Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Ultrasound biliary tract, Ultrasound liver, Vaccination site pain
Clinical narrative: Interchange of vaccine products; bad headache , occasional dull headache; Nausea; High blood pressure; Chest pain; very sick; Dizziness, dizzy, lightheadedness , dizziness is like being on a boat, dizziness- like waves, dizziness -a rocking feeling; Dizziness; Typical body aches/pain radiating out of the right side; seasick like vertigo; Seasick like vertigo; Nausea; Headache; Chills; left arm hurt; Left arm hurt; Like a rash (not severe) , rash was also on her arms/elbows; Itchiness on the inside of her legs; bleeds a little if she scratches the area; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeds a little if she scratches the area), PAIN (Typical body aches/pain radiating out of the right side), MOTION SICKNESS (seasick like vertigo), VERTIGO (Seasick like vertigo) and HYPERTENSION (High blood pressure) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Non-smoker. Concurrent medical conditions included Hearing loss (hearing loss and tinnitus for the past 10 years. She reported she uses a hearing aid.), Tinnitus (hearing loss and tinnitus for the past 10 years. She reported she uses a hearing aid.) and Allergy to animal (she has cat allergies).   On 08-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced HAEMORRHAGE (bleeds a little if she scratches the area) and PRURITUS (Itchiness on the inside of her legs). On 18-Nov-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurt), RASH (Like a rash (not severe) , rash was also on her arms/elbows) and VACCINATION SITE PAIN (left arm hurt). On 19-Nov-2021, the patient experienced PAIN (Typical body aches/pain radiating out of the right side), MOTION SICKNESS (seasick like vertigo), VERTIGO (Seasick like vertigo), DIZZINESS (Dizziness), the first episode of NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). On 26-Nov-2021, the patient experienced HYPERTENSION (High blood pressure), CHEST PAIN (Chest pain), ILLNESS (very sick), DIZZINESS (Dizziness, dizzy, lightheadedness , dizziness is like being on a boat, dizziness- like waves, dizziness -a rocking feeling), HEADACHE (bad headache , occasional dull headache) and the second episode of NAUSEA (Nausea). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In November 2021, VACCINATION SITE PAIN (left arm hurt) had resolved. On 21-Nov-2021, PAIN (Typical body aches/pain radiating out of the right side), MOTION SICKNESS (seasick like vertigo), VERTIGO (Seasick like vertigo), DIZZINESS (Dizziness), HEADACHE (Headache) and CHILLS (Chills) had resolved. On 26-Nov-2021, HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain) had resolved. At the time of the report, HAEMORRHAGE (bleeds a little if she scratches the area) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved and PRURITUS (Itchiness on the inside of her legs), ILLNESS (very sick), PAIN IN EXTREMITY (Left arm hurt), RASH (Like a rash (not severe) , rash was also on her arms/elbows), DIZZINESS (Dizziness, dizzy, lightheadedness , dizziness is like being on a boat, dizziness- like waves, dizziness -a rocking feeling), HEADACHE (bad headache , occasional dull headache) and the last episode of NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2021, Blood pressure measurement: abnormal (abnormal) her blood pressure came down spike in blood pressure was very unusual. On 26-Nov-2021, Chest X-ray: normal (normal) The chest X-ray ruled out a stroke. On 26-Nov-2021, Electrocardiogram: normal (normal) reported the EKG was relatively normal with a few inconstancies. On 26-Nov-2021, Ultrasound biliary tract: normal (normal) ultrasound of gallbladder and liver, and the test results were normal. On 26-Nov-2021, Ultrasound liver: normal (normal) ultrasound of gallbladder and liver, and the test results were normal.         No treatment medication information was provided by reporter. No concomitant medication information was provided by reporter.  Company comment: This is a spontaneous case concerning a 59-year-old female  patient with medical history of hearing loss and tinnitus for the past 10 years,  who experienced unexpected events of Motion sickness, vertigo, dizziness and other non serious events. The events started after the third dose of mRNA-1273 vaccine. She experienced  body aches, chills, headache, dizziness, nausea, high blood pressure, and chest pain. On 26Nov2021 she went to the hospital; diagnostic test included Chest X-ray, electrocardiogram, Ultrasound of liver and biliary tract, all results were normal. She was released from the hospital 5 or 6 hours later. No outpatient treatment medications were given. Medical history of hearing loss and tinnitus remains a confounder for events motion sickness, vertigo and dizziness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 59-year-old female  patient with medical history of hearing loss and tinnitus for the past 10 years,  who experienced unexpected events of Motion sickness, vertigo, dizziness and other non serious events. The events started after the third dose of mRNA-1273 vaccine. She experienced  body aches, chills, headache, dizziness, nausea, high blood pressure, and chest pain. On 26Nov2021 she went to the hospital; diagnostic test included Chest X-ray, electrocardiogram, Ultrasound of liver and biliary tract, all results were normal. She was released from the hospital 5 or 6 hours later. No outpatient treatment medications were given. Medical history of hearing loss and tinnitus remains a confounder for events motion sickness, vertigo and dizziness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.