Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Computerised tomogram thorax, Dizziness, Electrocardiogram, Flushing
Clinical narrative: His blood pressure continued to increase/elevated bp/He took his blood pressure measuring at 204/93 at 95bpm; continues to feel a little uneasy on his feet/ He felt unsteady on feet; uneasy stomach; He was diagnosed with "an extra heart beat" (PAC); dry heaves turned into vomiting / had the dry heaves again; Later that day the dry heaves turned into vomiting and the room was spinning/the spinning sensation he was experiencing/he continues to feel dizzy with any sudden moves including turning his head; He also had some mild lightheadedness and felt a little flushed after the second shot; He also had some mild lightheadedness and felt a little flushed after the second shot; dry heaves turned into vomiting; Starting 8FEB2023 he had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach; Starting 8FEB2023 he had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (His blood pressure continued to increase/elevated bp/He took his blood pressure measuring at 204/93 at 95bpm) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Previously administered products included for Product used for unknown indication: Influenza shot.. Past adverse reactions to the above products included No adverse event with Influenza shot. Concomitant products included LOSARTAN for an unknown indication.    On 06-Feb-2023 at 1:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023, the patient experienced DIZZINESS (Starting 8FEB2023 he had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach) and COLD SWEAT (Starting 8FEB2023 he had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach). On an unknown date, the patient experienced HYPERTENSION (His blood pressure continued to increase/elevated bp/He took his blood pressure measuring at 204/93 at 95bpm) (seriousness criterion hospitalization), LIMB DISCOMFORT (continues to feel a little uneasy on his feet/ He felt unsteady on feet), ABDOMINAL DISCOMFORT (uneasy stomach), SUPRAVENTRICULAR EXTRASYSTOLES (He was diagnosed with "an extra heart beat" (PAC)), RETCHING (dry heaves turned into vomiting / had the dry heaves again), VOMITING (dry heaves turned into vomiting), VERTIGO (Later that day the dry heaves turned into vomiting and the room was spinning/the spinning sensation he was experiencing/he continues to feel dizzy with any sudden moves including turning his head), DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot) and FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot). The patient was hospitalized from 09-Feb-2023 to 11-Feb-2023 due to HYPERTENSION. The patient was treated with MECLOZINE (MECLIZINE [MECLOZINE]) for Spinning sensation, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (His blood pressure continued to increase/elevated bp/He took his blood pressure measuring at 204/93 at 95bpm), DIZZINESS (Starting 8FEB2023 he had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach), COLD SWEAT (Starting 8FEB2023 he had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach), RETCHING (dry heaves turned into vomiting / had the dry heaves again), VOMITING (dry heaves turned into vomiting), VERTIGO (Later that day the dry heaves turned into vomiting and the room was spinning/the spinning sensation he was experiencing/he continues to feel dizzy with any sudden moves including turning his head), DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot) and FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) was resolving and LIMB DISCOMFORT (continues to feel a little uneasy on his feet/ He felt unsteady on feet), ABDOMINAL DISCOMFORT (uneasy stomach) and SUPRAVENTRICULAR EXTRASYSTOLES (He was diagnosed with "an extra heart beat" (PAC)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2023, Blood pressure measurement: 204/93. On 08-Feb-2023, Heart rate: 95 heart beats per minute. On 09-Feb-2023, Blood pressure measurement: Patient blood pressure continued to increase and patient was transferred to hospital at approximately 4:00 PM on 9-FEB-2023. On 09-Feb-2023, Blood test: Patient went to the ER (9-FEB-2023). Patient received testing including a blood workup, EKG, CT scan. On 09-Feb-2023, Computerised tomogram: Patient went to the ER (9-FEB-2023). Patient received testing including a blood workup, EKG, CT scan. On 09-Feb-2023, Electrocardiogram: Patient went to the ER  (9FEB2023). patient received testing including a blood workup, EKG, CT scan. On 10-Feb-2023, Blood pressure measurement: Patient was admitted around 10:00 PM on 9-FEB-2023 with an elevated BP and On 10-FEB-2023, blood pressure went down to 80 / 62 and at a minimum of 72 systolic. On 10-Feb-2023, Computerised tomogram thorax: They did more tests and scans including chest CT, EKG, and MRIs as Patient had a history of stroke from 2001. Patient was diagnosed with "an extra heart beat" (PAC). On 11-FEB-2023 they took a detailed MRI to look for any new strokes which was negative. On 10-Feb-2023, Electrocardiogram: They did more tests and scans including chest CT, EKG, and MRIs as Patient had a history of stroke from 2001. Patient was diagnosed with "an extra heart beat" (PAC). On 11-FEB-2023 they took a detailed MRI to look for any new strokes which was negative. On 11-Feb-2023, Blood culture: Negative. On 11-Feb-2023, Blood pressure measurement: 128/70. On 11-Feb-2023, Magnetic resonance imaging: Negative. On 11-Feb-2023, SARS-CoV-2 test: Negative. On 11-Feb-2023, Urine analysis: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 11-Feb-2021, the patient received first dose of Moderna monovalent vaccine of batch number 030M20A. On 11-Mar-2021, the patient received second dose of Moderna monovalent vaccine of batch number 026A21A. On 18-Nov-2021, the patient received third booster dose of Moderna monovalent vaccine of batch number 069F21A. On 18-Aug-2022, the patient received fourth booster dose of Moderna monovalent vaccine of batch number 011B22A.  Starting 8-FEB-2023, patient had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach. Patient took his blood pressure. Later that day the dry heaves turned into vomiting and the room was spinning. Patient toughed it out through the night and on 9-FEB-2023. Patient called the facility who recommended patient go to the emergency room. Patient took blood pressure that morning like he does daily. Patient took a sip of water then had the dry heaves again. Patient then went to the ER (9-FEB-2023). Patient received testing and they injected something to calm the stomach. Normally patient takes losartan in the morning, which hadn't been able to take because of the vomiting but they gave patient that medication. Patient blood pressure continued to increase and was transferred to the hospital at approximately 4:00 PM on 9-FEB-2023. Upon arrival they repeated many of the same tests. Patient was admitted around 10:00 PM on 9-FEB-2023 with an elevated BP.Patient was given meclizine to stop the spinning sensation that patient was experiencing. They did more tests as patient has a history of stroke from 2001. Patient was diagnosed with "an extra heartbeat" (PAC). Patient felt unsteady on feet at discharge on 11-FEB-2023 at approximately 1:30 PM or 2:30 PM.Today was the first day the spinning has completely stopped, But patient continues to feel dizzy with any sudden moves including turning his head. Patient also continues to feel a little uneasy on feet. Patient never had fever following any of these doses.     This case was linked to MOD-2023-712025 (Patient Link).  company comment-This spontaneous case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the unexpected serious (hospitalization) event of Hypertension, unexpected non-serious AESI of Supraventricular extrasystoles that occurred in context with the fifth dose of mRNA-1273.222 (Original/Omicron BA.4/5) in covid-19 vaccination series. about 2 days after the vaccination patient had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach. His blood pressure measuring at 204/93 at 95bpm. Later that day the dry heaves turned into vomiting. Next day he went to emergency, received testing including a blood workup, EKG, CT scan and they injected something to calm the stomach. Normally he takes losartan in the morning, which hadn't been able to take because of the vomiting, but they gave patient that medication. Patient blood pressure continued to increase and was transferred to the hospital. Upon arrival they repeated many of the same tests including blood samples, EKG, CT scan, and MRI and was admitted with an elevated BP. Next day blood pressure went down to 80/62 and at a minimum of 72 systolic. Meclizine given to stop the spinning sensation. more tests of chest CT, EKG, and MRIs as he has a history of stroke from 2001. Patient was diagnosed with "an extra heartbeat" (PAC). Next day they took a detailed MRI to look for any new strokes which was negative, he was discharged. But patient continues to feel dizzy with any sudden moves including turning his head. Patient also continues to feel a little uneasy on feet. Patients elderly age could be a risk factor for the event Hypertension. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the unexpected serious (hospitalization) event of Hypertension, unexpected non-serious AESI of Supraventricular extrasystoles that occurred in context with the fifth dose of mRNA-1273.222 (Original/Omicron BA.4/5) in covid-19 vaccination series. about 2 days after the vaccination patient had a sudden onset of symptoms with dizziness, cold sweats, and an uneasy stomach. His blood pressure measuring at 204/93 at 95bpm. Later that day the dry heaves turned into vomiting. Next day he went to emergency, received testing including a blood workup, EKG, CT scan and they injected something to calm the stomach. Normally he takes losartan in the morning, which hadn't been able to take because of the vomiting, but they gave patient that medication. Patient blood pressure continued to increase and was transferred to the hospital. Upon arrival they repeated many of the same tests including blood samples, EKG, CT scan, and MRI and was admitted with an elevated BP. Next day blood pressure went down to 80/62 and at a minimum of 72 systolic. Meclizine given to stop the spinning sensation. more tests of chest CT, EKG, and MRIs as he has a history of stroke from 2001. Patient was diagnosed with "an extra heartbeat" (PAC). Next day they took a detailed MRI to look for any new strokes which was negative, he was discharged. But patient continues to feel dizzy with any sudden moves including turning his head. Patient also continues to feel a little uneasy on feet. Patients elderly age could be a risk factor for the event Hypertension. The benefit-risk relationship of mRNA-1273 is not affected by this report.