Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia, Oropharyngeal discomfort, Throat irritation, Throat tightness
Clinical narrative: Itching throat; Light headed; Felt throat closing/Sensation of throat closing; Coughing; Abdominal cramping; Red/itchy eyes; Red/itchy eyes; Nausea; Chills; Vomiting; Feel like crap; Left arm weakness; Hypersersitiver to other allergies; Still feel tired and rundown; had an allergic reaction; Weird feeling in throat; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), THROAT IRRITATION (Itching throat) and DIZZINESS (Light headed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Bipolar disorder since October 2002, Thyroid disorder NOS, Premature ventricular contractions, Allergy to vaccine (Extensive history of allergic reactions to vaccines: flu vaccine, pneumonia shot, and tetanus shot (about 1993), Rash, cough gets really bad, itching, Have tried nasal shots .), Hypersensitivity reaction (Very long history), Hives and Anaphylaxis. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE and TOPIRAMATE for Bipolar disorder, METOPROLOL for Premature ventricular contractions, LEVOTHYROXINE for Thyroid disorder NOS, CLONAZEPAM and BUPROPION HCL for an unknown indication.    On 18-May-2021 at 1:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-May-2021, the patient experienced THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing) (seriousness criterion hospitalization), COUGH (Coughing) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal cramping) (seriousness criterion hospitalization), EYE PRURITUS (Red/itchy eyes) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red/itchy eyes) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), DIZZINESS (Light headed) (seriousness criterion hospitalization) and OROPHARYNGEAL DISCOMFORT (Weird feeling in throat). On 18-May-2021 at 2:00 PM, the patient experienced THROAT IRRITATION (Itching throat) (seriousness criterion hospitalization) and ALLERGY TO VACCINE (had an allergic reaction). On an unknown date, the patient experienced FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness), HYPERSENSITIVITY (Hypersersitiver to other allergies) and FATIGUE (Still feel tired and rundown). The patient was hospitalized from 18-May-2021 to 18-May-2021 due to ABDOMINAL PAIN, CHILLS, COUGH, DIZZINESS, EYE PRURITUS, NAUSEA, OCULAR HYPERAEMIA, THROAT IRRITATION, THROAT TIGHTNESS and VOMITING. The patient was treated with EPINEPHRINE 18-May-2021 for Adverse event, at a dose of 0.3 milligram, right upper leg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 18-May-2021 for Adverse event, at a dose of 25 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) on 18-May-2021 for Adverse event, at a dose of 50 milligram and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intravenous) 18-May-2021 for Adverse event, at a dose of Long acting. On 18-May-2021, THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), DIZZINESS (Light headed) and OROPHARYNGEAL DISCOMFORT (Weird feeling in throat) had resolved with sequelae. On 18-May-2021 at 4:25 PM, THROAT IRRITATION (Itching throat) and ALLERGY TO VACCINE (had an allergic reaction) had resolved with sequelae. At the time of the report, FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness) and HYPERSENSITIVITY (Hypersersitiver to other allergies) outcome was unknown and FATIGUE (Still feel tired and rundown) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), THROAT IRRITATION (Itching throat), DIZZINESS (Light headed), OROPHARYNGEAL DISCOMFORT (Weird feeling in throat), ALLERGY TO VACCINE (had an allergic reaction) and HYPERSENSITIVITY (Hypersersitiver to other allergies) to be possibly related. No further causality assessments were provided for FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness) and FATIGUE (Still feel tired and rundown).    The patient had additional events to Flu and pneumonia vaccine like itching, the patient also tried nasal, shots.   The residual effects included left arm weakness, continued Premature ventricular contractions (PVCs) for four days and still had hypersensitivity to other allergies 29 Jun 2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It was reported since patient won't  be getting the second shot, or one for the variant If there is one. She kept wearing mask and had never stop. But she also did not know abut the protection at all.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01 JUL 2021. Patient demographic (pregnancy, height, weight, race), Allergic history (Hypersensitivity reaction, Hives, Anaphylactic reaction.), Concomitant medication(Bupropion, Clonazepam),  Event details ( Throat tightness, Vomiting, Chills, Nausea, Fatigue, Intentional product use issue, Feeling abnormal, Dizziness, Ocular hyperaemia, Eye pruritus, Abdominal pain, Cough), Hospitalization details, event outcome were updated. On 13-Jul-2021: Live follow up received on 13 JUL 2021. no new information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.