Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Headache, Illness, Inappropriate schedule of product administration
Clinical narrative: Chest congestion; covid illness; Headache; Achiness; Inappropriate schedule of product administration dose 1 on 28/jul/2021 and dose 2 on 9/sept/2021; I was positive; Inappropriate route of vaccination; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration dose 1 on 28/jul/2021 and dose 2 on 9/sept/2021), CHEST DISCOMFORT (Chest congestion), COVID-19 (I was positive) and ILLNESS (covid illness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009CZ1A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to COVID-19 and Sinusitis on 01-Jul-2021. Concurrent medical conditions included Drug allergy (respiratory reaction), Iodine allergy (skin sensitivity), Drug allergy (skin sensitivity) and Asthma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression, ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). In August 2021, the patient experienced COVID-19 (I was positive). On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration dose 1 on 28/jul/2021 and dose 2 on 9/sept/2021). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest congestion), ILLNESS (covid illness), HEADACHE (Headache) and MYALGIA (Achiness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX COUGH) for Adverse event, at a dose of 1 dosage form; IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 1 dosage form. On 28-Jul-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. On 03-Sep-2021, COVID-19 (I was positive) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration dose 1 on 28/jul/2021 and dose 2 on 9/sept/2021) had resolved and CHEST DISCOMFORT (Chest congestion), ILLNESS (covid illness), HEADACHE (Headache) and MYALGIA (Achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took two doses on same day 28-JUL-2021 with in gap of 30-45 minutes as vaccine was given with a wrong needle .   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Significant Follow-up received in which patient demographic details were added. Medical History information is added. Product dosage information is added. Event is added.; Sender's Comments: This case of inappropriate schedule of product administration and inappropriate route of vaccination concerns a 63-year-old, female patient with a recent previous exposure to SARS-CoV-2 history, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred approximately six days after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was negative as patient experienced the event after dose 1, resolved prior to dose 2, with no occurrence of the same event after the last dose. The patient's previous exposure to SARS-CoV-2 (the weekend before being vaccinated) and negative rechallenge remains as a relevant confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.