Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site swelling, Malaise, Pain in extremity, Sinusitis
Clinical narrative: eye infection; I had a Sinus infection; Patient just felt like someone had put their weight on her and literally sucked out what little energy patient had; Patient got sick; had a little sore arm,; was exhausted/I just felt like someone had put their weight on me and literally sucked out what little energy I had/very tired; Swelling on injection site; COVID/Eventually on a Cruise ship they got COVID disease; This spontaneous case was reported by a nurse and describes the occurrence of EYE INFECTION (eye infection), SINUSITIS (I had a Sinus infection), ASTHENIA (Patient just felt like someone had put their weight on her and literally sucked out what little energy patient had), ILLNESS (Patient got sick) and PAIN IN EXTREMITY (had a little sore arm,) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Detachment retinal, Glaucoma, Dry eyes, GI upset, Nervous system disorder, Adverse reaction, Sickness and Clinical trial participant. Previously administered products included for Product used for unknown indication: Astrazeneca Vaccine (OCT-NOV2020 and 2 doses) in 2020; for Drug use for unknown indication: PLAVIX. Past adverse reactions to the above products included Allergy with PLAVIX; and No adverse event with Astrazeneca Vaccine. Concurrent medical conditions included Milk allergy, Binswanger's disease, Drug allergy, Pollen allergy, Ragweed allergy and Stroke (Had a stroke last summer).    On 06-Sep-2022, the patient received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE INFECTION (eye infection), SINUSITIS (I had a Sinus infection), ASTHENIA (Patient just felt like someone had put their weight on her and literally sucked out what little energy patient had), ILLNESS (Patient got sick), PAIN IN EXTREMITY (had a little sore arm,), FATIGUE (was exhausted/I just felt like someone had put their weight on me and literally sucked out what little energy I had/very tired), VACCINATION SITE SWELLING (Swelling on injection site) and COVID-19 (COVID/Eventually on a Cruise ship they got COVID disease). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, EYE INFECTION (eye infection), SINUSITIS (I had a Sinus infection), ASTHENIA (Patient just felt like someone had put their weight on her and literally sucked out what little energy patient had) and ILLNESS (Patient got sick) outcome was unknown and PAIN IN EXTREMITY (had a little sore arm,), FATIGUE (was exhausted/I just felt like someone had put their weight on me and literally sucked out what little energy I had/very tired), VACCINATION SITE SWELLING (Swelling on injection site) and COVID-19 (COVID/Eventually on a Cruise ship they got COVID disease) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered FATIGUE (was exhausted/I just felt like someone had put their weight on me and literally sucked out what little energy I had/very tired) to have an unknown relationship. No further causality assessments were provided for EYE INFECTION (eye infection), SINUSITIS (I had a Sinus infection), ASTHENIA (Patient just felt like someone had put their weight on her and literally sucked out what little energy patient had), ILLNESS (Patient got sick), PAIN IN EXTREMITY (had a little sore arm,), VACCINATION SITE SWELLING (Swelling on injection site) and COVID-19 (COVID/Eventually on a Cruise ship they got COVID disease).    Concomitant medication details not reported by the reporter. Patient was on oral antibiotics. She continued the Doxycycline twice a day for the next month, and then patient had to have surgery on her eyes. She was finishing a 30-day supply and she was getting another 30 days supply, before surgery. She talked to the pharmacist, and they like patient to be off antibiotics for two weeks before she got the vaccine. Patient and her husband received 2 doses of Astra Zeneca COVID-19 vaccine, at the time they were not unblinded so they went a head and received Moderna COVID-19 vaccines. She doesn't know if the tiredness was due to COVID Disease or her Neurological condition, Binswanger Disease.   This case was linked to US-MODERNATX, INC.-MOD-2023-729751, US-MODERNATX, INC.-MOD-2023-729758, US-MODERNATX, INC.-MOD-2023-729726 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2023: Medical history updated. Event outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729751:Monovalent Product of Wife's case US-MODERNATX, INC.-MOD-2023-729758:Monovalent Product of Husband's case US-MODERNATX, INC.-MOD-2023-729726:Other Patient case