Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: cough; loss of taste; loss of smell; fever; cardiovascular side effects, with a jumping heart, and with the need of the installation of a heart pacer; Patient had 8 Covid shots and had a sore arm every time; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (cardiovascular side effects, with a jumping heart, and with the need of the installation of a heart pacer) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Covid vaccine (Dose 1, IM, ROA: right arm) on 10-Jan-2021, Pfizer Covid vaccine (Dose 2, IM, she would guess probably right arm again) on 09-Feb-2021, Pfizer Covid vaccine (Dose 3, probably right arm again) on 10-Sep-2021, Pfizer Covid vaccine (Dose 4 and site of administration: right arm) on 01-Apr-2022. Past adverse reactions to the above products included Pain in arm with Pfizer Covid vaccine, Pfizer Covid vaccine, Pfizer Covid vaccine and Pfizer Covid vaccine. Concurrent medical conditions included Latex allergy ((she was recovering from an allergic reaction she had to a pair of socks with latex), About 10 years ago she developed a latex allergy).    On 06-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 2022, the patient experienced PALPITATIONS (cardiovascular side effects, with a jumping heart, and with the need of the installation of a heart pacer) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Patient had 8 Covid shots and had a sore arm every time). On an unknown date, the patient experienced COUGH (cough), AGEUSIA (loss of taste), ANOSMIA (loss of smell) and PYREXIA (fever). At the time of the report, PALPITATIONS (cardiovascular side effects, with a jumping heart, and with the need of the installation of a heart pacer) had resolved and COUGH (cough), AGEUSIA (loss of taste), ANOSMIA (loss of smell), PAIN IN EXTREMITY (Patient had 8 Covid shots and had a sore arm every time) and PYREXIA (fever) outcome was unknown.        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.   The patient received Comirnaty 2024/25 vaccine and after that she developed a sore arm and slight fever after 2-3 days. 6 days after administration she started to feel the tip of her tongue was numb and her lips were red and tingling and swelling. She developed peeling sores inside her mouth and burning sensation. This disappeared after a few days and came back with more strange symptoms. The skin inside of her mouth started peeling and then disappeared. Her tongue turned green for 1 day and then gray and then disappeared. She then had a sore throat for only 1 day and then her neck was sore for 1 day and then everything went away. In the next month, she came back to the physician with tongue and lips still numb. Sometimes she felt numbness and swelling in lips and tongue. Her left cheek was swelling, it was manageable but annoying and repetitive. Patient was fully vaccinated since 2021, and one was Moderna vaccine. It was reported that when she received a dose of the Moderna vaccine, she developed cardiovascular side effects, with a jumping heart, and required installation of a heart pacer, and then the symptoms disappeared in about 4 months. The patient reported that when she got infected and developed COVID-19 like symptoms, she had fever, cough, loss of taste and smell. Patient did not have cardiologic conditions before.  She received the Comirnaty in 2023, and she started experiencing symptoms but symptoms that were regular for administration of vaccine such as chills, fever, pain at the injection site, and normal symptoms. This was first time that it happened with the patient after receiving the Comirnaty vaccine. Patient stated that the chills and slight fever occurred on Thursday, 05-Sep-2024 and were gone by Friday, 06-Sep-2024. She woke in the middle of the night and had a sore arm that lasted a couple of days. It was reported that on Sunday, the other symptoms started. It was reported that, the patient got Covid on 26-Aug-2023 between dose 6 and 7.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.