Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Hyperhidrosis, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Nasal Congestion  after the Bivalent Booster; Pain all over the body after the Bivalent Booster; Burning in eyes after the Bivalent Booster/Burning in the eyes when trying to watch TV or read a book, after the Bivalent Booster; No appetite after the Bivalent Booster; Aches  all over the body after the Bivalent Booster; Strong Headaches after the Bivalent Booster; Weak voice after the Bivalent Booster; General weakness 50% better after the Bivalent Booster; Sweating continues on and off after the Bivalent Booster; Fever 103F after the Bivalent Booster; Shivers after the Bivalent Booster; Weakness after the Bivalent Booster; Throat hurting after the Bivalent Booster; Not able to go to work after the Bivalent Booster/"Headache does not give me clarity to read and understand" after the Bivalent Booster; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness after the Bivalent Booster), OROPHARYNGEAL PAIN (Throat hurting after the Bivalent Booster), NASAL CONGESTION (Nasal Congestion  after the Bivalent Booster), PAIN (Pain all over the body after the Bivalent Booster) and EYE IRRITATION (Burning in eyes after the Bivalent Booster/Burning in the eyes when trying to watch TV or read a book, after the Bivalent Booster) in a 68-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.     Concurrent medical conditions included Diabetes (for the past 2 years and it is being controlled with diet and exercise) and Hypertension (for the past 30 years). Concomitant products included LISINOPRIL (ZESTRIL) for Hypertension.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to go to work after the Bivalent Booster/"Headache does not give me clarity to read and understand" after the Bivalent Booster). On 05-Nov-2022, the patient experienced ASTHENIA (Weakness after the Bivalent Booster), OROPHARYNGEAL PAIN (Throat hurting after the Bivalent Booster), PYREXIA (Fever 103F after the Bivalent Booster) and CHILLS (Shivers after the Bivalent Booster). On 08-Nov-2022, the patient experienced DYSPHONIA (Weak voice after the Bivalent Booster), ASTHENIA (General weakness 50% better after the Bivalent Booster) and HYPERHIDROSIS (Sweating continues on and off after the Bivalent Booster). On 09-Nov-2022, the patient experienced NASAL CONGESTION (Nasal Congestion  after the Bivalent Booster), EYE IRRITATION (Burning in eyes after the Bivalent Booster/Burning in the eyes when trying to watch TV or read a book, after the Bivalent Booster), DECREASED APPETITE (No appetite after the Bivalent Booster) and HEADACHE (Strong Headaches after the Bivalent Booster). 09-Nov-2022, the patient experienced PAIN (Pain all over the body after the Bivalent Booster) and MYALGIA (Aches  all over the body after the Bivalent Booster). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 81 milligram. On 06-Nov-2022, ASTHENIA (Weakness after the Bivalent Booster), OROPHARYNGEAL PAIN (Throat hurting after the Bivalent Booster), PYREXIA (Fever 103F after the Bivalent Booster) and CHILLS (Shivers after the Bivalent Booster) had resolved. At the time of the report, NASAL CONGESTION (Nasal Congestion  after the Bivalent Booster), PAIN (Pain all over the body after the Bivalent Booster), EYE IRRITATION (Burning in eyes after the Bivalent Booster/Burning in the eyes when trying to watch TV or read a book, after the Bivalent Booster), DECREASED APPETITE (No appetite after the Bivalent Booster), DYSPHONIA (Weak voice after the Bivalent Booster), HYPERHIDROSIS (Sweating continues on and off after the Bivalent Booster), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to go to work after the Bivalent Booster/"Headache does not give me clarity to read and understand" after the Bivalent Booster), MYALGIA (Aches  all over the body after the Bivalent Booster) and HEADACHE (Strong Headaches after the Bivalent Booster) outcome was unknown and ASTHENIA (General weakness 50% better after the Bivalent Booster) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2022, Body temperature: 103 F. In November 2022, SARS-CoV-2 test: Negative.         Bivalent booster dose batch no. was reported as 015422A or 015H22A. It was reported that patient had first Primary monovalent dose on 04-May-2021, Lot no. 003C21A, 2nd Primary monovalent dose on 01-Jun-2021, Lot no. 049C21A and monovalent booster dose on 03-JAN-2022 (Lot no. P13H21B or 013H21B It was reported that patient had shivering continued on and off on 08-Nov-2022. Patient reported she drank fluids. It was reported that the doctor had prescribed, fluids and rest and over the counter fever medications. Patient treatment medications also included Glucose tablets.   This case was linked to MOD-2022-670195, MOD-2022-670217, MOD-2022-670195 (Patient Link).