Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Lethargy, Nausea, Pain in extremity
Clinical narrative: Lethargic; Dizziness; Nausea; Headaches; Had a sore arm; Pain at the injection side /injection site pain; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (Lethargic), DIZZINESS (Dizziness), NAUSEA (Nausea), HEADACHE (Headaches) and PAIN IN EXTREMITY (Had a sore arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient has never had COVID positive test or diagnosis.  No vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for COVID-19 vaccination: Pfizer (Dose no:1, Lot number, Dose and Date administered: unknown), Pfizer (Dose no:1, Lot number and Dose and Date administered: unknown). Past adverse reactions to the above products included Pain in extremity with Pfizer; and Vaccination site pain with Pfizer. Concurrent medical conditions included Drug allergy (Sensitivity to sulfa) and Penicillin allergy (Sensitivity to penicillin).   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced LETHARGY (Lethargic), DIZZINESS (Dizziness), NAUSEA (Nausea), HEADACHE (Headaches), PAIN IN EXTREMITY (Had a sore arm) and VACCINATION SITE PAIN (Pain at the injection side /injection site pain). The patient was treated with PARACETAMOL (TYLENOL) in August 2022 for Headache, at an unspecified dose and frequency. In August 2022, LETHARGY (Lethargic) and VACCINATION SITE PAIN (Pain at the injection side /injection site pain) had resolved. At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea), HEADACHE (Headaches) and PAIN IN EXTREMITY (Had a sore arm) had not resolved.            Concomitant medication list was not provided.  Patient received first and second boosters on unknown date in Jan 2022 and 11-Aug-2022.  The patient stated that the patient was born elsewhere, but was currently in different country. It was reported that after receiving fourth Moderna booster, patient had some long-lasting symptoms and harsh side effects that patient had not had with the first three shots. Patient had pain at the injection side was more painful than the previous shots. The nausea, headaches, and dizziness had been going on for a week. Patient reported that the fourth dose was the worst and most lingering. Patient also reported that patient was not taking any medications, so there would not be any drug interactions. Patient was nauseated to the point where patients patience was thin.  It was nagging and annoying because patient had not had this with previous doses. The patient added that the worst symptom was injection site pain and lethargy for a day.   The adverse event caused the patient to seek medical care, called doctor on 17-Aug-2022. The patient had not experienced a similar event in the past.  Treatment medication include basic home remedies to help with nausea.   This case was linked to MOD-2022-629991 (Patient Link).