Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Weakness; More severe headaches; Nausea; Tremendous pain/ Lot of pain due to the towel being on her/ She thought she was in "sheer agony"; Delirium/ She thought that she had a towel over her feet, legs, arms, and chest/ out of my mind; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium/ She thought that she had a towel over her feet, legs, arms, and chest/ out of my mind) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 041L20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve disease NOS (Diagnosed about 15 years ago) and Mitral valve replacement (Mechanical heart valve 15 years ago, Stable). Concurrent medical conditions included Drug allergy (Some Beta blockers), Diabetes, Glaucoma, Cholesterol and Blood pressure. Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure abnormal, METOPROLOL SUCCINATE for Cardiac disorder, SIMVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Aug-2021, received third 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) .5 milliliter. In August 2021, the patient experienced DELIRIUM (Delirium/ She thought that she had a towel over her feet, legs, arms, and chest/ out of my mind) (seriousness criterion medically significant) and PAIN (Tremendous pain/ Lot of pain due to the towel being on her/ She thought she was in "sheer agony"). On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weakness), HEADACHE (More severe headaches) and NAUSEA (Nausea). In August 2021, DELIRIUM (Delirium/ She thought that she had a towel over her feet, legs, arms, and chest/ out of my mind) had resolved. On 25-Aug-2021, ASTHENIA (Weakness), HEADACHE (More severe headaches) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN (Tremendous pain/ Lot of pain due to the towel being on her/ She thought she was in "sheer agony") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that having experienced severe side effects after the 1st two doses, patient asked the nurse if there was anything she could do to alleviate any symptoms after her 1st booster dose. The nurse told the patient to hydrate herself before receiving the vaccination, however the patient reported that it didn't help her, and the side effects were even a little worse with the 1st booster dose of Moderna. Patient thought she was in "sheer agony" and that she had a towel over her feet, legs, arms, and chest. The only places she didn't have the towel on was her face and head. She called her sister to come and take the towel off of her, because she was in a lot of pain due to the towel being on her. However, when her sister arrived, she saw that caller was somewhat "out of my mind" and there were no towels on her. The delirium lasted for about 6-7 hours. The patient reported that she did mention the reactions to her HCPs (Cardiologist and Internist). However, they could not help the patient in making a decision about the 2nd booster. Patient wants to take the 2nd booster due to her pre-existing conditions and health. Patient was extremely scared with what she had experienced after all doses of the Moderna vaccine. It was reported that the patient had some slate work done on her back and she was in tremendous pain.  "Experience was really scary",since this is the way that the patient is describing her experienced towards the adverse events.  No treatment information was reported. Patient was on Blood thinners after the surgery for the mechanical heart valve. Patient also had cholesterol, heart and blood pressure issues. Patient had an increased chance of getting serious infections for even smaller infections like sinus. Patient did not have an history of taking any drugs or smoking.   This case was linked to MOD-2022-540133, MOD-2022-540288 (Patient Link).  Company Comment:This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Delirium (described as patient thought that she had a towel over her feet, legs, arms, and chest and getting out of her mind), which occurred on the same month after receiving the booster dose of mRNA-1273 vaccine. Patient received 2 previous doses of Moderna COVID-19 vaccine with the 1st dose administered approximately 7 months prior to the booster dose of mRNA-1273 vaccine. Patient reported that couple of hours after receiving the first dose of Moderna CoVID-19 vaccine, she started experiencing headache which lasted for 4 days, then she experienced even more severe headaches and nausea with the 2nd dose. She noticed the headache got worse if she moved her head up and down. After receiving the booster dose of mRNA-1273 vaccine, patient experienced more severe headaches, weakness, and nausea that lasted for 4 days. Patient also experienced delirium lasted for about 6-7 hours and tremendous pain, which the patient thought she was in "sheer agony" and had a towel over her feet, legs, arms, and chest that causing a lot of pain. No further details about the diagnostic procedures and treatments were provided. At the time of report, the event Delirium was resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Delirium (described as patient thought that she had a towel over her feet, legs, arms, and chest and getting out of her mind), which occurred on the same month after receiving the booster dose of mRNA-1273 vaccine. Patient received 2 previous doses of Moderna COVID-19 vaccine with the 1st dose administered approximately 7 months prior to the booster dose of mRNA-1273 vaccine. Patient reported that couple of hours after receiving the first dose of Moderna CoVID-19 vaccine, she started experiencing headache which lasted for 4 days, then she experienced even more severe headaches and nausea with the 2nd dose. She noticed the headache got worse if she moved her head up and down. After receiving the booster dose of mRNA-1273 vaccine, patient experienced more severe headaches, weakness, and nausea that lasted for 4 days. Patient also experienced delirium lasted for about 6-7 hours and tremendous pain, which the patient thought she was in "sheer agony" and had a towel over her feet, legs, arms, and chest that causing a lot of pain. No further details about the diagnostic procedures and treatments were provided. At the time of report, the event Delirium was resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.