Age: 63.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Body temperature, Inappropriate schedule of product administration, Nasopharyngitis, White blood cell count
Clinical narrative: At night patient woke up shivering and very cold, that lasted 7 or 8 hours; Booster dose-1 is on Apr2022 and Booster dose-2 on 18Jul2022; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (At night patient woke up shivering and very cold, that lasted 7 or 8 hours), CHILLS (At night patient woke up shivering and very cold, that lasted 7 or 8 hours) and PYREXIA (Fever of 103°F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE for an unknown indication.    The patient's past medical history included Lupus syndrome (Had lupus). Concurrent medical conditions included Pulmonary edema (Fluids in lung).   In April 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2022, the patient received dose of VARICELLA ZOSTER VACCINE (unknown route) at an unspecified dose. On 18-Jul-2022, the patient experienced NASOPHARYNGITIS (At night patient woke up shivering and very cold, that lasted 7 or 8 hours) (seriousness criterion hospitalization), CHILLS (At night patient woke up shivering and very cold, that lasted 7 or 8 hours) (seriousness criterion hospitalization), PYREXIA (Fever of 103°F) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose-1 is on Apr2022 and Booster dose-2 on 18Jul2022). The patient was hospitalized on sometime in July 2022 due to CHILLS, NASOPHARYNGITIS and PYREXIA. On 19-Jul-2022, NASOPHARYNGITIS (At night patient woke up shivering and very cold, that lasted 7 or 8 hours), CHILLS (At night patient woke up shivering and very cold, that lasted 7 or 8 hours) and PYREXIA (Fever of 103°F) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose-1 is on Apr2022 and Booster dose-2 on 18Jul2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2022, Body temperature: 103 103 Degree F. On 20-Jul-2022, White blood cell count: Low.         It was unknown if patient had any allergies. Concomitant medication included antibiotics for fluid in her lungs. Patient stated she was under a lot of concomitant and regular medications. Patient was still hospitalized. As per report from doctor the low count of white blood cells might be sue to vaccine but was not sure. It was unknown if the condition of lupus began before or after vaccine. No treatment medication reported.  Company Comment: This is a spontaneous case concerning  a  63-year-old, female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) event of Nasopharyngitis and additional event of Inappropriate schedule of product administration occurred. The events occurred on the same day after the fourth dose of mRNA-1273 Vaccine. It was also reported that patient also received dose of Varicella zoster vaccine at an unspecified dose and unknown route. Patients experienced high grade fever at 103 degree Fahrenheit and low levels of White blood cell count. No treatment medication were reported. Patient stated she was under a lot of concomitant and regular medications. Patient was still hospitalized. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.    This case was linked to MOD-2022-610689 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  63-year-old, female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) event of Nasopharyngitis and additional event of Inappropriate schedule of product administration occurred. The events occurred on the same day after the fourth dose of mRNA-1273 Vaccine. It was also reported that patient also received dose of Varicella zoster vaccine at an unspecified dose and unknown route. Patients experienced high grade fever at 103 degree Fahrenheit and low levels of White blood cell count. No treatment medication were reported. Patient stated she was under a lot of concomitant and regular medications. Patient was still hospitalized. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.