Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Inappropriate schedule of product administration, Tremor, Vaccination complication
Clinical narrative: received the second dose >35 days after first dose; Face seem twisted, nose and mouth were off centered; Release of fluid to her lungs dose 1 and 2; The shivers were so bad that she could not talk, she got stuck in the car, chattering and shaking; fatigue; shaking uncontrollably, tremors, shaking; Had a fluttering feeling in her chest; lingering symptoms for a month after the shot; Asthma flare ups; Has been sick for a while now; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Had a fluttering feeling in her chest), FACIAL ASYMMETRY (Face seem twisted, nose and mouth were off centered), CHEST DISCOMFORT (Release of fluid to her lungs dose 1 and 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose >35 days after first dose) and TREMOR (shaking uncontrollably, tremors, shaking) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 012M20M) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (asthma flare ups since in her 20's). Concomitant products included ALBUTEROL SULFATE for Asthma, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced CARDIAC FLUTTER (Had a fluttering feeling in her chest), CHEST DISCOMFORT (Release of fluid to her lungs dose 1 and 2), TREMOR (shaking uncontrollably, tremors, shaking), CHILLS (The shivers were so bad that she could not talk, she got stuck in the car, chattering and shaking) and FATIGUE (fatigue). On 24-Mar-2021, the patient experienced FACIAL ASYMMETRY (Face seem twisted, nose and mouth were off centered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose >35 days after first dose). In 2021, the patient experienced VACCINATION COMPLICATION (lingering symptoms for a month after the shot), ASTHMA (Asthma flare ups) and ILLNESS (Has been sick for a while now). At the time of the report, CARDIAC FLUTTER (Had a fluttering feeling in her chest), FACIAL ASYMMETRY (Face seem twisted, nose and mouth were off centered), CHEST DISCOMFORT (Release of fluid to her lungs dose 1 and 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose >35 days after first dose), TREMOR (shaking uncontrollably, tremors, shaking), VACCINATION COMPLICATION (lingering symptoms for a month after the shot), ASTHMA (Asthma flare ups), ILLNESS (Has been sick for a while now), CHILLS (The shivers were so bad that she could not talk, she got stuck in the car, chattering and shaking) and FATIGUE (fatigue) outcome was unknown.        Other medication include : steroids and anti-inflammatories; prednisone 10mg x 5 days; azithromycin (which patient might not take) Symptoms after second dose: within an hour her face seem twisted, nose and mouth were off centered; she went to the hospital and they did stroke tests: everything normal. They referred her to neurologic control which she only did a few months ago. They said that it could have been something stress-related. She was diagnosed with tremors; the shivers were the more severe thing, she was shaking uncontrollably, and this started hours after she was released from the hospital after all the tests were done. The shivers were so bad that she could not talk, she got stuck in the car, chattering and shaking, they covered with blankets, she could not hold a conversation. towards the end of the call she mentions that there was fluid release into lungs like in the first one and that she had a fluttering feeling in her chest. She did not go to the hospital because they did not know what had happened the first time. She was never diagnosed with anything other than her asthma; she mentions that a doctor told her that there was thickening in the wall of her heart but another doctor dismissed this. She also said she experienced fatigue and that there were lingering symptoms for a month after the shot.  Company Comment  This is a case of inappropriate schedule of product administration concerning a 64-year-old female patient, with medical history of asthma on albuterol, who experienced the non-serious, unexpected, AESI event of cardiac flutter and other non-serious unexpected events of asthma aggravated, chest discomfort, facial asymmetry, illness and vaccination complication, on unspecified date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  After second dose, within an hour her face seem twisted, nose and mouth were off centered; she went to the hospital and they did stroke tests and everything was normal. She went to neurology clinic and was told that it was due to stress. Patient also experienced tremor, patient was shaking uncontrollably and had a fluttering feeling on her chest, but patient did not go to the hospital. Patient was also having asthma flare ups and have been feeling sick since the vaccine. The patient's history of asthma and use of albuterol remains as a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a case of inappropriate schedule of product administration concerning a 64-year-old female patient, with medical history of asthma on albuterol, who experienced the non-serious, unexpected, AESI event of cardiac flutter and other non-serious unexpected events of asthma aggravated, chest discomfort, facial asymmetry, illness and vaccination complication, on unspecified date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  After second dose, within an hour her face seem twisted, nose and mouth were off centered; she went to the hospital and they did stroke tests and everything was normal. She went to neurology clinic and was told that it was due to stress. Patient also experienced tremor, patient was shaking uncontrollably and had a fluttering feeling on her chest, but patient did not go to the hospital. Patient was also having asthma flare ups and have been feeling sick since the vaccine. The patient's history of asthma and use of albuterol remains as a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.