Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Oropharyngeal pain, Product dose omission issue, Swelling, Swelling face
Clinical narrative: felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot; couldn't swallow; antibodies absent; Fatigue/tiredness; Severe sore throat/not just a severe throat; Neck swelling; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt great weight and pressure on my chest) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Type 2 diabetes mellitus since an unknown date. Concurrent medical conditions included Drug allergy (allergic to medications), Allergy to animals and Perfume sensitivity. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, ESZOPICLONE (LUNESTA) for Sleep disorder NOS, GLIMEPIRIDE for Type 2 diabetes mellitus.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat), SWELLING (Neck swelling), SWELLING FACE (Facial swelling) and FATIGUE (Fatigue/tiredness). On 15-Apr-2021, the patient experienced DRUG SPECIFIC ANTIBODY (antibodies absent). On an unknown date, the patient experienced CHEST PAIN (felt great weight and pressure on my chest) (seriousness criterion hospitalization), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot) and DYSPHAGIA (couldn't swallow). The patient was hospitalized from 25-Mar-2021 to 26-Mar-2021 due to CHEST PAIN. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHEST PAIN (felt great weight and pressure on my chest) and OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat) had resolved and SWELLING (Neck swelling), SWELLING FACE (Facial swelling), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot), DYSPHAGIA (couldn't swallow), DRUG SPECIFIC ANTIBODY (antibodies absent) and FATIGUE (Fatigue/tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Antibody test: negative (Negative) states that patient does not have any antibodies.     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.   The patient's HCP advised to wait for two  more weeks to receive the second dose of vaccine.  Med Info Agent: *Crosslink with MOD21-058959, MOD21-062129, MOD21-076250, MOD21-085519* Call received from consumer who stated she had reported a previous event, but is frustrated because on the form it says if you have a problem, call us, but there is no number to call. Caller provided her address and confirmed contact information, contact information updated. The consumer stated she does not leave her house, and she does not have a fax machine, so it makes it difficult for her to send it back. The caller would like the company to know about this, but did not have any further requests. Consumer stated she will eventually have someone send it out for her. Caller stated it wasn't just a severe throat as the form mentions, she couldn't swallow, but did not elaborate. Consumer stated she is not going to get the second shot per providers direction, and stated she had no antibodies from the first dose. No further information provided.  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.  This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs.   This case was linked to MOD-2021-058039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: significant: event added On 03-May-2021: Missed dose On 20-May-2021: Significant follow-up received On 21-May-2021: VAER from uploaded; 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.  This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs.