Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Atypical pneumonia, Blood pressure measurement, COVID-19, Electrocardiogram, Flushing
Clinical narrative: tachycardia; Walking pneumonia; covid 19; she has flushing of her face; palpitations, her heart rate increases; She becomes wobbly; her blood pressure goes up; This spontaneous case was reported by a patient and describes the occurrence of ATYPICAL PNEUMONIA (Walking pneumonia) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Relevant medical history or conditions, allergy, concomitant diseases and risk factor of the patient were none.    On 21-Sep-2022, 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. In November 2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced FLUSHING (she has flushing of her face), PALPITATIONS (palpitations, her heart rate increases), GAIT DISTURBANCE (She becomes wobbly) and HYPERTENSION (her blood pressure goes up). In September 2023, the patient experienced ATYPICAL PNEUMONIA (Walking pneumonia) (seriousness criterion medically significant) and COVID-19 (covid 19). On an unknown date, the patient experienced TACHYCARDIA (tachycardia). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 21-Sep-2022, FLUSHING (she has flushing of her face), PALPITATIONS (palpitations, her heart rate increases), GAIT DISTURBANCE (She becomes wobbly) and HYPERTENSION (her blood pressure goes up) had resolved. At the time of the report, ATYPICAL PNEUMONIA (Walking pneumonia) and COVID-19 (covid 19) had resolved and TACHYCARDIA (tachycardia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2022, Blood pressure measurement: blood pressure goes up and down. On 21-Sep-2022, Heart rate: increases. On an unknown date, Electrocardiogram: was found to have tachycardia but very mild so no meds were given..         Patient receives other vaccines 4 weeks prior to covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that Immediately after every dose (in 10-15 minutes), her heart rate increases, her blood pressure goes up, she becomes wobbly, and she has flushing of her face. These pretty much fade within an hour or 2 tops.  She had Covid-19 in Sep-2023 that was why she was just scheduling it now as she needs to have that 3-month period interval between the getting the disease and the vaccine administration. She was not hospitalized during the Covid bout, but she had walking pneumonia as a complication, so she had to take unspecified antibiotics together with the Paxlovid. It had completely cleared, and she is perfectly well now.  Patient had Cardiac monitor for 2 weeks and was found to had tachycardia but very mild so no medication was given.   This case was linked to MOD-2024-757183 (Patient Link).  Company Comment: This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history who experienced the serious (due to medically significant) unexpected, event of Atypical pneumonia, among other non-serious unexpected events of Palpitations, Tachycardia, Flushing, Hypertension, Gait disturbance and COVID-19. The event Atypical pneumonia occurred approximately 1 year after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) received as the fifth dose of COVID-19 vaccination schedule, the event COVID-19 occurred at the same time of the pneumonia and the rest of the events occurred on the same day after the administration of each dose administration. The patient had previously received 4 doses of Moderna vaccine as follows: 1st dose - 17Mar2021, 2nd dose - 14Apr2021, 3rd dose - 15Nov2021 and 4th dose - 29Apr2022. The patient was no admitted due to pneumonia and was treated with unspecified antibiotics together with the Paxlovid. The outcome of the events was reported as recovered. The event was considered as not related to the vaccine due to lack of biological plausibility; the pneumonia was secondary to the COVID-19 infection. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.