Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Gingival swelling, Headache, Laryngoscopy
Clinical narrative: Difficulty breathing; Diarrhea; Swelling under tooth line on soft tissue; May have been a blocked salivary duct or swollen lymph nodes; Latest swelling she experienced  hit her like a brick; Second dose not received; Chills; Nausea; Difficulty swallowing; Dizziness; Neck and clavicle swelling/concerned about the Carotid artery due to swelling in that area; Irregular heart rate/palpitations; Chest tightness; Fatigue; Vaccination site pain; Headache; Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck; Pain in her face; Sore throat; Fever/temp fluctuated between 98.6 and 100.9; Sore arm; Got very cold; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FACIAL PAIN (Pain in her face), SWELLING FACE (Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck), DYSPHAGIA (Difficulty swallowing) and DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Numbness in fingers, Pneumonia, Headache and Root canal procedure. Previously administered products included for Influenza immunisation: Flu shot (The patient described flu-like symptoms and reported that patient was chronically ill with colds, several bouts of bronchitis, one bout of pneumonia for a total of 9 months and never had another flu shot until approx. 15 years later. My allergist gave it in 3 doses, then for several years two doses, then 1 dose, then back to 2 doses. Reactions were numbness and tingling in fingers and arm, severe headaches. I must pre and post medicate with one dose Zyrtec 2 days prior, the day of the shot with Zyrtec in the AM and in the PM plus Tylenol ½ hr. prior to the shot and then 1 dose Zyrtec the following two days.) in October 2011; for Hypothyroidism: Armor thyroid (For 6-8 years) and Synthroid (For 12 years). Past adverse reactions to the above products included Flu like symptoms with Flu shot; No adverse event with Armor thyroid; and No adverse reaction with Synthroid. Concurrent medical conditions included Pollen allergy, Allergy to vaccine (Flu-like symptoms) since October 2011, Drug allergy (My first root canal I had many doses of Novocain which didn't numb me totally. Afterward I had facial swelling on the left side of my face which came and went spontaneously, often completely closing my left eye. It lasted approx. 1 month.), Contrast media allergy (Red Rash all over), Drug allergy (Dark thoughts), Shellfish allergy (Allergic to Bivalve shellfish. Caused Diarrhea), Drug allergy (Allergic to Lisinopril), Drug allergy (Allergic to Zofran Anaphylaxis reaction), Allergy to antibiotic (Allergic to Erythromycin), Drug allergy (Allergic to Celexa), Drug allergy (Allergic to Prednisone. Caused Rash), Drug allergy (Allergic to Advair. Caused Itchy rash), Allergy to antibiotic (Allergic to Augmentin-Diarrhea), Milk allergy (From age 7. Hives in mouth; lactose intolerant since my 40s. This includes milk in liquid form or soft cheeses only: i.e. milk, milk shakes, ice cream, cottage cheese, pudding etc.), Hereditary leiomyomatosis renal cell carcinoma, Irritable bowel syndrome, Hypothyroidism, Cataract, Adhesive tape allergy (Allergy to Bandage adhesive. Caused Blisters), Allergy to antibiotic (Allergic to Antibiotic cream. Caused Blisters and rash) and Contrast media allergy (Allergic to MRI Contrast. Caused Anaphylaxis). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for Hypothyroidism, VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and PARACETAMOL (TYLENOL) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING COLD (Got very cold). On 18-Feb-2021, the patient experienced MYALGIA (Sore arm). On 16-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever/temp fluctuated between 98.6 and 100.9). On 26-Mar-2021, the patient experienced FACIAL PAIN (Pain in her face). On 08-Apr-2021, the patient experienced SWELLING FACE (Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck). On an unknown date, the patient experienced DYSPHAGIA (Difficulty swallowing), DIZZINESS (Dizziness), SWELLING (Neck and clavicle swelling/concerned about the Carotid artery due to swelling in that area), PALPITATIONS (Irregular heart rate/palpitations), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), GINGIVAL SWELLING (Swelling under tooth line on soft tissue), LYMPHADENOPATHY (May have been a blocked salivary duct or swollen lymph nodes), FEELING ABNORMAL (Latest swelling she experienced  hit her like a brick), PRODUCT DOSE OMISSION ISSUE (Second dose not received), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache). The patient was treated with CLINDAMYCIN for Swelling, at a dose of 300 mg and IBUPROFEN (ADVILMED) at a dose of 1 dosage form. On 23-May-2021, PYREXIA (Fever/temp fluctuated between 98.6 and 100.9) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FACIAL PAIN (Pain in her face), SWELLING FACE (Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck), DYSPHAGIA (Difficulty swallowing), DIZZINESS (Dizziness), SWELLING (Neck and clavicle swelling/concerned about the Carotid artery due to swelling in that area), PALPITATIONS (Irregular heart rate/palpitations), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), GINGIVAL SWELLING (Swelling under tooth line on soft tissue), LYMPHADENOPATHY (May have been a blocked salivary duct or swollen lymph nodes), FEELING ABNORMAL (Latest swelling she experienced  hit her like a brick), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Sore arm) and HEADACHE (Headache) had not resolved, FEELING COLD (Got very cold) had resolved and PRODUCT DOSE OMISSION ISSUE (Second dose not received), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 30-Mar-2021, Computerised tomogram: negative (Negative) negative. On 30-Mar-2021, X-ray: abnormal (abnormal) definite swelling.  Nasal passages were clear.. On 21-Apr-2021, Laryngoscopy: normal (normal) normal Nasal passages  throat and vocal cords were fine.  Liquid from salivary glands clear. On an unknown date, Body temperature: 98.6 - 100.9 (abnormal) 98.6 - 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient visited Dentist, EENT, endodontist, and physician to rule out the blocked salivary duct, swelling in face neck and clavicular area and was also concerned about the carotid artery. Due to swelling in that area patient had difficulty in breathing, swallowing, and choking at times. Patient also visited their ophthalmologist because swelling has affected their eyes and for their cataract surgery which was postponed for two months because of swelling.  The patient also reported that before receiving any vaccine they took medication to overcome its effects but in case of mRNA1273 they did not take any medication prior to shot.  On 21-July-2021, the patient reported that 5 months after the first vaccine, the patient still experiencing the side effect and reported that they consulted with an EENT specialist who did a scope of their nasal passages and vocal cords and the result was normal. The patient also reported that the swelling on the left side of their face occasionally goes up to their forehead down to their shoulders and still comes and goes. On 14-Jun-2021, the patient had an MRI as a regular follow up for a hereditary condition (hereditary leiomyoma and after that patient had another bout of facial swelling which they experienced on 21-Jul-2021. The patient also had headache and difficulty in swallowing.  The patient also informed that on 31-May-2021 performed lab test for COVID antibodies and on 03-Jun-2021 had the results. At the laboratory the patient was told that the results from the antibodies were from their previous COVID-19 infection on late December 2019 and not from the vaccination on February. In addition, the patient also mentioned the patient still didn't receive the second shot of the vaccine, because of the ongoing reaction.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up was received and added new events. Updated the description of the event in the I-narrative.; Sender's Comments: Company comment:  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for the events of Chills, Pain in extremity and Fatigue. The other listed events started over thirty days after the vaccination and thus are unlikely related.