Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, COVID-19 immunisation, Headache, Heart rate
Clinical narrative: Interchange of vaccine products; Revaccination with different Covid-19 vaccine; About 12 hours after, she had a racing heart; Body aches; Fever; Headaches; Pain in her upper left arm when pressed around the inoculation area.; Felt weak; Off-balance/off-centered; PAC (premature atrial contractions) benign; This spontaneous case was reported by a patient and describes the occurrence of SUPRAVENTRICULAR EXTRASYSTOLES (PAC (premature atrial contractions) benign), PALPITATIONS (About 12 hours after, she had a racing heart), ASTHENIA (Felt weak), BALANCE DISORDER (Off-balance/off-centered) and MYALGIA (Body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) 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 (Dose number: 1, Lot number: EL9266 and dose was unknown) on 18-Feb-2021, Pfizer (Dose Number: 2, Lot number: EN6205 and dose was unknown) on 11-Mar-2021, Pfizer (Dose Number: 1st booster and Lot number: FD0810 and dose was unknown) on 20-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced PALPITATIONS (About 12 hours after, she had a racing heart). In April 2022, the patient experienced MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headaches). In 2022, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (PAC (premature atrial contractions) benign), ASTHENIA (Felt weak), BALANCE DISORDER (Off-balance/off-centered) and VACCINATION SITE PAIN (Pain in her upper left arm when pressed around the inoculation area.). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine). The patient was treated with METOPROLOL SUCCINATE at a dose of taking half pills and METOPROLOL SUCCINATE at a dose of 25 milligram. In April 2022, PYREXIA (Fever) and HEADACHE (Headaches) had resolved. At the time of the report, SUPRAVENTRICULAR EXTRASYSTOLES (PAC (premature atrial contractions) benign) and PALPITATIONS (About 12 hours after, she had a racing heart) was resolving and ASTHENIA (Felt weak), BALANCE DISORDER (Off-balance/off-centered), MYALGIA (Body aches), VACCINATION SITE PAIN (Pain in her upper left arm when pressed around the inoculation area.), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Heart rate: About 105 all night long. On 13-Apr-2022, Heart rate: Regular (Normal). On an unknown date, Heart rate: High as 165. and Went from 120 to 160s.         No concomitant product use was reported.  The patient never had COVID positive test or not diagnosed.  The patient received 2nd booster of Moderna COVID19 Vaccine. The night that she had her booster, about 12 hours after, she had a racing heart, about 105 all night long. She had fever, body aches, headaches, felt like crap. The following day, her heart was at a regular heart rate (it was normal) but extremely irregular. The headaches and fever lasted at least 24 hours. She was not felt like herself for about a week. At night she had the tachycardia. She contacted cardiology, who ordered a monitor. She wore it for 17 days, just under 3 weeks. The monitored started at 5 PM on 06-May-2022 and ended on 23-May-2022. They found PAC (premature atrial contractions), which they said were benign.  She felt weak and off balance. She was not falling down, but off centered. She had many bouts during the day, and they lasted a number of minutes. She was less disturbed by them by the time the monitor was wrapping up. The irregularity continued at a much lesser rate. She had to go to the emergency room for tachycardia at rest. It was as high as 165. It went anywhere from 120 to 160s for approximately 4 hours. They put her on a beta blocker. Her heart rate was pretty much regular, and she was weaning off the medication. For the past month, she had pain in her upper left arm when pressed around the inoculation area. She was most aware when getting in and out of the car, when she pushes it on that side. It was not aching or hurting with regular activities. The patient not experienced a similar event in the past.  When the patient was in the emergency room on 16-Jul-2022, they gave her a beta blocker and IV. She was at the time of report taking a 30-day course of the beta blocker (metoprolol succ ER 25 mg). She was taking half pills for the last 10 days because she can't stop taking it abruptly. Company comment: This spontaneous case concerns a 76 years old female, with no relevant medical history, who experienced the unexpected non serious AESI event supraventricular extrasystole, which occurred unspecified days after third dose (reported as booster dose) of mRNA-1273 vaccine. Additionally non serious event palpitation is also reported. The patient was noted to have received three doses with Comirnaty (Interchange of vaccine products) approximately 5 months Prior to mRNA-1273. Patient experienced racing heart after 12 hours vaccination booster vaccination, she also had fever, body aches, headaches, felt like crap. The following day, her heart was at a regular heart rate (it was normal) but extremely irregular. The headaches and fever lasted at least 24 hours. Patient didn't feel like herself for about a week. At night, patient had the tachycardia. Patient had contacted cardiologist advised to wear monitor patient wore it for 17 days. They found premature atrial contractions, which they said were benign, patient felt weak and off balance. Patient not falling down, but off-centered. patient went to emergency for tachycardia It was as high as 165. It went anywhere from 120 to160s for approximately 4 hours. They put her on a beta blocker. Her heart rate is pretty much regular and she is weaning off the medication. For the past month, she has pain in her upper left arm when pressed around the inoculation area. She is most aware when getting in and out of the car, when she pushes it on that side. It doesn't ache or hurt with regular activities. At the time of report event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns a 76 years old female, with no relevant medical history, who experienced the unexpected non serious AESI event supraventricular extrasystole, which occurred unspecified days after third dose (reported as booster dose) of mRNA-1273 vaccine. Additionally non serious event palpitation is also reported. The patient was noted to have received three doses with Comirnaty (Interchange of vaccine products) approximately 5 months Prior to mRNA-1273. Patient experienced racing heart after 12 hours vaccination booster vaccination, she also had fever, body aches, headaches, felt like crap. The following day, her heart was at a regular heart rate (it was normal) but extremely irregular. The headaches and fever lasted at least 24 hours. Patient didn't feel like herself for about a week. At night, patient had the tachycardia. Patient had contacted cardiologist advised to wear monitor patient wore it for 17 days. They found premature atrial contractions, which they said were benign, patient felt weak and off balance. Patient not falling down, but off-centered. patient went to emergency for tachycardia It was as high as 165. It went anywhere from 120 to160s for approximately 4 hours. They put her on a beta blocker. Her heart rate is pretty much regular and she is weaning off the medication. For the past month, she has pain in her upper left arm when pressed around the inoculation area. She is most aware when getting in and out of the car, when she pushes it on that side. It doesn't ache or hurt with regular activities. At the time of report event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report