Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate irregular, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: 1st dose of Pfizer vaccine on 21Feb2021,2nd dose of Pfizer vaccine on 21Mar2021/ r got moderna covid-19 booster on 21Oct202; Injection site hot; Injection site is hard; Injection site Red; Chills; Hives; Red/itchy eyes; Feeling hot; Cough; Red/itchy eyes; Sneezing; Irregular heart rate; runny nose; flushing thought out the body/flushing; general aches/pain; dizziness; fever; palpitations while in store; sweating; cold; itching; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations while in store), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), PRURITUS (itching) and FLUSHING (flushing thought out the body/flushing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis. Previously administered products included for COVID-19 vaccination: Pfizer BionTech COVID-19 Vaccine (First dose:lot# EN5318) on 21-Feb-2021 and Pfizer BionTech COVID-19 Vaccine (Second Dose lot# EN6202) on 21-Mar-2021; for Product used for unknown indication: flu. Past adverse reactions to the above products included No adverse event with Pfizer BionTech COVID-19 Vaccine, Pfizer BionTech COVID-19 Vaccine and flu. Concurrent medical conditions included Hypothyroidism and Blood pressure abnormal. Concomitant products included AMLODIPINE from an unknown date to 22-Oct-2021 for Blood pressure management, LEVOTHYROXINE for Hypothyroidism, UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced PALPITATIONS (palpitations while in store), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), PRURITUS (itching), PAIN (general aches/pain), DIZZINESS (dizziness) and PYREXIA (fever). On 22-Oct-2021, the patient experienced FLUSHING (flushing thought out the body/flushing), URTICARIA (Hives), EYE PRURITUS (Red/itchy eyes), FEELING HOT (Feeling hot), COUGH (Cough), OCULAR HYPERAEMIA (Red/itchy eyes), SNEEZING (Sneezing), HEART RATE IRREGULAR (Irregular heart rate), RHINORRHOEA (runny nose) and CHILLS (Chills). On 25-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site Red). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Pfizer vaccine on 21Feb2021,2nd dose of Pfizer vaccine on 21Mar2021/ r got moderna covid-19 booster on 21Oct202). At the time of the report, PALPITATIONS (palpitations while in store), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), PRURITUS (itching), FLUSHING (flushing thought out the body/flushing), PAIN (general aches/pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (Injection site hot), URTICARIA (Hives), EYE PRURITUS (Red/itchy eyes), FEELING HOT (Feeling hot), COUGH (Cough), OCULAR HYPERAEMIA (Red/itchy eyes), SNEEZING (Sneezing), HEART RATE IRREGULAR (Irregular heart rate), RHINORRHOEA (runny nose), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE ERYTHEMA (Injection site Red) and CHILLS (Chills) had not resolved and PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Pfizer vaccine on 21Feb2021,2nd dose of Pfizer vaccine on 21Mar2021/ r got moderna covid-19 booster on 21Oct202) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2021, Heart rate: irregular (abnormal) irregular.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PALPITATIONS (palpitations while in store), NASOPHARYNGITIS (cold), PRURITUS (itching), FLUSHING (flushing thought out the body/flushing), URTICARIA (Hives), EYE PRURITUS (Red/itchy eyes), FEELING HOT (Feeling hot), COUGH (Cough), OCULAR HYPERAEMIA (Red/itchy eyes), SNEEZING (Sneezing), HEART RATE IRREGULAR (Irregular heart rate), RHINORRHOEA (runny nose) and CHILLS (Chills) to be probably related. No further causality assessments were provided for HYPERHIDROSIS (sweating), PAIN (general aches/pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE ERYTHEMA (Injection site Red), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Pfizer vaccine on 21Feb2021,2nd dose of Pfizer vaccine on 21Mar2021/ r got moderna covid-19 booster on 21Oct202).    Treatment information was not reported.  Company Comment  This is a spontaneous case concerning a 72-year-old female patient with relevant medical history of Hypothyroidism and Blood pressure abnormal, who experienced AESI, non serious, unexpected event of Heart rate irregular. The event occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. Medical history of Hypothyroidism and Blood pressure abnormal remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 28-OCT-2021 contains significant information. Patient demographic details added. Updated start date of Dose 1, Medical history added, concomitants added, additional events added, updated events start date added.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with relevant medical history of Hypothyroidism and Blood pressure abnormal, who experienced AESI, non serious, unexpected event of Heart rate irregular. The event occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. Medical history of Hypothyroidism and Blood pressure abnormal remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.