Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Retching
Clinical narrative: low blood pressure; fever; paralyzed; Revaccination with different COVID-19; Interchange of vaccine products; felt like heaving and throwing up however he did not throw up; had an infection in his right leg and his scalp; feels like hell and is tired; Patient did not feel like eating.; left arm is sore; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (low blood pressure), PYREXIA (fever) and PARALYSIS (paralyzed) in a 91-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Tumor excision in 2022. Previously administered products included for COVID-19 prophylaxis: Johnson and Johnson Covid-19  vaccine (dose 1). Past adverse reactions to the above products included Adverse reaction with Johnson and Johnson Covid-19  vaccine.   On 25-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jul-2023, the patient experienced DECREASED APPETITE (Patient did not feel like eating.), PAIN IN EXTREMITY (left arm is sore), INFECTION (had an infection in his right leg and his scalp) and IMMUNISATION REACTION (feels like hell and is tired). On 26-Jul-2023, the patient experienced RETCHING (felt like heaving and throwing up however he did not throw up). On an unknown date, the patient experienced HYPOTENSION (low blood pressure) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), PARALYSIS (paralyzed) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, HYPOTENSION (low blood pressure), PYREXIA (fever), PARALYSIS (paralyzed), DECREASED APPETITE (Patient did not feel like eating.), PAIN IN EXTREMITY (left arm is sore), RETCHING (felt like heaving and throwing up however he did not throw up), INFECTION (had an infection in his right leg and his scalp) and IMMUNISATION REACTION (feels like hell and is tired) had not resolved and COVID-19 IMMUNISATION (Revaccination with different COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low blood pressure. On an unknown date, Body temperature: 103 degrees Fahrenheit.     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.   No concomitant medication was reported. It was reported  that the patient was very sick. The patient felt like hell and was tired. The left arm was sore. On 25 July, the patient's arm was sore, patient was tired and went to bed. The patient did not felt like eating. Patient felt shitty.  On 26 July, the patient stayed in bed. The patient felt like Hell. The patient did not eat and drank 2 cans of Arnold Palmer ICE tea. In the evening the patient was able to have orange juice, noodle soup, and more iced tea. The patient felt like heaving and throwing up however, did not throw up. The patient was in the hospital 4 weeks ago for a low blood pressure and a fever of 103 degrees Fahrenheit. The patient had an infection in the right leg and the scalp. The patient had a tumor taken from the right leg a year ago and was now paralyzed in the right leg however the patient was regaining feeling. The patient was using a walker. The patient had a catheter in the right leg.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 91-year-old-male patient with no medical history reported who experienced the serious (hospitalization) unexpected events of hypotension and pyrexia along with the unexpected and serious (medically significant) event of paralysis. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. A dose of mRNA-1273 vaccine (given on an unknown date) and a dose of Johnson and Johnson vaccine were also given (revaccination with different COVID-19 vaccine and interchange of vaccine products). It was reported that the following day patient received mRNA-1273.222 (Original/Omicron BA.4/5) vaccine he was very sick, felt like hell and was tired. His left arm was sore. Patient did not feel like eating. He felt like heaving and throwing up however he did not throw up. The patient was in the hospital 4 weeks before mRNA-1273.222 (Original/Omicron BA.4/5) for a low blood pressure and a fever of 103 degrees Fahrenheit. The patient had an infection in his right leg and his scalp. He had a tumor taken from his right leg a year ago and is now paralyzed in his right leg however he is regaining feeling. The patient is using a walker. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 91-year-old-male patient with no medical history reported who experienced the serious (hospitalization) unexpected events of hypotension and pyrexia along with the unexpected and serious (medically significant) event of paralysis. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. A dose of mRNA-1273 vaccine (given on an unknown date) and a dose of Johnson and Johnson vaccine were also given (revaccination with different COVID-19 vaccine and interchange of vaccine products). It was reported that the following day patient received mRNA-1273.222 (Original/Omicron BA.4/5) vaccine he was very sick, felt like hell and was tired. His left arm was sore. Patient did not feel like eating. He felt like heaving and throwing up however he did not throw up. The patient was in the hospital 4 weeks before mRNA-1273.222 (Original/Omicron BA.4/5) for a low blood pressure and a fever of 103 degrees Fahrenheit. The patient had an infection in his right leg and his scalp. He had a tumor taken from his right leg a year ago and is now paralyzed in his right leg however he is regaining feeling. The patient is using a walker. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.