water bottles per day).  Company Comment: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and  treatment are required for further assessment. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Concomitant medication Prolia, Treatment medication Arnica tablets were added. New events severe stomach cramps - PMS type, extreme fatigue, too sick, so much muscle pain - Muscle pain throughout the body was intense were added. On 10-May-2021: Reporter's FAX number was added. On 10-Jun-2021: Treatment medication Imodium and Magnesium were added. New events were added. On 23-Jun-2021: Outcome, FAX number updated On 01-Jul-2021: event added, lab data, medical history, con-med added; Sender's Comments: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and  treatment are required for further assessment. Further information has been requested.