Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ears described as piercingly loud; Injection site itchy, red, swollen, and hard as a rock; Injection site itchy, red, swollen, and hard as a rock; Injection site itchy, red, swollen, and hard as a rock; Injection site itchy, red, swollen, and hard as a rock; fatigue; headache; Did not feel well enough to drive; Blood pressure increased; heart rate went to 135 bpm; Expired vaccine administered; felt like her heart was beating out of her chest; irregular heartbeat; did not feel right; A spontaneous report was received from a 54 year old female patient who experienced expired vaccine administered, felt like her heart was beating out of her chest; irregular heartbeat, ringing in her ears described as piercingly loud, did not feel right, blood pressure increased, heart rate went to 135 bpm, injection site itchy, red, swollen, and hard as a rock, did not feel well enough to drive, fatigue, and headache with the use of mRNA-1273.    The patient's medical history included fatigue going back months, iron deficiency diagnosed Dec 2020, heart Arrhythmia, Allergy to penicillin, Allergy to nubain, several environmental allergies, Allergy to topical Metrogel, allergy to topical benzyl peroxide. There were no concomitant medications provided.  On 08 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly, in her left deltoid,  for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient experienced expired vaccine administered, noting that the facility where she was vaccinated saying they had a dose that was going to expire in 10 minutes and if she could come get vaccinated. She stated by the time the dose was administered if was about 50 minutes. She noted that the first 15 minutes she felt fine and and after bending over to pick up some papers, she did not feel right and felt like her heart was beating out of her chest. She denied feeling stressed, denied throat swelling, difficulty breathing, and no rash. At that time she was laid down on a gurney. Her blood pressure had increased to 190/unknown number and her heart rate went to 135 bpm. The patient declined to go to the emergency room and sat in the outpatient waiting room for two hours.  She reported she did not feel well enough to drive and had to get a ride home. That same night she experienced an irregular heartbeat, but felt it was due to donating blood. She woke up around midnight and her blood pressure was 188/80 and she experienced ringing in her ears described as piercingly loud. The next morning her blood pressure was back down to 106/unknown number. She noted it took a long time to get her heart rate and blood pressure back down to normal. She felt it was due to not having enough water the previous day and night. On 09 Jan 2021 she experienced fatigue, headache, and injection site itchy, red, swollen, and hard as a rock. She took paracetamol and the headache was relieved. Additionally, she took diphenhydramine hydrochloride for the injection site reaction which resolved from 11 Jan 2021 until 15 Jan 2021, when it started itching again, described as "like it reactivated again." At that time, she treated with unspecified topical cream. As of 19 Jan 2021 the injection site still had a reaction.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event of fatigue was unknown at the time of this report. The events of expired vaccine administered, felt like her heart was beating out of her chest; irregular heartbeat, ringing in her ears described as piercingly loud, did not feel right, headache, blood pressure increased, did not feel well enough to drive, and heart rate went to 135 bpm was recovered/resolved. The events of injection site itchy, red, swollen, and hard as a rock were not recovered/not resolved at the time of this report.; Reporter's Comments: This case concerns 54-year-old, female, with a medical history of fatigue going back months, iron deficiency (Dec 2020), heart Arrhythmia, Allergy to penicillin, Nubain, and topical creams including Metro-gel and benzyl peroxide, among others, who experienced out of specification product use and  non-serious unexpected event of heart rate irregular, tinnitus, feeling abnormal, blood pressure increased, heart rate increased and malaise, and non-serious expected events of  injection site pruritus, injection site induration, injection site erythema, injection site swelling, fatigue and headache. There was no AEs associated with out of specification product use. However, the event of heart rate irregular, heart rate irregular, and malaise occurred 1 days after mRNA-1273 (Lot# 026L20A), while  the events of headache, tinnitus, injection site pruritus, injection site induration, injection site swelling and fatigue occurred 2 days after mRNA-1273 (Lot# 026L20A). The event of feeling abnormal occurred on an unspecified date after mRNA-1273 (Lot# 026L20A). Treatment included Tylenol, Benadryl and topical cream.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.